Country: Նիդերլանդեր
language: հոլանդերեն
source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ESKETAMINEHYDROCHLORIDE 28,8 mg/ml SAMENSTELLING overeenkomend met ; ESKETAMINE 25 mg/ml
International Drug Development 104 boulevard Auguste Blanqui 75013 PARIS (FRANKRIJK)
N01AX14
ESKETAMINEHYDROCHLORIDE 28,8 mg/ml SAMENSTELLING overeenkomend met ; ESKETAMINE 25 mg/ml
Oplossing voor injectie of infusie
NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)
Intraveneus gebruik, Intramusculair gebruik
Esketamine
1900-01-01
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ESKETAMINE IDD 5 MG/ML, OPLOSSING VOOR INJECTIE/INFUSIE ESKETAMINE IDD 25 MG/ML, OPLOSSING VOOR INJECTIE/INFUSIE esketamine 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 Esketamine IDD is and what it is used for 2. What you need to know before you are given Esketamine IDD 3. How to use Esketamine IDD 4. Possible side effects 5. How to store Esketamine IDD 6. Contents of the pack and other information 1. WHAT ESKETAMINE IDD AND WHAT IT IS USED FOR Esketamine IDD belongs to one of a group of medicines called general anaesthetics, which is used to put you to sleep during an operation. Esketamine IDD is used: - to initiate and perform general anaesthesia, as the only anaesthetic or possibly in combination with sleeping pills (hypnotics), - to supplement regional anaesthesia (local anaesthesia), - for anaesthesia and pain relief (analgesia) in emergency situations, - for pain control in artificial respiration (intubation). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ESKETAMINE IDD _ _ ESKETAMINE IDD MUST NOT BE USED: - if you are allergic to esketamine or any of the other ingredients of this medicine (listed in section 6), - if high blood pressure or increased pressure in the brain is a serious risk for you, - if you have poorly controlled or untreated high blood pressure, - if you have a condition called eclampsia or pre-eclampsia (which is a complication of pregnancy that causes high blood pressure), - if you have an overactive thyroid (insufficiently treated hyperthyroidism), - in situations during childbirth which require relaxed uterus muscle, (e.g. threat of a ute read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Esketamine IDD 5 mg/ml, oplossing voor injectie/infusie Esketamine IDD 25 mg/ml, oplossing voor injectie/infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Esketamine IDD 5 mg/ml, oplossing voor injectie/infusie 1 ml solution for injection/infusion contains 5 mg esketamine as 5.77 mg of esketamine hydrochloride. 1 ampoule of 5 ml solution for injection/infusion contains 25 mg of esketamine as 28.83 mg esketamine hydrochloride. 1 vial of 20 ml solution for injection/infusion contains 100 mg of esketamine as 115.40 mg esketamine hydrochloride. Esketamine IDD 25 mg/ml, oplossing voor injectie/infusie 1 ml solution for injection/infusion contains 25 mg of esketamine as 28.83 mg of esketamine hydrochloride. 1 ampoule of 2 ml solution for injection/infusion contains 50 mg of esketamine as 57.66 mg of esketamine hydrochloride. 1 ampoule containing 10 ml solution for injection/infusion contains 250 mg of esketamine as 288.30 mg of esketamine hydrochloride. 1 vial of 10 ml solution for injection/infusion contains 250 mg of esketamine as 288.3 mg of esketamine hydrochloride. 1 vial of 50 ml solution for injection/infusion contains 1250 mg of esketamine as 1441.5 mg of esketamine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution. pH 3.0 – 4.0. Osmolality = 270 – 310 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Induction and maintenance of general anaesthesia, as the only anaesthetic or possibly in combination with hypnotics. - Supplementation of regional or local anaesthesia. - Anaesthesia and pain relief (analgesia) in emergency medicine. - Pain control in artificial respiration (intubation). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Esketamine should be administered only by specialist of anaesthesiology or emergency medicine. Esketamine is for hospital use only. As aspiration cannot be completely excluded and due to the po read_full_document