Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
ZIPRASIDONE AS HYDROCHLORIDE MONOHYDRATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N05AE04
CAPSULES
ZIPRASIDONE AS HYDROCHLORIDE MONOHYDRATE 80 MG
PER OS
Required
PFIZER INC, USA
ZIPRASIDONE
ZIPRASIDONE
•Schizophrenia.Treatment of schizophrenia and for maintenance of clinical improvement during continuationTherapy in adults.•Bipolar mania.Ziprasidone is indicated as monotherapy in the treatment of adults with manic or mixed episodes associatedwith bipolar disorder with or without psychotic features.•Bipolar disorder.Maintenance treatment of bipolar disorder, as an adjunct to lithium or valproate in adults.
2022-02-28
Geodon Capsules PIL CC 090522 2020-0065988 2020-0065987, 2022-0078298 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only GEODON ® 20 MG CAPSULES GEODON ® 40 MG CAPSULES GEODON ® 60 MG CAPSULES GEODON ® 80 MG CAPSULES EACH CAPSULE CONTAINS: ZIPRASIDONE (AS HYDROCHLORIDE MONOHYDRATE) 20 MG, 40 MG, 60 MG, 80 MG Inactive ingredients and allergens in this medicine: See section 2 under "Important information about some of this medicine’s ingredients" and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is not intended for treatment of children and adolescents under 18 years of age. Important information that you should know: GEODON IS NOT INTENDED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS, WHO ARE BEING TREATED WITH ANTIPSYCHOTICS, ARE AT HIGH RISK OF DEATH. 1. WHAT IS THIS MEDICINE INTENDED FOR? An antipsychotic medicine for treatment of schizophrenia in adults, for treatment of manic episodes that are part of bipolar disorder (bipolar mania) in adults, as well as for maintenance treatment of bipolar disorder, in combination with lithium or valproate in adults. THERAPEUTIC GROUP: Atypical antipsychotics – antagonists for D 2 dopamine and 5HT 2A serotonin receptors in the brain. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in the medicine (see section 6). • You are suffering or have recently suffered from severe dysfunction of the heart, such as QT interval prolongation syn Olvassa el a teljes dokumentumot
Geodon IM & Capsules CC LPD 090522 2020-0065988 2020-0065987, 2022-0078298 1 FULL PRESCRIBING INFORMATION _ _ NAME OF THE MEDICINAL PRODUCT Geodon ® IM 20 mg Geodon ® 20 mg Capsules Geodon ® 40 mg Capsules Geodon ® 60 mg Capsules Geodon ® 80 mg Capsules QUALITATIVE AND QUANTITATIVE COMPOSITION GEODON ® INTRAMUSCULAR Geodon ® IM 20 mg contains 40.93 mg of ziprasidone mesylate trihydrate. GEODON ® ORAL CAPSULES Each capsule contains 20, 40, 60 or 80 mg of ziprasidone (as hydrochloride monohydrate) Excipients with known effect: Each capsule contains lactose For the full list of excipients, _see section_ _Description (10)_ in this leaflet. PHARMACEUTICAL FORM Capsules OR Powder for solution for injection WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. GEODON ® IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _[SEE WARNINGS AND PRECAUTIONS (4.1)]. _ 1 INDICATIONS AND USAGE GEODON ® INTRAMUSCULAR Ziprasidone powder and solvent for solution for injection is indicated for the rapid control of agitation in adult patients with schizophrenia, when oral therapy is not appropriate, for a maximum of 3 consecutive days. Treatment with ziprasidone powder and solvent for solution for injection should be discontinued, and the use of oral ziprasidone should be initiated, as soon as clinically appropriate. GEODON ® ORAL CAPSULES Ziprasidone hydrochloride monohydrate oral capsules are indicated for: Schizophrenia. Treatment of schizophrenia and for maintenance of clinical improvement during continuation therapy in adults. Bipolar mania. Ziprasidone is indicated as monotherapy in the treatment of adults with manic or mixed episodes associated with bipolar disorder with or without psychotic features. Bipolar Disorder Maintenance treatment of bipolar disorder, as an adjunct to lithium or valproate in adults. When deciding among the alternative treatm Olvassa el a teljes dokumentumot