Zinacef powder for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefuroxime (cefuroxime sodium)

Available from:

ACS Dobfar S.p.A

ATC code:

J01DC02

INN (International Name):

cefuroxime (cefuroxime sodium)

Dosage:

750mg

Pharmaceutical form:

powder for solution for injection

Units in package:

glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-08-04

Summary of Product characteristics

Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS
_ZINACEF _
CEFUROXIME SODIUM.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ZINACEF _Injection contains 250 mg, 750 mg, 1 g and 1.5 g of
cefuroxime (as
cefuroxime
sodium).
_ZINACEF MONOVIAL™ _contains 750 mg and 1.5 g of cefuroxime (as
cefuroxime
sodium).
PHARMACEUTICAL FORM
Powder for solution for injection (Injection)
Powder for solution for infusion (_MONOVIAL_)
CLINICAL INFORMATION
INDICATIONS
Zinacef is a bactericidal cephalosporin antibiotic which is resistant
to most
beta-lactamases and is active against a wide range of Gram-positive
and Gram-negative
organisms.
It is indicated for the treatment of infections before the infecting
organism has been
identified or when caused by sensitive bacteria. Susceptibility to
cefuroxime sodium will
vary with geography and time and local susceptibility data should be
consulted where
available (_see Clinical Pharmacology, Pharmacodynamic effects_).
Indications include:
-
Respiratory tract infections for example, acute exacerbation of
chronic bronchitis,
infected bronchiectasis, bacterial pneumonia, lung abscess and
post-operative chest
infections.
-
Ear, nose and throat infections for example, sinusitis, tonsillitis,
pharyngitis and
otitis media.
Page 2 of 16
-
Urinary tract infections for example, acute and chronic
pyelonephritis, cystitis and
asymptomatic bacteriuria.
-
Soft-tissue infections for example, cellulitis, erysipelas and wound
infections.
-
Bone and joint infections for example, osteomyelitis and septic
arthritis.
-
Obstetric and gynaecological infections pelvic inflammatory diseases.
-
Gonorrhoea particularly when penicillin is unsuitable.
-
Other infections including septicaemia, meningitis and peritonitis.
-
Prophylaxis against infection in abdominal, pelvic, orthopaedic,
cardiac,
pulmonary, oesophageal and vascular surgery where there is increased
risk from
infection.
Usually cefuroxime sodium will be effective alone, but when
appropriate it may be used
in combination with an aminoglycoside antibiotic, or in