Flumazenil 0.1 mg/ml solution for injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Flumazenil

Disponibil de la:

Fresenius Kabi Deutschland GmbH

Codul ATC:

V03AB; V03AB25

INN (nume internaţional):

Flumazenil

Dozare:

0.1 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Zonă Terapeutică:

Antidotes; flumazenil

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2007-07-06

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUMAZENIL 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, 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 is and what it is used for
2. What you need to know before you use Flumazenil
3. How to use Flumazenil
4. Possible side effects
5. How to store Flumazenil
6. Contents of the pack and other information
1.
WHAT FLUMAZENIL IS AND WHAT IT IS USED FOR
Flumazenil is a counteragent (antidote) for the complete or partial
reversal of the
central sedative effects of benzodiazepines (specific group with
sedative, sleep
inducing, muscle relaxing and anxiolytic properties).
It may therefore be used in anaesthesia to wake you up after certain
diagnostic tests
or in intensive care if you have been hold under sedative conditions.
Flumazenil may
also be used for the diagnosis and treatment of intoxications or
overdose with
benzodiazepines.
Flumazenil 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 USE FLUMAZENIL
DO NOT USE FLUMAZENIL
−
if you are ALLERGIC to flumazenil or any of the other ingredients
(listed in section 6).
−
if benzodiazepines have been administered to you to control a
POTENTIALLY LIFE-
THREATENING SITUATION (for example control of pressure in the brain or
a serious
epileptic seizure).
−
in mixed INTOXICATIONS with benzodiazepines and certain types of other
antidepressants (so called tricyclic and tetracyclic antidepressants
like Imipramin,
Clomipramin, Mirtazepine or Mianserin). The toxicity of these
antidepres

Caracteristicilor produsului

Health Products Regulatory Authority
26 March 2021
CRN009ZPM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flumazenil 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.
Excipients with known effect:
Each 10 ml ampoule contains 37 mg of sodium
For the full list ofexcipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Concentrate for solution for infusion
Clear colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flumazenil 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 patients and
hospitalized patients.
- For the reversal of conscious sedation induced with benzodiazepines
in children > 1 year of age
_In intensive care situations_
-For the specific reversal of the central effects of benzodiazepines,
in order to restore spontaneous respiration.
-For diagnosis and treatment of intoxications or overdose with only or
mainly benzodiazepines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults:
_Anaesthesia_
The recommended starting dose is 0.2 mg administered intravenously
over 15 seconds. If the required level of consciousness is
not obtained within 60 seconds, a further dose of 0.1 mg can be
injected and repeated at 60-second intervals, up to a
maximum dose of 1.0 mg. The usual dose required lies between 0.3 and
0.6 mg, but may deviate depending on the patient's
characteristics and the benzodiazepine used.
_Intensive Care_
The recommended starting dose is 0.3 mg administered intravenously
over