Septrin Paediatric Suspension

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

trimethoprim, sulfamethoxazole

Mevcut itibaren:

Aspen Bad Oldesloe GmbH

INN (International Adı):

trimethoprim, sulfamethoxazole

Doz:

8mg/ml+40mg/ml

Farmasötik formu:

suspension

Reçete türü:

Prescription

Bilgilendirme broşürü

SEPTRIN®
PAEDIATRIC SUSPENSION
TRIMETHOPRIM-SULFAMETHOXAZOLE
QUALITATIVE AND QUANTITATIVE COMPOSITION
FORMULATION
TRIMETHOPRIM
SULFAMETHOXAZOLE
CONTENT
CONTENT
Paediatric Oral Suspension
40 mg per 5 ml
200 mg per 5 ml
PHARMACEUTICAL FORM
Suspension.
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.
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_ (_P. carinii_)
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 (including gastroenteritis due to
enterotoxigenic _E. coli_).
OTHER BACTERIAL INFECTIONS CAUSED BY SENSITIVE ORGANISMS
There are a number of other bacterial infections caused by sensitive
organisms
for which treatment with _SEPTRIN_ may be appropriate; the use of
_SEPTRIN_ in such
condit

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
1.
NAME OF THE MEDICINAL PRODUCT
_ _
_ _
SeptrinPaediatricSuspension
_ _
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_ _
Each5 mlcontains200 mgSulfamethoxazoleand40 mgTrimethoprim
_ _
Excipients:
Thisproductcontainslessthan1mmolofsodium(23mg)perdose,andthereforeis
essentiallysodiumfree.
_ _
Also contains3.25 g sorbitolper5 mlandless than100 mgof ethanolper5
ml. For
afulllistof excipients,seeSection6.1
_ _
3.
PHARMACEUTICAL FORM
_ _
_ _
Suspension
_ _
Off whiteincolour.
_ _
_ _
_ _
4. CLINICAL PARTICULARS
_ _
_ _
4.1
THERAPEUTIC INDICATIONS
_ _
_ _
SeptrinPaediatricSuspensionisindicatedfor thetreatmentof
thefollowinginfections when
owing tosensitiveorganisms(seesection5.1):
_ _
Treatmentandpreventionof _Pneumocystis jiroveci (P.
carinii)_pneumonitis
Treatmentandprophylaxisof toxoplasmosis
Treatmentof nocardiosis
_ _
ThefollowinginfectionsmaybetreatedwithSeptrinwherethereisbacterialevidence
of
sensitivitytoSeptrinandgood reasontopreferthecombinationof
antibioticsin
Septrintoasingleantibiotic:
_ _
Acuteuncomplicatedurinarytractinfection
Acuteotitismedia
Acuteexacerbationofchronicbronchitis
Considerationshouldbegiventoofficialguidanceon theappropriateuseof
antibacterialagents.
_ _
_ _
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_ _
Methodof administration:oral.
_ _
ItmaybepreferabletotakeSeptrinwithsomefood or drinktominimisethe
possibilityof gastrointestinaldisturbances.
_ _
Standarddosagerecommendationsfor acuteinfections
_ _
_Children aged 12 years and under:_
_ _
STANDARD DOSAGE
Age
PaediatricSuspension
6 to12 years
10 mlevery12 hours
6 monthsto5 years
5 mlevery12 hours
6 weeks to5 months
2.5 mlevery12 hours
_ _
Thisdosageapproximatesto6 mgtrimethoprimand30 mgsulfamethoxazoleper
kilogrambody weightper24 hours.
_ _
Treatmentshouldbecontinueduntilthepatienthas
beensymptomfreefor
two
days;
themajoritywillrequiretreatmentfor
atleast5
days.
Ifclinicalimprovementisnot
evidentafter7 days'therapy,thepatientshouldbereassessed.
_ _
As
analternativetoStandardDosag