Cefuroximnatrium Sandoz infuus 1500 mg, poeder voor oplossing voor intraveneuze infusie

Pays: Pays-Bas

Langue: néerlandais

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingrédients actifs:

CEFUROXIM NATRIUM SAMENSTELLING overeenkomend met ; CEFUROXIM

Disponible depuis:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Code ATC:

J01DC02

DCI (Dénomination commune internationale):

CEFUROXIME SODIUM COMPOSITION corresponding to ; CEFUROXIME

forme pharmaceutique:

Poeder voor oplossing voor infusie

Composition:

GEEN HULPSTOFFEN,

Mode d'administration:

Intraveneus gebruik

Domaine thérapeutique:

Cefuroxime

Descriptif du produit:

Hulpstoffen: GEEN HULPSTOFFEN;

Date de l'autorisation:

2004-10-04

Notice patient

Sandoz B.V.
Page 1
Cefuroximnatrium Sandoz injectie 250 mg/ injectie
750 mg /injectie 1500 mg/ infuus 1500 mg
V18
1.3.1.3 Package Leaflet
Mei 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIMNATRIUM SANDOZ INJECTIE 250 MG, POEDER VOOR OPLOSSING VOOR
INJECTIE
CEFUROXIMNATRIUM SANDOZ INJECTIE 750 MG, POEDER VOOR OPLOSSING VOOR
INJECTIE
CEFUROXIMNATRIUM SANDOZ INJECTIE 1500 MG, POEDER VOOR OPLOSSING VOOR
INJECTIE
CEFUROXIMNATRIUM SANDOZ INFUUS 1500 MG, POEDER VOOR OPLOSSING VOOR
INTRAVENEUZE INFUSIE
cefuroxime (as cefuroxime 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 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 nurse. This includes
any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is an antibiotic used in adults and
children. It works by killing bacteria that
cause infections. It belongs to a group of medicines called
cephalosporins.
[Nationally completed name] is used to treat infections of:
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissue
•
the abdomen
[Nationally completed name] is also used:
• to prevent infections during surgery.
2
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY COMPLETED NAME]
YOU MUST NOT BE GIVEN [NATIONALLY COMPLETED NAME]:
Sandoz B.V.
Page 2
Cefuroximnatrium Sandoz injectie 2

Résumé des caractéristiques du produit

Sandoz B.V.
Page 1
Cefuroximnatrium Sandoz injectie 250 mg/ injectie
750 mg/ injectie1500 mg /infuus 1500 mg
RVG 28712-14, 31112
V17
1.3.1.1 Summary of Product Characteristics
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroximnatrium Sandoz injectie 250 mg, poeder voor oplossing voor
injectie
Cefuroximnatrium Sandoz injectie 750 mg, poeder voor oplossing voor
injectie
Cefuroximnatrium Sandoz injectie 1500 mg, poeder voor oplossing voor
injectie
Cefuroximnatrium Sandoz infuus 1500 mg, poeder voor oplossing voor
intraveneuze infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg of cefuroxime (as cefuroxime sodium)
Excipients with known effect
Each vial contains 12.9 mg of sodium
Each vial contains 750 mg of cefuroxime (as cefuroxime sodium)
Excipients with known effect
Each vial contains 38.6 mg of sodium
Each vial contains 1500 mg of cefuroxime (as cefuroxime sodium)
Excipients with known effect
Each vial contains 77.3 mg of sodium
Each infusion bottle contains 1500 mg of cefuroxime (as cefuroxime
sodium)
Excipients with known effect
Each vial contains 77.3 mg of sodium
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for solution/suspension for injection
Powder for solution for infusion
White to yellowish powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
[Nationally completed name] 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).
Sandoz B.V.
Page 2
Cefuroximnatrium Sandoz injectie 250 mg/ injectie
750 mg/ injectie1500 mg /infuus 1500 mg
RVG 28712-14, 31112
V17
1.3.1.1 Summary of Product Characteristics
Mei 2020
•
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 gast