Tiopental Abboxia Pulver till injektionsvätska, lösning

Country: Sweden

Bahasa: Sweden

Sumber: Läkemedelsverket (Medical Products Agency)

Bahan aktif:

tiopentalnatrium

Boleh didapati daripada:

Abboxia AB

Kod ATC:

N01AF03

INN (Nama Antarabangsa):

sodium thiopental

Borang farmaseutikal:

Pulver till injektionsvätska, lösning

Komposisi:

tiopentalnatrium 1 g Aktiv substans

Jenis preskripsi:

Receptbelagt

Ringkasan produk:

Förpacknings: Injektionsflaska, 1 x 0,5 g; Injektionsflaska, 10 x 0,5 g; Injektionsflaska, 1 x 1,0 g; Injektionsflaska, 10 x 1,0 g

Status kebenaran:

Avregistrerad

Tarikh kebenaran:

2021-02-09

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTOCUR 0.5 G POWDER FOR SOLUTION FOR INJECTION
PENTOCUR 1 G POWDER FOR SOLUTION FOR INJECTION
thiopental sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pentocur is and what it is used for
2.
What you need to know before you are given Pentocur
3.
How Pentocur is given
4.
Possible side effects
5.
How to store Pentocur
6.
Contents of the pack and other information
1.
WHAT PENTOCUR IS AND WHAT IT IS USED FOR
Pentocur contains the active substance “thiopental sodium”. It is
a thiobarbiturate with rapid onset for
intravenous administration.
Pentocur is used:
•
to start general anaesthesia (a state of heavy sleep e.g. during
surgery)
•
to provide hypnosis (you are sleepy but not completely asleep) during
anaesthesia together with
other anaesthetic agents
•
as part of treatment for cramps (including those caused by local
anaesthetics)
•
to reduce pressure in the skull (intracranial pressure) in patients
where the pressure is increased (if
respiratory assistance is provided)
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PENTOCUR
PENTOCUR SHOULD NOT BE GIVEN TO YOU:
-
if you are allergic to thiopental, barbiturates or any of the other
ingredients of this medicine (listed in
section 6)
-
in case of obstruction of the airways (respiratory obstruction)
-
if you have acute asthma (severe asthma attack)
-
if you suffer from hereditary muscle degeneration (myotonic dystrophy)
-
if you are in severe shock
-
if you have porphyria
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Pentocur. The health
care professionals should be extra
careful and may have to adjust your dose, if you ha

Ciri produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pentocur 0.5 g powder for solution for injection
Pentocur 1 g powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Pentocur 0.5 g powder for solution for injection contains
500 mg thiopental sodium (as
thiopental sodium and sodium carbonate).
Each vial of Pentocur 1 g powder for solution for injection contains
1000 mg thiopental sodium (as
thiopental sodium and sodium carbonate).
Excipients with known effect:
Each vial of Pentocur 0.5 g contains 2.2-2.4 mmol sodium (51-56 mg).
Each vial of Pentocur 1 g contains 4.4-4.9 mmol sodium (102-112 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection
Yellowish-white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous anaesthesia.
Induction of general anaesthesia and also as an adjunct to provide
hypnosis during balanced anaesthesia with
other anaesthetic agents, including analgesics and muscle relaxants.
As an adjunct for control of
_ _
refractory convulsive disorders of various aetiology, including those
caused by
local anaesthetics.
Reducing the intracranial pressure in patients with increased
intracranial pressure, if controlled ventilation is
provided.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Using of thiopental is reserved only for health care personnel trained
in anaesthesiology. A person qualified
in the use of anaesthetics should be constantly available during the
administration of the medicinal product.
After continuous administration of thiopental the effect duration is
prolonged, personnel qualified in the use
of anaesthetics should be constantly available during the
administration of the medicinal product.
A normal adult dose for induction of anaesthesia is 4-6 mg/kg body
weight, but the individual response to the
drug is so varied that there can be no fixed dosage. The drug should
be titrated against patient requirements
as governed by age, sex, body weight and the p