This brand name is authorized in Nigeria.
The drug AVROFLOX TN contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
A4P49JAZ9H - OFLOXACIN
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Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both Gram-negative and Gram-positive organisms. The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination. |
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2
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UNII
033KF7V46H - TINIDAZOLE
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Tinidazole is active against both protozoa and obligate anaerobic bacteria. The activity against protozoa involves Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia. The mode of action of tinidazole against anaerobic bacteria and protozoa involves penetration of the drug into the cell of the micro-organism and subsequent damage of DNA strands or inhibition of their synthesis. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-1981 | Caplet | Avroflox Tn TAB 200 mg; 600 mg 1 x 10's (in PVC-Alu blister) | Oral caplet Oblong, nearly white to off-white caplet marked with "AVRO AFXTN" on one side and scored on the revise side 6/14/2024 17:23:54 AVROFLOX TN OFLOXACIN, TINIDAZOLE B4-1981 CAPLET ORAL OFLOXACIN, TINIDAZOLE OFLOXACIN 200MG, TINIDAZOLE 600MG 1 X 10 POM SKG-PHARMA LIMITED 7/9 SAPARA STREET, OFF OBA AKRAN AVENUE, IKEJA LAGOS SKG-PHARMA LIMITED 7/9 SAPARA STREET, OFF OBA AKRAN AVENUE, IKEJA LAGOS NIGERIA 24/11/2022 23/11/2027 No J01RA09 | 24/11/2022 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J01MA01 | Ofloxacin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01M Quinolone antibacterials → J01MA Fluoroquinolones |
| J01RA11 | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01R Combinations of antibacterials → J01RA Combinations of antibacterials | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| NG | Registered Drug Product Database | B4-1981 |
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