Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
ASENAPINE AS MALEATE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
N05AH05
TABLETS SUBLINGUAL
ASENAPINE AS MALEATE 10 MG
PER OS
Required
MERCK SHARP & DOHME CORP., USA
ASENAPINE
ASENAPINE
Schizophrenia SAPHRIS is indicated for the treatment of schizophrenia in adults. The efficacy of SAPHRIS was established in two 6-week trials and one maintenance trial in adults Bipolar Disorder Monotherapy: SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy trials in adults Adjunctive Therapy: SAPHRIS is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in one 3-week adjunctive trial in adults.
2016-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 THE DISPENSING OF THIS MEDICINE REQUIRES A DOCTOR'S PRESCRIPTION. READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED IN NOVEMBER 2011. SAPHRIS ® 5 MG SAPHRIS ® 10 MG SUBLINGUAL TABLETS SUBLINGUAL TABLETS COMPOSITION Each sublingual tablet contains: Saphris 5 mg: 5 mg of Asenapine Saphris 10 mg: 10 mg of Asenapine INACTIVE INGREDIENTS:_ _ Gelatin, Mannitol. THERAPEUTIC GROUP: Antipsychotics THERAPEUTIC ACTIVITY_ _ Saphris is used to treat schizophrenia and manic episodes associated with bipolar I disorder. WHEN SHOULD THE PREPARATION NOT BE USED? - Do not use this medicine if you are allergic to asenapine or any of the other ingredients. - Do not take Saphris while you are pregnant, unless your doctor tells you so. If you are taking Saphris and you become pregnant or you plan to get pregnant, ask your doctor as soon as possible whether you may continue taking Saphris. - Do not breast-feed when taking Saphris. - Do not use this medicine if you have severe liver function problems. - Do not use this medicine in elderly patients with dementia. DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A DOCTOR BEFORE STARTING TREATMENT if you are breastfeeding if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome) if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia) You should be aware that both of these conditions may be caused by this type of medicine. if you have a heart disease or heart disease treatment that makes you prone to low blood pressure if you are diabetic or prone to diabetes if you have epilepsy (seizures) if you experience any difficulty in swallowing (dysphagia) if you have difficulty controlling core body temper Lesen Sie das vollständige Dokument
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SAPHRIS ® (ASENAPINE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SAPHRIS. SAPHRIS (ASENAPINE) SUBLINGUAL TABLETS INITIAL U.S. APPROVAL: 2009 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _ ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. SAPHRIS IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1) ---------------------------RECENT MAJOR CHANGES--------------------------- Indications and Usage, Schizophrenia (1.1) 09/2010 Indications and Usage, Bipolar Disorder (1.2) 09/2010 Dosage and Administration, Schizophrenia (2.2) 09/2010 Dosage and Administration, Bipolar Disorder (2.3) 09/2010 Contraindications (4) 08/2011 Warnings and Precautions, Hypersensitivity Reactions (5.7) 08/2011 ---------------------------INDICATIONS AND USAGE----------------------------- SAPHRIS is an atypical antipsychotic indicated for: • Treatment of schizophrenia in adults. (1.1) Efficacy was established in two 6-week clinical trials and one maintenance trial in patients with schizophrenia in adults. (14.1) • Acute treatment, as monotherapy or adjunctive therapy, of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 3-week monotherapy trials and in one 3-week adjunctive trial in patients with manic or mixed episodes associated with bipolar I disorder in adults. (14.2) -------------------------DOSAGE AND ADMINISTRATION---------------------- STARTING DOSE RECOMMENDED DOSE MAXIMUM DOSE Schizophrenia – acute treatment in adults (2.2) 5 mg sublingually twice daily 5 mg sublingually twice daily 10 mg sublingually twice daily Schizophrenia – maintenance treatment in adults (2.2) 5 mg sublingually twice daily for one week 10 mg sublingually twice daily 10 mg sublingually twice dai Lesen Sie das vollständige Dokument