Breast cancer
Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Prostate cancer
Talazoparib is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); Age ≥ 75 years; hot failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
Famotidine 10 mg is intended for the following indications:
·The short-term symptomatic relief of heartburn, indigestion (dyspepsia) and excess acid.
·Prevention of these symptoms when associated with meals including nocturnal symptoms.
• indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
• Treatment of diabetes insipidus (excluding nephrogenic diabetes insipidus).
• Control of bleeding esophageal varices.
Bortezomib 2.5 mg/ml Solution for Injection as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Bortezomib 2.5 mg/ml Solution for Injection in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Bortezomib 2.5 mg/ml Solution for Injection in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Bortezomib 2.5 mg/ml Solution for Injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation
Omeprazole capsules are indicated for:
Adults
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in
peptic ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
• Treatment of reflux oesophagitis
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Paediatric use
Children over 1 year of age and ≥ 10 kg
• Treatment of reflux oesophagitis
• Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease
Children and adolescents over 4 years of age
• In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori
PROGESTERONE indicated in adult women.
Oral Route:
Gynaecological:
- Disorders due to progesterone insufficiency, Particularly:
- premenstrual syndrome,
- menstrual irregularities with dysovulation or anovulation,
- benign breast disorders,
- peri-menopause.
- treatment of menopause (in addition to oestrogen therapy).
- sterility due to luteal failure.
Obstetric:
- Threatened miscarriage or prevention of repeated miscarriage due to proven luteal insufficiency.
- Threatened premature delivery.
Vaginal Route:
- Subfertility or primary/secondary infertility due to partial or total luteal phase deficiency (in particular: irregular ovulation, supplementation of the luteal phase during in vitro fertilisation, egg donations).
- Threat of miscarriage or prevention of recurrent miscarriages due to luteal phase deficiency.
- Prevention of a premature singleton birth in women at risk, with a short cervical length of [less or equal] 25 mm measured between weeks 16 and 24 of pregnancy (weeks 18 and 26 of amenorrhoea)
Treatment of prostate cancer in the following settings:
• In the treatment of metastatic prostate cancer where Goserelin acetate has demonstrated comparable survival benefits to surgical castrations
• In the treatment of locally advanced prostate cancer, as an alternative to surgical castration where Goserelin acetate has demonstrated comparable survival benefits to an anti-androgen
• As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where Goserelin acetate has demonstrated improved disease-free survival and overall survival
• As neo-adjuvant treatment prior to radiotherapy in patients with high risk localised or locally advanced prostate cancer where Goserelin acetate has demonstrated improved disease-free survival
• As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression where
Goserelin acetate has demonstrated improved disease-free survival
Goserelin acetate 10.8 mg is indicated in the management of oestrogen-receptor (ER) positive early and advanced breast cancer in pre and peri menopausal women.
This medicinal product is for diagnostic use.
Diagnostic indications
Cardiac, circulatory and micro-circulatory diagnostics:
·measurement of cardiac output and stroke volume
·measurement of circulating blood volumes
·measurement of cerebral perfusion
Liver function diagnostics:
·measurement of liver blood flow
·measurement of excretory function of the liver
Ophthalmic angiography diagnostics:
·measurement of perfusion of the choroid
