Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Cefazolin sodium 1.048 g equivalent to 1 g cefazolin
AFT Pharmaceuticals Ltd
Cefazolin sodium 1.08 g (equivalent to 1 g cefazolin)
1 g
Powder for injection
Active: Cefazolin sodium 1.048 g equivalent to 1 g cefazolin
Vial, glass, single dose, Type I with rubber stopper, 1 dose unit
Prescription
Prescription
Qilu Antibiotics Pharmaceutical Co Ltd
Cefazolin-AFT is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infection: Due to S. pneumoniae, Klebsiella sp, H. influenzae, Staph, aureus (including penicillinase-producing strains), and Group A ?-haemolytic streptococci. Injectable penicillin G benzathine is considered to be the medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin-AFT is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin in the subsequent prevention of rheumatic fever are not available at present.
Package - Contents - Shelf Life: Vial, glass, single dose, Type II with rubber stopper - 1 dose units - 30 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) - Vial, glass, single dose, Type I with rubber stopper - 1 dose units - 24 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) - Vial, glass, single dose, Type II with rubber stopper - 5 dose units - 30 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) - Vial, glass, single dose, Type I with rubber stopper - 5 dose units - 24 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) - Vial, glass, single dose, Type II with rubber stopper - 10 dose units - 30 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) - Vial, glass, single dose, Type I with rubber stopper - 10 dose units - 24 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)
2010-07-29
NEW ZEALAND DATA SHEET 1 PRODUCT NAME Cefazolin-AFT powder for injection equivalent to Cefazolin 500 milligram, 1 gram and 2 gram. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of cefazolin sodium 524 mg equivalent to 500 mg cefazolin One vial of cefazolin sodium 1048 mg equivalent to 1000 mg cefazolin One vial of cefazolin sodium 2097 mg equivalent to 2000 mg cefazolin For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM White to off-white powder which reconstitutes with Sterile Water for Injection to give a colourless solution. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Cefazolin-AFT is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infection: Due to _S. pneumoniae_, _Klebsiella sp_, _H. influenzae_, _Staph aureus _(including penicillinase-producing strains), and Group A β-haemolytic streptococci. Injectable penicillin G benzathine is considered to be the medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin-AFT is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present. Genitourinary Tract Infections: Due to _E. coli_, _P. mirabilis, Klebsiella sp_., and some strains of Enterobacter and enterococci. Skin and Soft-tissue Infections: Due to _Staph. aureus _(including penicillinase-producing strains) and Group A β- haemolytic streptococci and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, _P. mirabilis, Klebsiella sp_., and _Staph. aureus_. Bone and Joint Infections: Due to _Staph. aureus_. Septicaemia: Due to _S. pneumoniae_, _Staph. aureus _(penicillin-susceptible and penicillin-resistant), _P. mirabilis, E. coli, _ _and Klebsiella sp_. Endocarditis: Due to _ Staph. aureus _ (penicillin-susceptible and penicillin-resistant) and Group A β Preberite celoten dokument