Midazolam-Baxter

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Midazolam 1 mg/mL

Beschikbaar vanaf:

Baxter Healthcare Ltd

INN (Algemene Internationale Benaming):

Midazolam 1 mg/mL

Dosering:

1 mg/mL

farmaceutische vorm:

Solution for injection

Samenstelling:

Active: Midazolam 1 mg/mL Excipient: Hydrochloric acid Hydrochloric acid (pH adjuster) Sodium chloride Sodium hydroxide Water for injection

Prescription-type:

Class C5 Controlled Drug

Geproduceerd door:

Sun Pharmaceutical Industries Ltd

therapeutische indicaties:

Premedication before induction of anaesthesia (i.m. or, especially in children, rectal, intranasal or oral administration).

Product samenvatting:

Package - Contents - Shelf Life: Ampoule, glass, Clear type I glass, 5 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, 5 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, 5 mL - 25 dose units - 24 months from date of manufacture stored at or below 30°C protect from light

Autorisatie datum:

2015-05-18

Productkenmerken

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