מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Sulfamethoxazole 80 mg/mL; Trimethoprim 16 mg/mL
Pfizer New Zealand Limited
Sulfamethoxazole 80 mg/mL
480 mg/5mL
Solution for injection
Active: Sulfamethoxazole 80 mg/mL Trimethoprim 16 mg/mL Excipient: Propylene glycol Purified water
Ampoule, glass, Type I, clear, one point cut, 5 x 5ml, 25 mL
Prescription
Prescription
Virchow Laboratories Limited
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)
1987-06-18
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 Page 2 of 21 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 קרא את המסמך השלם