FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion
Icelandic: Kyprolis 10 mg innrennslisstofn, lausn Kyprolis 30 mg innrennslisstofn, lausn Kyprolis 60 mg innrennslisstofn, lausn
English: PFS months median (95% CI) HR (95% CI); 1-sided p-valueb
Icelandic: PFS mánuðir, miðgildi (95% CI) HR (95% CI); 1-hliða p-gildib
English: • Multi-organ failure
Icelandic: Bilun í mörgum líffærum
English: 30 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with an orange plastic flip off cap.
Icelandic: 30 ml gegnsætt hettuglas úr gleri af tegund I, lokað með flúoropólýmer, lagskiptum tappa úr teygjanlegri fjölliðu og álinnsigli með fjarlægjanlegri appelsínugulri hettu úr plasti.
English: Renal function should be monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance.
Icelandic: mánaðarlega eða í samræmi við samþykktar klínískar leiðbeiningar, sérstaklega hjá sjúklingum með lægri kreatínínúthreinsun í upphafi.
English: • Low blood pressure (hypotension)
Icelandic: Lágur blóðþrýstingur (lágþrýstingur)
English: Carfilzomib is a cytotoxic agent.
Icelandic: Carfilzomib er frumuskemmandi lyf.
English: • Fluid in the lungs
Icelandic: Vökvi í lungum
English: Discard unused portions in accordance with local requirements.
Icelandic: Farga skal öllum lyfjaleifum í samræmi við gildandi reglur.
English: Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes.
Icelandic: Carfilzomib olli litningaskemmdum eða litningasundrun í in vitro prófi á litningafráviki í útlægum blóðeitilfrumum.
English: Cycle 1
Icelandic: Vika 1
English: • Blood clots in the veins (deep vein thrombosis)
Icelandic: Blóðtappi í bláæðum (djúpbláæðarstorka)
English: Haemorrhage
Icelandic: Heilablóðfall
English: As Kyprolis is administered in combination with other medicinal products, the summary of product characteristics of these other medicinal products must be consulted prior to initiation of treatment with Kyprolis.
Icelandic: 4.4 Sérstök varnaðarorð og varúðarreglur við notkun Þegar Kyprolis er gefið samhliða öðrum lyfjum verður að lesa samantekt á eiginleikum þeirra lyfja áður en meðferð með Kyprolis er hafin.
English: For men taking Kyprolis
Icelandic: Fyrir karlmenn sem nota Kyprolis
English: Infusion reactions, including life-threatening reactions, have been reported in patients who received Kyprolis.
Icelandic: Greint hefur verið frá viðbrögðum við innrennsli, þ.m.t. lífshættulegum viðbrögðum, hjá sjúklingum sem fengu Kyprolis.
English: Carfilzomib had antiproliferative and proapoptotic activities in preclinical models in haematologic tumours.
Icelandic: Carfilzomib hafði neikvæð áhrif á fjölgun og jákvæða verkun á stýrðan frumudauða í forklínískum líkönum (preclinical models) í blóðæxlum.
English: Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay.
Icelandic: Carfilzomib framkallaði ekki stökkbreytingu í in vitro sýklaprófi fyrir afturhvarfs stökkbreytingu
English: 50 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a purple plastic flip off cap.
Icelandic: 50 ml gegnsætt hettuglas úr gleri af tegund I, lokað með flúoropólýmer, lagskiptum tappa úr teygjanlegri fjölliðu og álinnsigli með fjarlægjanlegri rauðfjólublárri hettu úr plasti.
English: Kd Arm (N = 464)
Icelandic: Kd hópur (N = 464)
English: Baseline hepatic function status had no marked effect on the total systemic exposure (AUClast) of carfilzomib following single or repeat-dose administration (geometric mean ratio in AUClast at the 27 mg/m2 dose in cycle 1, day 16 for mild and moderate impairment versus normal hepatic function were 144.4% and 126.1%, respectively; and at the 56 mg/m2 dose in cycle 2, day 1 were 144.7% and 121.1%).
Icelandic: 1 á degi 16 fyrir væga og miðlungsmikla skerðingu samanborið við eðlilega lifrarstarfsemi 144,4% og 126,1% í sömu röð; og var við 56 mg/m2 skammt í meðferðarlotu 2 á degi 1, 144,7% og 121,1%).
English: Monkeys administered a single bolus intravenous dose of carfilzomib at 3 mg/kg (which corresponds to 36 mg/m2 and is similar to the recommended dose in humans of 27 mg/m2 based on BSA) experienced hypotension, increased heart rate, and increased serum levels of troponin T. The repeated bolus intravenous administration of carfilzomib at ≥ 2 mg/kg/dose in rats and 2 mg/kg/dose in monkeys using dosing schedules similar to those used clinically resulted in mortalities that were due to toxicities occurring in the cardiovascular (cardiac failure, cardiac fibrosis, pericardial fluid accumulation, cardiac haemorrhage/degeneration), gastrointestinal (necrosis/haemorrhage), renal (glomerulonephropathy, tubular necrosis, dysfunction), and pulmonary (haemorrhage/inflammation) systems.
Icelandic: Apar sem fengu staka inndælingu 3 mg/kg skammts af carfilzomibi (sem svara til 36 mg/m2 og er sambærilegt ráðlögðum skammti hjá mönnum sem er 27 mg/m2 miðað við líkamsyfirborð) fengu lágþrýsting, aukinn hjartslátt og aukið magn troponín T í sermi.
English: Increased alanine aminotransferase Increased aspartate aminotransferase Gammaglutamyltransferase increased
Icelandic: Aukinn aspartatamínótransferasi
English: Kyprolis 30 mg powder for solution for infusion
Icelandic: Kyprolis 30 mg innrennslisstofn, lausn
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1060/002
English: • Runny nose, nasal congestion or sneezing
Icelandic: Nefrennsli, nefstífla eða hnerri
English: Vd Arm (N = 465)
Icelandic: Vd hópur (N = 465)
English: Kyprolis in combination with dexamethasone
Icelandic: Kyprolis í samsetningu með dexamethasoni
English: Consequently, as a precautionary measure, breast-feeding is contra-indicated during and for at least 2 days after treatment with Kyprolis.
Icelandic: Af því leiðir að í varúðarskyni skal ekki gefa brjóst meðan á meðferð með Kyprolis stendur og í a.m.k.
English: • Flu-like symptoms (influenza)
Icelandic: Flensulík einkenni (inflúensa)
English: Kyprolis in combination with lenalidomide and dexamethasonea
Icelandic: Kyprolis í samsetningu með lenalidomidi og dexamethasoni
English: GRH0219EN v1
Icelandic: GRH0172IS v2
English: Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Icelandic: Greint hefur verið frá tilfellum æxlislýsuheilkennis, einnig banvænum, hjá sjúklingum sem fá Kyprolis.
English: What you need to know before you use Kyprolis
Icelandic: Áður en byrjað er að nota Kyprolis
English: In vitro, at concentrations (3 µM) lower than those expected at therapeutic doses, carfilzomib inhibits the efflux transport of digoxin, a P-gp substrate, by 25%.
Icelandic: Carfilzomib hamlar útflæði digoxins, P-gp hvarfefnis, um 25% in vitro í lægri styrkleika (3 µM) en gert er ráð fyrir við meðferðarskammta.
English: Number of Subjects at Risk:
Icelandic: Fjöldi sjúklinga:
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; PFS = progression-free survival; mo = months; HR = hazard ratio; CI = confidence interval
Icelandic: Kd = Kyprolis ásamt dexamethasoni; Vd = bortezomib ásamt dexamethasoni; PFS = lifun án versnunar sjúkdóms; mán.
English: Kyprolis 10 mg powder for solution for infusion
Icelandic: Kyprolis 10 mg innrennslisstofn, lausn
English: Stop Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Icelandic: Stöðva skal Kyprolis vegna lungnaháþrýstings þar til ástandið hefur lagast eða náð upphafsgildum aftur og íhuga skal hvort hefja eigi meðferð með Kyprolis aftur út frá mati á ávinningi/áhættu (sjá kafla 4.2).
English: Carfilzomib is eliminated primarily via metabolism with subsequent excretion of its metabolites in urine.
Icelandic: Brotthvarf carfilzomibs gerist fyrst og fremst með umbroti og umbrotsefnin sem myndast eru skilin út með þvagi.
English: LIST OF EXCIPIENTS Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Icelandic: HJÁLPAREFNI Betadex súlfóbútýleter natríum, vatnsfrí sítrónusýra (E330), natríumhýdroxíð.
English: • Bleeding in the stomach and bowels
Icelandic: Blæðing í maga og þörmum
English: There is no known specific antidote for carfilzomib overdose.
Icelandic: Ekki er vitað um neitt sértækt mótefni við carfilzomib ofskömmtun.
English: Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Icelandic: Greint hefur verið frá kuldahrolli, lágþrýstingi, skertri nýrnastarfsemi, blóðflagnafæð og eitilfrumnafæð sem komu fljótt fram eftir 200 mg skammt af Kyprolis, sem gefinn var fyrir mistök.
English: Hepatic impairment
Icelandic: Hjartasjúkdómar
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib and dexamethasone; CI = confidence interval; NE = not estimable; HR = Hazard Ratio; ORR = overall response rate; CR = complete response; VGPR = very good partial response a. These endpoints were determined by an Independent Review Committee b. Statistically significant c. Overall response is defined as achieving a best overall response of PR, VGPR, CR, or sCR d. Statistically significant, 1-sided p value = 0.0005 e. Statistically significant, 1-sided p value = 0.0001
Icelandic: Kd = Kyprolis ásamt dexamethasoni; Vd = bortezomib og dexamethason; CI = öryggismörk; NE = ekki hægt að meta; HR = áhættuhlutfall; ORR = heildarhlutfall svörunar; CR = fullnaðarsvörun; VGPR = mjög góð hlutasvörun a. Endapunktar ákvarðaðir af óháðri matsnefnd b. Tölfræðilega marktækt c.
English: • Cough which could include chest tightness or pain, nasal congestion (bronchitis)
Icelandic: Hósti sem getur haft brjóstþyngsli eða verki í för með sér, nefstífla (berkjubólga)
English: Instructions for reconstitution and preparation of Kyprolis powder for solution for infusion for intravenous administration
Icelandic: Kyprolis innrennslisstofns, lausnar til gjafnar í bláæð
English: Study eligibility criteria allowed patients previously treated with carfilzomib (n = 3) or bortezomib (n = 502) to be enrolled as long as patients had at least a partial response (PR) to prior proteasome inhibitor therapy, were not removed from proteasome inhibitor therapy due to toxicity, and had at least a 6-month proteasome inhibitor treatment-free interval from last dose.
Icelandic: Skilyrði rannsóknarinnar fyrir þátttöku leyfðu sjúklingum sem áður höfðu fengið meðferð með carfilzomibi (n = 3) eða bortezomibi (n = 502) að taka þátt, svo framarlega sem sjúklingarnir höfðu sýnt a.m.k.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1060/001
English: Pulmonary haemorrhage Interstitial lung disease
Icelandic: Millivefslungnasjúkdómur Lungnabólga
English: Symptoms may include fever, chills, arthralgia, myalgia, facial flushing, facial oedema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina.
Icelandic: Einkenni geta verið hiti, kuldahrollur, liðverkur, vöðvaverkir, roði í andliti, bjúgur í andliti, uppköst, máttleysi, mæði, lágþrýstingur, yfirlið, þyngsli fyrir brjósti eða hjartaöng.
English: • Serious infection including infection in the blood (sepsis)
Icelandic: Eiturverkanir ekki í blóði (nýru)
English: Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Icelandic: Betadex súlfóbútýleter natríum, vatnsfrí sítrónusýra (E330), natríumhýdroxíð.
English: Recommended actions and dose modifications are presented in table 3.
Icelandic: Ráðlögð viðbrögð og skammtaaðlögun er talin upp í töflu
English: Discard any unused portion left in the vial.
Icelandic: Fargið ónotuðum lyfjaleifum sem kunna að vera eftir í hettuglasinu.
English: Lymphopenia Leukopenia
Icelandic: Lifrarbilun Gallteppa
English: • A general feeling of illness or discomfort
Icelandic: Lasleikatilfinning eða óþægindi
English: Dyspnoea was commonly reported in patients treated with Kyprolis.
Icelandic: Algengt var að greint væri frá mæði hjá sjúklingum sem fengu meðferð með Kyprolis.
English: Infusion site reactions
Icelandic: Viðbrögð á innrennslisstað
English: Musculoskeletal pain Musculoskeletal chest pain
Icelandic: Lungnasegarek Lungnabjúgur Blóðnasir
English: Gastrointestinal haemorrhage Dyspepsia Toothache
Icelandic: Útbrot Kláði Roði Ofsvitnun
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of carfilzomib.
Icelandic: Hvert hettuglas inniheldur 10 mg af carfilzomibi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1060/003
English: In vitro, carfilzomib was found to have minimal neurotoxicity and minimal reaction to non-proteasomal proteases.
Icelandic: In vitro reyndust taugaskemmdir carfilzomibs vera í lágmarki og viðbrögð við próteinkljúfum sem ekki eru meltikorn voru í lágmarki.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 60 mg of carfilzomib.
Icelandic: Hvert hettuglas inniheldur 60 mg af carfilzomibi.
English: Stop Kyprolis for grade 3 or 4 cardiac events until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment (see section 4.2).
Icelandic: 3. eða 4. stigs hjartasjúkdómur þar til bati hefur náðst og íhuga skal hvort hefja eigi meðferð aftur með Kyprolis með eins þrepa skammtalækkun út frá mati á ávinningi/áhættu (sjá kafla 4.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 60 mg powder for solution for infusion carfilzomib
Icelandic: Kyprolis 60 mg innrennslisstofn, lausn carfilzomib
English: Evaluate and stop Kyprolis until resolved and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Icelandic: Kyprolis þar til ástand hefur lagast eða náð grunngildi og íhuga hvort hefja eigi meðferð með Kyprolis aftur út frá mati á ávinningi/áhættu (sjá kafla 4.2).
English: Therefore, resumption of therapy should be discussed with experts in managing HBV.
Icelandic: Því skal ræða við sérfræðinga í meðferð HBV um hvort hefja skuli meðferð að nýju.
English: Hypertensive emergency
Icelandic: SÉRSTÖK VARNAÐARORÐ
English: • Heart attack
Icelandic: Hjartaáfall
English: Pneumonitis
Icelandic: Lyfjaofnæmi
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 30 mg powder for solution for infusion carfilzomib
Icelandic: Kyprolis 30 mg innrennslisstofn, lausn carfilzomib
English: Infusion related reaction
Icelandic: Viðbrögð við innrennsli
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 30 mg of carfilzomib.
Icelandic: Hvert hettuglas inniheldur 30 mg af carfilzomibi.
English: Death, n (%) Median OS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Icelandic: HR (Kd/Vd) (95% CI) p-gildi (1-hliða)
English: Caution should be observed when carfilzomib is combined with substrates of P-gp (e.g. digoxin, colchicine).
Icelandic: P-gp (t.d. digoxin, colchicin).
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion carfilzomib
Icelandic: Kyprolis 10 mg innrennslisstofn, lausn carfilzomib
English: LIST OF EXCIPIENTS
Icelandic: Hlutfall lifunar
English: For clinical management of cardiac disorders during Kyprolis treatment, see section 4.4.
Icelandic: Upplýsingar um klíníska meðhöndlun hjartasjúkdóma meðan á meðferð með Kyprolis stendur má sjá í kafla 4.4.
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis.
Icelandic: Greint hefur verið frá tilfellum blóðsegareks í bláæðum, þ.m.t. segamyndun í djúplægum bláæðum og banvænum tilfellum lungnasegareks, hjá sjúklingum sem fengu Kyprolis.
English: If you are given too much Kyprolis
Icelandic: áður en Kyprolis er gefið.
English: Death, n (%) Median OS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Icelandic: HR (KRd/Rd) (95% CI) p-gildi (1-hliða)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kyprolis 10 mg powder for solution for infusion Each vial contains 10 mg of carfilzomib.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Kyprolis 10 mg innrennslisstofn, lausn carfilzomib i.v.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion.
Icelandic: Blandað lyfið á að vera tær, litlaus til lítillega gul lausn.
English: Pneumonia Respiratory tract infection
Icelandic: Lungnabólga Sýking í öndunarvegi
English: Remove vial from refrigerator just prior to use.
Icelandic: Takið hettuglas úr kæli rétt fyrir notkun.
English: Kaplan-Meier curve of overall survival in relapsed multiple myelomaa
Icelandic: Meier ferill yfir heildarlifun fyrir mergæxli með bakslagia
English: Kyprolis contains sodium
Icelandic: Kyprolis inniheldur natríum
English: There have been cases of QT interval prolongation reported in clinical studies.
Icelandic: QT bils í klínískum rannsóknum.
English: Table 4.
Icelandic: Tafla 4. minnkun
English: Acute respiratory failure
Icelandic: Sýking í öndunarfærum
English: Electrocardiographic changes
Icelandic: Breytingar á hjartaafriti
English: In clinical studies with Kyprolis, cardiac failure was reported in approximately 7% of subjects (5% of subjects had grade ≥ 3 events), myocardial infarction was reported in approximately 2% of subjects (1.5% of subjects had grade ≥ 3 events) and myocardial ischaemia was reported in approximately 1% of subjects (< 1% of subjects had grade ≥ 3 events).
Icelandic: 2% þátttakenda (1,5% þátttakenda var með atvik af gráðu ≥ 3) og blóðþurrð í hjarta hjá u.þ.b. 1% þátttakenda (< 1% þátttakenda var með atvik af gráðu ≥ 3).
English: Thrombocytopenia Neutropenia Anaemia
Icelandic: Uppköst Niðurgangur Hægðatregða Kviðverkir
English: Dose modifications during Kyprolis treatment
Icelandic: Tafla 3. Skammtaaðlögun meðan á meðferð með Kyprolis stendur
English: For clinical management of hepatic toxicity during Kyprolis treatment, see section 4.4.
Icelandic: Upplýsingar um klíníska meðhöndlun eiturverkana á lifur meðan á meðferð með Kyprolis stendur má sjá í kafla 4.4.
English: The geometric mean ratios in AUClast at the 27 mg/m2 dose cycle 1, day 16 and at the 56 mg/m2 dose cycle 2, day 1 for ESRD versus normal renal function were 139.72% and 132.75%, respectively.
Icelandic: Margfeldismeðaltalshlutfall AUClast eftir 27 mg/m2 skammt á degi 16 í lotu 1 og eftir 56 mg/m2 skammt á degi 1 í lotu
English: Drug hypersensitivity
Icelandic: TTP Segaöræðakvilli
English: No starting dose adjustment is recommended in patients with mild or moderate hepatic impairment based on available pharmacokinetic data.
Icelandic: Á grundvelli fyrirliggjandi upplýsinga um lyfjahvörf er engin skammtaaðlögun á upphafsskammti ráðlögð hjá sjúklingum með vægt eða miðlungsmikið skerta lifrarstarfsemi.
English: Other non-haematologic toxicity
Icelandic: Aðrar eiturverkanir ekki í blóði
English: For clinical management of hypertension during Kyprolis treatment, see section 4.4.
Icelandic: Upplýsingar um klíníska meðhöndlun mæði meðan á meðferð með Kyprolis stendur má sjá í kafla 4.4.
English: Summary of safety profile
Icelandic: Niðurstöður rannsóknar
English: The second study was conducted in 23 relapsed multiple myeloma patients with creatinine clearance ≥ 75 mL/min (n = 13) and patients with end stage renal disease (ESRD) requiring dialysis (n = 10).
Icelandic: Síðari rannsóknin var gerð hjá 23 sjúklingum með endurkomið mergæxli með kreatínínúthreinsun ≥ 75 ml/mín.
English: Infusion reactions
Icelandic: Hitatilfinning
English: Kaplan-Meier curve of progression-free survival in relapsed multiple myelomaa
Icelandic: Meier ferill af lifun án versnunar sjúkdóms fyrir mergæxli með bakslagia
English: Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis.
Icelandic: Háþrýstingur, þ.m.t. háþrýstingskreppa og háþrýstingur sem þarf að bregðast strax við, hefur komið fram við notkun Kyprolis.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Icelandic: Upplýsingar um blöndun og undirbúning
English: The study showed significant improvement in PFS for patients in the Kd arm over those in the Vd arm (HR: 0.53, 95% CI: 0.44, 0.65 [p value < 0.0001]) (see figure 3).
Icelandic: (HR: 0,53; 95% CI: 0,44; 0,65 [p gildi < 0,0001]) (sjá mynd 3).
English: Increased blood creatinine
Icelandic: Aukið kreatínín í blóði
English: Paediatric population
Icelandic: Ristilbólga af völdum
English: Vomiting Diarrhoea Constipation Abdominal pain Nausea
Icelandic: Stórfrumuveirusýking Endurvirkjun lifrarbólguveiru B
English: Acute kidney injury Renal failure Renal impairment Decreased creatinine renal clearance
Icelandic: Sýkingar af völdum sýkla og sníkjudýra
English: Injury, poisoning and procedural complications
Icelandic: Eftirlit með vökvun, vökvum og söltum
English: Enrolled subjects were defined as refractory to a therapy if they met any of the following 3 criteria: nonresponsive (< minimal response) to any regimen; progression during any regimen; or progression within 60 days of completion of any regimen.
Icelandic: Svara ekki meðferð á einhverju lyfi (< lágmarkssvörun), versnun meðan á einhverri lyfjameðferð stendur eða versnun innan 60 daga eftir að einhverri lyfjameðferð lauk.
English: Paraesthesia Hypoaesthesia
Icelandic: Endurvirkjun lifrarbólguveiru
English: Renal impairment
Icelandic: Kvíði Ruglástand
English: • Toothache
Icelandic: 13. LOTUNÚMER
English: Pruritus Erythema Hyperhidrosis
Icelandic: Inflúensulík einkenni Lasleiki
English: This is normal, they will not harm you.
Icelandic: Það er eðlilegt, þær munu ekki skaða þig.
English: Here are some reminders.
Icelandic: Hér eru nokkrar áminningar.
English: Extra items you will need:
Icelandic: Viðbótarhlutir sem þú munt þarfnast:
English: Get medical help immediately.
Icelandic: Leitið tafarlaust læknishjálpar.
English: But your doctor will have told you exactly how much to use, when to use it, and how often.
Icelandic: Læknirinn hefur sagt þér nákvæmlega hve mikið á að nota, hvenær á að nota það og hve oft.
English: These instructions are only for you.
Icelandic: Þessar leiðbeiningar eiga aðeins við um þig.
English: Wash your hands.
Icelandic: Þvoðu hendurnar.
English: - Are you exercising more than usual?
Icelandic: Stundar þú meiri hreyfingu en venjulega?
English: If you find it hard to press the button in:
Icelandic: Ef þér finnst erfitt að þrýsta hnappnum inn:
English: Read this first
Icelandic: Lesið þetta fyrst
English: This is especially important if you have other injector pens.
Icelandic: Þetta er sérstaklega mikilvægt ef þú ert með aðra innsælingarpenna.
English: If you do not follow all of these instructions, you may get too much or too little insulin.
Icelandic: Ef þú fylgir ekki öllum leiðbeiningunum gæti verið að þú fengir of mikið eða of lítið insúlín.
English: If you do not respond to glucagon, you will have to go to hospital.
Icelandic: Ef þú svarar ekki glucagoni munt þú þurfa að fara á sjúkrahús.
English: If this happens to you, tell your doctor.
Icelandic: Ef þetta kemur fyrir þig skaltu segja lækninum frá því.
English: Ask your doctor to tell you about glucagon.
Icelandic: Þú skalt biðja lækninn um að segja þér frá glucagoni.
English: If you need to, you can inject soon after a meal.
Icelandic: Ef þú þarft þess getur þú sprautað því fljótlega eftir máltíð.
English: Never share your pen - it is only for you.
Icelandic: Deilið aldrei lyfjapennanum - hann er aðeins fyrir þig.
English: This can be caused if:
Icelandic: Þetta getur verið vegna þess að:
English: • Always carry sugar with you.
Icelandic: Alltaf vera með sykur á þér.
English: The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.
Icelandic: Tímamismunur milli landa getur þýtt að þú þurfir að fá inndælingarnar og máltíðir á öðrum tíma en þegar þú ert heima.