GANITE (Page 3 of 3)

OVERDOSAGE

Rapid intravenous infusion of gallium nitrate or use of doses higher than recommended (200 mg/m2) may cause nausea and vomiting and a substantially increased risk of renal insufficiency. In the event of overdosage, further drug administration should be discontinued, serum calcium should be monitored, and the patient should receive vigorous intravenous hydration, with or without diuretics, for 2-3 days. During this time period, renal function and urinary output should be carefully monitored so that fluid intake and output are balanced.

DOSAGE AND ADMINISTRATION

The usual recommended dose of Ganite is 200 mg per square meter of body surface area (200 mg/m2) daily for 5 consecutive days. In patients with mild hypercalcemia and few symptoms, a lower dosage of 100 mg/m2 /day for 5 days may be considered. If serum calcium levels are lowered into the normal range in less than 5 days, treatment may be discontinued early. The daily dose must be administered as an intravenous infusion over 24 hours. The daily dose should be diluted, preferably in 1,000 mL of 0.9% Sodium Chloride Injection USP, or 5% Dextrose Injection USP, for administration as an intravenous infusion over 24 hours. Adequate hydration must be maintained throughout the treatment period, with careful attention to avoid overhydration in patients with compromised cardiovascular status. Controlled studies have not been undertaken to evaluate the safety and effectiveness of retreatment with gallium nitrate.

When Ganite is added to either 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP, it is stable for 48 hours at room temperature (15°C to 30°C) or for 7 days if stored under refrigeration (2°C to 8°C). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.

Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.

Store at controlled room temperature 20°-25°C (68°-77°F).

Contains no preservative. Discard unused portion.

Rx only

Ganite® is a trademark of Genta Incorporated.

Manufactured for:
Genta Incorporated
Berkeley Heights, NJ 07922
1-888-TO-GENTA

Revised: October 2006

30105902

Principal Display Panel — Vial Label

Vial Label
(click image for full-size original)

Vial Label

Rx only NDC 66657-301-01

Ganite®

(gallium nitrate injection)

500mg

25mg/mL

Sterile Solution • For Intravenous Use

20mL Single-Use Vial

Sterile, aqueous, preservative-free, buffered
solution. For parenteral administration via infusion.
Discard unused portion.

Dilute in an isotonic saline or dextrose solution.

Each mL contains: Gallium nitrate 25mg (on an
anhydrous basis) and Sodium citrate dihydrate
(28.75mg).

Store at controlled room temperature 20°-25°C (68°-77°F).

Manufactured for:
Genta Incorporated
Berkeley Heights, NJ 07922
1-888-TO-GENTA

GANITE
gallium nitrate injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66657-301
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALLIUM NITRATE (Gallium cation) GALLIUM NITRATE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66657-301-05 5 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (66657-301-01)
1 NDC:66657-301-01 20 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (66657-301-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019961 09/17/2003
Labeler — Genta Incorporated (602834483)
Establishment
Name Address ID/FEI Operations
Cangene BioPharma Inc 050783398 MANUFACTURE (66657-301), STERILIZE (66657-301)

Revised: 03/2012 Genta Incorporated

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