Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Midazolam 5 mg/mL
Baxter Healthcare Ltd
Midazolam 5 mg/mL
5 mg/mL
Solution for injection
Active: Midazolam 5 mg/mL Excipient: Hydrochloric acid Hydrochloric acid (pH adjuster) Sodium chloride Sodium hydroxide Water for injection
Class C5 Controlled Drug
Sun Pharmaceutical Industries Ltd
Premedication before induction of anaesthesia (i.m. or, especially in children, rectal, intranasal or oral administration).
Package - Contents - Shelf Life: Ampoule, glass, Clear type I glass, 10 mL - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 3 mL - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 1 mL - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 10 mL - 10 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 3 mL - 10 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 1 mL - 10 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 3 mL - 25 dose units - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Clear type I glass, 1 mL - 25 dose units - 24 months from date of manufacture stored at or below 30°C protect from light
2015-05-18
NEW ZEALAND DATA SHEET MIDAZOLAM‐BAXTER Data Sheet 4 March 2019 Page 1 of 15 Baxter Healthcare Ltd 1. MIDAZOLAM‐BAXTER MIDAZOLAM‐BAXTER 1mg/mL solution for injection. MIDAZOLAM‐BAXTER 5mg/mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MIDAZOLAM‐BAXTER 1mg/mL solution for injection: Each 5mL ampoule contains 5mg of midazolam (as hydrochloride). MIDAZOLAM‐BAXTER 5mg/mL solution for injection: Each 1mL ampoule contains 5mg of midazolam (as hydrochloride). Each 3mL ampoule contains 15mg of midazolam (as hydrochloride). Each 10mL ampoule contains 50mg of midazolam (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A clear, colourless to pale yellow, sterile solution, free from particles, with a pH between 2.9 ‐ 3.7. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Premedication before induction of anaesthesia (I.M. or, especially in children, rectal, intranasal or oral administration). Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia (I.V. administration), or in children intranasal or oral administration. Long‐term sedation in intensive care units (I.V. 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 (I.V. injection, I.V. infusion). Ataralgesia in combination with ketamine in children (I.M. administration). 4.2 Dose and method of administration Method of administration For intramuscular, intravenous, rectal, intranasal or oral administration (see instructions in section 4.2, ‘Dose’). Dose 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 Lees het volledige document