FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration, oteracil was distributed at high concentrations in normal gastrointestinal tract tissues while considerably lower concentrations were seen in blood and tumour tissue in animal studies.
Icelandic: Í kjölfar inntöku dreifðist óterasíl af miklum styrk í eðlilegan vef í meltingarvegi en í mun minni styrk í blóði og æxlisvef í dýrarannsóknum.
English: • Severe bone marrow suppression (severe leukopaenia, neutropaenia, or thrombocytopaenia; see section 4.2, Table 5).
Icelandic: Alvarleg beinmergsbæling (alvarleg hvítkornafæð, daufkyrningafæð eða blóðflagnafæð; sjá töflu 5).
English: Grade 1 Any occurrence
Icelandic: Stig 1
English: Hearing impairment, deafness
Icelandic: Heyrnarskerðing, heyrnarleysi
English: - Skin: loss of skin colour, peeling skin, excessive body hair, nail shrinkage, excessive sweating, - General: general condition worsening, weight increase, redness and swelling at the injection site, cancer pain and bleeding, multiple organ failure - Changes in blood tests: high blood sugar, high blood lipids, changes in blood clotting time, high blood cell counts, low or high protein level - Other: frequent urination, blood in urine, neck pain, back pain, breast pain, muscle tightness or cramps, joint swelling, limb discomfort, muscle weakness, arthritis inflammation and pain
Icelandic: - Breytingar sem fram koma í blóðrannsóknum: hár blóðsykur, há blóðfita, breytingar á storknunartíma blóðs, mikill blóðfrumnafjöldi, lág eða há prótíngildi - Annað: tíð þvaglát, blóð í þvagi, hálsverkur, bakverkur, verkur í brjósti, stífleiki í vöðvum eða krampar, bólga í liðamótum, óþægindi í útlimum, liðbólga og liðverkir
English: Rhabdomyolysis
Icelandic: Karnóbavax
English: Teysuno contains the active substances tegafur gimeracil and oteracil.
Icelandic: - Virku innihaldsefnin eru tegafúr, gimeracíl og oteracil.
English: Caution is advised as folinic acid is known to enhance the activity of 5-FU.
Icelandic: Gæta skal varúðar þar sem vitað er að fólínsýra magnar áhrif 5-FU.
English: Renal failure, blood creatinine increased, glomerular filtration rate decreased, blood urea increased
Icelandic: Nýrnabilun, aukið kreatínín í blóði, hægari gauklasíun, aukið þvagefni í blóði
English: Gimeracil inhibits the metabolism of 5-FU by reversibly and selectively inhibiting DPD, the primary metabolic enzyme for 5-FU, so that higher plasma concentrations of 5-FU are achieved with the administration of a lower dose of tegafur.
Icelandic: Gimerasíl hamlar umbroti 5-FU með því að hamla sértækt og afturkræft DPD, sem er megin ensímið í umbroti 5-FU þannig að meiri styrkur 5-FU næst í blóðvökva með lægri skammti tegafúrs.
English: If indicated, the dose of phenytoin should be adjusted according to the phenytoin SmPC.
Icelandic: Ef notkun fenýtóíns er æskileg skal aðlaga skammtinn samkvæmt Samantekt á eiginleikum lyfs fyrir fenýtóín.
English: There is no known antidote available in case of overdose.
Icelandic: Ekki er til neitt þekkt mótefni gegn ofskömmtun.
English: Uncommon side effects (may affect 1 to 10 in 1,000 people) include:
Icelandic: Sjaldgæfar aukaverkanir (geta komið fyrir hjá 1 til 10 einstaklingum af 1.000) eru m.a.:
English: The washout period described in the SmPC of other fluoropyrimidine medicinal products should be followed if Teysuno is to be administered subsequent to other fluoropyrimidine medicinal products.
Icelandic: Virða skal útskilnaðartímabil sem greint er frá í Samantekt á eiginleikum lyfs fyrir önnur flúorpýrimidín lyf ef gefa á Teysuno í kjölfar annarra flúorpýrimidín lyfja.
English: Adrenal haemorrhage
Icelandic: Millivefslungnasjúkdómur
English: - Nerve: headache, dizziness, sleeplessness, changes in taste - Eye: eye problems, increased or decreased tearing discomfort, vision problems, serious illness with blistering of the eyes, wearing away of the surface “skin” of the eye (corneal erosion).
Icelandic: - Augu: augnvandamál, aukin eða minnkuð óþægindi af tárarennsli, sjóntruflanir, alvarlegur sjúkdómur með blöðrumyndum í augum sem eyðir „húðinni“ á yfirborði augans (fleiður á glæru).
English: Capsule contents: lactose monohydrate, magnesium stearate Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, talc
Icelandic: Hylkisskelin: gelatín, rautt járnoxíð (E172), títantvíoxíð (E171), natríum lárýl súlfat, talkúm
English: Teysuno 15 mg/4.35 mg/11.8 mg hard capsules tegafur/gimeracil/oteracil
Icelandic: Teysuno 15 mg/4,35 mg/11,8 mg hörð hylki tegafúr/gimerasíl/óterasíl
English: Tegafur is a prodrug of 5-FU with good oral bioavailability.
Icelandic: Tegafúr er forlyf 5-FU og hefur gott aðgengi eftir inntöku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil and 15.8 mg oteracil (as salt).
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 20 mg af tegafúri, 5,8 mg af gimerasíli og 15,8 mg af óterasíli (sem salt).
English: Mean 5-FU maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) values were approximately 3-fold higher after Teysuno administration than after administration of tegafur alone, despite a 16-fold lower Teysuno dose (50 mg of tegafur) compared to tegafur alone (800 mg), and are attributed to inhibition of DPD by gimeracil.
Icelandic: 3 sinnum hærri eftir lyfjagjöf með Teysuno en eftir lyfjagjöf með tegafúr einu sér, þrátt fyrir 16 sinnum lægri skammt af Teysuno (50 mg af tegafúr) en tegafúri einu sér (800 mg), en þetta er vegna hömlunar DPD fyrir tilstilli gimerasíls.
English: Dose modifications for Teysuno for adverse reactions in general except for haematologic and renal toxicities
Icelandic: Teysuno vegna almennra aukaverkana, nema eiturverkana á blóð eða nýru
English: The hard capsules have a white body and white cap imprinted "TC442" in grey.
Icelandic: Harða hylkið er hvítt og matt og á efri hluta hylkisins er prentað „TC442“ í gráu.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
Icelandic: Teysuno 15 mg/4,35 mg/11,8 mg hörð hylki
English: - Gut and mouth: dry mouth, sores in mouth, throat, and oesophagus, hiccups, abdominal pain, indigestion, stomach or bowel inflammation, perforation of the stomach, small intestine, and large bowel.
Icelandic: - Meltingarvegur og munnur: munnþurrkur, sár í munni, hálsi og vélinda, hiksti, kviðverkir, meltingartruflanir, maga- og þarmabólga, rof í maga, smáþörmum og ristli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as salt).
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 15 mg af tegafúri, 4,35 mg af gimerasíli og 11,8 mg af óterasíli (sem salt).
English: Calculated creatinine clearance ≥30 ml/mina Neutrophils ≥1.5 x 109/l
Icelandic: Útreiknuð kreatínín úthreinsun ≥ 30 ml/mín.
English: • End stage renal disease patients requiring dialysis.
Icelandic: Sjúklingar með nýrnasjúkdóm á lokastigi sem þurfa á skilun að halda.
English: Contusion, medication error a Adverse reactions in the Investigations system organ class (SOC) have been reallocated to clinically appropriate SOCs related to their target organ.
Icelandic: Mar, röng lyfjagjöf a Aukaverkunum í líffæraflokknum Rannsóknarniðurstöður hefur verið raðað eftir klínískt viðeigandi marklíffærum.
English: Capsule contents Lactose monohydrate Magnesium stearate
Icelandic: laktósaeinhýdrat, magnesíumsterat
English: • Eye disorder includes adverse reactions of eye pruritus, ocular hyperaemia, eye irritation, eye disorder, and foreign body sensation in eyes.
Icelandic: Til Augnraskana teljast aukaverkanirnar augnkláði, blóðsöfnun í auga, erting í auga, augnröskun og tilfinning um aðskotahlut í auga.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/669/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/11/669/003
English: Administration of Teysuno under fed conditions resulted in decreased AUC0-inf for oteracil of approximately 71% and gimeracil of approximately 25% relative to fasting administration.
Icelandic: Lyfjagjöf Teysuno samhliða neyslu fæðu olli lækkuðu AUC0-inf gildi hvað varðar óterasíl sem nemur u.þ.b. 71 % og hvað varðar gimerasíl sem nemur u.þ.b. 25 % miðað við lyfjagjöf á fastandi maga.
English: (pain, swelling and redness of hands and/or feet), pigmented skin patches - Kidney: decreased urine volume, changes in blood tests which show the way the kidney is working, kidney impairment and failure - Other: chills, weight decrease, swelling in specific areas and muscle bone pain
Icelandic: - Nýru: minnkað þvagmagn, breytingar á blóðrannsóknum sem sýna hvernig nýrun starfa, skert starfsemi nýrna og nýrnabilun - Annað: hrollskjálfti, þyngdartap, þroti á sérstökum svæðum ásamt vöðva- og beinverkjum
English: Resumption criteria for Teysuno treatment
Icelandic: Skilyrði fyrir því að meðferð með Teysuno sé hafin á ný
English: There are no clinical data on the distribution of radiolabeled components of Teysuno.
Icelandic: Engar klínískar upplýsingar liggja fyrir um dreifingu geislamerktra hluta Teysuno.
English: Diarrhoea, vomiting, nausea, constipation
Icelandic: Meltingarfæri Niðurgangur, uppköst, ógleði, hægðatregða
English: Cisplatin a Expressed as tegafur content.
Icelandic: Cisplatín a Miðað við tegafúr innihald.
English: Severe renal impairment
Icelandic: Útlægur taugakvilli
English: - Skin: hair loss, itchiness, rash or dermatitis, skin reaction, dry skin, hand-and-foot reaction
Icelandic: - Húð: hárlos, kláði, útbrot eða húðþroti, viðbrögð í húð, þurr húð, viðbrögð á höndum og fótum (sársauki, þroti og roði á höndum og/eða fótum), mislitir húðflekkir
English: Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil, and 11.8 mg oteracil (as monopotassium).
Icelandic: Hvert hart hylki inniheldur 15 mg af tegafúri, 4,35 mg af gimerasíli og 11,8 mg af óterasíli (sem einkalíum).
English: United Kingdom Nordic Pharma Tel: +44 (0) 118 207 9160 info@nordicpharma.co.uk
Icelandic: +44 (0) 118 207 9160 info@nordicpharma.co.uk
English: Platelets Haemoglobin Teysuno dose modification
Icelandic: Breytingar á skömmtum Teysuno a.e.
English: Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil, and 15.8 mg oteracil (as monopotassium).
Icelandic: Hvert hart hylki inniheldur 20 mg af tegafúri, 5,8 mg af gimerasíli og 15,8 mg af óterasíli (sem einkalíum).
English: The plasma concentrations of uracil returned to baseline levels approximately 48 hours after dosing indicating reversibility of DPD inhibition by gimeracil.
Icelandic: Styrkur úrasíls í blóðvökva náði grunngildi á ný u.þ.b. 48 klst. eftir skömmtun sem gefur til kynna að DPD hemlun fyrir tilstilli gimerasíls sé afturkræf.
English: Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Icelandic: Ávísa skal sjúklingum lyfjum gegn uppköstum og niðurgangi á göngudeild.
English: Teysuno dose
Icelandic: Skammtar Teysuno
English: In man, the apparent terminal elimination half-life (T1/2) of 5-FU observed after administration of Teysuno (containing tegafur, a 5-FU prodrug) was longer (approximately 1.6 - 1.9 hours) than that previously reported after intravenous administration of 5-FU (10 to 20 minutes).
Icelandic: Hjá mönnum var sýnilegur helmingunartími brotthvarfs (T1/2) 5-FU eftir lyfjagjöf með Teysuno (sem inniheldur tegafúr, forlyf 5-FU) lengri (u.þ.b.
English: Brivudine
Icelandic: Prentblek
English: In a Phase I Teysuno monotherapy study that investigated the pharmacokinetics of components and metabolites in patients with normal and impaired renal function, patients with mild renal impairment (CrCl 51 to 80 ml/min) receiving the same monotherapy dose of 30 mg/m2 twice daily (the maximum tolerated dose for monotherapy) as patients with normal renal function (CrCl >80 ml/min) had an increase in mean 5-FU AUC0-inf relative to that of the normal patients.
Icelandic: I rannsókn á einlyfjameðferð með Teysuno, þar sem lyfjahvörf innihaldsefna og umbrotsefna voru rannsökuð hjá sjúklingum með eðlilega og skerta nýrnastarfsemi, kom í ljós að sjúklingar með væga skerðingu á nýrnastarfsemi (CrCl 51 til 80 ml/mín.)
English: Injury, poisoning and procedural complications
Icelandic: Áverkar,eitranir og fylgikvillar meðferðar
English: - Lung and nasal passages: shortness of breath, cough
Icelandic: - Lungu og nefgöng: mæði, hósti
English: a Treatment for patients with CrCl <30 ml/min is not recommended unless the benefits of Teysuno treatment clearly outweigh the risks.
Icelandic: a Ekki er mælt með meðferð fyrir sjúklinga með CrCl <30 ml/mín.
English: • Pregnancy and breast-feeding.
Icelandic: Meðganga og brjóstagjöf.
English: • Vision disorder includes adverse reactions of blurred vision, diplopia, photopsia, reduced visual acuity, and blindness;
Icelandic: Til Sjóntruflana flokkast aukaverkanirnar þokusýn, tvísýni, ljósblossar, minnkuð sjónskerpa og blinda;
English: o To help manage nausea and vomiting: ▪ Lie down or take deep breaths when feeling nauseous ▪ Avoid tight clothing - Low red blood cell count leading to anaemia o You may have symptoms such as cold hands and feet, looking pale, light-headedness, fatigue, breathlessness.
Icelandic: ▪ Leggstu niður eða dragðu andann djúpt þegar þú finnur fyrir ógleði ▪ Forðastu að vera í fötum sem þrengja að þér - Lágt hlutfall rauðra blóðkorna leiðir til blóðleysis:
English: ANNEX III LABELLING AND PAGKAGE LEAFLET
Icelandic: VIÐAUKI III ÁLETRANIR OG FYLGISEÐILL
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg hard capsules
Icelandic: HEITI LYFS Teysuno 20 mg/5,8 mg/15,8 mg hörð hylki
English: Capsule contents: lactose monohydrate, magnesium stearate Capsule shells: gelatin, titanium dioxide (E171), sodium lauryl sulphate, talc
Icelandic: Innihald hylkis: laktósaeinhýdrat, magnesíumsterat Hylkisskelin: gelatín, títantvíoxíð (E171), natríumlárýlsúlfat, talk Blek: rautt járnoxíð (E172), gult járnoxíð, Indígókarmín (E132), karnóbavax, bleikjað gljálakk, glýserýlmónóóleat
English: Cerebrovascular accident, cerebellar infarction, cerebrovascular disorder, convulsion, ischaemic stroke, syncope, hemiparesis, aphasia, ataxia, metabolic encephalopathy, loss of consciousness, acoustic neuritis, memory impairment, balance disorder, somnolence, tremor, ageusia, parosmia, burning sensation, formication
Icelandic: Heilablóðfall, slag í hnykli, heila- og æðaröskun, krampar, blóðþurrðarslag, yfirlið, helftarlömun, málstol, slingur, efnaskiptaheilakvilli, meðvitundarleysi, heyrnartaugarbólga, minnisröskun, jafnvægisröskun, svefnhöfgi, skjálfti,, bragðleysi, lyktarröskun, brunatilfinning, náladofi
English: No data are available on the concomitant use of methotrexate with Teysuno in combination with cisplatin.
Icelandic: Engar upplýsingar liggja fyrir um samhliða notkun metótrexats með Teysuno ásamt cisplatíni.
English: During and up to 6 months after treatment with Teysuno, you must use contraceptive measures.
Icelandic: Meðan á meðferð með Teysuno stendur og allt að 6 mánuðum eftir að henni lýkur þarftu að nota getnaðarvarnir.
English: In a dose escalation study comparing the tolerability of 5-FU in Teysuno and tegafur + gimeracil (no oteracil), the 25 mg/m2 dose level could not be attained in the absence of oteracil due to the occurrence of dose limiting toxicities (Grade 3 diarrhoea in 2 patients, and cardio-respiratory arrest in 1 patient) in the tegafur+gimeracil arm.
Icelandic: Í rannsókn á smáauknum skömmtum þar sem þol gagnvart 5-FU var borið saman hvað varðar Teysuno annars vegar og tegafúr + gimerasíl hins vegar (ekkert óterasíl), reyndist ekki mögulegt að ná 25 mg/m2 skammti án óterasíls vegna eiturverkana sem urðu til þess að takmarka þurfti skammta
English: Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations
Icelandic: Hjartabilun, brátt hjartadrep, vökvasöfnun í gollurshúsi, gáttatif, hjartaöng, tif í hjarta, hraðtaktur, hjartsláttarónot
English: If you experience any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor.
Icelandic: Látið lækninn vita ef vart verður við aukaverkanir sem ekki er minnst á í þessum fylgiseðli eða ef aukaverkanir sem taldar eru upp reynast alvarlegar.
English: The capsule has an opaque white body and opaque white cap imprinted “TC442” in grey.
Icelandic: Hylkið er hvítt og matt og á efri hluta hylkisins er prentað „TC442“ í gráu.
English: Ethnic differences
Icelandic: Munur á kynþáttum
English: Gastro-oesophageal junction Both
Icelandic: Maga- og vélindamót Hvort tveggja
English: Multi-organ failure, performance status decreased, pain, oedema, chest pain, chest discomfort, generalized oedema, face oedema, local swelling, localized oedema, weight increased, early satiety, feeling cold, injection site reaction, malaise
Icelandic: Bilun í ýmsum líffærum, minnuð afköst, viðbrögð á stungustað, verkir, bjúgur, verkur fyrir brjósti, óþægindi fyrir brjósti, almennur bjúgur, bjúgur í andliti, staðbundinn þroti, staðbundinn bjúgur, þyngdaraukning, snemmkomin seddutilfinning, kuldatilfinning, aukaverkun á stungustað, máttleysi
English: Adverse reactions of Grade 3 or higher such as increased blood creatinine, decreased creatinine clearance, toxic nephropathy, and acute renal failure have all been reported in patients receiving Teysuno in combination with cisplatin (see section 4.8).
Icelandic: 3 eða hærra, svo sem aukningu kreatíníns í blóði, minnkaða kreatínín úthreinsun, nýrnasjúkdóm vegna eiturverkana og bráða nýrnabilun hjá sjúklingum sem fengu
English: - Heart: irregular or fast heart beat, chest pain, accumulation of excess fluid around the heart,
Icelandic: - Hjarta: óreglulegur eða hraður hjartsláttur, brjóstverkur, uppsöfnun umframvökva kringum hjartað, hjartaáfall, hjartabilun - Blóðæðar: æðabólga, hitakóf
English: No data are available on the concomitant use of nitromidazoles with Teysuno in combination with cisplatin.
Icelandic: Engar upplýsingar liggja fyrir um samhliða notkun nítróímídasóls með Teysuno ásamt cisplatíni.
English: Hyperglycaemia, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hypophosphatameia, hypermagnesaemia, gout, hypoproteinaemia, hyperglobulinaemia, hyperlipidaemia, oral intake reduced
Icelandic: Hár blóðsykur, Aukning alkalín fosfatasa í blóði, laktat dehýdrógenasa í blóði hækkaður, blóðfosfatlækkun, magnesíumhækkun, þvagsýrugigt, prótínskortur í blóði, ofgnótt glóbúlíns í blóði, blóðfituhækkun, minnkuð inntaka um munn
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC53.
Icelandic: Flokkun eftir verkun: æxlishemjandi lyf, andmetabólítar, ATC flokkur:
English: - Mental: seeing and hearing some things that are not there, personality change, unable to sit still, confusion, feeling of nervousness, depression, sexual dysfunction - Nerve:, voice disorder, inability to speak and understand words, memory problem, unsteady gait, balance problems, one sided body weakness, sleepiness, nerve inflammation, distorted sense of smell, brain dysfunction, fainting, loss of consciousness, stroke, seizures
Icelandic: - Taugar: raddtruflanir, vangeta til að tala og skilja orð, minnisvandamál, óstöðugt göngulag, jafnvægistruflanir, slappleiki öðrum megin í líkamanum, syfja, taugabólga, truflað lyktarskyn, truflanir í heila, yfirlið, meðvitundarleysi, slag, flog, - Augu: kláði og roði í augum, ofnæmisviðbrögð í augum, slapandi efra augnlok
English: Table 3: Teysuno dose reduction schedule for treatment-related toxicities in general, except for haematologic and renal toxicities
Icelandic: Áætlun um skammtaminnkun fyrir Teysuno hvað varðar almennar meðferðartengdar eiturverkanir, nema eiturverkanir á blóð eða nýru Eiturverkanastiga Breytingar á skömmtum Teysuno í 21 dags meðferðarlotu
English: Leukoencephalopathy, anosmia
Icelandic: Endurvakning lifrarbólgu
English: Ocular toxicity
Icelandic: Eiturverkanir á augu
English: Teysuno is contraindicated during breast-feeding (see section 4.3).
Icelandic: Brjóstagjöf er frábending við notkun Teysuno (sjá kafla 4.3).
English: Teysuno dose modification criteria
Icelandic: Skilyrði fyrir breytingu á skömmtum
English: Similar inhibition was seen following single and multiple dosing.
Icelandic: Svipuð hemlun kom fram í kjölfar stakra og margra skammta.
English: Manifestations of acute overdose reported include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation, bleeding, bone marrow depression, and respiratory failure.
Icelandic: Einkenni bráðrar ofskömmtunar sem greint var frá voru m.a. ógleði, uppköst, niðurgangur, slímhimnubólga, erting í meltingarvegi, blæðing, beinmergsbæling og öndunarbilun.
English: Teysuno is contraindicated in pregnancy (see section 4.3).
Icelandic: Meðganga er frábending við notkun Teysuno (sjá kafla 4.3).
English: - Ear: hearing problems - Blood vessels: high or low blood pressure, blood clots in the leg and lung
Icelandic: - Æðar: hár eða lágur blóðþrýstingur, segamyndun í fótleggjum og lungum
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS/
English: There was no effect of gimeracil on renal clearance of tegafur, FBAL, and 5-FU following administration of Teysuno as compared to their clearance following administration of tegafur alone.
Icelandic: Gimerasíl hafði engin áhrif á úthreinsun tegafúrs, FBAL og 5-FU um nýru í kjölfar lyfjagjafar með Teysuno í samanburði við úthreinsun eftir lyfjagjöf með tegafúri einu sér.
English: Following a reduced dose of Teysuno 20 mg/m2 administered once daily to the severe renal impairment group (CrCl < 30 ml/min), the single-dose AUC0-inf and multiple-dose AUC0-τ values for 5-FU were approximately 2-fold higher in the severe renal impairment group compared to those observed in the normal renal function group receiving 30 mg/m2 twice daily.
Icelandic: Í kjölfar lyfjagjafar með minnkuðum skammti sem nemur 20 mg/m2 af Teysuno einu sinni á dag hjá hópnum með alvarlega skerta nýrnastarfsemi (CrCl < 30 ml/mín.) reyndust AUC0-inf eftir staka skammta og AUC0-τ eftir marga skammta hvað varðar 5-FU u.þ.b.
English: Treatment-related bone marrow suppression, including neutropaenia, leukopaenia, thrombocytopaenia, anaemia, and pancytopaenia, has been reported among patients treated with Teysuno in combination with cisplatin.
Icelandic: Tilkynnt var um meðferðartengda beinmergsbælingu, ásamt daufkyrningafæð, hvítkornafæð, blóðflagnafæð, blóðleysi og blóðfrumnafæð hjá sjúklingum sem fengu meðferð með Teysuno samhliða cisplatíni.
English: The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey.
Icelandic: Meginhluti hylkisins er hvítur og ógagnsær og lokið ógagnsætt og brúnt með gráu áletruninni „TC448“.
English: Exfoliative rash, skin exfoliation, necrolytic migratory erythema, blood blister, dermatitis allergic, skin reaction, dermatitis acneiform, erythema, increased tendency to bruise, purpura, hyperhidrosis, night sweats, nail atrophy, pigmentation disorder, skin discoloration, hypertrichosis
Icelandic: Útbrot ásamt flögnun, húðflögnun, flökkudrepsroði, blöðrur sem innihalda blóð, ofnæmishúðbólga, húðviðbrögð, húðbólga með þrymlabólum, roði, aukin tilhneiging til mars, purpuri, ofsvitnun, nætursviti, naglarýrnun, húðlitarröskun, breyting á húðlit, ofvöxtur hárs
English: doses, steady-state conditions are reached for tegafur, gimeracil, and oteracil at the latest by Day 8.
Icelandic: Í kjölfar lyfjagjafar 30 mg/m2 skammta náðist jafnvægi tegafúrs, gimerasíls og óterasílats í síðasta lagi á degi 8.
English: Acute pancreatitis
Icelandic: Innihald hylkis
English: Neoplasms benign, malignant and unspecified (Incl.
Icelandic: Æxli, góðkynja og illkynja (einnig blöðrur og separ)
English: No data are available on the concomitant use of cimetidine with Teysuno in combination with cisplatin.
Icelandic: Engar upplýsingar liggja fyrir um samhliða notkun címetidíns með Teysuno ásamt cisplatíni.
English: Vertigo, ear congestion, ear discomfort
Icelandic: - Eyru: svimi, eyrnastíflur, óþægindi í eyrum
English: Febrile neutropenia, lymphopenia
Icelandic: Ristruflun, eymsli í brjóstum, verkur í geirvörtum