Deferasirox is indicated for the treatment of chronic iron overload due to frequentblood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with betathalassemia major aged 6 years and older.
Deferasirox is also indicated for the treatment of chronic iron overload due to bloodtransfusions when deferoxamine therapy is contraindicated or inadequate in the followingpatient groups:
-in pediatric patients with beta thalassemia major with iron overload due tofrequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years
Breast cancer
Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
• operable node-positive breast cancer
• operable node-negative breast cancer
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
Non-small cell lung cancer
Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Prostate cancer
Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Gastric adenocarcinoma
Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease
Head and neck cancer
Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck
Aminocaproic acid is indicated for use in patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in:
•Urology (surgery of the bladder and prostate)
•Gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated
•Obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect
•Heart surgery (with or without bypass placement)
•Gastroenterology
•Odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulanttherapy) Life-threatening haemorrhages induced by thrombolytics (streptokinase, etc.). Haemorrhages associated with thrombocytopenia, thrombopenic purpura, leukaemia. Nonsurgical haematuria of the lower urinary tract (secondary to cystitis, etc.). Intense menstruations, menorrhagia and haemorrhagic metropathies. Angioneurotic oedema.
Schizophrenia and other psychoses (especially paranoia), mania and hypomania. In anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behavior. Is used as an adjunct in the short-term management of these conditions.
·Intractable hiccup.
·Nausea and vomiting in terminal illness (where other drugs have failed or are not available).
·Induction of hypothermia is facilitated by Chlorpromazine Tablets which prevents shivering and causes vasodilatation.
Childhood schizophrenia and autism
Chlorpromazine Hydrochloride is intended for the following indications:
treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.
Chlorpromazine Hydrochloride is intended for the following indications:
treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.
Indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Dexrofex is also indicated for the treatment of chronic iron overload due to blood transfusions when Feroxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older. Ferox is also indicated for the treatment of chronic iron overload requiring chelation therapy when Feroxamine therapy is contraindicated or inadequate in patients with non-transfusion- dependent thalassaemia syndromes aged 10 years and older.
Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
Amisulpride also regulates secondary negative symptoms in productive state, as well as affective disorders such as depressive mood.
