Midazolam-Baxter

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Midazolam 1 mg/mL

Διαθέσιμο από:

Baxter Healthcare Ltd

INN (Διεθνής Όνομα):

Midazolam 1 mg/mL

Δοσολογία:

1 mg/mL

Φαρμακοτεχνική μορφή:

Solution for injection

Σύνθεση:

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

Τρόπος διάθεσης:

Class C5 Controlled Drug

Κατασκευάζεται από:

Sun Pharmaceutical Industries Ltd

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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

Ημερομηνία της άδειας:

2015-05-18

Αρχείο Π.Χ.Π.

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