Sodium valproate 400mg4ml solution for injection ampoules

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Sodium valproate

Disponible des:

Wockhardt UK Ltd

Designació comuna internacional (DCI):

Sodium valproate

Dosis:

100mg/1ml

formulario farmacéutico:

Solution for injection

Vía de administración:

Intravenous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: ; GTIN: 5012727907871

Informació per a l'usuari

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Wockhardt UK Limited
SODIUM VALPROATE INJ 100MG/ML AMP COMMON LEAFLET
105857/6
See uploaded pdf
475 x 150mm
MPI
3
04/08/2017
880758
446
6pt (Main Body) / 7.5pt (Variables)
UK
English
446
MEASURE BAR SHOULD BE 150MM AT 100% SCALE
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in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
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PACKAGE LEAFLET INFORMATION FOR THE PATIENT
SODIUM VALPROATE 100MG/ML SOLUTION FOR INJECTION OR INFUSION THIS MEDICINE IS
SUBJECT TO ADDITIONAL
MONITORING.
This will allow quick
identifica
tion 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 given 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 ARE GIVEN 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, 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 p

Fitxa tècnica

OBJECT 1
SODIUM VALPROATE 100MG/ML SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 18-Oct-2017 | 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
Sodium Valproate 100mg/ml Solution for Injection or Infusion
2. Qualitative and quantitative composition
Each ml of solution contains 100 mg sodium valproate. Each 4 ml
ampoule contains 400 mg sodium
valproate. Each 10 ml ampoule contains 1000 mg sodium valproate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection or Infusion.
A clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of epileptic patients who would normally be maintained
on oral sodium valproate, and for
whom oral therapy is temporarily not possible.
4.2 Posology and method of administration
Sodium valproate injection may be given by direct slow intravenous
injection or by infusion using a
separate intravenous line in normal saline, dextrose 5%, or dextrose
saline.
_DOSAGE_
Dosage requirements vary according to age and body weight.
Each vial of sodium valproate injection is for single dose injection
only. For instructions on preparation
and dilution of sodium valproate injection before administration see
section 6.6.
Sodium valproate injection should not be administered via the same IV
line as other IV additives. The
intravenous solution is suitable for infusion by PVC, polyethylene or
glass containers.
Patients already satisfactorily treated with oral sodium valproate may
be continued at their current dosage
using continuous or repeated infusion. Other patients may be given a
slow intravenous injection over 3-5
minutes, usually 400-800mg depending on body weight (up to 10mg/kg)
followed by continuous or
repeated infusion up to a maximum of 2