DBL SULFAMETHOXAZOLE 400MG AND TRIMETHOPRIM 80MG CONCENTRATE INJECTION BP

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

SULPHAMETHOXAZOLE; TRIMETHOPRIM

Fáanlegur frá:

PFIZER PRIVATE LIMITED

ATC númer:

J01EE01

Skammtar:

80 mg/mL

Lyfjaform:

INJECTION

Samsetning:

SULPHAMETHOXAZOLE 80 mg/mL; TRIMETHOPRIM 16mg/mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

Siegfried Hameln GmbH

Leyfisstaða:

ACTIVE

Leyfisdagur:

1988-06-30

Vara einkenni

DBL™ SULFAMETHOXAZOLE 400 MG AND TRIMETHOPRIM 80 MG
1. NAME OF THE MEDICINE
Sulfamethoxazole/trimethoprim
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Sulfamethoxazole 400 mg and Trimethoprim 80 mg is an antibacterial
combination
product, containing 16 mg Trimethoprim and 80 mg Sulfamethoxazole per
mL in a 40 percent
propylene glycol vehicle.
Excipients with known effect:
•
Sulfites
•
Alcohol 10% v/v
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Concentrated injection.
Colourless to slightly yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parenteral administration of DBL Sulfamethoxazole 400 mg and
Trimethoprim 80 mg 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
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 may be mixed only
with the
following infusion solutions:
•
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% Dextran 70 in 0.9% Sodium Chloride Injection
•
Hartmann’s Injection
No other agent should be added to or mixed with the infusion.
It is important to adhere to the following minimum dilution scheme,
which is based on a
proportion of 1 mL DBL Sulfamethoxazole 400 mg and Trimethoprim 80 mg
to 25 to 30 mL
infusion fluid. Add one ampoule (5 mL) to 125 mL infusion solution;
two ampoules (10 mL)
to 250 mL infusion solu