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Amphotericin B Emulsion Injection 50mg/10ml (Amfotaj) Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml Amphotericin B Emulsion Injection 5mg/ml

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Amphotericin B Emulsion Injection 5mg/ml (Amfotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Amphotericin B Emulsion Injection 5mg/ml
Each vial contains:
Amphotericin B USP……5mg
Excipients………………………………….q.s
Water for Injections USP…………...q.s to 1ml

THERAPEUTIC INDICATIONS:

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections including BLACK FUNGAL INFECTION. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.

DIRECTION OF USE:

For intravenous infusion to hospitalized patient only.
Please refer to the accompanying package insert for detailed dosage, direction for use and precautions.

CAUTION & WARNING:

CAUTION:
This Injection should not be use if it contains visible particulate matter. Shake well before use.
Discard any unused portion after initial use.
Dispersion should be protected from light during administration.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE:
Store at a temperature 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Do not freeze.
Protect from direct light & moisture.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by the Physician.

Amphotericin B Emulsion Injection 5mg/ml Technical Specification:

Product Name:Amphotericin B Emulsion Injection
Brand Name:Amfotaj
Strength:5mg/ml (50mg/10ml)
Dosage Form:Sterile Liquid for Injection (Emulsion)
Packing:10ml Single dose Vial +1 5µ syringe filter
Route of Administration:For I.V. Infusion use for hospitalized patients 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 injection is used to treat fungal infections including BLACK FUNGAL INFECTION. It works by slowing the growth of fungi that cause infection.
Storage:Store at a temperature between 2°C to 8°C. Protect from light & moisture. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Amphotericin B Emulsion Injection 5mg/ml

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Amphotericin B Emulsion Injection 5mg/ml
    Each vial contains:
    Amphotericin B USP……………………5mg
    Excipients……………………………..q.s
    Water for Injections USP……………q.s to 1ml

THERAPEUTIC INDICATIONS:

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections including BLACK FUNGAL INFECTION. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.

DIRECTION OF USE:

For intravenous infusion to hospitalized patient only.
Please refer to the accompanying package insert for detailed dosage, direction for use and precautions.

CAUTION & WARNING:

CAUTION: 

This Injection should not be use if it contains visible particulate matter.
Shake well before use.
Discard any unused portion after initial use.
Dispersion should be protected from light during administration.

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

STORAGE & DOSAGE:

Storage:  Store at a temperature between 2°C to 8°C.
Protect from light & moisture.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: The recommended daily dosage for adults and children is 5mg/kg given as single infusion, administered intravenously at a rate of about 2.5mg/kg/hour. 

For Kala Azar: The recommended total dose for adults and children for the treatment of Visceral Leishmaniasis (Kala Azar) is 15mg/kg and can be administered in any one of the following dosing regimens. 

  1. A single dose of 15mg/kg/day administered over a period of 4 hours (not recommended for children below 5 years of age) 
  2. A dose of 5mg/kg/day on three alternative days. 
  3. A dose of 7.5mg/kg/day on two alternative days. 

For Febrile neutropenia: The recommended dose id 5mg/kg/day.