Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Midazolam
Accord Healthcare Ireland Ltd.
N05CD08
Midazolam
1 milligram(s)/millilitre
Solution for injection/infusion in pre-filled syringe
midazolam
Marketed
2020-09-11
Var PSUSA-00002057-202209 13 July 2023 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE midazolam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or nurse. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe is and what it is used for 2. What you need to know before you are given Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe 3. How to use Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe 4. Possible side effects 5. How to store Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe 6. Contents of the pack and other information 1. WHAT MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE IS AND WHAT IT IS USED FOR Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe contains contains Midazolam. This belongs to a group of medicines called ‘benzodiazepines’. Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe works quickly to make you feel sleepy or to put you to sleep. It also makes you calm and relaxes your muscles. Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe is used in adults: • As a general anaesthetic to put you to sleep or to keep you asleep. Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe is also used in adults and in children (≥ 12 years age): • To make you feel calm and sleepy if you are in intensive care. This is called ‘sedation’. • Before and during a medical test or procedure where you are going to stay awake. It makes you feel calm and sleepy. Th Belgenin tamamını okuyun
Health Products Regulatory Authority 25 August 2023 CRN00DR4K Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midazolam 1 mg/ml solution for injection/infusion in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains midazolam hydrochloride corresponding to 1 mg midazolam. Each 5 ml pre-filled syringe contains midazolam hydrochloride corresponding to 5 mg midazolam. Excipient with known effect: Contains 3.53 mg sodium (as sodium chloride) per ml of solution for injection or infusion. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion in pre-filled syringe (graduation 0.1 ml) Clear, colorless to pale yellow solution free from foreign particles with a pH in the range of 2.9 - 3.7 and 270 mOsm/kg to 330 mOsm/kg osmolality. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam 1 mg/ml Solution for injection/infusion in pre-filled syringe is a short acting sleep-inducing drug that is indicated: 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 • SEDATION IN INTENSIVE CARE UNITS Inchildren: • _Conscious Sedation_ before and during diagnostic or therapeutic procedures with or without local anaesthesia • _Anaesthesia_ - Premedication before induction of anaesthesia • _Sedation in Intensive Care Units_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE IS RECOMMENDED TO BE ADMINISTERED IN ADULTS AND IN CHILDREN AGED 12 YEARS AND ABOVE. Standard Dosage Midazolam is a potent sedative agent that requires titration and slow administration. Titration is strongly recommended to safely obtain the desired level of sedation according to the clinical need, physical status, age and concomitant medication. In adults over 60 yea Belgenin tamamını okuyun