Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi winthrop industrie - klópídógrel - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - blóðþurrðandi lyf - efri fyrirbyggja atherothrombotic eventsclopidogrel er ætlað:fullorðinn sjúklingar sem þjáist af kransæðastíflu (frá nokkrum dögum fyrr en minna en 35 dögum), blóðþurrðar heilablóðfall (frá 7 daga þar til að minna en 6 mánuðum) eða komið útlæga slagæð sjúkdómur. fullorðinn sjúklingar sem þjáist af bráðu kransæðastíflu:ekki l hækkun bráð kransæðastíflu (óstöðug hálsbólgu eða ekki q-bylgja kransæðastíflu), þar á meðal sjúklinga gangast undir stoðneti staðsetningar eftir stungið kransæðastíflu afskipti, ásamt asetýlsalisýlsýru (asa). st segment elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. fyrirbyggja atherothrombotic og bláæðum atburðum í gáttum fibrillationin fullorðinn sjúklinga með gáttum tif sem hafa minnsta kosti einn hættu þáttur í æðum viðburði, eru ekki við hæfi fyrir meðferð með c-k-mótlyf (vka) og sem hafa lágt blæðingar hættu, eða er ætlað ásamt asa til að fyrirbyggja atherothrombotic og bláæðum viðburði, þar á meðal heilablóðfall.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi winthrop industrie - klópídógrel vetnissúlfat - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - blóðþurrðandi lyf - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. fyrirbyggja atherothrombotic og bláæðum atburðum í gáttum fibrillationin fullorðinn sjúklinga með gáttum tif sem hafa minnsta kosti einn hættu þáttur í æðum viðburði, eru ekki við hæfi fyrir meðferð með vítamín-k blokkum og sem hafa lágt blæðingar hættu, eða er ætlað ásamt asa til að fyrirbyggja atherothrombotic og bláæðum viðburði, þar á meðal heilablóðfall.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

teva b.v. - salmeterol, flútikasón nef - pulmonary disease, chronic obstructive; asthma - lyf til veikindi öndunarvegi sjúkdómum, - airexar spiromax er ætlað til notkunar hjá fullorðnum 18 ára og eldri. asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist. langvinn veikindi í lungum (llt)airexar viðeigandi er ætlað til meðferð við sjúklinga með llt, með fev1.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - apixaban - venous thromboembolism; stroke; arthroplasty - blóðþurrðandi lyf - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. fyrirbyggja heilablóðfall og almenn stíflu í fullorðinn sjúklinga með ekki-valvular gáttum tif (nvaf), með einum eða fleiri hættu þættir, eins og áður en heilablóðfall eða tímabundin blóðþurrðar árás (tia); aldri stærri 75 ár; háþrýstingur; sykursýki; einkennum hjartabilun (nyha flokki sem stóð ii). meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir (sjá kafla 4. 4 fyrir haemodynamically óstöðug pe sjúklingar). 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 ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir (sjá kafla 4. 4 fyrir haemodynamically óstöðug pe sjúklingar).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - Óviðeigandi adh heilkenni - Þvagræsilyf, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - blóðþurrðandi lyf - til að koma í veg fyrir segareki í bláæðum (vte) hjá fullorðnum sjúklingum sem gangast undir valhimnubólgu eða meðhöndlun á hné. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 fyrir haemodynamically óstöðug pe sjúklingar). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 og 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - blóðþurrðandi lyf - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.