Septrin Paediatric Suspension suspension oral

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

trimethoprim, sulfamethoxazole

Tilgjengelig fra:

Aspen Bad Oldesloe GmbH

ATC-kode:

J01EE01

INN (International Name):

trimethoprim, sulfamethoxazole

Dosering :

8mg/ml+ 40mg/ml

Legemiddelform:

suspension oral

Enheter i pakken:

glass bottle 100ml and double-ended measuring spoon (2,5ml/5ml)

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2019-01-18

Informasjon til brukeren

SEPTRIN
®
PAEDIATRIC SUSPENSION
TRIMETHOPRIM-SULFAMETHOXAZOLE
QUALITATIVE AND QUANTITATIVE COMPOSITION
FORMULATION
TRIMETHOPRIM
CONTENT
SULFAMETHOXAZOLE
CONTENT
Paediatric Oral Suspension
40 mg per 5 ml
200 mg per 5 ml
PHARMACEUTICAL FORM
Oral suspension.
PHARMACOTHERAPEUTIC GROUP:
Combinations of sulphonamides and trimethoprim, incl. derivatives. ATC
code: J01EE01.
CLINICAL PARTICULARS
INDICATIONS
_SEPTRIN_ should only be used where, in the judgment of the physician,
the benefits of treatment outweigh
any possible risks; consideration should be given to the use of a
single effective antibacterial agent.
The _in vitro_ susceptibility of bacteria to antibiotics varies
geographically and with time; the local situation
should always be considered when selecting antibiotic therapy.
_SEPTRIN_ paediatric suspension is indicated in children aged 12 years
and under (infants (>6 weeks to <2
years old) and children (>2 to <12 years old) for the treatment of the
following infections:
URINARY TRACT INFECTIONS
Treatment of acute uncomplicated urinary tract infections. It is
recommended that initial episodes of
uncomplicated urinary tract infections be treated with a single
effective antibacterial agent rather than the
combination.
RESPIRATORY TRACT INFECTIONS
Treatment of middle ear infection. _SEPTRIN_ is not indicated for
prophylactic or prolonged administration
in middle ear infection.
Treatment of acute exacerbations of chronic bronchitis.
Treatment and prevention of Pneumocystis jiroveci pneumonitis _(see
Dosage and Administration and _
_Adverse Reactions)_.
GASTROINTESTINAL TRACT INFECTIONS
Clinicians should be aware that first line therapy in the management
of all patients with diarrhoeal disease
is the maintenance of adequate hydration.
Treatment of cholera, as an adjunct to fluid and electrolyte
replacement, when the organism has been
shown to be sensitive in vitro.
Treatment of shigellosis, this regime may be less effective in some
parts of the world due to resistant
organisms.
Treatment of travellers' diarrhoea (i

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_SEPTRIN_ 40 mg/200 mg per 5 ml Paediatric Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 40 mg Trimethoprim and 200 mg Sulfamethoxazole
Excipient(s) with known effect:
This product contains less than 1 mmol of sodium (23 mg) per dose, and
therefore is essentially
sodium free.
Also
contains
3.25 g sorbitol per 5
ml,
less
than
100 mg of
ethanol per 5 ml
and
methyl
hydroxybenzoate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral suspension
Off white in colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_SEPTRIN_ should only be used where, in the judgment of the physician,
the benefits of treatment
outweigh any possible risks; consideration should be given to the use
of a single effective
antibacterial agent.
The _in vitro_ susceptibility of bacteria to antibiotics varies
geographically and with time; the local
situation should always be considered when selecting antibiotic
therapy.
_SEPTRIN_ paediatric suspension is indicated in children aged 12 years
and under (infants (>6 weeks
to <2 years old) and children (>2 to <12 years old) for the treatment
of the following infections:
URINARY TRACT INFECTIONS
Treatment of acute uncomplicated urinary tract infections. It is
recommended that initial episodes
of uncomplicated urinary tract infections be treated with a single
effective antibacterial agent rather
than the combination.
RESPIRATORY TRACT INFECTIONS
Treatment of middle ear infection. _ SEPTRIN_ is not indicated for
prophylactic or prolonged
administration in middle ear infection.
Treatment of acute exacerbations of chronic bronchitis.
Treatment and prevention of _Pneumocystis jiroveci_ pneumonitis (see
Dosage and Administration
and Adverse Reactions).
2
GASTROINTESTINAL TRACT INFECTIONS
Clinicians should be aware that first line therapy in the management
of all patients with diarrhoeal
disease is the maintenance of adequate hydration.
Treatment of cholera, as an adjunct to fluid and