DBL SULFAMETHOXAZOLE 400 mg and TRIMETHOPRIM 80 mg/5 mL concentrated injection ampoule

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

trimethoprim, Quantity: 16 mg/mL; sulfamethoxazole, Quantity: 80 mg/mL

Disponible depuis:

Pfizer Australia Pty Ltd

forme pharmaceutique:

Injection, concentrated

Composition:

Excipient Ingredients: sodium metabisulfite; propylene glycol; ethanol; diethanolamine; sodium hydroxide; water for injections; hydrochloric acid

Mode d'administration:

Intravenous

Unités en paquet:

5x5mL

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

INDICATIONS AS AT 31 OCTOBER 2003 :Parenteral administration of sulfamethoxazole/trimethoprim is indicated where oral dosage is not desirable or practical, e.g. pre- and post-operative infections associated with surgery, trauma or gynaecology; septicaemia and other infections due to sensitive organisms such as typhoid and paratyphoid.

Descriptif du produit:

Visual Identification: Colourless to slightly yellow solution; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

1991-10-08

Notice patient

DBL™
SULFAMETHOXAZOLE 400
MG AND TRIMETHOPRIM
80 MG CONCENTRATE
INJECTION BP
_Sulfamethoxazole (sul-fa-meth-OX-a-zole) and trimethoprim
(try-METH-oh-prim)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL
Sulfamethoxazole 400mg and
Trimethoprim 80mg Concentrate
Injection BP. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DBL
Sulfamethoxazole 400mg and
Trimethoprim 80mg Concentrate
Injection BP against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DBL
SULFAMETHOXAZOLE
400MG AND
TRIMETHOPRIM 80MG
CONCENTRATE INJECTION
BP IS USED FOR
DBL Sulfamethoxazole 400mg and
Trimethoprim 80mg Concentrate
Injection BP is an antibacterial
product containing two different
antibiotics, sulfamethoxazole and
trimethoprim. Together, both drugs
are more efficient than either one is
alone.
Sulfamethoxazole/trimethoprim is
used to treat infections where
treatment with the oral dosage form
of the antibiotic is not appropriate.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
DBL Sulfamethoxazole 400mg and
Trimethoprim 80mg Concentrate
Injection BP for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
SULFAMETHOXAZOLE 400MG AND
TRIMETHOPRIM 80MG CONCENTRATE
INJECTION BP IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
sulfamethoxazole
•
any medicine containing
trimethoprim
•
any of the ingredients listed at the
end of this leaflet.
Some people are allergic to ‘sulfa’
drugs. Sulfamethoxazole is a ‘sulfa’-
containing medic

Résumé des caractéristiques du produit

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AUSTRALIAN
PRODUCT
INFORMATION
-
DBL™
SULFAMETHOXAZOLE
400
MG
AND
TRIMETHOPRIM
80
MG
CONCENTRATE
INJECTION BP
1. NAME OF THE MEDICINE
Sulfamethoxazole/trimethoprim
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Sulfamethoxazole 400 mg and Trimethoprim 80 mg Concentrate
Injection BP is an
antibacterial
combination
product,
containing
16
mg
Trimethoprim
BP
and
80
mg
Sulfamethoxazole BP per mL in a 40 percent propylene glycol vehicle.
EXCIPIENT(S) WITH KNOWN EFFECT:
•
sulfites
•
alcohol 10% v/v.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
The solution is clear and has a pH of approximately 10. Hydrochloric
acid and sodium
hydroxide are used to adjust the pH during the manufacture of DBL
Sulfamethoxazole 400 mg
and Trimethoprim 80 mg Concentrate Injection BP.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parenteral administration of DBL Sulfamethoxazole 400 mg and
Trimethoprim 80 mg
Concentrate Injection BP is indicated where oral dosage is not
desirable or practical, e.g. pre-
and post-operative infections associated with surgery, trauma or
gynaecology; septicaemia and
other infections due to sensitive organisms such as typhoid and
paratyphoid.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL Sulfamethoxazole 400 mg and Trimethoprim 80 mg Concentrate
Injection BP must be
diluted
prior
to
administration.
Sulfamethoxazole/trimethoprim
should
be
administered
intravenously only in the form of an infusion solution, and may not be
injected undiluted either
intravenously or direct into the infusion tube.
DBL Sulfamethoxazole 400 mg and Trimethoprim 80 mg Concentrate
Injection BP may be
mixed only with the following infusion solutions:
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5% Glucose Injection
4% Glucose/0.18% Sodium Chloride Injection
0.9% Sodium Chloride
10% Glucose Injection
2.5% Glucose/0.45% Sodium Chloride Injection
0.45% Sodium Chloride Injection
10% Dextran 40 in 5% Glucose
6% D