Bactrim suspension oral

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

sulfamethoxazole, trimethoprim

Commercializzato da:

Eumedica Pharmaceuticals AG

Codice ATC:

J01EE01

INN (Nome Internazionale):

sulfamethoxazole, trimethoprim

Dosaggio:

200mg/5ml+ 40mg/5ml

Forma farmaceutica:

suspension oral

Confezione:

100ml glass bottle

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2021-11-23

Scheda tecnica

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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.
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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