Human Pharma Products

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1 Human Pharma Products Product (active ingredient) Actilyse (alteplase) Actilyse Cathflo (alteplase) Aptivus (tipranavir) Asasantin Retard (aspirin, dipyridamole) Atrovent (ipratropium bromide) Beromun (tasonermin) Formulation Strength Indication Therapy Area Powder and solvent for solution for injection and infusion Powder for solution for injection and infusion Soft Capsule (adults and adolescents >12y) Solution (children from 2-12y) Capsule (modified release) 10mg, 20mg, 50mg o Thrombolytic treatment in acute MI o Thrombolytic treatment in acute massive PE with haemodynamic instability o Fibrinolytic treatment of acute ischaemic stroke Lytics 2mg Thrombolytic treatment of occluded central venous access devices including those used for haemodialysis 250mg 100mg/ml 25mg aspirin + 100mg dipyridamole Combination antiretroviral treatment (with low dose ritonavir) of HIV-1 infection in highly pre-treated patients with virus resistant to multiple protease inhibitors Secondary prevention of ischaemic stroke and transient ischaemic attacks Inhaler (CFC-Free) 20mcg/actuation Regular treatment of reversible bronchospasm associated with COPD and chronic asthma Unit Dose Vial 250mcg/1ml, o Treatment of reversible bronchospasm associated with (nebuliser solution) 500mcg/2ml COPD [250mcg/ml] o Treatment of reversible airways obstruction as in acute and chronic asthma, when used concomitantly with inhaled beta 2 -agonists. Powder and solvent 1mg/5ml Combination with melphalan via mild hyperthermic for solution for isolated limb perfusion (ILP) as: infusion o adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation o or in the palliative situation, for irresectable soft tissue sarcoma of the limbs Virology Oncology

2 Buscopan (hyoscine butylbromide) Catapres (clonidine hydrochloride) Combivent (ipratropium bromide, salbutamol sulphate) Giotrif (afatinib) Immukin (interferon gamma- 1b) Jardiance (emapgliflozin) Ampoule (solution for injection) 20mg/ml Acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem, e.g. gastroduodenal endoscopy. 10mg Relief of spasm of the genito-urinary tract or gastrointestinal tract and for the symptomatic relief of Irritable Bowel Syndrome 100mcg Treatment of all grades of essential and secondary hypertension Ampoule 150mcg/ml Treatment of hypertensive crises (solution for injection) Unit Dose Vial (nebuliser solution) 500mcg ipratropium bromide + 2.5mg salbutamol Management of bronchospasm in patients suffering from COPD who require regular treatment with both ipratropium and salbutamol 20mg, 30mg, 40mg, 50mg As monotherapy for the treatment of o o Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with activating EGFR mutation(s) locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy Solution for injection 2 x 10 6 IU (0.1mg)/0.5ml o Reduction of the frequency of serious infections in patients with: o chronic granulomatous disease (CGD) o severe, malignant osteopetrosis 10mg, 25mg Treatment of type 2 diabetes mellitus to improve glycaemic control in adults as: o monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered Consumer Healthcare Oncology Virology

3 inappropriate due to intolerance. o add-on combination therapy with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control Jentadueto 2.5mg linagliptin + 850mg Treatment of adult patients with type 2 diabetes mellitus: (linagliptin, metformin) metformin; 2.5mg linagliptin mg metformin o as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. o in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. o in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin and metformin alone do not provide adequate glycaemic control. Metalyse Powder and solvent 8,000 units (40mg)/8ml, Thrombolytic treatment of suspected myocardial infarction (tenecteplase) for solution for 10,000 units (50mg)/10ml with persistent ST elevation or recent left Bundle Branch injection [1,000 units (5mg)/ml] Block within 6 hours after the onset of acute myocardial Lytics infarction (AMI) symptoms Micardis 20mg, 40mg, 80mg o Treatment of essential hypertension in adults. (telmisartan) o Reduction of cardiovascular morbidity in adults with: o manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or o type 2 diabetes mellitus with documented target organ damage MicardisPlus 40/12.5mg (40mg Treatment of essential hypertension

4 (hydrochlorothiazide, telmisartan) Mirapexin (pramipexole) Ofev (nintedanib) Oramorph (morphine sulphate) Persantin (dipyridamole) (immediate release) Prolonged Release = telmisartan mg hydrochlorothiazide); 50/12.5mg (80mg telmisartan mg hydrochlorothiazide) As base (salt): 0.088mg (0.125mg), 0.18mg (0.25mg), 0.35mg (0.5mg), 0.53mg (0.75mg), 0.7mg (1.00mg), 0.88mg (1.25mg), 1.05mg (1.5mg) As base (salt): 0.26mg (0.375mg), 0.52mg (0.75mg), 1.05mg (1.5mg), 1.57mg (2.25mg), 2.1mg (3.0mg), 2.62mg (3.75mg), 3.15mg (4.5mg) o Treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa o Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54mg of base (0.75mg of salt) Treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa Soft capsule 100mg, 150mg Treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults. Oral Solution 10mg/5ml Relief of severe pain Concentrate Oral 20mg/ml Solution 25mg, 100mg Adjunct to oral anti-coagulation for prophylaxis of (Immediate Release) thromboembolism associated with prosthetic heart valves Retard = Capsule 200mg o Secondary prevention of ischaemic stroke and (prolonged release) transient ischaemic attacks either alone or in conjunction with aspirin o An adjunct to oral anti-coagulation for prophylaxis of thromboembolism associated with prosthetic heart valves Ampoule 10mg/2ml o Adults: alternative to exercise stress in thallium-201 (solution for myocardial imaging. infusion) o Children: alternative to exercise stress in myocardial Neurology Neurology Neurology

5 Pradaxa (dabigatran etexilate) Praxbind (idarucizumab) Rinatec Nasal Spray (ipratropium bromide) Spiolto (tiotropium and olodaterol) Spiriva (tiotropium) Respimat = Solution for inhalation 2.5mcg/2.5mg/actuation perfusion imaging Capsule 75mg, 110mg, 150mg o Primary prevention of VTE in patients who have undergone elective total hip or knee replacement surgery (75mg and 110mg) o Prevention of stroke and systemic embolism in patients with atrial fibrillation (110mg and 150mg) o Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (110mg and 150mg) Solution for 2.5g/50ml Specific reversal agent for dabigatran and is indicated in injection/infusion adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: o For emergency surgery/urgent procedures o In life-threatening or uncontrolled bleeding. Nasal Spray solution 21mcg/actuation Symptomatic relief of rhinorrhoea in allergic and nonallergic rhinitis Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). HandiHaler = capsule 18mcg Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD) Respimat = Solution for inhalation 2.5mcg/actuation Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids ( 800 µg budesonide/day or equivalent) and long-acting β2 agonists and who experienced one or more severe exacerbations in the previous year.

6 Striverdi (olodaterol) Synjardy (emagliflozin, metformin) Trajenta (linagliptin) Vargatef (nintedanib) Respimat = Solution Maintenance bronchodilator treatment in patients with 2.5mcg/actuation for inhalation chronic obstructive pulmonary disease (COPD). 5mg/850mg, Treatment of type 2 diabetes mellitus as an adjunct to diet 5mg/1,000mg, and exercise to improve glycaemic control 12.5mg/850mg, o in patients inadequately controlled on their maximally 12.5mg/1,000mg tolerated dose of metformin alone o in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin o in patients already being treated with the combination of empagliflozin and metformin as separate tablets. 5mg Treatment of type 2 diabetes mellitus to improve glycaemic control in adults: o as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. o as combination therapy o in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. o in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. o in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control. Soft capsule 100mg, 150mg 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 Oncology

7 Viramune (nevirapine anhydrate) (Immediate Release) Prolonged Release = (children > 3y able to swallow tablets) Suspension 200mg 100mg, 400mg 50mg/5ml chemotherapy. Combination with other anti-retroviral medicinal products for the treatment of HIV-1 Virology

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