INTIRACETAM CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML

HAUPT PHARMA WUELFING GMBH - GERMANYRAFARM S.A. (GREECE)🇸🇬 Health Sciences Authority

Approval Date: Apr 27, 2021
Approval ID: 77fd95f5d9ad93a4
Company: HAUPT PHARMA WUELFING GMBH - GERMANYRAFARM S.A. (GREECE)
Type: Therapeutic

Approval Details

Approval Id: 77fd95f5d9ad93a4
Drug Name: INTIRACETAM CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML
Product Name: INTIRACETAM CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML
Approval Number: SIN16169P
Approval Date: 2021-04-27
Registrant: INTEGA PTE LTD
Licence Holder: INTEGA PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INFUSION, SOLUTION CONCENTRATE
Dosage: DOSAGE AND ADMINISTRATION Intiracetam therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. The total daily dose and frequency of administration should be maintained. Concentrate for solution for infusion Intiracetam concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as 15-minute intravenous infusion (see Section Incompatibilities and Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is no experience with administration of intravenous Intiracetam for longer period than 4 days. Intiracetam concentrate is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible. Please refer to Section INCOMPATIBILITIES AND USE AND HANDLING for recommendation on the preparation and administration of Intiracetam Concentrate for Solution for Infusion 100mg/ml – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Adults <ul> <li>Monotherapy Adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily. The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established. There are no data available.</li> <li>Add-on therapy Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more The initial therapeutic dose is 500mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerance, the daily dose can be increased up to 1,500mg twice daily. Dose changes can be made in 500mg twice daily increases or decreases every two to four weeks.</li> </ul> Children The safety and efficacy of Intiracetam Concentrate for Solution for Infusion in infants and children less than 4 years have not been established. <ul> <li>Monotherapy The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established. There are no data available.</li> <li>Add-on therapy for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50kg: The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used. Dose in children 50 kg or greater is the same as in adults.</li> </ul> Dose recommendations for children and adolescents: <img src="/TGIF/Intiracetam-Table1.png" alt="Intiracetam Dosage Table 1" /> Infants and children less than 4 years There are insufficient data to recommend the use of levetiracetam in children under 4 years of age. For children with renal impairment, Intiracetam dose needs to be adjusted based on the renal function as Intiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients. Elderly Adjustment of the dose is recommended in elderly patients with compromised renal function. Renal impairment The daily dose must be individualised according to renal function (see section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, using the following formula: <img src="/TGIF/Intiracetam-Formula1.png" alt="Intiracetam Dosage Formula 1" /> Then CLcr is adjusted for body surface area (BSA) as follows: <img src="/TGIF/Intiracetam-Formula2_290722.png" alt="Intiracetam Dosage Formula 2" /> Dosing adjustment for adult and adolescent patients weighing more than 50 kg with impaired renal function <img src="/TGIF/Intiracetam-Table2_290722.png" alt="Intiracetam Dosage Table 2" /> Hepatic impairment No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <60 ml/min/1.73m2.
Route Of Administration: INTRAVENOUS
Indication Info: INDICATIONS Intiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Intiracetam is indicated as adjunctive therapy in the treatment of: <ul> <li>partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy</li> <li>myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy</li> <li>primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy</li> </ul> Intiracetam Concentrate is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible.
Contraindications: CONTRAINDICATIONS Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.
Atc Code: N03AX14
Atc Item Name: levetiracetam
Pharma Manufacturer Name: INTEGA PTE. LTD.
Company Detail Path: /organization/intega-pte-ltd

Active Ingredients

Levetiracetam

100.00 mg/ml

LEVETIRACETAM

100 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 27, 2021

Approval ID

77fd95f5d9ad93a4

Type

Therapeutic

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