Ceftriaxon Sandoz 0,5, poeder voor oplossing voor injectie 0,5 g

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

CEFTRIAXON DINATRIUM 3,5-WATER SAMENSTELLING overeenkomend met ; ; CEFTRIAXON 0-WATER 500 mg/flacon

Disponible depuis:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Code ATC:

J01DD04

DCI (Dénomination commune internationale):

CEFTRIAXON DINATRIUM 3,5-WATER SAMENSTELLING overeenkomend met ; ; CEFTRIAXON 0-WATER 500 mg/flacon

forme pharmaceutique:

Poeder voor oplossing voor injectie

Composition:

GEEN HULPSTOFFEN,

Mode d'administration:

Intraveneus gebruik

Domaine thérapeutique:

Ceftriaxone

Descriptif du produit:

Hulpstoffen: GEEN HULPSTOFFEN;

Date de l'autorisation:

1900-01-01

Notice patient

Sandoz B.V.
Page 1/10
Ceftriaxon Sandoz 0,5, 1, 2
RVG 26049-50-51
1313-V17
1.3.1.3 Bijsluiter
Augustus 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFTRIAXON SANDOZ
® 0,5, POEDER VOOR OPLOSSING VOOR INJECTIE
0,5 G
CEFTRIAXON SANDOZ
® 1, POEDER VOOR OPLOSSING VOOR INJECTIE/INFUSIE
1 G
CEFTRIAXON SANDOZ
® 2, POEDER VOOR OPLOSSING VOOR INJECTIE/INFUSIE
2 G
ceftriaxone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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 [nationally completed name] is and what it is used for
2.
What you need to know before you are given [nationally completed name]
3.
How [nationally completed name] is given
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 given to adults and
children (including newborn
babies). 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 brain (meningitis).
•
the lungs.
•
the middle ear.
•
the abdomen and abdominal wall (peritonitis).
•
the urinary tract and kidneys.
•
bones and joints.
•
the skin or soft tissues.
•
the blood.
•
the heart.
It can be given:
•
to treat specific sexually transmitted infections (gonorrhoea and
syphilis).
•
to treat patients with low white blood cell counts (neutropenia) who
have fever due to
bacterial infection.
•
to treat infections of the chest in adults with chronic bronchitis.
•
to treat Lyme disease (caused by tick bites) in adults and children
including newborn
babies f

Résumé des caractéristiques du produit

Sandoz B.V.
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Ceftriaxon Sandoz 0,5/1/2
RVG 26049-50-51
1311-V18
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxon Sandoz 0,5, poeder voor oplossing voor injectie 0,5 g
Ceftriaxon Sandoz 1, poeder voor oplossing voor injectie/infusie 1,0 g
Ceftriaxon Sandoz 2, poeder voor oplossing voor injectie/infusie 2,0 g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] 0.5 g powder for solution for injection:
Each vial contains: 0.5 g ceftriaxone (as ceftriaxone disodium,
hydrated)
[Nationally completed name] 1 g powder for solution for
injection/infusion:
Each vial contains: 1 g ceftriaxone (as ceftriaxone disodium,
hydrated)
[Nationally completed name] 2 g powder for solution for
injection/infusion:
Each vial contains: 2 g ceftriaxone (as ceftriaxone disodium,hydrated)
Excipients with known effect:
Each vial of ceftriaxone 0.5 g contains 1.8 mmol sodium (42 mg
sodium).
Each vial of ceftriaxone 1 g contains 3.6 mmol sodium (83 mg sodium).
Each vial of ceftriaxone 2 g contains 7.2 mmol sodium (166 mg sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection
Powder for solution for injection/infusion
Powder for solution for injection/infusion
The powder is coloured white to yellowish.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for the treatment of the
following infections in adults and
children including term neonates (from birth):
Sandoz B.V.
Page 2/24
Ceftriaxon Sandoz 0,5/1/2
RVG 26049-50-51
1311-V18
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2021
•
Bacterial Meningitis
•
Community acquired pneumonia
•
Hospital acquired pneumonia
•
Acute otitis media
•
Intra-abdominal infections
•
Complicated urinary tract infections (including pyelonephritis)
•
Infections of bones and joints
•
Complicated skin and soft tissue infections
•
Gonorrhoea
•
Syphilis
•
Bacterial endocarditi