Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
olanzapine pamoate
Eli Lilly Nederland B.V.
N05AH03
olanzapine
Psycholeptics
Schizophrenia
Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Revision: 21
Authorised
2008-11-19
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYPADHERA 210 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION ZYPADHERA 300 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION ZYPADHERA 405 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION olanzapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What ZYPADHERA is and what it is used for 2. What you need to know before you are given ZYPADHERA 3. How ZYPADHERA is given 4. Possible side effects 5. How to store ZYPADHERA 6. Contents of the pack and other information 1. WHAT ZYPADHERA IS AND WHAT IT IS USED FOR ZYPADHERA contains the active substance olanzapine. ZYPADHERA belongs to a group of medicines called antipsychotics and is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. ZYPADHERA is intended for adult patients who are sufficiently stabilised during treatment with oral olanzapine. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZYPADHERA _ _ YOU SHOULD NOT BE GIVEN ZYPADHERA IF YOU HAVE: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in section 6). AN ALLERGIC REACTION may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your nurse or doctor. • been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye). WARNINGS AND PRECAUTIONS Talk to your doctor or n Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection 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 210 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine. After reconstitution each ml of suspension contains 150 mg olanzapine. 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 the 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 4.1 THERAPEUTIC INDICATIONS Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection. Posology Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response. In order to identify the first ZYPADHERA dose for all patients the scheme in Table 1 should be considered. 3 TABLE 1 RECOMMENDED DOSE SCHEME BETWEEN ORAL OLANZAPINE AND ZYPADHERA Target oral olanzapine dose Re Przeczytaj cały dokument