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:

2023-05-18

Patient Information leaflet

Reference: Zinacef 750 mg powder for solution for injection or
infusion, dated 28.1.2022 MHRA
PIL Zinacef MHRA 750 mg Powder Sol i.m i.v (GE+MD) ENG 24.02.2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Trade name of the medicinal product:
ZINACEF®
750 MG
POWDER FOR SOLUTION FOR INJECTION
(FOR INTRAMUSCULAR OR INTRAVENOUS USE)
International nonproprietary name: cefuroxime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zinacef is and what it is used for
2.
What you need to know before you are given Zinacef
3.
How Zinacef is given
4.
Possible side effects
5.
How to store Zinacef
6.
Contents of the pack and other information
7.
Information for the Healthcare Professionals
1 WHAT ZINACEF IS AND WHAT IT IS USED FOR
PHARMACOTHERAPEUTIC GROUP: antibacterials for systemic use,
second-generation
cephalosporins, ATC code: J01DC02
Zinacef contains an antibiotic cefuroxime used in adults and children.
It works by killing
bacteria that cause infections. It belongs to a group of antibiotics
called cephalosporins.
ZINACEF IS USED TO TREAT INFECTIONS OF:
• the lungs or chest
• the urinary tract
• the skin and soft tissue
• the abdomen.
Zinacef is also used:
• to prevent infections during surgery.
Your doctor may test the type of bacteria causing your infection and
monitor whether the
bacteria are sensitive to Zinacef during your treatment.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZINACEF
YOU MUST NOT BE GIVEN ZINACEF :
• IF YOU ARE ALLERGIC TO ANY CEPHALOSPORIN ANTIBIOTICS.
Reference

Summary of Product characteristics

Reference:
Zinacef 750 mg powder for solution for injection or infusion, dated
28.1.2022 MHRA
SPC Zinacef MHRA 750 mg Powder Sol i.m i.v (GE+MD) ENG 24.02.2023
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zinacef_®_ 750 mg
Powder for solution for injection (for intramuscular or intravenous
use)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 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 for intravenous and intramuscular injection
White to light yellow powder.
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).
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)
Soft-tissue infections: cellulitis,
erysipelas and wound infections.
Intra-abdominal infections
Reference:
Zinacef 750 mg powder for solution for injection or infusion, dated
28.1.2022 MHRA
SPC Zinacef MHRA 750