Country: Իսրայել
language: անգլերեն
source: Ministry of Health
HYDROXYCARBAMIDE
TZAMAL BIO-PHARMA LTD
L01XX05
CAPSULES
HYDROXYCARBAMIDE 500 MG
PER OS
Required
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
HYDROXYCARBAMIDE
Treatment of patient with chronic myeloid leukaemia (CML) in the chronic or accelerated phase of the disease.Treatment of patients with essential thrombocytaemia or polycythaemia vera with a high risk for thrmboembolic complications.
2021-12-22
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Hydroxyurea medac 500 mg Capsules Active ingredient Each capsule contains: hydroxycarbamide 500 mg Inactive ingredients and allergens: See section 2 "Important information about some of this medicine’s ingredients" and section 6 "Additional information". Read the entire leaflet carefully before you start 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 to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is this medicine intended for? Hydroxyurea Medac is indicated for the treatment of patients with chronic myeloid leukemia (CML) in the chronic or accelerated phase of the disease. Hydroxyurea Medac is also indicated for the treatment of patients with essential thrombocythemia or polycythemia vera with a high risk of thromboembolic complications. Therapeutic group: Hydroxyurea Medac contains the active ingredient hydroxycarbamide, which belongs to the group of medicines used in certain blood diseases and interfering with the growth of cancer cells. 2. Before using this medicine Do not use this medicine if: ● You are sensitive (allergic) to the active ingredient (hydroxycarbamide) or to any of the other ingredients in this medicine (see section 6 "Additional information"). Stop the treatment if hypersensitivity to Hydroxyurea Medac occurs. ● The blood cell count is too low. Special warnings about using this medicine ● Treatment with hydroxycarbamide requires comprehensive observation (see section "Tests and follow-up"). ● You should drink plenty of liquids during the treatment. ● Secondary leukemia may develop due to long-term treatment with hydroxycarbamide. It is currently unknown to what extent this results from the underlying dis read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hydroxyurea medac 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 500 mg hydroxycarbamide. Excipient with known effect This medicine contains 25 mg lactose monohydrate per capsule. This medicine contains less than 1 mmol sodium (23 mg) per capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule White, gelatin capsules, filled with an off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of patients with chronic myeloid leukaemia (CML) in the chronic or accelerated phase of the disease. Treatment of patients with essential thrombocythaemia or polycythaemia vera with a high risk for thromboembolic complications. 4.2 Posology and method of administration Posology Therapy should only be conducted by a physician experienced in oncology or haematology. Doses are based on real or ideal bodyweight of the patient, whichever is the less. In CML hydroxycarbamide is usually given at an initial dose of 40 mg/kg daily dependent on the white cell count. The dose is reduced by 50 % (20 mg/kg daily) when the white cell count has dropped below 20 x 10 9 /l. The dose is then adjusted individually to keep the white cell count at 5 – 10 x 10 9 /l. The hydroxycarbamide dose should be reduced if white cell counts fall below 5 x 10 9 /l, and increased if white cell counts > 10 x 10 9 /l are observed. If the white cell count falls below 2.5 x 10 9 /l, or the platelet count below 100 x 10 9 /l, therapy should be interrupted until the counts rise significantly towards normal. An adequate trial period for determining the antineoplastic effect of Hydroxyurea medac is six weeks. Therapy should be interrupted indefinitely if there is significant progress of the disease. If there is significant clinical response therapy may be continued indefinitely. In essential thrombocythaemia, hydroxycarbamide is usually given at starting doses of 15 mg/kg/day with dose adjustment to maintain a platelet co read_full_document