Anexate

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Flumazenil 0.1 mg/mL;  

Доступна с:

Pharmaco (NZ) Ltd

ИНН (Международная Имя):

Flumazenil 0.1 mg/mL

дозировка:

0.5 mg/5mL

Фармацевтическая форма:

Solution for injection

состав:

Active: Flumazenil 0.1 mg/mL   Excipient: Acetic acid Edetic acid Sodium chloride Sodium hydroxide Water for injection

Штук в упаковке:

Ampoule, glass, 5 x 5ml ampoules, 25 mL

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Perrigo API Ltd

Терапевтические показания :

Latest Regulatory Activity

Обзор продуктов:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 5ml ampoules - 25 mL - 60 months from date of manufacture stored at or below 30°C

Дата Авторизация:

1987-04-30

тонкая брошюра

_ _

1
CONSUMER MEDICINE INFORMATION
ANEXATE
®
FLUMAZENIL
0.5 MG/5ML INJECTION SOLUTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ANEXATE injection. It
does not contain all the
available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your being given
ANEXATE injection against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT ANEXATE IS GIVEN FOR
ANEXATE contains the active ingredient flumazenil.
ANEXATE is used to reverse the effects of benzodiazepines, a class of
anti-anxiety or sedative
medicines.
Common benzodiazepines are:
•
alprazolam (Arrow-Alprazolam
®
, Xanax
®
)
•
clobazam (Frisium
®
)
•
clonazepam (Paxam
®
, Rivotril
®
)
•
diazepam (D-Pam
®
,
Propam
®
, Stesolid
®
)
•
lormetazepam (Noctamid
®
)
•
lorazepam (Ativan
®
, Lorzem
®
)
•
midazolam (Hypnovel
®
)
•
nitrazepam (Insoma
®
, Nitrados
®
)
•
oxazepam (Ox-Pam
®
)
•
temazepam (Euhypbnos
®
, Normison
®
, Somapam
®
)
•
triazolam (Halcion
®
,
Hypam
®
,
Trycam
®
)
ANEXATE is given to arouse people after surgery or in cases of
suspected or known benzodiazepine
overdose.
Your doctor may have prescribed ANEXATE for another reason. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS WHY ANEXATE HAS BEEN PRESCRIBED FOR YOU.
ANEXATE is not addictive.
This medicine is available only with a doctor’s prescription.
_ _

2
BEFORE YOU RECEIVE ANEXATE
_WHEN YOU SHOULD NOT RECEIVE ANEXATE _
YOU SHOULD NOT BE GIVEN ANEXATE IF:
•
YOU HAVE HAD AN ALLERGIC REACTION TO ANEXATE OR ANY OF THE INGREDIENTS
LISTED AT THE END OF
THIS LEAFLET
•
YOU ARE TAKING A BENZODIAZEPINE TO CONTROL A POTENTIALLY
LIFE-THREATENING CONDITION
•
THE PACKAGE IS TORN OR SHOWS SIGNS OF TAMPERING
•
THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED
If you take this medicine

Характеристики продукта

NEW ZEALAND DATA SHEET
ANEXATE-ANEXATE002
07 August 2018
Page 1 of 8
ANEXATE® 0.5MG/5ML, SOLUTION FOR INJECTION
Flumazenil
1 PRODUCT NAME
Anexate, 0.5mg/5mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 0.1mg flumazenil
1 ampoule with 5 mL contains 0.5mg flumazenil
For full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Solution for injection. Anexate is a colourless to almost-colourless,
sterile, clear liquid.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anexate is indicated for reversal of the centrally sedative effects of
benzodiazepines. It should
therefore be used in anaesthesia and intensive care in the following
indications:
_IN ANAESTHESIA _
•
Termination
of
general
anaesthesia
induced
and
maintained
with
benzodiazepines
in
inpatients.
•
Reversal of benzodiazepine sedation in short diagnostic and
therapeutic procedures in both
inpatients and outpatients.
•
Reversal of paradoxical reactions due to benzodiazepines.
_IN INTENSIVE CARE AND IN THE MANAGEMENT OF UNCONSCIOUSNESS OF UNKNOWN
ORIGIN _
•
For the diagnosis and/or management of benzodiazepine overdose due to
self-poisoning or
accidental overdose.
•
As a diagnostic measure in unconsciousness of unknown origin to
differentiate between
involvement of benzodiazepines, other medicines or drugs or brain
damage.
•
Anexate may also be used for specific reversal of the central effects
of benzodiazepines in
drug or medicine overdose (return to spontaneous respiration and
consciousness in order to
render intubation unnecessary or allow extubation).
4.2
DOSE AND METHOD OF ADMINISTRATION
Anexate
is
recommended
for
intravenous
(IV)
use
only
and
should
be
administered
by
an
anaesthesiologist or experienced physician.
For instructions on handling Anexate, see Section 6.6.
NEW ZEALAND DATA SHEET
ANEXATE-ANEXATE002
07 August 2018
Page 2 of 8
Dosage
should
be
titrated
for
the
intended
effect.
Since
the
duration
of
action
of
some
benzodiazepines may exceed that of Anexate, repeated doses may be
required