מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Midazolam 1 mg/mL (present as 1.1111mg/mL midazolam hydrochloride);
Roche Products (NZ) Ltd
Midazolam 1 mg/mL (present as 1.1111mg/mL midazolam hydrochloride)
1 mg/mL
Solution for injection
Active: Midazolam 1 mg/mL (present as 1.1111mg/mL midazolam hydrochloride) Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide as 1N solution, for pH adjustment, pH 3.3±0.1 Water for injection
Ampoule, glass, 5mL, 10 dose units
Class C5 Controlled Drug
Class C5 Controlled Drug
F.I.S. Fabbrica Italiana Sintetici SpA
Hypnovel is indicated for Adults · Premedication before induction of anaesthesia · Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia · Long-term sedation in intensive care units · Induction and maintenance of anaesthesia. As an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia, including total intravenous anaesthesia. Children · Premedication before induction of anaesthesia · Conscious sedation before diagnosticc or surgical interventions carried out under local anaesthesia · Ataralgesia in combination with ketamine · Ataralgesia in combination with ketamine in children (i.m. administration).
Package - Contents - Shelf Life: Ampoule, glass, 5mL - 10 dose units - 60 months from date of manufacture stored at or below 30°C. (approved to 35°C)
1988-05-13
_ _ _ _ Hypnovel Ampoules 170918 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION HYPNOVEL ® MIDAZOLAM SOLUTION FOR INJECTION 5MG/5ML AND 15MG/3ML IN AMPOULES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hypnovel solution for injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of your using Hypnovel against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT IS HYPNOVEL USED FOR Hypnovel may be given as a sedative during some short medical procedures. Hypnovel may be given before an operation to produce sleepiness or drowsiness and to relieve anxiety. It may also be used in combination with other anaesthetic agents to keep you asleep during an operation. If you are in an intensive care unit, you may receive Hypnovel as a sedative. Hypnovel belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. Hypnovel can cause sedation (sleepiness), short term amnesia (no memory of events around the time you are given Hypnovel, and/or anaesthesia (heavy sleep for surgery) depending on the dose you are given. Your doctor, however, may have prescribed Hypnovel for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY HYPNOVEL HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a prescription. BEFORE YOU RECEIVE HYPNOVEL _WHEN YOU MUST NOT HAVE HYPNOVEL SOLUTION FOR INJECTION _ DO NOT HAVE HYPNOVEL IF: _ _ _ _ Hypnovel Ampoules 170918 2 1. YOU HAVE HAD AN ALLERGIC REACTION TO HYPNOVEL SOLUTION FOR INJECTION OR TABLETS, ANY OTHER BENZODIAZEPINE MEDICINE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN HYPNOVEL, TALK TO YOUR DOCTOR. _BEFORE YOU RECEIVE IT _ TELL YOUR DOCTOR IF: 1. YOU קרא את המסמך השלם
NEW ZEALAND DATA SHEET Hypnovel 170717 1 1. PRODUCT NAME Hypnovel ® 5mg/5mL and 15mg/3mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: midazolam as hydrochloride Ampoules 5mg/5 mL and 15mg/3 mL solution for intravenous (IV), intramuscular (IM), intranasal, oral and rectal administration. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypnovel is indicated for ADULTS • Premedication before induction of anaesthesia. • Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia. • Long-term sedation in intensive care units. • Induction and maintenance of anaesthesia. As an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia. CHILDREN • Premedication before induction of anaesthesia. • Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia. • Ataralgesia in combination with ketamine. 4.2 DOSE AND METHOD OF ADMINISTRATION In the case of elderly patients with organic cerebral changes or impaired cardiac and respiratory function, the dosage should be determined with caution. Special factors relating to each patient should be taken into consideration. NEW ZEALAND DATA SHEET Hypnovel 170717 2 Initial and subsequent intravenous injections must be given slowly (see Section 4.2, _ induction _ _of anaesthesia_ and _conscious sedation_ for specific recommendations) The medicine takes effect about two minutes after the injection is started. PREMEDICATION BEFORE AN OPERATION _ADULTS – PREMEDICATION BEFORE AN OPERATION _ _Intramuscular administration _ In patients suffering from pain before an intervention. Administration alone or in combination with anticholinergics and possibly analgesics. These doses should be administered about 30 minutes before induction of anaesthesia. _ _ 0.07-0.10 mg per kg bodyweight i.m. according to age and general condition o קרא את המסמך השלם