País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 1000 mg
AdiraMedica Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; pregelatinised maize starch; copovidone; magnesium stearate; purified talc; titanium dioxide; polyvinyl alcohol; macrogol 3350; polysorbate 80; macrogol 4000
Oral
60 tablets
(S4) Prescription Only Medicine
Levetiracetam 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).
Visual Identification: White colored, oval shaped, film coated tablets, embossed with OL bisect 1000 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2018-12-07
Levenakai Tablets version: 2.0 Page 1 of 32 AUSTRALIAN PRODUCT INFORMATION –LEVENAKAI (LEVETIRACETAM) 1 NAME OF THE MEDICINE Levetiracetam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levenakai film-coated tablets are available in strengths of 250 mg, 500 mg, 750 mg and 1000 mg levetiracetam. Levetiracetam is a white to off-white powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/ 100mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. It does not contain any excipient with known affect. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Levetiracetam film coated tablets are available in four different strengths with the following descriptions: 250 mg: Blue Coloured, ‘Oval’ shaped, film coated tablets, embossed with “OL” bisect “250” on one side and plain on other side. 500 mg: Yellow Coloured, ‘Oval’ shaped, film coated tablets, embossed with “OL” bisect “500” on one side and plain on other side. *750 mg: Orange Coloured, ‘Oval’ shaped, film coated tablets, embossed with “OL” bisect “750” on one side and plain on other side. 1000 mg: White Coloured, ‘Oval’ shaped, film coated tablets, embossed with “OL” bisect “1000” on one side and plain on other side. *This strength is currently not distributed in Australia Levenakai Tablets version: 2.0 Page 2 of 32 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Levetiracetam 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 adolesc Llegiu el document complet