FrancophonIA/ELRC3.0 huggingface dataset:
English: Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with CellCept.
Icelandic: Vart hefur orðið við einstök tilvik um óeðlilega myndun daufkyrninga, að meðtöldu áunnu PelgerHuet frábrigði, hjá sjúklingum sem fengið hafa CellCept.
English: Method and route of administration
Icelandic: Aðferð við gjöf og íkomuleið
English: STATEMENT OF ACTIVE SUBSTANCE(S) 5 ml suspension contains 1 g mycophenolate mofetil when reconstituted.
Icelandic: VIRK(T) EFNI 5 ml af dreifu innihalda 1 g af mýcófenólat mofetíli eftir blöndun.
English: Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
Icelandic: Í þessum kafla á að leggja áherslu á ítarlegar, fræðandi og samfelldar samræður sjúklinga við heilbrigðisstarfsmenn um hættu sem stafar af mýcófenólat mofetíli á meðgöngu og viðeigandi aðgerðir til að draga úr henni, þ.m.t. önnur meðferðarúrræði ef við á. Leggja á áherslu á nauðsyn þess að stýra því hvort og hvenær þungun verður.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/002 CellCept
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/002 CellCept
English: Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal and hepatic transplant patients.
Icelandic: Vegna mikils munar á tíðni sumra aukaverkana eftir því hvers kyns líffæraígræðslu var um að ræða er tíðni tilgreind sérstaklega fyrir sjúklinga sem fengu nýrna- og lifrarígræðslu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001 CellCept
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/001 CellCept
English: Discard the vial if particulate matter or discoloration is observed.
Icelandic: Farga á hettuglasinu ef agnir eða litabreytingar sjást.
English: • The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
Icelandic: Dagskammtur er 8 hylki (2 g af lyfinu) tekinn í tvennu lagi.
English: Congenital disorders
Icelandic: Meltingartruflanir
English: Do not use after the expiry date stated on the carton and vial label (EXP).
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og merkimiða á hettuglösunum (Fyrnist).
English: 4 Vials
Icelandic: 4 daga
English: Hyperglycemia
Icelandic: Taugakerfi Sundl
English: Pregnancy and breast-feeding
Icelandic: Efnaskipti og næring Blóðsýring
English: The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
Icelandic: Dagskammtur er 6 töflur (3 g af lyfinu) tekinn í tvennu lagi.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including CellCept.
Icelandic: (PML-heilabólgu) sem tengdust JC-veiru hjá sjúklingum sem fengu meðferð með ónæmisbælandi lyfjum, þ.m.t. CellCept.
English: (mycophenolate mofetil)
Icelandic: Sýndareitilæxli (pseudo-lymphoma)
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacture(s) responsible for batch release CellCept 500 mg powder for concentrate for solution for infusion CellCept 1 g/5 ml powder for oral suspension: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
Icelandic: FRAMLEIÐANDI/FRAMLEIÐENDUR SEM ER(U) ÁBYRGUR/ÁBYRGIR FYRIR LOKASAMÞYKKT Heiti og heimilisfang/-föng framleiðanda/framleiðenda sem er(u) ábyrgur/ábyrgir fyrir lokasamþykkt CellCept 500 mg stofn fyrir innrennslisþykkni, lausn CellCept 1 g/5 ml mixtúruduft, dreifa:
English: Inspect the resulting solution for particulate matter and discoloration prior to further dilution.
Icelandic: Lausnin er skoðuð með tilliti til agna og litabreytinga áður en hún er þynnt.
English: Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal, hepatic and cardiac transplant patients.
Icelandic: Vegna mikils munar á tíðni sumra aukaverkana eftir því hvers kyns líffæraígræðslu var um að ræða er tíðni tilgreind sérstaklega fyrir sjúklinga sem fengu nýrna-, lifrarog hjartaígræðslu.
English: MPA AUC values obtained following administration of 1 g BID intravenous CellCept to renal transplant patients in the early post-transplant phase are comparable to those observed following 1 g BID oral CellCept.
Icelandic: AUC gildi fyrir MPA eftir gjöf á CellCept 1 g í æð tvisvar á dag hjá nýrnaþegum stuttu eftir ígræðslu voru sambærileg við gildi eftir CellCept 1 g til inntöku tvisvar á dag.
English: Allow it to dry in the air before using it again.
Icelandic: Látið hann þorna fyrir næstu notkun.
English: Skin problems such as:
Icelandic: Hjarta- og æðakvillar svo sem:
English: 5 ml of the reconstituted suspension contain 1 g of mycophenolate mofetil.
Icelandic: 5 ml af blandaðri mixtúru innihalda 1 g af mýcófenólat mofetíli.
English: • telmisartan - used to treat high blood pressure
Icelandic: • telmisartan - notað við háum blóðþrýstingi.
English: Contents of the pack and other information Making-up the medicine
Icelandic: Hugsanlegar aukaverkanir Hvernig geyma á CellCept Pakkningar og aðrar upplýsingar Blöndun lyfsins
English: The first dose is given within 3 days of the transplant operation.
Icelandic: Fyrsti skammturinn er gefinn innan 3 sólarhringa frá ígræðslu.
English: NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
Icelandic: CellCept 1 g/5 ml mixtúruduft, dreifa (mýcófenólat mofetíl)
English: CellCept 500 mg film-coated tablets
Icelandic: CellCept 500 mg filmuhúðaðar töflur (mýcófenólat mofetíl)
English: What CellCept contains
Icelandic: CellCept inniheldur
English: Hypercholesterolemia
Icelandic: Blóðkalíumlækkun
English: The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
Icelandic: Dagskammtur er 12 hylki (3 g af lyfinu) tekinn í tvennu lagi.
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
Icelandic: CellCept 500 mg stofn fyrir innrennslisþykkni, lausn (mýcófenólat mofetíl)
English: Take the dispenser and push the plunger completely down toward the tip of the dispenser.
Icelandic: Ýtið stimplinum alveg niður að oddi skammtarans.
English: CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion.
Icelandic: CellCept 500 mg stofn fyrir innrennslisþykkni, lausn á að gefa sem innrennsli í bláæð.
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion.
Icelandic: HEITI LYFS CellCept 500 mg stofn fyrir innrennslisþykkni, lausn.
English: Do this by: wearing protective clothing which covers your head, neck, arms and legs using a sunscreen with a high protection factor.
Icelandic: • nota viðeigandi hlífðarfatnað, sem hylur höfuð, háls, handleggi og fótleggi
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to IV mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
Icelandic: Meðalaðgengi mýcófenólat mofetíls eftir inntöku byggt á AUC fyrir MPA er 94% miðað við mýcófenólat mofetíl í æð.
English: Contents of the pack and other information What CellCept contains
Icelandic: Hugsanlegar aukaverkanir Hvernig geyma á CellCept Pakkningar og aðrar upplýsingar
English: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Icelandic: Eftir inntöku frásogast mýcófenolat mofetíl hratt og vel og breytist í virka umbrotsefnið MPA.
English: Very Common Very Common General disorders and administration site conditions Asthenia
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Þróttleysi
English: Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Icelandic: Karlar mega ekki gefa sæði meðan á meðferð með CellCept stendur og í a.m.k.
English: There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Icelandic: Tilkynnt hefur verið um gammaglóbúlínlækkun hjá sjúklingum sem fá CellCept ásamt öðrum ónæmisbælandi lyfjum.
English: The shelf-life of the reconstituted suspension is 2 months.
Icelandic: Geymsluþol mixtúrudufts, dreifu er 2 ár.
English: Neoplasm
Icelandic: Æðavíkkun
English: Ecchymosis
Icelandic: Æxli
English: (E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), red iron oxide (E172).
Icelandic: Hýdroxýprópýl metýlsellulósi, hýdroxýprópýl sellulósi, títan tvíoxíð (E171), pólýetýlenglýkól 400, indígókarmín állitur (E132), rautt járnoxíð (E172).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack:150 (3 packs of 50) film-coated tablets
Icelandic: 150 filmuhúðaðar töflur (3 pakkar með 50 töflum)
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg tablets mycophenolate mofetil
Icelandic: HEITI LYFS CellCept 500 mg töflur mýcófenólat mofetíl
English: Gastrointestinal hemorrhage
Icelandic: Blóðkalíumhækkun
English: Contraception in men taking CellCept
Icelandic: Getnaðarvarnir hjá körlum sem fá CellCept
English: The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals
Icelandic: Fræðsluefni handa heilbrigðisstarfsfólki á að innihalda:
English: titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac.
Icelandic: Hylkið sjálft: gelatín, indígókarmín (E132), gult járnoxíð (E172), rautt járnoxíð (E172), títan tvíoxíð (E171), svart járnoxíð (E172), kalíum hýdroxíð, flögulakk.
English: Hypogammaglobulinaemia
Icelandic: Gammaglóbúlínskortur
English: Diarrhea
Icelandic: Takrólímus
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Icelandic: í annaðhvort útlæga eða miðlæga bláæð (sjá kafla 6.6).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/002
English: Powder for concentrate for solution for infusion: 3 years.
Icelandic: Stofn fyrir innrennslisþykkni, lausn:
English: This belongs to a group of medicines called “immuno-suppressants”.
Icelandic: • Það tilheyrir flokki ónæmisbælandi lyfja.
English: METHOD OF ADMINISTRATION For intravenous infusion only Read the package leaflet before use
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF Einungis til innrennslis í bláæð
English: • CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90),
Icelandic: CellCept hylki: forgelatíneruð maíssterkja, natríumcroskarmellósi, pólyvídón (K-90), magnesíum stearat
English: Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
Icelandic: Ónæmisbælandi lyf, ATC flokkur:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/004
English: Keep the blister in the outer carton in order to protect from light.
Icelandic: Geymið ekki við hærri hita en 30°C. Geymið þynnurnar í ytri umbúðum til varnar gegn ljósi.
English: Mouth, esophageal, gastric, duodenal, and intestinal ulcers often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis and colitis were commonly reported during the pivotal clinical trials.
Icelandic: Í klínísku lykilrannsóknunum var algengt að tilkynnt væri um sár í munni, vélinda, maga, skeifugörn og smáþörmum, sem oft voru erfiðari viðfangs vegna blæðingar, auk blóðugra uppkasta, sortusaurs og blæðandi maga- eða ristilbólgu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/006
English: As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of CellCept is correlated with MPA concentration.
Icelandic: á bráðri höfnun eftir nýrnaígræðslu, tengist virkni CellCept til ónæmisbælingar því hversu mikill styrkur MPA er.
English: CellCept capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Icelandic: CellCept hylkjum á einungis að ávísa til sjúklinga með líkamsyfirborð a.m.k.
English: Hypophosphatemia
Icelandic: Blóðfosfatlækkun
English: No pharmacokinetic data are available for paediatric patients following hepatic transplants.
Icelandic: Engar upplýsingar um lyfjahvörf liggja fyrir um börn eftir lifrarígræðslur.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/001
English: • Cellcept is provided in a 20 mL type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Icelandic: CellCept er í 20 ml glærum hettuglösum úr gleri af tegund
English: CAUTION: CELLCEPT I.V.
Icelandic: CellCept hylki:
English: magnesium stearate
Icelandic: Blóðmagnesíumlækkun Algengar
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/005
English: The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension.
Icelandic: Fullt heiti lyfsins er CellCept 1 g/5 ml mixtúruduft, dreifa. • Í þessum fylgiseðli er stutta heitið CellCept notað.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/96/005/003
English: In healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin or metronidazole separately.
Icelandic: CellCept samhliða norfloxacíni eða metronidazóli.
English: • CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium,
Icelandic: Örkristallaður sellulósi, pólyvídón (K-90), natríumcroskarmellósi, magnesíum stearat
English: Skin and subcutaneous tissues disorders Acne
Icelandic: Húð og undirhúð Bólur
English: Esophagitis
Icelandic: Skjálfti
English: Inspect the infusion solution for particulate matter or discoloration.
Icelandic: leiði til aukningar á styrkleika MPAG og gancíklóvírs.
English: Agitation
Icelandic: Lágþrýstingur
English: Name and address of the manufacturer(s) responsible for batch release CellCept 250 mg capsules CellCept 500 mg film-coated tablets Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
Icelandic: Heiti og heimilisfang/-föng framleiðanda/framleiðenda sem er(u) ábyrgur/ábyrgir fyrir lokasamþykkt CellCept 250 mg hylki CellCept 500 mg filmuhúðaðar töflur:
English: values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g bid in the early and late post-transplant period.
Icelandic: CellCept skammt sem nam 1 g tvisvar á dag snemma og seint á tímabilinu eftir ígræðslu (post-transplant period).
English: Paresthesia
Icelandic: Aukaverkun
English: • tablet coating: hydroxypropyl methycellulose, hydroxypropyl cellulose, titanium dioxide
Icelandic: • skjálfti, vöðvakrampar, rykkjakrampar
English: Add the rest of the water.
Icelandic: Því sem eftir er af vatninu er hellt í flöskuna.
English: The full name of your medicine is CellCept 500 mg film-coated tablets.
Icelandic: Fullt heiti lyfsins er CellCept 500 mg filmuhúðaðar töflur. • Í þessum fylgiseðli er stutta heitið CellCept notað.
English: Mouth ulceration
Icelandic: Sáramyndun í munni
English: This leaflet was last revised on {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu/ Upplýsingar á íslensku eru á http://www.serlyfjaskra.is.
English: Gastro-intestinal
Icelandic: Hjartaígræðsla
English: No pharmacokinetic data with CellCept for infusion are available for paediatric renal transplant patients.
Icelandic: Engar upplýsingar um lyfjahvörf CellCept til innrennslis eru fyrir hendi varðandi börn sem fengið hafa nýra.
English: • Diarrhoea: if this happens, it is important that you drink more water than usual.
Icelandic: Ef niðurgangur kemur fram er áríðandi að drekka meira vatn en venjulega.
English: You should tell your doctor if you have any of the following:
Icelandic: Láttu lækninn vita ef þú ert með eitthvað af eftirtöldu:
English: The safety and efficacy of VELCADE in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun VELCADE hjá börnum yngri en 18 ára (sjá kafla 5.1 og 5.2).
English: VELCADE should not be used in children and adolescents because it is not known how the medicine will affect them.
Icelandic: Ekki skal nota VELCADE handa börnum og unglingum vegna þess að ekki er vitað hvaða áhrif lyfið hefur á þá.
English: Consider reduction of the melphalan dose by 25% in the next cycle.
Icelandic: Íhugið að minnka skammtinn af melfalani um 25% í næstu meðferðarlotu
English: If you are given too much VELCADE
Icelandic: Ef þú færð of mikið af VELCADE
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Icelandic: Stigun byggð á NCI Common Toxicity Criteria CTCAE útgáfu 4.0.
English: • Disorders that affect your lungs, preventing your body from getting enough oxygen.
Icelandic: Sjúkdómar sem hafa áhrif á lungu, sem koma í veg fyrir að líkaminn fái nægjanlegt súrefni.
English: Based on Independent Review Committee (IRC) assessment (radiological data only).
Icelandic: Byggt á mati óháðrar umsagnarnefndar (Independent Review Committee (IRC)) (einungis gögn um geislagreiningu).
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the VcDx group.
Icelandic: Miðgildi meðferðartíma var 13 vikur í VDDx hópnum og 11 vikur í VcDx hópnum.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Icelandic: Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu.
English: No new safety concerns were observed during the study, and in particular VELCADE did not exacerbate target organ damage (heart, kidney and liver).
Icelandic: Engin ný öryggisatriði komu fram í rannsókninni og sérstaklega olli VELCADE ekki versnun á skemmdum í marklíffærum (hjarta, nýru og lifur).
English: • Hormone abnormality which may affect salt and water absorption
Icelandic: Hormónaröskun sem getur haft áhrif á frásog salta og vatns.
English: • that VELCADE is to be given only by IV or SC injections; no other route of administration is allowed
Icelandic: • að VELCADE sé einungis ætlað til notkunar i.v. eða s.c.; aðrar íkomuleiðir eru ekki leyfðar
English: VELCADE must be reconstituted by a healthcare professional (see section 6.6).
Icelandic: Blöndun VELCADE á að vera í höndum heilbrigðisstarfsmanns (sjá kafla 6.6).
English: Modification of starting dose
Icelandic: Breytingar á upphafsskammti
English: Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Icelandic: Meðferðarlengd (miðgildi = 17 vikur) og lengd eftirfylgni (miðgildi = 40 mánuðir) voru sambærileg í báðum meðferðarhópunum.
English: Exposure of VELCADE (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Icelandic: Útsetning fyrir VELCADE (AUC og Cmax, leiðrétt fyrir skammta) var sambærileg milli allra hópanna (sjá kafla 4.2).
English: Based on Kaplan-Meier product limit estimates.
Icelandic: á Kaplan-Meier product limit mati.
English: What VELCADE is and what it is used for
Icelandic: Upplýsingar um VELCADE og við hverju það er notað
English: When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Icelandic: Þegar VELCADE er gefið samhliða thalidomíði og dexametasoni er lengd meðferðarlotu 28 dagar (4 vikur).
English: Intent to Treat Population n=74
Icelandic: Þýðið sem ætlunin var að meðhöndla n = 74
English: VELCADE may have a moderate influence on the ability to drive and use machines.
Icelandic: VELCADE getur haft væg áhrif á hæfni til aksturs eða notkunar véla.
English: It is recommended that patients receive 2 cycles of VELCADE following a confirmation of a complete response.
Icelandic: Mælt er með því að sjúklingar fái 2 meðferðarlotur af VELCADE eftir að staðfesting á fullnaðarsvörun liggur fyrir.
English: • low numbers of red or white blood cells
Icelandic: • of fá rauð eða hvít blóðkorn
English: Vc=VELCADE; M=melphalan, P=prednisone
Icelandic: Vc = VELCADE, M = melfalan, P = prednisón
English: Your doctor will work out your dose of VELCADE according to your height and weight (body surface area).
Icelandic: Læknirinn mun reikna skammtinn af VELCADE út frá hæð þinni og þyngd (líkamsyfirborði).
English: Day 8, 11
Icelandic: Dagur 8, 11
English: ≤ 0.75 x 10
Icelandic: ANC ≤ 0,75 x 10
English: Common Sleep disorders and disturbances*
Icelandic: Svefnraskanir og -truflanir*
English: If VELCADE is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Icelandic: Ef VELCADE er notað á meðgöngu eða ef kona verður þunguð meðan hún fær lyfið, skal gera henni kunnugt um hugsanlega áhættu fyrir fóstrið.
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE must be considered unless the benefit of treatment clearly outweighs the risk.
Icelandic: Hverfi eiturverkanir ekki eða ef þær koma aftur fram við minnsta skammt, verður að íhuga að hætta notkun VELCADE, nema ávinningur vegi augljóslega þyngra en áhættan.
English: • Constipation with or without bloating (can be severe)
Icelandic: Hægðatregða með eða án uppþembu (getur verið veruleg).
English: VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Icelandic: VELCADE var einungis gefið í samsetningum 1 og 2 til að forðast hugsanlega skörun eiturverkunar við lyf gefin samhliða í samsetningu
English: Day 1, 4
Icelandic: Dagur 1, 4
English: Date of first authorisation: 26 April 2004
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 26. apríl 2004.
English: What VELCADE is and what it is used for What you need to know before you use VELCADE How to use VELCADE
Icelandic: Upplýsingar um VELCADE og við hverju það er notað Áður en byrjað er að nota VELCADE Hvernig nota á VELCADE
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
Icelandic: Fyrirbyggjandi meðferð með veirulyfjum var gefin 137 af 240 sjúklingum (57%) í VcR-CAP hópnum.
English: A group of dialysis patients who were dosed after dialysis was also included in the study (n=8).
Icelandic: Hópur sjúklinga, sem var í skilun og fékk skammta eftir skilun, var einnig með í rannsókninni (n = 8).
English: The final analysis for OS was performed after a median follow-up of 82 months.
Icelandic: Lokagreining á heildarlifun var gerð eftir eftirfylgni í 82 mánuði (miðgildi).
English: Overall, VELCADE was administered for the treatment of multiple myeloma in 3,974 patients.
Icelandic: Í heildina var VELCADE notað til meðferðar við mergæxli hjá 3.974 sjúklingum.
English: Overall response (CR+CRu+PR)
Icelandic: Heildarsvörun (CR+CRu+PR)
English: It is, therefore, likely that bortezomib could have a potential effect on either male or female fertility.
Icelandic: Því er líklegt að bortezomib geti hugsanlega haft áhrif, hvort sem er, á frjósemi karl- eða kvendýra.
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in VcDx group and 52/242 [21%] in VDDx group).
Icelandic: Vísar til svarhlutfalls eftir aðra ígræðslu hjá sjúklingum sem fengu aðra ígræðslu (42/240 [18% ] í VcDx hópnum og 52/242 [21%] í VDDx hópnum).
English: Fertility Fertility studies were not conducted with VELCADE (see section 5.3).
Icelandic: Frjósemi Ekki hafa verið gerðar rannsóknir á frjósemi með VELCADE (sjá kafla 5.3).