מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gemcitabine hydrochloride
Actavis UK Ltd
L01BC05
Gemcitabine hydrochloride
1gram
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5012617018090
Gemcitabine 38mg/ml Powder for Solution for Infusion PIL - UK item no: AAAG9427 print proof no: 4 origination date: 12.06.14 originated by: S.Anson revision date: 25.11.14 revised by: S.Anson dimensions: 124 x 700 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. 2. 3. 4. 5. 6. 1. 2. 3. date sent: 12.06.14 supplier: Nerviano technically app. date: 16.06.14 min pt size: 9 TECHNICAL APPROVAL Black PHARMACODE PHARMACODE 10 MM 219 MM 453 MM 1 2 3 4 5 6 7 8 9 10 11 10 MM ! INSTRUCTION FOR USE Cytotoxic _HANDLING_ The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. 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 RECONSTITUTION (AND _ _FURTHER DILUTION, IF PERFORMED)_ The only approved diluent for reconstitution of gemcitabine sterile powder is sodium chloride 9mg/ml (0.9%) solution for injection (without preservative). Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40mg/ml. Reconstitution at concentrations greater than 40mg/ ml may result in incomplete dissolution and should be avoided. 1. Use aseptic technique during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration. 2. To reconstitute, add the appropriate volume of sterile sodium chloride 9mg/ml (0.9%) solution for injection without preservative (as stated in the table below) and shake to dissolve: Presentation Volume of sterile sodium chloride 9mg/ml (0.9%) solution for injection (without preservative) to קרא את המסמך השלם
OBJECT 1 GEMCITABINE 38MG/ML POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 22-Sep-2015 | Accord-UK Ltd 1. Name of the medicinal product Gemcitabine 38mg/ml powder for solution for infusion 2. Qualitative and quantitative composition One ml of the reconstituted solution for infusion (see section 6.6) contains 38mg gemcitabine (as hydrochloride). _200MG VIAL:_ Each vial contains 200mg of gemcitabine (as hydrochloride). Contains approximately 0.15mmol (3.56mg) sodium per 200mg vial. _1G VIAL:_ Each vial contains 1g of gemcitabine (as hydrochloride). Contains approximately 0.77mmol (17.81mg) sodium per 1g vial. _2G VIAL:_ Each vial contains 2g of gemcitabine (as hydrochloride). Contains approximately 1.54mmol (35.62mg) sodium per 2g vial. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion. White or almost white compact aggregate. After reconstitution in sodium chloride 0.9% the solution is clear to pale opalescent and colourless to pale yellow. The pH of the reconstituted solution in sodium chloride 0.9% solution is 3.0 ± 0.3. The osmolarity of the reconstituted solution (38mg/ml of gemcitabine (as hydrochloride) in sodium chloride 0.9% solution) is 775 mOsm/l. 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 קרא את המסמך השלם