Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistiskā fibroze - other respiratory system products - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 un 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 un 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistiskā fibroze - other respiratory system products - orkambi tabletes ir indicēts, lai ārstētu cistiskā fibroze (cf) pacientiem vecumā no 6 gadiem un vecākiem, kas ir homozygous par f508del cftr mutācija gēnu. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistiskā fibroze - other respiratory system products - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cistiskā fibroze - other respiratory system products - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - velaglucerase alfa - gošē slimība - citas gremošanas trakta un metabolisma produkti, - vpriv ir indicēts ilgstošai enzīmu aizstājterapijai (ert) pacientiem ar 1. tipa gošē slimību.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - erektilā disfunkcija - uroloģiskie līdzekļi - erektilā disfunkcijas ārstēšana pieaugušiem vīriešiem. lai tadalafils būtu efektīvs, nepieciešama seksuāla stimulācija. tadalafilu mylan nav indicēts lietošanai sievietēm.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

regeneron uk limited - rilonacepts - cryopyrin saistītie periodiskie sindromi - imūnsupresanti - rilonacept regeneron tiek norādīts cryopyrin saistīto periodisku sindromi (caps) ārstēšanai ar smagi simptomi, ieskaitot ģimenisko aukstā auto iekaisuma sindroms (fcas) un muckle wells sindroms (mws) pieaugušajiem un bērniem vecumā no 12 gadiem un vecāki.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate - rhinitis, allergic, seasonal; rhinitis, allergic, perennial - deguna preparāti, kortikosteroīdi - pieaugušie, pusaudži (12 gadi un vecāki) un bērni (6-11 gadi). avamys ir indicēts alerģiskā rinīta simptomu ārstēšanai.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - nātrija tiosulfāts - ear diseases; ototoxicity - visi pārējie terapeitiskie produkti - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinakalceta hidrohlorīds - hyperparathyroidism, secondary; hypercalcemia - kalcija homeostāze - sekundāra hiperparatireoidisms (hpt) ārstēšana pacientiem ar nieru slimību beigu stadijā (esrd) uz apkopes dialīzes terapiju. cinacalcet mylan var izmantot kā daļu no terapijas shēmu, tostarp fosfātu saistvielām un/vai d vitamīna sterīni, pēc vajadzības. samazināt hypercalcaemia pacientiem ar:parathyroid carcinomaprimary hpt, par kurām parathyroidectomywould jānorāda, pamatojoties uz seruma kalcija līmeni (kā noteikts attiecīgās ārstēšanas vadlīnijas), bet kam parathyroidectomy nav klīniski atbilstošs, vai ir kontrindicēta.