Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VINORELBINE TARTRATE
Flynn Pharma Ltd
VINORELBINE TARTRATE
10 Base mg/ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-03-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vinorelbine 10 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 10 mg of vinorelbine (as vinorelbine tartrate). Each 1 ml concentrate for solution for infusion contains vinorelbine tartrate equivalent to 10 mg vinorelbine. Each 5 ml concentrate for solution for infusion contains vinorelbine tartrate equivalent to 50 mg vinorelbine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to pale yellow solution, and free from visible particles. pH: 3 - 4 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinorelbine is indicated for the treatment of: - Non small cell lung cancer (stage 3 or 4); - As single agent in patients with metastatic breast cancer (stage 4), where treatment with anthracycline and taxane containing chemotherapy has failed or is not appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous infusion only. Vinorelbine 10 mg/ml concentrate for solution for infusion should be given in cooperation with a physician with extensive experience in therapy with cytostatics. The use of intrathecal route is contra-indicated. For instructions regarding use and handling, see section 6.6. Vinorelbine may be administered by slow bolus (5-10 minutes) after dilution in 20-50 ml of normal saline or glucose 50 mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution. Administration should always be followed by a normal saline infusion to flush the vein. _Non-small cell lung cancer: _As a single agent the normal dose is 25-30 mg/m², administered once wee Read the complete document