Bactrim suspension oral

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

sulfamethoxazole, trimethoprim

Доступна с:

F. Hoffmann-La Roche AG

код АТС:

J01EE01

ИНН (Международная Имя):

sulfamethoxazole, trimethoprim

дозировка:

200mg/5ml+ 40mg/5ml

Фармацевтическая форма:

suspension oral

Штук в упаковке:

100ml glass bottle

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-07-26

тонкая брошюра

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BACTRIM
®
200 MG+40 MG SYRUP
_sulfamethoxazole + trimethoprim _
-
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Bactrim
®
is and what it is used for
2. What you need to know before you take Bactrim
®
3. How to take Bactrim
®
4. Possible side effects
5. How to store Bactrim
®
6. Contents of the pack and other information
1. WHAT BACTRIM
® IS AND WHAT IT IS USED FOR
Bactrim
®
syrup contains two active substances: trimethoprim and
sulfamethoxazole. Combined, they
complement each other to form a medicine that can kill a wide range of
organisms that cause disease.
Because there are two active substances, the risk that the bacteria
“get used to” the medicine (i.e. develop
resistance) is also lower.
Bactrim
®
is used in the following diseases:
-
Infections of the upper and lower airways and ears, such as
inflammation of the bronchi, pneumonia,
otitis media, sinus infections;
-
Infections of the kidneys, bladder, urinary and genital organs;
-
Gastrointestinal infections, such as diarrhoea caused by bacteria,
cholera, and typhoid and
paratyphoid fever.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACTRIM
®
This medicine has been prescribed for you to treat your current
illness. The active substance combination
in Bactrim
®
is not effective against all microorganisms that cause infectious
diseases. Use of an
incorrectly chosen or improperly dosed antibiotic can cause
complications.

Характеристики продукта

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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