Страна: Малта
Език: английски
Източник: Medicines Authority
Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland
V03AB35
SUGAMMADEX 100 mg/ml
SOLUTION FOR INJECTION
SUGAMMADEX 100 mg/ml
POM
ALL OTHER THERAPEUTIC PRODUCTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-01-09
Page 1 of 8 ANNEX III LABELLING AND PACKAGE LEAFLET Page 2 of 8 B. PACKAGE LEAFLET Page 3 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER SUGAMMADEX ASPEN 100 MG/ML SOLUTION FOR INJECTION 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 anaesthetist or doctor. If you get any side effects, talk to your anaesthetist 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 Aspen is and what it is used for 2. What you need to know before Sugammadex Aspen is given 3. How Sugammadex Aspen is given 4. Possible side effects 5. How to store Sugammadex Aspen 6. Contents of the pack and other information 1. WHAT SUGAMMADEX ASPEN IS AND WHAT IT IS USED FOR WHAT SUGAMMADEX ASPEN IS Sugammadex Aspen 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 ASPEN 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 Aspen 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 child Прочетете целия документ
Page 1 of 18 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 18 1. NAME OF THE MEDICINAL PRODUCT Sugammadex Aspen 100 mg/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex. Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex. Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex. Excipient with known effect The total amount of sodium in each mL is up to 9.5 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless to slightly yellow/brown solution free from visible particles. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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: _ _ _ _ _ _ Page 3 of 18 _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/T1 ratio to 0.9 is around 3 minutes (see section 5.1). A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T Прочетете целия документ