WARNING - FDA records indicate that this drug has been recalled.

Baxter Healthcare Corp.

Product Description:	0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
Status:	Ongoing
City:	Deerfield
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	Nationwide
Classification:	Class I
Product Quantity:	189,120 bags
Reason For Recall:	Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall Initiation Date:	20150717
Report Date:	20150826

B. Braun Medical Inc

Product Description:	0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
Status:	Ongoing
City:	Irvine
State:	CA
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	Nationwide, Puerto Rico and Spain
Classification:	Class I
Product Quantity:	53,592 units
Reason For Recall:	Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall Initiation Date:	20131121
Report Date:	20140507

Hospira Inc.

Product Description:	0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Status:	Ongoing
City:	Lake Forest
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern:	Nationwide.
Classification:	Class I
Product Quantity:	9,912 VisIV flex containers
Reason For Recall:	Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Recall Initiation Date:	20150305
Report Date:	20150513

Hospira Inc.

Product Description:	0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
Status:	Ongoing
City:	Lake Forest
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Press Release
Distribution Pattern:	Nationwide
Classification:	Class I
Product Quantity:	661,128 containers
Reason For Recall:	Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Recall Initiation Date:	20150120
Report Date:	20150429

Baxter Healthcare Corp.

Product Description:	0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Status:	Ongoing
City:	Deerfield
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Letter
Distribution Pattern:	Nationwide
Classification:	Class I
Product Quantity:	133,600 bags
Reason For Recall:	Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall Initiation Date:	20150717
Report Date:	20150826

Sodium Chloride

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Sodium Chloride Recall

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Side Effects & Adverse Reactions

Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP.

Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Depending on the volume and rate of infusion, the intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Administer 0.9% Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypernatremia, hyperchloremia, or metabolic acidosis.

Administer Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism [e.g., associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia]. Certain medications may increase risk of sodium and fluid retention, see Drug Interactions.

Administer Sodium Chloride Injection, USP with particular caution, to patients with severe renal impairment. In such patients, administration of Sodium Chloride Injection, USP may result in sodium retention.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

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History

There is currently no drug history available for this drug.

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Other Information

Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:

0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

VIAFLO is a flexible plastic container fabricated from a multilayer sheeting (PL-2442) composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Two different administration connectors are available with VIAFLO containers. The VIAFLO dripless access container (DAC) will not drip once the spike is removed. The non-DAC VIAFLO will drip once the spike is removed from the administration port.

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Sodium Chloride Manufacturers

Baxter Healthcare Corporation

Sodium Chloride | Bioactive Nutritional

DIRECTIONS: Three sprays per day. Hold in mouth for two minutes.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Sodium Chloride | Taro Pharmaceuticals U.s.a., Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Use aseptic technique for entry and withdrawal from container.

This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Mckesson Packaging Services Business Unit Of Mckesson Corporation

Sodium Chloride | Mckesson Packaging Services Business Unit Of Mckesson Corporation

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Hospira, Inc.

Sodium Chloride | Hospira, Inc.

Use in accord with any warnings or precautions appropriate to the medication being administered.

No Recall
Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
General Injectables & Vaccines, Inc

Sodium Chloride | General Injectables & Vaccines, Inc

The dosage of Sodium Chloride Injection, USP, 23.4%, as an additive in parenteral fluid therapy is predicated on specific requirements of the patient after necessary clinical and laboratory information is considered and correlated. The appropriate volume is then withdrawn for proper dilution. Having determined the milliequivalents of sodium chloride to be added, divide by four to calculate the numbers of milliliters (mL) of sodium chloride to be used. Withdraw this volume aseptically and transfer the additive solution into appropriate intravenous solutions such as 5% Dextrose Injection. The properly diluted solutions may be given intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Medefil, Inc.

Sodium Chloride | Medefil, Inc.

2 DOSAGE & ADMINISTRATION
2.1 Recommended Dosage The volume of preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the drug manufacturer. 2.2 Instruction for Administration (Refer figure 1 – figure 5 for pictorial presentation) Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping. Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. (Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated. (Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use. Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion. Do not reuse disposable syringes. 2.3 Preparation and Handling Precautions Before use check for any possible incompatibility with sodium chloride. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Do not store reconstituted solution or drugs for injection unless otherwise directed by the manufacturer of the solute. Adding additives may be incompatible. Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. Do not freeze. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

No Recall
General Injectables & Vaccines, Inc

Sodium Chloride | General Injectables & Vaccines, Inc

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Physicians Total Care, Inc.

Sodium Chloride | Physicians Total Care, Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Physicians Total Care, Inc.

Sodium Chloride | Physicians Total Care, Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
West-ward Pharmaceutical Corp.

Sodium Chloride | West-ward Pharmaceutical Corp.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Use aseptic technique for entry and withdrawal from container.

This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
West-ward Pharmaceutical Corp.

Sodium Chloride | West-ward Pharmaceutical Corp.

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Baxter Healthcare Corporation

Sodium Chloride | Baxter Healthcare Corporation

As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition, concomitant treatment, and on the patient’s clinical and laboratory response to treatment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Do not administer unless solution is clear and seal is intact.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.

No Recall
B. Braun Medical Inc.

Sodium Chloride | B. Braun Medical Inc.

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See PRECAUTIONS, Pediatric Use.)

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures.

When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly.

Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
App Pharmaceuticals, Llc

Sodium Chloride | App Pharmaceuticals, Llc

Sodium chloride injection is administered intravenously only after addition to a larger volume of fluid.

The dose, dilution and rate of injection are dependent upon the individual needs of each patient.

All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

No Recall
App Pharmaceuticals, Llc

Sodium Chloride | App Pharmaceuticals, Llc

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
App Pharmaceuticals, Llc

Sodium Chloride | App Pharmaceuticals, Llc

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter must be flushed in its entirety with 2 mL of Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
App Pharmaceuticals, Llc

Sodium Chloride | App Pharmaceuticals, Llc

The dosage of Sodium Chloride Injection, USP, 23.4%, as an additive in parenteral fluid therapy is predicated on specific requirements of the patient after necessary clinical and laboratory information is considered and correlated. The appropriate volume is then withdrawn for proper dilution. Having determined the milliequivalents of sodium chloride to be added, divide by four to calculate the numbers of milliliters (mL) of sodium chloride to be used. Withdraw this volume aseptically and transfer the additive solution into appropriate intravenous solutions such as 5% Dextrose Injection. The properly diluted solutions may be given intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
App Pharmaceuticals, Llc

Sodium Chloride | App Pharmaceuticals, Llc

Sodium chloride injection is administered intravenously only after addition to a larger volume of fluid.

The dose, dilution and rate of injection are dependent upon the individual needs of each patient.

All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered.

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

23.4% Sodium Chloride Injection, USP is administered intravenously, but only after dilution in a larger volume of fluid. Maintenance electrolyte solutions usually contain sodium at a concentration of 33 to 40 mEq/L, on the assumption the patient will receive two to three liters of fluid/day. A typical oral salt intake of 10 g/day is equivalent to 171 mEq/day. But intake can range from 5 to15 g of sodium chloride/day, and patients on a sodium-restricted diet may receive 1 to 2 g of sodium/day. The actual dose of sodium chloride administered depends upon specific patient requirements, which are usually determined by review of serial blood samples and clinical evaluation. In solutions for total parenteral nutrition (TPN), adults typically receive 120 mEq of sodium/day (range: 75-180 mEq/day), whereas preterm infants receive 3-4 mEq/kg/day.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Discard unused portion.

Directions for Proper Use of Pharmacy Bulk Package

Use Aseptic Technique
For hanger application, peel off the paper liner from both ends of the tape hanger to expose 3/4 in. long adhesive portions. Adhere each end to the label on the bottle. During use, container must be stored and all manipulations performed in an appropriate laminar flow hood. Remove cover from container and cleanse closure with antiseptic. Insert suitable sterile dispensing set or transfer device and suspend unit in a laminar flow hood. The closure should be entered only once and after initial entry, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from initial closure puncture is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. Sequentially dispense aliquots of 23.4% Sodium Chloride Injection, USP into I.V. containers using appropriate transfer device. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

No Recall
Remedyrepack Inc.

Sodium Chloride | Remedyrepack Inc.

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

Recall
Remedyrepack Inc.

Sodium Chloride | Remedyrepack Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Remedyrepack Inc.

Sodium Chloride | Remedyrepack Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Baxter Healthcare Corporation

Sodium Chloride | Baxter Healthcare Corporation

All injections in AVIVA plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition, concomitant treatment, and on the patient’s clinical and laboratory response to treatment.

When other electrolytes or medicines are added to this solution, the dosage and the infusion rate will also be dictated by the dose regimen of the additions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Do not administer unless solution is clear and seal is intact.

Additives may be incompatible with Sodium Chloride Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sodium Chloride Injection, USP is appropriate. After addition, check for unexpected color changes and/or the appearance of precipitates, insoluble complexes or crystals.

The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible must not be used. When introducing additives to Sodium Chloride Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.

No Recall
Baxter Healthcare Corporation

Sodium Chloride | The Body Shop Wake Forest

Directions:
Apply liberally 15 minutes before sun exposure Sun protection measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including limit time in the sun especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses reapply this product at least every 2 hours use water resistant sunscreen if swimming or sweating Children under 6 months of age : ask a doctor.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Mylan Pharmaceuticals Inc.

Sodium Chloride | Mylan Pharmaceuticals Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Remedyrepack Inc.

Sodium Chloride | Remedyrepack Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Remedyrepack Inc.

Sodium Chloride | Remedyrepack Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
American Regent, Inc.

Sodium Chloride | American Regent, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Cardinal Health

Sodium Chloride | Cardinal Health

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
B. Braun Medical Inc.

Sodium Chloride | B. Braun Medical Inc.

This solution is for intravenous use only.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use.

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used.

Addition of medication should be accomplished using aseptic technique in order to assure sterility.

Physicochemical studies have shown that the container and solution can withstand freezing.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
B. Braun Medical Inc.

Sodium Chloride | Medinatura

General Considerations
The dosage schedules listed below can be used as a general guide for the administration of Zeel® Injection Solution. If co-administration with a local anesthetic is desired, Zeel® Injection Solution may be mixed with lidocaine or similar agents at the discretion of the physician. Zeel® Injection solution may be administered s.c., i.d., i.m., i.a. or i.v.
• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampulein 24 hours.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Draw up the contents of the ampule into the syringe. Discard half or one third of the contents, depending on the required dosage, before administering

• Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product.

Standard Dosage - for the treatment of arthrosis/osteoarthritis and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

Adults and children 12 years and older:

1 ampule 1 to 3 times per 7 days

Children 6 to 11 years:

2/3 of an ampule 1 to 3 times per 7 days

Acute Dosage - for the treatment of arthrosis/osteoarthritis and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

Adults and children 12 years and older:

1 ampule daily, and then continue with standard dosage

Children 6 to 11 years:

2/3 of an ampule daily, and then continue with standard dosage

Co-administration therapy with Traumeel® Injection Solution - for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.
In the treatment of musculoskeletal conditions, if co-administration with another homeopathic medicinal product is desired, Zeel® Injection Solution may be mixed in a ratio of 1:1 with Traumeel® Injection Solution. For convenience, the daily dose of Zeel® Injection Solution may be administered at the same time as a Traumeel® Injection Solution, according to the dosing recommendations for each medication.

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Fresenius Kabi Usa, Llc

Sodium Chloride | Fresenius Kabi Usa, Llc

The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data.

For use in one patient, on one occasion only. It does not contain antimicrobials. Any unused portion should be discarded. Care should be taken with intravenous technique to avoid injection site reactions and infections.

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS).

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B. Braun Medical Inc.

Sodium Chloride | B. Braun Medical Inc.

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Maximum intravenous dosage should be 100 mL given over a period of one hour. Before additional amounts are given, the serum electrolyte concentrations, including chloride and bicarbonate, should be determined to evaluate the need for more sodium chloride.

Intravenous administration of these solutions should not exceed 100 mL/hour or 400 mL/24 hours.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS).

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

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Baxter Healthcare Corporation

Sodium Chloride | Baxter Healthcare Corporation

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

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Fresenius Medical Care North America

Sodium Chloride | Fresenius Medical Care North America

The dose is dependent upon the age, weight and clinical condition of the patient.

Drug Interactions:

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

INSTRUCTIONS FOR USE

Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Check for leaks by squeezing container firmly. If leaks are found discard unit as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administrations.

To Add Medication

(Use aseptic technique)
Prepare medication port. With a needle of appropriate length, puncture resealable additive port and inject. Withdraw needle after injecting medication. Mix container contents thoroughly.
Preparation for Administration

(Use aseptic technique)

Note: See appropriate I.V. administration set Instructions For Use.
Close flow control clamp on the administration set. Remove cap from sterile administration set port at bottom of container by securely grasping the flanges and twisting as indicated below. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. Suspend container. If the administration set contains a drip chamber, squeeze and release to establish proper fluid level in chamber. Open clamp. Eliminate air from remainder of set. Attach set to patient access device. Begin infusion.
WARNING: Do not use flexible container in series connections.

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Fresenius Medical Care North America

Sodium Chloride | Hyland's

Children under 3 years of age: Tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application, or gently place cotton in ear to keep drops in.

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Hospira, Inc.

Sodium Chloride | Hospira, Inc.

14.6% Sodium Chloride Injection, USP Additive Solution is administered intravenously only after addition to a larger volume of fluid.

The dose, dilution and rate of injection are dependent upon the individual needs of each patient.

All or part of the contents of one or more additive containers may be added to an intravenous solution container. Concentrations of up to 5% sodium chloride have been administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

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Us Medsource, Llc

Sodium Chloride | Us Medsource, Llc

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

No Recall
Baxter Healthcare Corporation

Sodium Chloride | Baxter Healthcare Corporation

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in Mini-Bag™ Plus containers are intended for intravenous administration using sterile equipment.

Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier.
To Open
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity should diminish gradually.

Prior to use, check that the vial adaptor cover is intact. Check the solution container for minute leaks by squeezing inner bag firmly. If leaks are found or if the vial adaptor cover is not intact, discard product as sterility may be impaired.
To Assemble and Reconstitute
See other side for detailed instructions.

Additives may be incompatible.

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Us Medsource, Llc

Sodium Chloride | Us Medsource, Llc

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

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West-ward Pharmaceutical Corp.

Sodium Chloride | Pharmacia And Upjohn Company

If significant diarrhea occurs during therapy, this antibacterial should be discontinued. (See WARNING box.)
INTRAMUSCULAR Adults
Serious infections—600 mg (2 mL) intramuscularly every 24 hours. More severe infections—600 mg (2 mL) intramuscularly every 12 hours or more often.
Pediatric patients over 1 month of age
Serious infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often.
INTRAVENOUS Adults
The intravenous dose will be determined by the severity of the infection. For serious infections doses of 600 mg of lincomycin (2 mL of LINCOCIN) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations daily intravenous doses of as much as 8 grams have been given. Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 mL of appropriate solution (see PHYSICAL COMPATIBILITIES) and infused over a period of not less than one hour.
Dose Vol. Diluent Time 600 mg 100 mL 1 hr 1 gram 100 mL 1 hr 2 grams 200 mL 2 hr 3 grams 300 mL 3 hr 4 grams 400 mL 4 hr
These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin.
Pediatric patients over 1 month of age
10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults.

NOTE: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.
SUBCONJUNCTIVAL INJECTION
0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibacterial (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens.
Patients with diminished renal function
When therapy with LINCOCIN is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys.

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Nephron Pharmaceuticals Corporation

Sodium Chloride | Nephron Pharmaceuticals Corporation

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Nephron Pharmaceuticals Corporation

Sodium Chloride | Nephron Pharmaceuticals Corporation

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Mallinckrodt Inc.

Sodium Chloride | Mallinckrodt Inc.

The 50 mL syringe and the 125 mL syringe are for single patient use only. Determine the volume of the saline flush for each patient individually based, in part, on the imaging procedure, the location of the vascular access device, the length of tubing between the Mallinckrodt contrast agent power injector and the vascular access device and the recommendations made on the package insert for the contrast agent. Typical Sodium Chloride Injection USP 0.9% flush volumes following contrast agent administration in adults are 10 to 25 mL per injection at rates not to exceed 10 mL/sec. Use of some Mallinckrodt contrast agent power injectors allows for additional infusion of Sodium Chloride Injection USP 0.9% to maintain the patency of vascular access. Typical infusion rates used for this purpose are in the range of 0.5 to 1 mL per minute. Individualize infusion rates and flush volumes for each patient based on their body weight, fluid status and concomitant medical conditions. Consult the Mallinckrodt contrast agent power injector manual for proper use.

2.1 Drug Handling Inspect the syringe for signs of break in sterility. Do not use if the syringe or its tip cap shows signs of damage, leakage or displacement. Do not use if the solution is hazy, cloudy, discolored or contains particulate matter. Use aseptic technique. Expel residual air in both the syringe and tubing prior to connection with the patient’s vascular access. Instructions for assembly and inspection of the Sodium Chloride Injection USP 0.9% syringes prior to use are printed on this sheet.

2.2 50 mL Syringe Assembly and Inspection
NOTE: Exterior of syringe is not sterile.
Contents of syringe and area under tip cap and piston ribs are sterile and should be treated accordingly.

Remove syringe from carton and inspect the area around the tip cap and outside of piston for signs of leakage. Do not use if leakage is observed.

After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the piston rotates freely.

Prior to using the syringe, twist off tip cap and discard. The area under the tip cap is sterile, caution should now be used when handling. Syringe is now ready for needle or infusion tubing attachment.

2.3 125 mL Syringe Assembly and Inspection
NOTE: Exterior of syringe is not sterile.
Contents of syringe and area under tip cap and piston ribs are sterile and should be treated accordingly.

Remove syringe from carton and inspect the area around the tip cap and outside of piston for signs of leakage. Do not use if leakage is observed. Load syringe into power injector.

To remove tip cap from syringe, push in and twist off, then discard.
The area under the cap is sterile. Caution should now be used when handling.

Next remove cap from luer locknut dust cover by twisting to break tamper evident seal. Discard cap.

Attach luer locknut to syringe by holding dust cover and screwing to the stop.
Remove and discard dust cover when ready to attach sterile connector tubing.

No Recall
B. Braun Medical Inc.

Sodium Chloride | B. Braun Medical Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Hospira, Inc.

Sodium Chloride | Hospira, Inc.

The dose is dependent upon the age, weight and clinical condition of the patient.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall