Thiopental 500mg powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thiopental sodium

Available from:

Kyowa Kirin Ltd

ATC code:

N01AF03

INN (International Name):

Thiopental sodium

Dosage:

500mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010100; GTIN: 5027229000166 5038903000174

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
THIOPENTAL SODIUM 500 MG
POWDER FOR SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE RECEIVING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
–
Please keep this leaflet. You may need to read it again.
–
If you have any further questions, ask the 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.
WHAT IS IN THIS LEAFLET:
1.
What Thiopental injection is and what it is used for
2.
What you need to know before Thiopental injection is given
3.
How Thiopental injection is given
4.
Possible side effects
5.
How to store Thiopental injection
6.
Contents of the pack and other information
1.
WHAT THIOPENTAL INJECTION IS AND WHAT IT IS USED FOR
Thiopental injection contains the active ingredient thiopental sodium
(as thiopental sodium and
sodium carbonate) which is also known as thiopentone sodium. It is an
anaesthetic agent, which may
be given:

as a general anaesthetic or to make you sleepy before using another
anaesthetic agent

before using agents to prevent pain or to relax muscles

to control fits

to reduce intracranial pressure.
This injection is usually given to you by a doctor directly into a
vein.
2.
WHAT YOU NEED TO KNOW BEFORE THIOPENTAL INJECTION IS GIVEN
YOU MUST NOT BE GIVEN THIOPENTAL INJECTION IF YOU:

are
ALLERGIC
to thiopental sodium or have had reactions to thiopental or to other
barbiturates
(such as some anaesthetics)

have any
RESPIRATORY ABNORMALITIES
(including difficulty in breathing), such as an obstruction
in your lungs or in the tubes leading to them

have
ACUTE ASTHMA
(short term asthma)

are in
SEVERE SHOCK

have
MYOTONIC DYSTROPHY
- a muscular disease

have the condition known as
PORPHYRIA
- a metabolic disorder.
If any of these apply to you, tell the doctor or nurse, they will
usually decide to use another medicine
instead.
TAKE SPECIAL CARE WITH THIOPENTAL INJECTION
Tell your doctor befo

Summary of Product characteristics

OBJECT 1
THIOPENTAL INJECTION
Summary of Product Characteristics Updated 02-Jan-2018 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Thiopental Sodium 500mg Powder for Solution for Injection
2. Qualitative and quantitative composition
Each vial contains 500mg Thiopental Sodium (as Thiopental Sodium and
Sodium Carbonate Ph. Eur.)
Contains 53.5mg sodium per vial
For a full list of excipients see section 6.1
3. Pharmaceutical form
Powder for solution for injection in a vial (Powder for Injection).
Yellow-white freeze dried powder.
4. Clinical particulars
4.1 Therapeutic indications
1. Thiopental sodium is used for the induction of general anaesthesia
and is also used as an adjunct to
provide hypnosis during balanced anaesthesia with other anaesthetic
agents, including analgesics and
muscle relaxants.
2. Thiopental sodium is also used as an adjunct for control of
convulsive disorders of various aetiology,
including those caused by local anaesthetics.
3. Thiopental sodium has now been used to reduce the intracranial
pressure in patients with increased
intracranial pressure, if controlled ventilation is provided.
4.2 Posology and method of administration
Intravenous injection.
Thiopental Sodium 500mg Injection is administered intravenously
normally as a 2.5% w/v (500mg in
20ml) solution. On occasions it may be administered as a 5% w/v
solution (500mg in 10ml).
The intravenous injection preparation should be used after
reconstitution of the sterile powder with Water
for Injections, usually to produce a 2.5% w/v solution and this should
be discarded after seven hours. (For
instructions on dilution of the product before administration, see
section 6.6.)
Use in anaesthesia
Normal dosage for the induction of anaesthesia is 100mg to 150mg
injected over 10 to 15 seconds. If
necessary a repeat dose of 100mg to 150mg may be given after one
minute. No fixed dosage
recommendations for the intravenous injection can be given, since the
dosage will need to be carefully
adjusted according to the patient's response. Factors such as