FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of patient sub-populations from week 24 to week 27 with maintenance dose of Velphoro (1,000 to 3,000 mg iron/day) or low dose (250 mg iron/day) of Velphoro demonstrated superiority of the maintenance dose.
Icelandic: 27 með viðhaldsskammti af Velphoro (1.000 til 3.000 mg af járni/dag) eða lágum skammti (250 mg af járni/dag) af Velphoro sýndi fram á yfirburði viðhaldsskammtsins.
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets
Icelandic: HEITI LYFS Velphoro 500 mg tuggutöflur
English: In these clinical trials, approximately 43% of patients experienced at least one adverse reaction during Velphoro treatment, which were reported as serious adverse reactions in 0.36%.
Icelandic: eina aukaverkun meðan á meðferð með Velphoro stóð, og voru tilkynntar sem alvarlegar aukaverkanir í 0,36%.
English: The maximum recommended dose is 3,000 mg iron (6 tablets) per day.
Icelandic: Ráðlagður hámarksskammtur er 3.000 mg af járni (6 töflur) á sólarhring.
English: The distribution studies in humans were not performed.
Icelandic: Ekki hafa verið gerðar rannsóknir á dreifingu hjá mönnum.
English: Common (may affect up to 1 in 10 people): feeling sick (nausea), constipation, vomiting, indigestion, pain in stomach and gut, gas, tooth discolouration, change in taste.
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum): velgja (ógleði), hægðatregða, uppköst, meltingartruflanir, maga- og þarmaverkir, vindgangur, breyttur litur tanna, breyting á bragðskyni.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Icelandic: Hafið samband við fulltrúa markaðsleyfishafa ef óskað er upplýsinga um lyfið:
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia; ATC code: V03AE05
Icelandic: Lyf til meðferðar á hýperkalemíu og hýperfosfatemíu; ATC-flokkur:
English: High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton.
Icelandic: Flaska úr háþéttni pólýetýleni (HDPE) með barnaöryggisloki úr pólýprópýleni og þynnuinnsigli, sem inniheldur sameindasíuþurrkefni og bómull.
English: - The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Icelandic: - Virka efnið er járn sem sucroferric oxýhýdroxíð, einnig þekkt sem blanda af fjölkjarna járn(III)oxýhýdroxíði, súkrósa og sterkju.
English: Talk to your doctor or pharmacist before taking Velphoro: - if you have had peritonitis, an inflammation of the peritoneum (the thin tissue that lines the inner wall of the abdomen) within the last 3 months, - if you have significant stomach and/or liver problems, - if you have had major surgery on your stomach and/or intestines.
Icelandic: - ef þú hefur fengið lífhimnubólgu, þ.e. bólgu í lífhimnunni (þunna vefnum sem þekur innri vegg kviðarholsins) síðastliðna 3 mánuði, - ef þú ert með alvarlega maga- og/eða lifrarsjúkdóma, - ef þú hefur gengist undir stóra skurðaðgerð á maga og/eða görnum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACK) - 90 (3 PACKS OF 30) CHEWABLE TABLETS
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (FJÖLPAKKNING) - 90 (3 PAKKNINGAR MEÐ 30) TUGGUTÖFLUM
English: Velphoro works by binding phosphorus from food in your digestive tract (stomach and intestines).
Icelandic: Verkun Velphoro felst í því að binda fosfór úr fæðunni í meltingarveginum (maga og görnum).
English: Velphoro can cause discoloured (black) stool.
Icelandic: Velphoro getur valdið breyttum lit (svörtum) á hægðum.
English: There are no available clinical data from the use of Velphoro in breast-feeding women.
Icelandic: Ekki liggja fyrir neinar klínískar upplýsingar um notkun Velphoro hjá konum með barn á brjósti.
English: How to store Velphoro
Icelandic: Hvernig geyma á Velphoro
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France
Icelandic: Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRAKKLAND
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRANCE
Icelandic: Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex Frakkland
English: PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets
Icelandic: LYFJAFORM OG INNIHALD 30 × 1 tuggutöflur
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Icelandic: Hver tuggutafla inniheldur 500 mg af járni sem sucroferric oxýhýdroxíð, einnig þekkt sem fjölkjarna járn(III)-oxýhýdroxíð, súkrósa og sterkja.
English: Multipacks are available for the blister packs with 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablets each).
Icelandic: Þynnupakkningarnar eru fáanlegar í fjölpakkningum með 90 tuggutöflum (innihalda 3 stakar pakkningar, hver með 30 × 1 tuggutöflum).
English: Method of administration - Velphoro should only be taken by mouth.
Icelandic: - Aðeins skal taka Velphoro um munn.
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Icelandic: LYFJAFORM OG INNIHALD 30 tuggutöflur
English: If you are pregnant or breastfeeding, or you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum eða lyfjafræðingi áður en lyfið er notað.
English: 4.7 Effects on ability to drive and use machines Velphoro has no or negligible influence on the ability to drive and use machines.
Icelandic: Velphoro hefur engin eða óveruleg áhrif á hæfni til aksturs og notkunar véla.
English: When administering any medicinal product that is already known to interact with iron (like alendronate and doxycycline) or has the potential to interact with Velphoro based only on in vitro studies like levothyroxine, the medicinal product should be administered at least one hour before or two hours after Velphoro.
Icelandic: Þegar gefa á lyf sem vitað er að hefur milliverkanir við járn (t.d. alendrónat eða doxýcýklin) eða milliverkar mögulega við Velphoro, einungis byggt á in vitro rannsóknum, svo sem levótýroxín skal gefa lyfið a.m.k.
English: If you are not sure, talk to your doctor before taking this medicine.
Icelandic: Ef þú ert ekki viss skaltu leita upplýsinga hjá lækninum.
English: Hepatic impairment
Icelandic: Ógleði Hægðatregða
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/001 30 chewable tablets
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/943/001 30 tuggutöflur
English: PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets.
Icelandic: LYFJAFORM OG INNIHALD 30 × 1 tuggutöflur.
English: How to take Velphoro
Icelandic: Hvernig nota á Velphoro
English: Velphoro should only be used in these patients following careful assessment of benefit/risk.
Icelandic: Þessir sjúklingar skulu aðeins nota Velphoro að undangengnu nákvæmu mati á ávinningi og áhættu.
English: What Velphoro contains
Icelandic: Velphoro inniheldur
English: Table 1 Adverse reactions detected in clinical trials System Organ Class
Icelandic: Tafla 1 Aukaverkanir sem fram komu við klínískar rannsóknir
English: Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable tablets.
Icelandic: Álþynna/rifgötuð stakskammtaþynna úr áli með barnaöryggi, hver þynna inniheldur 6 tuggutöflur.
English: Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Icelandic: Dýrarannsóknir á eiturverkun á æxlun og fósturþroska benda ekki til skaðlegra áhrifa á meðgöngu, þroska fósturvísis/fósturs, got eða eftirburðarþroska (sjá kafla.
English: Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD.
Icelandic: Velphoro er ætlað til stjórnunar á sermisþéttni fosfórs hjá fullorðnum sjúklingum með langvinnan nýrnasjúkdóm sem eru í blóðskilun eða kviðskilun.
English: Velphoro contains starches.
Icelandic: Velphoro inniheldur súkrósa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON -30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS)
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA - 30 TUGGUTÖFLUR (5 ÞYNNUR MEÐ 6 TUGGUTÖFLUM)
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Icelandic: Velphoro 500 mg tuggutöflur járn sem sucroferric oxýhýdroxíð
English: If you stop taking Velphoro
Icelandic: Ef hætt er að nota Velphoro
English: Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Icelandic: Sermisþéttni fosfórs lækkar vegna minnkaðs frásogs fosfats úr fæðu.
English: Any instances of overdose of Velphoro (e.g. hypophosphataemia) should be treated by standard clinical practice.
Icelandic: Öll tilfelli ofskömmtunar með Velphoro (t.d. blóðfosfatsskort) skal meðhöndla samkvæmt stöðluðum klínískum starfsvenjum.
English: No dose-dependent trends were observed in the adverse reaction profile of Velphoro.
Icelandic: Engin skammtaháð tilhneiging kom fram í tengslum við aukaverkanir Velphoro.
English: It is unlikely that this medicine would pass into the mother's milk.
Icelandic: Ólíklegt er að lyfið berist í brjóstamjólk.
English: The absolute absorption studies in humans were not performed.
Icelandic: Ekki hafa verið gerðar rannsóknir á heildarfrásogi hjá mönnum.
English: Velphoro is for use by adult patients who undergo haemodialysis or peritoneal dialysis (procedures to eliminate toxic substances from the blood) because of chronic kidney disease; it is used in order to help control the phosphorus level in their blood when it is too high (hyperphosphataemia).
Icelandic: Velphoro er ætlað til notkunar fyrir fullorðna sjúklinga sem gangast undir blóðskilun eða kviðskilun (ferli sem beitt er til að fjarlægja eiturefni úr blóðinu) vegna langvinnra nýrnasjúkdóma.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Tablets must be chewed or crushed and taken with meals.
Icelandic: Töflurnar verður að tyggja eða mylja og þær verður að taka með máltíðum.
English: Discoloured stool
Icelandic: Vatnsfrí kísilkvoða
English: Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Icelandic: Hver tuggutafla inniheldur 500 mg af járni sem sucroferric oxýhýdroxíð.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Icelandic: VIRK(T) EFNI Hver tuggutafla inniheldur 500 mg af járni sem sucroferric oxýhýdroxíð.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/943/004
English: In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 - 2,000 mg iron per day (3 to 4 tablets).
Icelandic: Klínísk meðferð byggir á nauðsyn þess að stjórna sermisþéttni fosfórs, en sjúklingar sem svara meðferð með Velphoro ná yfirleitt ákjósanlegri sermisþéttni fosfórs með skömmtunum
English: Velphoro is for oral administration only and must be taken with meals.
Icelandic: Velphoro er eingöngu til inntöku og verður að taka með mat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Icelandic: YTRI UMBÚÐUM YTRI ASKJA - GLAS MEÐ 30 OG 90 TUGGUTÖFLUM
English: Information about sucrose and starches (carbohydrates) Velphoro contains sucrose.
Icelandic: Upplýsingar um súkrósa og sterkju (kolvetni)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Icelandic: INNRI UMBÚÐUM MERKIMIÐI - GLAS MEÐ 30 OG 90 TUGGUTÖFLUM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/943/003
English: INFORMATION IN BRAILLE velphoro
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI velphoro
English: • Haemochromatosis and any other iron accumulation disorders.
Icelandic: Járngeymdarkvilli eða aðrir járnuppsöfnunarsjúkdómar.
English: Colloidal anhydrous silica 6.2 Incompatibilities
Icelandic: 6.2 Ósamrýmanleiki
English: Abdominal distension Gastritis Abdominal discomfort Dysphagia Gastro-oesophageal reflux disease (GORD) Tongue discolouration
Icelandic: Magabólga Óþægindi í kvið Kyngingartregða Maga- vélindisbakflæðissjúkdómur (GORD)
English: - When taking Velphoro you should adhere to your recommended diet and treatments prescribed by your doctor such as calcium supplements, vitamin D3 or calcimimetics.
Icelandic: Velphoro er tekið, eins og varðandi inntöku á kalsíumuppbót, D3-vítamíni eða kalsíumhermandi lyfjum.
English: Nervous system disorders
Icelandic: Litarbreyting á hægðum
English: The usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets).
Icelandic: 1.500 mg af járni á sólarhring (3 töflur).
English: Maximum tolerated daily dose
Icelandic: Hámarks þolanlegur dagskammtur
English: Diarrhoea* Faeces discoloured
Icelandic: Tafla yfir aukaverkanir
English: See leaflet for furher information.
Icelandic: - Þessu lyfi hefur verið ávísað til persónulegra nota.
English: Only for the blister packs: - Separate the blister pack at perforations.
Icelandic: Aðeins fyrir þynnupakkningar:
English: None of the events were fatal.
Icelandic: Ekkert tilvikanna var banvænt.
English: YERVOY should not be frozen.
Icelandic: YERVOY má ekki frjósa.
English: Very limited data are available.
Icelandic: Mjög takmarkaðar upplýsingar liggja fyrir.
English: All patients were followed for at least 1 year.
Icelandic: 12. Öllum sjúklingum var fylgt eftir í minnst 1 ár.
English: a gp100 peptide vaccine is an experimental control.
Icelandic: a gp100 peptíðbóluefni er tilraunasamanburður
English: Number of Patients (%)
Icelandic: Fjöldi sjúklinga (%)
English: Duration of follow-up ranged up to 55 months.
Icelandic: Tímalengd eftirfylgni var allt að 55 mánuðum.
English: The study enrolled 13 patients < 12 of age and 20 patients ≥ 12 years of age.
Icelandic: Rannsóknin tók til 13 sjúklinga < 12 ára og 20 sjúklinga ≥ 12 ára.
English: Age ≥ 12 to 21 years
Icelandic: Aldur≥ 12 til 21 árs
English: These medicines may interfere with the effect of YERVOY.
Icelandic: Þessi lyf geta truflað áhrif YERVOY.
English: Deaths for pediatric patients are those with on-study events within 30 days of the last dose, except for “All Deaths,” which were >30 days after the last dose.
Icelandic: Dauðsföll hjá sjúklingum á barnsaldri eru þau sem urðu á rannsóknartíma innan 30 daga eftir síðasta skammt, fyrir utan „Öll dauðsföll“ sem urðu >30 dögum eftir síðasta skammt.
English: MedDRA v.17.0 for CA184070, v.19.0 for CA184178, and V.12.1 for Adult Safety Pool.
Icelandic: MedDRA v.17.0 fyrir CA184070, v.19.0 fyrir CA184178 og V.12.1 fyrir sameinaðar öryggisupplýsingar hjá fullorðnum.
English: Do not drive, cycle or use machines after you have been given YERVOY unless you are sure you are feeling well.
Icelandic: Hvorki má að aka, hjóla eða nota vélar eftir YERVOY innrennsli nema öruggt sé að líðan sé í lagi.
English: Median age was 15 years.
Icelandic: Miðgildi aldurs var 15 ár.
English: Most patients were male (58%) and white (92%).
Icelandic: Flestir sjúklinganna voru karlkyns (58%) og hvítir (92%).
English: Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Korea
Icelandic: Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Kórea
English: Children younger than 12 years of age
Icelandic: Börn yngri en 12 ára
English: The relationship of these malformations to treatment is unclear.
Icelandic: Tengsl þessa vanþroska við meðferðina eru óljós.
English: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States
Icelandic: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057
English: You will also have blood tests during treatment.
Icelandic: Einnig verða blóðsýni tekin á meðan á meðferð stendur.
English: Overall survival (OS) was also evaluated.
Icelandic: Heildarlifun (OS) var einnig metin.
English: In Phase 2 studies, this increase was dose-dependent.
Icelandic: Í II. stigs rannsóknum var þessi aukning skammtaháð.
English: No new or unexpected irARs were observed in this study.
Icelandic: Engar nýjar eða óvæntar ónæmistengdar aukaverkanir komu fram í rannsókninni.
English: The majority had received all 4 doses during induction.
Icelandic: Flestir höfðu fengið alla 4 skammta upphafsmeðferðarinnar.
English: What YERVOY is and what it is used for 2.
Icelandic: Upplýsingar um YERVOY og við hverju það er notað 2.
English: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events.
Icelandic: Stigun eiturverkana er samkvæmt National Cancer Institute Common Terminology Criteria for Adverse Events.
English: Tell your doctor immediately if you have any of these signs or symptoms or they get worse.
Icelandic: Segið lækninum þegar í stað ef eitthvert þessara einkenna kemur fram eða ef þau versna.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Icelandic: Á heildina litið var ekki munur á öryggi og verkun lyfsins hjá öldruðum (≥ 65 ára) og yngri sjúklingum (< 65 ára).
English: Not reached (5.2, NE)
Icelandic: Ekki náð (5,2, NE)
English: Table 3C:
Icelandic: Tafla 3C:
English: 14 months
Icelandic: 14 mánuðir
English: “+” denotes a censored observation.
Icelandic: “+” táknar að mæling er takmörkuð (censored observation).
English: All patients were HLA-A2*0201 type; this HLA type supports the immune presentation of gp100.
Icelandic: Allir sjúklingarnir voru af HLA-A2*0201 gerð; þessi HLA gerð styður ónæmistjáningu gp100.
English: Age 12 to < 18 years
Icelandic: Aldur 12 til < 18 ára
English: How YERVOY is given YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Icelandic: Gjöf YERVOY YERVOY er gefið á sjúkrahúsi eða á læknastofu undir eftirliti reynds læknis.
English: Version 4.0 (NCI-CTCAE v4).
Icelandic: Útgáfa 4.0 (NCI-CTCAE v4).
English: CA184332 and CA184338
Icelandic: CA184332 og CA184338
English: At the time of this analysis, medians were not reached for patients with CR or PR.
Icelandic: Þegar þessi greining var gerð voru ekki komi miðgildi fyrir sjúklinga með CR eða PR.
English: Do not take any other medicines during your treatment without talking to your doctor first.
Icelandic: Ekki má taka önnur lyf meðan á meðferðinni stendur án þess að tala við lækninn.
English: if you have any history of inflammation of the lungs
Icelandic: ef þú ert með sögu um bólgu í lungum
English: Complete response (CR) Partial response (PR) Stable disease (SD)
Icelandic: Alger svörun (CR) Hlutasvörun (PR) Stöðugur sjúkdómur (SD)
English: For patients with a history of autoimmune disease, see also section 4.4.
Icelandic: Sjúklingar með sögu um sjálfsnæmissjúkdóm, sjá einnig kafla 4.4
English: Fertility studies have not been performed.
Icelandic: Rannsóknir á frjósemi hafa ekki verið gerðar.
English: Based on a stratified log-rank test.
Icelandic: Samkvæmt lagskiptri raðprófanaskrá (log-rank).
English: (HR 0.89 with a 95% CI of 0.76, 1.04 and log-rank test P-value = 0.1548).
Icelandic: (HR 0,89 með 95% CI: 0,76; 1,04 og log-rank próf p-gildi= 0,1548).
English: The potential risk of treatment to the developing foetus is unknown.
Icelandic: Möguleg hætta fyrir fóstur er ekki þekkt.
English: Cmax, Cmin and AUC of ipilimumab were found to be dose proportional within the dose range examined.
Icelandic: Cmax, Cmin og AUC ipilimumabs voru í réttu hlutfalli við skammta á því skammtabili sem skoðað var.
English: Skin:
Icelandic: Húð:
English: A total of 77 patients had a history of previously treated brain metastases.
Icelandic: Alls höfðu 77 sjúklingar sögu um fyrri meðferð við meinvörpum í heila.
English: What YERVOY is and what it is used for
Icelandic: Upplýsingar um YERVOY og við hverju það er notað
English: If you become pregnant while using YERVOY tell your doctor.
Icelandic: Ef þú verður barnshafandi meðan á meðferð með YERVOY stendur skaltu láta lækninn vita.
English: Neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Icelandic: Hlutleysandi mótefni gegn ipilimumabi var á bilinu 0 til 0,3%.
English: Your doctor will continue giving you YERVOY for a total of 4 doses, depending on your tolerance to the treatment.
Icelandic: Læknirinn heldur áfram að gefa þér YERVOY, alls 4 skammta, eftir því hvernig þú þolir meðferðina.
English: How to store YERVOY 6.
Icelandic: 5. Hvernig geyma á YERVOY 6.
English: Attribution to ipilimumab reported as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070.
Icelandic: Greint frá tengslum við imilimumab sem hugsanlega, líklega, ótvírætt eða vantar fyrir CA184178 og Adult Safety Pool, og tengt eða vantar fyrir CA184070.
English: Table 3A
Icelandic: Tafla 3A
English: The most common clinical presentation includes headache and fatigue.
Icelandic: Meðal algengustu klínísku einkennanna eru höfuðverkur og þreyta.
English: It is available in packs containing either 1 glass vial of 10 ml or 1 glass vial of 40 ml.
Icelandic: Það er í pakkningum með 1 glerhettuglasi með 10 ml eða 1 glerhettuglasi með 40 ml.
English: Only very limited data are available in children younger than 12 years of age.
Icelandic: Aðeins mjög takamarkaðar upplýsingar liggja fyrir hjá börnum yngri en 12 ára.
English: 10 months
Icelandic: 10 mánuðir
English: Table 3B
Icelandic: Tafla 3B
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Icelandic: Geymsluskilyrði lyfsins eftir fyrstu opnun eða þynningu, sjá kafla 6.3.
English: Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) Sodium chloride
Icelandic: Tris hýdróklóríð (2-amínó-2-hýdroxymetýl-1,3-própanedíól hýdróklóríð) Natríumklóríð
English: Do not stop treatment with YERVOY unless you have discussed this with your doctor.
Icelandic: Þú skalt ekki hætta meðferð með YERVOY nema ræða það við lækninn.
English: The amount of YERVOY you will be given will be calculated based on your body weight.
Icelandic: Magn YERVOY sem þú færð er reiknað út frá líkamsþyngd.
English: Until administration of all 4 doses or 16 weeks from first dose, whichever occurs earlier.
Icelandic: Þar til allir 4 skammtarnir hafa verið gefnir eða 16 vikur eru liðnar frá fyrsta skammti, hvort sem verður á undan.
English: You may notice the appearance of new lesions or growth of existing lesions on your skin, which can be expected when you are being treated with YERVOY.
Icelandic: Þú gætir tekið eftir nýjum sárum á húð eða sár sem fyrir eru gætu stækkað, eins og búast má við meðan á meðferð með YERVOY stendur.
English: The primary efficacy endpoint was 1-year survival rate.
Icelandic: Aðalendapunktur verkunar var 1 árs lifunarhlutfall.
English: NCI-CTCAE v4 Gradea
Icelandic: NCI-CTCAE v4a
English: Please refer to the package leaflet of nivolumab in order to understand the use of this medicine.
Icelandic: Lestu fylgiseðilinn fyrir nivolumab til þess að skilja hvernig lyfið er notað.
English: Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Icelandic: Slembiröðunin var lagskipt samkvæmt PD-L1 tjáningu (≥ 5% miðað við < 5% tjáningu æxlisfrumuhimnu), BRAF stöðu og M stöðu samkvæmt stigun AJCC (American Joint Committee on Cancer).
English: The estimated geometric mean CL is 8.72 mL/h in adolescent patients aged ≥12 to <18 years.
Icelandic: Áætlað margfeldismeðaltal úthreinsunar er 8,72 ml/klst. hjá sjúklingum á unglingsaldri ≥12 til <18 ára.
English: Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Icelandic: Upplýsingar í þessum köflum endurspegla fyrst og fremst reynslu úr III. stigs rannsókn, MDX010-20.