MIDAZ Injection 5mgmL

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

MIDAZOLAM

Доступна з:

JETPHARMA SDN. BHD.

ІПН (Міжнародна Ім'я):

MIDAZOLAM

Одиниць в упаковці:

1ml mL; 3ml mL

Виробник:

INTAS PHARM LTD

інформаційний буклет

Not applicable

Характеристики продукта

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only.
MIDAZ INJECTION
1MG/ML (5ML) & 5MG/ML (1ML & 3ML) (MIDAZOLAM INJECTION)
COMPOSITION
Active ingredient: midazolam as hydrochloride
Ampoules 5mg/5mL, 5 mg/1mL and 15mg/3mL for IV or IM administration
NAME AND STRENGTH OF ACTIVE INGREDIENT
Midazolam 1mg/mL
Midazolam 5mg/mL
DOSAGE FORM
Injection
PRODUCT DESCRIPTION
A clear colorless to pale yellow solution filled in a clear glass
ampoule. When examined
under suitable conditions of visibility it should be practically free
from foreign particles.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group:
Hypnotics and sedatives (benzodiazepine derivatives), ATC code:
N05CD08.
Midazolam is a derivative of the imidazobenzodiazepine group. The free
base is a lipophilic
substance with low solubility in water.
The basic nitrogen in position 2 of the imidazobenzodiazepine ring
system enables the active
ingredient of midazolam to form water-soluble salts with acids. These
produce a stable and
well tolerated injection solution.
The pharmacological action of midazolam is characterised by short
duration because of rapid
metabolic transformation. Midazolam has a sedative and sleep-inducing
effect of pronounced
intensity. It also exerts an anxiolytic, an anticonvulsant and a
muscle-relaxant effect.
After i.m. or i.v. administration anterograde amnesia of short
duration occurs (the patient
does not remember events that occurred during the maximal activity of
the compound).
PHARMACOKINETIC PROPERTIES
_Absorption after i.m. injection _
Absorption of midazolam from the muscle tissue is rapid and complete.
Maximum plasma
concentrations are reached within 30 minutes. The absolute
bioavailability after i.m. injection
is over 90%.
_ _
_ _
_ _
_Distribution _
When midazolam is injected i.v., the plasma concentration-time curves
show one or two
distinct phases of distribution. The volume of distribution at steady
state is 0.7 - 1.2 l/kg. 96 -
98% of midazolam is bound to plasma proteins. The major fraction of
pl