MIDAZOLAM INJECTION SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)

Dostupno od:

MYLAN PHARMACEUTICALS ULC

ATC koda:

N05CD08

INN (International ime):

MIDAZOLAM

Doziranje:

1MG

Farmaceutski oblik:

SOLUTION

Sastav:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

1/2/5/10ML

Tip recepta:

Targeted (CDSA IV)

Područje terapije:

BENZODIAZEPINES

Proizvod sažetak:

Active ingredient group (AIG) number: 0119935002; AHFS:

Status autorizacije:

CANCELLED PRE MARKET

Datum autorizacije:

2017-05-09

Svojstava lijeka

_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
MIDAZOLAM INJECTION
1 MG/ML AND 5 MG/ML
BENZODIAZEPINE
PREMEDICANT/SEDATIVE/ANESTHETIC AGENT
MYLAN PHARMACEUTICALS ULC DATE OF PREPARATION: JULY 16, 2014
85 ADVANCE ROAD
ETOBICOKE, ON
M8Z 2S6
SUBMISSION CONTROL NO: 175409
_Page 2 of 49 _
PRODUCT MONOGRAPH
Pr
Midazolam Injection
1 mg/mL and 5 mg/mL
THERAPEUTIC CLASSIFICATION
Benzodiazepine
Premedicant/Sedative/Anesthetic Agent
GENERAL
ADULT AND PEDIATRIC
Intravenous Midazolam Injection 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.
The 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
_Page 3 of 49 _
must be calculated on a mg/kg basis, and initial dose