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

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefazolin (cefazolin sodium)

Available from:

Hankook Korus Pharm Co.

ATC code:

J01DB04

INN (International Name):

cefazolin (cefazolin sodium)

Dosage:

1000mg

Pharmaceutical form:

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

Units in package:

(10) glass vials

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-07-23

Patient Information leaflet

CEPHALOSPORIN ANTIBIOTICS
CEFAZOLIN-ASTERIA INJ. 1G
(CEFAZOLIN SODIUM)
POWDER FOR SOLUTION FOR IM/IV INJECTION
COMPOSITION: Each vial contains Cefazolin Sodium USP equivalent to
Cefazolin 1g.
DESCRIPTION: Cefazolin Sodium is white or almost white crystalline
powder.
INDICATIONS:
Cefazolin for injection is indicated in the treatment of the following
serious infections due to
susceptible organisms:
RESPIRATORY
TRACT
INFECTIONS Tonsillitis, pharyngitis, pneumonia, bronchitis, pulmonary
abscess, empyema, pleurisy sinusitis, laryngitis and otitis media
SKIN, SOFT-TISSUE AND POSTOPERATIVE INFECTIONS Lymphangitis,
abscesses, cellulites, decubitus
ulcers, mastitis
GASTROINTESTINAL TRACT INFECTIONS Cholangitis, cholecystitis
GENITOURINARY TRACT INFECTIONS Pyelonephritis, cystitis and adnexitis
OTHER INFECTIONS
septicemia, endocarditis, osteomyelitis, peritonitis, puerperal sepsis
DOSAGE AND 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
very severe, life-
threatening infections.
Childeren: The following dosage chart is a useful guide * to Cefazolin
therapy in children.
Percentage of Adult Dose
Age and Weight
Total Daily Dose Maximum
l00%
Adult(65Kg)
1.5g to 6g
75%
12 years (40kg) 1.125g to 4.5g
50%
7 years (23kg)
750mg to 3g
25%
1 year (l0kg)
375mg to 1.5g
20%
4 months (6.5kg)
300mg to 1.2g
For in-between ages, in-between percentages are used e.g. at 10 years,
66% and at three years
33% of the adult dose.
INTRAVENOUS INFUSION : Use sterile water for injection. Add 4 mL to
the 1g vial. Withdraw the
entire content and add to an intravenous solution of physiological
saline (or 5% Dextrose in
water).
DIRECT INTRAVENOUS INJECTION : Reconstitute as directed above: inject
intravenously slowly
and with care.
INTRAMUSCULAR INJECTION : Add 2 mL to

Summary of Product characteristics

Summary of product characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Cefazolin-Asteria Inj. 1g
2.
QUALITATIVEAND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/vial
Use
1
Cefazolin Sodium
1g(Potency)
Active
ingredient
3.
PHARMACEUTICAL FORM
White or almost white crystalline powder.
Powder for solution for i/m and i/v injection 1000mg
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 add to an intravenous solution o