Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
ABIRATERONE ACETATE
J-C HEALTH CARE LTD
L02BX03
TABLETS
ABIRATERONE ACETATE 250 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
ABIRATERONE
ABIRATERONE
Zytiga is a CYP17 inhibitor indicated:- in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.- for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
2017-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Zytiga ® 250 mg Tablets Active ingredient and its quantity Abiraterone acetate 250 mg, equivalent to 223 mg of abiraterone. Inactive ingredients and allergens in the preparation – see section 2 “Important information about some of the ingredients of the medicine” and section 6 “ F u r t h e r Information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Zytiga 250 mg is a prescription medicine containing an active ingredient called abiraterone acetate. Zytiga 250 mg is a CYP17 enzyme inhibitor, given in c o m b i n a t i o n w i t h p r e d n i s o n e f o r t h e t r e a t m e n t of: • metastatic castration-resistant prostate cancer. • adult males with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). Therapeutic group: Specific inhibitor of the enzyme CYP17. 2. BEFORE USING THE MEDICINE Do not use the medicine: • If you are sensitive (allergic) to abiraterone acetate or to any of the additional ingredients contained in the medicine. For a list of the additional ingredients, see section 6 “Further Information”. • If you are a woman, and especially a pregnant woman. Zytiga 250 mg is intended for use in males only. • If you suffer from severe liver damage. • In combination with Ra-223 (used to treat prostate cancer). Do not take the medicine if any of the above apply to your condition. If you are not sure, consult with your doctor or pharmacist before taking the medicine. Special warnings regardi Διαβάστε το πλήρες έγγραφο
דומע 1 ךותמ 22 Zytiga 250mg_PI_Apr2023_ref_EU SmPC_Jun2022 1. NAME OF THE MEDICINAL PRODUCT ZYTIGA 250 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of abiraterone acetate equivalent to 223 mg of abiraterone. Excipients with known effect Each tablet contains 198.65 mg of lactose monohydrate and 6.8 mg of sodium. For the full list of excipients, see section 7 .1. 3. PHARMACEUTICAL FORM Tablet White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side. 4 INDICATIONS AND USAGE Zytiga 250 mg is a CYP17 inhibitor indicated in combination with prednisone for the treatment of _ _ patients with metastatic castration-resistant prostate cancer. The treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). 5 DOSAGE AND ADMINISTRATION 5.1 recommended dose for metastatic CRPC The recommended dose of ZYTIGA 250 mg is 1, 000 mg (four 250mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally TWICE daily. 5.2 recommended dose for metastatic High-risk mHSPC The recommended dose of Zytiga 250 mg is 1,000 mg (four 250mg tablets) administered orally once daily in combination with prednisone 5mg administered orally ONCE daily... 5.3 important administration instructions Patients receiving Zytiga 250 mg should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ZYTIGA 250 MG must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA 250 MG is taken and for at least one hour after the dose of ZYTIGA 250 MG is taken _[see _ _Method of administration (5.5)]._ The tablets should be swallowed whole with water. Do not crush or chew tablets. Serum transaminases should be measured prior to starting treatment with Zytiga 250 mg, every two weeks for the first three months of treatment and monthly thereafter. B Διαβάστε το πλήρες έγγραφο