View drug registration information details.
| Items | Registration information |
|---|
| ID | 354 |
|---|
| No | 354 |
|---|
| Brand Name | AMPHOTIN 50 |
|---|
| Ingredients | AMPHOTERICIN B IP 50 MG |
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| Dosage Form | POWDER FOR INJECTION |
|---|
| Primary Packaging | VIAL |
|---|
| Storage | STORE IN A REFRIGERATOR BETWEEN 2C TO 8C, PROTECT FROM LIGHT |
|---|
| Shelf Life | 2 YEARS |
|---|
| Pack Size | BOX OF 10 VIALS |
|---|
| Dispensing Category | Prescription only |
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| ATC Classification | J02AA01 |
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| Pharmaceutical Class | ANTIBACTERIAL |
|---|
| Indications | PROGRESSIVE, POTENTIALLY FATAL INFECTIONS, THIS POTENT DRUG SHOULD NOT BE USED TO TREAT THE COMMON FORMS OF FUNGAL DISEASE WHICH SHOW ONLY POSITIVE SKIN OR SEROLOGICAL TEST, IT IS SPECIALLY INTENDED TO TREAT CRYPTOCOCCOSIS, NORTH AMERICAN BLASTOMYCOSIS, THE DISSEMINATED FORMS OF CANDIDOSIS, COCCIDIODOMYCOSIS AND HISTOPLASMOIS |
|---|
| Contraindications | HYPERENSITIVITY, |
|---|
| Side Effects | ANAEMIA, HYPOKALAEMIA, HEADACHE, HYPOTENSION, DYSPNOEA, NAUSEA, VOMITING, LIVER TEST ABNORMALITIES, HEPATIC FUNCTION ABNORMAL, PYREXIA, BLOOD CREATINIE INCREASED |
|---|
| Unit Price | |
|---|
| EDL |
Yes |
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| Description | 10 ML CLEAR MOULDED GLASS VIAL CONTAINING YELLOW CAKED STOPPERED AND SEAL WITH 20 MM LIGHT BLUE COLOR FLIP OFF SEAL, EMBOSSED UNITED BIOTECH LABELED AND PLACE IN A PLASTIC TRAY, THIS PLASTIC TRAY IS PACKED IN A MONO CARTON ALONG WITH INSERT |
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| Note | |
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| License Owner | CBF PHARMA CO.,LTD |
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| Manufacturer | UNITED BIOTECH (P) LIMITED |
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| Country | INDIA |
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| Import Registration No | MB/05/255 |
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| Import Registration Date | 2016-07-26 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2023-05-05 |
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| FDD Registration No | 06 I 4941/20 |
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| FDD Registration Date | 2023-08-14 |
|---|
| Expiry Date | 2026-08-13 |
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