GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Famotidine Dry Powder for Injection (Lyophilized) 20mg
B) Famotidine Dry Powder for Injection (Lyophilized) 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Famotidine Dry Powder for Injection (Lyophilized) 20mg
each ml contains
famotidine………………………..20mg
L-aspartic acid ……………………4 mg
mannitol…………………………… 20 mg
Water for injection
Contains no preservatives
B) B) Famotidine Dry Powder for Injection (Lyophilized) 40mg
each ml contains
famotidine………………………..40mg
L-aspartic acid ……………………4 mg
mannitol…………………………… 20 mg
Water for injection
Contains no preservatives

THERAPEUTIC INDICATIONS:

CAUTION: For intravenous infusion after dilution..
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

CAUTION & SCHEDULE:

CAUTION: For intravenous infusion after dilution..
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Store at 2 to 8°C (36° to 45°F) If solution freezes, bring to room temperature, allow sufficient time to solubilize
Dosage: Single Dose Vial.
As directed by the Physician.

Famotidine Dry Powder for Injection (Lyophilized) 20mg Technical Specification:

Product Name:
Famotidine Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:20mg, 40mg
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:For intravenous infusion after dilution.
Packing:20 mg per 2 mL(10 mg/mL).For the preparation of Intravenous solutions 25 x 2 ml.
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antacid
Indication: to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers.
Storage:Store at 2 to 8°C (36° to 45°F) If solution freezes, bring to room temperature, allow sufficient time to solubilize

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Famotidine Dry Powder for Injection (Lyophilized) 20mg
  • Famotidine Dry Powder for Injection (Lyophilized) 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Famotidine Dry Powder for Injection (Lyophilized) 20mg
    each ml contains
    Famotidine………………………..20mg
    L-aspartic acid ……………………4 mg
    mannitol…………………………… 20 mg
    Water for injection
    Contains no preservatives
  • Famotidine Dry Powder for Injection (Lyophilized) 40mg
    famotidine………………………..40mg
    L-aspartic acid ……………………4 mg
    mannitol…………………………… 20 mg
    Water for injection
    Contains no preservatives

THERAPEUTIC INDICATIONS:

to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers.

CAUTION & SCHEDULE:

CAUTION:
For intravenous infusion after dilution.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:Store at 2 to 8°C (36° to 45°F) If solution freezes, bring to room temperature, allow sufficient time to solubilize
Dosage: Single Dose Vial.
As directed by the Physician.