about the product
Dosage 100 mg: white film-coated tablets, round, biconvex. In the cross-section, the core is white or almost white.
Dosage 300 mg: white film-coated tablets, oval, biconvex. In the cross-section, the core is white or almost white.
Specifications
use
Recommended dose
The recommended dose of the drug is 300 mg once a day (1 tablet of 300 mg or 3 tablets of 100 mg).
Dose adjustment
If necessary, your doctor can reduce the daily dose to 200 mg (two tablets of 100 mg each), and further, if necessary, to 100 mg.
The way and method of administration
The drug VANDETANIB-PROMOMED should be taken orally, regardless of food intake.
If you are unable to swallow a tablet whole, then VANDETANIB-PROMOMED tablets can be dissolved in half a glass (50 ml) of non-carbonated drinking water. Other liquids cannot be used. The tablet should be dipped into water without crushing, stirring until dissolved (for about 10 minutes) and immediately drink the resulting suspension. Mix the leftovers with an additional half cup of water and drink.
VANDETANIB-PROMOMED suspension can also be administered through a nasogastric tube or gastrostomy (an artificial opening connecting the anterior abdominal wall and the stomach so that food and medications are injected directly into the stomach).
Duration of therapy
Your doctor will determine the duration of therapy depending on your condition and the severity of the adverse reactions.
Help
Package leaflet
VANDETANIB-PROMOMED is indicated for adults over 18 years of age for the treatment of a certain type of thyroid cancer (unresectable locally advanced or metastatic medullary thyroid cancer).
Treatment with VANDETANIB-PROMOMED is selected and monitored by a doctor, so the likelihood that you will receive more or less of it than you need is minimal. However, if you have any doubts, consult your doctor.
In case of overdose of the drug, it is possible to increase the frequency and severity of some adverse reactions, such as rash, diarrhea and increased blood pressure. Heart problems may occur, such as increased heart rate.
If you have taken a higher dose of the drug than you should have, stop taking the drug immediately and consult your doctor.
Like all medications, VANDETANIB-PROMOMED can cause undesirable reactions, but they do not occur in everyone.
It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of the drug, and prescribe additional therapy).
Some adverse reactions can be serious and life-threatening.
Tell your doctor immediately if you experience any of the following adverse reactions:
- Medicinal skin reactions: fever and "malaise", followed by a widespread rash on the skin and mucous membranes in the form of spots, blisters, weeping erosions (oval or round skin lesions with a wet, wet surface), crusts, possible detachment of skin areas (toxic epidermal necrolysis, Stevens-Johnson syndrome).
- Disorders characterized by severe malaise, fever, decreased blood pressure, decreased urine output per day (diuresis), increased heart rate and respiration (sepsis).
- Disorders of the nervous system, manifested by loss of consciousness, headache, dizziness (ischemic disorders of cerebral circulation, cerebral edema), possibly seizures (reversible posterior leukoencephalopathy syndrome).
- Cardiac disorders, manifested by chest pain, loss of consciousness, cardiac arrhythmias (cardiac arrest, cardiac conduction disorders, ventricular arrhythmia, acute heart failure).
- Vascular disorders, manifested by increased blood pressure, headache, loss of consciousness (hypertensive crisis, aneurysm and arterial dissection).
- Respiratory system disorders, manifested by weakness, cough, wheezing, confusion (interstitial lung disease, pneumonitis), possibly high fever (pneumonia, aspiration pneumonia). Gastrointestinal disorders, manifested by sudden acute abdominal pain, possibly vomiting, high fever (appendicitis, peritonitis, diverticulitis, abdominal abscess) and bleeding (gastrointestinal bleeding, intestinal perforation).
Do not take the drug VANDETANIB-PROMOMED:
- If you are allergic to vandetanib or any other components of the drug listed in section 6 of the leaflet
- If you have congenital disorders of conduction of impulses in the heart
- If according to the electrocardiogram (ECG) You have an elongation of the QT interval (a measurement to assess the electrical properties of the heart performed on an ECG)
- If you are simultaneously taking other medications that can prolong the QTc interval (the corrected QT interval used to diagnose heart diseases and predict the risk of their development), affect changes in heart rhythm, and cause irregular and rapid heart contractions (fluttering/flickering), for example, arsenic drugs, cisapride, erythromycin (intravenously), toremifene, misolastine, moxifloxacin, antiarrhythmic drugs
- If you have liver failure
- If you are pregnant or breastfeeding
Tell your doctor that you are taking, have recently taken, or are about to take any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with VANDETANIB-PROMOMED, and possibly adjust the doses of the medications you are taking.
Read the list of medications in the subsections "Contraindications", "Special instructions and precautions" in the leaflet for information about medications that should not be taken in conjunction with VANDETANIB-PROMOMED.
Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro
Keep the drug out of the reach of the child so that the child cannot see it. Do not use the drug after the expiration date (shelf life) indicated on the cardboard pack after "Good before". The expiration date is the last day of the given month. Store at temperatures below 30 °C. Store in the original packaging (pack).
The drug VANDETANIB-PROMOMED is intended only for the treatment of adults. Do not give the drug to children under the age of 18, as efficacy and safety have not been established.
Consult your doctor before taking VANDETANIB PROMOMED. In some cases, taking the drug VANDETANIB-PROMOMED requires special precautions.
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