Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
docetaxel
Accord Healthcare Polska Sp. z o.o.
L01CD02
docetaxel
20mg/ml
concentrate for solution for infusion
4ml concentrate in glass vial 5ml
Prescription
Registered
2021-03-17
61 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOCETAXEL ACCORD 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION DOCETAXEL ACCORD 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION DOCETAXEL ACCORD 160 MG/8 ML CONCENTRATE FOR SOLUTION FOR INFUSION docetaxel 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, hospital pharmacist or nurse. If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Docetaxel Accord is and what it is used for 2. What you need to know before you use Docetaxel Accord 3. How to use Docetaxel Accord 4. Possible side effects 5. How to store Docetaxel Accord 6. Contents of the pack and other information 1. WHAT DOCETAXEL ACCORD IS AND WHAT IT IS USED FOR The name of this medicine is Docetaxel Accord. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids. Docetaxel Accord has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. - For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide. - For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin. - For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone. - For the treatment of metastatic gastric cancer, docetaxel is administered i Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel. Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel. Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel. Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion One vial of 8 ml of concentrate contains 160 mg of docetaxel. Excipient with known effect 3 _Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion_ Each vial of 1ml of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). _Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion_ Each vial of 4ml of concentrate contains 2 ml of ethanol anhydrous (1.58 g). _Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion_ Each vial of 8ml of concentrate contains 4 ml of ethanol anhydrous (3.16 g). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear pale yellow to brownish-yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer operable node-negative breast cancer . For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1). Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with loc Lire le document complet