Zolacef 1g powder for solution for injection or infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefazolin (cefazolin sodium)

Available from:

PharmaTech CJSC

ATC code:

J01DB04

INN (International Name):

cefazolin (cefazolin sodium)

Dosage:

1000mg

Pharmaceutical form:

powder for solution for injection or infusion

Units in package:

(1) glass vial 10ml, (50) glass vials 10ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-12-21

Patient Information leaflet

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
Package leaflet: information for the Patient
Zolacef
1.0 g powder for solution for injection or infusion
cefazolin sodium
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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Zolacef is and what it is used for
2.
What you need to know before you are given Zolacef
3.
How Zolacef is given
4.
Possible side effects
5.
How to store Zolacef
6.
Contents of the pack and other information
1.
What Zolacef
is and what it is used for
This medicine contains the active substance cefazolin, which is an
antibiotic. Zolacef is used to treat
bacterial infections caused by cefazolin-susceptible bacteria, e.g:

Infections of skin and soft tissue

Infections of bones and joints
Zolacef can also be used before, during and after surgery to prevent
possible infections.
2.
What you need to know before you are given Zolacef
-
if you are allergic to cefazolin or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic (hypersensitive) to any cephalosporin antibiotics.
-
have ever had a severe allergic (hypersensitive) reaction to any other
type of beta lactam
antibiotic (penicillins, monobactams and carbapenems).
Warnings and precautions
Talk to your doctor or pharmacist before using Zolacef if you:

Are prone to allergic reactions (e.g. hay fever or bronchial asthma),
since then the risk of severe
allergic reactions to Zolacef is increased.
PharmaTech CJSC 111 Raffi st. Yerevan, 0

Summary of Product characteristics

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
SUMMARY OF THE PRODUCT CHARACTERISTICS
ZOLACEF
®
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
1G
cefazolin sodium
1.
NAME OF THE MEDICINAL PRODUCT
Zolacef
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefazolin Sodium (equivalent to cefazolin 1.0 g.)
The sodium content is 48 mg (2.1 mEq) per 1 gram of cefazolin sodium.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zolacef is indicated for the treatment of the following infections
caused by cefazolin-susceptible micro-
organisms:
-
skin and soft tissue infections
-
bone and joint infections.
Perioperative
prophylaxis.
For
surgical
operations
with
increased
risk
of
infections
with
anaerobic
pathogens, e.g. colorectal surgery, a combination with an appropriate
drug with activity against anaerobes is
recommended.
The use of cefazolin should be limited to cases where parenteral
treatment is needed.
Susceptibility of causative organism to the treatment should be tested
(if possible), although therapy may be
initiated before the results are available.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage as well as the method of administration are dependent on
the location and severity of the
infection and on the clinical and bacteriological progress. Local
therapeutic guidance should be taken into
consideration.
ADULTS AND ADOLESCENTS (ABOVE 12 YEARS OF AGE AND ≥ 40 KG
BODYWEIGHT)

Infections caused by sensitive micro-organisms: 1 g - 2 g cefazolin
per day divided into 2-3 equal doses.

Infections caused by moderately sensitive micro-organisms: 3 g - 4 g
cefazolin per day divided into 3-4
equal doses.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
In severe infections, doses of up to 6 g per day can be administered
in three or