FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: I et klinisk studie med axitinib til behandling af patienter med RCC, hvor patienter med ubehandlede hjernemetastaser var blevet ekskluderet, blev der rapporteret blødningsrelaterede bivirkninger hos 21,4% af patienterne i behandling med axitinib.
English: Axitinib has not been studied in subjects with renal impairment.
Danish: Axitinib er ikke undersøgt hos patienter med nedsat nyrefunktion.
English: In cases of suspected overdose, axitinib should be withheld and supportive care instituted.
Danish: Ved mistanke om overdoseringer bør behandlingen ophøre og understøttende behandling iværksættes.
English: PHARMACEUTICAL FORM AND CONTENTS 180 tablets
Danish: 180 tabletter
English: 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.
Danish: I fire kliniske studier med axitinib til behandling af patienter med RCC (N = 537) så man hæmoglobinniveauer over det normale hos 13,6% af patienterne i behandling med axitinib.
English: Arterial embolic and thrombotic events (see section 4.4)
Danish: Arterielle tromboemboliske hændelser (se pkt.
English: Thyroid dysfunction (see section 4.4)
Danish: Thyroideadysfunktion (se pkt.
English: In clinical studies with axitinib for the treatment of patients with RCC, patients with serum creatinine > 1.5 times the ULN or calculated creatinine clearance < 60 mL/min were excluded.
Danish: Patienter med serumkreatinin >1,5 gange den øvre normal grænse eller beregnet kreatininclearance <60 ml/min blev ekskluderet fra de kliniske studier.
English: Inlyta 1 mg is available in bottles of 180 tablets and blisters of 14 tablets.
Danish: Inlyta 1 mg fås i beholdere med 180 tabletter og i blisterpakninger med 14 tabletter.
English: Grade > 3 haemorrhagic adverse reactions were reported in 3.1% of patients receiving axitinib (including cerebral haemorrhage, gastric haemorrhage, lower gastrointestinal haemorrhage and haemoptysis).
Danish: Blødningsrelaterede bivirkninger grad ≥3 blev set hos 3,1% af patienterne i behandling med axitinib (herunder hjerneblødning, gastrisk blødning, nedre gastrointestinal blødning og hæmoptyse).
English: In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
Danish: Proteinuri Der er rapporteret proteinuri, herunder grad 3- og 4-proteinuri, i kliniske studier med axitinib (se pkt.
English: INFORMATION IN BRAILLE Inlyta 7 mg
Danish: Inlyta 7 mg
English: 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%).
Danish: 4.4) I et klinisk studie med axitinib til behandling af patienter med RCC, blev der rapporteret arterielle tromboemboliske bivirkninger hos 4,7% af de patienter,der fik axitinib, herunder myokardieinfarkt (1,4%), transitorisk cerebral iskæmi (0,8%) og cerebrovaskulære hændelser (0,6%).
English: Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population.
Danish: Axitinib er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) og bør ikke anvendes til denne gruppe patienter.
English: • Swelling of the abdomen, legs, or ankles, protruding neck veins, excessive tiredness,
Danish: • Opsvulmet mave, hævede ben eller ankler, fremstående blodårer på halsen, usædvanlig træthed,
English: Very common Arthralgia Pain in extremity
Danish: Meget almindelig Artralgi Ekstremitetssmerter
English: Fatal haemorrhage was reported in one patient (0.3%) receiving axitinib (gastric haemorrhage).
Danish: Dødelig blødning sås hos 1 patient (0,3%) i behandling med axitinib (gastrisk blødning).
English: • If during treatment with this medicine, you get symptoms such as excessive tiredness, swelling of the abdomen, legs or ankles, shortness of breath, or protruding neck veins.
Danish: • Hvis du får symptomer såsom usædvanlig træthed, opsvulmet mave, hævede ben eller ankler, åndenød eller fremstående blodårer på halsen under behandling med Inlyta.
English: Inlyta can cause thyroid gland problems.
Danish: Inlyta kan give problemer med skjoldbruskkirtlen.
English: Median OS d in months (95% CI)
Danish: HR (95% CI)
English: 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).
Danish: Der er set venøse tromboemboliske hændelser (herunder lungeemboli, dyb venetrombose og retinal vene okklusion/trombose) i kliniske studier med axitinib (se pkt.
English: INFORMATION IN BRAILLE Inlyta 5 mg
Danish: Inlyta 5 mg
English: Venous embolic and thrombotic events (see section 4.4)
Danish: Venøse tromboemboliske hændelser (se pkt.
English: 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%).
Danish: 4.4) I et klinisk studie med axitinib til behandling af patienter med RCC, blev der rapporteret venøse tromboemboliske hændelser hos 3,9% af patienterne, herunder lungeemboli (2,2%), retinalveneokklusion (trombose) (0,6%) og dyb venetrombose (0,6%).
English: Hyperthyroidismc
Danish: Hypertyreose
English: • Heart failure events.
Danish: • Hjertesvigt.
English: Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib (see section 4.8, polycythaemia).
Danish: Behandling med axitinib kan medføre stigning i hæmoglobin eller hæmatokrit, som tegn på en øget mængde røde blodlegemer (se pkt.
English: Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations (see section 4.5).
Danish: Samtidig anvendelse af potente CYP3A4/5-induktorer Samtidig anvendelse af axitinib og potente CYP3A4/5-induktorer kan nedsætte plasmakoncentrationen af axitinib (se pkt.
English: Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Danish: Leverfunktionen skal kontrolleres før initiering af behandlingen og regelmæssigt under hele behandlingen med axitinib.
English: The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known.
Danish: Behandlingen med axitinib skal afbrydes midlertidigt eller permanent hos patienter med symptomer på PRES. Sikkerheden ved genoptagelse af behandlingen hos patienter, som har haft PRES, kendes ikke.
English: Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations (see section 4.5).
Danish: Samtidig anvendelse af potente CYP3A4/5-hæmmere Samtidig anvendelse af axitinib og potente CYP3A4/5-hæmmere kan øge plasmakoncentrationen af axitinib (se pkt.
English: Fatal cardiac failure was reported in 0.6 % of patients receiving axitinib.
Danish: Dødeligt hjertesvigt blev rapporteret hos 0,6 % af patienterne, der fik axitinib.
English: United Kingdom Pfizer Limited Tel: +44 (0) 1304 616161
Danish: Tel: +44 (0)1304 616161
English: Very common Diarrhoea Vomiting
Danish: Mave-tarm-kanalen Meget almindelig Diarré Opkastning
English: Grade 4 cardiac failure adverse reactions were reported in 0.6 % of patients receiving axitinib.
Danish: Grad 4 hjertesvigt blev rapporteret hos 0,6 % af patienterne, der fik axitinib.
English: Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 3.1% of patients receiving axitinib.
Danish: Grad 3/4 venøse tromboemboliske hændelse blev rapporteret hos 3,1% af patienterne i behandling med axitinib.
English: INFORMATION IN BRAILLE Inlyta 3 mg
Danish: Inlyta 3 mg
English: Very common Dyspnoead Cough
Danish: Meget almindelig Dyspnø Hoste
English: Inlyta 5 mg: each tablet contains 5 mg axitinib
Danish: Inlyta 5 mg: hver tablet indeholder 5 mg axitinib
English: Inlyta 7 mg: each tablet contains 7 mg axitinib
Danish: Inlyta 7 mg: hver tablet indeholder 7 mg axitinib
English: Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib.
Danish: Inlyta 5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 5 mg axitinib.
English: Inlyta 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib.
Danish: Inlyta 7 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 7 mg axitinib.
English: Grade 3/4 cardiac failure events were reported in 1.0% patients and fatal cardiac failure events were reported in 0.3% patients receiving axitinib.
Danish: Grad 3/4 hjertesvigt blev rapporteret hos 1,0 % af patienterne, og dødeligt hjertesvigt blev rapporteret hos 0,3 % af patienterne, der fik axitinib.
English: Pfizer Luxembourg SARL, organizačná zložka
Danish: Pfizer Luxembourg SARL Pfizer.
English: Inlyta 1 mg: each tablet contains 1 mg axitinib
Danish: Inlyta 1 mg: hver tablet indeholder 1 mg axitinib
English: Patients should be advised that they may experience events such as dizziness and/or fatigue during treatment with axitinib.
Danish: Der bør dog udvises forsigtighed ved bilkørsel eller betjening af maskiner, hvis patienten oplever svimmelhed eller træthed under behandling med axitinib.
English: Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population (see sections 4.4 and 5.2).
Danish: Axitinib er ikke undersøgt hos patienter med alvorligt nedsat leverfunktion (Child-Pugh class C) og bør ikke anvendes til denne gruppe patienter (se pkt.
English: Inlyta 7 mg film-coated tablets are red, diamond shaped and debossed with “Pfizer” on one side and “7 XNB” on the other.
Danish: Inlyta 7 mg filmovertrukne tabletter er røde, diamantformede, præget med “Pfizer” på den ene side og “7 XNB” på den anden.
English: Each film-coated tablet contains 58.8 mg of lactose monohydrate.
Danish: Inlyta 5 mg filmovertrukken tablet Hver filmovertrukken tablet indeholder 58,8 mg lactosemonohydrat.
English: Inlyta 1 mg film-coated tablet
Danish: Inlyta 1 mg filmovertrukken tablet
English: • Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome),
Danish: • Rødmen og opsvulmning af håndflader og fodsåler (hånd- og fodsyndrom), hududslæt, tør hud
English: Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below.
Danish: Der skal observeres for bestemte hændelser, som beskrevet herunder, før behandlingsstart og regelmæssigt under behandlingen med axitinib.
English: Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib.
Danish: Inlyta 3 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 3 mg axitinib.
English: 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.
Danish: I poolede kliniske studier med axitinib (N = 672) til behandling af RCC blev der rapporteret gastrointestinal perforation og fistler hos 1,9% af de patienter, der fik axitinib.
English: Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Danish: Inlyta 5 mg fås i beholdere med 60 tabletter og i blisterpakninger med 14 tabletter.
English: Oropharyngeal pain
Danish: Orofaryngeal smerte
English: Inlyta 3 mg: each tablet contains 3 mg axitinib
Danish: Inlyta 3 mg: hver tablet indeholder 3 mg axitinib
English: Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Danish: Inlyta 7 mg fås i beholdere med 60 tabletter og i blisterpakninger med 14 tabletter.
English: EU/1/12/777/011 56 tablets
Danish: EU/1/12/777/010 28 tabletter EU/1/12/777/011 56 tabletter
English: Inlyta 7 mg film-coated tablet
Danish: Inlyta 7 mg filmovertrukken tablet
English: Inlyta 7 mg film-coated tablets EU/1/12/777/010
Danish: Inlyta 7 mg filmovertrukne tabletter EU/1/12/777/010
English: Red diamond shaped film-coated tablet debossed with “Pfizer” on one side and “7 XNB” on the other.
Danish: Rød rombeformet filmovertrukken tablet præget med ”Pfizer” på den ene side og ”7 XNB” på den anden.
English: Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other.
Danish: Inlyta 1 mg filmovertrukne tabletter er røde, ovale, præget med “Pfizer” på den ene side og “1 XNB” på den anden.
English: Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and “5 XNB” on the other.
Danish: Inlyta 5 mg filmovertrukne tabletter er røde, trekantede, præget med “Pfizer” på den ene side og “5 XNB” på den anden.
English: Each film-coated tablet contains 82.3 mg of lactose monohydrate.
Danish: Inlyta 7 mg filmovertrukken tablet Hver filmovertrukken tablet indeholder 82,3 mg lactosemonohydrat.
English: Inlyta 5 mg film-coated tablet
Danish: Inlyta 5 mg filmovertrukken tablet
English: Polycythaemia (see Elevation of haemoglobin or haematocrit in section 4.4)
Danish: Polycytæmi (stigning i hæmoglobin eller hæmatokrit se pkt.
English: Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Danish: Hæmoglobin og hæmatokrit skal kontrolleres før initiering og periodisk under hele behandlingen med axitinib.
English: The medicines listed in this leaflet may not be the only ones that could interact with Inlyta.
Danish: Der kan være andre lægemidler end dem, der er nævnt her, som kan påvirke virkningen af Inlyta.
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, polycythaemia was reported in 1.5% of patients receiving axitinib.
Danish: I poolede kliniske studier med axitinib (N = 672) til behandling af patienter med RCC blev der rapporteret polycytæmi hos 1,5% af de patienter, der fik axitinib.
English: Each film-coated tablet contains 33.6 mg of lactose monohydrate.
Danish: Inlyta 1 mg filmovertrukken tablet Hver filmovertrukken tablet indeholder 33,6 mg lactosemonohydrat.
English: • Inflammation of the gall bladder
Danish: • Betændelseslignende tilstand i galdeblære
English: Hepatic impairment
Danish: Slimhindeinflammation
English: Inlyta 3 mg film-coated tablet
Danish: Inlyta 3 mg filmovertrukken tablet
English: Inlyta 3 mg film-coated tablets are red, round and debossed with “Pfizer” on one side and “3 XNB” on the other.
Danish: Inlyta 3 mg filmovertrukne tabletter er røde, runde, præget med “Pfizer” på den ene side og “3 XNB” på den anden.
English: If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
Danish: Kontakt lægen, hvis du vil vide mere om, hvordan medicinen virker, eller hvorfor du skal tage den.
English: Inlyta 7 mg film-coated tablets
Danish: Inlyta 7 mg filmovertrukne tabletter
English: Inlyta 5 mg film-coated tablets EU/1/12/777/004
Danish: Inlyta 5 mg filmovertrukne tabletter EU/1/12/777/004
English: 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).
Danish: Der er set arterielle tromboemboliske hændelser (herunder transitorisk cerebral iskæmi, myokardieinfarkt, cerebrovaskulært tilfælde og nethindearterieokklusion) i kliniske studier med axitinib (se pkt.
English: In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported (see section 4.8).
Danish: Gastrointestinal perforation og fisteldannelse Der er set gastrointestinal perforation og fistler i kliniske studier med axitinib (se pkt.
English: EU/1/12/777/008 56 tablets
Danish: EU/1/12/777/007 28 tabletter EU/1/12/777/008 56 tabletter
English: Inlyta 3 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Danish: Inlyta 3 mg fås i beholdere med 60 tabletter og i blisterpakninger med 14 tabletter.
English: Inlyta 1 mg film-coated tablets EU/1/12/777/001
Danish: Inlyta 1 mg filmovertrukne tabletter EU/1/12/777/001
English: Inlyta 3 mg film-coated tablets EU/1/12/777/007
Danish: Inlyta 3 mg filmovertrukne tabletter EU/1/12/777/007
English: Uncommon Neutropaenia Leukopaenia
Danish: Neutropeni Leukopeni
English: Your doctor may subsequently increase or decrease your dose depending on how you tolerate treatment with Inlyta.
Danish: Lægen kan herefter øge eller nedsætte dosis.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported in 1.4% of patients receiving axitinib.
Danish: 4.4) I et klinisk studie med axitinib til behandling af patienter med RCC, så man polycytæmi hos 1,4% af patienterne.
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Danish: Det anbefales at vælge anden samtidig medicin uden eller med minimalt CYP3A4/5-inducerende potentiale.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1.7% of patients receiving axitinib, including anal fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal gastrointestinal perforation was reported in one patient (0.1%).
Danish: 4.4) I et klinisk studie med axitinib til behandling af patienter med RCC sås hændelser med gastrointestinal perforation hos 1,7% af patienterne i behandling med axitinib, herunder analfistler (0,6%), fistler (0,3%) og gastrointestinal perforation (0,3%).
English: Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy (see section 4.4).
Danish: Håndteringen af nogle af bivirkningerne kan kræve midlertidig eller permanent afbrydelse af behandlingen (se pkt.
English: 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.
Danish: I poolede kliniske studier med axitinib (N = 672) til behandling af RCC blev der rapporteret blødningsrelaterede hændelser hos 25,7% af de patienter, der fik axitinib.
English: If a strong CYP3A4/5 inhibitor must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Danish: Hvis samtidig behandling med en potent CYP3A4/5-hæmmer afbrydes, bør det overvejes at vende tilbage til den oprindelige axitinib-dosis (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Inlyta 1 mg film-coated tablets axitinib
Danish: Inlyta 1 mg filmovertrukne tabletter axitinib
English: The tablets should be taken orally twice daily approximately 12 hours apart with or without food (see section 5.2).
Danish: Tabletterne kan tages med eller uden mad (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Inlyta 7 mg film-coated tablets axitinib
Danish: Inlyta 7 mg filmovertrukne tabletter axitinib
English: Sími: +354 540 8000
Danish: Icepharma hf, Sími: +354 540 8000
English: 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.
Danish: I poolede kliniske studier med axitinib (N = 672) til behandling af RCC blev der rapporteret arterielle tromboemboliske hændelser hos 2,8% af de patienter, der fik axitinib.
English: Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
Danish: Blødning Blødning er set i kliniske studier med axitinib (se pkt.
English: Grade 4 haemorrhagic adverse reactions were reported in 1% of patients and fatal haemorrhage were reported in 0.4% of patients receiving axitinib.
Danish: Grad 3 bivirkninger blev rapporteret hos 3%, grad 4 1%, og dødelige blødningsrelaterede bivirkninger blev rapporteret hos 0,4% af de patienter, der fik axitinib.
English: 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.
Danish: I poolede kliniske studier med axitinib (N = 672) til behandling af RCC blev der rapporteret venøse tromboemboliske hændelser hos 2,8% af de patienter, der fik axitinib.
English: • Under-active thyroid gland (may show in your blood tests)
Danish: • Nedsat aktivitet af skjoldbruskkirtlen (ses i blodprøver)
English: • Blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Danish: • Blodpropper, inklusive slagtilfælde og hjertetilfælde.
English: Each film-coated tablet contains 35.3 mg of lactose monohydrate.
Danish: Inlyta 3 mg filmovertrukken tablet Hver filmovertrukken tablet indeholder 35,3 mg lactosemonohydrat.
English: SN
Danish: mg
English: EU/1/12/777/002 56 tablets
Danish: EU/1/12/777/001 28 tabletter EU/1/12/777/002 56 tabletter
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Danish: Thyroideafunktionen skal kontrolleres før initiering af behandlingen og periodisk under hele behandlingen.
English: Hypersensitivity to axitinib or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: EU/1/12/777/005 56 tablets
Danish: EU/1/12/777/004 28 tabletter EU/1/12/777/005 56 tabletter
English: Inlyta 5 mg film-coated tablets
Danish: Inlyta 5 mg filmovertrukne tabletter axitinib
English: Very common Proteinurial Common
Danish: Myalgi Nyrer og urinveje Meget almindelig Proteinuri Almindelig
English: 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.
Danish: I poolede kliniske studier med axitinib (N = 672) til behandling af RCC blev der rapporteret hypotyreose hos 24,6% af de patienter, der fik axitinib, og hypertyreose hos 1,6% af de patienter, der fik axitinib.
English: Inlyta 3 mg film-coated tablets
Danish: Inlyta 3 mg filmovertrukne tabletter axitinib
English: 1.48f (0.79, 2.75)
Danish: 29,4 (24,5-IE) 27,8 (23,1-34,5) 0,81 (0,56-1,19)
English: Grade 4 arterial embolic and thrombotic events were reported in 1.3% of patients.
Danish: Der blev rapporteret arterielle tromboemboliske hændelser af grad 3/4 hos 3,3% af patienterne.
English: • Hyper-active thyroid gland (may show in your blood tests)
Danish: • Øget aktivitet i skjoldbruskkirtlen (ses i blodprøver)
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Danish: Det anbefales at vælge anden samtidig medicin uden eller med minimalt CYP3A4/5-hæmmende potentiale.
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Danish: 28 tabletter 56 tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 mg axitinib.
Danish: Hver filmovertrukken tablet indeholder 1 mg axitinib
English: Grade 4b
Danish: BILAG IV
English: 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).
Danish: Hvis samtidig behandling med en potent CYP3A4/5-induktor afbrydes, bør det overvejes at vende tilbage til den oprindelige axitinib-dosis (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib.
Danish: Inlyta 1 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 1 mg axitinib.
English: Proteinuria
Danish: forstoppelse