FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open- label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Icelandic: 457 sjúklingar þátt í áframhaldandi opinni rannsókn þar sem gefin voru 40 mg af adalimumabi/MXT aðra hverja viku í allt að 10 ár.
English: Myocardial infarction arrhythmia, congestive heart failure
Icelandic: Hjartadrep hjartsláttartruflun, hjartabilun
English: (See section
Icelandic: Endapunktur
English: • increased lipids in the blood;
Icelandic: hækkuð þvagsýra í blóði
English: Children and adolescents from 2 years of age weighing less than 30 kg
Icelandic: Börn og unglingar frá 2 ára aldri sem vega minna en 30 kg
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Icelandic: • krabbamein, meðtalið eitlakrabbamein og sortuæxli (tegund húðkrabbameins)
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled studies.
Icelandic: Verkun og öryggi adalimumabs var metið í fimm tvíblindum samanburðarrannsóknum með slembivali.
English: Solution for injection 1 vial
Icelandic: 1 sæfð sprauta til inndælingar
English: In monotherapy, some patients who experience a decrease in their response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Icelandic: Þegar Kromeya er gefið eitt og sér gætu þeir sjúklingar, sem finna fyrir minnkandi svörun við Kromeya 40 mg aðra hverja viku haft ávinning af því að auka skammtinn í 40 mg af adalimumabi vikulega eða 80 mg aðra hverja viku.
English: It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Icelandic: Mikilvægt er að segja lækninum frá því ef barnið fær einkenni eins og hita, sár, þreytu eða tannvandamál.
English: Solution for injection (injection).
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Icelandic: Í þessum rannsóknum greindust 11,9% sjúklinga sem fengu meðferð með adalimumabi og 8,1% sjúklinga sem fengu meðferð með lyfleysu eða virku samanburðarlyfi, sem voru í upphafi með neikvæðan títra andkjarnamótefna, með jákvæðan títra í viku
English: Not applicable
Icelandic: Engin aukning
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
Icelandic: 4 ára til 17 ára sem vega 15 kg til minna en 30 kg
English: If these medicines do not work well enough, you will be given Kromeya to treat your rheumatoid arthritis.
Icelandic: Ef þessi lyf verka ekki nægjanlega verður þér gefið Kromeya við iktsýki.
English: • paediatric uveitis
Icelandic: • tvísýni
English: • Upright and stable during use,
Icelandic: Stendur upp á endann og er stöðugt við notkun,
English: 2.8 Hold the vial and lift the packaging off. To ensure the adapter remains on top of the vial, hold the packaging by the outer rim.
Icelandic: Til að tryggja að millistykkið verði áfram á loki hettuglassins skal halda um ytri brún pakkningarinnar.
English: Kromeya dose for paediatric patients with plaque psoriasis
Icelandic: Kromeya skammtar fyrir sjúklinga með festumeinstengda liðagigt
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis study III).
Icelandic: Öryggi og verkun adalimumabs var einnig rannsakað í slembaðri tvíblindri rannsókn (sórarannsókn III) hjá fullorðnum sjúklingum, sem komu til greina fyrir altæka meðferð, með í meðallagi mikinn til mikinn langvinnan skellusóra auk sóra á höndum og/eða fótum.
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Icelandic: Í 3. stigs samanburðarrannsóknum á adalimumabi hjá sjúklingum á aldrinum 4 til 17 ára með sjálfvakta fjölliðagigt og hjá sjúklingum á aldrinum 6 til 17 ára með festumeinstengda liðagigt, var aukning
English: In adult patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/mL during the induction period.
Icelandic: Hjá sjúklingum með sáraristilbólgu, leiðir 160 mg hleðsluskammtur adalimumabs í viku 0, sem fylgt er eftir með 80 mg af adalimumabi í viku 2, til þess að lægsta sermisþéttni adalimumabs verður um það bil 12 μg/ml á innleiðingartímabilinu.
English: Injury, poisoning and procedural complications
Icelandic: Áverkar, eitranir og fylgikvillar aðgerða
English: bleeding, paleness.
Icelandic: Blóð og eitlar*
English: Ulcerative colitis Age or body weight
Icelandic: Skellusóri Aldur eða líkamsþyngd
English: Kromeya is used to treat rheumatoid arthritis in adults.
Icelandic: Kromeya er notað til meðferðar á iktsýki hjá fullorðnum.
English: In study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Icelandic: Marktækur munur sást í rannsókn UV I adalimumab í hag samanborið við lyfleysu fyrir hvern þátt meðferðarbrests.
English: Week 52 Fistula remission3
Icelandic: Tafla 15 Sórarannsókn II (CHAMPION)
English: a partial remission ASDAS
Icelandic: Ráðlagður skammtur
English: Sustained remission
Icelandic: FYRNINGARDAGSETNING
English: Figure Q Warning: Call your healthcare professional or pharmacist if you have any problem.
Icelandic: Hafðu samband við lækninn, hjúkrunarfræðinginn eða lyfjafræðing ef einhver vandamál koma upp.
English: Adalimumab 40 mg eow N=109
Icelandic: Adalimumab 40 mg aðra hverja viku N=109
English: Table 9 ACR responses in placebo-controlled trials (percent of patients)
Icelandic: Tafla 9 ACR svörun í samanburðarrannsóknum með lyfleysu (Hlutfall sjúklinga)
English: • The expiration date on the pre-filled pen has not passed (Figure I).
Icelandic: Fyrningardagsetning á áfyllta lyfjapennanum sé ekki liðin (mynd I).
English: Refer to Storage information for -how to store your unused syringe(s).
Icelandic: Upplýsingar um geymsluskilyrði um hvernig geyma skal ónotaða áfyllta lyfjapenna.
English: • < 40 kg: 20 mg every week
Icelandic: ≥ 40 kg 20 mg aðra hverja viku
English: 3.2 Hold the vial adapter, insert the syringe tip into it and screw to connect.
Icelandic: á hettuglasinu, setjið endann á sprautunni í það og snúið til að tengja.
English: If these medicines do not work well enough, your child will be given Kromeya to reduce the signs and symptoms of his/her disease.
Icelandic: Ef svörun við þeim er ekki nægjanleg verður barninu gefið Kromeya til að draga úr einkennum sjúkdóms þeirra.
English: 2.2 Check the label on the vial for Kromeya and expiration date.
Icelandic: Notkun hanska kemur ekki í staðinn fyrir handþvott 2.2 Athugaðu merkimiðann og fyrningardagsetninguna á Kromeya hettuglasinu.
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Icelandic: Það náðist vegna fækkunar um að meðaltali 62,6% (88,9% að miðgildi) í adalimumab hópnum samanborið við 11,6% (50,0% að miðgildi) í lyfleysuhópnum.
English: The recommended dose of Kromeya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Icelandic: Ráðlagður skammtur af Kromeya fyrir börn með sjálfvakta fjölliðagigt, 2 ára og eldri er byggður á líkamsþyngd (tafla 1).
English: • stroke;
Icelandic: • bólgur.
English: NE
Icelandic: Svimi
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use is supplied in a glass vial.
Icelandic: Kromeya 40 mg/0,8 ml stungulyf, lausn til notkunar handa börnum kemur í hettuglasi úr gleri.
English: Uveitis
Icelandic: Aukaverkun
English: Warning: Do not touch the yellow connector.
Icelandic: Ekki snerta gula millistykkið.
English: Step 3 Prepare Syringe
Icelandic: Skref 4 Veljið stungustaðinn
English: Musculoskeletal pain
Icelandic: Klínískt sjúkdómshlé Bati slímhúðar
English: Syringe plunger
Icelandic: Sjúklingar fengu
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Icelandic: Kromeya er notað til meðferðar við sjálfvakinni fjölliðagigt hjá börnum og festumeinstengdri liðagigt.
English: • ankylosing spondylitis,
Icelandic: Bath Ankylosing
English: The recommended dose of Kromeya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Icelandic: Ráðlagður skammtur af Kromeya fyrir sjúklinga með festumeinstengda liðagigt, 6 ára og eldri er byggður á líkamsþyngd (tafla 2).
English: • allergic reactions (including seasonal allergy);
Icelandic: • ofnæmisviðbrögð (þ.m.t. árstíðabundið ofnæmi)
English: MRI sacroiliac joints d,i
Icelandic: h segulómun spjald-og mjaðmarbeinsliða d,i
English: • Kromeya Vial Kit is for single use only.
Icelandic: Kromeya sett með hettuglasi er einungis til notkunar í eitt skipti.
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Kromeya.
Icelandic: Rannsaka á alla sjúklinga fyrir meðferð og meðan á meðferð með Kromeya stendur m.t.t. húðkrabbameins sem er ekki sortuæxli, sérstaklega sjúklinga með sögu um víðtæka ónæmisbælandi meðferð og sórasjúklinga sem hafa fengið meðferð með PUVA.
English: • heart stops pumping;
Icelandic: hjartað hættir að slá
English: • increased sweating;
Icelandic: • aukin svitamyndun
English: Table 22 Maintenance of clinical remission and response (percent of patients)
Icelandic: Tafla 22 Hve lengi klínískt sjúkdómshlé stóð og svörun (Hlutfall sjúklinga)
English: Clinical response
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Icelandic: 16 var samkvæmt mati með mælikvarða á lífsgæðum einstaklinga með húðsjúkdóm (Dermatology Life Quality Index) sýnt fram á marktækan árangur miðað við upphafsgildi samanborið við lyfleysu (rannsóknir
English: Kromeya is administered via subcutaneous injection.
Icelandic: Kromeya er fáanlegt í öðrum lyfjaformum.
English: If your child takes Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Icelandic: Vera má að hættan á því að fá eitilkrabbamein, hvítblæði eða aðrar tegundir krabbameins sé meiri hjá barni sem notar Kromeya.
English: 1.5 Caution: Do not pick up the syringe by the plunger or the needle cap.
Icelandic: Ekki taka sprautuna úr öskjunni með því að taka um stimpilinn eða nálarhettuna.
English: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Icelandic: Einn 0,8 ml áfylltur lyfjapenni inniheldur 40 mg adalimumab.
English: Kromeya 40 mg solution for injection in pre-filled syringe
Icelandic: Kromeya 40 mg stungulyf, lausn í áfylltri sprautu
English: Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Icelandic: Ein 0,8 ml áfyllt sprauta inniheldur 40 mg adalimumab.
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af 10 einstaklingum)
English: • psoriasis,
Icelandic: • sóra
English: • scar;
Icelandic: • kláði
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Icelandic: sýkingar í öndunarvegi (þ.m.t. kvef, nefrennsli, sýking í ennisholum, lungnabólga)
English: No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Icelandic: ALT ≥ 3 föld eðlileg efri mörk kom fram í 3. stigs rannsókn á adalimumabi hjá börnum með skellusóra.
English: Erosion score
Icelandic: góðkynja æxli
English: 3.2 Check the liquid to make sure that:
Icelandic: 3.2 Skoðaðu vökvann til að ganga úr skugga um að:
English: h
Icelandic: f
English: Inflammation
Icelandic: Bólusetningar
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use
Icelandic: Kromeya 40 mg/0,8 ml stungulyf, lausn til notkunar handa börnum
English: Adverse reaction flushing, haematoma
Icelandic: veruleg ofnæmisviðbrögð með losti
English: CD study I and CD study II induction of remission and response rates are presented in Table 21.
Icelandic: Hlutfall þeirra sem náðu sjúkdómshléi og hlutfall svörunar í CD rannsókn I og CD rannsókn II koma fram í töflu
English: • high blood measurements for white blood cells;
Icelandic: hvít blóðkorn mælast mörg í blóði
English: 4.4 Pull back the pink needle safety cover toward the syringe.
Icelandic: 2.4 Fjarlægið gulu hettuna varlega af hettuglasinu.
English: Warning: Do not remove the needle cap while allowing syringe to reach room temperature.
Icelandic: Ekki fjarlægja nálarhettuna á meðan sprautan nær stofuhita.
English: Liver failure
Icelandic: Aukning lifrarensíma
English: Table 23 Maintenance regimen
Icelandic: Tafla 23
English: Single use components and medicine vial (adalimumab) for subcutaneous injection
Icelandic: Einnota hlutar og hettuglas með lyfi (adalimumab) til inndælingar undir húð
English: Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Icelandic: Sjúklingar sem fengu meðferð með adalimumabi sýndu tölfræðilega marktækan ávinning eftir 26 vikur samanborið við lyfleysu með mælikvarða á lífsgæðum einstaklinga með húðsjúkdóm (Dermatology Life Quality Index, DLQI).
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Icelandic: Húðkrabbamein fyrir utan sortuæxli (þ.m.t. grunnfrumukrabbamein og flöguþekjukrabbamein), góðkynja æxli
English: • injection site reactions (including pain, swelling, redness or itching);
Icelandic: áhrif á stungustað (þ.m.t. sársauki, þroti, roði eða kláði)
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Icelandic: Í 3. stigs samanburðarrannsóknum á adalimumabi hjá sjúklingum með iktsýki og sóraliðbólgu, sem stóðu yfir í 4 til 104 vikur, var aukning á ALT ≥
English: • anxiety;
Icelandic: • hryggikt
English: confidence interval)
Icelandic: öryggisbil)
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Icelandic: Blóðkalíumlækkun, blóðþvagsýruhækkun, óeðlilegt natríum í blóði, blóðkalsíumlækkun, blóðsykurshækkun, blóðfosfatskortur, vessaþurrð
English: Adult Uveitis
Icelandic: Iktsýki hjá fullorðnum
English: 6.1 Remove the needle cap • Hold the pre-filled pen upwards and pull the needle cap straight off (Figure L).
Icelandic: Haltu á áfyllta lyfjapennanum og láttu hann vísa upp og dragðu nálarhettuna beint af (mynd L).
English: The recommended dose of Kromeya for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Icelandic: Ráðlagður skammtur af Kromeya fyrir börn með æðahjúpsbólgu 2 ára og eldri er byggður á líkamsþyngd (tafla 5).
English: • Store the pre-filled pen in a refrigerator between 2°C to 8°C.
Icelandic: Geymið áfyllta lyfjapennann í kæli við 2°C til 8°C.
English: Hepatic or renal impairment
Icelandic: Aldur eða líkamsþyngd
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Icelandic: Miðgildi tíma fram að meðferðarbresti var 24,1 vika hjá þeim sem fengu lyfleysu en ekki var hægt að meta miðgildi tíma fram að meðferðarbresti hjá þeim sem fengu adalimumab þar sem innan við helmingur þeirra varð fyrir meðferðarbresti.
English: Kromeya is used to treat psoriatic arthritis in adults.
Icelandic: Kromeya er notað til meðferðar við sóraliðbólgu hjá fullorðnum.
English: Paediatric Crohn's disease
Icelandic: Crohns sjúkdómur börnum
English: • facial oedema (swelling) associated with allergic reactions;
Icelandic: • bjúgur í andliti (þroti) í tengslum við ofnæmisviðbrögð
English: Heart failure
Icelandic: Mjög sjaldgæfar hjartastopp
English: Surgery or dental procedures
Icelandic: Ofanvert á lærum eða
English: Corticosteroid taper was permitted after week
Icelandic: Kaplan-Meier gröf samantekt á tíma til meðferðarbrests við eða eftir viku
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3% on placebo and 10% on adalimumab.
Icelandic: 52 hjá 3% sjúklinga sem fengu lyfleysu og 10% sjúklinga sem fengu adalimumab.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Icelandic: Hjá börnum með í meðallagi alvarlegan til alvarlegan Crohns sjúkdóm var upphafsskammtur adalimumab 160/80 mg eða 80/40 mg í viku 0 og viku 2 í opnu rannsókninni eftir því hvort líkamsþyngd var undir eða yfir 40 kg.
English: • inflammation of the eye lid and eye swelling;
Icelandic: • bólga í augnloki og bólga í auga
English: Paediatric uveitis Age or body weight
Icelandic: Sáraristilbólga Aldur eða líkamsþyngd
English: Kromeya is used to treat moderate to severe plaque psoriasis in adults.
Icelandic: Kromeya er notað til meðferðar á meðalalvarlegum eða alvarlegum skellusóra hjá fullorðnum.
English: Traceability
Icelandic: Greining
English: The decision to stop using Kromeya should be discussed with your child's doctor.
Icelandic: Ræða skal við lækni barnsins um hvort hætta eigi að nota Kromeya.
English: ANNEX III
Icelandic: RA rannsókn III
English: Subcutaneous use For single use only
Icelandic: Til notkunar undir húð Einungis til notkunar í eitt skipti
English: Tachycardia
Icelandic: Aldurshópur
English: • bruising;
Icelandic: • brjóstverkur
English: • headache;
Icelandic: hárlos;
English: Transparent syringe housing
Icelandic: Klínískt sjúkdómshlé
English: Week 12 Week 24 ASAS 70 Week 2
Icelandic: ASAS 70 Vika 2
English: Based on rank analysis
Icelandic: Í CD rannsókn
English: Check with your child's doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.
Icelandic: Látið lækni barnsins eða lyfjafræðing vita um allar aukaverkanir.
English: Doses of 20, 40 or 80 mg of adalimumab or placebo were given every other week for 24 weeks.
Icelandic: Í 24 vikur var aðra hverja viku gefinn 20, 40 eða 80 mg skammtur af adalimumabi eða lyfleysa.
English: Frequency
Icelandic: Hraðsláttur
English: VIAL LABEL
Icelandic: Gegnsæ nálarhlíf
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Icelandic: Hugsanlega færðu fyrst önnur sjúkdómstemprandi gigtarlyf, t.d. metotrexat, ef þú ert með meðalalvarlega eða alvarlega iktsýki.
English: Table 11 Radiographic mean changes over 12 months in RA study III
Icelandic: á 12 mánuðum í RA rannsókn III
English: Pregnancy
Icelandic: útbrot
English: Without MTX
Icelandic: Án metotrexat
English: Lupus-like syndrome
Icelandic: Samanburður við lyfleysu
English: Kromeya 40 mg solution for injection in pre-filled syringe Kromeya 40 mg solution for injection in pre-filled pen
Icelandic: Kromeya 40 mg stungulyf, lausn í áfylltum lyfjapenna
English: • hepatitis (liver inflammation);
Icelandic: • lotunúmer lyfsins (er á merkimiða hettuglassins).
English: Plunger
Icelandic: Brotthvarf
English: Citric acid monohydrate Sodium citrate
Icelandic: fosfat mælist lágt í blóði
English: Symptoms of infections
Icelandic: sýkingar í kynfærum
English: Maintenance of remission and response rates are presented in Table 22.
Icelandic: Hlutföll viðhalds sjúkdómshlés og svörunar koma fram í töflu 22.
English: Non-infectious uveitis Age or body weight
Icelandic: Æðahjúpsbólga sem ekki er af völdum sýkingar Aldur eða líkamsþyngd
English: N
Icelandic: I
English: • high blood sugar;
Icelandic: hár blóðsykur
English: • impotence;
Icelandic: • getuleysi
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Icelandic: Lyfjaform Íkomuleið
English: EU Number
Icelandic: Umbúðir
English: N Engl J
Icelandic: S.R.L.
English: Drug Utilisation Study (DUS)
Icelandic: Voluven (Hes
English: This includes recordings of trainings and accreditation.
Icelandic: I Listi yfir lyf og lyfjaform
English: Whereas
Icelandic: Isohes
English: 4 Brunkhorst FM, Engel C, Bloos F et al.
Icelandic: Fresenius Kabi Hellas A.E.
English: Scientific conclusions
Icelandic: Finnland
English: N Engl J Med
Icelandic: Fresenius Kabi Nv/Sa Voluven
English: Revised CMDh position
Icelandic: Vioser S.A.
English: Hydroxyethyl starch (HES) solutions for infusion contain starch with different molecular weights (mainly 130kD; 200kD) and substitution ratio (the number of hydroxyethyl groups per glucose molecule).
Icelandic: Natríumklóríð 9 g/1000 ml, pólý (0 2 hýdroxýetýl) sterkja 60 g/1000 ml
English: Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis.
Icelandic: Fresenius Kabi Pharma Portugal Lda.
English: Perner A, Haase N, Guttormsen AB et al. Hydroxyethyl starch 130/0.42 versus ringer's acetate in severe sepsis.
Icelandic: Magnesíumklóríðhexahýdrat 0,3 gl, kalíumklóríð 0,3 gl, natríumklóríð 6,02 gl, natríumasetatþríhýdrat 4,63 gl, hýdroxýetýlsterkja 130/0,4 60 gl
English: Communication measures
Icelandic: Lettland
English: Med 2008; 358(2):125-39 5 Myburgh J, Finder S, Bellomo R et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care.
Icelandic: Magnesíumklóríðhexahýdrat 0,203 g/1000 ml, kalíumklóríð 0,298g/1000 ml, natríumklóríð 6,252 g/1000 ml, kalsíumklóríðdýhýdrat 0,367 g/1000 ml, natríumasetatþríhýdrat 3,266 g/1000 ml, l-eplasýra 0,671 g/1000 ml, hýdroxýetýlsterkja 130/0,4 60 g/1000 ml
English: Revised grounds for PRAC recommendation
Icelandic: Equihes Ecobag
English: 1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyethyl_starch containing_solutions/human_referral_prac_000012.jsp&mid=WC0b01ac05805c516f http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyethyl_starchcontaining_medicines/human_referral_prac_000029.jsp&mid=WC0b01ac05805c516f
Icelandic: Magnesíumklóríðhexahýdrat 0,203 g/1000 ml, kalíumklóríð 0,298g/1000 ml, natríumklóríð 6,252 g/1000 ml, kalsíumklóríðdýhýdrat 0,367 g/1000 ml, eplasýra 0,671 g/1000 ml, natríumasetatþríhýdrat 3,266 g/1000 ml, hýdroxýetýlsterkja 130/0,4 60 g/1000 ml
English: Detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Icelandic: Infomed Fluids
English: Packaging Package size
Icelandic: Íkomuleið Umbúðir Pakkningastærð
English: Take the tablet with plenty of water.
Icelandic: Taktu töfluna með miklu af vatni.
English: It is important to keep taking Edarbi every day at the same time.
Icelandic: Mikilvægt er að taka Edarbi á sama tíma á hverjum degi.