Vinorelbin Ebewe

Vinorelbin Ebewe

vinorelbine tartrate

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Vinorelbine (as tartrate)
Indications/Uses
Non-small-cell lung cancer (NSCLC). Metastatic breast cancer.
Dosage/Direction for Use
NSCLC 25-30 mg/m2 per wk. Advanced or metastasized breast cancer 25-30 mg/m2 once per wk. Max: 35.4 mg/m2 single dose.
Contraindications
Hypersensitivity w/ vinorelbine or other vinca alkaloids. Neutrophil granulocytes <1,500/mm3 or severe existing or past infection (w/in last 2 wk). Thrombocyte value <75,000/mm3. Severe hepatic dysfunction unrelated to the cancer. In combination w/ yellow fever vaccination. Women of childbearing potential not using effective contraception. Pregnancy & lactation.
Special Precautions
Exclusively for IV administration. Close haematological monitoring (determination of Hb level & number of leucocytes, neutrophils & thrombocytes prior to each fresh infusion). Delay treatment if neutrophil granulocyte value drops to <1,500/mm3 &/or thrombocyte value drops to <75,000/mm3. Immediate exam if patient shows any signs or symptoms of infection. History of CHD. Severe hepatic dysfunction. Do not give simultaneously w/ radiotherapy if liver is included in the treatment field. Avoid contact w/ the eye. Concomitant use w/ strong CYP3A4 inhibitors or inducers. Not recommended in combination w/ attenuated live vaccines. Consider suitable prophylaxis to avoid the risk of bronchial spasm.
Adverse Reactions
Neutropenia, anemia; loss of deep tendon reflexes; constipation, nausea, vomiting, diarrhoea, stomatitis, oesophagitis, anorexia; changed hepatic function values; alopecia; fatigue, fever, pain in various places, asthenia, erythema, pain, dicoloration & phlebitis at the inj point. Infection; thrombocytopenia, febrile neutropenia, neutropenic sepsis w/ potentially fatal outcome; allergic reactions; paresthesia w/ sensorimotor symptoms; dyspnoea, bronchial spasms; skin reactions; myalgia, arthralgia; elevated creatinine.
Drug Interactions
Increased probability of myelosuppressive side effects w/ medicinal products of known myelotoxicity. Influence in the conc w/ CYP3A4 inhibitors & inducers. Higher incidence of granulocytopenia in combined treatment w/ cisplatin. Increased risk of bronchial spasm w/ mitomycin C. Possible interaction w/ oral anticoagulant. Potential risk of a fatal systemic illness w/ yellow fever vaccines & other attenuated live vaccines. Decreased GI resorption or increased toxicity of phenytoin. Decreased efficacy w/ phenytoin. Possible elevated neurotoxicity w/ itraconazole. Excessive immunosuppression & risk of a lymphoproliferative disorder w/ cyclosporine & tacrolimus.
ATC Classification
L01CA04 - vinorelbine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Vinorelbin Ebewe conc for soln for infusion 10 mg/mL
Packing/Price
1's
Form
Vinorelbin Ebewe conc for soln for infusion 50 mg/5 mL
Packing/Price
1's
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