Midazolam

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Midazolam 5 mg/mL;  

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Midazolam 5 mg/mL

Dosagem:

5 mg/mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Midazolam 5 mg/mL   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Unidades em pacote:

Ampoule, PEsteriluer, 10mL, 5 dose units

Classe:

Class C5 Controlled Drug

Tipo de prescrição:

Class C5 Controlled Drug

Fabricado por:

Perrigo API Ltd

Indicações terapêuticas:

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

Resumo do produto:

Package - Contents - Shelf Life: Ampoule, PEsteriluer, 10mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. In sachet 8 months opened stored at or below 25°C protect from light. Out of sachet - Ampoule, PEsteriluer, 3mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. In sachet 8 months opened stored at or below 25°C. Out of sachet - Ampoule, PEsteriluer 1mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. in sachet 8 months opened stored at or below 25°C protect from light. Out of sachet

Data de autorização:

1999-06-30

Características técnicas

Version: pfdmidai10419
Supersedes: pfdmidai10218
Page 1 of 26
NEW ZEALAND
DATA SHEET
1.
PRODUCT NAME
Midazolam 1 mg/mL and 5 mg/mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Midazolam Injection contains 1 mg and 5 mg
midazolam.
Each vial of Midazolam Injection 1 mg/mL contains 8 mg/mL sodium.
Each vial of Midazolam Injection 5 mg/mL contains 8 mg/mL sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution
for injection
Midazolam Injection is a sterile, isotonic, clear, colourless to pale
yellow solution in a ready-to-
use, single dose presentation. Midazolam Injection contains midazolam.
_ROUTES OF ADMINISTRATION_
: Intravenous (i.v.), intramuscular (i.m.), rectal, intranasal or oral
(see
section 4.1).
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
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.
Version: pfdmidai10419
Supersedes: pfdmidai10218
Page 2 of 26
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). T