Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Sugammadex sodium
Laboratoire AGUETTANT
V03AB35
Sugammadex sodium
Solution for injection in pre-filled syringe
sugammadex
Not marketed
2023-09-22
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUGAMMADEX 50 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SUGAMMADEX 10 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE sugammadex 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 further questions, ask your anaesthesist or doctor. - If you get any side effects, talk to your anaesthesist or other doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sugammadex is and what it is used for 2. What you need to know before Sugammadex is given 3. How Sugammadex is given 4. Possible side effects 5. How to store Sugammadex 6. Contents of the pack and other information 1. WHAT SUGAMMADEX IS AND WHAT IT IS USED FOR WHAT SUGAMMADEX IS Sugammadex contains the active substance sugammadex. Sugammadex is considered to be a _Selective Relaxant Binding Agent_ since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide. WHAT SUGAMMADEX IS USED FOR When you have some types of operations, your muscles must be completely relaxed. This makes it easier for the surgeon to do the operation. For this, the general anaesthetic you are given includes medicines to make your muscles relax. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again. Sugammadex is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier. It does this by combining with the rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used f Прочитать полный документ
Health Products Regulatory Authority 22 September 2023 CRN00D3FR Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sugammadex 10 mg/ml solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml prefilled syringe contains sugammadex sodium equivalent to 100 mg of sugammadex. Each mL of solution for injection contains sugammadex sodium equivalent to 10 mg sugammadex. Excipient(s) with known effect" "Contains 42.6 mg sodium per 10 ml prefilled syringe" For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear colourless to slightly yellow solution, free from visible particles pH: 7.0 – 8.0 Osmolality: 270 – 330 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SUGAMMADEX is indicated in reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: SUGAMMADEX is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Sugammadex should only be administered by, or under the supervision of an anaesthetist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4). The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed. The recommended dose does not depend on the anaesthetic regimen. Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade. The pre-filled syringe 100 mg/10 ml is more adapted to children and adults weighing less than 50 kg. In case of high doses or weights over 50 kg, other presentations or formulations are available. _Adults _ _ _ Routine reversal A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T Прочитать полный документ