Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sulfamethoxazole, trimethoprim
Eumedica Pharmaceuticals AG
J01EE01
sulfamethoxazole, trimethoprim
200mg/5ml+ 40mg/5ml
suspension oral
100ml glass bottle
Prescription
Registered
2021-11-23
Page 1 of 20 spcera-en-bacsyr-000-jul22-clean.docx SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bactrim 200 mg+40 mg _ _ oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sulfamethoxazole (SMZ) and trimethoprim (TMP) 2.1 GENERAL DESCRIPTION Sulfamethoxazole (SMZ) and trimethoprim (TMP). The combination of the two active substances SMZ and TMP has established itself under the name co-trimoxazole. Pale yellow oral suspension in an amber glass bottle of 100 ml. _ _ 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bactrim oral suspension contains 200 mg SMZ and 40 mg TMP / 5 ml. _Excipients which shall be taken into account in the medicinal product composition: _ Methyl-p-hydroxybenzoate (E 218), propyl-p-hydroxybenzoate (E 216), sorbitol solution 70% (non- crystallising) (E 420), banana flavouring (contains propylene glycol (E 1520)) and vanilla flavouring (contains ethanol 9 mg / 5 ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _S_ uspension, oral. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Owing to the sometimes-serious side effects of Bactrim and the emergence of resistance, a risk-benefit assessment should always be made prior to using Bactrim, compared to other active substances that may also be considered for these indications. Infections due to co-trimoxazole-sensitive organisms, such as: Infections of the upper and lower respiratory tract and of the ear: acute exacerbations of chronic bronchitis, bronchiectasis, pneumonia (including _Pneumocystis jirovecii_ (formerly _carinii_ ) pneumonia), sinusitis, otitis media. Urogenital infections: acute and chronic cystitis, pyelonephritis, urethritis, prostatitis. Page 2 of 20 spcera-en-bacsyr-000-jul22-clean.docx Gastrointestinal infections including: travellers' diarrhoea, chronic typhoid fever carriers, cholera (as a complementary measure to fluid and electrolyte intake). Cotrimoxazole should only be used for the following infections if the following currently recommended antibiotics cannot b Прочитать полный документ