Examples of using Vargatef in English and their translations into German
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Colloquial
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Official
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Ecclesiastic
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Medicine
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
How does Vargatef work?
Vargatef contains soya.
How is Vargatef used?
Vargatef 100 mg soft capsules.
Other information about Vargatef.
Why is Vargatef approved?
If you stop taking Vargatef.
Vargatef should therefore only be initiated at least 4 weeks after major surgery.
If you forget to take Vargatef.
Table 2: Recommended dose adjustments for Vargatef(nintedanib) in case of AST and/or ALT and bilirubin elevations.
Other medicines and Vargatef.
Vargatef must not be used in patients who are hypersensitive(allergic) to nintedanib, peanut or soya, or any of the other ingredients.
The following medicines may decrease the blood levels of nintedanib andthus may lead to reduction of the effectiveness of Vargatef.
In the clinical trial(LUME-Lung 1; see section 5.1) with Vargatef, the frequency of bleeding in both treatment arms was comparable see section 4.8.
If you cannot tolerate the recommended dose of 400 mg per day because of side effects(see section 4)your doctor may reduce the daily dose of Vargatef.
Vargatef 150 mg capsules are brown-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure“150”.
In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily,treatment with Vargatef should be permanently discontinued.
Table 1: Recommended dose adjustments for Vargatef(nintedanib) in case of diarrhoea, vomiting and other non-haematological or haematological adverse reactions.
No increased frequency of cerebral bleeding in patients with adequately pre-treated brain metastases which were stablefor≥ 4 weeks before start of treatment with Vargatef was observed.
During treatment with Vargatef your doctor will regularly monitor your blood cells and examine you for signs of infection, such as inflammation, fever or tiredness.
Patients who developed thromboembolic events during treatment andwho required anticoagulant treatment were allowed to continue Vargatef and did not show an increased frequency of bleeding events.
In addition, the company that markets Vargatef will conduct studies to find ways to identify those patients who are most likely to benefit from treatment with the medicine.
Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, for example loperamide, and may require interruption,dose reduction or discontinuation of therapy with Vargatef see section 4.2.
Treatment with Vargatef may lead to a reduced number of a type of your white blood cells(neutropenia) which are important for the body's reaction against bacterial or fungal infections.
The values should be monitored as clinically indicated or periodically during treatment, i.e. inthe combination phase with docetaxel at the beginning of each treatment cycle and monthly in case Vargatef is continued as monotherapy after discontinuation of docetaxel.
The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type.
In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer thatdid not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer.
Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer(NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
In addition, Vargatef led to an improvement in overall survival(how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone.