FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Red iron oxide (E172) Yellow iron oxide (E172) Edible black ink
Icelandic: Títantvíoxíð (E171) Indígókarmín (E132) Rautt járnoxíð (E172) Gult járnoxíð (E172) Ætilegt (edible) svart blek
English: Hyperglycaemia (reported especially in diabetic patients) Hyponatraemia
Icelandic: Hár blóðsykur (einkum tilkynnt hjá sjúklingum með sykursýki) Blóðnatríumlækkun
English: YENTREVE is a hard gastro-resistant capsule.
Icelandic: YENTREVE er hart sýruþolið hylki.
English: • throat tightness, nose bleeds
Icelandic: Herpingur í hálsi, blóðnasir
English: Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Icelandic: Innihald hylkisins: hýprómellósi, hýprómellósa metýlcellulósa acetat succinat, súkrósi, sykurperlur, talkúm, títantvíoxíð (E171), triethýl sítrat.
English: Dermatitis contact Cold sweat Increased tendency to bruise
Icelandic: Ofsakláði Snertiofnæmi Kaldur sviti Aukin tilhneiging til marbletta
English: Black iron oxide - synthetic (E172) Propylene glycol
Icelandic: Samtengt svart járnoxíð (E172) Própýlenglýkól
English: Call your doctor or pharmacist immediately if you take more than the amount of YENTREVE prescribed by your doctor.
Icelandic: Ef stærri skammtur en mælt er fyrir um er tekinn Hafðu tafarlaust samband við lækninn eða lyfjafræðing ef þú hefur tekið meira af YENTREVE en læknirinn mælti fyrir um.
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Icelandic: Ljósopsstæringu hefur verið lýst og tengd við duloxetin, því ætti að nota duloxetin með varúð hjá sjúklingum með hækkaðan augnþrýsting, eða með þekkta hættu á bráðri þrönghornsgláku.
English: In these women, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.
Icelandic: Enginn ávinningur kann að nást með YENTREVE hjá þessum konum umfram þann sem næst með hefðbundnum ráðleggingum varðandi hegðunarmynstur.
English: YENTREVE is available in 2 strengths: 20 and 40 mg.
Icelandic: YENTREVE er fáanlegt í tveimur styrkleikum:
English: What YENTREVE looks like and contents of the pack
Icelandic: Útlit YENTREVE og pakkningastærðir
English: Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise.
Icelandic: Áreynsluþvagleki einkennist af ósjálfráðum þvagleka við líkamlega áreynslu eða athafnir svo sem við hlátur, hósta, hnerra, lyftingar eða æfingar.
English: Titanium dioxide (E171) Triethyl citrate
Icelandic: Títantvíoxíð (E171) Þríetýl sítrat
English: 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Icelandic: 1Einnig hefur verið greint frá tilfellum af krömpum og eyrnasuði að meðferð lokinni.
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, inflammation of the mouth, burping, difficulty swallowing, breaking wind, bad breath
Icelandic: Blóðug uppköst eða svartar tjörukenndar hægðir, meltingartruflun, munnbólgur, ropi,
English: The concomitant use of YENTREVE with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Icelandic: Ekki er mælt með samhliða notkun á YENTREVE og sérhæfðum, afturkræfum MAO-hemlum eins og moclobemíði (sjá kafla 4.4).
English: General disorders and administration site conditions Fatigue
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Þreyta
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome
Icelandic: Serótónínheilkenni (mjög sjaldgæf viðbrögð sem geta valdið mikilli hamingjukennd, svefnhöfga, klunnahætti, eirðarleysi, tilfinningu um ölvun, hita, svitamyndun eða stirðum vöðvum), krampar, skyndilegir vöðvakippir, óeirð eða skert geta til að sitja eða standa kyrr, erfiðleikar við að stjórna hreyfingum t.d. skortur á samhæfingu eða ósjálfráðar hreyfingar í vöðvum, fótaóeirð (restless legs syndrome)
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with YENTREVE, you should see your doctor.
Icelandic: Ef þú verður var/vör við einhver óvenjuleg einkenni þegar þú tekur önnur lyf með YENTREVE skaltu hafa samband við lækninn.
English: In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking placebo.
Icelandic: 44% sjúklinga sem meðhöndlaðir voru með YENTREVE og 24% sjúklinga sem fengu lyfleysu aukaverkanir þegar meðferð var hætt skyndilega.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink
Icelandic: Títantvíoxíð (E171) Indígókarmín (E132) Ætilegt (edible) svart blek
English: Reporting of side effects
Icelandic: Upplýsingar um virkni
English: • headache, dizziness, feeling sluggish, feeling sleepy, tremor, numbness, including numbness,
Icelandic: Höfuðverkur, sundl, silagangur, syfja, skjálfti, doði, þar með talið doði eða náladofi í húð
English: Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Icelandic: Hvert hylki inniheldur 20 eða 40 mg af duloxetini (sem hýdróklóríð).
English: YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'.
Icelandic: Ógegnsætt blátt, áletrað með „20 mg“ og lokað með ógegnsæju bláu loki, áletrað með ‘9544'.
English: YENTREVE must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Icelandic: Skert lifrarstarfsemi YENTREVE má ekki að gefa konum með lifrarsjúkdóm með skerta lifrarstarfsemi (sjá kafla 4.3 og
English: Talk to your doctor before you take Yentreve if you: - are taking medicines to treat depression (see ‘Other medicines and YENTREVE') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage.
Icelandic: (sjá „Meðganga og brjóstagjöf“) - ef þú átt á hættu að natríumgildi verði lágt (til dæmis ef þú ert að taka þvagræsilyf, sérstaklega ef þú ert aldraður) - ef þú tekur önnur lyf núna sem gætu valdið lifrarskaða - ef þú tekur önnur lyf sem innihalda duloxetin (sjá „Notkun annarra lyfja samhliða YENTREVE“)
English: • dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Icelandic: Sundl, náladofa eða tilfinningu um raflost (sérstaklega í höfði), svefntruflanir (skýra drauma, martraðir, svefnleysi), þreytu, syfju, eirðarleysi eða óróleika, kvíða, ógleði eða uppköst, skjálfta, höfuðverk, vöðvaverk, bráðlyndi, niðurgang, mikla svitamyndun eða svima.
English: Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.
Icelandic: Að auka skammtinn smám saman getur dregið úr hættunni á ógleði og svima, en ekki alveg komið í veg fyrir hana.
English: The initiation of treatment with YENTREVE is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Icelandic: Ekki má hefja meðferð með YENTREVE hjá sjúklingum með háþrýsting sem ekki næst stjórn á vegna hugsanlegra hættu á hættulegri blóðþrýstingshækkun hjá sjúklingunum (sjá kafla 4.4 og 4.8).
English: YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
Icelandic: YENTREVE 40 mg hörð sýruþolin hylki Duloxetin
English: In pre/postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposure levels below maximum clinical exposure (AUC).
Icelandic: Rannsóknir á eituráhrifum í rottum fyrir og eftir fæðingu sýndu hegðunarraskanir hjá afkvæmum við almenna útsetningu undir mestu klínísku útsetningu (AUC).
English: YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'.
Icelandic: Ógegnsætt appelsínugult, áletrað með ‘40 mg' og lokað með ógegnsæju bláu loki, áletrað með ‘9545'.
English: Supra-ventricular arrhythmia, mainly atrial fibrillation6
Icelandic: Hjartsláttartruflanir ofan slegils, aðallega gáttatitringur6
English: YENTREVE with food, drink and alcohol
Icelandic: YENTREVE með mat, drykk eða áfengi YENTREVE má taka án tillits til máltíða.
English: YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules
Icelandic: YENTREVE 40 mg hörð sýruþolin hylki YENTREVE 20 mg hörð sýruþolin hylki
English: The European Medicines Agency has waived the obligation to submit the results of studies with Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence.
Icelandic: Lyfjastofnun Evrópu hefur fallið frá kröfu um að lagðar verði fram niðurstöður úr rannsóknum á
English: YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women.
Icelandic: YENTREVE er lyf til inntöku sem er notað til að meðhöndla áreynsluþvagleka hjá konum.
English: Blood potassium increased
Icelandic: Hækkað kalíum í blóði
English: Syncope2
Icelandic: Yfirlið2
English: YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
Icelandic: YENTREVE 20 mg hörð sýruþolin hylki Duloxetin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ÖSKJUR FYRIR 20 MG HÖRÐ SÝRUÞOLIN HYLKI
English: YENTREVE contains sucrose
Icelandic: YENTREVE inniheldur súkrósa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ÖSKJUR FYRIR 40 MG HÖRÐ SÝRUÞOLIN HYLKI
English: Psychiatric disorders Insomnia
Icelandic: Slæm svefngæði heilkenni6
English: Hepatic impairment
Icelandic: Bráður lifrarskaði
English: • grinding or clenching the teeth, feeling disorientated, lack of motivation, difficulty or failure to experience orgasm, unusual dreams
Icelandic: Tannagnístran, vistarfirring, sinnuleysi, erfiðleikar við að ná eða skortur á fullnægingu,
English: The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Icelandic: Algengustu aukaverkanirnar sem vart varð við hjá sjúklingum á YENTREVE meðferð voru ógleði, höfuðverkur, munnþurrkur, svefnhöfgi og sundl.
English: Avda.
Icelandic: YENTREVE.
English: Each capsule contains 40 mg of duloxetine (as hydrochloride).
Icelandic: Hvert hylki inniheldur 40 mg af duloxetini (sem hýdróklóríð).
English: Haemorrhage
Icelandic: Vessaþurrð
English: 98 hard gastro-resistant capsules.
Icelandic: LYFJAFORM OG INNIHALD 98 hörð sýruþolin hylki.
English: • large pupils (the dark centre of the eye), problems with eyesight, eyes feel dry
Icelandic: Þanin sjáöldur (stórir augasteinar), sjóntruflanir, augnþurrkur
English: Gynaecological haemorrhage Menopausal symptoms
Icelandic: Stoðkerfisverkur Vöðvastífni Vöðvakrampar Kjálkastjarfi
English: Sleep disorder
Icelandic: Svefnleysi Æsingur
English: pricking or tingling of the skin
Icelandic: Húð og undirhúð
English: • feeling sick (nausea), dry mouth, constipation • fatigue
Icelandic: Ógleði, munnþurrkur, hægðatregða •
English: The use of YENTREVE while breastfeeding is not recommended.
Icelandic: YENTREVE meðan á brjóstagjöf stendur.
English: Nervous system disorders Headache
Icelandic: Hjartsláttarónot Hraðtaktur
English: Each capsule contains 20 mg of duloxetine (as hydrochloride).
Icelandic: Hvert hylki inniheldur 20 mg af duloxetini (sem hýdróklóríð).
English: Menstrual disorder
Icelandic: Óeðlilegar tíðablæðingar
English: Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Icelandic: Einkenni ofskömmtunar (duloxetin eitt og sér eða í samsetningu með öðrum lyfjum) eru svefnhöfgi, dá, serótónínheilkenni, krampar, uppköst og hraðtaktur.
English: Laryngitis
Icelandic: Ofskynjanir
English: Hepatitis3
Icelandic: Geðhæð6
English: INSTRUCTIONS ON USE 16.
Icelandic: Skynhreyfieirðarleysi6
English: What you need to know before you take YENTREVE DO NOT take YENTREVE if you:
Icelandic: Leitaðu ráða hjá lækninum áður en þú tekur Yentreve:
English: Lilly Portugal - Produtos Farmacêuticos, Lda Tel: + 351 21-4126600
Icelandic: Lilly Portugal - Produtos Farmacêuticos, Lda
English: Muscle spasm
Icelandic: Lasleiki, skjálfti
English: YENTREVE 40 mg hard gastro-resistant capsules.
Icelandic: YENTREVE 40 mg hörð sýruþolin hylki.
English: Eosinophilic pneumonia6
Icelandic: Lifrarbilun6
English: Feeling hot
Icelandic: Einkennileg líðan
English: Monoamine oxidase inhibitors (MAOIs): You should not take YENTREVE if you are taking or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Icelandic: - Tekur eða hefur tekið á síðustu 14 dögum, annað lyf þekkt sem mónóamín oxidasa hemill (MAO
English: Hyper-sensitivity disorder
Icelandic: Athyglistruflanir Bragðskynstruflun
English: YENTREVE 20 mg hard gastro-resistant capsules.
Icelandic: YENTREVE 20 mg hörð sýruþolin hylki.
English: Gastrointestinal haemorrhage7 Gastroenteritis Stomatitis
Icelandic: 28 hörð, sýruþolin hylki
English: Sugar spheres
Icelandic: Sykurperlur
English: Serotonin syndrome6
Icelandic: Vöðvarykkjakrampi6
English: For patients with severe renal impairment, see section 4.3.
Icelandic: Sjá kafla 4.3 um sjúklinga með alvarlega skerta nýrnastarfsemi.
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips
Icelandic: öndunarerfiðleikum eða sundli með bólginni tungu eða vörum
English: Pollakiuria Urine odour abnormal
Icelandic: Munnþurrkur Hægðatregða
English: Urine flow decreased
Icelandic: SNRI-lyfja sé hætt.
English: Postpartum haemorrhage6
Icelandic: Óeðlileg seyting þvagstemmuvaka (SIADH)6
English: Endocrine disorders
Icelandic: Ofnæmissjúkdómar
English: Very Rare phosphokinase increased
Icelandic: Mjög algengar Algengar
English: Hypertension3,7 Flushing
Icelandic: Blæðing í maga og görnum7
English: However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily.
Icelandic: YENTREVE 20 mg tvisvar á dag eru hins vegar takmarkaðar.
English: Orgasm abnormal Abnormal dreams
Icelandic: afbrigðilegir draumar
English: • chest pain, feeling cold, thirst, feeling hot
Icelandic: Brjóstverkur, kuldatilfinning, þorsti, hitatilfinning
English: Feeling abnormal Feeling cold Thirst
Icelandic: óeðlileg lykt af þvaginu
English: Respiratory, thoracic and mediastinal disorders Yawning
Icelandic: Öndunarfæri, brjósthol og miðmæti
English: YENTREVE and Pelvic Floor Muscle Training (PFMT): During a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
Icelandic: YENTREVE dró meira úr tíðni þvagleka samanborið við hvort sem er lyfleysu eða grindarbotnsþjálfun eina sér í 12 vikna tvíblindri, samanburðarrannsókn með slembivali við lyfleysu.
English: • passing bright red blood in your stools, inflammation of the large intestine (leading to diarrhoea)
Icelandic: Blóðugar hægðir, ristilbólga (sem veldur niðurgangi)
English: Somnolence
Icelandic: Andremma
English: Dry mouth
Icelandic: Þornun líkamsvefja
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Icelandic: Fylgjast skal náið með sjúklingum uns bati fæst, því ekki er víst að batamerki sjáist á fyrstu vikum meðferðar.
English: Adopted at the 7-10 September 2015 PRAC
Icelandic: Samþykkt á fundi PRAC 7.-10. september 2015
English: EMA/PRAC/590265/2015
Icelandic: EMA/PRAC/633529/2015 Corr1
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 September 2015
Icelandic: 30 Churchill Place ● Canary Wharf ● London E14 5EU ●
English: Bisphosphonates (alendronic acid; alendronic acid, colecalciferol; clodronic acid; etidronic acid; ibandronic; neridronic acid; pamidronic acid; risedronic acid; tiludronic acid; zoledronic acid) - Osteonecrosis of the external auditory canal (EPITT no 18256)
Icelandic: Bisfosfónöt (alendronic acid; alendronic acid, colecalciferol; clodronic acid; etidronic acid; ibandronic; neridronic acid; pamidronic acid; risedronic acid; tiludronic acid; zoledronic acid) - beindrep í hlust2 (EPITT nr. 18256)
English: Possible side effects Tell your doctor immediately if you experience:
Icelandic: Kafli 4, Hugsanlegar aukaverkanir Láttu lækninn vita strax ef þú færð:
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Icelandic: Hafðu samband við lækninn ef þú færð verk í eyra, útferð úr eyra og/eða sýkingu í eyra.
English: The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals' which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
Icelandic: Textinn í þessu skjali fyrir lyfjaupplýsingar er útdráttur úr skjali sem nefnist “PRAC ráðleggingar vegna ræsimerkja (PRAC recommendations on signals)” en í því skjali er heildartexti með ráðleggingum PRAC um uppfærslu á lyfjaupplýsingum ásamt almennum leiðbeiningum um hvernig skuli afgreiða ræsimerki.
English: Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Icelandic: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
English: Trabectedin - Capillary leak syndrome (EPITT no 18115)
Icelandic: 4. Trabectedín - Háræðalekaheilkenni (EPITT nr. 18115)
English: Section 4.8 - Undesirable effects: Respiratory, thoracic and mediastinal disorders
Icelandic: Section 4.8 - Undesirable effects:
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Icelandic: Skýrt hefur verið frá beindrepi í hlust2 við notkun bisfosfónata, einkum í tengslum við langtíma meðferð.
English: HLA-DRB1*04:03 allele (susceptibility to IAS odds ratio: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio: 56.6) is especially found in Japanese and Korean patients.
Icelandic: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio:
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Icelandic: Hugsanlegir áhættuþættir fyrir beindrepi í hlust2 eru meðal annars notkun stera og krabbameinslyfjameðferð og/eða staðbundnir áhættuþættir svo sem sýking eða áverki.
English: - a cough or breathing problems as these may indicate inflammation problems of the lung (interstitial lung disease or pulmonary hypertension);
Icelandic: hósta eða öndunarerfiðleika, þar sem það getur verið vísbending um lungnabólgukvilla (millivefslungnasjúkdóm eða lungnaháþrýsting).
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility [...] may also occur with an unknown frequency.
Icelandic: Aðrar aukaverkanir svo sem nýrnabilun, lækkuð þvagsýruþéttni í blóði, lungnaháþrýstingur, ófrjósemi karlmanna [...]geta einnig komið fram en tíðni þessara aukaverkana er ekki þekkt
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension has have been reported during treatment with leflunomide (see section 4.8).
Icelandic: Skýrt hefur verið frá millivefslungnasjúkdómi sem og mjög sjaldgæfum tilvikum um lungnaháþrýsting meðan á meðferð með leflúnómíði stendur (sjá kafla 4.8).
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Icelandic: Hafa skal í huga hugsanlegt beindrep3 í hlust2 hjá sjúklingum sem nota bisfosfónöt og fá einkenni frá eyra þ.m.t. langvinnar sýkingar í eyra.
English: Very rare
Icelandic: Koma örsjaldan fyrir
English: Frequency ‘not known': pulmonary hypertension
Icelandic: Frequency unknown:
English: The risk of its their occurrence is can be increased in patients with a history of interstitial lung disease.
Icelandic: Hjá sjúklingum með sögu um millivefslungnasjúkdóm er aukin hætta á að þessir sjúkdómarurinn komi fram.
English: Section 4.
Icelandic: Kafli 4, Hugsanlegar aukaverkanir
English: Packaging Package size bottle (HDPE) 168 (4 x 42) tablets bottle (HDPE) 42 tablets
Icelandic: 168 (4 x 42) töflur
English: Name
Icelandic: Umbúðir
English: May be harmful to the teeth.
Icelandic: Getur verið skaðlegt fyrir tennur.
English: - you are planning to have a baby.
Icelandic: - ef þú hyggst eignast barn.
English: Talk to your child´s doctor if this happens.
Icelandic: Ræddu við lækni barnsins ef þetta gerist.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/727/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/11/727/001
English: Take the medicine pack and this leaflet with you.
Icelandic: Taktu lyfjapakkann og þennan fylgiseðil með þér.
English: Date of latest renewal: 18 November 2016
Icelandic: 18 nóvember 2016
English: 15 months
Icelandic: 15 mánuðir.
English: Remove the syringe from your mouth.
Icelandic: Taktu sprautuna úr munninum.
English: The apparent body clearance is 4832 ± 2562 ml/min/m2.
Icelandic: Heildarúthreinsun líkamans var 4832 ± 2562 ml/mín/m2.
English: Ask your doctor if you would like more explanation about this disease.
Icelandic: Spyrðu lækninn ef þú óskar þess að fá nánari upplýsingar um sjúkdóminn.
English: The infectious disease and complications may be more severe in these patients than in non-treated patients.
Icelandic: Smitsjúkdómurinn og fylgikvillar geta verið alvarlegri hjá þessum sjúklingum en hjá sjúklingum sem ekki fá meðferð.
English: Do not take Xaluprine if you are planning to have a baby without first speaking to your doctor for advice.
Icelandic: Ekki taka Xaluprine ef þú hyggst eignast barn án þess að leita ráða hjá lækni fyrst.
English: The frequency of NUDT15 c.415C>T has an ethnic variability of approximately 10 % in East Asians, 4 % in Hispanics, 0.2 % in Europeans and 0 % in Africans.
Icelandic: Tíðni NUDT15 c.415C>T er breytileg eftir kynstofnum og er um 10 % hjá þeim frá Austur-Asíu, 4 % hjá þeim frá Rómönsku Ameríku, 0,2 % hjá þeim frá Evrópu og 0 % hjá þeim frá Afríku.
English: - When you take Xaluprine your doctor will take regular blood tests.
Icelandic: - Þegar þú tekur Xaluprine mun læknirinn taka reglulega blóðsýni.