Sodium Valproate 100mg/mL Solution for Injection or Infusion

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium valproate 100 mg/mL

Available from:

Max Health Limited

INN (International Name):

Sodium valproate 100 mg/mL

Dosage:

100 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Sodium valproate 100 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Monobasic sodium phosphate dihydrate Phosphoric acid Sodium hydroxide Water for injection

Prescription type:

Prescription

Manufactured by:

SCI Pharmtech, Inc

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type l neutral glass, 10 mL ampoules (10 mL fill) - 5 dose units - 24 months from date of manufacture stored at or below 30°C. do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type l neutral glass, 5 mL ampoules (4 mL fill) - 5 dose units - 24 months from date of manufacture stored at or below 30°C. do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type l neutral glass, 10 mL ampoules (10 mL fill) - 10 dose units - 24 months from date of manufacture stored at or below 30°C. do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type l neutral glass, 5 mL ampoules (4 mL fill) - 10 dose units - 24 months from date of manufacture stored at or below 30°C. do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2014-06-18

Summary of Product characteristics

Sodium Valproate 100mg/ml Solution for Injection or Infusion New
Zealand Data Sheet
Page 1 of 17
NAME OF MEDICINE
Sodium Valproate 100mg/ml Solution for Injection or Infusion
CHEMICAL NAME
Sodium di-n-propylacetic acid
CHEMICAL STRUCTURE
CAS REGISTRY NUMBER
1069-66-5
DESCRIPTION
Each mL of solution contains 100 mg sodium valproate. Each 4mL ampoule
contains 400 mg sodium
valproate. Each 10mL ampoule contains 1000 mg sodium valproate.
Excipients:
Disodium hydrogen phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Phosphoric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for Injections
PHARMACOLOGY
CLASS: Anticonvulsant, antipsychotic.
SITE AND MODE OF ACTION: The mode of action of sodium valproate has
not been fully established. Its
anticonvulsant effect is attributed to the blockade of voltage
dependent Na+ channels and increased
brain levels of γ-aminobutyric acid (GABA). The GABA-ergic effect is
also believed to possibly contribute
towards the antimanic properties of sodium valproate.
In animals, sodium valproate raises cerebral and cerebellar levels of
the inhibitory synaptic transmitter,
GABA, possibly by inhibiting GABA degradative enzymes, such as GABA
transaminase and/or succinic
semialdehyde dehydrogenase and/or by inhibiting the reuptake of GABA
by neuronal cells.
Sodium valproate exhibits marked anticonvulsant activity in animals,
demonstrated by the various tests
used to detect antiepileptic activity.
Sodium valproate appears to have no significant hypnotic effect (an
incidence of about 0.2% was noted
for drowsiness in a survey of unwanted effects), nor does it have any
significant action on the autonomic
nervous system, respiration, blood pressure, renal function or body
temperature. It does have a
spasmolytic action on the isolated ileum preparation but no effect on
the nictitating membrane.
PHARMACODYNAMICS
IN EPILEPSY: Sodium valproate has been shown to be effective in the
treatment of absence seizures (petit
mal), tonic-clonic seizures (grand mal) and myoclonic se