Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Midazolam hydrochloride
CHEPLAPHARM Arzneimittel GmbH
N05CD; N05CD08
Midazolam hydrochloride
10 mg/2ml
Solution for injection
Benzodiazepine derivatives; midazolam
Marketed
1983-04-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HYPNOVEL ® 10 MG/2 ML SOLUTION FOR INJECTION HYPNOVEL ® 10 MG/5 ML SOLUTION FOR INJECTION Midazolam (as midazolam hydrochloride) 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 or nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hypnovel is and what it is used for 2. What you need to know before you are given Hypnovel 3. How Hypnovel is given 4. Possible side effects 5. How to store Hypnovel 6. Contents of the pack and other information 1. WHAT HYPNOVEL IS AND WHAT IT IS USED FOR Hypnovel contains the active substance midazolam, which belongs to a group of medicines known as benzodiazepines. It is a short-acting medicine that is used to induce sedation (a very relaxed state of calm, drowsiness or sleep) and relieves anxiety and muscle tension. This medicine is used for: • Conscious sedation (an awake but very relaxed state of calm or drowsiness during a medical test or procedure) in adults and children. • Sedation of adults and children, in intensive care units. • Anaesthesia in adults, used alone or with other medicines. • Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic) in adults and children. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYPNOVEL YOU MUST NOT BE GIVEN HYPNOVEL IF: • You are allergic (hypersensitive) to midazolam or any of the other ingredients of the medicine (listed in section 6). • You are allergic to other benzodiazepine medicines, such as diazepam or nitrazepam. • You have severe breathing problems and you are going to have Hyp Read the complete document
Health Products Regulatory Authority 21 September 2023 CRN00DRX2 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hypnovel 10 mg/2 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 5mg midazolam (as midazolam hydrochloride). One ampoule of 2 ml contains 10mg midazolam. Excipient(s) with known effect: Sodium 2.2mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypnovel 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 IN CHILDREN 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 STANDARD DOSAGE Health Products Regulatory Authority 21 September 2023 CRN00DRX2 Page 2 of 16 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 years, debilitated or chronically ill patients and paediatric patients, dose should be determined with caution and risk factors related to each patient should be taken into account. Standard dosages are provided in the table below. Additional details are provided in the text following the table. Indication Adults < 60 y Adults ≥ 60 y / debilitated or chronically ill Children Conscious sedation _I.V._ Initial dose: 2 - 2.5mg Titration doses: 1mg Total dose: 3.5 - 7.5mg _I.V._ Initial Read the complete document