VINORELBINE STRIDES 10 Mg/Ml Concentrate for Soln for Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
VINORELBINE TARTRATE
Available from:
Strides Arcolab International Limited
INN (International Name):
VINORELBINE TARTRATE
Dosage:
10 Mg/Ml
Pharmaceutical form:
Concentrate for Soln for Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vinorelbine Strides 10 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 10mg vinorelbine equivalent to 13.85mg vinorelbine tartrate.
Each 1 ml vial contains 10 mg vinorelbine (as tartrate).
Each 5 ml vial contains 50 mg vinorelbine (as tartrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly yellow solution with a pH of 3.3 to 3.8
Diluted product: the osmolarity of the diluted product is about 330 mOsm/l.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vinorelbine is indicated in the treatment of:
-
Non-small cell lung cancer (stage 3 or 4).
-
As single agent to 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 Strides should be administered under the supervision of a physician with extensive experience in therapy
with cytostatics.
Strictly intravenous administration after appropriate dilution.
Intra-thecal administration of vinorelbine may be fatal.
Instructions for use and handling: refer to section 6.6.
Vinorelbine Strides may be administered by slow bolus (6-10 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 with at least 250 ml of an isotonic solution infusion to flush the vein.
_Non-small cell lung cancer_
As a single agent the normal dose is
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