Cefuroximnatrium Sandoz injectie 750 mg, poeder voor oplossing voor injectie

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

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

Δραστική ουσία:

CEFUROXIM NATRIUM 789 mg/flacon SAMENSTELLING overeenkomend met ; CEFUROXIM 750 mg/flacon

Διαθέσιμο από:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Φαρμακολογική κατηγορία (ATC):

J01DC02

INN (Διεθνής Όνομα):

CEFUROXIM NATRIUM 789 mg/flacon SAMENSTELLING overeenkomend met ; CEFUROXIM 750 mg/flacon

Φαρμακοτεχνική μορφή:

Poeder voor oplossing voor injectie

Σύνθεση:

GEEN HULPSTOFFEN,

Οδός χορήγησης:

Parenteraal, Intramusculair gebruik, Intraveneus gebruik

Θεραπευτική περιοχή:

Cefuroxime

Περίληψη προϊόντος:

Hulpstoffen: GEEN HULPSTOFFEN;

Ημερομηνία της άδειας:

1900-01-01

Φύλλο οδηγιών χρήσης

Sandoz B.V.
Page 1
Cefuroximnatrium Sandoz injectie 250 mg/ injectie 750
mg/ injectie1500 mg
RVG 28712-14
V21
1.3.1.3 Leaflet
Mei 2023
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
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]:
•
IF YOU ARE ALLERGIC TO CEFUROXIME
to
ANY CEPHALOSPORIN ANTIBIOTICS
or any of the other ingredients of
this medicine listed in section 6 .
Sandoz B.V.

Αρχείο Π.Χ.Π.

Sandoz B.V.
Page 1
Cefuroximnatrium Sandoz injectie 250 mg/ injectie 750
mg/ injectie1500 mg
RVG 28712-14
V20
1.3.1.1 Summary of Product Characteristics
Mei 2023
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
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).
•
Community acquired pneumonia.
•
Acute exacerbations of chronic bronchitis.
Sandoz B.V.
Page 2
Cefuroximnatrium Sandoz injectie 250 mg/ injectie 750
mg/ injectie1500 mg
RVG 28712-14
V20
1.3.1.1 Summary of Product Characteristics
Mei 2023
•
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 tr