Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 ja 5. 1 erinevate kombinatsioonide kohta kättesaadavate andmete osas).

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastilised ained - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - sclerosis multiplex, relapsing-remitting - immunosuppressants, valikuline immunosuppressants - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimetüülfumaraat - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosupressandid - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - eesnäärmevähk - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - kaspofungiinatsetaat - candidiasis; aspergillosis - antimükoosid süsteemseks kasutamiseks - ravi invasiivse kandidoosi täiskasvanud või pediaatrilised patsiendid. ravi invasiivse aspergillosis täiskasvanud või pediaatrilised patsiendid, kes on tulekindlad või sallimatu amphotericin b, lipiidide ravimvormide amphotericin b ja/või itraconazole. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. empiiriline ravi eeldada, seeninfektsioonide (nt candida või aspergillus) febriilsed, neutropaenic täiskasvanud või pediaatrilised patsiendid.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - bortesomiib - mitu müeloomit - antineoplastilised ained - bortezomib kokkuleppel, kui monotherapy või koos pegylated liposomal doxorubicin või deksametasooni on näidustatud ravi täiskasvanud patsientidel, kellel on progresseeruv hulgimüeloom, kes on saanud vähemalt 1 enne ravi ja kes on juba läbinud või on sobimatud vereloome tüvirakkude siirdamine. bortezomib kokkuleppel koos melphalan ja prednisooni on näidustatud ravi täiskasvanud patsientidel, kellel on varem ravimata hulgimüeloom, kes ei ole abikõlblikud suure annusega keemiaravi koos vereloome tüvirakkude siirdamine. bortezomib kokkuleppel koos deksametasooni või deksametasooni ja talidomiid, on näidustatud induktsiooni ravi täiskasvanud patsientidel, kellel on varem ravimata hulgimüeloom, kes on kõlblikud suure annusega keemiaravi koos vereloome tüvirakkude siirdamine. bortezomib kokkuleppel koos rituksimabi, tsüklofosfamiid, doxorubicin ja prednisooni on näidustatud ravi täiskasvanud patsientidel, kellel on varem ravimata mantlit raku lümfoom, kes ei sobi vereloome tüvirakkude siirdamine.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - ibandroonhape - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - narkootikumid luuhaiguste raviks - ibandronic acid on näidatud täiskasvanute forprevention, kardiovaskulaarsed sündmused (patoloogilised luumurrud, luude tüsistused nõuavad kiiritusravi või operatsioon) patsientidel, kellel on rinnavähi ja luu metastases. ravi kasvaja põhjustatud hypercalcaemia koos või ilma metastases. ravi osteoporoosi puhul postmenopausis naistel suurenenud risk luumurdude (vt lõik 5. vähendada riski lülisamba murrud on tõendatud meditsiinilise efektiivsuse kohta d) reieluu kaela murdude ei ole tuvastatud.