ZINACEF 750 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CEFUROXIME AS SODIUM

Available from:

NOVARTIS ISRAEL LTD., ISRAEL

ATC code:

J01DC02

Pharmaceutical form:

POWDER FOR SOLUTION OR SUSPENSION FOR INJECTION OR INFUSION

Composition:

CEFUROXIME AS SODIUM 750 MG/VIAL

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

SANDOZ AG, SWITZERLAND

Therapeutic group:

CEFUROXIME

Therapeutic area:

CEFUROXIME

Therapeutic indications:

Therapeutic indications Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth)• Community acquired pneumonia• Acute exacerbations of chronic bronchitis• Complicated urinary tract infections, including pyelonephritis• Soft-tissue infections: cellulitis, erysipelas and wound infections• Intra-abdominal infections • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section) • nose infections for example, sinusitis • septic arthritis

Authorization date:

2014-12-31

Patient Information leaflet

ראורבפ
2019
:ןודנה
ZINACEF 750MG
יז ףסאנ
750
ג"מ
CEFUROXIME (AS CEFUROXIME SODIUM) 750MG
INJ/INF
FOR SOLUTION FOR
POWDER
ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
ג תרבח
ןיילקתימסוסקל
( מ"עב לארשי
GSK
ןולעה ןוכדע לע עידוהל תשקבמ )
לש אפורל
רישכתה
ZINACEF 750MG
ב
וז העדוה
םינוכדעה םינייוצמ
דבלב םייתוהמה
ב
.אפורל ןולע
ולעב
ן
םנשי
.םיפסונ םייוניש
היוותה
לארשיב רישכתל המושרה :
Therapeutic indications
Zinacef is indicated for the treatment of the infections listed below
in adults and children, including neonates
(from birth)
• Community acquired pneumonia
• Acute exacerbations of chronic bronchitis
• Complicated urinary tract infections, including pyelonephritis
• Soft-tissue infections: cellulitis, erysipelas and wound
infections
• Intra-abdominal infections
• Prophylaxis against infection in gastrointestinal (including
oesophageal), orthopaedic, cardiovascular, and
gynaecological surgery (including caesarean section)
• nose infections for example, sinusitis
• septic arthritis
ע
: אפורל ןולעב םיאבה םיפיעסב ושענ
םייתוהמ םינוכד
4.4
Special warnings and precautions for
use
Intracameral use and eye disorders
Zinacef is not formulated for intracameral use. Individual cases and
clusters of serious ocular
adverse reactions have been reported following unapproved intracameral
use of cefuroxime
sodium compounded from vials approved for intravenous/intramuscular
administration. These
reactions included macular oedema, retinal oedema, retinal detachment,
retinal toxicity, visual
impairment, visual acuity reduced, vision blurred, corneal opacity and
corneal oedema.
Important information about excipients
Zinacef powder for solution for injection and infusion contains
sodium. This should be considered for
patients who are on a controlled sodium diet.
750 mg vial:
This medicinal product contains 42 m

Summary of Product characteristics

Page 1 of 11
ZINACEF 750 MG
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zinacef 750 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 750 mg of cefuroxime (as cefuroxime sodium).
Each vial contains 42 mg of sodium.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for solution or suspension for injection or infusion.
Cefuroxime is a white to cream powder to which appropriate amounts of
water are added to prepare
an
off-white
suspension
for
intramuscular
use
or
a
yellowish
solution
for
intravenous
administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zinacef is indicated for the treatment of the infections listed below
in adults and children, including
neonates (from birth) (see sections 4.4 and 5.1).
•
Community acquired pneumonia
•
Acute exacerbations of chronic bronchitis
•
Complicated urinary tract infections, including pyelonephritis
•
Soft-tissue infections: cellulitis, erysipelas and wound infections
•
Intra-abdominal infections (see section 4.4)
•
Prophylaxis
against
infection
in
gastrointestinal
(including
oesophageal),
orthopaedic,
cardiovascular, and gynaecological surgery (including caesarean
section)
•
Nose infections for example, sinusitis
•
Septic arthritis
In the treatment and prevention of infections in which it is very
likely that anaerobic organisms will be
encountered, cefuroxime should be administered with additional
appropriate antibacterial agents.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Table 1. Adults and children _
≥
_ 40 kg _
INDICATION
DOSAGE
Community
acquired
pneumonia
and
acute
exacerbations of chronic bronchitis
750 mg every 8 hours
(intravenously or intramuscularly)
Page 2 of 11
INDICATION
DOSAGE
Soft-tissue infections: cellulitis, erysipelas and
wound infections.
Intra-abdominal infections
Sinusitis, septic arthritis
750 mg every 8 hours
(intravenously
or
intramuscularly).