מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CEFTRIAXON DINATRIUM 3,5-WATER SAMENSTELLING overeenkomend met ; ; CEFTRIAXON 0-WATER 1 g/flacon
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J01DD04
CEFTRIAXON DINATRIUM 3,5-WATER SAMENSTELLING overeenkomend met ; ; CEFTRIAXON 0-WATER 1 g/flacon
Poeder voor oplossing voor injectie of infusie
GEEN HULPSTOFFEN,
Intraveneus gebruik
Ceftriaxone
Hulpstoffen: GEEN HULPSTOFFEN;
1900-01-01
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 קרא את המסמך השלם
Sandoz B.V. Page 1/24 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 קרא את המסמך השלם