Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Ceftriaxone sodium 596mg (Present as 0.596g ceftriaxone Sodium*3.5H2O. Eq 0.53965g of ceft. sodium anh or 0.5g ceftriaxone anh)
AFT Pharmaceuticals Ltd
Ceftriaxone sodium 539.65 mg (equivalent to ceftriaxone 500 mg)
500 mg
Powder for injection
Active: Ceftriaxone sodium 596mg (Present as 0.596g ceftriaxone Sodium*3.5H2O. Eq 0.53965g of ceft. sodium anh or 0.5g ceftriaxone anh)
Vial, glass, Type 1 with rubber stopper (Qilu), 1 dose unit
Prescription
Prescription
Qilu Antibiotics Pharmaceutical Co Ltd
Infections caused by pathogens sensitive to Ceftriaxone e.g.: · sepsis; · meningitis; · abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts); · infections of the bones, joints, soft tissue, skin and of wounds; · infections in patients with impaired defence mechanisms; · renal and urinary tract infections; · respiratory tract infections, particularly pneumonia, and ear, nose and throat infections; · genital infections, including gonorrhoea. · perioperative prophylaxis of infections.
Package - Contents - Shelf Life: Vial, glass, Type II with rubber stopper (Qilu Antibiotic) - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type II with rubber stopper (Qilu) - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber stopper (Qilu) - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type II with rubber stopper (Qilu Antibiotic) - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type II with rubber stopper (Qilu) - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber stopper (Qilu) - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type II with rubber stopper (Qilu Antibiotic) - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type II with rubber stopper (Qilu) - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber stopper (Qilu) - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2010-09-14
Page 1 of 18 NEW ZEALAND DATA SHEET 1. CEFTRIAXONE-AFT POWDER FOR INJECTION Ceftriaxone-AFT 500 mg powder for injection. Ceftriaxone-AFT 1 g powder for injection. Ceftriaxone-AFT 2 g powder for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ceftriaxone-AFT 500 mg: each vial contains 500 mg ceftriaxone (as sodium). Ceftriaxone-AFT 1 g: each vial contains 1 g ceftriaxone (as sodium). Ceftriaxone-AFT 2 g: each vial contains 2 g ceftriaxone (as sodium). Excipients with known effect: Each gram of ceftriaxone contains approximately 83 mg (3.6 mmol) of sodium. 3. PHARMACEUTICAL FORM Powder for injection. White to pale yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infections caused by pathogens sensitive to ceftriaxone e.g.: • sepsis; • meningitis; • abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts); • infections of the bones, joints, soft tissue, skin and of wounds; • infections in patients with impaired defence mechanisms; • renal and urinary tract infections; • respiratory tract infections, particularly pneumonia, and ear, nose and throat infections; • genital infections, including Gonorrhoea. • perioperative prophylaxis of infections. 4.2 DOSE AND METHOD OF ADMINISTRATION Considerations should be given to local guidelines on appropriate use of antibacterial agents. Dose _Adults and children over twelve years _ The usual dosage is 1-2 g of ceftriaxone administered once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, administered once daily. Twice daily (12 hourly) administration may be considered where doses greater than 2g daily are administered. Specific dosage schedules Page 2 of 18 _Gonorrhoea _ For the treatment of gonorrhoea (penicillinase-producing and non-penicillinase-producing strains), a single IM dose of 250 mg ceftriaxone is recommended. _Perioperative prophylaxis _ To prevent postoperative infections in contaminated or potentially conta Đọc toàn bộ tài liệu