Navirel (vinorelbine) infusions 10 mg/ml. 5 ml. (50 mg.) vial №1

Description

Navirel composition and form of release
Active ingredient: vinorelbine.
Available in the form of a concentrate (10 mg / ml) for the preparation of a solution for infusion.

Pharmacological properties
It is an antineoplastic agent. It is a vegetable alkaloid of Catharanthus roseus (pink periwinkle). The drug blocks mitosis (indirect division) of cells at the metaphase stage.

Indications
Navirel is used:

• with non-small cell lung cancer (stage III-IV);
• in metastatic breast cancer (at stage V) in cases when chemotherapy (anthracyclines, taxanes) was ineffective, or if the patient has contraindications to therapy with anthracyclines, taxanes.

Contraindications:

• with intolerance to the components;
• with pronounced suppression of the functional state of the bone marrow;
• pregnant women, lactating mothers;
• when the number of neutrophilic granulocytes is less than 1500 / mm3;
• with serious infections;
• with a platelet count of less than 100,000 / mm3;
• with severe liver failure, not associated with the tumor process;
• in combination with certain medicines (see package insert).

Children
It is not used in pediatrics.

Application during pregnancy and lactation
Navirel is not used during these periods.

Method of administration and dosage
Navirel is used intravenously only (by slow injection or rapid infusion).
Intrathecal administration is not allowed.
After the end of the drug administration, a 0.9% sodium chloride solution is injected to wash the vein.
Standard doses for adults with non-small cell lung cancer: as monotherapy, 25-30 mg / m2 body surface is used once a week; with polychemotherapy, the dosage regimen depends on the treatment protocol, usually the same dose (25-30 mg / m2) is prescribed, but after long intervals (for example, 1st and 5th days or 1st and 8th days 3- weekly course).

The standard doses for metastatic breast cancer are 25 – 30 mg / m2 once a week.

The maximum single dose is 35.4 mg / m2.

Overdose
Symptoms: depression of the functional state of the bone marrow with the development of fever, infections, paralytic intestinal obstruction.
Symptomatic therapy is indicated. It is important to continuously monitor vital signs, to determine the number of blood cells on a daily basis. If necessary, apply the transfusion of granulocyte mass, the introduction of drugs that stimulate granulocytopoiesis, antibiotics.

Side effects:

• Infections / invasions: bacterial, viral, fungal infections of different localization, septicemia, neutropenic sepsis.
• Hematological disorders: neutropenia, thrombocytopenia, leukopenia, anemia, febrile neutropenia.
• Immune disorders: systemic allergic reactions, including shock, Quincke’s edema.
• Metabolic disorders: syndrome of inappropriate antidiuretic hormone secretion, hyponatremia.
• Neurological disorders: decreased deep tendon reflexes, Guillain-Barré syndrome, paresthesias with motor or sensory symptoms, weakness in the lower extremities.
• Cardiovascular disorders: arterial hypotension / hypertension, hot flashes, angina pectoris, ischemic heart disease, transient ECG changes, myocardial infarction, collapse, tachycardia, palpitation, arrhythmia.
• Respiratory disorders: shortness of breath, bronchospasm, interstitial lung disease.
• Digestive disorders: intestinal paresis, nausea, constipation / diarrhea, anorexia, vomiting, stomatitis, esophagitis, pancreatitis, intestinal obstruction, liver dysfunction.
• Dermatological disorders: alopecia, rashes, urticaria, pruritus, erythema of the palms / soles.
• Musculoskeletal disorders: pain in the jaw, myalgia, arthralgia.
• Urinary disorders: increased creatinine levels.
• General disorders: fatigue, asthenia, fever, pain of various localization, tissue necrosis, reactions at the injection site (vein discoloration, erythema, pain, phlebitis), cellulitis.

Storage conditions and periods
Store Navirel at +2 – + 8 ° С for no more than three years.