Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
MEDISPEC (M) SDN.BHD
LEVETIRACETAM
6 x 10 Tablets; 3x10 Tablets; 10x10 Tablets
UNISON LABORATORIES CO.LTD
_CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ 1 LECETAM FILM COATED TABLET Levetiracetam (250mg, 500mg) WHAT IS IN THIS LEAFLET 1. What LECETAM is used for 2. How LECETAM works 3. Before you use LECETAM 4. How to use LECETAM 5. While you are using it 6. Side effects 7. Storage and Disposal of LECETAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LECETAM IS USED FOR LECETAM is used: • on its own in adults and adolescents from 16 years of age with a certain type of newly diagnosed epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizures with or without secondary generalization). LECETAM has been given to you by your doctor to reduce the number of fits. • as an add-on to other antiepileptic medicines to treat: - partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy. - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy - primary generalized tonic-clonic seizures (major fits, including loss of consciousness) in adults and children from 12 years of age with Idiopathic Generalized Epilepsy. HOW LECETAM WORKS LECETAM is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). BEFORE YOU USE LECETAM - _ When you must not use _ _it_ Do not take LECETAM • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). _Pregnancy and _ _breastfeeding:_ If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. LECETAM should not be used during pregnancy unless clearly necessary Prečítajte si celý dokument
IRA Memo 22-096 (D)_Dec 2022 (RA) _PART II – SECTION P3.2 –QUEST 3+ _ 1 of 4 PART II – SECTION P: PRODUCT INFORMATION P3. MANUFACTURER P3.2 Manufacturing Process and Process Controls The manufacturing process includes the following stages: 0 MACHINE/ EQUIPMENT USED FOR WEIGHING PROCESS FOR FINAL BLENDING PROCESS Weighing Balance Container Blender (CB240) FOR PREPARATION OF GRANULATING LIQUID (BINDER) PROCESS Container Blender Machine FOR TABLETING PROCESS Stainless Steel Tank Rotary Tableting Machine Homogenizer FOR FILM COATING PROCESS FOR PREMIXING PROCESS Stainless Steel Tank Stainless Steel Tank Homogenizer High Speed Mixer Machine Film Coating Machine FOR WET GRANULATION PROCESS FOR PRIMARY PACKAGING PROCESS High Speed Mixer Machine Blister Packing Machine Wet Granulator Machine FOR SECONDARY PACKAGING PROCESS FOR DRYING PROCESS Auto Shrink Machine Fluid Bed Dryer Machine Air Blower FOR SCREENING PROCESS Stainless Steel Tank Dry Granulator Machine Container Blender (CB240) STAGE 1 : WEIGHING THE INGREDIENTS The specified quantities of all the ingredients in the formula are accurately weighed. STAGE 2 : PREPARATION OF GRANULATING LIQUID (BINDER) Dissolve 1.3300 Kg Povidone (PVP K-30) into a stainless steel tank containing 3.4000 Kg Isopropyl alcohol, then add 1.4500 Kg Purified water. Switch on a Homogenizer, stir until completely dissolved and a clear solution is obtained. STAGE 3 : PREMIXING 3.1 Pass 50.0000 Kg Levetiracetam and 3.6000 Kg Croscarmellose sodium through a 40 mesh screen into a stainless steel tank. 3.2 Transfer the ingredients from stage 3.1 into High Speed Mixer Machine and mix together for 5 minutes. STAGE 4 : WET GRANULATION 4.1 Add the granulating liquid (stage 2) into High Speed Mixer Machine and mix for approximately 3 minutes or until a damp mass is obtained (additional quantity of Purified water and Isopropyl alcohol are allowed to be added as appropriate). 4.2 Move out the mixture parts stuck on the inner side of the mixer using a clean spatula and add into the mixture then mix Prečítajte si celý dokument