SODIUM VALPROATE JUNO sodium valproate 400 mg/4mL solution for injection, ampoule

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

sodium valproate, Quantity: 400 mg

Доступна з:

Juno Pharmaceuticals Pty Ltd

Фармацевтична форма:

Injection, solution

Склад:

Excipient Ingredients: water for injections

Адміністрація маршрут:

Intravenous, Intravenous Infusion

Одиниць в упаковці:

10 ampoules

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Sodium valproate Juno is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Огляд продуктів:

Visual Identification: Sodium valproate Juno 400 mg/4 mL is a clear colourless sterile solution presented in transparent colorless type 1 glass ampoules of 5 ml in 10 pack; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Статус Авторизація:

Registered

Дата Авторизація:

2017-12-13

інформаційний буклет

Sodium Valproate Juno
1
SODIUM VALPROATE JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SODIUM VALPROATE JUNO?
Sodium Valproate Juno contains the active ingredient sodium valproate.
Sodium Valproate Juno is used for the treatment of
epilepsy in adults and children
For more information, see Section 1. Why am I using Sodium Valproate
Juno?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM VALPROATE JUNO?
Do not use if you have ever had an allergic reaction to Sodium
Valproate Juno or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Sodium Valproate Juno?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sodium Valproate Juno and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE SODIUM VALPROATE JUNO?
•
If you are not currently taking Sodium Valproate Juno or any other
form of sodium valproate by mouth, your doctor will
decide what dose you will receive, depending on your condition and
other factors such as your weight. Sodium Valproate
Juno will be given to you as an infusion or injection into the veins.
More instructions can be found in Section 4. How do I use Sodium
Valproate Juno?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM VALPROATE JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sodium Valproate Juno.
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are
taking this medicine.
•
If you become pregnant while you are taking this medicine, tell your
doctor immediately.
THINGS YOU
SHOULD NOT D

Характеристики продукта

Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
SODIUM VALPROATE JUNO_ (SODIUM VALPROATE) _
_ _
1 NAME OF THE MEDICINE
Sodium valproate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium valproate Juno is a clear colourless sterile solution
containing sodium valproate 400
mg in 4 mL water for injections. The pH of the solution ranges from
7.0 to 9.0.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Sodium valproate, 400 mg / 4 mL, solution for injection ampoule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium valproate Juno is used for the treatment of patients with
epilepsy or mania, who would
normally be maintained on oral sodium valproate, and for whom oral
therapy is temporarily not
possible.
4.2 DOSE AND METHOD OF ADMINISTRATION
Sodium valproate Juno may be given by direct slow intravenous
injection or by slow intravenous
infusion in 0.9% NaCl (normal saline), 5% glucose solution or glucose
saline, using a separate
intravenous line. The recommended concentration of the intravenous
infusion solution is 4
mg/mL, with 8 mg/mL being the maximum concentration.
Sodium valproate Juno should not be administered at the same time as
other intravenous
additives via the same IV line. The intravenous solution is suitable
for infusion by PVC,
polyethylene or glass containers. Sodium valproate Juno should be
replaced by oral sodium
valproate therapy as soon as practicable.
Each ampoule of Sodium valproate Juno is for single dose injection
only. Sodium valproate
Juno is intended for use in one patient on one occasion only, any
unused portion should be
discarded.
NEVER
ADMINISTER
SODIUM
VALPROATE
JUNO
OTHER
THAN
BY
THE
INTRAVENOUS ROUTE (see SECTIONS 4.3 CONTRAINDICATIONS).
MONOTHERAPY
Daily dosage requirements vary according to age and body weight.
ADULTS
Patients already satisfactorily treated with sodium valproate may be
continued at their current
dosage using continuous infusion. For example, a patient stabilised on
25 mg/kg administered
daily shou