Posology : מינונים

4.2. Posology and method of administration                                                                                       Oesophagitis.
Strictly intravenous administration after appropriate dilution.                                                Common:           Diarrhoea usually mild to moderate may occur.
Intra-thecal administration of vinorelbine may be fatal and is therefore contra-indicated.                     Rare:             Paralytic ileus, treatment may be resumed after recovery of normal bowel mobility.
Instructions for use and handling: refer to paragraph 6.6.                                                                       Pancreatitis have been reported It is recommended to infuse Vinorelbine-Trima over 6-10 minutes after dilution in 20-50 ml of sodium Hepatobiliary disorders chloride 9 mg/ml (0.9%) solution for injection or in glucose solution for injection 5%.
Very common:     Transient elevations of liver function tests (G1-2) without clinical symptoms were The infusion time of 6 to 10 minutes must be followed as the risk of venous irritation is increased if reported (SGOT in 27.6% and SGPT in 29.3%) the infusion exposure time is increased.
Administration should always be followed with at least 250 ml of an isotonic solution for infusion             Skin and subcutaneous tissue disorders to ush the vein.                                                                                               Very common:    Alopecia, usually mild in nature, may occur (G3-4: 4.1% with vinorelbine as single chemotherapeutic agent).
Non-small cell lung cancer and advanced breast cancer                                                          Rare:           Generalized cutaneous reactions have been reported with vinorelbine (as rash, In monotherapy the usual dose given is 25-30 mg/m² once weekly.                                                                pruritus, urticaria) In combination chemotherapy the usual dose (25-30 mg/m²) is usually maintained, while the                      Not known:      Erythema on hands and feet, palmar-plantar erythrodysesthesia syndrome.
frequency of administration is reduced e.g. day 1 and 5 every 3 weeks or day 1 and 8 every 3 weeks according to treatment protocol.                                                                               Musculoskeletal and connective tissue disorders Common:         Arthralgia including jaw pain and myalgia.
Hormone-resistant prostate cancer
The usual dose given is 30 mg/m2 on days 1 and 8 every 3 weeks with low doses of corticosteroids               Renal and urinary disorders everyday (i.e. hydrocortisone 40 mg/day).                                                                      Common:          Creatinine increased Administration in the elderly                                                                                  General disorders and administration site conditions Clinical experience has not identi ed relevant differences among elderly patients with regard to the           Very common:    Reactions at the injection site may include erythema, burning pain, vein discoloration response rate, although greater sensitivity in some of these patients cannot be excluded. Age does                             and local phlebitis (G 3-4: 3.7% with vinorelbine as single chemotherapeutic not modify the pharmacokinetics of vinorelbine.                                                                                agent).
Common:         Asthenia, Fatigue, fever, pain at different locations including chest pain and Administration in patients with liver insuf ciency                                                                             pain at the tumour site have been experienced by patients receiving vinorelbine The pharmacokinetics of vinorelbine is not modi ed in patients presenting moderate or severe                                   therapy.
liver impairment.                                                                                              Rare:           Local necrosis has been observed. Proper positioning of the intravenous needle Nevertheless as a precautionary measure a reduced dose of 20mg/m2 and close monitoring of                                      or catheter and bolus injection followed by liberal ushing of the vein can limit haematological parameters is recommended in patient with severe liver impairment (refer to these effects.
sections 4.4 and 5.2).
As with other vinca-alkaloids vinorelbine has a moderate vesicant power.
Administration in patients with renal insuf ciency
Given the minor renal excretion, there is no pharmacokinetic justi cation for reducing the dose of             4.9. Overdose vinorelbine in patients with renal insuf ciency.                                                               Symptoms Overdosage with vinorelbine could produce bone marrow hypoplasia sometimes associated with Administration in children                                                                                     infection, fever and paralytic ileus.
Safety and ef cacy in children have not been established and administration is therefore not recommended (see section 5.1)                                                                                  Antidote There is no known antidote for overdosage of vinorelbine.