Thiopental Momaja Pdr for Soln for Injection 500mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

THIOPENTAL SODIUM

Available from:

Momaja s.r.o.

ATC code:

N01AF03

INN (International Name):

THIOPENTAL SODIUM

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

THIOPENTAL SODIUM 500 mg

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Authorised

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THIOPENTAL MOMAJA 500MG POWDER FOR SOLUTION FOR INJECTION
THIOPENTAL MOMAJA 1G POWDER FOR SOLUTION FOR INJECTION
THIOPENTAL SODIUM AND SODIUM CARBONATE
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, please ask your doctor or
pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Thiopental Momaja is and what it is used for
2.
What you need to know before you are given Thiopental Momaja
3.
How Thiopental Momaja is given
4.
Possible side effects
5.
How to store Thiopental Momaja
6.
Contents of the pack and other information
1. WHAT THIOPENTAL MOMAJA IS AND WHAT IT IS USED FOR
Thiopental Momaja is a pharmaceutical product for use as an
anaesthetic from the group of
barbiturates.
Thiopental Momaja is used:

for short duration anaesthesia without intubation (brief anaesthesia
during surgical procedures not
requiring any preparation for artificial respiration),

for induction of general anaesthesia with or without intubation
(induction of longer duration
anaesthesia for surgical procedures with or without preparation for
artificial respiration).
_Note:_ As with all barbiturates, it is necessary to administer an
analgesic agent when performing
anaesthesia with Thiopental Momaja.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN THIOPENTAL MOMAJA
THIOPENTAL MOMAJA MUST NOT BE GIVEN IF YOU:

are allergic to thiopental sodium and sodium carbonate or other
barbiturates (medicines that are
chemically
similar
to
Thiopental
Momaja
and
are
used
in
patients
with
seizures
and
for
anaesthesia) or any of the other ingredients of this medicine (listed
in section 6).

have
serious
intoxication
with
alcohol,
sleeping
medicines,
painkillers
and
psychopharmacological medicines (medi

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Thiopental Momaja 500 mg powder for solution for injection
Thiopental Momaja 1g powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 500_ _mg thiopental sodium and sodium carbonate
(equivalent to 470 mg thiopental
sodium). Sodium content is 53mg/vial.
1 vial contains 1000_ _mg thiopental sodium and sodium carbonate
(equivalent to 940 mg thiopental
sodium). Sodium content is 106mg/vial.
3.
PHARMACEUTICAL FORM
Yellowish-white powder for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thiopental Momaja is used:

For short duration anaesthesia without intubation (brief anaesthesia
during surgical procedures
not requiring any preparation for artificial respiration),

For induction of general anaesthesia with or without intubation
(induction of longer duration
anaesthesia for surgical procedures with or without preparation for
artificial respiration).
Note: As with all barbiturates, it is necessary to administer an
analgesic agent when performing
anaesthesia with Thiopental Momaja.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Thiopental Momaja should only be used when qualified staff and the
necessary specialist equipment
for resuscitation and endotracheal intubation for the treatment of
emergency medical conditions, such
as respiratory failure and respiratory arrest, are available.
Posology
The dose depends on the specific sensitivity of the patient and the
desired depth of anaesthesia. The
following information is given solely as a guideline. Optimal efficacy
can be achieved most safely by
the slow repeated injection of small doses.
For the induction of general anaesthesia, the average dose for the
intravenous injection is 5 mg
Thiopental sodium per one kilogram of body weight. The duration of the
effect is about 6 to 8 minutes.
In general, 100 to 200 mg of Thiopental sodium is injected slowly over
a period of 20 seconds. Any
additional doses depend on the sensitivity of a respe