Ferring Pharmaceuticals Inc.

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Ferring Pharmaceuticals Inc. Drugs

Zomacton

Zomacton

The recommended dose is up to 0.1 mg/kg administered subcutaneously three (3) times per week ( up to 0.3 mg/kg/week).

ZOMACTON 5 mg should be reconstituted with 1-5 mL of bacteriostatic 0.9% sodium chloride for injection, USP (benzyl alcohol preserved). Reconstituted ZOMACTON 5 mg vials should not be used if the patient has a known sensitivity to benzyl alcohol. Benzyl alcohol as a preservative in bacteriostatic normal saline, USP, has been associated with toxicity in newborns. WHEN ADMINISTERING ZOMACTON TO NEWBORNS, RECONSTITUTE WITH STERILE NORMAL SALINE FOR INJECTION, USP.

ZOMACTON 10 mg should be reconstituted with 1 mL syringe of bacteriostatic water for injection containing 0.33% metacresol as a preservative. Reconstituted ZOMACTON 10 mg vials should not be used if the patient is allergic to metacresol.

The stream of normal saline should be aimed against the side of the vial to prevent foaming. Swirl the vial with a GENTLE rotary motion until the contents are completely dissolved and the solution is clear. DO NOT SHAKE. Since ZOMACTON is a protein, shaking or vigorous mixing will cause the solution to be cloudy. If the resulting solution is cloudy or contains particulate matter, the contents MUST NOT be injected.

Occasionally, after refrigeration, some cloudiness may occur. This is not unusual for proteins like ZOMACTON. Allow the product to warm to room temperature. If cloudiness persists or particulate matter is noted, the contents MUST NOT be used.

Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions.

ZOMACTON 5 mg and 10 mg can be administered using a standard sterile disposable syringe or a ZOMA-Jet™ Needle-Free injection device. For proper use, please refer to the User's Manual provided with the administration device.
Ddavp

Ddavp

Central Cranial Diabetes Insipidus

DDAVP Nasal Spray dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.

The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard DDAVP Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Ddavp

Ddavp

Central Cranial Diabetes Insipidus

This drug is administered into the nose through a soft, flexible plastic rhinal tube which has four graduation marks on it that measure 0.2, 0.15, 0.1 and 0.05 mL. DDAVP Rhinal Tube dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Ddavp

Ddavp

Central Diabetes Insipidus

The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal DDAVP therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of DDAVP Tablet therapy to assure adequate antidiuretic response. Modification in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Adults and Children

It is recommended that patients be started on doses of 0.05 mg (½ of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuretic. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

Primary Nocturnal Enuresis

The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal DDAVP therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response. Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before desmopressin acetate administration, until the next morning, or at least 8 hours after administration. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)
Ddavp

Ddavp

Hemophilia A and von Willebrand's Disease (Type I)

DDAVP Injection 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg DDAVP/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If DDAVP Injection 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.

The necessity for repeat administration of DDAVP or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Diabetes Insipidus

This formulation is administered subcutaneously or by direct intravenous injection. DDAVP Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

The usual dosage range in adults is 0.5 mL (2.0 mcg) to 1 mL (4.0 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal DDAVP and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.

Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

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

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmcokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

Directions for use of One Point Cut (OPC) Ampules for DDAVP Injection
Use aseptic technique to clean ampule. Gently tap the top of the ampule to assist the flow of the solution from the upper portion of the ampule to the lower portion. Locate the blue dot on the upper portion of the ampule. Below this dot is a small score on the neck of the ampule. Hold the ampule with the blue dot facing away from you. Cover the vial with an appropriate wipe. Apply pressure to the top and bottom portions of the ampule to snap the ampule open away from you.
Desmopressin Acetate So...

Desmopressin Acetate Solution

Hemophilia A and von Willebrand's Disease (Type I): DESMOPRESSIN ACETATE Injection 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg DESMOPRESSIN ACETATE/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If DESMOPRESSIN ACETATE Injection 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.

The necessity for repeat administration of DESMOPRESSIN ACETATE or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. DESMOPRESSIN ACETATE Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

The usual dosage range in adults is 0.5 mL (2.0 mcg) to 1 mL (4.0 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal DESMOPRESSIN ACETATE and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.

Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

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

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmcokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

Directions for use of One Point Cut (OPC) Ampules for DESMOPRESSIN ACETATE Injection:
Use aseptic technique to clean ampule. Gently tap the top of the ampule to assist the flow of the solution from the upper portion of the ampule to the lower portion. Locate the blue dot on the upper portion of the ampule. Below this dot is a small score on the neck of the ampule. Hold the ampule with the blue dot facing away from you. Cover the vial with an appropriate wipe. Apply pressure to the top and bottom portions of the ampule to snap the ampule open away from you.
Atopalm Tolnaftate Anti...

Atopalm Tolnaftate Antifungal

2.1 Dosing Overview

Prepopik®, supplied as a powder, must be reconstituted with cold water right before its use [see Dosage and Administration (2.2)]. There are two dosing regimens, each requires two separate dosing times:
The preferred method is the "Split-Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy [see Dosage and Administration (2.3)] The alternative method is the "DayBefore" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy [see Dosage and Administration (2.4)].
Additional fluids must be consumed after every dose in both dosing regimens [see Dosage and Administration (2.3, 2.4)]. Instruct patients to consume only clear liquids (no solid food or milk) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Instruct patients that if they experience severe bloating, distention, or abdominal pain following the first dose, delay the second dose until their symptoms resolve.

2.2 Reconstitution of the Prepopik® Powder
(a) Reconstitute the Prepopik ® powder right before each administration. Do not prepare the solution in advance. (b) Fill the supplied dosing cup with cold water up to the lower (5-ounce) line on the cup and pour in the contents of one packet of Prepopik ® powder. (c) Stir for 2 to 3 minutes. The reconstituted Prepopik ® solution may become slightly warm as the powder dissolves.
2.3 Split-Dose Dosing Regimen (Preferred Method)

The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:
Take the first dose during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM) followed by five 8-ounce drinks (upper line on the dosing cup) of clear liquids before bed. Consume clear liquids within 5 hours. Take second dose the next day approximately 5 hours before the colonoscopy followed by at least three 8-ounce drinks of clear liquids before the colonoscopy. Consume clear liquids within 5 hours up until 2 hours before the time of the colonoscopy.
2.4 Day-Before Dosing Regimen (Alternative Method)

The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. Instruct patients to take two separate doses in conjunction with fluids, as follows:
Take the first dose in the afternoon or early evening (e.g., 4:00 to 6:00 PM) before the colonoscopy followed by five 8-ounce drinks (upper line on the dosing cup) of clear liquids before the next dose. Consume clear liquids within 5 hours. Take the second dose approximately 6 hours later in the late evening (e.g., 10:00 PM to 12:00 AM), the night before the colonoscopy followed by three 8-ounce drinks of clear liquids before bed. Consume clear liquids within 5 hours.
Desmopressin Acetate So...

Desmopressin Acetate Solution

Central Cranial Diabetes Insipidus: This drug is administered into the nose through a soft, flexible plastic rhinal tube which has four graduation marks on it that measure 0.2, 0.15, 0.1 and 0.05 mL. DESMOPRESSIN ACETATE Rhinal Tube dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DESMOPRESSIN ACETATE. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DESMOPRESSIN ACETATE administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Lysteda

Lysteda

2.1 Recommended Dosage

The recommended dose of LYSTEDA for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. LYSTEDA may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.

2.2 Renal Impairment

In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of LYSTEDA in Patients with Renal Impairment LYSTEDA Serum Creatinine (mg/dL) Adjusted Dose Total Daily Dose Cr above 1.4 and ≤ 2.8 1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation 2600 mg Cr above 2.8 and ≤ 5.7 1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation 1300 mg Cr above 5.7 650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation 650 mg
Firmagon

Firmagon

FIRMAGON is for subcutaneous administration only and is not to be administered intravenously.

Dosing information:
Starting dose Maintenance dose – Administration every 28 days 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL
The first maintenance dose should be given 28 days after the starting dose.

FIRMAGON is administered as a subcutaneous injection in the abdominal region. As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given in areas of the abdomen that will not be exposed to pressure, e.g. not close to waistband or belt nor close to the ribs.

FIRMAGON is supplied as a powder to be reconstituted with Sterile Water for Injection, USP (WFI). The reconstitution procedure needs to be carefully followed. Administration of other concentrations is not recommended. See Instructions for Proper Use.

Instructions for Proper Use

NOTE:

Gloves should be worn during preparation and administration

Reconstituted drug must be administered within one hour after addition of Sterile Water for Injection, USP (WFI)

Keep the vials vertical at all times

Do not shake the vials

Follow aseptic technique

FIRMAGON 120 mg

The Treatment Initiation pack contains 2 vials of FIRMAGON 120 mg that must be prepared for 2 subcutaneous injections. Hence, the instructions here below need to be repeated a second time.

Prepare FIRMAGON 120 mg for reconstitution by gathering the following:

6 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection

2 reconstitution needles – 21G / 2 inch

2 administration needles for subcutaneous injection – 27G / 1-1/4 inch

2 injection syringes (5 mL)

Draw up 3 mL WFI with a reconstitution needle (21G / 2 in).

Inject the WFI slowly into the FIRMAGON 120 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.

Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. Avoid shaking to prevent foam formation. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take up to 15 minutes.

Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 3 mL of FIRMAGON 120 mg without turning the vial upside down.

Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.

Inject 3 mL of FIRMAGON 120 mg subcutaneously immediately after reconstitution.
Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient). Repeat reconstitution procedure for the second dose. Choose a different injection site and inject 3 mL.
FIRMAGON 80 mg

The Treatment Maintenance pack contains 1 vial of FIRMAGON 80 mg that must be prepared for subcutaneous injection.

Prepare FIRMAGON 80 mg for reconstitution by gathering the following:

4.2 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection

1 reconstitution needle – 21G / 2 inch

1 administration needle for subcutaneous injection – 27G / 1-1/4 inch

1 injection syringe (5 mL)

Draw up 4.2 mL WFI with the reconstitution needle (21G / 2 in).

Inject the WFI slowly into the FIRMAGON 80 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.

Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. Avoid shaking to prevent foam formation. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take up to 15 minutes.

Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 4 mL of FIRMAGON 80 mg without turning the vial upside down.

Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.

Inject 4 mL of FIRMAGON 80 mg subcutaneously immediately after reconstitution:

Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees.

Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
Lysteda

Lysteda

2.1 Recommended Dosage

The recommended dose of LYSTEDA for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. LYSTEDA may be administered without regard to meals. Tablets should be swallowed whole and not chewed or broken apart.

2.2 Renal Impairment

In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of LYSTEDA in Patients with Renal Impairment LYSTEDA Serum Creatinine (mg/dL) Adjusted Dose Total Daily Dose Cr above 1.4 and ≤ 2.8 1300 mg (two 650 mg tablets) two times a day for a maximum of 5 days during menstruation 2600 mg Cr above 2.8 and ≤ 5.7 1300 mg (two 650 mg tablets) once a day for a maximum of 5 days during menstruation 1300 mg Cr above 5.7 650 mg (one 650 mg tablet) once a day for a maximum of 5 days during menstruation 650 mg
Dinoprostone Insert

Dinoprostone Insert

The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12 hour period. Dinoprostone Vaginal Insert should be removed upon onset of active labor or 12 hours after insertion.

Dinoprostone Vaginal Insert is supplied in an individually wrapped aluminium/polyethylene package with a "tear mark" on one side of the package. The package should only be opened by tearing the aluminium package along the tear mark. The package should never be opened with scissors or other sharp objects which may compromise or cut the knitted polyester pouch that serves as the retrieval system for the polymeric slab.

Dinoprostone Vaginal Insert must be kept frozen until use, and is administered by placing one unit transversely in the posterior fornix of the vagina immediately after removal from its foil package. The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of water-miscible lubricant may be used to assist insertion of Dinoprostone Vaginal Insert. Care should be taken not to permit excess contact or coating with the lubricant which could prevent optimal swelling and release of dinoprostone from the vaginal insert. Patients should remain in the recumbent position for 2 hours following insertion, but thereafter may be ambulatory. If the patient is ambulatory, care should be taken to ensure the vaginal insert remains in place. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Dinoprostone Vaginal Insert should also be removed prior to amniotomy.

Upon removal of Dinoprostone Vaginal Insert, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient. This is accomplished by visualizing the knitted polyester retrieval system and confirming that it contains the slab. In the rare instance that the slab is not contained within the polyester retrieval system, a vaginal exam should be performed to remove the slab.
Acthrel

Acthrel

Dosage

A single intravenous dose of ACTHREL® at 1 mcg/kg is recommended for the testing of pituitary corticotrophin function. A dose of 1 mcg/kg is the lowest dose that produces maximal cortisol responses and significant (though apparently sub-maximal) ACTH responses. Doses above 1 mcg/kg are not recommended. (See PRECAUTIONS and ADVERSE REACTIONS).

At a dose of 1 mcg/kg, the ACTH and cortisol responses to ACTHREL® are prolonged and remain elevated for up to 2 hours. The maximum increment in plasma ACTH occurs between 15 and 60 minutes after ACTHREL® administration, whereas the maximum increment in plasma cortisol occurs between 30 and 120 minutes. In a clinical study of 30 normal healthy men, the peak plasma ACTH and cortisol responses to ACTHREL® administration in the early afternoon occurred at 42 ± 29 minutes and 65 ± 26 minutes (average ±SD), respectively. If a repeated evaluation using the corticorelin stimulation test with ACTHREL® is needed, it is recommended that the repeat test be carried out at the same time of day as the original test because there are differences in basal levels and peak response levels following a.m. or p.m. administration to normal humans.

Administration

ACTHREL® is to be reconstituted aseptically with 2 mL of Sodium Chloride injection, USP (0.9% sodium chloride), at the time of use by injecting 2 mL of the saline diluent into the lyophilized drug product cake. To avoid bubble formation, DO NOT SHAKE the vial; instead, roll the vial to dissolve the product. The sterile solution containing 50 mcg corticorelin/mL is then ready for injection by the intravenous route. The dosage to be administered is determined by the patient's weight (1 mcg corticorelin/kg). Some of the adverse effects can be reduced by administering the drug as an infusion over 30 seconds instead of as a bolus injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
1% Teat Dip

1% Teat Dip

FIRMAGON is for subcutaneous administration only.

Dosing information:
Starting dose Maintenance dose – Administration every 28 days 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL
The first maintenance dose should be given 28 days after the starting dose.

FIRMAGON is administered as a subcutaneous injection in the abdominal region. As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given in areas of the abdomen that will not be exposed to pressure, e.g., not close to waistband or belt nor close to the ribs.

FIRMAGON is supplied as a powder to be reconstituted with Sterile Water for Injection, USP (WFI).

The instruction for reconstitution needs to be carefully followed. Administration of other concentrations is not recommended. See Instructions for Proper Use.

Instructions for Reconstitution

The following information is intended for healthcare professionals only:

NOTE:
Reconstituted drug must be administered within one hour after addition of Sterile Water for Injection, USP Do not shake the vials Follow aseptic technique
FIRMAGON 240 mg – Starting Dose

The pack contains 2 sets of FIRMAGON 120 mg vial, Sterile Water for Injection, USP syringe, vial adapter, and administration needle. For each subcutaneous injection, the drug product must be prepared using the following instructions.
1. Uncap vial and wipe the vial rubber stopper with an alcohol pad. Remove the cover from the vial adapter package. Attach the vial adapter to the vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place (see Figure A). 2. Assembly of the syringe is required. Prepare the prefilled syringe by attaching the plunger. 3. Remove the cap of the prefilled syringe. Attach the syringe to the vial by screwing it on to the adapter. Transfer all Sterile Water for Injection, USP to the vial (see Figure B). 4. With the syringe still attached to the adapter, swirl gently until the liquid looks clear and free of powder or particles (see Figure C). If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly. Avoid shaking to prevent foam formation. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes. 5. Turn the vial upside down and draw up to the 3 mL mark on the syringe for injection (see Figure D).Always make sure to withdraw the precise volume and expel any air bubbles. 6. Detach the syringe from the vial adapter and attach the administration needle to the syringe. 7. Immediately after reconstitution, inject 3 mL of FIRMAGON 120 mg slowly.Perform a deep subcutaneous injection.To do so: pinch the skin of the abdomen, elevate the subcutaneous tissue and insert the needle at a 45 degree angle (see Figure E).Do not inject into a vein or muscle. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the product can no longer be used. Discontinue the injection and discard the syringe and the needle (reconstitute a new dose for the patient).No injections should be given in areas where the patient will be exposed to pressure, e.g., around the belt or waistband or close to the ribs. 8. Repeat the reconstitution procedure for the second 120 mg vial to complete the 240 mg starting dose and choose a different injection site for the second dose.
FIRMAGON 80 mg – Maintenance Dose

The pack contains 1 set of FIRMAGON 80 mg vial, Sterile Water for Injection, USP syringe, vial adapter, and administration needle. For the subcutaneous injection, the drug product must be prepared using the following instructions.
1. Uncap vial and wipe the vial rubber stopper with an alcohol pad. Remove the cover from the vial adapter package. Attach the adapter to the powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place (see Figure A). 2. Assembly of the syringe is required. Prepare the prefilled syringe by attaching the plunger. 3. Remove the cap of the prefilled syringe. Attach the syringe to the vial by screwing it on to the adapter. Transfer all Sterile Water for Injection, USP to the vial (see Figure B). 4. With the syringe still attached to the adapter, swirl gently until the liquid looks clear and free of powder or particles (see Figure C). If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly. Avoid shaking to prevent foam formation. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes. 5. Turn the vial upside down and draw up to the 4 mL mark on the syringe for injection (see Figure D).Always make sure to withdraw the precise volume and expel any air bubbles. 6. Detach the syringe from the vial adapter and attach administration needle to the syringe. 7. Immediately after reconstitution, inject 4 mL of FIRMAGON 80 mg slowly.Perform a deep subcutaneous injection.To do so: pinch the skin of the abdomen, elevate the subcutaneous tissue and insert the needle at a 45 degree angle (see Figure E).Do not inject into a vein or muscle. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the product can no longer be used. Discontinue the injection and discard the syringe and the needle (reconstitute a new dose for the patient).No injections should be given in areas where the patient will be exposed to pressure, e.g., around the belt or waistband or close to the ribs.
Endometrin

Endometrin

2.1 General Dosing Information

The dose of Endometrin is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of Endometrin in this age group has not been determined.
Desmopressin Acetate

Desmopressin Acetate

Central Diabetes Insipidus

The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablet therapy to assure adequate antidiuretic response. Modification in dosage regimen should be implemented as necessary to assure adequate water turnover.

Adults and Children

It is recommended that patients be started on doses of 0.05 mg (½ of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1mg to 1.2mg divided into two or three daily doses as needed to obtain adequate antidiuretic. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

Primary Nocturnal Enuresis

The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal desmopressin acetate therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients (adults up to 45 years of age and children age 6 years and older) is 0.2 mg at bedtime. The dose may be titrated up to 0.6mg to achieve the desired response. Fluid restriction should be observed, and fluid intake should be limited to aminimum from 1 hour before desmopressin acetate administration, until the next morning, or at least 8 hours after administration. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Renal Concentration Capacity Test in Pediatrics

Desmopressin acetate tablets 0.6 mg (3 × 0.2 mg), for children between 3 and 18 years of age, should be taken at bedtime after bladder emptying. Urine osmolality should be measured in the first voided volume occurring >1 hour after administration.
Novarel

Novarel

(Intramuscular Use Only): The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient, and the physician's preference. The following regimens have been advocated by various authorities.

Prepubertal cryptorchidism not due to anatomical obstruction:
(1) 4,000 USP Units three times weekly for three weeks. (2) 5,000 USP Units every second day for four injections. (3) 15 injections of 500 to 1,000 USP Units over a period of six weeks. (4) 500 USP Units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later, giving 1,000 USP Units per injection.
Selected cases of hypogonadotropic hypogonadism in males:
(1) 500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks. (2) 4,000 USP Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP Units three times weekly for an additional three months. Reconstitution volume Concentration Administration 1 mL 10,000 IU/mL Administer entire dose at once 10 mL 1,000 IU/mL Multiple dose administration, refrigerate between doses
Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins (See prescribing information for menotropins for dosage and administration for that drug product).

5,000 to 10,000 USP Units one day following the last dose of menotropins. (A dosage of 10,000 USP Units is recommended in the labeling for menotropins).

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

Disposing of Needles and Syringes

To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container. Sharps containers should then be taken to a collection center for proper disposal. Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps.

In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins. Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.
Bravelle

Bravelle

2.1 General Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer BRAVELLE® subcutaneously in the abdomen or intramuscularly as described in Instructions for Use. A healthcare provider should administer BRAVELLE® intramuscularly.
2.2 Recommended Dosing for Induction of Ovulation

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
For women who have received GnRH agonist or antagonist pituitary suppression, a starting dose of 150 International Units per day of BRAVELLE® is administered subcutaneously or intramuscularly for 5 days in the first cycle of treatment. In subsequent cycles of treatment, the starting dose (and dosage adjustments) of BRAVELLE® should be determined based on the history of the ovarian response to BRAVELLE®. The following should be considered when planning the woman's individualized dose of BRAVELLE®: Appropriate BRAVELLE® dose adjustment(s), based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results), should be used to prevent multiple follicular growth and cycle cancellation. Do not make adjustments in dose more frequently than once every 2 days and do not exceed more than 75 to 150 International Units per adjustment. Use the lowest dose of BRAVELLE® that will achieve desired results. The maximum, individualized, daily dose of BRAVELLE® is 450 International Units per day. In general, do not exceed 12 days of treatment. When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation. Withhold hCG in cases where the ovarian monitoring on the last day of BRAVELLE® treatment suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) [see Warnings and Precautions (5.2, 5.3, 5.11)]. Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions (5.2, 5.3)].
2.3 Recommended Dosing for Assisted Reproduction Technology

The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of BRAVELLE® for women who have received a GnRH agonist for pituitary suppression is 225 International Units. BRAVELLE® may be administered together with MENOPUR® (menotropins for injection, USP), and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of BRAVELLE® and 75 International Units of MENOPUR® or 75 International Units of BRAVELLE® and 150 International Units of MENOPUR®).
Beginning on cycle day 2 or 3, a starting dose of 225 International Units of BRAVELLE® is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 12 days. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 2 days or by more than 75 - 150 International Units at each adjustment. Continue treatment until adequate follicular development is evident, and then administer hCG. Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of BRAVELLE® therapy [see Warnings and Precautions (5.2, 5.3, 5.11)]. Do not administer daily doses of BRAVELLE® or BRAVELLE® in combination with MENOPUR® that exceed 450 International Units.
Menopur

Menopur

2.1 General Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer MENOPUR® subcutaneously in the abdomen as described in Instructions for Use. MENOPUR® may be administered together with BRAVELLE® (urofollitropin for injection, purified).
2.2 Recommended Dosing for Assisted Reproductive Technology

The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of MENOPUR® for women who have received a GnRH agonist for pituitary suppression is 225 International Units. MENOPUR® may be administered together with BRAVELLE® (urofollitropin for injection, purified) and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of MENOPUR® and 75 International Units of BRAVELLE® or 75 International Units of MENOPUR® and 150 International Units of BRAVELLE®).
Beginning on cycle day 2 or 3, a starting dose of 225 International Units of MENOPUR® is administered subcutaneously daily. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 2 days or by more than 150 International Units at each adjustment. Continue treatment until adequate follicular development is evident, and then administer hCG.Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of MENOPUR® therapy [see Warnings and Precautions (5.1, 5.2, 5.10)]. Do not administer daily doses of MENOPUR® or MENOPUR® in combination with BRAVELLE® that exceed 450 International Units. Therapy should not exceed 20 days.

Ferring Pharmaceuticals Inc.

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