Cefazolin PharmSol 1000 mg powder for solution for injection/infusion

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

CEFAZOLIN SODIUM

Disponível em:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

Código ATC:

J01DB04

DCI (Denominação Comum Internacional):

CEFAZOLIN SODIUM 1 g

Forma farmacêutica:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composição:

CEFAZOLIN SODIUM 1 g

Tipo de prescrição:

POM

Área terapêutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Authorised

Data de autorização:

2020-07-30

Folheto informativo - Bula

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFAZOLIN PHARMSOL 1000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFAZOLIN
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.
•
If you notice 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 Cefazolin PharmSol is and what it is used for
2.
What you need to know before you take Cefazolin PharmSol
3.
How to take Cefazolin PharmSol
4.
Possible side effects
5.
How to store Cefazolin PharmSol
6.
Contents of the pack and other information
1.
WHAT CEFAZOLIN PHARMSOL IS AND WHAT IT IS USED FOR
CEFAZOLIN PHARMSOL
contains the active substance cefazolin which belongs to a group of
medicines called
cephalosporins which are antibiotics. These medicines work by killing
bacteria that cause infections.
Cefazolin is used to treat bacterial infections caused by
cefazolin-susceptible bacteria in adults and
children over the age of 1 month, e.g.:
•
Infections of the skin and soft tissue
•
Infections of the bones and joints
Due to or as a precaution against the occurrence of infection before,
during or after an operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFAZOLIN PHARMSOL DO NOT USE CEFAZOLIN PHARMSOL:
•
If you are allergic to cefazolin, any other cephalosporin antibiotics
or any of the other ingredients
of this medicine (listed in section 6).
•
If you have ever had a severe allergic (hypersensitive) reaction to
any other type of betalactam
antibiotic (penicillins, monobactams and carbapenems).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking
CEFAZOLIN PHARMSOL
if you:
•
are prone to allergic reactions (e.g. hay fever or bronchial asthma),
or if you had other than serious
allergic reactions to penic

Características técnicas

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefazolin PharmSol 1000 mg powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1g cefazolin (as 1.048 g cefazolin sodium).
The sodium content of each vial is 2.2 mmol (50.6 mg per 1 g
cefazolin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion
А white or almost white powder, very hydroscopic.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefazolin is indicated for the treatment of the following infections
caused by cefazolin-susceptible micro-
organisms in adults and children over the age of 1 month (see section
5.1):
•
infections of the skin and soft tissue
•
infections of the bones and joints
•
perioperative prophylaxis: the prophylactic preoperatively,
intraoperatively and postoperatively to
reduce the incidence of certain postoperative infections in patients
undergoing surgical procedures
which are classified as contaminated or potentially contaminated.
The use of cefazolin should be limited to cases where parenteral
treatment is necessary.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage depends on the sensitivity of the pathogen (see section
5.1) and the severity of the disease.
Posology
_Adults and adolescents > 12 years with normal kidney function _
_Infections caused by highly sensitive pathogens: _
The usual dosage in adults is 1 g to 2 g per day, administered in two
or three equal doses (one dose every
8 or 12 hours).
_Infections caused by less sensitive pathogens: _
The usual dose is 3 g to 4 g per day, administered in three or four
equal doses (one dose every 6 or 8
hours).
In severe infections, doses of up to 6 g per day can be administered
in three or four equal doses (one dose
every 6 or 8 hours).
Page 2 of 13
_Prophylaxis of perioperative infections _
To prevent postoperative infecti