الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antitrombootilised ained - prasugrel mylan, co manustada atsetüülsalitsüülhape (asa), on näidustatud ennetamine atherothrombotic sündmuste täiskasvanud patsientidel, kellel on äge koronaarsündroom (ma. ebastabiilne stenokardia, mitte-st-segmendi elevatsiooniga müokardiinfarkt [ua/nstemi] või st-segmendi elevatsiooniga müokardiinfarkt [stemi]) läbivad esmase või hilineb perkutaanse koronaarse interventsiooni (pci).

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan 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. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. , kolmekordne kombineeritud ravi) lisandina toitumise ja treeningu patsientidel, ebapiisavalt kontrollitud nende maksimaalne talutav annus metformiin ja sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan 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.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - rinnanäärmed - endokriinset ravi - fulvestrant on näidustatud ravi östrogeeni retseptor positiivne, lokaalselt kaugelearenenud või metastaatilise rinnavähi postmenopausis naised:ei ole varem ravitud endokriinse ravi, orwith haiguse retsidiivi või pärast abiaine anti-östrogeeni ravi või haiguse progresseerumise kohta ravi antiestrogen.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan ireland limited - fingolimod vesinikkloriid - sclerosis multiplex, relapsing-remitting - immunosupressandid - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 ja 5. 1)orpatients kiiresti arenev raske relapsing remitting sclerosis multiplex määratud 2 või enam puuet ägenemiste ühe aasta, ja on 1 või enam gadoliinium suurendada kahjustused aju mri või olulist kasvu, t2 kahjustus koormus võrreldes varasema hiljutise mrt.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan ireland limited - fingolimod vesinikkloriid - sclerosis multiplex, relapsing-remitting - immunosupressandid - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 ja 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):ravi hiv-1 nakkuse retroviirusevastast ravi (art)-kogenud täiskasvanud patsientidele, sealhulgas neid, mis on väga eeltöödeldud. ravi hiv-1 nakkuse pediaatrilised patsiendid alates vanusest 3 aastat ja vähemalt 15 kg kehakaalu kohta. otsustades ravi alustada darunavir co-manustatakse koos väikeses annuses ritonaviiri, tuleks hoolikalt kaaluda ravi ajalugu konkreetse patsiendi ja mustreid mutatsioonid on seotud erinevate mõjurite. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 ja 5. darunavir co-manustatakse koos väikeses annuses ritonaviir on näidustatud kombinatsioonis teiste viirusevastase ravimitega ravi patsientidel, kellel on inimese immuunpuudulikkuse viiruse (hiv-1) nakkus.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. otsustades ravi alustada darunavir sellisel kunsti-kogenud patsientidel, genotypic katsetamine peaks juhendi kasutamine darunavir (vt lõigud 4. 2, 4. 3, 4. 4 ja 5.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan s.a.s - ritonaviir - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - ritonaviiriga on näidustatud kombinatsioonis teiste retroviirusevastaste ravimitega hiv-1 infektsiooniga patsientidel (täiskasvanutel ja lastel 2 aastat ja vanemad).

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan ireland limited - rivaroksabaan - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombootilised ained - 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.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinavir, ritonaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - lopinaviiri/ritonaviiriga on näidustatud kombinatsioonis teiste retroviirusevastaste ravimitega ravi inimese immuunpuudulikkuse viiruse (hiv-1) nakatunud täiskasvanutel, noorukitel ja üle 2-aastastel lastel. valik lopinavir/ritonaviiri raviks proteaasi inhibiitor kogenud hiv-1 nakatunud patsientidega peaks põhinema individuaalsel viiruse resistentsuse testimise ja raviga patsientide ajalugu.

الاتحاد الأوروبي - الإستونية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antitrombootilised ained - clopidogrel/atsetüülsalitsüülhape mylan on näidustatud sekundaarseks ennetamiseks atherothrombotic sündmuste täiskasvanud patsientidel, arvestades juba nii clopidogrel ja atsetüülsalitsüülhape (asa). clopidogrel/atsetüülsalitsüülhape mylan on fikseeritud annuse kombinatsioon ravimi jätkamine ravi:non-st segmendi elevatsiooniga äge koronaarsündroom (ebastabiilne stenokardia või mitte-q-wave müokardiinfarkt), k.a patsiendid toimumas stent paigutuse pärast perkutaanne südame interventionst segmendi elevatsiooniga ägeda müokardiinfarkti meditsiiniliselt ravitud patsientide abikõlblikud trombolüütiline ravi.