VALPROATE-AFT sodium valproate 400 mg/4 ml solution for intravenous infusion or injection ampoules

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

sodium valproate, Quantity: 100 mg/mL

Disponibil de la:

AFT Pharmaceuticals Pty Ltd

Forma farmaceutică:

Injection, intravenous infusion

Compoziție:

Excipient Ingredients: monobasic potassium phosphate; dibasic sodium phosphate dodecahydrate; water for injections; nitrogen

Calea de administrare:

Intravenous

Unități în pachet:

5 ampoules box, 4 ampoules box, 1 ampoule box

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Valproate-AFT 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.

Rezumat produs:

Visual Identification: Valproate-AFT comes as a clear colourless solution in glass ampoules; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-02-14

Prospect

_Valproate-AFT_
1
VALPROATE-AFT
_Sodium Valproate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Valproate-AFT.
It does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of using Valproate-AFT
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VALPROATE-AFT IS
USED FOR
Valproate-AFT is a medicine used to
for the treatment of epilepsy in
adults and children.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of seizures,
ranging from mild to severe.
Valproate-AFT belongs to a group of
medicines called anticonvulsants.
These medicines are thought to work
by controlling brain chemicals which
send signals to nerves so that seizures
do not happen.
Valproate-AFT may also be used to
control mania, a mental condition
with episodes of overactivity, elation
or irritability.
Valproate-AFT may be used alone or
in combination with other medicines
to treat your condition.
Valproate-AFT may be used short-
term in place of oral sodium
valproate tablets or liquid when the
medicine cannot be given by mouth.
Your doctor, however, may have
prescribed
Valproate-AFT
for
another reason.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
There is no evidence that Valproate-
AFT is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT RECEIVE _
_IT_
YOU SHOULD NOT RECEIVE VALPROATE-
AFT IF YOU HAVE OR HAVE HAD ANY OF
THE FOLLOWING MEDICAL CONDITIONS:
•
liver disease (hepatic
dysfunction) or severe hepatitis.
•
a family history of hepatitis,
especially when caused by
medicines. Medicines used in the
treatment of epilepsy, including
Valproate-AFT m

Caracteristicilor produsului

Page 1 of 30
AUSTRALIAN PRODUCT INFORMATION – VALPROATE-AFT
(SODIUM VALPROATE)
1
NAME OF THE MEDICINE
Sodium valproate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valproate-AFT Solution for Infusion or Injection is a sterile,
non-pyrogenic solution:
-
300 mg/3 ml of solution packed in 5 ml capacity glass ampoule.
-
400 mg/4 ml of solution packed in 5 ml capacity glass ampoule.
-
1000 mg/10 ml of solution packed in 10 ml capacity glass ampoule.
-
300 mg/3 ml of solution packed in 5 ml capacity glass vial.
-
400 mg/4 ml of solution packed in 5 ml capacity glass vial.
-
1000 mg/10 ml of solution packed in 10 ml capacity glass vial.
For the full list of excipients, see Section 6.1, List of Excipients.
Sodium valproate is a white, odourless, crystalline powder with a
saline taste. It is highly
soluble
in water and alcohol. Its molecular weight is 166 . 2 . It is quite
dissimilar to other
established anticonvulsants such as barbiturates, hydantoins,
succinamides,
oxazolidinediones and acetylureas in that it has no nitrogen or
aromatic moiety.
3
PHARMACEUTICAL FORM
Solution for injection or infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_EPILEPSY_
_ _
Valproate-AFT 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.
Page 2 of 30
4.2
DOSE AND METHOD OF ADMINISTRATION
Sodium valproate tablets, liquid and syrup are unavailable in the
Valproate-AFT brand.
Information obtained using sodium valproate tablet, liquid and syrup
formulations have been
retained throughout the PI, where appropriate, for continuity and
prescriber information.
Valproate-AFT 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.
Valproate-AFT should not be adminis