左乙拉西坦注射液EMEA说明书

提供了左乙拉西坦SUN注射的EMEA批准说明书

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

提供了左乙拉西坦SUN注射的EMEA批准说明书

1. NAME OF THE MEDICINAL PRODUCT

Levetiracetam SUN 100 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 100 mg of levetiracetam.

Each 5 ml vial contains 500 mg of levetiracetam.

Excipients:

Each vial contains 57 mg of sodium (11.4 mg/ml).

For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless concentrate. 4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Levetiracetam SUN is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.

Levetiracetam SUN is indicated as adjunctive therapy - in the treatment of partial onset seizures with or without secondary generalisation in adults and

children from 4 years of age with epilepsy - in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with

Juvenile Myoclonic Epilepsy - in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12

years of age with Idiopathic Generalised Epilepsy.

Levetiracetam SUN concentrate is an alternative for patients when oral administration is temporarily not feasible.

4.2 Posology and method of administration

Monotherapy for 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.

Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more

The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment.

提供了左乙拉西坦SUN注射的EMEA批准说明书

Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.

Elderly (65 years and older)

Adjustment of the dose is recommended in elderly patients with compromised renal function (see "Renal impairment" below).

Renal impairment

The daily dose must be inpidualised according to renal function.

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 weighting 50 kg or more, the following formula: [140-age (years)] x weight (kg) CLcr (ml/min) = -------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)

Then CLcr is adjusted for body surface area (BSA) as follows: CLcr (ml/min)

2

CLcr (ml/min/1.73 m) = -------------------------------- x 1.73 BSA subject (m2)

Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function 2Mild 50-79 500 to 1,000 mg twice daily Moderate 30-49 250 to 750 mg twice daily Severe < 30 250 to 500 mg twice daily End-stage renal disease patients -- 500 to 1,000 mg once daily (2) (2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.

For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients.

The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, for young adolescents and children using the following formula (Schwartz formula):

Height (cm) x ks

2

CLcr (ml/min/1.73 m) = -------------------------------------------

Serum Creatinine (mg/dl)

提供了左乙拉西坦SUN注射的EMEA批准说明书

ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male

Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function

levetiracetam.

(2) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.

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/1.73 m2.

The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.

Monotherapy

The safety and efficacy of Levetiracetam SUN in children below and adolescents 16 years as monotherapy treatment have not been established. There are no data available.

Add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg

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.

(2) Dose in children and adolescen …… 此处隐藏：30926字，全部文档内容请下载后查看。喜欢就下载吧 ……