FLUMAZENIL

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

FLUMAZENIL

Mevcut itibaren:

Fresenius Kabi Limited

ATC kodu:

V03AB25

INN (International Adı):

FLUMAZENIL

Doz:

0.1 Mg/Ml

Farmasötik formu:

Solution for Injection and Concentrate for Infusion

Reçete türü:

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

Terapötik alanı:

flumazenil

Yetkilendirme durumu:

Not Marketed

Yetkilendirme tarihi:

2007-07-06

Bilgilendirme broşürü

M0xxxxx/00 UK
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 held 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 (hypersensitive) 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 Imipramine,
Clomipramine, Mirtazapine or Mianserin). The toxicity
of these antidepressants can be masked by protective
benzodiazepine effects. If you are showing signs of
a significant overdose of these antidepressants,
Flumazenil must not be used to reverse
benzodiazepine effects.
WARNINGS AND PRECAUTIONS
-
If YOU DO NOT WAKE UP after Flumazenil is
administered,
another reason for this will be considered
because Flumazenil
specifically reverses the effects of
benzodiazepines.
-
If Flumazenil is administered to you at the END OF your
OPERATION to wake you up,

Ürün özellikleri

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.
Each 5 ml ampoule contains 0.80 mmol (or 18.5 mg) of sodium.
Each 10 ml ampoule contains 1.61 mmol (or 37 mg) of sodium.
For a full list of excipients, 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
Flumazenil should be administered intravenously by an anaesthetist or
experienced physician.
Flumazenil may be administered as infusion (see 6.6).
Flumazenil may be used concomitantly with other resuscitative
measures.
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 betw