Cefazolin-Asteria Inj. 1g 1000mg powder for solution for i/m and i/v injection

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

cefazolin (cefazolin sodium)

Saadav alates:

Hankook Korus Pharm Co.

ATC kood:

J01DB04

INN (Rahvusvaheline Nimetus):

cefazolin (cefazolin sodium)

Annus:

1000mg

Ravimvorm:

powder for solution for i/m and i/v injection

Ühikuid pakis:

(10) glass vials

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2019-01-18

Toote omadused

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_Summary of product characteristics_
1.
NAME OF THE MEDICINAL PRODUCT
Cefazolin-Asteria Inj. 1g
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION Active ingredient
No.
Chemical Name
Specification
Quantity/vial
Use
1
Cefazolin Sodium
USP
1g(Potency)
Active
ingredient
3.
PHARMACEUTICAL FORM
Power for Injection
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Cefazolin for injection is indicated in the treatment of the following
infections due to the
susceptible organisms:
Respiratory tract infections
: Tonsillitis, pharyngitis, Pneumonia, bronchitis, pulmonary
abscess,emphysema, Pleurisy sinusitis, Laryngitis and otitis media
Skin,
Soft-tissue
and
postoperative
Infections
:Lymphangitis,
absesses,
cellulites,
decubitus,ulcers, and mastitis
Gastrointestinal tract infections
: Cholangitis, cholecystitis
Genito urinary tract infections
:Pyelonephritis, cystitis, and adenitis
Other infections
: Bactericidal, septicemia, endocarditis, osteomyelitis, peritonitis,
andpuerperal
sepsis.
4.2 Posology and method of administration
For the treatment of mild- to moderate bacterial infections, 1.5 to 2g
per day in equally divided
doses, two or three times daily. For the treatment of severe bacterial
infection, 3-4g per day in
equally divided doses two or three times daily.
Higher and/or more frequent doses (up to 6g daily) may be given in the
very severe, life-
threatening infections.
Children: the following dosage chart is the useful guide to Cefazolin
therapy in children.
Percentage of the Adult dose
Age and Weight
Total daily dose maximum
100 %
Adult (65kg)
1.5g to 6g
75%
12years(40kg)
1.125g to 4.5g
50%
7years(23kg)
750mg to 3g
25%
7years(23kg)
375mg to 1.5g
20%
4months (6.5kg)
300mg to 1.2g
For in –between ages, in –between percentages are used e.g. at 10
years, 66% and three years 33
% of the adult dose.
Intravenous infusion: Use sterile water for injection, Add 2 mL to the
500mg vial and 4mL of
the 1g vial. Withdraw the entire content and a