Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MIDAZOLAMHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; MIDAZOLAM 1 mg/ml
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N05CD08
MIDAZOLAMHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; MIDAZOLAM 1 mg/ml
Oplossing voor injectie of infusie
NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Intraveneus gebruik, Intramusculair gebruik, Rectaal gebruik
Midazolam
Hulpstoffen: NATRIUMCHLORIDE; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);
2012-11-12
Sandoz B.V. Page 1/11 Midazolam Sandoz 1 mg/ml en 5 mg/ml – oplossing voor injectie of infusie RVG 110832-110837 1311-V7a 1.3.1.3 Bijsluiter Oktober 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER MIDAZOLAM SANDOZ 1 MG/ML, OPLOSSING VOOR INJECTIE OF INFUSIE MIDAZOLAM SANDOZ 5 MG/ML, OPLOSSING VOOR INJECTIE OF INFUSIE midazolam 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, pharmacist 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, 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 use [nationally completed name] 3. How to use [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] contains the active substance midazolam and belongs to a group of medicines known as benzodiazepines. It is a short-acting medicine that induces sedation – a state of calm, drowsiness or sleep - and relieves anxiety and muscle tension. It has anticonvulsant effects and causes loss of memory for recent events. [NATIONALLY COMPLETED NAME] IS USED FOR: • conscious SEDATION during a medical test or procedure, in adults and children • sedation in intensive care units, in adults and children • ANAESTHESIA in adults, used alone or with other anaesthetic medicines • sedation before induction of anaesthesia, in adults and children 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY COMPLETED NAME] YOU MUST NOT BE GIVEN [NATIONALLY CO Lugege kogu dokumenti
Sandoz B.V. Page 1/22 Midazolam Sandoz 1 mg/ml en 5 mg/ml – oplossing voor injectie of infusie RVG 110832-37 1311-V5 1.3.1.1 Samenvatting van de Productkenmerken juli 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Midazolam Sandoz 1 mg/ml, oplossing voor injectie of infusie Midazolam Sandoz 5 mg/ml, oplossing voor injectie of infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection or infusion contains 1 mg of midazolam (as hydrochloride). Each ampoule of 5 ml solution for injection or infusion contains 5 mg of midazolam (as hydrochloride). _ _ Each ml of solution for injection or infusion contains 5 mg of midazolam (as hydrochloride). Each ampoule of 1 ml solution for injection or infusion contains 5 mg of midazolam (as hydrochloride). Each ampoule of 3 ml solution for injection or infusion contains 15 mg of midazolam (as hydrochloride). Each ampoule of 10 ml solution for injection or infusion contains 50 mg of midazolam (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion. Clear, slightly yellow solution. pH 2.9 – 3.7. Osmolality 280 – 330 mOsmol/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is indicated for i.v. use, i.m. use and rectal use only. Midazolam is a short-acting sleep-inducing medicinal product that is indicated for: IN ADULTS: • CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia • ANAESTHESIA - Premedication before induction of anaesthesia - Induction of anaesthesia - As a sedative component in combined anaesthesia Sandoz B.V. Page 2/22 Midazolam Sandoz 1 mg/ml en 5 mg/ml – oplossing voor injectie of infusie RVG 110832-37 1311-V5 1.3.1.1 Samenvatting van de Productkenmerken juli 2023 • SEDATION IN INTENSIVE CARE UNITS IN CHILDREN: • CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia • ANAESTHESIA - Premedicat Lugege kogu dokumenti