מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
UPJOHN (MALAYSIA) SDN. BHD.
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
30Capsule Capsules; 100Capsule Capsules; 100 Capsules; 30 Capsules; 100 Capsules; 30 Capsules
PFIZER IRELAND PHARMACEUTICALS
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ZELDOX ® CAPSULE Ziprasidone hydrochloride monohydrate (40 mg, 60 mg) 1 WHAT IS IN THIS LEAFLET 1. What ZELDOX is used for 2. How ZELDOX works 3. Before you use ZELDOX 4. How to use ZELDOX 5. While you are using it 6. Side effects 7. Storage and Disposal of ZELDOX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ZELDOX IS USED FOR Schizophrenia: ZELDOX is used for the management of a mental disorder known as schizophrenia and other psychotic disorders, and for maintenance of clinical improvement and prevention of relapse during continuation therapy. Bipolar mania: ZELDOX is also used for the treatment of manic or mixed episodes associated with bipolar disorder with or without psychotic features. Bipolar I disorder: ZELDOX is used for the short-term treatment of manic or mixed episodes associated with bipolar I disorder. ZELDOX is also used along with lithium or valproate for the maintenance treatment of bipolar I disorder. HOW ZELDOX WORKS ZELDOX capsules belong to a group of medicines called antipsychotics. It works by changing the activity of certain natural substances in the brain. BEFORE YOU USE ZELDOX - _When you must not use it_ - if you are allergic (hypersensitive) to ZELDOX or any of the other ingredients of ZELDOX capsules. Signs of an allergic reaction include rash, itching, swelling in the face or lips, difficulty in breathing. - if you have recently had a heart attack. - - if you have heart rhythm problems and are taking certain medicines for it (Class IA and III antiarrhythmic drugs). - if you have uncompensated heart failure. - if you have long QT interval syndrome. _Pregnancy and lactation_ You should not take ZELDOX capsules during pregnancy unless you are told otherwise by your doctor because there is a risk that this medicine may harm your baby. ZELDOX should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to t קרא את המסמך השלם
Pfizer Confidential LPD Title : Ziprasidone Capsules (Zeldox) LPD Date : 20 January 2020 Country : Malaysia Reference Documents : CDS Version 1 7.0 dated 14 September 201 8, Sweden SmPC (Date of approval - 05 July 201 9) Reason for Change : PfLEET 2018 -0038356 Addition of falls as a warning : PfLEET 2019 -0054001 BoH Query for a ddition of ADRs as per BoH directive dated 23 Oct 2018 : PfLEET 2019 -0056574 (S2), Update Lactation section as per BoH recommendation : PfLEET 2019 -0054001 (S1), Add footnote for Sleep Aponea ADR in sec 4.8 Deleted: 25 Deleted: 2 Deleted: 0 Deleted: 28 Deleted: July August Deleted: Novembe r Deleted: 2017 Deleted: 19 Deleted: 5 Deleted: 16 Deleted: November Deleted: 5 Deleted: 29 Deleted: September Deleted: 6 Deleted: revision Deleted: directive קרא את המסמך השלם