Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Mylan (Pty) Ltd, 4 Brewery street, Isando, Gauteng, Republic of South Africa
PRETAMYL 200 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablets. White to off-white oval tablets debossed with M on one side and P200 on the other side. |
Each PRETAMYL tablet contains 200 mg pretomanid.
Contains sugar: lactose monohydrate 294,4 mg per tablet.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
The mechanism of action of pretomanid is thought to involve inhibition of the synthesis of cell wall lipids under aerobic conditions and generation of reactive nitrogen species under anaerobic conditions. Reductive activation of pretomanid by a mycobacterial deazaflavin (F420)-dependent nitro-reductase is required for activity under both aerobic and anaerobic conditions. |
| List of Excipients |
|---|
|
Colloidal silicon dioxide |
PRETAMYL is packaged in either white, round, high-density polyethylene bottles with white polypropylene child-resistant closure or child-resistant blister packages comprised of a polyvinylchloride film with foil and paper backing.
Pack sizes:
Bottles of 30 tablets and 28 tablets.
Unit dose blister pack of 28 (2 strips of 14 tablets).
Mylan (Pty) Ltd, 4 Brewery street, Isando, Gauteng, Republic of South Africa
54/20.2.3/0657.655
16 March 2021
| Drug | Countries | |
|---|---|---|
| PRETAMYL | South Africa |
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