Indications : התוויות

Therapeutic indications                                                           treatment of the patient. The injection can be completed in about 1 minute,        dyspnoea, which made chronic use of corticosteroids necessary. Vinblastine          concomitantly take medicinal products of which it is known that they Vinblastine has proved effective in the treatment of the following neoplasms,         provided that the needle is well placed in the vein and that no vinblastine        may not be administered again (see also section 4.5).                               inhibit the medicinal product metabolism via iso-enzymes of the hepatic either alone or in conjunction with other oncolytic drugs:                            is injected outside the veins, which can cause cellulitis or phlebitis. In order   Caution is needed with liver insufficiency, because it is likely that delayed       cytochrome CYP3A, or in patients with liver function disorders. The Frequently Responsive Malignancies:                                                   to prevent vinblastine from extravascularization it is recommended to first        excretion will occur and the dose will have to be adjusted (see section 4.2).       concomitant administration of vinblastine sulfate and an inhibitor of this
• Generalized Hodgkin's disease (Stages III and IV, Ann Arbor modification            flush the needle and syringe with venous blood before withdrawing the              Caution is needed in patients with ischemic heart disease.                          metabolic route can cause a faster occurrence and/or increased severity of Rye staging system).                                                             needle. If extravascularization occurs the injection should be discontinued        This product is generally not recommended in combination with live                  of side effects.
• Non-Hodgkin's lymphoma:                                                             immediately, and any remaining portion of the dose should then be introduced       attenuated vaccines, phenytoin and itraconazole (see section 4.5).                  The concomitant oral or intravenous use of digitoxin and combinations of - Reticulum-cell sarcoma.                                                           into another vein. Vinblastine should not be diluted in large quantities                                                                                               chemotherapeutic drugs including vinblastine sulfate can lead to reduced of solution (e.g., 100 to 250 ml) and should not be administered as a              Careful monitoring of the peripheral nervous system is recommended in
- Lymphosarcoma.                                                                                                                                                       order to allow dose adjustments.                                                    blood levels of digitoxin, thereby lowering the efficacy of digitoxin. slow infusion (30 to 60 minutes or more), because this can increase the                                                                                                The concomitant oral or intravenous use of phenytoin and combinations of
• Mycosis fungoides.                                                                  risk of irritation. In connection with the increased risk of thrombosis, it is     Elevation of the serum uric acid levels can occur during the remission-
• Neuroblastoma.                                                                                                                                                         induction with lymphoma; therefore the serum uric acid levels should be             chemotherapeutic drugs including vinblastine sulfate can lead to reduced not recommended to administer vinblastine in an extremity in which the                                                                                                 blood levels of phenytoin and to a greater frequency of attacks. The dose
• Histiocytosis X.                                                                    circulation has been obstructed or shows the inclination to obstruct due           monitored or suitable measures should be taken. During treatment with vinblastine, intensive sun exposure is to be avoided.         adjustment of phenytoin should occur on the basis of the blood level.
Less Frequently Responsive Malignancies:                                              to compression or invasion of the tumour, phlebitis or varices.                                                                                                        The contribution of vinblastine sulfate to this interaction is not clear. The
• Choriocarcinoma resistant to other chemotherapeutic agents.                         If reconstituted vinblastine sulfate is supplied in a different container from     Care should be taken to avoid contact of vinblastine with the eyes.                 interaction is possibly the result of a reduced absorption of phenytoin and
• Embryonal carcinoma of the testis.                                                  the original Blastovin Teva glass vial, for instance in a syringe, then it is      Orthostatic hypotension may be aggravated in elderly patients.                      an increase in the metabolism and elimination rate.
• Carcinoma of the breast, unresponsive to appropriate endocrine surgery              required to supply it in an outer container with the inscription: “solely for      When suspecting inadequate secretion of ADH, serum levels of electrolytes           With the combination vinblastine and mitomycin a severe, sometimes and hormonal therapy.                                                               intravenous administration”.                                                       and fluid balance should be monitored.                                              irreversible pulmonary toxicity has been described, particularly in already 4.3 Contraindications                                                              Constipation may occur as an undesirable effect of vinblastine sulfate; this        injured tissue (see section 4.4). Vinblastine used as part of a combination