Trade Name of the Medicinal Product:
10 mg/ml concentrate for solution for infusion 1 vial of 1 ml - 10 mg/ml concentrate for solution for infusion 1 vial of 5 ml - NAVELBINE® 20 mg soft capsule - NAVELBINE® 30 mg soft capsule.
Qualitative and Quantitative Composition* Therapeutic Indications: Treatment of non-small cell lung cancer. Treatment of metastatic breast cancer. Treatment of Prostate Cancer (1).
Posology and Method of Administration* Contra-indications: pregnancy, lactation. Hypersensitivity to vinorelbine or other vinca alkaloids and other ingredients. Neutrophil count < 1500/mm3 or severe infection, patients with current or recent (within 2 weeks) history of infection. Patients requiring long-term oxygen therapy. For the Oral form: disease significantly affecting absorption - previous significant surgical resection of stomach or small bowel - severe hepatic insufficiency not related to the tumoral process. Special Warnings and Precautions for Use* Interactions with other Medicaments* Undesirable Effects* Pharmacological Properties* Preclinical safety Data* Pharmaceutical Particulars* Overdosage* Special Precautions for Storage* Instruction for Use/Handling*
Administrative Data: Marketing Authorisation Holder PIERRE FABRE PHARMA, Via G.G. Winckelmann,1 - 20 146 MILAN. Marketing Authorisation Number: 1 vial of 1 ml 027865082 September 1993 - 1 vial of 5 ml 027865094 September 1993 - M.A. No 027865106: 1 soft capsule NAVELBINE® 20 mg. M.A. No 027865118: 1 soft capsule NAVELBINE® 30 mg. Date of First Authorisation/Renewal of Autorisation: 14 August 2001/14 August 2006. Licence PIERRE FABRE MEDICAMENT-CNRS. NAVELBINE®: a registered trademark of PIERRE FABRE MEDICAMENT. Laboratoires PIERRE FABRE ONCOLOGIE - 45, place Abel-Gance, 92100 Boulogne FRANCE. Tel: +33 (0)1 49 10 80 00 - Fax: +33 (0)1 49 10 96 93. Pharmacovigilance: Tel: +33 (0)1 49 10 96 18
*For complete information, see the summary of product characteristic of your own country
(1) Approval in Mexico and South Korea for the I.V. form
Trade Name of the Medicinal Product:
10 mg/ml concentrate for solution for infusion 1 vial of 1 ml - 10 mg/ml concentrate for solution for infusion 1 vial of 5 ml - NAVELBINE® 20 mg soft capsule - NAVELBINE® 30 mg soft capsule.
Qualitative and Quantitative Composition* Therapeutic Indications: Treatment of non-small cell lung cancer. Treatment of metastatic breast cancer. Treatment of Prostate Cancer (1).
Posology and Method of Administration* Contra-indications: pregnancy, lactation. Hypersensitivity to vinorelbine or other vinca alkaloids and other ingredients. Neutrophil count < 1500/mm3 or severe infection, patients with current or recent (within 2 weeks) history of infection. Patients requiring long-term oxygen therapy. For the Oral form: disease significantly affecting absorption - previous significant surgical resection of stomach or small bowel - severe hepatic insufficiency not related to the tumoral process. Special Warnings and Precautions for Use* Interactions with other Medicaments* Undesirable Effects* Pharmacological Properties* Preclinical safety Data* Pharmaceutical Particulars* Overdosage* Special Precautions for Storage* Instruction for Use/Handling*
Administrative Data: Marketing Authorisation Holder PIERRE FABRE PHARMA, Via G.G. Winckelmann,1 - 20 146 MILAN. Marketing Authorisation Number: 1 vial of 1 ml 027865082 September 1993 - 1 vial of 5 ml 027865094 September 1993 - M.A. No 027865106: 1 soft capsule NAVELBINE® 20 mg. M.A. No 027865118: 1 soft capsule NAVELBINE® 30 mg. Date of First Authorisation/Renewal of Autorisation: 14 August 2001/14 August 2006. Licence PIERRE FABRE MEDICAMENT-CNRS. NAVELBINE®: a registered trademark of PIERRE FABRE MEDICAMENT. Laboratoires PIERRE FABRE ONCOLOGIE - 45, place Abel-Gance, 92100 Boulogne FRANCE. Tel: +33 (0)1 49 10 80 00 - Fax: +33 (0)1 49 10 96 93. Pharmacovigilance: Tel: +33 (0)1 49 10 96 18
*For complete information, see the summary of product characteristic of your own country
(1) Approval in Mexico and South Korea for the I.V. form
