FrancophonIA/ELRC3.0 huggingface dataset:
English: To minimise foam formation, gently swirl and invert the vial for at least 30 seconds or until the powder is completely dissolved.
Icelandic: 30 sek. eða þar til duftið er alveg uppleyst.
English: Two hundred seventeen (217) patients 65 years and older received belatacept across one Phase 2 and two Phase 3 renal studies.
Icelandic: Í einni II. stigs rannsókn og tveimur III.stigs nýrnarannsóknum fengu tvöhundruð og sautján (217) sjúklingar 65 ára og eldri belatacept.
English: aProportion of Patients with Measured GFR < 60 ml/min/1.73 m2 or with a Decrease in Measured GFR ≥ 10 ml/min/1.73 m2 from Month 3 to Month 12. b Measured GFR was assessed by iothalamate at Year 1 and 2 only c Calculated GFR was assessed by MDRD formula at Month 1, Years 1, 2, and 3
Icelandic: Reiknaður meðalhraði gauklasíunarc ml/mín/1,73 m2 1. mánuður 1. ár 2. ár 3. ár a Hlutfall sjúklinga með mældan gauklasíunarhraða < 60 ml/mín/1,73 m2 eða með hraða gauklasíunar minnkaðan um ≥ 10 ml/mín/1,73 m2 frá 3. mánuði til 12. mánaðar.
English: Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation.
Icelandic: Sérfræðingur í nýrnasjúkdómum ávísar NULOJIX og hefur eftirlit með meðferðinni.
English: In the individual studies, the percentage of patients with antibodies ranged from 4.5% and 5.2% in the Phase 3 studies to 11.8% in the long-term extension of the Phase 2 study.
Icelandic: stigs rannsóknum til 11,8% í langtíma II. stigs framhaldsrannsókninni.
English: Lung cancer, rectal cancer, breast cancer, a form of cancer in the bones, musles, or fat tissue, tumor of the skin and intestinal tract caused by a herpes virus and seen in patients with a weakened immune system, prostate cancer, cancer of the cervix, throat cancer, cancer of the lymph nodes, cancer of the bone marrow, cancer of the kidney, kidney tubes, or bladder Fungal infection of brain, inflammation of the brain, serious brain infection called PML (progressive multifocal leukoencephalopathy)
Icelandic: Lungnakrabbamein, krabbamein í endaþarmi, brjóstakrabbamein, krabbamein í beinum, vöðvum eða fituvef, æxli í húð og meltingarvegi af völdum herpesveiru sem sést hjá sjúklingum með veiklað ónæmiskerfi, krabbamein í blöðruhálskirtli, leghálskrabbamein, krabbamein í hálsi, eitlakrabbamein, krabbamein í beinmerg, krabbamein í nýra, nýrnapípum eða blöðru
English: Contrada Fontana del Ceraso 03012 Anagni (FR) - Italy
Icelandic: Bristol-Myers Squibb S.R.L. Contrada Fontana del Ceraso 03012 Anagni (FR)
English: PTLD in belatacept-treated patients most often presented in the central nervous system (CNS).
Icelandic: Eitilfrumnafjölgun eftir ígræðslu hjá sjúklingum sem fengu belatacept kom oftast fram í miðtaugakerfi.
English: Infusion-related reactions have been reported with belatacept administration in clinical studies.
Icelandic: Greint hefur verið frá ofnæmi sem tengist belatacepti í klínískum rannsóknum.
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, sodium chloride, and for pH adjustment sodium hydroxide and hydrochloric acid.
Icelandic: Hjálparefni: súkrósi, natríumtvíhýdrogenfosfat einhýdrat, natríumklóríð og til þess að stilla pH natríumhýdroxíð og saltsýra.
English: Gastrointestinal symptoms may include pain on swallowing; painful mouth ulcers; white patches in the mouth or throat; upset stomach; stomach pain; vomiting; or diarrhoea.
Icelandic: Einkenni frá meltingarfærum geta meðal annars verið verkur þegar kyngt er, sársaukafull sár í munni, hvítir blettir í munni eða í koki, uppþemba, kviðverkir, uppköst eða niðurgangur.
English: Dangerously low red blood cells, dangerously lowered white cell counts, destruction of red blood cells, blood clotting problems, acid in the blood from diabetes, lack of acid in the blood Improper production of hormones by the adrenal glands Low vitamin D levels
Icelandic: Hættulega fá rauð blóðkorn, hættulega fá hvít blóðkorn, eyðileggingu rauðra blóðkorna, blóðstorkuvandamál, blóðsýringu vegna sykursýki, breytingar á fótum vegna sykursýki, blóðlýtingu
English: Progression of Chronic Kidney Disease (CKD) Staging In Study 1 by Year 3, mean calculated GFR was 21 ml/min/1.73 m2 higher with belatacept, and 10% and 20% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Icelandic: Á 3. ári í rannsókn 1 var meðalhraði gauklasíunar 21 ml/mín/1,73 m2 hærri eftir belatacept og 10% sjúklinga náðu 4/5 stigun langvinns nýrnasjúkdóms (gauklasíunarhraði < 30 ml/mín/1,73 m2) með belatacepti borið saman við 20% með ciclosporini.
English: Belatacept was not teratogenic when administered to pregnant rats and rabbits at doses up to 200 mg/kg and 100 mg/kg daily, respectively, representing approximately 16 and 19 times the exposure associated with the maximum recommended human dose (MRHD) of 10 mg/kg based on AUC.
Icelandic: Belatacept hafði ekki vanskapandi áhrif þegar það var gefið ungafullum rottum í skömmtum allt að 200 mg/kg og kanínum í skömmtum allt að 100 mg/kg á sólarhring sem samsvarar u.þ.b.
English: Progressive multifocal leukoencephalopathy
Icelandic: Sjaldgæfar blóðfosfataskortur
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Icelandic: Upplýsingar fyrir notanda lyfsins NULOJIX 250 mg stofn fyrir innrennslisþykkni, lausn belatacept
English: Dose of belatacept for renal transplant recipients
Icelandic: Skammtur belatacepts fyrir nýrnaþega
English: Insert the syringe needle into the vial through the centre of the rubber stopper.
Icelandic: Stingið nálinni í gegnum miðju gúmmítappans á hettuglasinu.
English: Guillian-Barré syndrome (a condition that causes muscle weakness or paralysis) EBV (Epstein-Barr virus) lymphoproliferative disease Blood clotting in veins, inflamed veins, periodic leg cramps Abnormal arteries, scarring of the arteries, clotting in the arteries, narrowing of the arteries, temporary redness of the face/skin, swelling of the face Stones in the gallbladder, fluid filled pocket in the liver, fatty liver Skin disease with thickened patches of red skin, often with silvery scales, abnormal hair growth, excessive hair breakage, nails breaking, ulcer on the penis Abnormal balance of minerals in the body causing bone problems, bone inflammation, abnormal weakening of the bone leading to bone problems, inflammation of the lining of the joints, rare bone condition
Icelandic: Húðsjúkdómur með þykkum rauðum flekkjum, oft með silfurlitu hreistri, óeðlilegur hárvöxtur, miklar brotskemmdir í hári, brotnar neglur, sár á getnaðarlim Truflun á snefilefnajafnvægi sem veldur beinkvillum, bólgu í beinum, veiklun í beinum sem veldur beinvandamálum, bólga í ytra byrði liða, sjaldgæfur kvilli í beinum Bólga í eistum, óeðlilega langvarandi holdris, óeðlilegar frumur í leghálsi, fyrirferð í brjósti, verkur í eistum, sár á kynfærasvæði hjá konum, rýrnun veggja í leggöngum, ófrjósemi eða vanhæfni til að verða ófrísk, þroti í pung
English: Kidney or bladder symptoms may include tenderness at the site of your transplanted kidney; difficulty passing urine; changes in the amount of urine you produce; blood in the urine; pain or burning on urination.
Icelandic: Einkenni frá nýrum og blöðru geta meðal annars verið eymsli þeim megin sem ígrædda nýrað er, erfiðleikar við þvaglát, breytingar á þvagmagni, blóð í þvagi, verkur eða sviði við þvaglát.
English: Any malignant neoplasm Non-melanoma skin cancer Malignant neoplasms excluding nonmelanoma skin cancers
Icelandic: Öll illkynja æxli Húðkrabbamein sem er ekki sortuæxli Illkynja æxli að frátöldu húðkrabbameini sem er ekki sortuæxli Eitilfrumnafjölgun eftir ígræðslu (PTLD)
English: The reconstituted solution should be clear to slightly opalescent and colourless to pale yellow.
Icelandic: Eftir blöndun á lausnin að vera tær til örlítið ópallýsandi og litlaus/fölgul.
English: Infection with the strongyloides worm, diarrheal infection with Giardia parasite Kidney disease that is caused by a virus (polyomavirus-associated nephropathy), inflammation of the kidneys, scarring of the kidneys, shrinkage of the small tubes in the kidney, inflammation of the bladder with bleeding
Icelandic: Sýking af völdum strongyloidorms, niðurgangur vegna sýkingar af völdum sníkjudýrsins gíardía Nýrnasjúkdómur af völdum polýomaveiru, sýking í nýrum, örvefur í nýrum, rýrnun nýrnapípla, bólga í blöðru ásamt blæðingu
English: Injury, poisoning and procedural complications Very Common graft dysfunction Common chronic allograft nephropathy (CAN), incisional hernia
Icelandic: Algengar langvinn græðlingsbilun (chronic allograft nephropathy (CAN)), skurðarhaull (incisional hernia)
English: Presented in Table 2, by system organ classification and frequency categories, is the list of adverse reactions with at least a suspected causal relationship, reported in clinical trials cumulatively up to Year 3 and pooled for both belatacept regimens (MI and LI).
Icelandic: grunur leikur um tengsl, og greint var frá í klínískum rannsóknum og safnað saman fram að 3. ári úr báðum meðferðarhópum belatacepts (MI og LI).
English: Failure of transplanted organ to work, problems during or after a transfusion, separation of the wound edges before it heals, broken bone, complete tear or separation of tendon, low blood pressure during or after a procedure, high blood pressure during or after a procedure, bruise/collection of blood within the soft tissues after a procedure, pain related to a procedure, headache related to a procedure, bruise of the soft tissue Tests may show:
Icelandic: Bilun ígrædda líffærisins, vandamál meðan á blóðgjöf stendur, gliðnun sárabarma áður en sár grær, beinbrot, rifnar sinar, lágur blóðþrýstingur á meðan eða eftir aðgerð, hár blóðþrýstingur á meðan eða eftir aðgerð, mar/blóð í mjúkvefjum eftir aðgerð, verkur tengdur aðgerð, höfuðverkur tengdur aðgerð, mar í mjúkvefjum
English: It is very important for you to keep all appointments to receive NULOJIX.
Icelandic: Mjög mikilvægt er að fá NULOJIX skammtinn á réttum tíma.
English: Blood and lymphatic system disorders Very Common anaemia, leukopenia Common thrombocytopenia, neutropenia, leukocytosis, polycythaemia, lymphopenia
Icelandic: Algengar blóðflagnafæð, daufkyrningafæð, hvítfrumnafjölgun, rauðkornadreyri (polycythaemia), eitilfrumnafæð
English: After reconstitution, each ml of concentrate contains 25 mg belatacept.
Icelandic: Eftir blöndun inniheldur hver ml 25 mg belatacept.
English: Total dose of belatacept in mg equals the patient weight in kg times the belatacept dose in mg/kg (5 or 10 mg/kg, see section 3) Dose modification of NULOJIX is not recommended for a change in body weight of less than
Icelandic: Heildarskammtur belatacepts í mg jafngildir líkamsþyngd sjúklingsins í kg margfaldað með belatacept skammtinum í mg/kg (5 eða 10 mg/kg, sjá kafla 3).
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion
Icelandic: HEITI LYFS NULOJIX 250 mg stofn fyrir innrennslisþykkni, lausn
English: Genital herpes
Icelandic: Kynfæraherpes
English: Method of administration NULOJIX is for intravenous use only.
Icelandic: Lyfjagjöf NULOJIX er eingöngu ætlað til notkunar í bláæð.
English: Autoimmunity
Icelandic: Sjálfsnæmi
English: This will avoid aggregate formation.
Icelandic: Það kemur í veg fyrir froðumyndun.
English: After reconstitution, each ml of concentrate contains 25 mg of belatacept.
Icelandic: Eftir blöndun inniheldur hver ml af þykkninu 25 mg belatacept.
English: Each vial is co-packaged with a disposable polypropylene syringe.
Icelandic: Einnota polypropylen sprauta fylgir hverju hettuglasi.
English: Intravenous use.
Icelandic: Hugsanlegar aukaverkanir.
English: Malignancies
Icelandic: Húðkrabbamein
English: Uncommon acute respiratory distress syndrome, pulmonary hypertension, pneumonitis, haemoptysis, bronchopneumopathy, painful respiration, pleural effusion, sleep apnoea syndrome, dysphonia, oropharyngeal blistering
Icelandic: Sjaldgæfar brátt andnauðarheilkenni, lungnaháþrýstingur, lungnabólga, blóðhósti, berkjukvilli, sársauki við öndun, fleiðrusvökvi, kæfisvefn, raddtruflun, blöðrumyndun í munnkoki
English: The solution for infusion is to be used in conjunction with a sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 µm to 1.2 µm).
Icelandic: Innrennslislausnina á að nota með sæfðri, sprautusíu (gatastærð 0,2 míkróm til 1,2 míkróm) án sótthitavalda (non-pyrogenic) með lágt próteinbindistig.
English: If you are infected with a virus called cytomegalovirus (CMV)
Icelandic: Cytomegaloveira (CMV)
English: Muscle pain, muscle weakness, bone pain, joint swelling, abnormal cartilage between bones of the spine, sudden inability to bend joint, muscle spasms, arthritis Blockage of kidney blood vessels, enlarged kidney due to blockage of urine flow out of the kidney, backflow of urine from the bladder into the kidney tubes, inability to hold urine, incomplete emptying of the bladder, urinating at night, sugar in the urine Increase in body weight, decrease in body weight Cataract, increased blood congestion in the eye, blurred vision Shaking or tremors, dizziness, fainting or passing out, ear pain, buzzing, ringing or other persistent noise in the ears
Icelandic: Vöðvaverkur, vöðvamáttleysi, beinverkir, bólga í liðum, óeðlilegir liðþófar í hryggjarliðum, skyndileg vanhæfni í að beygja liði, sinadráttur, liðbólga Þrengsli í nýrnaæðum, nýrnastækkun vegna hindrunar á þvagrennsli frá nýra, bakflæði þvags úr blöðru og í nýrnapípur, þvagleki, erfiðleikar með að tæma blöðruna, næturþvaglát, sykur í þvagi Aukin líkamsþyngd, minnkuð líkamsþyngd
English: To assess for the presence of neutralising antibodies, samples from 29 patients with confirmed binding activity to the modified cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) region of the molecule were assessed by an in vitro assay; 8 (27.6%) patients were shown to possess neutralising antibodies.
Icelandic: Til að meta hvort hlutleysandi mótefni væru til staðar voru sýni úr 29 sjúklingum með staðfesta bindingu við frumudrepandi T eitilfrumu tengdan mótefnavaka-4
English: Uncommon diabetic ketoacidosis, diabetic foot, alkalosis, decreased appetite, vitamin D
Icelandic: Sjaldgæfar ketónblóðsýring af völdum sykursýki, sykursýkisár á fæti, blóðlýting, minnkuð matarlyst, D vítamín skortur
English: At a given dose of MMF, MPA exposure is approximately 40% higher with belatacept coadministration than with ciclosporin coadministration.
Icelandic: 40% hærri þegar belatacept er gefið samhliða, samanborið við samhliða gjöf ciclosporins.
English: Fluid in the lungs, wheezing, chest pain or angina, enlarged heart muscle (bottom of the heart) Infection of the blood or tissues, respiratory infections, pneumonia, flu, sinus inflammation, runny nose, sore throat, pain in the mouth/throat region, herpes virus infections, shingles and other viral infections, mouth sores, thrush, kidney infection, fungal skin infections,fungal infections of the nails and other fungal infections, skin infection, infection of soft tissues, wound infection,
Icelandic: Sýking í blóði eða vefjum, öndunarfærasýkingar, lungnabólga, flensa, bólga í ennisholum, nefrennsli, særindi í hálsi, verkur í munni og koki, herpesveirusýking, ristill og aðrar veirusýkingar, munnsár, þruska, sýking í nýrum, sveppasýkingar í húð, sveppasýkingar í nöglum, og aðrar sveppasýkingar, sýking í húð, sýking í mjúkvefjum, sýkt sár, staðbundnar sýkingar, hægur bati, blóðugt mar, uppsöfnun sogæðavökva umhverfis ígrædda nýrað.
English: deficiency
Icelandic: Bólusetningar
English: There are no adequate data from use of belatacept in pregnant women.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um notkun belatacepts á meðgöngu.
English: Lymphocyte depleting therapies to treat acute rejection should be used cautiously.
Icelandic: Nota skal eitilfrumnaeyðandi meðferðir til meðhöndlunar á bráðri höfnun með varúð.
English: Cases of PTLD varied by serostatus.
Icelandic: PTLD tilvik voru breytileg eftir mótefnastöðu.
English: Uncommon hypogammaglobulinaemia, seasonal allergy Endocrine disorders
Icelandic: Sjaldgæfar gammaglobulinskortur, árstíðabundið ofnæmi
English: Changes in blood levels of different salts or electrolytes Increased amounts of cholesterol and triglyceride (blood fats) High levels of sugar in your blood
Icelandic: Aukið magn kólesteróls og þríglýseríða (blóðfitur) Hækkaðan blóðsykur
English: How to store NULOJIX 6.
Icelandic: 3. Hvernig nota á NULOJIX
English: Description of selected adverse reactions
Icelandic: Hagnýt atriði fyrir blöndun hettuglasanna
English: Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Icelandic: Þú getur verið í aukinni hættu á að fá blóðtappa í ígrædda nýrað en það fer eftir nýranu sem þú fékkst.
English: In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies.
Icelandic: 56 dögum (u.þ.b. 7 helmingunartímar) eftir að meðferð með belatacepti var hætt.
English: Make up each vial with 10.5 ml reconstitution solution.
Icelandic: Bætið u.þ.b. 10,5 ml af þynningarlausninni.
English: Use of immunosuppressants, including belatacept, can increase susceptibility to infection, including fatal infections, opportunistic infections, tuberculosis, and herpes (see progressive multifocal leukoencephalopathy (PML) warning below and also section 4.8).
Icelandic: Notkun ónæmisbælandi lyfja, þ.m.t. belatacepts, getur aukið næmi fyrir sýkingum, m.a. lífshættulegum sýkingum, tækifærissýkingum, berklum og herpes (sjá varnaðarorð um ágenga fjölhreiðra innlyksuheilabólgu
English: Inflammation of the colon (large bowel) caused by the cytomegalovirus, inflammation of the pancreas, ulcer in the stomach, small intestines, or large intestine, blockage of the small intestine, black, tar-like stools, rectal bleeding, abnormal colour of the stool
Icelandic: Bólga í ristli af völdum cytomegaloveiru, brisbólga, sár í maga, smáþörmum eða þörmum, þrengsli í smáþörmum, svartar, tjöruhægðir, blæðing frá endaþarmi, óeðlilegur litur hægða Bakteríusýkingar, bólga eða sýking í innra byrði hjartans, berklar, beinsýking, bólgnir eitlar, langvinn útvíkkun loftvega sem veldur tíðum lungnasýkingum
English: Common sepsis, pneumonia, influenza, gastroenteritis, herpes zoster, sinusitis, herpes simplex, oral candidiasis, pyelonephritis, onychomycosis, BK virus infection, respiratory tract infection, candidiasis, rhinitis, cellulitis, wound infection, localised infection, herpes virus infection, fungal infection, fungal skin infection
Icelandic: Algengar blóðsýking, lungnabólga, inflúensa, maga- og garnabólga, ristill, skútabólga, herpes simplex, hvítsveppasýking í munnholi, nýrna- og skjóðubólga, naglsveppur, BK veirusýking, öndunarfærasýking, hvítsveppasýking, nefrennsli, netjubólga, sýkt sár, staðbundin sýking, herpes veirusýking, sveppasýking, sveppasýking í húð
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Icelandic: 5. AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR) Eingöngu einnota.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
Icelandic: Hagnýt atriði fyrir blöndun innrennslisvökvans
English: Common weight increase, diabetes mellitus, dehydration, weight decrease, acidosis, fluid retention, hypercalcaemia, hypoproteinaemia
Icelandic: Algengar þyngdaraukning, sykursýki, vessaþurrð, þyngdartap, blóðsýring, vökvasöfnun, blóðkalsíumhækkun, próteinlækkun í blóði
English: Vascular disorders
Icelandic: Sveppasýkingar Berklar
English: Common renal tubular necrosis, renal vein thrombosis*, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia
Icelandic: Langvinn græðlingsbilun (chronic allograft nephropathy (CAN))/milllivefsnetjuhersli og rýrnun pípla ((Interstitial Fibrosis and Tubular Atrophy) (IFTA))
English: Respiratory, thoracic and mediastinal disorders Very Common dyspnoea, cough Common pulmonary oedema, wheezing, hypocapnea, orthopnoea, epistaxis, oropharyngeal pain
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Mjög algengar þvagfærasýking, sýking í efri öndunarvegi, cytomegaloveirusýking*, berkjubólga
English: Start (Day of Transplant):_______________ Most recent: _________________________ Next treatment date:____________________ Patient's Name:_______________________ Doctor's Name:_______________________ Doctor's Phone:_______________________ If NULOJIX is stopped, keep this card with you for an additional 3 months.
Icelandic: Dagsetning næstu meðferðar:________________________
English: Allergic reactions related to belatacept use have been reported in the clinical studies.
Icelandic: Í klínískum rannsóknum á belatacepti hefur verið greint frá innrennslistengdum aukaverkunum.
English: Malignancies excluding nonmelanoma skin cancer and PTLD
Icelandic: Illkynja æxli að frátöldu húðkrabbameini sem er ekki sortuæxli og PTLD
English: Uncommon hypoacusis
Icelandic: Óeðlileg vökvasöfnun
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28.
Icelandic: Lyf til ónæmisbælingar, sérhæfð lyf til ónæmisbælingar, ATC flokkur:
English: Uncommon cholelithiasis, hepatic cyst, hepatic steatosis Skin and subcutaneous tissue disorders Common acne, pruritis, alopecia, skin lesion, rash, night sweats, hyperhidrosis
Icelandic: Húð og undirhúð Algengar þrymlabólur, kláði, skalli, sár á húð, útbrot, nætursviti, ofsviti
English: Maintenance phase
Icelandic: 14. AFGREIÐSLUTILHÖGUN
English: Uncommon transplant failure, transfusion reaction, wound dehiscence, fracture, tendon rupture, procedural hypotension, procedural hypertension, post-procedural haematoma, procedural pain, procedural headache, contusion
Icelandic: Sjaldgæfar bilun í ígrædda líffærinu, viðbrögð við blóðgjöf, opnun sárs, beinbrot, sinarof, lágþrýstingur tengdur aðgerð, háþrýstingur tengdur aðgerð, margúll tengdur aðgerð, verkur tengdur aðgerð, höfuðverkur tengdur aðgerð, mar
English: What you need to know before you use NULOJIX
Icelandic: Áður en byrjað er að nota NULOJIX
English: Use aseptic technique to make up the vials and dilute the solution for administration.
Icelandic: Að viðhafðri smitgát skal leysa innihald hettuglasanna upp og þynna lausnina fyrir lyfjagjöf.
English: Practical details on the reconstitution of vials
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: In Study 1, mean calculated GFR at 7 years was 74.0, 77.9 and 50.7 mL/min/1.73 m2 in the belatacept MI, belatacept LI and ciclosporin groups, respectively.
Icelandic: Í rannsókn 1 var meðalgildi reiknaðs GFR eftir 7 ár 74,0 ml/mín/1,73 m
English: Uncommon acute coronary syndrome, atrioventricular block second degree, aortic valve disease, arrhythmia supraventricular
Icelandic: Sjaldgæfar bráður kransæðasjúkdómur, II. gráðu gáttasleglarof, sjúkdómur í ósæðarloku, ofansleglahraðsláttur
English: Pancreatic enzymes in the blood increased, troponin levels in the blood increased, prostatespecific antigen (PSA) increased, high uric acid levels in the blood, CD-4 lymphocyte cell counts decreased, low blood sugar
Icelandic: Aukið briskirtilsensím í blóði, aukin troponíngildi í blóði, óeðlileg þvagpróf, próf sem sýna fram á cytomegaloveiru, aukning á sértækum vaka fyrir blöðruhálskirtil, aukin þvagsýra í blóði, fækkun CD4 eitilfrumna, blóðsykursfall.
English: GFRb ml/min/1.73 m2 Year 1
Icelandic: 50,7 ml/mín/1,73 m2 (ciclosporin).
English: People are at a higher risk of developing PTLD in the following cases:
Icelandic: Í fylgiseðlinum eru eftirfarandi kaflar:
English: Very Common hypertension, hypotension Common shock, infarction, haematoma, lymphocele, angiopathy, arterial fibrosis
Icelandic: Einkyrningafæð, rauðkornabrestur, kyrningahrap, blóðlýsa, segahneigð (hypercoagulation)
English: Cracking of the corner of the mouth, swollen gums, salivary gland pain Increased sexual desire
Icelandic: Sprungur í munnvikum, bólga í góm, verkur í munnvatnskirtli Aukin kynhvöt
English: trichorrhexis
Icelandic: Brotthvarf
English: Absorption
Icelandic: Sviðatilfinning
English: • Decide what other medicines you should take with Sovaldi and for how long;
Icelandic: • að ákveða hvaða annað lyf þú skulir taka með Sovaldi og hve lengi;