Thiopental Panpharma 1g powder for solution for injection

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Malta Medicines Authority

Ակտիվ բաղադրիչ:

THIOPENTAL SODIUM

Հասանելի է:

Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France

ATC կոդը:

N01AF03

INN (Միջազգային անվանումը):

THIOPENTAL SODIUM 1000 mg

Դեղագործական ձեւ:

POWDER FOR SOLUTION FOR INJECTION

Կազմը:

THIOPENTAL SODIUM 1000 mg

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

ANESTHETICS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2017-12-14

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THIOPENTAL PANPHARMA 500MG POWDER FOR SOLUTION FOR INJECTION
THIOPENTAL PANPHARMA 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 Panpharma is and what it is used for
2.
What you need to know before you are given Thiopental Panpharma
3.
How Thiopental Panpharma is given
4.
Possible side effects
5.
How to store Thiopental Panpharma
6.
Contents of the pack and other information
1. WHAT THIOPENTAL PANPHARMA IS AND WHAT IT IS USED FOR
Thiopental Panpharma is a pharmaceutical product for use as an
anaesthetic from the group of
barbiturates.
Thiopental Panpharma 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 Panpharma.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN THIOPENTAL PANPHARMA
THIOPENTAL PANPHARMA MUST NOT BE GIVEN IF YOU:
•
are allergic to thiopental sodium and sodium carbonate or other
barbiturates (medicines that are
chemically similar to Thiopental Panpharma 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
an

Ապրանքի հատկությունները

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Thiopental Panpharma 500 mg powder for solution for injection
Thiopental Panpharma 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).
1 vial contains 1000
_ _
mg thiopental sodium and sodium carbonate (equivalent to 940 mg
thiopental
sodium).
Excipients with known effect
:
Thiopental Panpharma 500 mg powder for solution for injection contains
53 mg of sodium, i.e.
2.30 mmol of sodium in one vial.
Thiopental Panpharma 1
g
powder for solution for injection contains 106 mg of sodium, i.e.
4.61 mmol of sodium in one vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Yellowish-white powder for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thiopental Panpharma 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 Panpharma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Thiopental Panpharma 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 avera