ALFASAN DORMINAL 20% INJECTION PENTOBARBITAL SODIUM 200MGML

Country: Malaysia

Language: English

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

Active ingredient:

PENTOBARBITAL SODIUM

Available from:

DELFI MARKETING SDN.BHD.

INN (International Name):

PENTOBARBITAL SODIUM

Units in package:

100.00 mcg/mL

Manufactured by:

Alfasan International BV

Summary of Product characteristics

ALFASAN
DORMINAL 20% INJECTION
(PENTOBARBITAL SODIUM 200MG/ML)
ACTIVE SUBSTANCE
Pentobarbital Sodium
200 mg/ml
(Equivalent
to
182.3mg/ml
pentobarbital)
PRODUCT DESCRIPTION
A limped pale red coloured injectable
solution
packed
in
colourless
vials,
glass
type
11,
of
100mL
with
butyl
rubber
stoppers
and
non-
reusable
aluminium closures.
PHARMACODYNAMICS
Pentobarbitone
is
an
anaesthetic
agent
and
belongs
to
the
group
of
barbituric acid derivatives.The LD50 in
dogs and cats is approximately 40 to
60mg/kg
bodyweight
when
injected
intravenously.
In endothermic animals, the immediate
effect
is
the
loss
of
consciousness
followed by deep anaesthesia followed
by
death.
Breathing
stops
and
is
quickly followed by cardiac arrest.
PHARMACOKINETICS
Pentobarbital is absorbed quite rapidly
from
the
gut
after
oral
or
rectal
administration
with
peak
plasma
concentrations occurring between 30-
60 minutes after oral dosing in humans.
The
onset
of
action
usually
occurs
within 15-60 minutes after oral dosing
and
within
1
minute
after
IV
administration.
Pentobarbital,
like
all
barbiturates,
distributes rapidly to all body tissues
with highest
concentrations found in
the liver and brain. It is 35-45% bound
to
plasma
proteins
in
humans.
Although less lipophilic than the ultra-
short
acting
barbiturates
(e.g.
thiopental), pentobarbital is highly lipid
soluble
and patient
fat
content
may
alter
the
distributive
qualities
of
the
drug.
All
barbiturates
cross
the
placenta
and
enter
milk
(at
concentrations
far
below
those
of
plasma).
Pentobarbital
is
metabolized
in
the
liver principally by oxidation. Excretion
of
the
drug
is
not
appreciably
enhanced by increasing urine flow or
alkalinizing
the
urine.
Ruminants
(especially
sheep
and
goats)
metabolize
pentobarbital
at
a
very
rapid rate. The elimination half-life in
the
goat
has
been
reported
to
be
approximately 0.9 hrs. Conversely, the
half-life
in
dogs
is
approximately
8
hours and ranges from 15-50 hours in
man.
INDICATION
For euthanasia of domestic pets and
smaller farm animals.
RECOMMENDED DOSAG