Cefazolin-AFT

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Cefazolin sodium 2.097 g equivalent to 2 g cefazolin

제공처:

AFT Pharmaceuticals Ltd

INN (International Name):

Cefazolin sodium 2.101 g (equivalent to 2 g cefazolin)

복용량:

2 g

약제 형태:

Powder for injection

구성:

Active: Cefazolin sodium 2.097 g equivalent to 2 g cefazolin

처방전 유형:

Prescription

Manufactured by:

Qilu Antibiotics Pharmaceutical Co Ltd

치료 징후:

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.

제품 요약:

Package - Contents - Shelf Life: Vial, glass, 20 mL Type II and butyl rubber stopper and aluminum cap - 1 dose units - 24 months from date of manufacture stored at or below 30°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 20 mL Type II and butyl rubber stopper and aluminum cap - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 20 mL Type II and butyl rubber stopper and aluminum cap - 10 dose units - 24 months from date of manufacture stored at or below 30°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

승인 날짜:

2016-02-04

제품 특성 요약

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