देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
MIDAZOLAM HYDROCHLORIDE
Martindale Pharmaceuticals Ltd
N05CD; N05CD08
MIDAZOLAM HYDROCHLORIDE
5 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; midazolam
Not marketed
2011-01-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Midazolam 5 mg/ml Solution for injection or infusion Midazolam (as Midazolam Hydrocloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFOMRAITON FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Midazolam is and what it is used for 2. What you need to know before Midazolam is given 3. How Midazolam will be given 4. Possible side effects 5. How to store Midazolam 6. Contents of the pack and other information 1. WHAT MIDAZOLAM IS AND WHAT IT IS USED FOR Midazolam 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 MIDAZOLAM IS GIVEN YOU SHOULD NOT BE GIVEN MIDAZOLAM IF: - you are allergic (hypersensitive) to Midazolam hydrochloride or any of the other ingredients in this 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 Midazolam for conscious sedation. You must not be given Midazolam if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine. TAKE SPECIAL CARE WITH MIDAZOLAM CHILDREN AND B पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 24 September 2019 CRN008MQ1 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midazolam 5 mg/ml Solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: midazolam as hydrochloride. Ampoules 5mg/ml; for IV., IM and rectal administration. Each ml of solution for injection or infusion contains 5mg midazolam (as the hydrochloride). Each 2ml of solution for injection or infusion contains 10mg midazolam (as the hydrochloride). Each 5ml of solution for injection or infusion contains 25mg midazolam (as the hydrochloride). Excipient(s) with known effect: Sodium 1.97 mg/ml. For a full list of Excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless solution. pH 2.9-3.7 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam Solution for Injection or Infusion 5 mg/ml is a short-acting sedative and sleep-inducing drug. The indications are as follows: In adults and children Conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia, Premedication before induction of anaesthesia, Sedation in Intensive Care Units. In adults Induction of anaesthesia, As an induction agent or as a sedative component in combined anaesthesia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Midazolam is a potent sedative that requires dose titration and slow administration. Dose titration is required to optimize safety whilst achieving 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, the dose should be determined with caution and risk factors related to each patient should be taken into account. Standard dosages are shown in the table below; additional details are provided in the text following the table. Standard Dosage: INDICATION ADULTS<60 YEARS ADULTS 60 YEARS+/DEBILITATED OR SE पूरा दस्तावेज़ पढ़ें