GENERIC NAME OF MEDICINAL PRODUCT:
A. Liposomal Amphotericin B Injection IP 50mg (Amfotaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Liposomal Amphotericin B Injection IP 50mg
Each Vial contains:
Amphotericin B IP (Intercalated into
Liposomal Membrane) …….…………………..50mg
Excipients………………….…………………………….q.s
Each Vial contains:
Amphotericin B IP (Intercalated into
Liposomal Membrane) …….…………………..50mg
Excipients………………….…………………………….q.s
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 IP 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.
Use only after reading the direction on the pack insert.
CAUTION AND SCHEDULE:
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.
WARNING:
Not to be sold by retail without the prescription of a Registered Medical practitioner.
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.
WARNING:
Not to be sold by retail without the prescription of a Registered Medical practitioner.
STORAGE AND DOSAGE:
Storage: Store at 2°C to 8°C.
Protect from light and moisture.
Do not freeze.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.
Protect from light and moisture.
Do not freeze.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.
Liposomal Amphotericin B Injection IP 50mg Technical Specification:
| Product Name: | Liposomal Amphotericin B Injection IP |
| 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) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| 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 Injection IP 50mg (Amfotaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Liposomal Amphotericin B Injection IP 50mg
Each Vial contains:
Amphotericin B IP (Intercalated into
Liposomal Membrane) …….…………………………..50mg
Excipients………………….…………………………….q.s
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 IP 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 AND SCHEDULE:
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.
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 at 2°C to 8°C.
Protect from light and moisture.
Do not freeze.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.
Note:
- Amphotericin B liposomal for Injection is Not Interchangeable or Substitutable on a mg per Basis with other Amphotericin B product.
- 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).
- The Indian Council Of Medical Research(ICMR) informed that liposomal amphotericin B is not only medication activity for the treatment of Mucormycosis. also called black fungus.***ICMR Approved drug for treating black fungus.
- Each carton contains one pre packed disposable Sterile 5µm Syringe filter.
