DORMICUM INJECTION 15 mg3 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MIDAZOLAM

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

N05CD08

Dosage:

15 mg/3 ml

Pharmaceutical form:

INJECTION

Composition:

MIDAZOLAM 5 mg/ml

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

CENEXI

Authorization status:

ACTIVE

Authorization date:

1988-04-27

Patient Information leaflet

1
DORMICUM
®
Midazolam
SHORT-ACTING
BENZODIAZEPINE
FOR
PREMEDICATION,
SEDATION,
INDUCTION AND MAINTENANCE OF ANESTHESIA
AMPOULES
FOR
INTRAVENOUS,
INTRAMUSCULAR
AND
RECTAL
ADMINISTRATION
COMPOSITION
_Active ingredient_
: midazolam as hydrochloride.
Ampoules
15
mg/3
ml
and
5
mg/5
ml
for
i.v.,
i.m.
and
rectal
administration.
The content of the vial is a clear liquid, practically free from
particles
and colourless to yellowish.
_Excipients_
: sodium chloride, hydrochloric acid, sodium hydroxide,
water for injection.
Sterile product.
PROPERTIES AND EFFECTS
Dormicum has hypnotic and sedative effects characterized by a rapid
onset and short duration. It also exerts anxiolytic, anticonvulsant
and
muscle-relaxant effects. Dormicum impairs psychomotor function after
single
and/or
multiple
doses
but
causes
minimal
haemodynamic
changes.
The
central
actions
of
benzodiazepines
are
mediated
through
an
enhancement
of
the
GABAergic
neurotransmission
at
inhibitory
synapses. In the presence of benzodiazepines the affinity of the GABA
receptor
for
the
neurotransmitter
is
enhanced
through
positive
allosteric
modulation
resulting
in
an
increased
action
of
released
GABA on the postsynaptic transmembrane chloride ion flux.
Chemically, midazolam is a derivative of the imidazobenzodiazepine
group. Although 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
Dormicum
to
form
water-soluble
salts
with
acids.
These
produce
a
stable
and
well
tolerated injection solution.
This together with rapid metabolic transformation are the reasons for
rapid onset and, because of rapid metabolic transformation, short
duration of effects. Because of its low toxicity, midazolam has a wide
therapeutic range.
After parenteral administration anterograde amnesia of short duration
occurs (the patient does not recall events that occurred during the
peak
of activity of the compound).
PHARMACOKINETICS
_Absorption after intramuscular injection

Summary of Product characteristics

1
INJ-DOR-2019 04-0
DORMICUM
®
Midazolam
SHORT-ACTING
BENZODIAZEPINE
FOR
PREMEDICATION,
SEDATION,
INDUCTION AND MAINTENANCE OF ANESTHESIA
AMPOULES
FOR
INTRAVENOUS,
INTRAMUSCULAR
AND
RECTAL
ADMINISTRATION
COMPOSITION
_Active ingredient_
: midazolam as hydrochloride.
Ampoules
15
mg/3
ml
and
5
mg/5
ml
for
i.v.,
i.m.
and
rectal
administration.
The content of the vial is a clear liquid, practically free from
particles
and colourless to yellowish.
_Excipients_
: sodium chloride, hydrochloric acid, sodium hydroxide,
water for injection.
Sterile product.
PROPERTIES AND EFFECTS
Dormicum has hypotic and sedative effects characterized by a rapid
onset and short duration. It also exerts anxiolytic, anticonvulsant
and
muscle-relaxant effects. Dormicum impairs psychomotor function after
single
and/or
multiple
doses,
but
causes
minimal
haemodynamic
changes.
The
central
actions
of
benzodiazepines
are
mediated
through
an
enhancement
of
the
GABAergic
neurotransmission
at
inhibitory
synapses. In the presence of benzodiazepines the affinity of the GABA
receptor
for
the
neurotransmitter
is
enhanced
through
positive
allosteric
modulation
resulting
in
an
increased
action
of
released
GABA on the postsynaptic transmembrane chloride ion flux.
Chemically, midazolam is a derivative of the imidazobenzodiazepine
group. Although 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
Dormicum
to
form
water-soluble
salts
with
acids.
These
produce
a
stable
and
well
tolerated injection solution.
This together with rapid metabolic transformation are the reasons for
rapid onset and, because of rapid metabolic transformation, short
duration of effects. Because of its low toxicity, midazolam has a wide
therapeutic range.
After parenteral administration anterograde amnesia of short duration
occurs (the patient does not recall events that occurred during the
peak
of activity of the compound).
PHARMACOKINETICS
_Absorption after intra