Valproate-AFT

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Sodium valproate 100 mg/mL

MAH:

AFT Pharmaceuticals Ltd

dosage:

100 mg/mL

pharmaceutical_form:

Solution for injection

composition:

Active: Sodium valproate 100 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Monobasic potassium phosphate Water for injection

prescription_type:

Prescription

therapeutic_indication:

The treatment of patients with epilepsy or bipolar disorder, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

leaflet_short:

Package - Contents - Shelf Life: Ampoule, glass, (Type 1), 4 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 10 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 3 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 4 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 3 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 10 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 3 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 4 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Ampoule, glass, (Type 1), 10 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 3 mL fill - 1 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 10 mL fill - 1 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 4 mL fill - 1 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 4 mL fill - 4 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 3 mL fill - 4 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 10 mL fill - 4 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 10 mL fill - 5 dose units - 48 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 4 mL fill - 5 dose units - 6 months from date of manufacture stored at or below 30°C - Vial, glass, single dose, (Type 1) with bromobutyl stopper and aluminium cap, 3 mL fill - 5 dose units - 6 months from date of manufacture stored at or below 30°C

authorization_date:

2019-03-04

PIL

Valproate-AFT
Page 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 or to control
bipolar mood disorder where
periods of mania alternate with
periods
of depression.
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 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

SPC

New Zealand Data Sheet
Valproate-AFT - sodium valproate
1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Valproate-AFT Intravenous solution for infusion or injection, 300 mg/3
ml, vials
Valproate-AFT Intravenous solution for infusion or injection, 400 mg/4
ml, vials
Valproate-AFT Intravenous solution for infusion or injection, 1000
mg/10 ml vials
Valproate-AFT Intravenous solution for infusion or injection 300 mg/3
ml, ampoules
Valproate-AFT Intravenous solution for infusion or injection, 400 mg/4
ml, ampoules
Valproate-AFT Intravenous solution for infusion or injection, 1000
mg/10 ml ampoules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valproate-AFT Solution for Infusion or Injection is a sterile,
non-pyrogenic solution containing 100
mg/mL of sodium valproate
For the full list of excipients, see Section 6.1, List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection or infusion, 100 mg/mL
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
The treatment of patients with epilepsy or bipolar disorder, who would
normally be maintained on oral
sodium valproate/valproic acid, and for whom oral therapy is
temporarily not possible.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ _
Valproate-AFT IV 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 IV should not be administered at the same time as other
intravenous additives via the
same
IV line. The intravenous solution is suitable for infusion by PVC,
polyethylene or glass
containers.
New Zealand Data Sheet
Valproate-AFT - sodium valproate
2
Each vial or ampoule of Valproate-AFT IV is for single dose injection
only. To reduce microbiological
hazard,
use as soon as practicable after reconstitution. If storage is
necessary hold at 2 to 8ºC for not
more
than 24 hours. Valproate-AFT IV is intended for use in o