Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Midazolam 5 mg/mL;
Viatris Limited
Midazolam 5 mg/mL
5 mg/mL
Solution for injection
Active: Midazolam 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Ampoule, glass, 1 mL, type I, clear, colourless, with one-point cut, 5 x 1 mL in a carton, 5 mL
Class C5 Controlled Drug
Class C5 Controlled Drug
Cambrex Profarmaco Milano Srl
Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia (intravenous administration), or in children intranasal or oral administration. Long-term sedation in intensive care units (intravenous administration as bolus injection or continuous infusion).
Package - Contents - Shelf Life: Ampoule, glass, 10 mL, type I, clear, colourless, with one-point cut, L in a carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 10 mL, type I, clear, colourless, with coloured break, in a carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 3 mL, type I, clear, colourless, with one-point cut, in a carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 3 mL, type I, clear, colourless, with coloured break, in a carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 1 mL, type I, clear, colourless, with one-point cut, in a carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 1 mL, type I, clear, colourless, with coloured break, in a carton - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 1 mL, type I, clear, colourless, with one-point cut, in a carton - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 1 mL, type I, clear, colourless, with coloured break, in a carton - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
2010-12-10
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION MIDAZOLAM VIATRIS _MIDAZOLAM 1 MG/ML AND 5 MG/ML AMPOULES_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MIDAZOLAM VIATRIS. 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 you taking MIDAZOLAM VIATRIS against the benefits they expect it will have 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 MIDAZOLAM VIATRIS IS USED FOR MIDAZOLAM VIATRIS is used for the following_._ may be given as a sedative during some short medical procedures. 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 MIDAZOLAM VIATRIS as a sedative. This medicine belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. MIDAZOLAM VIATRIS can cause sedation (sleepiness), short term amnesia (no memory of events around the time you are given MIDAZOLAM VIATRIS, and/or anaesthesia (heavy sleep for surgery) depending on the dose you are given. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN MIDAZOLAM VIATRIS _WHEN YOU MUST NOT USE _ _IT_ DO NOT HAVE MIDAZOLAM VIATRIS IF YOU HAVE AN ALLERGY TO: any medicine containing midazolam or any other benzodiazepine medicine. any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongu Lees het volledige document
Page 1 of 22 NEW ZEALAND DATA SHEET MIDAZOLAM VIATRIS 1. PRODUCT NAME Midazolam Viatris, 1 mg/mL or 5 mg/mL, ampoules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 1 mg/mL or 5 mg/mL of midazolam For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Midazolam Viatris solution for injection is a clear, colourless solution, packaged in a clear colourless ampoule. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Premedication before induction of anaesthesia (intramuscular or, especially in children, rectal, intranasal or oral administration). Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia (intravenous administration), or in children intranasal or oral administration. Long-term sedation in intensive care units (intravenous administration as bolus injection or continuous infusion). Induction and maintenance of anaesthesia. As an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia, including total intravenous anaesthesia (intravenous injection, intravenous infusion). Ataralgesia in combination with ketamine in children (intramuscular administration). _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ This product is for single patient use only. Use once and discard any residue. In the case of elderly patients with organic cerebral changes or impaired cardiac and respiratory function, the dosage should be determined with caution, the special factors relating to each patient being taken into consideration. Initial and subsequent intravenous injections must be given slowly (approximately 2.5 mg in 10 seconds for induction of anaesthesia and 1 mg in 30 seconds for conscious sedation). The medicine takes effect about two minutes after the injection is started. Dosage should be individualised. Page 2 of 22 PREMEDICATION BEFORE AN OPERATION _INTRAMUSCULAR ADMINISTRATION_ In patients suffering from pain before an intervention. Administration alone or in combination with anticholinergics and poss Lees het volledige document