FrancophonIA/ELRC3.0 huggingface dataset:
English: Chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort [Hypericum perforatum]) with cabozantinib should therefore be avoided.
Icelandic: öflugra CYP3A4 örva (t.d. fenýtóíns, karbamazepíns, rífampisíns, fenóbarbitals eða jurtalyfja sem innihalda jóhannesarjurt (Hypericum perforatum)) samhlíða cabozantinibi.
English: Cabozantinib should not be administered to patients with serious haemorrhage or recent haemoptysis.
Icelandic: Cabozantinib skal ekki gefa sjúklingum með alvarlegar blæðingar eða sem nýlega hafa fengið blóðhósta.
English: How to take COMETRIQ
Icelandic: Hvernig nota á COMETRIQ
English: Avoid becoming pregnant while being treated with COMETRIQ.
Icelandic: Forðast skal þungun meðan á meðferð með COMETRIQ stendur.
English: There are no data on human fertility.
Icelandic: Ekki liggja fyrir gögn um frjósemi hjá mönnum.
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Icelandic: Hætta skal notkun cabozantinibs hjá sjúklingum þar sem vandamál við græðslu sára þarfnast læknismeðferðar.
English: EU/1/13/890/002 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) EU/1/13/890/003 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) EU/1/13/890/005 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/890/002 7 x 20 mg og 7 x 80 mg hylki (100 mg skammtur á dag í 7 daga) EU/1/13/890/003 21 x 20 mg og 7 x 80 mg hylki (140 mg skammtur á dag í 7 daga) EU/1/13/890/005 56 hylki (4 þynnuspjöld með:
English: 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose) 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose) 112 capsules (4 blister cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose)
Icelandic: 84 hylki (4 þynnuspjöld með 21 x 20 mg) (60 mg dagskammtur) 56 hylki (4 þynnuspjöld með 7 x 20 mg og 7 x 80 mg) (100 mg dagskammtur) 112 hylki (4 þynnuspjöld með 21 x 20 mg og 7 x 80 mg) (140 mg dagskammtur)
English: Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Icelandic: Hver 140 mg dagskammtur inniheldur samtals þrjú grá 20 mg hylki og eitt appelsínugult 80 mg hylki.
English: Push capsule through foil
Icelandic: Ýtið hylkinu í gegn um filmuna
English: 100 mg Dose
Icelandic: 100 mg skammtur
English: What COMETRIQ contains
Icelandic: COMETRIQ inniheldur
English: Each daily dose is provided in one row and contains one 80 mg capsule and one 20 mg capsule:
Icelandic: Hver dagskammtur er í einni röð og inniheldur eitt 80 mg hylki og eitt 20 mg hylki:
English: If you take COMETRIQ whilst using oral contraceptives, the oral contraceptives may be ineffective.
Icelandic: Ef COMETRIQ er notað samtímis getnaðarvarnarlyfjum til inntöku er ekki víst að getnaðarvörnin sé örugg.
English: Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Icelandic: Samhliða notkun cabozantinibs og ketókónazóls, sem er öflugur CYP3A4 hemill, olli auknum styrk cabozantinibs í plasma.
English: The COMETRIQ 80 mg capsules contain cabozantinib (S)-malate equivalent to 80 mg of cabozantinib.
Icelandic: COMETRIQ 80 mg hylki innihalda cabozantinib (S)-malat sem samsvarar 80 mg af cabozantinibi.
English: • Chills, tremors
Icelandic: Hrollur, skjálfti
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, hair colour changes, rash, dry skin, alopecia, erythema hyperkeratosis, acne, blister, hair growth abnormal, skin exfolation, skin hypopigmentation skin ulcer, telangiectasia
Icelandic: Húð og undirhúð handa- og fótaheilkenni, breytingar á hárlit, útbrot, húðþurrkur, hármissir, hörundsroði siggmein, örtur, blöðrur, óeðlilegur hárvöxtur, húðflögnun, skortur á litarefnum í húð húðsár, háræðavíkkun
English: Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Icelandic: Bæði karl- og kvensjúklingar og makar þeirra verða að nota örugga getnaðarvörn meðan á meðferðinni stendur og í a.m.k.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARD 140 mg dose
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ÞYNNUSPJALD, 140 mg skammtur
English: Dispensing instructions
Icelandic: NOTKUNARLEIÐBEININGAR
English: Urine protein should be monitored regularly during cabozantinib treatment.
Icelandic: Fylgjast skal reglulega með próteini í þvagi meðan á meðferð með cabozantinibi stendur.
English: Talk to your doctor BEFORE taking COMETRIQ if you or your partner are considering or planning to have a baby after your treatment has finished.
Icelandic: Leitið ráða hjá lækninum ÁÐUR en COMETRIQ er tekið ef þungun er fyrirhugðu eftir að meðferð lýkur.
English: Investigations weight decreased, serum ALT, AST, and ALP increased, blood LDH increased, blood TSH increased, lymphopenia, neutropenia, thrombocytopenia blood creatinine phosphokinase increased activated partial thromboplastin time shortened, eosinophil count increased, platelet count increased
Icelandic: öður þyngdartap, hækkað ALT, AST og ALP í sermi, hækkað LDH í blóði, hækkað TSH í blóði, eitilfrumnafæð, daufkyrningafæð, blóðflagnafæð aukning kreatínkínasa í blóði styttur virkjaður þrombóplastíntími, fjölgun eósínfíkla, aukning blóðflagna
English: The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule.
Icelandic: Hörðu hylkin eru appelsínugul með áletruninni „XL184 80mg“ í svörtum lit.
English: BLISTER CARD, 60 mg dose
Icelandic: YTRI UMBÚÐUM ÞYNNUSPJALD, 60 mg skammtur
English: • Seizures, headaches, confusion, or finding it difficult to concentrate.
Icelandic: Flog, höfuðverkur, ringlun eða einbeitingarskortur.
English: Each daily dose is provided in one row and contains one 80 mg capsule and three 20 mg capsules:
Icelandic: Hver dagskammtur er í einni röð og inniheldur eitt 80 mg hylki og þrjú 20 mg hylki:
English: • Blister, pain of the hands or soles of the feet, rash or redness of the skin, dry skin
Icelandic: Blöðrur, verkur í höndum eða iljum, útbrot eða roði í húð, húðþurrkur
English: Hemorrhage has been observed with cabozantinib.
Icelandic: Blæðingar hafa komið fram við notkun cabozantinibs.
English: • Haemorrhoids
Icelandic: Innihald hylkis
English: EU/1/13/890/006 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for 28
Icelandic: EU/1/13/890/006 112 hylki (4 þynnuspjöld með 21 x 20 mg og 7 x 80 mg) (140 mg skammtur á dag í 28 daga)
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Icelandic: Látið lækninn vita við þungun eða ef þungun er fyrirhuguð á meðan á meðferð með COMETRIQ stendur.
English: The most common laboratory abnormalities were increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), lymphopenia, hypocalcaemia, neutropenia, thrombocytopenia, hypophosphataemia, hyperbilirubinemia, hypomagnesaemia, and hypokalaemia.
Icelandic: Algengustu breytingar á rannsóknarniðurstöðum voru aukning í aspartat amínótransferasa (AST), aukning í alanín amínótransferasa (ALT), aukning í alkalínskum fosfatasa (ALP), eitilfrumnafæð, blóðkalsíumlækkun, daufkyrningafæð, blóðflagnafæð, blóðfosfatlækkun, gallrauðadreyri, blóðmagnesíumlækkun og blóðkalíumlækkun.
English: • Blood clots in the arteries
Icelandic: Blóðkekkir í slagæðum
English: NOAEL for embryo-foetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
Icelandic: NOAEL mörkin fyrir eiturverkun á fósturvísis-/fósturþroska og vansköpun voru lægri en klínísk útsetning hjá mönnum við meðferðarskammta.
English: Median Overall Survival
Icelandic: Miðgildi heildarlifunar
English: Efficacy with cabozantinib was observed in medullary thyroid cancer patients with wild-type or mutant RET.
Icelandic: Áhrif cabozantinibs kom fram hjá sjúklingum með kjarnakrabbamein í skjaldkirtli sem höfðu villigerð RET eða stökkbreytt RET.
English: - have had surgery within the last month (or if surgical procedures are planned), including dental procedures - have had radiotherapy in the last 3 months - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis or diverticulitis) - have been told that your cancer has spread to your airway or oesophagus - have a recent history of blood clot in the leg, stroke, or heart attack - are taking medicines to control your heart rhythm, have a slow heart rate, have problems with your heart or have problems with the levels of calcium, potassium or magnesium in your blood - have severe liver or kidney disease.
Icelandic: ‐ ert með háan blóðþrýsting ‐ ert með eða hefur verið með slagæðargúlp (útvíkkun og veikingu æðaveggs) eða rof í æðavegg ‐ ert með niðurgang ‐ hefur nýlega hóstað upp blóði eða fengið alvarlegar blæðingar ‐ hefur farið í aðgerð síðastliðinn mánuð (eða ef aðgerð er fyrirhuguð), þ.m.t. hjá tannlækni ‐ hefur farið í geislameðferð síðastliðna 3 mánuði ‐ ert með bólgusjúkdóm í meltingarvegi (t.d. Crohns sjúkdóm, sáraristilbólgu eða sarpbólgu)
English: These patients (n=16) showed significant prolongation of PFS (HR of 0.15) and an objective response rate of 31%.
Icelandic: Þessir sjúklingar (n=16) sýndu marktæka lengingu
English: Cabozantinib exhibited dose-related tumour growth inhibition, tumor regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Icelandic: Cabozantinib sýndi skammtaháð, hamlandi áhrif á æxlisvöxt, æxlisminnkun og/eða hamlaði meinvörpum í fjölbreyttum forklínískum æxlislíkönum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARD, 100 mg dose
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ÞYNNUSPJALD, 100 mg skammtur
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Icelandic: 21 x 20 mg hylki og 7 x 80 mg hylki (140 mg skammtur á dag í 7 daga) Hver 140 mg dagskammtur inniheldur samtals þrjú grá 20 mg hylki og eitt appelsínugult 80 mg hylki.
English: The COMETRIQ 20 mg capsules contain cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Icelandic: COMETRIQ 20 mg hylki innihalda cabozantinib (S)-malat sem samsvarar 20 mg af cabozantinibi.
English: Gastric pH modifying agents
Icelandic: Lyf sem breyta pH í magavökva
English: Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Icelandic: Því skal gæta varúðar við samhliða notkun öflugra CYP3A4 hemla (t.d. rítónavírs, ítrakónazóls, erýtrómýsíns, claritrómýsíns, greipaldinsafa) og cabozantinibs.
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Icelandic: 24 klukkustundum eftir inntöku, sem bendir til þess að cabozantinib fari um lifrar-þarma hringrásina (enterohepatic recirculation).
English: COMETRIQ 20 mg hard capsules
Icelandic: COMETRIQ 20 mg hörð hylki
English: Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmarplantar erythrodysaesthesia syndrome (PPES), and gastrointestinal (GI) events (abdominal or mouth pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Icelandic: Aukaverkanir sem koma almennt snemma fram eru m.a. blóðkalsíumlækkun, blóðkalíumlækkun, blóðflagnafæð, háþrýstingur, handa- og fótaheilkenni (palmar-plantar erythrodysaesthesia syndrome (PPES)) og aukaverkanir í meltingarvegi (verkir í kvið eða munni, bólgur í slímhúð, hægðatregða, niðurgangur, uppköst).
English: Blister cards containing:
Icelandic: Hvert þynnuspjald inniheldur:
English: • Inflammation of the oesophagus; symptoms can include heartburn, chest pain, feeling sick, altered taste, bloating, belching and indigestion
Icelandic: Bólgur í vélinda; einkenni geta verið m.a. brjóstsviði, verkur í brjósti, ógleði, breyting á bragðskyni, uppþemba, ropi og meltingartruflanir
English: Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant arterial thromboembolic complication.
Icelandic: Hætta skal notkun cabozantinibs hjá sjúklingum sem fá brátt hjartadrep eða aðrar aukaverkanir tengdar segareki í slagæðum sem eru klínískt mikilvægar.
English: • Chest pain due to blockage in arteries, rapid heartbeat
Icelandic: Brjóstverkur vegna stíflaðra slagæða, hraður hjartsláttur
English: Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Icelandic: Samhliða notkun cabozantinibs og rífampisíns, sem er öflugur örvi á CYP3A4 olli minnkuðum styrk cabozantinibs í plasma.
English: Peel paper backing
Icelandic: Flettið pappírshlífinni af
English: The 100 mg daily dose blister card contains seven 80 mg capsules and seven 20 mg capsules as 7 daily doses in total.
Icelandic: Þynnuspjaldið með 100 mg dagskammti inniheldur sjö 80 mg hylki og sjö 20 mg hylki sem eru alls 7 dagskammtar.
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Icelandic: Breyting á skammtastærð er ekki nauðsynleg þegar lyf, sem breyta pH í magavökva (t.d. PPI, H2 viðtakamótlyf og sýrubindandi lyf) eru gefin samhliða cabozantinibi.
English: COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules
Icelandic: COMETRIQ 20 mg hörð hylki COMETRIQ 80 mg hörð hylki
English: The 140 mg daily dose blister card contains seven 80 mg capsules and twenty one 20 mg capsules as 7 doses in total.
Icelandic: Þynnuspjaldið með 140 mg dagskammti inniheldur sjö 80 mg hylki og tuttugu og eitt 20 mg hylki sem eru alls 7 dagskammtar.
English: Infections and infestations abscess (including visceral, skin, tooth), pneumonia, folliculitis, fungal infection (including skin, oral, genital)
Icelandic: Sýkingar af völdum sýkla og sníkjudýra ígerð (þ.m.t. í iðrum, húð, tönnum), lungnabólga, hárslíðursbólga, sveppasýking (þ.m.t. í húð, munni, kynfærum)
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Icelandic: Æxlishemjandi lyf, próteinkínasahemill, ATC flokkur:
English: The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Icelandic: Miðgildi tímalengdar hlutlægrar svörunar var 14,6 mánuðir (95% CI:
English: Each row of the blister card contains the daily dose.
Icelandic: Hver röð á þynnuspjaldinu inniheldur einn dagskammt.
English: Concomitant treatment with strong CYP3A4 inhibitors, which may increase cabozantinib plasma concentrations, should be used with caution.
Icelandic: Gæta skal varúðar við samhliða meðferð með öflugum CYP3A4 hemlum sem geta aukið styrk cabozantinibs í plasma.
English: • Inflammation of the lips and corners of the mouth
Icelandic: Bólgur í vörum og munnvikjum
English: Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Icelandic: 81% af heildar geislavirkninni sem gefin var og þar af voru 54% í hægðum og 27% í þvagi.
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Icelandic: Ef möguleiki er á þungun hjá þér eða maka þínum skal nota öruggar getnaðarvarnir meðan á meðferð stendur og í a.m.k.
English: Patients should be advised regarding oral hygiene practice.
Icelandic: Ráðleggja skal sjúklingum að sinna munnhirðu.
English: 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
Icelandic: 7 x 20 mg og 7 x 80 mg hylki (100 mg skammtur á dag í 7 daga) 21 x 20 mg og 7 x 80 mg hylki (140 mg skammtur á dag í 7 daga) 28 daga pakkning sem inniheldur:
English: three grey 20 mg
Icelandic: = 60 mg þrjú grá 20 mg
English: Cabozantinib should be discontinued in patients who experience a GI perforation or a GI or non-GI fistula.
Icelandic: Hætta skal notkun cabozantinibs hjá sjúklingum sem fá rof í meltingarvegi eða fistil í eða utan meltingarvegar.
English: • Swelling, pain in your hands and feet, or shortness of breath.
Icelandic: Bólgur, verki í höndum og fótum eða andnauð.
English: EU/1/13/890/001 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) EU/1/13/890/004 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
Icelandic: EU/1/13/890/001 21 x 20 mg hylki (60 mg skammtur á dag í 7 daga) EU/1 13/890/004 84 hylki (4 þynnuspjöld með:
English: Table 1: Adverse reactions reported with cabozantinib
Icelandic: Aukaverkanir sem tilkynnt hefur verið um við notkun cabozantinibs
English: Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.
Icelandic: Hvert hart hylki inniheldur cabozantinib (S)-malat sem samsvarar 20 mg eða 80mg af cabozantinibi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/003
Icelandic: EU/1/13/890/003
English: COMETRIQ 80 mg hard capsules
Icelandic: COMETRIQ 80 mg hörð hylki
English: Non-GI fistula should be ruled out as appropriate in cases of onset of mucositis after start of therapy.
Icelandic: Útiloka skal fistla utan meltingarvegar, eins og við á, ef upp kemur slímubólga eftir að meðferð hefst.
English: • Symptoms including pain in the abdomen, nausea, vomiting, constipation, or fever.
Icelandic: Einkenni á borð við verki í kvið, ógleði, uppköst, hægðatregðu eða hita.
English: A significant improvement in OS was observed in the subgroup of RET M918T mutation positive patients (n=81/219 cabozantinib arm): 44.3 months in the cabozantinib arm vs. 18.9 months in the placebo arm (HR = 0.60, p = 0.0255).
Icelandic: 44,3 mánuðir í cabozantinib hluta á móti 18,9 mánuðir í lyfleysu hluta (HR = 0,60, p = 0,0255).
English: To remove the capsules for your dose:
Icelandic: Hylkin eru tekin úr spjaldinu á eftirfarandi hátt:
English: Sodium starch glycolate
Icelandic: Lifur og gall gallsteinaveiki
English: Respiratory, thoracic, and mediastinal disorders dysphonia, oropharyngeal pain non-gastrointestinal fistula (including tracheal, pneumomediastinu m, tracheooesophageal), pulmonary embolism, respiratory tract haemorrhage (including pulmonary, bronchial, tracheal), pneumonia aspiration atelectasis, pharyngeal oedema, pneumonitis
Icelandic: Öndunarfæri, brjósthol og miðmæti raddtruflun, verkur í munnkoki fistill utan meltingarvegar (þ.m.t. í barka, miðmætisloft, barka- og vélinda), lungnasegarek, blæðingar í öndunarvegi (þ.m.t. lungum, berkjum, barka), ásvelgjulungnaból ga lungnasamfall, kokbjúgur, millivefsbjúgbólga lungna
English: Probability
Icelandic: Líkur
English: One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib.
Icelandic: Eitt hart hylki inniheldur cabozantinib (S)-malat sem samsvarar 20 mg eða 80 mg af cabozantinibi.
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms, pain in extremity musculoskeletal chest pain, osteonecrosis of jaw rhabdomyolysis
Icelandic: Stoðkerfi og stoðvefur liðverkur, vöðvakrampar, verkir í útlimum verkur frá brjóstgrind, beindrep í kjálka rákvöðvalýsa
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply).
Icelandic: 21 x 20 mg hylki og 7 x 80 mg hylki (140 mg skammtur á dag í 7 daga).
English: 7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply).
Icelandic: 7 x 20 mg hylki og 7 x 80 mg hylki (100 mg skammtur á dag í 7 daga).
English: The 60 mg daily dose blister card contains twenty-one 20 mg capsules as 7 daily doses in total.
Icelandic: Þynnuspjaldið með 60 mg dagskammti inniheldur tuttugu og eitt 20 mg hylki sem eru alls 7 dagskammtar.
English: Ear and labyrinth disorders ear pain, tinnitus hypoacusis
Icelandic: Eyru og völundarhús eyrnaverkur, eyrnasuð heyrnarskerðing
English: In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Icelandic: Hjá rottum olli cabozantinib fósturvísisláti, fósturbjúg, klofnum gómi/vör, vefjabresti í húð og snúnum eða vanþroskuðum hala.
English: 140 mg/day dose
Icelandic: 140 mg skammtur á dag
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/005 56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Icelandic: EU/1/13/890/005 56 hylki (4 þynnuspjöld með 7 x 20 mg og 7 x 80 mg) (100 mg skammtur á dag í 28 daga)
English: Wound complications
Icelandic: Hörð hylki
English: Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Icelandic: Hætta skal notkun cabozantinibs hjá sjúklingum sem fá beindrep í kjálka.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 140 mg dose (WITHOUT BLUE BOX)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM ÞYNNUSPJALD Í 28 DAGA PAKKNINGUM, 140 mg skammtur (ÁN BLÁS FERNINGS)
English: In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
Icelandic: Ef grunur leikur á ofskömmtun skal hætta meðferð með cabozantinibi og hefja stuðningsmeðferð.
English: One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
Icelandic: Eitt hart hylki inniheldur cabozantinib (S)-malat sem samsvarar 20 mg af cabozantinibi.
English: Gastrointestinal disorders diarrhoea, nausea, stomatitis, constipation, vomiting, abdominal pain, dyspepsia, dysphagia, glossodynia gastrointestinal perforation, gastrointestinal haemorrhage, pancreatitis, haemorrhoids, anal fissure, anal inflammation, cheilitis gastrointestinal fistula, oesophagitis
Icelandic: Taugakerfi bragðtruflun, höfuðverkur, svimi heilaslag, úttaugakvilli, náladofi, bragðleysi, skjálfti hreyfiglöp, athyglistruflun, lifrarheilakvilli, meðvitundarleysi, taltruflanir, afturkræft aftara heilakvillaheilkenn i
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Icelandic: Útvíkkun og veiking æðaveggs eða rof í æðavegg (slagæðargúlpur og flysjun slagæðar)
English: • 100 mg (1 orange 80 mg capsule and 1 grey 20 mg capsule)
Icelandic: 80 mg hylki og 1 grátt 20 mg hylki)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/004 84 capsules (4 blisters cards of 21 x 20 mg) (60 mg/day dose for 28 day supply) 13.
Icelandic: EU/1/13/890/004 84 hylki (4 þynnuspjöld með 21 x 20 mg) (60 mg skammtur á dag í 28 daga)
English: Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Icelandic: Hvert hart hylki inniheldur cabozantinib (S)-malat sem samsvarar 20 mg af cabozantinibi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/002
Icelandic: EU/1/13/890/002
English: 21 x 20 mg capsules (60 mg/day dose for a 7-day supply).
Icelandic: 21 x 20 mg hylki (60 mg skammtur á dag í 7 daga).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/006 112 capsules (4 blisters cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose for 28 day supply)
Icelandic: Boulogne-Billancourt Frakkland MARKAÐSLEYFISNÚMER EU/1/13/890/006 112 hylki (4 þynnuspjöld með 21 x 20 mg og 7 x 80 mg) (140 mg skammtur á dag í 28 daga) LOTUNÚMER
English: 60 mg/day dose
Icelandic: 60 mg skammtur á dag
English: Hypertension has been observed with cabozantinib.
Icelandic: Háþrýstingur hefur komið fram við notkun cabozantinibs.
English: 4.0 months
Icelandic: 4,0 mánuðir HR:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 100 mg dose (WITHOUT BLUE BOX)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM ÞYNNUSPJALD Í 28 DAGA PAKKNINGUM, 100 mg skammtur (ÁN BLÁS FERNINGS)