Cefazolin

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Cefazolin sodium 1.048 g equivalent to 1 g cephazolin (2% fill overage)

Dostępny od:

AFT Pharmaceuticals Ltd

INN (International Nazwa):

Cefazolin sodium 1.048 g (equivalent to 1 g cephazolin; 2% fill overage)

Dawkowanie:

1 g

Forma farmaceutyczna:

Powder for injection

Skład:

Active: Cefazolin sodium 1.048 g equivalent to 1 g cephazolin (2% fill overage) Excipient: Nitrogen

Sztuk w opakowaniu:

Vial, glass, 1 x 1g, 1 g

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

ACS Dobfar SpA

Podsumowanie produktu:

Package - Contents - Shelf Life: Vial, glass, 1 x 1g - 1 g - 24 months from date of manufacture stored at or below 30°C protect from light 24 hours reconstituted stored at 15°C to 25°C (Controlled room temp) protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 12 weeks reconstituted stored below -20°C (Deep freeze) protect from light - Vial, glass, 5 x 1g - 5 g - 24 months from date of manufacture stored at or below 30°C protect from light 24 hours reconstituted stored at 15°C to 25°C (Controlled room temp) protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 12 weeks reconstituted stored below -20°C (Deep freeze) protect from light - Vial, glass, 10 x 1g - 10 g - 24 months from date of manufacture stored at or below 30°C protect from light 24 hours reconstituted stored at 15°C to 25°C (Controlled room temp) protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 12 weeks reconstituted stored below -20°C (Deep freeze) protect from light

Data autoryzacji:

1999-05-04

Charakterystyka produktu

NEW ZEALAND DATA SHEET
Page 1 of 10
1 PRODUCT NAME
Cefazolin-AFT powder for injection equivalent to Cefazolin 500
milligram, 1 gram and 2gram.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of cefazolin sodium 540 mg equivalent to 500 mg cefazolin
One vial of cefazolin sodium 1080 mg equivalent to 1000 mg cefazolin
One vial of cefazolin sodium 2101 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:
NEW ZEALAND DATA SHEET
Page 2 of 10
Due to Staph. aureus (penicillin-susceptible and penicillin-resistant