البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gemcitabine hydrochloride
Actavis UK Ltd
L01BC05
Gemcitabine hydrochloride
40mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5012617026132
Gemcitabine 40mg/ml Concentrate for Solution for Infusion PIL - UK item no: AAAI6631 print proof no: 3 origination date: 13.01.16 originated by: S.Anson revision date: 14.01.16 revised by: S.Anson dimensions: 124 x 640 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 13.01.16 supplier: Actavis Nerviano technically app. date: 13.01.16 min pt size: 9 TECHNICAL APPROVAL 10 MM 10 MM 5 MM 10 MM 306 MM 14 MM 14 MM 20 MM -1 MM 20 MM +1 MM ITF 6 MM 306 MM N. 000000000.0 11 10 9 8 7 6 5 4 3 2 1 ✁ GEMCITABINE 40MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION PACKAGE LEAFLET: INFORMATION FOR THE USER _Continued over page_ _Continued on top of next column_ HANDLING The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Pregnant personnel should not handle the product. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses. If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water. INSTRUCTIONS FOR DILUTION The only approved diluent for dilution of Gemcitabine Concentrate for Solution for Infusion is sodium chloride 9mg/ml (0.9%) solution for injection (without preservative). • Use aseptic technique during dilution of gemcitabine for intravenous infusion administration. • Diluted solution is a clear colourless or light straw-coloured solution. • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer. The following information is intended for healthcare professionals only: INSTRUCTION اقرأ الوثيقة كاملة
OBJECT 1 GEMCITABINE 40MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 12-May-2017 | Accord-UK Ltd 1. Name of the medicinal product Gemcitabine 40mg/ml Concentrate for Solution for Infusion 2. Qualitative and quantitative composition Each ml of concentrate for solution for infusion contains 40 mg gemcitabine (as gemcitabine hydrochloride). Each 5 ml vial contains 200 mg gemcitabine (as gemcitabine hydrochloride) Each 25 ml vial contains 1 g gemcitabine (as gemcitabine hydrochloride) Each 50 ml vial contains 2 g gemcitabine (as gemcitabine hydrochloride) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion. The pH of the concentrate is 2.4 ± 0.4 and the osmolarity is 270-280 mOsmol/kg. Clear, colourless or pale yellow solution. 4. Clinical particulars 4.1 Therapeutic indications Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant / neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. 4.2 Posology and method of administration Gemcitabine shoul اقرأ الوثيقة كاملة