Ceftriaxon 0,5 g intramusculair Sandoz, poeder en oplosmiddel voor oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CEFTRIAXON DINATRIUM 3,5-WATER SAMENSTELLING overeenkomend met ; CEFTRIAXON 0-WATER ; LIDOCAINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; LIDOCAÏNE

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

J01DD54

INN (Algemene Internationale Benaming):

CEFTRIAXONE DISODIUM 3,5-WATER COMPOSITION corresponding to ; CEFTRIAXONE 0-WATER ; LIDOCAINEHYDROCHLORIDE 1-WATER COMPOSITION corresponding to ; LIDOCAINE

farmaceutische vorm:

Poeder en oplosmiddel voor oplossing voor injectie

Samenstelling:

NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,

Toedieningsweg:

Intramusculair gebruik

Therapeutisch gebied:

Ceftriaxone, Combinations

Product samenvatting:

Hulpstoffen: NATRIUMWATERSTOFCARBONAAT (E 500 (II)); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;

Autorisatie datum:

2010-10-22

Bijsluiter

Sandoz B.V.
Page 1/7
Ceftriaxon Sandoz
RVG 104048-56-57-60-61
1312-V5
1.3.1.2 Labelling
Juli 2019
LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxon 0,25 g intramusculair Sandoz, poeder en oplosmiddel voor
oplossing voor injectie
Ceftriaxon 0,5 g intramusculair Sandoz, poeder en oplosmiddel voor
oplossing voor injectie
Ceftriaxon 1 g intramusculair Sandoz, poeder en oplosmiddel voor
oplossing voor injectie
Ceftriaxon 1 g intraveneus Sandoz, poeder en oplosmiddel voor
oplossing voor injectie/infusie
ceftriaxon
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
[Nationally completed name] 0.25 g powder and solvent for solution for
i.m. injection:
Each vial contains: 0.25 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 1% (20 mg/2 ml) lidocaine hydrochloride
solution as a solvent
[Nationally completed name] 0.5 g powder and solvent for solution for
i.m. injection:
Each vial contains: 0.5 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 1% (20 mg/2 ml) lidocaine hydrochloride
solution as a solvent
[Nationally completed name] 1 g powder and solvent for solution for
i.m. injection:
Each vial contains: 1 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 1% (35 mg/3.5 ml) lidocaine hydrochloride
solution as a solvent
[Nationally completed name] 1 g powder and solvent for solution for
i.v. injection/infusion:
Each vial contains: 1 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 10 ml water for injection as a solvent
3.
LIST OF EXCIPIENTS
_[Nationally completed name] 0.25 g powder and solvent for solution
for injection: _
Contains lidocaine hydrochloride, water for injections, sodium
hydrogen carbonate.
_[Nationally completed name] 0.5 g, 1 g powder and solvent for
solution for injection: _
Contains lidocaine hydrochloride, water for injections, sodium
hydrogen carbonate, sodium.
_[Nationally completed name] 1 g powder and solvent for solution for
injection/infusion: _
Contains water for

Productkenmerken

Sandoz B.V.
Page 1/24
Ceftriaxon Sandoz
RVG 104048-56-57-60-61
1311-V9
1.3.1.1 Summary of Product Characteristics
Juli 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxon 0,25 g intramusculair Sandoz, poeder en oplosmiddel voor
oplossing voor injectie
Ceftriaxon 0,5 g intramusculair Sandoz, poeder en oplosmiddel voor
oplossing voor injectie
Ceftriaxon 1 g intramusculair Sandoz, poeder en oplosmiddel voor
oplossing voor injectie
Ceftriaxon 1 g intraveneus Sandoz, poeder en oplosmiddel voor
oplossing voor injectie/infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] 0.25 g powder and solvent for solution for
i.m. injection:
Each vial contains: 0.25 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 1% (20 mg/2 ml) lidocaine hydrochloride
solution as a solvent
[Nationally completed name] 0.5 g powder and solvent for solution for
i.m. injection:
Each vial contains: 0.5 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 1% (20 mg/2 ml) lidocaine hydrochloride
solution as a solvent
[Nationally completed name] 1 g powder and solvent for solution for
i.m. injection:
Each vial contains: 1 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 1% (35 mg/3.5 ml) lidocaine hydrochloride
solution as a solvent
[Nationally completed name] 1 g powder and solvent for solution for
i.v. injection/infusion:
Each vial contains: 1 g ceftriaxone (as ceftriaxone disodium,
hydrated)
Each ampoule contains: 10 ml water for injection as a solvent
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).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion.
The powder is coloured white to yellowish.
The solvent is a clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sandoz B.V.
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Ceftriaxon Sandoz