DBL™ Sulfamethoxazole 400mg and Trimethoprin 80mg Concentrate injection

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Sulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mL

Fáanlegur frá:

Pfizer New Zealand Limited

INN (Alþjóðlegt nafn):

Sulfamethoxazole 80 mg/mL

Skammtar:

480 mg/5mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Sulfamethoxazole 80 mg/mL Trimethoprim 16 mg/mL Excipient: Propylene glycol Purified water

Einingar í pakka:

Ampoule, glass, Type I, clear, one point cut, 5 x 5ml, 25 mL

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Virchow Laboratories Limited

Vörulýsing:

Package - Contents - Shelf Life: Ampoule, glass, Type I, clear, one point cut, 5 x 5ml - 25 mL - 24 months from date of manufacture stored at or below 30°C 24 hours opened stored at room temperature (below 30°C)

Leyfisdagur:

1987-06-18

Vara einkenni

Version: pfdsulfi10822
Supersedes: pfdsulfi10522
Page 1 of 21
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
™
Sulfamethoxazole 400 mg and Trimethoprim 80 mg Solution for Injection
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.
EXCIPIENT(S) WITH KNOWN EFFECT

Sodium metabisulfite

Ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
The solution is clear and has a pH of approximately 10.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
DOSAGE FOR ADULTS AND CHILDREN OVER 12 YEARS
Standard Dose: 10 mL diluted and infused twice daily.
For severe infections: 15 mL diluted and infused twice daily.
DOSAGE FOR CHILDREN TO 12 YEARS
The recommended dosage is approximately 6 mg trimethoprim and 30 mg
sulfamethoxazole
per kg bodyweight per day, divided into two equal doses, morning and
evening. As a guide,
the following doses of DBL Sulfamethoxazole 400 mg and Trimethoprim 80
mg may be used:
Version: pfdsulfi10822
Supersedes: pfdsulfi10522
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2 months to 5 months:
1.25 mL diluted and infused twice daily.
6 months to 5 years:
2.5 mL diluted and infused twice daily.
6 years to 12 years:
5 mL diluted and infused twice daily.
The recommended dosage for patients with documented _Pneumocystis
jirovecii _pneumonia is
20 mg/kg trimethoprim and 100 mg/kg sulfamethoxazole per 24 hours
given in equally divided
doses every 6 hours for 14 days.
DOSE ADJUSTMENTS
RENAL IMPAIRMENT
In patients with impaired renal function, the dosage and/or f