Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GEMCITABINE HYDROCHLORIDE
Fresenius Kabi Oncology Plc
L01BC; L01BC05
GEMCITABINE HYDROCHLORIDE
40 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Pyrimidine analogues; gemcitabine
Not marketed
2012-11-23
GEMCITABINE RTU - PACK INSERT - IRE+GBR+MT xxxxxx V003/BO (Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Gemita RTU\Ireland+UK+MT\08 Jan 2015\Gemcitabine RTU - Pack Insert - IRE+GBR+MT.indd Black FONT SIZE: 10 PT TIMES NEW ROMAN DATE: 4 SEPTEMBER 2017 3:31 PM VERSION: 13 FINAL PACKAGING SITE: BORDON MFG. SITE: BADDI DIMENSION: 592 X 300 MM FOLDING SIZE: 60 X 33 MM (OUTLINE OF FOLDING SIZE FOR INDICATION PURPOSE ONLY, IT SHOULD BE REMOVED BEFORE FINAL PRINTING.) Form No.: SOP/PDD/014-02 Rev. 00 THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: INSTRUCTION FOR USE Cytotoxic _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_ Instructions for dilution should be strictly followed in order to avoid adverse events. The only approved diluent for dilution of Gemcitabine 40 mg/ml concentrate for solution for infusion is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative). 1. Use aseptic technique during dilution of gemcitabine for intravenous infusion administration. 2. THE TOTAL QUANTITY of the gemcitabine 40 mg/ml concentrate for solution for infusion required for an individual patient SHOULD BE DILUTED INTO AT LEAST 500 ML OF STERILE SODIUM CHLORIDE 9 MG/ ML (0.9%) SOLUTION FOR INJECTION (WITHOUT PRESERVATIVE) AND INFUSED OVER 30 MIN. Further dilution with the same diluent can be done. Diluted solution is a clear colou Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 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 hydrochloride).Each 25 ml vial contains 1000 mg gemcitabine (as hydrochloride). Each 50 ml vial contains 2000 mg gemcitabine (as hydrochloride). Excipient(s) with known effect: 3.40 mg/ml to 3.70 mg/ml (0.15 mmol/ml to 0.16 mmol/ml) sodium. 421.0 mg/ml (42.1% w/v) ethanol (96%) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless to slightly yellow solution, free from visible particles. pH: 7.0 to 9.0 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 should only be prescribed by a physician Read the complete document