MIDAZOLAM INJECTION SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)

Beschikbaar vanaf:

NOVOPHARM LIMITED

ATC-code:

N05CD08

INN (Algemene Internationale Benaming):

MIDAZOLAM

Dosering:

5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

1/2/10 ML

Prescription-type:

Targeted (CDSA IV)

Therapeutisch gebied:

BENZODIAZEPINES

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2018-05-02

Productkenmerken

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