| ID | 100 |
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| No | 100 |
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| Brand Name | INDIRAB |
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| Ingredients | VERO CELL DERIVED PURIFIED BPL INACTIVATED PITMAN MOORE STRAIN OF RABIES VIRUS, POTENCY >= 2.5 IU |
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| Dosage Form | POWDER FOR SOLUTION FOR INJECTION |
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| Primary Packaging | VIAL |
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| Storage | STORE BETWEEN +2'C TO 8'C |
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| Shelf Life | 24 MONTHS |
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| Pack Size | 0.5 ML VIAL OF LYOPHILIZED VACCINE + 1 AMPOULE OF DILUENT 0.5 ML+ 1 DISPOSABLE SYRINGE WITH NEEDLE. |
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| Dispensing Category | Prescription only |
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| ATC Classification | J06AA06 |
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| Pharmaceutical Class | VACCINES, ANTISERA & IMMUNOLOGICALS |
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| Indications | RECOMMENDED FOR HIGH RISK PROFESSIONAL WHO ARE EXPOSED TO THE RISK OF RABIES AND TREATMENT OF SUBJECTS BITTEN BY SUSPICIOUS/RABID ANIMALS. |
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| Contraindications | THIS VACCINE MUST NOT BE USED IN THE FOLLOWING CASE : SEVERE FEBRILE INFECTION, ACUTE DISEASE, PROGRESSIVE CHRONIC DISEASE, KNOWN HYPERSENSITIVITY TO ANY OF THE INGREDIENTS OF THE VACCINE. |
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| Side Effects | MINOR LOCAL REACTIONS : PAIN, ERYTHEMA, OEDEMA, PRURITUS AND INDURATION AT THE INJECTION POINT. |
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| Unit Price | - |
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| EDL |
No |
|---|
| Description | FREEZE -DRIED CAKE IN THE VIAL, DISSOLVES READILY INTO SOLUTION WITH THE DILUENT SUPPLIED FORMING A CLEAR OR SLIGHTLY OPALESCENT SOLUTION |
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| Note | |
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| License Owner | ARAVANH PHARMA SOLE CO.,LTD |
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| Manufacturer | BHARAT BIOTECH INTERNATIONAL LIMITED |
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| Country | INDIA |
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| Import Registration No | 03/HD/AP/98/V/R/ IN FORM 28 -D |
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| Import Registration Date | 1998-10-14 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2021-08-27 |
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| FDD Registration No | 07 I 3860/13 |
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| FDD Registration Date | 2022-05-30 |
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| Expiry Date | 2025-05-29 |
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