Sodium Valproate Concentrated Solution for Injection 500mg/5ml

• Dossier: Ctd,Actd
• GMP: Chinese GMP
• Packing: Accoring to Client Requiremen
• Payment: Tt
• Transport Package: Free
• Specification: 500mg/5ml
• Model NO.: Injection
• Trademark: Sinolead
• Origin: China

Product Description

Basic Info.

 

Generic Name	Sodium Valproate Concentrated Solution for Injection
Strength	500mg/5ml
Packing	1vial/box
Origin	China

Component:
Sodium 2-valproate

Character:

This product is transparent liquid.

Indications:

This product is mainly used for simple or complex absence seizures, myoclonic seizures, and generalized tonic-clonic seizures (grand seizures). It also has a certain effect on complex partial seizures.

 

Usage and dosage:

For temporary substitution (e.g. while waiting for surgery) :

The intravenous solution is dissolved in 0.9% normal saline and is administered intravenously 4 to 6 hours after the last oral administration at the previously received therapeutic dose (usually an average dose of 20-30mg/kg/ day).

· Continuous intravenous infusion for 24 hours.

· Or intravenous infusion four times a day, each time about one hour. [1]

When an effective blood concentration needs to be reached quickly and administered:

Slow intravenous infusion at a dose of 15mg/kg for at least 5 minutes; Then, the plasma valproic acid concentration reached 75mg/l at a rate of 1mg/kg/hr, and the rate was adjusted according to the clinical situation.

Once the intravenous drip is stopped, oral administration is required immediately to replenish the active ingredient. The oral dose may be the previous dose or an adjusted dose. Or as prescribed by a doctor.

Girls, female adolescents, women of childbearing age and pregnant women

This product should be prescribed and supervised by a physician experienced in managing epilepsy. Treatment should only be initiated if other treatments are ineffective or intolerant (see [Warnings] and [Pregnancy]), and its risks and benefits should be reassessed with regular follow-up. It is best to use monotherapy with the lowest effective dose and, if possible, a sustained release formulation. During pregnancy, the daily dose should be divided into at least two doses.

Matters needing attention:

1. Use with caution when there is blood disease, liver disease history, kidney damage, organic encephalopathy. 2. Interference with diagnosis: Urine ketone test may be false positive due to the excretion of ketone metabolites in urine. Thyroid function tests may be affected. Lactate dehydrogenase, alanine aminotransferase, and aspartate aminotransferase may be mildly elevated and suggest asymptomatic hepatic poisoning. Serum bilirubin may be elevated, indicating potential severe liver poisoning. 3. Blood cell counts, including platelet counts, liver and kidney function tests should be performed before and during medication. Liver function should be reviewed every 1 to 2 months in the first half year, and the interval between review should be extended accordingly after half a year.