Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

TRIMETHOPRIM, SULFAMETHOXAZOLE

Tilgjengelig fra:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

ATC-kode:

J01EE01

INN (International Name):

TRIMETHOPRIM 40 mg/5ml SULFAMETHOXAZOLE 200 mg/5ml

Legemiddelform:

ORAL SUSPENSION

Sammensetning:

TRIMETHOPRIM 40 mg/5ml SULFAMETHOXAZOLE 200 mg/5ml

Resept typen:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-04-17

Informasjon til brukeren

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEPTRIN PAEDIATRIC 40 MG/200 MG PER 5ML ORAL SUSPENSION
TRIMETHOPRIM AND SULFAMETHOXAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR THEM.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your child’s doctor or
pharmacist.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm them,
even if their signs of illness are the same as your child.
-
If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Septrin Paediatric Suspension is and what it is used for.
2.
What you need to know before your child takes Septrin Paediatric
Suspension.
3.
How to give Septrin Paediatric Suspension.
4.
Possible side effects.
5.
How to store Septrin Paediatric Suspension.
6.
Contents of the pack and other information.
1.
WHAT SEPTRIN
PAEDIATRIC SUSPENSION IS AND WHAT IT IS USED FOR
Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension (called
‘Septrin Paediatric Suspension’ in this
leaflet) is a combination of two different antibiotics called
sulfamethoxazole and trimethoprim, which is used
to treat infections caused by bacteria. This medicine combination is
also named as co-trimoxazole. Like all
antibiotics, Septrin Paediatric Suspension only works against some
types of bacteria. This means that it is
only suitable for treating some types of infections.
Septrin Paediatric Suspension can be used to treat or prevent:
•
lung infections (pneumonia) caused by the micro-organism,
_Pneumocystis_
_jirovecii_
(previously known
as
_Pneumocystis carinii_
) (some people call this ‘PJP’).
Septrin Paediatric Suspension can be used to treat:
•
urinary bladder or urinary tract infections (water infections).
•
respiratory tract infections such as bronchitis.
•

Preparatomtale

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1.
NAME OF THE MEDICINAL PRODUCT
Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 40 mg Trimethoprim and 200 mg Sulfamethoxazole.
Excipients with known effect:
Contains 2.3 g of sorbitol (E 420) per 5 ml, 13.50 μL of ethanol per
5 ml, 5 mg of methyl hydroxybenzoate
(E218) per 5 ml, 10.95 mg of sodium per 5 ml (inclusive of 5mg of
sodium benzoate E 211), vanilla flavour
with 0.00015 μL sulphur dioxide per 5 ml and 750 mg of glycerol per
5ml.
For the full list of excipients, see section 6.1,
3.
PHARMACEUTICAL FORM
Oral suspension
An off-white, banana and vanilla flavoured syrup.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Septrin Paediatric Suspension is indicated in infants and children
aged 6 weeks to 12 years old ) for the
treatment of the following infections when owing to sensitive
organisms (see section 5.1) :
_-_
_ _
_Urinary tract infections: _
For simple urinary tract infections, trimethoprim alone or another
single
antimicrobial agent is the preferred treatment. Since trimethoprim is
also as efficacious as Septrin for
the prophylaxis of recurrent urinary tract infections, Septrin is not
indicated for prophylactic use.
_-_
_ _
_Respiratory tract infections: _
Septrin may be used as second line therapy in chronic obstructive
airways
disease or other respiratory tract infections, including acute otitis
media where sensitivity has been
demonstrated
or
is
highly
probable.
(Septrin
is
not
indicated
for
prophylactic
or
prolonged
administration in otitis media).
_-_
_ _
Treatment and prevention of
_Pneumocystis jirovecii pneumonitis (PJP)_
.
_-_
_ _
Septrin may be used in the management of other serious conditions such
as nocardiasis, toxoplasmosis
and brucellosis.
_ _
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be continued until the patient has been symptom free
for two days; acute infections will