GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amphotericin B Lipid Complex Injection 5mg/1ml (AMFOTAJ)
B. Amphotericin B Lipid Complex Injection 10mg/2ml (AMFOTAJ)
C. Amphotericin B Lipid Complex Injection 50mg/10ml (AMFOTAJ)
D. Amphotericin B Lipid Complex Injection 100mg/20ml (AMFOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Amphotericin B Lipid Complex Injection 5mg/1ml
a) Each ml contains:
Amphotericin B USP……….5mg
Sodium Chloride USP……..9mg
Water for Injection USP….q.s
b) LIPIDS:
Dimyristoylphosphatidylcholine (DMPC)……………………………3.4mg
Dimyristoylphosphatidylglycerol (DMPG as Sodium Salt)…..1.5mg

B. Amphotericin B Lipid Complex Injection 10mg/2ml
a) Each ml contains:
Amphotericin B USP……….5mg
Sodium Chloride USP……..9mg
Water for Injection USP…..q.s
b) LIPIDS:
Dimyristoylphosphatidylcholine (DMPC)……………………………3.4mg
Dimyristoylphosphatidylglycerol (DMPG as Sodium Salt)…..1.5mg

C. Amphotericin B Lipid Complex Injection 50mg/10ml
a) Each ml contains:
Amphotericin B USP……….5mg
Sodium Chloride USP……..9mg
Water for Injection USP…..q.s
b) LIPIDS:
Dimyristoylphosphatidylcholine (DMPC)……………………………3.4mg
Dimyristoylphosphatidylglycerol (DMPG as Sodium Salt)…..1.5mg


D. Amphotericin B Lipid Complex Injection 100mg/20ml
a) Each ml contains:
Amphotericin B USP……….5mg
Sodium Chloride USP……..9mg
Water for Injection USP….q.s
b) LIPIDS:
Dimyristoylphosphatidylcholine (DMPC)……………………………3.4mg
Dimyristoylphosphatidylglycerol (DMPG as Sodium Salt)…..1.5mg

THERAPEUTIC INDICATIONS:

Amphotericin B lipid complex injection is used to treat serious, possibly life-threatening fungal infections in people who did not respond or are unable to tolerate conventional amphotericin B therapy. Amphotericin B lipid complex injection is in a class of medications called antifungals.

DIRECTION OF USE:

For Intravenous Infusion use only.
See package inserts for usual dosage information.

CAUTION & WARNING:

CAUTION: Do not use in case any foreign particulate matter is observed inside the vial.
Discard unused portion.
Gently shake before use.
One Filter Needle W5 Micron Filter (Disposable)
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store protected from light at a temperature between 2°C to 8°C (36°F to 46°F).
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Amphotericin B Lipid Complex Injection 50mg/10ml Technical Specification:

Product Name:Amphotericin B Lipid Complex Injection
Brand Name:AMFOTAJ
Strength:5mg/ml, 10mg/2ml, 50mg/10ml, 100mg/20ml
Dosage Form:Liquid Injection
Packing:Single Dose Vial+ filter needle
Route of Administration:For I.V. Infusion 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
Indication: Amphotericin B lipid complex injection is used to treat serious, possibly life-threatening fungal infections in people who did not respond or are unable to tolerate conventional amphotericin B therapy. Amphotericin B lipid complex injection is in a class of medications called antifungals.
Storage:Store protected from light at a temperature between 2°C to 8°C (36°F to 46°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Amphotericin B Lipid Complex Injection 50mg/10ml (AMFOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amphotericin B Lipid Complex Injection 50mg/10ml
    a) Each ml contains:
    Amphotericin B USP……….5mg
    Sodium Chloride USP……..9mg
    Water for Injection USP….q.s
    b) LIPIDS:
    Dimyristoylphosphatidylcholine (DMPC)……………………………3.4mg
    Dimyristoylphosphatidylglycerol (DMPG as Sodium Salt)…..1.5mg

THERAPEUTIC INDICATIONS:

Amphotericin B lipid complex injection is used to treat serious, possibly life-threatening fungal infections in people who did not respond or are unable to tolerate conventional amphotericin B therapy. Amphotericin B lipid complex injection is in a class of medications called antifungals.

DIRECTION OF USE:

For Intravenous Infusion use only.
See package inserts for usual dosage information.

CAUTION & Warning:

CAUTION: Do not use in case any foreign particulate matter is observed inside the vial.
Discard unused portion.
Gently shake before use.
One Filter Needle W5 Micron Filter (Disposable)
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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

STORAGE & DOSAGE:

Storage: Store protected from light at a temperature between 2°C to 8°C (36°F to 46°F).
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.