Flumazenil Teva 0.1mg/ml solution for injection

Land: Malta

Sprache: Englisch

Quelle: Malta Medicines Authority

Wirkstoff:

FLUMAZENIL

Verfügbar ab:

Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands

ATC-Code:

V03AB25

INN (Internationale Bezeichnung):

FLUMAZENIL 0.1 mg/ml

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

FLUMAZENIL 0.1 mg/ml

Verschreibungstyp:

POM

Therapiebereich:

ALL OTHER THERAPEUTIC PRODUCTS

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2011-09-07

Gebrauchsinformation

Page 1 of 9
PACKAGE LEAFLET
Page 2 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUMAZENIL TEVA 0.1 MG/ML SOLUTION FOR INJECTION
flumazenil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Flumazenil Teva is and what it is used for
2.
What you need to know before you are given Flumazenil Teva
3.
How to use Flumazenil Teva
4.
Possible side effects
5.
How to store Flumazenil Teva
6.
Contents of the pack and other information
1.
WHAT FLUMAZENIL TEVA IS AND WHAT IT IS USED FOR
Flumazenil Teva contains a medicine called flumazenil. It is used to
wake you up after you have
been made sleepy by a medicine called a ‘benzodiazepine’.
Flumazenil Teva reverses the effects of the ‘benzodiazepine’
medicine. It is used to:
-
wake you up after an operation or medical test
-
help you to breathe for yourself and wake up if you have been on a
ventilator in intensive care
-
reverse any unexpected effects of benzodiazepine treatment
-
treat benzodiazepine overdose
-
help find the reason for loss of consciousness in unconscious
patients.
Flumazenil Teva is also used in children (more than 1 year old) to
wake them up after they have
been given a ‘benzodiazepine’ medicine to make them sleepy during
a medical procedure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUMAZENIL TEVA
YOU MUST NOT BE GIVEN FLUMAZENIL TEVA:
-
if you are allergic to flumazenil or any of the other ingredients of
this medicine (listed in section
6).
-
if you are already taking a ‘benzodiazepine’ medicine to treat a
very serious illness (for example
control of pressure in the brain or a serious epileptic seizure).
You must not be given Flumazenil Teva if any

Fachinformation

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Flumazenil Teva 0.1 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.1 mg flumazenil.
1 ampoule with 5 ml contains 0.5 mg flumazenil.
1 ampoule with 10 ml contains 1 mg flumazenil.
Excipient(s) with known effect:
This medicinal product contains 9.3 mg sodium chloride per ml (3.7 mg
sodium per ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Concentrate for solution for infusion
A clear, almost colourless solution, free from foreign matter.
The pH of the solution is 3.5–4.5 and the osmolality of the solution
is approximately 300
mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flumazenil Teva is indicated for the complete or partial reversal of
the central sedative effects of
benzodiazepines. It may therefore be used in anaesthesia and in the
intensive care in the following
situations:
In anaesthesia
-
Termination of hypnosedative effects in general anaesthesia induced
and/or maintained with
benzodiazepines in hospitalized patients.
-
Reversal of benzodiazepine sedation in short-term diagnostic and
therapeutic procedures in
ambulatory and hospitalized patients.
-
Reversal of paradoxical reactions due to benzodiazepines.
-
For the reversal of conscious sedation induced with benzodiazepines in
children > 1 year of
age.
In intensive care
-
For
the
specific
reversal
of
the
central
effects of benzodiazepines, in order to restore
spontaneous respiration.
-
For diagnosis and/or management of deliberate or accidental
benzodiazepine overdosage with
only or mainly benzodiazepines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Flumazenil Teva must be administered intravenously by an anaesthetist
or a doctor with experience
in anaesthesiology.
Page 3 of 10
Flumazenil Teva may be administered as injection or as infusion (for
instructions on dilution of the
medicinal product before administration, see section 6.6).
Flumazenil Teva