ORFIRIL INJECTION

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

VALPROIC ACID AS SODIUM

Beschikbaar vanaf:

MEGAPHARM LTD

ATC-code:

N03AG01

farmaceutische vorm:

SOLUTION FOR INJECTION / INFUSION

Samenstelling:

VALPROIC ACID AS SODIUM 300 MG / 3 ML

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

DESITIN ARZNEIMITTEL GMBH, GERMANY

Therapeutische categorie:

VALPROIC ACID

Therapeutisch gebied:

VALPROIC ACID

therapeutische indicaties:

Treatment of generalized seizures in the form of absence, myoclonic and tonic-clonic seizures and partial and secondary generalized seizures.

Autorisatie datum:

2015-02-28

Productkenmerken

1. NAME OF THE MEDICINAL PRODUCT
ORFIRIL INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
VALPROIC ACID (AS SODIUM)100 mg/ ml
One ampoule with 3 ml solution for injection contains 300 mg of sodium
valproate (equivalent to
260.28 mg of valproic acid).
One ampoule with 10 ml solution for injection contains 1,000 mg of
sodium valproate (equivalent
to 867.6 mg of valproic acid).
Excipient(s) with known effect:
1 ampoule with 3 ml solution for injection contains 1.81 mmol (41.6
mg) sodium.
1 ampoule with 10 ml solution for injection contains 6.0 mmol (138.8
mg) sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of:
- Generalized seizures in the form of absences, myoclonic and
tonic-clonic seizures
- Partial and secondary generalized seizures.
Combination treatment of other forms of seizures.
ORFIRIL INJECTION solution is used if oral sodium valproate therapy
cannot be given.
_Note: _
In infants, sodium valproate is the first-line drug only in
exceptional cases; it should be used only
with great caution and after careful consideration of the risk-benefit
ration and, if possible, as
monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ORFIRIL INJECTION is intended exclusively for intravenous
administration.
The dosage should be determined according to age and weight and
monitored individually by the
physician on the basis of concentration determinations. Close
monitoring of plasma levels and - if
necessary - dosage adjustments have to be performed during the
change-over to a parenteral
therapy, during the parenteral therapy and during the switch back to
oral therapy, in particular in
such patients receiving higher doses of valproate or in patients
receiving medicinal products
potentially influencing the metabolism of valproate. Therapeutic
efficacy is usually reached at
plasma levels between 50 and 100 mg/L (340-700

mol/L). The mean daily dosages during
maintenance treatment are as follows:
Child