VIMPAT lacosamide 200 mg/20 mL injection vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

lacosamide, Quantity: 10 mg/mL

Доступна с:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

ИНН (Международная Имя):

Lacosamide

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: water for injections; sodium chloride; dilute hydrochloric acid

Администрация маршрут:

Intravenous, Intravenous Infusion

Штук в упаковке:

5 x 20mL vials, 1 x 20mL vial

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Vimpat (lacosamide) injection for intravenous infusion is indicated as:,? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.,? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.,? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.,Vimpat (lacosamide) injection for intravenous infusion is indicated when oral administration is temporarily not feasible.

Обзор продуктов:

Visual Identification: clear and colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

2009-07-20

тонкая брошюра

_ _
1
VIMPAT

_ _injection (pronounced “vim-PAT”)
_Contains the active ingredient lacosamide (pronounced
"la-KOE-sa-mide")_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vimpat.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Vimpat
against the expected benefits it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT VIMPAT IS USED
FOR
Vimpat injection is used in patients
over 4 years in combination with
other medicines to control epilepsy.
Vimpat injection can only be used
by itself in patients over 16 years.
Epilepsy is a condition where you
have repeated seizures. There are
many different types of seizures,
ranging from mild to severe.
This medicine belongs to a group of
medicines called antiepileptics.
These medicines are thought to
work by controlling brain chemicals
which send signals to nerves so
that seizures do not happen.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that Vimpat is
addictive.
This medicine is available only with
a doctor’s prescription.
Vimpat is not recommended for use
in children under the age of 4 years
as its safety and effectiveness has
not been established in this age
group.
BEFORE YOU ARE GIVEN
VIMPAT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN VIMPAT IF
YOU HAVE AN ALLERGY TO:
•
Lacosamide or any of the
ingredients listed at the end of
this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
YOU SHOULD NOT BE GIVEN VIMPAT
IF YOU HAVE, OR HAVE HAD,

Характеристики продукта

Vimpat Inj PI
Page 1
AUSTRALIAN PRODUCT INFORMATION
VIMPAT (LACOSAMIDE) INJECTION
1
NAME OF THE MEDICINE
Lacosamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vimpat Injection contains 10 mg lacosamide per mL.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Vimpat Injection is a clear, colourless, sterile solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimpat (lacosamide) injection for intravenous infusion is indicated
as:

monotherapy in the treatment of partial-onset seizures with or without
secondary
generalisation in patients with epilepsy aged 16 years and older.

add-on therapy in the treatment of partial-onset seizures with or
without secondary
generalisation in patients with epilepsy aged 4 years and older.

add-on therapy in the treatment of primary generalised tonic-clonic
seizures in patients with
idiopathic generalised epilepsy aged 4 years and older.
Vimpat (lacosamide) injection for intravenous infusion is indicated
when oral administration is
temporarily not feasible.
4.2
DOSE AND METHOD OF ADMINISTRATION
Vimpat therapy can be initiated with either oral or IV administration.
The oral solution may be diluted
in a glass of water. Both the film-coated tablets and oral solution
may be taken with or without food.
Conversion to or from oral and IV administration can be done directly
without titration. The total
daily dose and twice daily administration should be maintained.
In accordance with current clinical practice, if Vimpat has to be
discontinued, it is recommended this
be done gradually (e.g. taper the daily dose by 200 mg/week).
Vimpat Injection can be administered intravenously without further
dilution or may be diluted before
use. The product solution was found to be physically compatible and
chemically stable for at least 24
hours when mixed with the following diluents and stored in glass or
PVC bags at ambient
temperature:
Sodium chloride 0.9% solution
Vimpat Inj PI
Page 2
Dextrose 5% solution
Lactated Ringer's solution.
To reduc