País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Docetaxel
Teva UK Ltd
L01CD02
Docetaxel
20mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5012617021052
Docetaxel 20mg/ml Concentrate for Solution for Infusion PIL - UK item no: AAAI5260 print proof no: 3 origination date: 20.11.15 originated by: S.Anson revision date: 17.03.16 revised by: S.Anson dimensions: 124 x 700 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 20.11.15 supplier: Actavis Nerviano technically app. date: 20.11.15 min pt size: 9 TECHNICAL APPROVAL DOCETAXEL 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION The following information is intended for medical or healthcare professionals only: DOCETAXEL 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION INSTRUCTIONS ON USE Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions. Cytotoxic agents should be prepared for administration only by personnel who have been trained in the safe handling of such preparations. Refer to local cytotoxic guidelines before commencing. The use of gloves is recommended. If Docetaxel concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water. PREPARATION OF THE SOLUTION FOR INFUSION More than one vial of Docetaxel 20mg/ml concentrate for solution for infusion may be necessary to obtain the required dose for individual patients. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of 20mg/ ml docetaxel from the appropriate number of vials using graduated syringes fitted with a needle. For example, a dose of 140mg docetaxel would require 7ml of Docetaxel 20mg/ml concentrate for solution for infusion. For doses below 192mg of docetaxel, inject the required volume of Docetaxel 20mg/ml concentrate for solution for infusion into a 250ml infusion bag or bottle containing either 250ml of 50mg/ml (5%) glucose solutio Leer el documento completo
DOCETAXEL ACTAVIS 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 01-Apr-2016 | Actavis UK Ltd 1. Name of the medicinal product Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion 2. Qualitative and quantitative composition Each single dose vial contains docetaxel 20 mg/ml Each 1 ml single dose vial contains 20 mg docetaxel Each 4 ml single dose vial contains 80 mg docetaxel Each 7 ml single dose vial contains 140 mg docetaxel Each 8 ml single dose vial contains 160 mg docetaxel Excipient with known effect: Ethanol absolute 400 mg/ml For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion The concentrate is a clear, pale yellow solution. 4. Clinical particulars 4.1 Therapeutic indications _BREAST CANCER_ Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion 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 Actavis 20mg/ml Concentrate for Solution for Infusion in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cance Leer el documento completo