Biseptol Medana suspension oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sulfamethoxazole, trimethoprim

Available from:

Pharmaceutical Works POLPHARMA S.A. Medana Branch in Sieradz

ATC code:

J01EE01

INN (International Name):

sulfamethoxazole, trimethoprim

Dosage:

200mg/5ml+ 40mg/5ml

Pharmaceutical form:

suspension oral

Units in package:

80ml glass bottle and measuring cup

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-08-10

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Biseptol Medana, 240 mg/5 ml, oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimethoprim (TM) and sulfamethoxazole (SMZ)
2.1
GENERAL DESCRIPTION
Trimethoprim (TM) and sulfamethoxazole (SMZ). The combination of the
two active substances TM and
SMZ has established itself under the name co-trimoxazole.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of suspension contains:
sulfamethoxazole 4.0 g
trimethoprim 0.8 g
5 ml of suspension contains 200 mg SMZ and 40 mg TM.
_Excipients which shall be taken into account the medicinal product
composition: _
5 ml of suspension contains: 2.42 g of maltitol, 7.5 mg of methyl
parahydroxybenzoate, 2.5 mg of propyl
parahydroxybenzoate, 142,72 mg of propylene glycol, 14 mg of
macrogolglycerol hydroxystearate, 38 mg
of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Suspension with white or light creamy color with a strawberry smell.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Owing to the sometimes-serious side effects of Biseptol Medana and the
emergence of resistance, a risk-
benefit assessment should always be made prior to using Biseptol
Medana, 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.
-
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 be administered:
-
Typhoid
fever,
parat