Epilim® 400 mg Powder for injection infusion

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

SODIUM VALPROATE

Предлага се от:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

АТС код:

N03AG01

дозиране:

400 mg/vial

Лекарствена форма:

INJECTION, POWDER, FOR SOLUTION

Композиция:

SODIUM VALPROATE 400 mg/vial

Начин на приложение:

INTRAVENOUS

Вид предписание :

Prescription Only

Произведено от:

sanofi S.R.L

Статус Оторизация:

ACTIVE

Дата Оторизация:

1990-11-23

Листовка

 
1
EPILIM
®
 400MG POWDER FOR INJECTION/INFUSION 
Sodium Valproate  

Intravenous                                

                [sanofi logo] 

TRADE NAME OF THE MEDICINAL PRODUCT 
Epilim 400mg Powder for injection/infusion 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Freeze dried Powder 

Per Vial 
Sodium Valproate (DCI)……………………………………..  
 400mg  
Solvent 
      Per 
Ampoule 
Water for Injection……………………………………………
  4ml 

PHARMACEUTICAL FORM 

Powder and Solvent for solution for injection/infusion. 
The powder is hygroscopic, white or practically
white crystalline. 
The solvent is a clear, colourless solution. 

CLINICAL PARTICULARS 
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) 

POSOLOGY AND METHOD OF ADMINISTRATION 
Epilim Intravenous may be given by
direct slow intravenous injection or by infusion using
a separate intravenous line 
in normal saline, dextrose 5%, or dextrose saline. 

_Epilepsy_ 
Daily dosage requirements vary according to age and
body weight. 

To
reconstitute, inject the solvent provided (4ml) into the vial, allow to dissolve and extract the appropriate dose.  
Due to displacement
of solvent by sodi

Данни за продукта

SG/EPI Inj/1223/CCDS V38
1
EPILIM
® 400MG POWDER FOR INJECTION/INFUSION
Sodium Valproate
Intravenous
TRADE NAME OF THE MEDICINAL PRODUCT
Epilim 400mg Powder for injection/infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Freeze dried Powder
Per Vial
Sodium Valproate (DCI)
............................................................. 400mg
Solvent
Per Ampoule
Water for Injection
......................................................................
4ml
PHARMACEUTICAL FORM
Powder and Solvent for solution for injection/infusion.
The powder is hygroscopic, white or practically white crystalline.
The solvent is a clear, colourless solution.
CLINICAL PARTICULARS
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)
POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Intravenous may be given by direct slow intravenous injection
or by infusion using a separate intravenous line
in normal saline, dextrose 5%, or dextrose saline.
_Epilepsy _
Daily dosage requirements vary according to age and body weight.
To reconstitute, inject the solvent provided (4ml) into the vial,
allow to dissolve and extract the appropriate dose. Due
to displacement of solvent by sodium valproate the concentration of
reconstituted sodium valproate is 100mg/ml.
Each vial of Epilim Intravenous is for single dose injection only. It
should be reconstituted immediately prior to use
and infusion solutions containing it used within 24 hours. Any unused
portion should be discarded
_(see Instructions _
_for Use/Handling). _
_ _
Epilim Intravenous should not be administered via the same IV line as
other IV additives. The intravenous sol