Moxifloxacin 400mg tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin. Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed:
- Acute bacterial sinusitis (adequately diagnosed)
- Acute exacerbations of chronic bronchitis (adequately diagnosed)
- Community-acquired pneumonia, except severe cases
- Mild to moderate pelvic inflammatory disease (i.e. infections of the female upper genital tract, including salpingitis and endometritis), without an associated tube-ovarian or pelvic abscess
Moxifloxacin 400mg tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate anti-bacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistant Neisseria gonorrhoeae unless moxifloxacin- resistant Neisseria gonorrhoeae can be excluded
Moxifloxacin 400mg tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:
- Community-acquired pneumonia
- Complicated skin and skin structure infections
Moxifloxacin 400mg film-coated tablets should not be used to initiate therapy for any type of skin structure infection or severe community-acquired pneumonia
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is required. Not indicated for use by women.
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.
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
Spikevax JN1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.
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.
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.
Inhibition/suppression of physiological lactation
Cabergoline is indicated for the inhibition of physiological lactation soon after delivery and for suppression of already established lactation:
1. After parturition, when the mother elects not to breast feed the infant or when breast feeding is contraindicated due to medical reasons related to the mother or the new-born.
2. After stillbirth or abortion.
Cabergoline prevents/suppresses physiological lactation by inhibiting prolactin secretion.
Treatment of hyperprolactinaemic disorders
