Anexate 500 micrograms/5ml, solution for injection or infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Flumazenil

Disponibil de la:

Cheplapharm Arzneimittel GmbH

Codul ATC:

V03AB; V03AB25

INN (nume internaţional):

Flumazenil

Dozare:

500 Micrograms/5ml

Forma farmaceutică:

Solution for injection/infusion

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Antidotes; flumazenil

Statutul autorizaţiei:

Marketed

Data de autorizare:

1988-02-18

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANEXATE
® 500 MICROGRAMS/5 ML SOLUTION FOR INJECTION OR INFUSION
Flumazenil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Anexate is and what it is used for
2.
What you need to know before you are given Anexate
3.
How Anexate will be given
4.
Possible side effects
5.
How Anexate is stored
6.
Contents of the pack and other information
1.
WHAT ANEXATE IS AND WHAT IT IS USED FOR
Anexate contains a medicine called flumazenil. It is used to wake you
up after you have been made sleepy
by a medicine called a ‘benzodiazepine’.
Anexate 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.
Anexate 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 ANEXATE
YOU MUST NOT BE GIVEN ANEXATE IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:

Flumazenil or any of the other ingredients of Anexate (listed in
section 6).

‘Benzodiazepine’ medicines. These include diazepam, midazolam and
temazepam.
You must not be given Anexate if any of the above apply to you. If you
are not sure, talk to your doctor or
nurse before having Anexate.
YOU MUST NOT BE GIVEN ANEXATE IF:

You are alre

Caracteristicilor produsului

Health Products Regulatory Authority
09 December 2020
CRN009ZTK
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anexate 500 micrograms/5ml, solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml ampoule contains 500 micrograms of flumazenil (100 micrograms
per ml).
Excipient(s) with known effect: Sodium 3.7 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection and infusion.
A clear, almost colourless, sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anexate is indicated for the complete or partial reversal of the
central sedative effects of benzodiazepines. It may therefore be
used in the following situations:
Termination of general anaesthesia induced and/or maintained with
benzodiazepines.
Reversal of benzodiazepine sedation in short diagnostic and
therapeutic procedures.
Reversal of paradoxical reactions due to benzodiazepines.
For the diagnosis and/or management of deliberate or accidental
benzodiazepine overdosage.
As a diagnostic measure in unconsciousness of unknown origin, to
differentiate between involvement of benzodiazepines and
other aetiologies.
For the specific reversal of the central effects of benzodiazepines,
to allow return to spontaneous respiration and
consciousness, in patients in intensive care.
For the reversal of conscious sedation induced with benzodiazepines in
children > 1 year of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Flumazenil must be administered intravenously by an anaesthetist or a
doctor with experience in anaesthesiology and in a unit
having the appropriate facilities available. Flumazenil may be
administered either undiluted or diluted.
For dilution, see section 6.6.
It can be administered together with other reanimation measures.
_ANAESTHESIOLOGY_
The initial dose is 200 micrograms administered intravenously in 15
seconds. If the desired degree of consciousness is not
obtained within 60 seconds, a second dose of 100 micrograms can be