MIDAZOLAM INJECTION SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)

Tilgjengelig fra:

NOVOPHARM LIMITED

ATC-kode:

N05CD08

INN (International Name):

MIDAZOLAM

Dosering :

5MG

Legemiddelform:

SOLUTION

Sammensetning:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5MG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

1/2/10 ML

Resept typen:

Targeted (CDSA IV)

Terapeutisk område:

BENZODIAZEPINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0119935001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2018-05-02

Preparatomtale

PRODUCT MONOGRAPH
MIDAZOLAM INJECTION
(midazolam)
NOVOPHARM STANDARD
I mg/mL, 5 mg/mL
THERAPEUTIC CLASSIFICATION
BENZODIAZEPINF
PREMEDICANT/SEDATIVE/ANESTHETIC AGENT
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
Canada
MI B 2K9
Date of Preparation:
June 19, 2001
Control# 068338
4
1
PRODUCT MONOGRAPH
MIDAZOLAM INJECTION
(MIDAZOLAM)
NOVOPHARM STANDARD
1 MG/ML, 5 MG/ML
THERAPEUTIC CLASSIFICATION
BENZODIAZEPINE
PREMEDICANT/SEDATIVE/ANESTHETIC AGENT
GENERAL
ADULT AND PEDIATRIC: INTRAVENOUS MIDAZOLAM HAS BEEN ASSOCIATED WITH
RESPIRATORY DEPRESSION AND
RESPIRATORY ARREST, ESPECIALLY WHEN USED FOR SEDATION IN NONCRITICAL
CARE SETTINGS. IN SOME CASES,
WHERE THIS WAS NOT RECOGNIZED PROMPTLY AND TREATED EFFECTIVELY, DEATH
OR HYPOXIC ENCEPHALOPATHY
HAS RESULTED. INTRAVENOUS MIDAZOLAM SHOULD BE USED ONLY IN HOSPITAL OR
AMBULATORY CARE SETTINGS,
THAT PROVIDE FOR CONTINUOUS MONITORING OF RESPIRATORY AND CARDIAC
FUNCTION, I.E., PULSE OXIMETRY.
IMMEDIATE AVAILABILITY OF RESUSCITATIVE DRUGS AND AGE AND
SIZE-APPROPRIATE EQUIPMENT FOR
BAG/VALVE/MASK VENTILATION AND INTUBATION, AND PERSONNEL TRAINED IN
THEIR USE AND SKILLED IN
AIRWAY MANAGEMENT SHOULD BE ASSURED (SEE WARNINGS). FOR DEEPLY SEDATED
PATIENTS, A
DEDICATED INDIVIDUAL, OTHER THAN THE PRACTITIONER PERFORMING THE
PROCEDURE, SHOULD MONITOR THE
PATIENT THROUGHOUT THE PROCEDURE.
4
.
2
e initial intravenous dose for sedation in adult patients may be as
little as 1 mg, but should not
exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for
older (over 60 years) or
debilitated patients and in patients receiving concomitant narcotics
or other central nervous
system depressants. The initial dose and all subsequent doses should
always be titrated slowly;
administered over 2-3 minutes and allow about 2 minutes to fully
evaluate the sedative effect.
The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5
mg/mL formulation is
recommended to facilitate slower injection. Doses of sedative
medications in pediatric patients
must be calculated on a mg/kg basi