SODIUM VALPROATE AGUETTANT SOLUTION FOR INJECTION 400MG4ML

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Sodium valproate

Disponibil de la:

AGUETTANT ASIA PACIFIC PTE. LTD.

Codul ATC:

N03AG01

Forma farmaceutică:

INJECTION, SOLUTION

Compoziție:

Sodium valproate 400mg/4ml

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

Prescription Only

Produs de:

Laboratoire Aguettant

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2018-08-16

Caracteristicilor produsului

SODIUM
VALPROATE
AGUETTANT
400
MG/4
ML,
SOLUTION
FOR
INJECTION
▼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 AGUETTANT 400 MG/4 ML, SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium valproate
..........................................................................................................................
400 mg
Per 4 ml of solution for injection.
This medicinal product contains sodium.
Each mL of solution for injection contains 13.83 mg of sodium,
equivalent to 0.60 of sodium.
Each 4 mL ampoule contains 55.32 mg of sodium, equivalent to 2.41 mmol
of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection. Clear and colourless.
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.
In the treatment of generalized or partial epilepsy, particularly with
the following patterns of seizures:
- absence
- myoclonic
- tonic-clonic
- atonic
- mixed
As well as, for partial epilepsy:
- simple or complex seizures
- secondary generalized seizures
- specific syndromes (West, Lennox-Gastaut)
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
SODIUM VALPROATE AGUETTANT may be given by direct slow intravenous
injection or by infusion
using a separate intravenous line in normal saline or dextrose 5%.
_Epilepsy _
Daily dosage requirements vary according to age and body weight.
SODIUM VALPROATE AGUETTANT 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 SODIUM VALPROATE
AGUETTANT may be continued at
their