Flumazenil-Baxter flumazenil 1 mg/10 mL solution for injection ampoule

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

flumazenil, Quantity: 1 mg

Доступна с:

Baxter Healthcare Pty Ltd

ИНН (Международная Имя):

Flumazenil

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: disodium edetate; sodium chloride; water for injections; sodium hydroxide; glacial acetic acid

Администрация маршрут:

Intravenous

Штук в упаковке:

5 ampoules, 10 ampoules

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Flumazenil-Baxter is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). Hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of Flumazenil-Claris. Not to be used in outpatients or short stay patients. Not to be used as a diagnostic.

Обзор продуктов:

Visual Identification: Clear colourless solution, practically free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Licence status A

Дата Авторизация:

2015-12-02

тонкая брошюра

FLUMAZENIL-CLARIS
FLUMAZENIL 0.5 MG/5 ML AND 1 MG/10 ML, SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Flumazenil-Claris. 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 you being given
Flumazenil-Claris against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT FLUMAZENIL-CLARIS IS USED FOR
Flumazenil-Claris is used to reverse benzodiazepine overdose, both
suspected and known. It is given
to arouse people after surgery or benzodiazepine overdose. Your doctor
may have prescribed
Flumazenil-Claris for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY FLUMAZENIL-
CLARIS HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN FLUMAZENIL-CLARIS
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE FLUMAZENIL-CLARIS IF:
•
YOU HAVE HAD AN ALLERGIC REACTION TO FLUMAZENIL-CLARIS OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET
•
YOU ARE TAKING A BENZODIAZEPINE FOR CONTROL OF A POTENTIALLY
LIFE-THREATENING CONDITION
_BEFORE YOU ARE GIVEN IT _
YOUR DOCTOR MUST KNOW ABOUT ALL THE FOLLOWING BEFORE YOU ARE GIVEN
FLUMAZENIL-CLARIS.
YOU MUST TELL YOUR DOCTOR IF:
1.
YOU ARE ALLERGIC TO ANY OTHER MEDICINES OR ANY OTHER SUBSTANCES SUCH
AS FOODS,
PRESERVATIVES OR DYES
2.
YOU SUFFER FROM EPILEPSY
3.
YOU HAVE SEVERE LIVER DISEASE
4.
YOU SUFFER FROM PANIC DISORDER
5.
YOU HAVE BEEN TAKING HIGH DOSES OF BENZODIAZEPINES AND /OR YOU HAVE
BEEN TAKING
BENZODIAZEPINES FOR A LONG TIME.
IF YOU HAVE NOT TOLD YOUR DOCTOR ABOUT ANY OF THE ABOVE, TELL THEM
BEFORE YOU ARE GIVEN
FLUMAZENIL-CLARIS.
_TAKING OTHER MEDICINES _
TELL YOUR DOCTOR IF YOU ARE TAKING ANY OTHER MEDICINES, INCLUDING ANY
THAT YOU HAVE BOUGHT FROM A
PHARMACY, SUPERMARKET OR HEALTH FOOD SHOP.
Some medicines ma

Характеристики продукта

Flumazenil-Baxter (Flumazenil)
Version 2.0
1 of 10
AUSTRALIAN PRODUCT INFORMATION – FLUMAZENIL-
BAXTER (FLUMAZENIL) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Flumazenil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Flumazenil (0.1 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flumazenil-Baxter
is
indicated
for
use
in
hospitalized
patients
for
the
reversal
of
acute
benzodiazepine effects (overdose or therapeutic). Hospitalized
patients are patients admitted to
hospital, inpatient care and under continued professional observation
while under the influence of
Flumazenil-Baxter. Not to be used in outpatients or short stay
patients. Not to be used as a
diagnostic.
4.2
DOSE AND METHOD OF ADMINISTRATION
Flumazenil-Baxter should be administered intravenously by an
anaesthetist or experienced
physician.
The use of Flumazenil-Baxter should be balanced against the risk of
precipitating withdrawal
symptoms (see Section 4.4 Identified precautions). The desirability of
retaining a degree of
sedation in the early postoperative period should be considered.
Flumazenil-Baxter may be diluted in glucose 5% in water or 0.9% NaCl
for infusion and may also
be
used
concurrently
with
other
resuscitative
procedures.
In
order
to
reduce
microbial
contamination hazards, infusion should be commenced as soon as
practicable after preparation.
Infusion should be completed within 24 hours of preparation and any
residue discarded.
Flumazenil-Baxter is for use in one patient only. Discard any
remaining contents.
Reversal of benzodiazepine effects at therapeutic doses (anaesthesia
or sedation)
The recommended initial dose is 0.2 mg administered i.v. within 15
seconds. If the desired degree
of consciousness is not obtained within 60 seconds following the first
i.v. administration, a second
dose of 0.1 mg can be injected and this may be repeated at 60 second
intervals where necessary,
up to a total dose o