GENERIC NAME OF MEDICINAL PRODUCT:

A. Amphotericin B for Injection IP 50mg (AMFOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC 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.

DIRECTION OF USE:

Reconstitute with the 10ml of Sterile Water for Injection IP.
The reconstituted solution should be used immediately after the preparation and protected from light during administration.
For dosage and administration refer pack inserts.

CAUTION AND SCHEDULE:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
Dispersion should be protected from the light during the administration.
Reconstituted solution should be use immediately after preparation.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C.
Protected from light.
DOSAGE: As directed by the Physician.

Amphotericin B for Injection IP 50mg Technical Specification:

Product Name:Amphotericin B for Injection IP
Brand Name:AMFOTAJ
Strength:50mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For IV Infusion use to hospitalized patients only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 non-invasive 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. Protected from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Amphotericin B for Injection IP 50mg (AMFOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC 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.

DIRECTION OF USE:

Reconstitute with the 10ml of Sterile Water for Injection IP.
The reconstituted solution should be used immediately after the preparation and protected from light during administration.
For dosage and administration refer pack inserts.

CAUTION AND SCHEDULE:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
Dispersion should be protected from the light during the administration.
Reconstituted solution should be use immediately after preparation.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C. Protected from light.

DOSAGE: As directed by the Physician.