País: Israel
Idioma: inglés
Fuente: Ministry of Health
OLANZAPINE AS PAMOATE MONOHYDRATE
ELI LILLY ISRAEL LTD
N05AH03
POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
OLANZAPINE AS PAMOATE MONOHYDRATE 405 MG
I.M
Required
LILLY S.A., SPAIN
OLANZAPINE
Zypadhera is indicated for the treatment of schizophrenia.The use of Zypadhera is limited to patients who have been diagnosed as non-compliant regarding taking prescribed medicines and as a consequence are prone to outbursts of psychotic episodes .Zypadhera is not to be used in patients whose condition is adequately controlled with oral Zyprexa .
2015-11-30
Page 1 of 9 Patient Package Insert in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed by a doctor’s prescription only ZYPADHERA 405 mg Powder and solvent for preparation of prolonged release suspension for injection ZYPADHERA 300 mg Powder and solvent for preparation of prolonged release suspension for injection Name and quantity of active ingredient: Each vial of powder contains: Each vial of powder contains: Olanzapine pamoate monohydrate equivalent to 405 mg Olanzapine Olanzapine pamoate monohydrate equivalent to 300 mg Olanzapine The reconstituted suspension contains: The reconstituted suspension contains: Olanzapine 150 mg/ml Olanzapine 150 mg/ml For a list of the inactive ingredients, please see section 6. Read this patient leaflet carefully in its entirety before using this medicine. This leaflet contains concise information regarding this medicine. If you have any further questions, please contact your doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not give this medication to others. it might harm them even if you think your illness is similar. Very important information about this medicine: Antipsychotics (like ZypAdhera) can increase the risk of death in elderly people who are experiencing confusion, memory loss, and loss of touch with reality (dementia associated with psychosis). This medicine is not intended for adult patients who suffer from psychosis related to dementia. ZypAdhera is usually not intended for children and adolescents under the age of 18, since there is limited experience with this group. This medicine is intended for adults who have previously been treated with olanzapine tablets. Page 2 of 9 1. WHAT IS THIS MEDICINE INTENDED FOR? ZypAdhera is an antipsychotic preparation containing the active ingredient Olanzapine. The preparation is administered as a prolonged release injection, for the treatment of schizophrenic patients. Therapeutic group: Atypical antipsychotic drugs. 2. BEFORE USING T Leer el documento completo
X ZYPAVL A 09 Page 1 of 21 1. NAME OF THE MEDICINAL PRODUCT ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine. After reconstitution each ml of suspension contains 150 mg olanzapine. ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine. After reconstitution each ml of suspension contains 150 mg olanzapine. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for prolonged release suspension for injection Powder: yellow solid Solvent: clear, colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 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. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ZYPADHERA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis 4.1 THERAPEUTIC INDICATIONS ZYPADHERA is indicated for the treatment of schizophrenia. The use of ZYPADHERA is limited to patients who have been diagnosed as non-compliant regarding taking prescribed medicines and as a consequence are prone to outbur Leer el documento completo