Zmax

Zmax Manufacturers

• Rebel Distributors Corp
  

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  Zmax | Rebel Distributors Corp

  

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  2.1 Adults

  Zmax should be taken as a single 2 g dose. Zmax provides a full course of antibacterial therapy in a single oral dose. It is recommended that Zmax be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).

  2.2 Pediatric patients

  For pediatric patients 6 months and older, Zmax should be taken as a single dose of 60 mg/kg (equivalent to 27 mg/lb) body weight. The Zmax dose in mL is equivalent to the child's weight in lb (1 mL/lb dose, see Table 1 below), for a body weight of less than 75 lb (34 kg). It is recommended that Zmax be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).

  Pediatric patients weighing 75 lb (34 kg) or more should receive the adult dose (2 g).

  Table 1. Zmax Pediatric Dosage Guidelines: 1-dose regimen Dosing Calculated on 1 mL/lb, Dose 1 mL of Suspension for every 1 lb of Body Weight for Children <75 lb (34 kg)* Weight 1 mL/lb Dose Lb Kg Dose Volume (mg) (mL) * To ensure accurate dosing, a dosing spoon, medicine syringe, or cup is recommended. 10 5 270 10 15 7 405 15 20 9 540 20 25 11 675 25 30 14 810 30 35 16 945 35 40 18 1080 40 45 20 1215 45 50 23 1350 50 55 25 1485 55 60 27 1620 60 65 30 1755 65 70 32 1890 70 ≥75 34 2000 Consume entire contents of bottle 2.3 Additional treatment after vomiting with Zmax

  In the event that a patient vomits within 5 minutes of administration, the health care provider should consider additional antibiotic treatment since there would be minimal absorption of azithromycin. Since insufficient data exist on absorption of azithromycin if a patient vomits between 5 and 60 minutes following administration, alternative therapy should be considered. Neither a second dose of Zmax nor alternative treatment is warranted if vomiting occurs ≥60 minutes following administration, in patients with normal gastric emptying. In patients with delayed gastric emptying, alternative therapy should be considered.

  2.4 Instructions for the pharmacist

  Constitute with 60 mL of water and replace cap. Shake bottle well before dispensing. Do not refrigerate. Constituted suspension should be consumed within 12 hours.

  For pediatric dosing in patients weighing less than 75 lb (34 kg), use of a dosing device is recommended. The pharmacist should inform the patient's caregiver that any suspension remaining after dosing MUST be discarded.

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• Pfizer Laboratories Div Pfizer Inc
  

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  Zmax | Bayer Healthcare Llc

  

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  For intravenous use after reconstitution only.

  2.1 Dose • Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. 1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. • Each vial of Kogenate FS has the recombinant factor VIII (rFVIII) potency in international units (IU, unit) stated on the label. One IU (unit), as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. • The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:

  Dosage (units) = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)

    or   IU/dL (or % normal) = Total Dose (IU)/body weight (kg) x 2 [IU/dL]/[IU/kg] • Titrate dose to the patient’s clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Kogenate FS. 2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that appropriate laboratory tests, including serial factor VIII activity assays, are performed [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. Control and Prevention of Bleeding Episodes

  A guide for dosing Kogenate FS for the control and prevention of bleeding episodes is provided in Table 1. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1.

  Table 1 Dosing for Control and Prevention of Bleeding Episodes

  Type of Bleeding Episodes

  Factor VIII Level Required
  (IU/dL or % of normal)

  Dose

  (IU/kg)

  Frequency of Doses

  (hours)

  Duration of Therapy

  (days)

  Minor

  Early hemarthrosis, minor muscle or oral bleeds.

  20 – 40

  10 – 20

  Repeat dose if there is evidence of further bleeding.

  Until bleeding is resolved

  Moderate

  Bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma.

  30 – 60

  15 – 30

  12 – 24

  Until bleeding is resolved

  Major

  Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath.

  Fractures.

  Head trauma.

  80 – 100

  Initial: 40 – 50

  Repeat: 20 – 25

  8 – 12

  Until bleeding is resolved

  Peri-operative Management

  A guide for dosing Kogenate FS during surgery (perioperative management) is provided in Table 2. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in Table 2.

  Table 2 Dosing for Peri-operative Management

  Type of Surgery

  Factor VIII Level Required
  (IU/dL or % of normal)

  Dose

  (IU/kg)

  Frequency of Doses

  (hours)

  Duration of Therapy

  (days)

  Minor

  Including tooth extraction

  30 – 60

  15 – 30

  12 – 24

  Until bleeding is resolved.

  Major

  Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma.

  100

  50

  Pre-operatively to achieve 100% activity.

  6 – 12 to keep FVIII activity in desired range

  Until healing is complete.

  Routine Prophylaxis in Adults

  The recommended dose for routine prophylaxis is 25 units per kg of body weight three times per week.

  Routine Prophylaxis in Children

  The recommended dose for routine prophylaxis is 25 units per kg of body weight every other day.5

  2.2 Preparation and Reconstitution

  Kogenate FS is administered by intravenous injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.

  Reconstitute and administer Kogenate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

  Product reconstitution, administration, and handling of the administration set and needles must be done with caution because percutaneous puncture with a needle contaminated with blood can transmit infectious viruses, including HIV (AIDS) and hepatitis. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted Kogenate FS product, in an appropriate container. Obtain immediate medical attention if injury occurs.

  For any questions about the handling, reconstitution and administration of Kogenate FS, contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).

  For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling.

  The procedures below are provided as general guidelines for the reconstitution of Kogenate FS with BIO-SET®, a needleless self-contained reconstitution system.

  • Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures. • Reconstitute the product with the components provided with each package. If any component of the package is opened or damaged, do not use this component. • Filter the reconstituted product to remove potential particulate matter in the solution. Filtering can be achieved by following the administration steps as described below.

  Vacuum Transfer and Reconstitution

  1. Prepare the product under aseptic conditions. 2. Warm the unopened diluent (as needed) and the concentrate to a temperature not to exceed 37°C or 99°F. 3. Remove the cap from the concentrate. Take out the prefilled diluent syringe and remove the tip cap. (Fig. A). 4. Connect the prefilled diluent syringe to the concentrate vial by gently screwing on to the BIO-SET connection (Fig. B). 5. Place the vial on a rigid, non-skid surface and hold it firmly with one hand. With the other hand, strongly press down the fingerplate near the syringe tip using your thumb and index finger (Fig. C) until the fingerplate meets the top edge of the BIO-SET. This confirms that the system is activated (Fig. D). 6. Grasp the plunger rod by the top plate and remove from carton. Avoid touching the sides and threads of the plunger rod. Immediately screw plunger rod into the syringe rubber stopper (Fig. E). 7. Inject the diluent into the concentrate by pushing down the plunger rod slowly (Fig. F). 8. Swirl gently until completely dissolved without creating excessive foaming (Fig. G). 9. Invert vial/syringe and transfer the solution into syringe that was used to deliver the diluent (Fig. H). Ensure that the entire contents of the reconstituted Kogenate FS vial are drawn into the syringe. 10. Unscrew the filled syringe to disconnect it from the empty concentrate vial (Fig. I). 11. Attach the filled syringe to the administration set provided and immediately inject intravenously (Fig. J). 12. If the same patient is to receive more than one vial, the diluent syringe provided should be used to reconstitute the powder in the product vials as described above. The reconstituted solutions should then be combined in a larger plastic syringe (not provided) (Fig. J). 2.3 Administration

  For intravenous use after reconstitution only.

  • Inspect Kogenate FS visually for particulate matter and discoloration prior to administration, wherever solution and container permit. Do not use Kogenate FS if you notice any particulates or turbidity in the solution. • Store the reconstituted Kogenate FS at room temperature prior to administration, but administer it within 3 hours. • Administer Kogenate FS with the administration set provided with the product as it incorporates an in-line filter. In situations where the administration set provided cannot be used (e.g. when infusing into a peripheral or central line), use a separate filter compatible with Kogenate FS.   NOTE: Do not use the administration set provided with the product to draw blood because it contains an in-line filter. When blood must be withdrawn prior to an infusion, use an administration set without a filter, then infuse Kogenate FS through an injection filter. For any questions about compatible separate filters, contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937). • Administer Kogenate FS over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient. Determine the pulse rate before and during administration of Kogenate FS. If there is a significant increase in pulse rate, reduce the rate of administration or temporarily halt the infusion allowing the symptoms to disappear promptly.

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