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Liposomal Amphotericin B For Injection 50mg (Amfotaj) Liposomal Amphotericin B For Injection 50mg Liposomal Amphotericin B For Injection 50mg Liposomal Amphotericin B For Injection 50mg Liposomal Amphotericin B For Injection 50mg Liposomal Amphotericin B For Injection 50mg Liposomal Amphotericin B For Injection 50mg Liposomal Amphotericin B For Injection 50mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Liposomal Amphotericin B For Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Liposomal Amphotericin B For Injection 50mg/vial
a) Each Vial Contains:
Amphotericin BP 
Equivalent to Amphotericin-B …………...50mg
Excipients…………………………….……q.s.
b) Sterile Water for Injection USP…20ml

THERAPEUTIC INDICATIONS:

Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people.

DIRECTION OF USE:

To be reconstituted with 12ml Sterile Water for Injection USP to each Liposomal amphotericin B Injection vial to yield a preparation congaing concentration of 4mg/ml Amphotericin B.
Use only after reading the direction on the pack insert.

CAUTION & WARNING:

CAUTION: After reconstitution do not use in case any foreign particulate matter is observed inside the vial.
Liposomal Amphotericin b Injection Amfotaj is not Interchangeable With other Amphotericin Product.
Dispersion to be protected from light during administration.
Inject the syringe contents through the filter, in to the appropriate amount of 5% Dextrose Injection (Use only one filter per vial of Amfotaj-50mg Vial).
***ICMR Approved drug for treating black fungus.
Each carton contains one pre packed disposable Sterile 5µm Syringe filter.
WARNING: Not to be sold by retail without the prescription of a Registered Medical practitioner.
Note: Amphotericin B liposomal for Injection is Not Interchangeable or Substitutable on a mg per Basis with other Amphotericin B product.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C. Protect from light and moisture. Do not freeze.
Read enclosed leaflet for reconstitution, dosage, administration and precautions.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by Physician.

Liposomal Amphotericin B For Injection 50mg Technical Specification:

Product Name:Liposomal Amphotericin B For Injection
Brand Name:Amfotaj
Strength:50mg
Dosage Form:Lyophilised Powder Injection (Sterile) *Preservative-free
Packing:1 Vial + WFI in a 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
Indication: Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people
Storage:Store at 2°C to 8°C. Protect from light and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Liposomal Amphotericin B For Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Liposomal Amphotericin B For Injection 50mg/vial
    a)Each Vial Contains:
    Amphotericin BP
    Equivalent to Amphotericin-B……………50mg
    Excipients…………………………….……q.s.
    b)Sterile Water for Injection USP…20ml

THERAPEUTIC INDICATION:

Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people.

DIRECTION OF USE:

To be reconstituted with 12ml Sterile Water for Injection USP to each Liposomal amphotericin B Injection vial to yield a preparation congaing concentration of 4mg/ml Amphotericin B.

Use only after reading the direction on the pack insert.

CAUTION & Warning:

CAUTION: After reconstitution do not use in case any foreign particulate matter is observed inside the vial.

Liposomal Amphotericin b Injection Amfotaj is not Interchangeable With other Amphotericin Product.
Dispersion to be protected from light during administration.

Inject the syringe contents through the filter, in to the appropriate amount of 5% Dextrose Injection (Use only one filter per vial of Amfotaj-50mg Vial)

***ICMR Approved drug for treating black fungus.
Each carton contains one pre packed disposable Sterile 5µm Syringe filter.

WARNING: Not to be sold by retail without the prescription of a Registered Medical practitioner.

Note: Amphotericin B liposomal for Injection is Not Interchangeable or Substitutable on a mg per Basis with other Amphotericin B product.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C. Protect from light and moisture. Do not freeze.

Read enclosed leaflet for reconstitution, dosage, administration and precautions.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Dosage: As directed by Physician.