GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amphotericin B for Injection USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Amphotericin B Injection USP 50mg
a) Each vial contains:
Amphotericin B USP……………..……..50mg
Excipient……………………………….q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml

THERAPEUTIC INDICATIONS:

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.

DIRECTION OF USE:

For Intravenous use only.
The injection should not be given at doses greater than 1.5mg/kg.
Please read complete warnings, overdosage, dosage and administration before use.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Exercise caution to prevent inadvertent overdosage, which can result in potentially Cardiac or Cardiopulmonary arrest.
Protect from light during administration.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C (36°F to 46°F).Store under refrigeration.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Amphotericin B for Injection USP 50mg Technical Specification:

Product Name:Amphotericin B for Injection USP
Brand Name:Amfotaj
Strength:50mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Fungal, Antibiotic
Indication: Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.
Storage:Store between 2°C to 8°C (36°F to 46°F). Store under refrigeration.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Amphotericin B for Injection USP 50mg (Amfotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amphotericin B for Injection USP 50mg
    a. Each vial contains:
    Amphotericin B USP……………..……..50mg
    Excipient………………………………….q.s
    b. This pack is also contains:
    One FFS ampule of Sterile Water for Injection USP…….10ml

THERAPEUTIC INDICATIONS:

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.

DIRECTION OF USE:

For Intravenous use only.
The injection should not be given at doses greater than 1.5mg/kg.
Please read complete warnings, overdosage, dosage and administration before use.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Exercise caution to prevent inadvertent over dosage, which can result in potentially Cardiac or Cardiopulmonary arrest.
Protect from light during administration.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C (36°F to 46°F). Store under refrigeration.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.