Nazione: Malta
Lingua: inglese
Fonte: Malta Medicines Authority
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
M03AC09
ROCURONIUM BROMIDE 10 mg/ml
SOLUTION FOR INJECTION/INFUSION
ROCURONIUM BROMIDE 10 mg/ml
POM
MUSCLE RELAXANTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-03-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ROCURONIUM KABI 10 MG/ML SOLUTION FOR INJECTION / INFUSION Rocuronium Bromide 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. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possibile side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Rocuronium Kabiis and what it is used for 2. What you need to know before you use Rocuronium Kabi 3. How to use Rocuronium Kabi 4. Possible side effects 5. How to store Rocuronium Kabi 6. Contents of the pack and other information 1. WHAT ROCURONIUM KABI IS AND WHAT IT IS USED FOR Rocuronium Kabi belongs to a group of medicines called muscle relaxants. Normally the nerves send messages to the muscles by impulses. Rocuronium Kabi acts by blocking these impulses so that the muscles become relaxed. When you have an operation your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. Rocuronium Kabi may also be used if you are having an anaesthesia to ease the insertion of a tube into your trachea (windpipe) for artificial ventilation (mechanical assistance of breathing). Rocuronium Kabi is indicated in adults and in neonates (0-27 days) infants and toddlers aged 28 days to 23 months, children aged 2 to 11 years and adolescents aged 12 to 17 years. Rocuronium Kabi may also be used in adults only as an adjunct in the intensive care unit (ICU) (e.g. to ease the insertion of a tube into your windpipe) for short term use. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROCURONIUM KABI DO NOT USE ROCURONIUM KABI - if you are ALLERGIC to rocuronium bromide, the bromide ion or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Rocuronium Kabi Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rocuronium Kabi 10 mg/ml solution for injection / infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection / infusion contains 10 mg rocuronium bromide. Each vial with 5 ml contains 50 mg rocuronium bromide. Each vial with 10 ml contains 100 mg rocuronium bromide. Excipient with known effect: Each 5 ml vial contains 0.72 mmol (or 16.7 mg) of sodium. Each 10 ml vial contains 1.44 mmol (or 33.4 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection / infusion Clear, colourless to pale brownish-yellow solution pH of the solution: 2.8 to 3.2 Osmolality: 270– 330 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rocuronium Kabi is indicated in adult and paediatric patients (from term neonates to adolescents (0 to < 18 years) as an adjunct to general anaesthesia to facilitate tracheal intubation during routine sequence induction and to provide skeletal muscle relaxation, during surgery. In adults Rocuronium Kabi is also indicated to facilitate tracheal intubation during rapid sequence induction and as an adjunct in the intensive care unit (ICU) (e.g. to facilitate intubation), for short term use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rocuronium bromide should be administered only by an experienced staff familiar with the use of neuromuscular blocking agents. Adequate facilities and staff for endotracheal intubation and artificial ventilation have to be available for immediate use. As with other neuromuscular blocking agents, the dosage of rocuronium bromide should be individualised in each patient. The method of anaesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicinal products that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscul Leggi il documento completo