Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CEFTRIAXON DINATRIUM 3,5-WATER SAMENSTELLING overeenkomend met ; CEFTRIAXON 0-WATER ; LIDOCAINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; LIDOCAÏNE
Sandoz B.V.
J01DD54
CEFTRIAXONE DISODIUM 3,5-WATER COMPOSITION corresponding to ; CEFTRIAXONE 0-WATER ; LIDOCAINEHYDROCHLORIDE 1-WATER COMPOSITION corresponding to ; LIDOCAINE
Poeder en oplosmiddel voor oplossing voor injectie
NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,
Intramusculair gebruik
Ceftriaxone, Combinations
Hulpstoffen: NATRIUMWATERSTOFCARBONAAT (E 500 (II)); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;
2010-10-22
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 Belgenin tamamını okuyun
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. Page 2/24 Ceftriaxon Sandoz Belgenin tamamını okuyun