Den Europæiske Union - estisk - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastiim - neutropenia; hematopoietic stem cell transplantation; cancer - koloonia stimuleerivaid faktoreid - biograstim on näidustatud vähendamine kestus neutropenia ja esinemissagedus febriilsed neutropenia patsientidel, keda on ravitud asutatud tsütotoksilist keemiaravi jaoks pahaloomulise kasvaja (välja arvatud krooniline müeloidne leukeemia ja müelodüsplastiline sündroom) ja vähenemine kestus neutropenia patsientidel toimumas myeloablative ravi, millele järgneb luuüdi siirdamine leidis, et olla suurenenud risk pikaajalise raske neutropenia. filgrastiimi ohutus ja efektiivsus on täiskasvanutel ja lastel, kes saavad tsütotoksilist kemoteraapiat. biograstim on näidustatud kasutuselevõtmise perifeerse vere eelkäijad rakkude (pbpc). patsientidel, lastele või täiskasvanutele, kellel on raske kaasasündinud, tsüklilise või idiopaatilise neutropenia koos absoluutse neutrofiilide arvu (anc) 0. 5 x 109/l ning on esinenud tõsised või korduvad infektsioonid, pikaajaline haldamine biograstim on näidustatud suurendada neutrofiilide arvu ja vähendada nende esinemissagedust ja kestvust nakkuse seotud üritused. biograstim on näidustatud ravi püsivad neutropenia (anc väiksem või võrdne 1-ga. 0 x 109/l) kaugelearenenud hiv-infektsiooniga bakteriaalsete infektsioonide riski vähendamiseks, kui teised neutropeenia ravivõimalused ei ole sobivad.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

viiv healthcare b.v. - maravirok - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

actavis group ptc ehf    - pioglitasoonvesinikkloriid - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone on ka näidatud koos insuliini tüüp-2 diabeet täiskasvanud patsientidel, kellel on ebapiisav glycaemic kontrolli insuliini, kellele metformiin ei sobi, sest vastunäidustusi või talumatust. pärast algatamist ravi pioglitazone, patsiente tuleks läbi vaadata pärast 3 kuni 6 kuud hinnata piisavust ravi (e. vähendada hba1c). patsientidel, kes ei näita piisava vastuse, pioglitazone tuleks lõpetada. arvestades võimalikke riske pikaajalise ravi, arstid tuleks kinnitada järgmiste korraliste kommentaare, mis kasu pioglitazone on hooldatud.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

intervet international b.v - fluralaner - nahaparasiidi-süsteemseks kasutamiseks, isoxazolines - dogs; cats - koerad:- ravi puugi ja kirbu infestatsioonid;preparaati võib kasutada osana ravi strateegia kontrolli kirbu allergia dermatiidi (fad). - raviks demodicosis põhjustatud demodex canis;- ravi sarcoptic mange (sarcoptes scabiei var. canis) nakatumise. - for reduction of the risk of infection with babesia canis canis via transmission by dermacentor reticulatus. [chewable tablets only]cats:- for the treatment of tick and flea infestations;the product can be used as part of a treatment strategy for the control of flea allergy dermatitis (fad). - raviks infestatsioonid koos kõrva lestad (otodectes cynotis).

Den Europæiske Union - estisk - EMA (European Medicines Agency)

virbac s.a. - clomipramine hydrochloride - psühhoanaleptikumid - koerad - as an aid in the treatment of separation related disorders in dogs manifested by destruction and inappropriate elimination (defecation and urination) and only in combination with behavioural modification techniques.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

intervet international bv - h7n1 alatüübi (tüvi a / ck / italy / 473/99) inaktiveeritud kogu lindude gripi viiruse antigeen - immunoloogilised ained - chicken; ducks - kanade ja partide aktiivseks immuniseerimiseks a-tüüpi lindude gripi alatüübi h7n1 vastu. efektiivsust on hinnatud kanade ja rõngastatud teali esialgsete tulemuste põhjal. kanadel on kliiniliste tunnuste vähenemine, suremus, eritumine ja viiruse ülekandmine pärast nakatamist kahe nädala jooksul pärast ühekordse annuse manustamist. pardides ilmnes pärast vaktsineerimist eritumise ja viiruse edasikandumise vähenemine kaks nädalat pärast üksikannuse vaktsineerimist. kuigi seda ei ole uuritud, seda eelkõige ai vaktsiini tüvi, uuringud teha muud tüved, mis näitavad, et kaitsev tase seerumis antikehade titres võib eeldada, et püsida kanad vähemalt 12 kuu jooksul pärast manustamist kaks annust vaktsiini. punktis oleva immuunsuse kestus ei ole teada.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastilised ained - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 ja 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastilised ained - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

actavis group ptc ehf   - pioglitasoonvesinikkloriid - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:as monotherapyin adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination withmetformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination withmetformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4. pärast algatamist ravi pioglitazone, patsiente tuleks läbi vaadata pärast 3 kuni 6 kuud hinnata piisavust ravi (e. vähendada hba1c). patsientidel, kes ei näita piisava vastuse, pioglitazone tuleks lõpetada. arvestades võimalikke riske pikaajalise ravi, arstid tuleks kinnitada järgmiste korraliste kommentaare, mis kasu pioglitazone on säilinud (vt lõik 4.

Den Europæiske Union - estisk - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibacterials süsteemseks kasutamiseks, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid. vajadusele kasutada antibakteriaalseid aineid.