Septrin Sugar-free Paediatric Suspension

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

sulfamethoxazole, Quantity: 32.922 mg/g; trimethoprim, Quantity: 6.584 mg/g

Inapatikana kutoka:

Arrotex Pharmaceuticals Pty Ltd

Dawa fomu:

Oral Liquid, suspension

Tungo:

Excipient Ingredients: methyl hydroxybenzoate; sodium benzoate; carmellose sodium; sorbitol; dispersible cellulose; glycerol; polysorbate 80; ethanol; sunset yellow FCF; allura red AC; saccharin sodium; citric acid; purified water; Flavour

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

100mL

Darasa:

Medicine Registered

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

INDICATIONS AS AT 01 MARCH 2002 : Upper and lower respiratory tract infections; renal and urinary tract infections; genital tract infections; gastrointestinal tract infections; skin and wound infections; septicaemias, and other infections caused by sensitive organisms.

Bidhaa muhtasari:

Visual Identification: A pink suspension with a characteristic cherry odour. Free from undispersed material.; Container Type: Bottle; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

1991-08-02

Taarifa za kipeperushi

SEPTRIN FORTE & SEPTRIN SUSPENSION- Consumer Medicine Information
Page 1 of 3
SEPTRIN FORTE &
SEPTRIN SUGAR-FREE PAEDIATRIC SUSPENSION
_trimethoprim and sulfamethoxazole_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
SEPTRIN. It does not contain all
of the available information. It
does not take the place of talking
to your doctor or pharmacist.
Taking any medicine involves
some risk. You doctor has
weighted the risks of you using
SEPTRIN against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING SEPTRIN, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it again.
WHAT SEPTRIN IS
USED FOR
SEPTRIN is used for the
treatment of a variety of bacterial
infections, including bronchitis
and infections of the ear, sinus,
kidney, bladder, stomach, bowel,
skin and wounds.
Trimethoprim and
sulfamethoxazole (the active
ingredients in SEPTRIN) belong
to a group of medicines called
"anti-infectives". They work in
slightly different ways to stop the
growth of bacteria causing the
infection.
IF YOU HAVE ANY QUESTIONS
ABOUT WHY YOU ARE TAKING
SEPTRIN, ASK YOUR DOCTOR OR
PHARMACIST.
Your doctor may have prescribed
it for another reason.
There is no evidence that this
medicine is addictive.
SEPTRIN is only available with a
doctor’s prescription.
BEFORE TAKING IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE SEPTRIN IF YOU
HAVE AN ALLERGY TO:
•
trimethoprim
•
Sulfamethoxazole
•
Any of the ingredients listed at
the end of this leaflet
DO NOT TAKE SEPTRIN AFTER THE
EXPIRY DATE PRINTED ON THE PACK
OR BOTTLE.
SEPTRIN may have no effect if
you take it after the expiry date.
DO NOT TAKE SEPTRIN IF THE
PACKAGING APPEARS TO HAVE
BEEN TAMPERED WITH.
DO NOT TAKE SEPTRIN TO TREAT
ANY OTHER CONDITIONS UNLESS
ADVISED BY YOUR DOCTOR.
DO NOT GIVE SEPTRIN TO
ANYONE ELSE, EVEN IF THEIR
SYMPTOMS SEEM SIMILAR TO
YOURS.
_BEFORE YOU START TO USE IT _
YOU MUST TELL YOUR DOCTOR IF:
YOU ARE ALLERGIC TO:
•
trimethoprim,

Tabia za bidhaa

1
AUSTRALIAN PRODUCT INFORMATION – SEPTRIN
(TRIMETHOPRIM/SULFAMETHOXAZOLE) ORAL LIQUID
1
NAME OF THE MEDICINE
Trimethoprim/sulfamethoxazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Septrin in an antibacterial combination containing trimethoprim and
sulfamethoxazole in a ratio of 1:5.
Each 5 mL of Septrin sugar free oral liquid contains 40 mg
trimethoprim and 200 mg sulfamethoxazole.
EXCIPIENT(S) WITH KNOWN EFFECT:
hydroxybenzoate, benzoate and saccharin
For the full list of excipients see section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
A pink suspension with a characteristic cherry odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Upper and lower respiratory tract infections; renal and urinary tract
infections; genital tract infections;
gastrointestinal tract infections; skin and wound infections;
septicaemias, and other infections caused
by sensitive organisms.
4.2
DOSE AND METHOD OF ADMINISTRATION
In the majority of acute infections, Septrin should be given for at
least 5 days or until the patient has
been symptom free for 2 days.
DOSAGE
_CHILDREN UNDER 12 YEARS _
6 to 12 years: 5 to 10 mL Septrin Paediatric Suspension every twelve
hours
2 to 5 years: 2.5 to 5 mL Septrin Paediatric Suspension every twelve
hours
under 2 years: 2.5 mL Septrin Paediatric Suspension every twelve
hours.
These amounts approximate to a dose of 6 mg/kg trimethoprim daily plus
30 mg/kg sulfamethoxazole
daily. For severe infections dosage may be increased by 50%.
_ _
_TREATMENT OF PNEUMOCYSTIS CARINII PNEUMONITIS _
The recommended dosage for patients with documented Pneumocystis
carinii pneumonitis is 20 mg/kg
trimethoprim and 100 mg/kg sulfamethoxazole per 24 hours given in
equally divided doses every 6
hours for 14 days. The aim is to obtain peak plasma or serum levels of
>5 microgram/mL (see section
4.8 ADVERSE EFFECT (UNDESIRABLE EFFECTS)
).
_ _
e003608
Septrin oral liquid PI-clean
Pg. 1
2
_USE IN THE ELDERLY_
See section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_DOSAGE IN PATIENTS WITH REDUCED RENAL FUNCTION_