Sodium valproate 200mg5ml oral solution sugar free

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Sodium valproate

Tersedia dari:

Wockhardt UK Ltd

Kode ATC:

N03AG01

INN (Nama Internasional):

Sodium valproate

Dosis:

40mg/1ml

Bentuk farmasi:

Oral solution

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04080100; GTIN: 5012727906256

Selebaran informasi

PACKAGE LEAFLET INFORMATION FOR THE USER
SODIUM VALPROATE WOCKHARDT 40MG/ML
ORAL SOLUTION (SUGAR FREE)
THIS MEDICINE IS SUBJECT TO ADDITIONAL MONITORING.
This will allow quick identification of new safety information.
You can help by reporting any side effects you may get. See the end of
section 4 for how to report side effects.
WARNING
Valproate can cause birth defects and problems with early
development of the child if it is taken during pregnancy. If you are
a female of childbearing age you should use an effective method of
contraception throughout your treatment.
Your doctor will discuss this with you but you should also follow
the advice in section 2 of this leaflet. Tell your doctor at once if
you
become pregnant or think you might be pregnant.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Sodium Valproate Oral Solution is and what it is used for
2.
What you need to know before you take Sodium Valproate Oral Solution
3.
How to take Sodium Valproate Oral Solution
4.
Possible side effects
5.
How to store Sodium Valproate Oral Solution
6.
Contents of the pack and other information
1. WHAT SODIUM VALPROATE ORAL SOLUTION IS AND WHAT IT IS
USED FOR
WHAT SODIUM VALPROATE ORAL SOLUTION IS
The name of your medicine is Sodium Valproate Wockhardt 40mg/ml
Oral Solution (sugar free).
In the rest of this leaflet it is called Sodium Valproate Oral
Solution.
WHAT SODIUM VALPROATE ORAL SOLUTION CONTAINS
Sodium Valproate Oral Solution contains a medicine called sodium
valproate. This belong

Karakteristik produk

OBJECT 1
SODIUM VALPROATE 40MG/ML ORAL SOLUTION (SUGAR
FREE)
Summary of Product Characteristics Updated 14-Mar-2018 | Wockhardt UK
Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Orlept (SF) liquid
Sodium Valproate 40mg/ml Oral Solution (sugar free)
2. Qualitative and quantitative composition
Sodium Valproate: 200mg in 5ml (equivalent to 40mg/ml)
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Liquid for oral use
Clear, colourless viscous liquid.
4. Clinical particulars
4.1 Therapeutic indications
For oral administration in the treatment of generalised, partial or
other epilepsy.
4.2 Posology and method of administration
For oral administration.
Daily dosage requirements vary according to age and body weight.
Sodium Valproate Oral Solution may be given twice daily. Sodium
Valproate Oral Solution should not be
diluted.
_DOSAGE:_
Usual requirements are as follows:
Adults:
Dosage should start at 600mg daily increasing by 200mg at three-day
intervals until control is achieved.
This is generally within the dosage range 1000mg to 2000mg per day
i.e. 20-30mg/kg body weight daily.
Where adequate control is not achieved within this range the dose may
be further increased to a maximum
of 2500mg per day.
Children over 20kg:
Initial dosage should be 400mg/day (irrespective of weight) with
spaced increases until control is
achieved; this is usually within the range 20-30mg/kg body weight per
day. Where adequate control is not
achieved within this range the dose may be increased to 35mg/kg body
weight per day.
Children under 20kg:
20mg/kg of body weight per day; in severe cases this may be increased
but only in patients in whom
plasma valproic acid levels can be monitored. Above 40mg/kg/day,
clinical chemistry and haematological
parameters should be monitored.
Use i