natgillin/translations-raw huggingface dataset:
i Including Budd-Chiari syndrome, deep vein thrombosis, jugular vein thrombosis, pelvic venous thrombosis, pulmonary embolism, retinal vein occlusion, retinal vein thrombosis, subclavian vein thrombosis, venous thrombosis, and venous thrombosis limb.
Sealhulgas Buddi-Chiari sündroom, süvaveenitromboos, kägiveeni tromboos, vaagnapiirkonna veenitromboos, kopsuarterite trombemboolia, reetina veeni sulgus, reetina veeni tromboos, rangluualuse veeni tromboos, veenitromboos ja jäseme veenitromboos.
Unchanged axitinib is not detected in the urine.
Neerukahjustus Aksitiniib ei ole muutumatul kujul uriinis tuvastatav.
Τηλ: +30 210 6785 800
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Compared to subjects with normal hepatic function, systemic exposure following a single dose of axitinib was similar in subjects with mild hepatic impairment (Child-Pugh class A) and higher (approximately two-fold) in subjects with moderate hepatic impairment (Child-Pugh class B).
Võrreldes normaalse maksafunktsiooniga patsientidega oli aksitiniibi plasmakontsentratsioon üksikannuse manustamisel kerge maksakahjustusega (Child-Pugh' klass A) isikutel sarnane ja mõõduka maksakahjustusega (Child-Pugh' klass B) isikutel ligikaudu kaks korda suurem.
Grade 3 venous embolic and thrombotic events were reported in 0.9% of patients.
3. astme venoosse emboolia ja tromboosi juhtusid esines 0,9%-l patsientidest.
Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Rääkige oma arstile, kui ravi ajal selle ravimiga tekib teil tugev kõhuvalu.
Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
Seepärast ei tohiks aksitiniibi koosmanustamine CYP1A1, CYP1A2 või CYP3A4/5 substraatidega plasmakontsentratsiooni in vivo vähendada.
In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8.
In vitro uuringud näitasid, et aksitiniibil on CYP2C8 inhibeeriv toime.
• Kidney failure
• neerupuudulikkus;
INFORMATION IN BRAILLE Inlyta 7 mg
inlyta 7 mg
What you need to know before you take Inlyta Do not take Inlyta:
Mida on vaja teada enne Inlyta võtmist
In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.
In vitro uuringud näitasid, et aksitiniibil on CYP1A2 inhibeeriv toime.
If a strong CYP3A4/5 inducer must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Kui tugeva CYP3A4/5 indutseerija koosmanustamine on vajalik, tuleb aksitiniibi annust kohandada (vt lõik 4.2).
Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below the expected human exposure.
Tiined hiired, kellele manustati aksitiniibi inimesele sobivate annustega sarnastes annustes, näitasid suulaelõhe ja skeletimuutuste tekkeriski suurenemist, sealhulgas hilinenud luustumist.
In a controlled clinical study with axitinib (N = 359) for the treatment of patients with RCC, cardiac failure events were reported in 1.7 % patients receiving axitinib, including cardiac failure (0.6%), cardiopulmonary failure (0.6%), left ventricular dysfunction (0.3%), and right ventricular failure
Kontrolliga kliinilises uuringus aksitiniibiga (N = 359) ravitud neerurakk-kartsinoomiga patsientidel teatati südamepuudulikkuse juhtudest 1,7%-l aksitiniibi saanud patsientidest, sealhulgas südamepuudulikkus (0,6%), kardiopulmonaalne puudulikkus (0,6%), vasaku vatsakese düsfunktsioon (0,3%) ja parema vatsakese puudulikkus (0,3%).
In clinical studies with axitinib, venous embolic and thrombotic events (including pulmonary embolism, deep vein thrombosis, and retinal vein occlusion/thrombosis) were reported (see section 4.8).
Aksitiniibi kliinilistes uuringutes on teatatud venoosse emboolia ja tromboosi juhte (sealhulgas kopsuemboolia, süvaveenitromboos ja silma võrkkesta veeni oklusioon/tromboos) (vt lõik 4.8).
m Including acute renal failure n Cholecystitis includes Cholecystitis acute, Cholecystitis, Cholecystitis infective.
Koletsüstiit hõlmab: äge koletsüstiit, koletsüstiit, nakkuslik koletsüstiit.
• Dehydration (loss of body fluids)
• dehüdratsioon (kehavedelike kadu);
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations (see section 4.5).
Koosmanustamine tugevate CYP3A4/5 inhibiitoritega Aksitiniibi ja tugevate CYP3A4/5 inhibiitorite koosmanustamine võib suurendada aksitiniibi plasmakontsentratsioone (vt lõik 4.5).
Very common Arthralgia Pain in extremity
Artralgia Valu jäsemetes
• Skin itching, redness of the skin, hair loss
• naha sügelemine, -punetus, juustekadu;
In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported (see section 4.8).
Kliinilistes uuringutes aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidel teatati väga sageli hüpertensioonist (vt lõik 4.8).
INFORMATION IN BRAILLE Inlyta 5 mg
inlyta 5 mg
In clinical studies with axitinib, arterial embolic and thrombotic events (including transient ischemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion) were reported (see section 4.8).
Aksitiniibi kliinilistes uuringutes on täheldatud arteriaalse emboolia ja tromboosi juhte (sealhulgas mööduv isheemiaatakk, müokardiinfarkt, ajuinsult ja silma võrkkesta arteri oklusioon) (vt lõik 4.8).
Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib.
Südamepuudulikkuse nähtusid või sümptomeid tuleb aksitiniibravi kestel perioodiliselt jälgida.
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations (see section 4.5).
Koosmanustamine tugevate CYP3A4/5 indutseerijatega Aksitiniibi koosmanustamine tugevate CYP3A4/5 indutseerijatega võib vähendada aksitiniibi plasmakontsentratsioone (vt lõik 4.5).
Thyroid dysfunction (see section 4.4)
Kilpnäärme talitluse häired (vt lõik 4.4)
If co-administration of the strong inducer is discontinued, the axitinib dose should be immediately returned to the dose used prior to initiation of the strong CYP3A4/5 inducer (see section 4.5).
Kui tugeva indutseerijaga koosmanustamine lõpetatakse, tuleb kaaluda aksitiniibi sellise annuse taaskasutamist, mis eelnes tugeva CYP3A4/5 indutseerija kasutamisele (vt lõik 4.5).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 September 2012
ESMASE MÜÜGILOA VÄLJASTAMISE KUUPÄEV/MÜÜGILOA UUENDAMISE KUUPÄEV
Fatal cardiac failure was reported in 0.6 % of patients receiving axitinib.
Surmaga lõppenud südamepuudulikkusest teatati 0,6%-l aksitiniibi saanud patsientidest.
Inlyta 1 mg is available in bottles of 180 tablets and blisters of 14 tablets.
1 mg Inlyta on saadaval 180 tabletiga pudelis ja 14 tabletiga blisterribades.
In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
Proteinuuria Aksitiniibi kliinilistes uuringutes on teatatud proteinuuriast, sealhulgas 3. ja 4. raskusastmes (vt lõik
Reversible physeal dysplasia was observed in mice and dogs given axitinib for at least 1 month at exposure levels approximately six-fold higher than the expected human exposure.
Kui hiirtele ja koertele manustati ligikaudu 6-kordne inimestel kasutatav aksitiniibi annus vähemalt 1 kuu jooksul, täheldati pöörduvat kasvuplaadi düsplaasiat.
Oropharyngeal pain
Limaskesta põletik
In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and thrombotic adverse reactions were reported in 4.7% of patients receiving axitinib, including myocardial infarction (1.4%), transient ischemic attack (0.8%) and cerebrovascular accident (0.6%).
Arteriaalse emboolia ja tromboosi juhud (vt lõik 4.4) Kontrolliga kliinilises uuringus neerurakk-kartsinoomiga patsientidel esines arteriaalset embooliat ja tromboosi kõrvaltoimena 4,7% aksitiniibiga ravitud patsientidest, sealhulgas müokardiinfarkti (1,4%), mööduvat isheemilist atakki (0,8%) ja ajuinsulti (0,6%).
Cutoff date: 03 June 2011. b Assessed by independent radiology review according to Response Evaluation Criteria in Solid
Hinnatud sõltumatu radioloogi poolt soliidtuumorite ravivastuse hindamise kriteeriumite (Response Evaluation Criteria in Solid Tumours, RECIST) kohaselt.
Grade 4 cardiac failure adverse reactions were reported in 0.6 % of patients receiving axitinib.
4. astme südamepuudulikkusega seotud kõrvaltoimetest teatati 0,6%-l aksitiniibi saanud patsientidest.
h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status.
Ühepoolne p-väärtus logaritmilisest astaktestist, stratifitseerituna ECOG staatuse alusel.
Talk to your doctor or nurse before taking Inlyta
Enne Inlyta võtmist pidage nõu oma arsti või meditsiiniõega:
In a controlled clinical study with axitinib for the treatment of patients with RCC that excluded patients with untreated brain metastasis, haemorrhagic adverse reactions were reported in 21.4% of patients receiving axitinib.
Kontrolliga kliinilises uuringus, kuhu ei kaasatud ravimata ajumetastaasidega patsiente, teatati 21,4%l aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidest kõrvaltoimena hemorraagiast.
Axitinib has not been studied in subjects with severe hepatic impairment (Child-Pugh class C) and should not be used in this population (see section 4.2 for dose adjustment recommendations).
Aksitiniibi ei ole uuritud raske maksakahjustusega (Child-Pugh' klass C) isikutel ja seetõttu ei tohi seda selles patsientiderühmas kasutada (vt lõik 4.2 „Annustamine ja manustamisviis“).
Grade 4 haemorrhagic adverse reactions were reported in 1% of patients and fatal haemorrhage were reported in 0.4% of patients receiving axitinib.
4. astme hemorraagilisi kõrvaltoimeid esines 1%-l patsientidest ja surmaga lõppenud hemorraagiat esines 0,4%-l patsientidest, kes kasutasid aksitiniibi.
PHARMACEUTICAL FORM AND CONTENTS 180 tablets
180 tabletti
Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below.
Allpool kirjeldatud spetsiifilisi kõrvaltoimeid tuleb jälgida enne ja perioodiliselt ravi ajal aksitiniibiga.
Grade 3 haemorrhagic adverse reactions were reported in 3% of patients.
3. astme hemorraagilisi kõrvaltoimeid esines 3%-l patsientidest.
In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3.9% of patients receiving axitinib, including pulmonary embolism (2.2%), retinal vein occlusion/thrombosis (0.6%) and deep vein thrombosis (0.6%).
Venoosse emboolia ja tromboosijuhud (vt lõik 4.4) Kontrolliga kliinilises uuringus teatati 3,9%-l aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidest venoosse emboolia ja tromboosi juhtudest, sealhulgas kopsuemboolia (2,2%), silma võrkkesta veeni oklusioon/tromboos (0,6%) ja süvaveenide tromboos (0,6%).
• Increase in the number of red blood cells (may show in your blood tests)
• vere punaliblede arvu suurenemine (võib kajastuda teie vereanalüüsides);
INFORMATION IN BRAILLE Inlyta 3 mg
inlyta 3 mg
A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (see section 4.2).
Mõõduka maksakahjustusega (Child-Pugh' klass B) patsientidel soovitatakse aksitiniibi annust vähendada (vt lõik 4.2).
Frequency category
Esinemissage duse kategooria
Each film-coated tablet contains 58.8 mg of lactose monohydrate.
Inlyta 5 mg õhukese polümeerikattega tablett Üks õhukese polümeerikattega tablett sisaldab 58,8 mg laktoosmonohüdraati.
In a clinical dose-finding study, concurrent elevations of ALT (12 times the ULN) and bilirubin (2.3 times the ULN), considered to be drug-related hepatotoxicity, were observed in 1 patient who received axitinib at a starting dose of 20 mg twice daily (4 times the recommended starting dose).
Annuse kohandamise kliinilises uuringus täheldati ühel patsiendil, kellele manustati aksitiniibi algannuses 20 mg kaks korda ööpäevas (neljakordne soovituslik algannus), samaaegset ALAT-i (12 korda ULN) ja bilirubiinisisalduse (2,3 korda ULN) suurenemist, mida loeti ravimiga seotud maksatoksilisuseks.
If a strong CYP3A4/5 inhibitor must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Kui tugeva CYP3A4/5 inhibiitori koosmanustamine on vajalik, tuleb aksitiniibi annust kohandada (vt lõik
Inlyta 7 mg: each tablet contains 7 mg axitinib
Inlyta 7 mg: üks tablett sisaldab 7 mg aksitiniibi.
In clinical studies with axitinib for the treatment of patients with RCC, events of hypothyroidism and, to a lesser extent, hyperthyroidism, were reported (see section 4.8).
Kliinilistes uuringutes teatati sageli aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidel hüpotüreoidismi ja vähemal määral hüpertüreoidismi (vt lõik 4.8).
Axitinib has not been studied in subjects with renal impairment.
Aksitiniibi ei ole neerukahjustusega patsientidel uuritud.
Grade 4 venous embolic and thrombotic events were reported in 1.2% of patients.
4. astme venoosse emboolia ja tromboosi juhtusid esines 1,2%-l patsientidest.
• Reduction in the number of blood platelets (cells that help blood to clot) (may show in your blood tests)
• trombotsüütide (hüübida aitavate rakkude) arvu vähenemine (võib kajastuda teie vereanalüüsides);
• Reduction in the number of red blood cells (may show in your blood tests)
• vere punaliblede arvu vähenemine (võib kajastuda teie vereanalüüsides);
Each film-coated tablet contains 82.3 mg of lactose monohydrate.
Inlyta 7 mg õhukese polümeerikattega tablett Üks õhukese polümeerikattega tablett sisaldab 82,3 mg laktoosmonohüdraati.
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome),
• punetus ja paistetus peopesadel ja jalataldadel (käe-jala sündroom), nahalööve, nahakuivus;
Inlyta 1 mg: each tablet contains 1 mg axitinib
Inlyta 1 mg: üks tablett sisaldab 1 mg aksitiniibi.
A significant increase in polyploidy was observed in vitro at concentrations > 0.22 µg/mL, and an elevation in micronucleated polychromatic erythrocytes was observed in vivo with No Observed Effect Level (NOEL) 69-fold the expected human exposure.
Väiketuumaliste polükromaatiliste erütrotsüütide arvu suurenemist in vivo täheldati kahjuliku toimeta annuse (NOAEL) puhul, mis ületas 69 korda inimesel eeldatava plasmakontsentratsiooni.
Fatal arterial embolic and thrombotic events were reported in 0.3% patients receiving axitinib.
Surmaga lõppenud arteriaalse emboolia ja tromboosi juhtusid esines 0,3%-l patsientidest, kes kasutasid aksitiniibi.
Fatal haemorrhage was reported in one patient (0.3%) receiving axitinib (gastric haemorrhage).
Surmaga lõppenud hemorraagiat teatati ühel aksitiniibiga ravitud patsiendil (0,3%) (maoverejooks).
Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Hemoglobiini ja hematokriti väärtusi tuleb ravi ajal aksitiniibiga jälgida enne ravi algust ja hiljem perioodiliselt.
Fatal venous embolic and thrombotic events were reported 0.1% patients receiving axitinib.
Surmaga lõppenud venoosse emboolia ja tromboosi juhtusid esines 0,1%-l patsientidest, kes kasutasid aksitiniibi.
PHARMACEUTICAL FORM AND CONTENTS 28 tablets
RAVIMVORM JA PAKENDI SUURUS
Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Maksafunktsioonide teste tuleb ravi ajal aksitiniibiga jälgida enne ravi algust ja hiljem perioodiliselt.
In clinical studies with axitinib for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported (see section
Kliinilistes uuringutes aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidel teatati südamepuudulikkuse juhtudest (sealhulgas südamepuudulikkus, kongestiivne südamepuudulikkus, kardiopulmonaarne puudulikkus, vasaku vatsakese düsfunktsioon, vähenenud väljutusfraktsioon ja parema vatsakese puudulikkus) (vt lõik 4.8).
If you vomit, an additional dose should not be taken.
Kui te oksendate Inlyta võtmise ajal Kui te oksendate, ärge võtke lisaannust.
In four clinical studies with axitinib for the treatment of patients with RCC (N = 537), elevated haemoglobin above ULN was observed in 13.6% receiving axitinib.
Neljas kliinilises uuringus teatati 13,6%-l aksitiniibiga ravitud neerurakk-kartsinoomiga (N = 537) patsientidest hemoglobiinitaseme tõusust üle ULN.
Grade 4 arterial embolic and thrombotic events were reported in 1.3% of patients.
4. astme arteriaalse emboolia ja tromboosi juhtusid esines 1,3%-l patsientidest.
In monotherapy studies with axitinib (N = 850), arterial embolic and thrombotic adverse reactions (including transient ischemic attack, myocardial infarction, and cerebrovascular accident) were reported in 5.3% of patients receiving axitinib.
Aksitiniibi monoteraapia uuringutes (N = 850) teatati 5,3%-l aksitiniibravi saavatest patsientidest kõrvaltoimena arteriaalse emboolia ja tromboosi juhtudest (sealhulgas mööduv isheemiline atakk, müokardiinfarkt ja ajuinsult).
Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib.
Inlyta 5 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 5 mg aksitiniibi.
EU/1/12/777/011 56 tablets
EU/1/12/777/010 28 tabletti EU/1/12/777/011 56 tabletti
Grade 3 arterial embolic and thrombotic events were reported in 1.2% of patients.
3. astme arteriaalse emboolia ja tromboosi juhtusid esines 1,2%-l patsientidest.
Thrombocytopenia Polycythaemiac
Hüperbilirubineemia
Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other.
Inlyta 1 mg õhukese polümeerikattega tabletid on punased ovaalsed ja pimetrükiga ”Pfizer” ühel ja ”1 XNB” teisel küljel.
Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended.
Proteinuuria esinemist on soovitatav ravi ajal aksitiniibiga jälgida enne ravi algust ja hiljem perioodiliselt.
Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine.
Teie arst peab olema enne ja ravi ajal Inlytaga veendunud, et teie vererõhk on kontrolli all.
Inlyta 3 mg: each tablet contains 3 mg axitinib
Inlyta 3 mg: üks tablett sisaldab 3 mg aksitiniibi.
• Protein in the urine (may show in your urine tests)
• valk uriinis (võib kajastuda teie uriiniproovis);
Each film-coated tablet contains 33.6 mg of lactose monohydrate.
Inlyta 1 mg õhukese polümeerikattega tablett Üks õhukese polümeerikattega tablett sisaldab 33,6 mg laktoosmonohüdraati.
Inlyta 5 mg: each tablet contains 5 mg axitinib
Inlyta 5 mg: üks tablett sisaldab 5 mg aksitiniibi.
• Bleeding.
• pearinglus;
Haemorrhoids
Hüpertüreoidism
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, arterial embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
Neerurakk-kartsinoomiga patsientidel läbiviidud aksitiniibi kliiniliste uuringute (N = 672) koondandmete kohaselt esines arteriaalse emboolia ja tromboosi juhtusid 2,8%-l patsientidest, kes kasutasid aksitiniibi.
Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib.
Surmaga lõppenud kopsuembooliast teatati ühel aksitiniibiga ravitud patsiendil (0,3%).
Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
Hemorraagia Aksitiniibi kliinilistes uuringutes on teatatud hemorraagiajuhtudest (vt lõik 4.8).
Cardiac failure events (see section 4.4)
Südamepuudulikkuse juhud (vt lõik 4.4)
Inlyta 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib.
Inlyta 7 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 7 mg aksitiniibi.
Toxicity findings in immature animals
Toksilisus noorloomadel
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, hypothyroidism was reported in 24.6% of patients receiving axitinib.
Neerurakk-kartsinoomiga patsientidel läbiviidud aksitiniibi kliiniliste uuringute (N = 672) koondandmete kohaselt esines hüpotüreoidismi 24,6%-l patsientidest, kes kasutasid aksitiniibi.
Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and “5 XNB” on the other.
Inlyta 5 mg õhukese polümeerikattega tabletid on punased kolmnurksed ja pimetrükiga ”Pfizer” ühel ja ”5 XNB” teisel küljel.
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, gastrointestinal perforation and fistula were reported in 1.9% of patients receiving axitinib.
Neerurakk-kartsinoomiga patsientidel läbiviidud aksitiniibi kliiniliste uuringute (N = 672) koondandmete kohaselt esines seedetrakti perforatsiooni ja fistulit 1,9%-l patsientidest, kes kasutasid aksitiniibi.
Inlyta 5 mg film-coated tablets EU/1/12/777/004
Inlyta 5 mg õhukese polümeerikattega tabletid EU/1/12/777/004
Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets.
7 mg Inlyta on saadaval 60 tabletiga pudelis ja 14 tabletiga blisterribades.
b National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 c See Description of selected adverse reactions section.
Riikliku Vähiinstituudi CTCAE, versioon 3.0
Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets.
5 mg Inlyta on saadaval 60 tabletiga pudelis ja 14 tabletiga blisterribades.
In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.
Kontrolliga kliinilises uuringus on kirjeldatud aksitiniibiga ravitud neerurakk-kartsinoomiga patsientidel maksaga seonduvaid kõrvaltoimeid.
Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib.
Inlyta 3 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 3 mg aksitiniibi.
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, venous embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
Neerurakk-kartsinoomiga patsientidel läbiviidud aksitiniibi kliiniliste uuringute (N = 672) koondandmete kohaselt esines venoosse emboolia ja tromboosi juhtusid 2,8%-l patsientidest, kes kasutasid aksitiniibi.
Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup
Varasema sunitiniibravi alarühma Kaplani-Meieri progressioonivaba elulemuse kõver sõltumatu hindamise järgi
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
EU/1/12/777/008 56 tablets
EU/1/12/777/007 28 tabletti EU/1/12/777/008 56 tabletti
Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup
Varasema tsütokiinravi alarühma Kaplani-Meieri progressioonivaba elulemuse kõver sõltumatu hindamise järgi
Inlyta 1 mg film-coated tablets
Inlyta 1 mg õhukese polümeerikattega tabletid
Vascular disorders Very common Hypertensiong Haemorrhagec,d,h
Hüpertensioon Hemorraagia c, d, h
Inlyta 7 mg film-coated tablets EU/1/12/777/010
Inlyta 7 mg õhukese polümeerikattega tabletid EU/1/12/777/010
Axitinib has not been studied in patients < 18 years of age.
Lapsed Aksitiniibi ei ole uuritud alla 18-aastastel lastel ja noorukitel.
Nausea
Neeluvalu
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, haemorrhagic events were reported in 25.7% of patients receiving axitinib.
Neerurakk-kartsinoomiga patsientidel läbiviidud aksitiniibi kliiniliste uuringute (N = 672) koondandmete kohaselt esines hemorraagia juhtusid 25,7%-l patsientidest, kes kasutasid aksitiniibi.
No dose adjustment is required when administering axitinib to patients with mild hepatic impairment (Child-Pugh class A).
Kerge maksakahjustusega (Child-Pugh' klass A) patsientidel ei ole vaja aksitiniibi annust kohandada.
Inlyta 1 mg film-coated tablets EU/1/12/777/001
Inlyta 1 mg õhukese polümeerikattega tabletid EU/1/12/777/001