Zepilen 1g powder for solution for injection/infusion

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

CEFAZOLIN SODIUM

Доступна с:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

код АТС:

J01DB04

ИНН (Международная Имя):

CEFAZOLIN SODIUM 1 g

Фармацевтическая форма:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

состав:

CEFAZOLIN SODIUM 1 g

Тип рецепта:

POM

Терапевтические области:

ANTIBACTERIALS FOR SYSTEMIC USE

Статус Авторизация:

Authorised

Дата Авторизация:

2019-04-25

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEPILEN 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Cefazolin as 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zepilen is and what it is used for
2.
What you need to know before you use Zepilen
3.
How to use Zepilen
4.
Possible side effects
5.
How to store Zepilen
6.
Contents of the pack and other information
1.
WHAT ZEPILEN IS AND WHAT IT IS USED FOR
Zepilen is a powder for the preparation of an injectable solution,
contains the active susbtance
cefazolin (as cefazolin sodium).
Cefazolin is an antibiotic medicine and belongs to a group of
medicines called cephalosporins.
Zepilen treats certain infections.
Zepilen is used to treat the following infections:
-
Skin and soft tissue infections
-
Bone and joint infections
-
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 USE ZEPILEN
DO NOT USE ZEPILEN:
-
If you are allergic to cefazolin, to other cephalosporins or any of
the other ingredients of this
medicine (listed in section 6).
-
If you have previously had an immediate and/ or severe allergic
reaction to penicillin or other
type of beta-lactam antibiotic.
-
Cefazolin should not be dissolved in Lidocaine solution for
administration to children under 1
years old.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Zepilen:
-
If you have a history of allergic reactions to penicillins or other
medicines.
You may be a

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zepilen 1 g powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of contains 1 g of cefazolin (as cefazolin sodium).
Excipient with known effect: sodium.
The sodium content is 50.6 mg (2.2 mmol) per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White or almost white, very hygroscopic powder for solution for
injection/infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefazolin is an antibacterial agent indicated in the treatment of the
following infections in adults and
in children aged more than one month old (see section 4.2, 4.4 and
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 where there is a risk of infection or potential risk of
infection.
The use of cefazolin should be limited to cases where parenteral
treatment is needed.
Susceptibility of causative organism to the treatment should be
tested.
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 and the severity
of the disease.
Posology
_Adults _
_Infections caused by highly susceptible gram-positive microorganisms
_
The usual dose in adults is 1 g to 2 g per day administered in two or
three equal doses.
_Infections caused by less susceptible gram-positive and gram-negative
microorganisms _
The usual dose is 3 g to 4 g per day administered in three or four
equal doses.
In severe infections, such as endocarditis, doses of up to 6 g per day
can be administered.
_Perioperative prophylactic use _
To prevent postoperative infection in contaminated or potentially
contaminated surgery, r