Posaconazole are indicated for use in the treatment of the following fungal infections in patients aged 13 and over:
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
Posaconazole indicated for use in the treatment of the following fungal infections in patients aged 18 and over:
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Posaconazole are also indicated for prophylaxis of invasive fungal infections in the following patients aged 13 and over:
- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infection
Pitolisant is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP). In addition to the treatment of narcolepsy with or without cataplexy in adults, adolescents and children from the age of 6 years.
Antiparkinsonian agent.
Treatment of Parkinson's disease, Zydolev ® frequently is helpful in the management of tremor, dysphagia, sialorrhea and postural instability associated with Parkinson's disease.
Macitentan, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease
This medicinal product is for diagnostic use.
Ultravist-240, -300, -370:
–Angiography, angiocardiography, digital subtraction angiography
–Contrast enhancement in computerised tomography
–Urography
–Visualization of body cavities
(Exception: myelography, ventriculography, cisternography)
Ultravist-300/-370:
Used in adult women for contrast-enhanced mammography to assess and detect known or suspicious lesions of the breast,
–in addition to mammography (with or without ultrasound) or
–as an alternative to magnetic resonance imaging (MRI) if MRI is contraindicated or not available.
Type 2 diabetes mellitus
Empagliflozin is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance
- in addition to other medicinal products for the treatment of diabetes
Heart failure
Empagliflozin is indicated in adult patients with heart failure (NYHA class II-IV) independent of left ventricular ejection fraction, with or without type 2 diabetes mellitus:
-to reduce the risk of cardiovascular death and hospitalization for heart failure
-to slow kidney function decline
Chronic kidney disease
Empagliflozin is indicated in adults for the treatment of chronic kidney disease.
Adults
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Paediatric population
Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.
