MIDAZOLAM INJECTION SOLUTION

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)

থেকে পাওয়া:

MYLAN PHARMACEUTICALS ULC

এটিসি কোড:

N05CD08

INN (International Name):

MIDAZOLAM

ডোজ:

5MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5MG

প্রশাসন রুট:

INTRAMUSCULAR

প্যাকেজ ইউনিট:

1/2/5/10ML

প্রেসক্রিপশন টাইপ:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2017-05-09

পণ্য বৈশিষ্ট্য

_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