SEPTRIN Concentrate for solution for infusion Ref.[108387] Active ingredients: Sulfamethoxazole Trimethoprim

Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Septrin 80 mg/400 mg per ampoule, concentrate for solution for infusion.

Pharmaceutical Form
Concentrate for Solution for Infusion. Clear faintly yellow to brown solution. The pH of the solution is in the range 9.6 to 10.5.

Qualitative and quantitative composition

Each 5 ml ampoule contains 80 mg trimethoprim and 400 mg sulfamethoxazole.

Excipients with known effect: Contains 38.25 mg of sodium per 5 ml ampoule (inclusive of sodium metabisulphite E 223), 0.5 mg ethanol (alcohol) per 5 ml ampoule and 2.25 g of propylene glycol (E 1520) per 5ml ampoule.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Sulfamethoxazole	Sulfamethoxazole competitively inhibits the utilisation of para-aminobenzoic acid in the synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis.
Trimethoprim	Trimethoprim is a dihydrofolate reductase inhibitor, inhibiting the conversion of bacterial dihydrofolic acid to tetrahydrofolic acid, required for the synthesis of some amino acids. Its effects are considerably greater on the cells of micro-organisms than on the mammalian cells.

List of Excipients
Propylene glycol Trometamol Sodium hydroxide Sodium metabisulphite (E223) Ethanol (96%) Water for injections

Pack sizes and marketing

5ml Type 1, clear-neutral glass ampoule.

Pack size: Box of 10x5ml ampoules.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1691/010/005

Date of first authorisation: 14^th November 1975
Date of last renewal: 14^th November 2005

Drugs

Drug	Countries
SEPTRIN	Australia, Spain, Ireland, Malta, Turkey

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