FLUMAZENIL MYLAN 0.1 MGML

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

FLUMAZENIL

Beschikbaar vanaf:

GENMEDIX , ISRAEL

ATC-code:

V03AB25

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

FLUMAZENIL 0.1 MG/ML

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

MYLAN S.A.S., FRANCE

Therapeutische categorie:

FLUMAZENIL

Therapeutisch gebied:

FLUMAZENIL

therapeutische indicaties:

Benzodiazepine antagonist for reversal of benzodiazepine anesthesia, as well as for patients with benzodiazepine intoxication.

Autorisatie datum:

2023-05-31

Bijsluiter

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור :ךיראת
22/05/13
םש
רישכת :תילגנאב
Flumazenil Mylan 0.1 mg/ml
רפסמ :םושיר
133
66
31544
00
םש
לעב :םושירה
Genmedix
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATIONS
4.1
THERAPEUTIC INDICATIONS
Flumazenil is indicated
,
_IN A HOSPITAL SETTING:_
....
In intensive care to neutralise the
sedative effects of benzodiazepines on
the central nervous system

specific cancellation of the effects on
the central nervous system by
excessive benzodiazepine doses (re-
establishment of spontaneous
ventilation to avoid intubation or
interrupt ventilatory assistance).
….
4.1
THERAPEUTIC INDICATIONS
Flumazenil is indicated
,
Benzodiazepine antagonist for reversal of
benzodiazepine anesthesia, as well as for
patients with Benzodiazepine intoxication
.
_IN A HOSPITAL SETTING:_
....
In intensive care to neutralise the sedative
effects of benzodiazepines on the central
nervous system
and treat a coma of
unknown aetiology, in adults and children
(including newborns) if the semiology is
compatible with the hypothesis of a
benzodiazepine or related substance-
induced coma:

diagnosis and/or treatment of
intentional or accidental
benzodiazepine overdose,

aetiological diagnosis of an
unexplained coma in order to
differentiate what is caused by a
benzodiazepine from another cause
(pharmacological or neurological).

specific cancellation of the effects on
the central nervous system by
excessive benzodiazepine doses (re-
establishment of spontaneous
ventilation to avoid intubation or
interrupt ventilatory assistance).
….
POSOLOGY AND
ADMINISTRATION
4.2. POSOLOGY AND METHOD OF
ADMINISTRATION
b) In children over 6
years
old
4.2. POSOLOGY AND METHOD OF
ADMINISTRATION
b) In children over 6
months
old
CONTRA-
INDICATIONS
4.5 INTERACTION WITH OTHER MEDICINAL
PRODUCTS AND OTHER FORMS

Productkenmerken

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FLUMAZENIL MYLAN 0.1 MG/ML, SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flumazenil
..................................................................................................................................
0.1 mg
For 1 ml of solution for injection
A 5 ml ampoule contains 0.5 mg of flumazenil.
A 10 ml ampoule contains 1 mg of flumazenil.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flumazenil is indicated,
Benzodiazepine antagonist for reversal of benzodiazepine anesthesia,
as well as for patients with
Benzodiazepine intoxication.
_IN A HOSPITAL SETTING:_
In anaesthesiology to neutralise the sedative effects of
benzodiazepines on the central nervous system
in adults and children older than 6 months
:
•
reversal of sedative effect during general anaesthesia induced and
maintained by benzodiazepines,
•
reversal of conscious sedation induced by benzodiazepines in short
operations with a diagnostic or
therapeutic objective.
In intensive care to neutralise the sedative effects of
benzodiazepines on the central nervous system
and treat a coma of unknown aetiology, in adults and children
(including newborns) if the semiology
is compatible with the hypothesis of a benzodiazepine or related
substance-induced coma:
•
diagnosis and/or treatment of intentional or accidental benzodiazepine
overdose,
•
aetiological diagnosis of an unexplained coma in order to
differentiate what is caused by a
benzodiazepine from another cause (pharmacological or neurological).
•
specific cancellation of the effects on the central nervous system by
excessive benzodiazepine
doses (re-establishment of spontaneous ventilation to avoid intubation
or interrupt ventilatory
assistance).
_ _
_IN AN EMERGENCY SITUATION OR MEDICAL TRANSPORT, IN ADULTS AND
CHILDREN OLDER THAN 6 YEARS: _
•
reversal of benzodiazepine-induced conscious sedation in case of
r