AURO-LEVETIRACETAM 500 levetiracetam 500 mg tablets Blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
28-11-2017

유효 성분:

levetiracetam, Quantity: 500 mg

제공처:

Strides Pharma Science Pty Ltd

INN (국제 이름):

Levetiracetam

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: povidone; purified talc; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 4000

관리 경로:

Oral

패키지 단위:

60

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

It is indicated for:,? use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME),and,? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).

제품 요약:

Visual Identification: Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating 'E' and '11' on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2011-12-23