FrancophonIA/ELRC3.0 huggingface dataset:
English: • Inflammation of a vein, blood clots in your veins and lungs
Icelandic: - Bláæðarbólga, blóðtappi í bláæðum og lungum
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint a
Icelandic: B = bortezomib; BTDx = bortezomib, thalidomíð, dexametason; TDx = thalidomíð, dexametason; PR = hlutasvörun; OR = líkindahlutfall
English: • Constipation with or without bloating (can be severe)
Icelandic: - Hiti - Ógleði eða uppköst, lystarleysi - Hægðatregða með eða án uppþembu (getur verið veruleg)
English: How bortezomib is given
Icelandic: Bortezomib er gefið á eftirfarandi hátt
English: In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Icelandic: 2. stigi 24% í hópnum sem fékk lyfið með inndælingu undir húð og 41% hjá hópnum sem fékk það með inndælingu í bláæð (p = 0,0124).
English: Note: Bortezomib is a cytotoxic agent.
Icelandic: Ath.: Bortezomib er frumudrepandi lyf.
English: Injury, poisoning and procedural complications
Icelandic: Áverkar og eitranir og fylgikvillar aðgerðar
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m and included in table 7.
Icelandic: Þessar aukaverkanir eru byggðar á samantekt upplýsinga um 5.476 sjúklinga, en af þeim voru
English: 9/l • Non-haematological toxicities should have resolved to grade 1 or baseline
Icelandic: Eiturverkanir, sem ekki tengjast blóði, skulu hafa gengið til baka niður á 1. stig eða að grunngildi
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Icelandic: Algengar Lyndisraskanir og -truflanir*, kvíðaröskun*, svefnraskanir ogtruflanir*
English: Time to progression Events n (%) Median a
Icelandic: Tími að framrás sjúkdóms Tilfelli n (%)
English: Patients with baseline grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Icelandic: 2. stigs úttaugakvilla eða blóðflagnafjölda <50.000/µl við grunnlínu voru útilokaðir frá þátttöku í rannsókninni.
English: d p-value from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
Icelandic: * CR+PR+MR **CR = CR, (IF-); nCR = CR (IF+) NA = á ekki við, NE = ekki metið
English: ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF BORTEZOMIB SINCE NO PRESERVATIVE IS PRESENT.
Icelandic: SMITGÁT SKAL VIÐHÖFÐ VIÐ ALLA MEÐHÖNDLUN BORTEZOMIBS ÞAR SEM EKKERT ROTVARNAREFNI ER Í LYFINU.
English: Rash*, Pruritus*, Erythema, Dry skin Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis
Icelandic: Sjaldgæfar Regnbogaroðasótt, ofsakláði, bráður daufkyrningahúðsjúkdómur með hita (acute febrile neutrophilic dermatosis), eitrunarútþot, eitrunardrep í húðþekju
English: Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Icelandic: Bortezomib sem einlyfjameðferð eða í samsettri meðferð með pegýleruðu liposomal doxorubicini eða dexametasoni er ætlað fullorðnum sjúklingum með versnandi mergæxli (multiple myeloma) sem hafa fengið a.m.k.
English: • Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion) and red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye
Icelandic: hnúður á augnloki (augnaþrymill) og rauð og þrútin augnlok, útferð úr augum, óeðlileg sjón,
English: When bortezomib is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Icelandic: Þegar bortezomib er gefið samhliða öðrum lyfjum skal fylgja leiðbeiningum um lyfjagjöf í samantekt á eiginleikum lyfjanna.
English: Undesirable effects in table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Icelandic: hugsanleg eða líkleg orsakatengsl við bortezomib.
English: Day rest period rest period
Icelandic: Dagur 29 Hvíld
English: What you need to know before you use Bortezomib Fresenius Kabi
Icelandic: Áður en byrjað er að nota Bortezomib Fresenius Kabi
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Icelandic: Ein algengasta eiturverkunin á blóðmynd í rannsóknum hjá sjúklingum með endurkomið mergæxli sem fengu meðferð með bortezomibi og hjá sjúklingum með áður ómeðhöndlað möttulfrumu eitlaæxli sem fengu meðferð með bortezomibi samhliða rituximabi, cyclophosphamíði, doxorubicini og prednisóni (BR-CAP) var skammvinn blóðflagnafæð.
English: • Fracture
Icelandic: - Beinbrot
English: • Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be
Icelandic: 9/l og heildarfjöldi daufkyrninga (absolute neutrophil count
English: Discontinue bortezomib if PML is diagnosed.
Icelandic: Hættið á meðferð með bortezomibi ef ágeng fjölhreiðra innlyksuheilabólga greinist.
English: -- -- -- -- rest period
Icelandic: -- Hvíld -
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Icelandic: Greint hefur verið frá afturkræfu aftara heilakvillaheilkenni hjá sjúklingum sem fá bortezomib.
English: Pulmonary disorders
Icelandic: - Vöðvakippir
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Virkniniðurstöður er að finna í töflu
English: • Gallstones
Icelandic: gallteppa
English: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Icelandic: ráðleggingar um hvernig draga megi úr hættu á að sprautum með blandaðri lausn til notkunar i.v.
English: • Genital swelling
Icelandic: #, Stevens-Johnson heilkenni
English: Oedema (inc peripheral), Chills, Pain*, Malaise*
Icelandic: Algengar Bjúgur (þ.m.t. útlægur), hrollur, verkur*, lasleiki*
English: Table 4: Posology for bortezomib combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Icelandic: Skömmtun bortezomibs í samsettri meðferð hjá sjúklingum með áður ómeðhöndlað mergæxli, sem hentar ígræðsla blóðmyndandi stofnfrumna
English: Combination therapy with pegylated liposomal doxorubicin Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Icelandic: Samsett meðferð með pegýleruðu liposomal doxorubicini Bortezomib Fresenius Kabi 3,5 mg stungulyfsstofn, lausn er gefið í bláæð eða undir húð í ráðlögðum skammti 1,3 mg/m líkamsyfirborðs tvisvar í viku í tvær vikur á 1., 4., 8. og 11. degi í 21 dags meðferðarlotu.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Icelandic: Bortezomib Fresenius Kabi 3,5 mg stungulyfsstofn, lausn bortezomib s.c. eða i.v.
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m Since dialysis may reduce bortezomib concentrations, bortezomib should be administered after the dialysis procedure (see section 5.2).
Icelandic: Ekki er þekkt hvort lyfjahvörf bortezomibs breytast hjá sjúklingum með verulega skerta nýrnastarfsemi sem ekki eru í skilun (CrCl < 20 ml/mín./1,73 m2).
English: Very common Decreased appetite Common
Icelandic: Minnkuð matarlyst
English: Bortezomib should not be administered intrathecally.
Icelandic: Bortezomib er eingöngu einnota.
English: • Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Icelandic: Sjaldgæfar Lungnasegarek, fleiðruvökvi, lungnabjúgur (þ.m.t. bráður), blæðing í lungnablöðrum
English: Uncommon Cardiac tamponade
Icelandic: Alvarleiki taugakvilla
English: • different reconstitution requirements for bortezomib 3.5 mg IV or SC use
Icelandic: 3,5 mg til notkunar i.v. eða s.c.
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Icelandic: Bortezomib Fresenius Kabi 3,5 mg stungulyfsstofn, lausn er gefin með inndælingu í bláæð eða undir húð í ráðlögðum skammti 1,3 mg/m líkamsyfirborðs, tvisvar sinnum í viku í tvær vikur á 1., 4., 8. og 11. degi í 21 dags meðferðarlotu.
English: When bortezomib is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Icelandic: Þegar bortezomib er gefið samhliða öðrum lyfjum skal einnig skoða frábendingar í samantekt á eiginleikum lyfs fyrir hin lyfin.
English: Bortezomib subcutaneous arm
Icelandic: Tafla með aukaverkunum
English: • Weight increase
Icelandic: - Þyngdaraukning
English: (conjunctivitis)
Icelandic: veruleg).
English: IV on day 1; doxorubicin
Icelandic: 17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI
English: BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Icelandic: Úthreinsun bortezomibs, stöðluð fyrir áhrifum flatarmáls líkamsyfirborðs hjá börnum var svipuð og hjá fullorðnum.
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib powder by using a syringe of the appropriate size without removing the vial stopper.
Icelandic: 3,5 ml af sæfðri natríumklóríð 9 mg/ml (0,9%) lausn fyrir stungulyf í hettuglasið með bortezomib duftinu með því að nota sprautu í viðeigandi stærð, án þess að fjarlægja tappann úr hettuglasinu.
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Icelandic: Sjúklingum sem svara a.m.k. að hluta til eftir 4 lotur má gefa allt að 6 lotur.
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib powder by using a syringe of the appropriate size without removing the vial stopper.
Icelandic: 1,4 ml af sæfðri natríumklóríð 9 mg/ml (0,9%) lausn fyrir stungulyf í hettuglasið með bortezomib duftinu með því að nota sprautu í viðeigandi stærð, án þess að fjarlægja tappann úr hettuglasinu.
English: SC or IV
Icelandic: VIÐAUKI III
English: • volume of reconstituted bortezomib (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
Icelandic: skammtaleiðbeiningar og dæmi: hvernig reikna á líkamsyfirborð sjúklings og rúmmál blandaðs bortezomibs (bæði til notkunar i.v. og s.c.) sem þarf fyrir mismunandi líkamsyfirborð (tilvísun í reiknistokk fyrir skammtastærðir)
English: • to report any adverse event, or medication error experienced with the administration of bortezomib 3.5 mg.
Icelandic: • að tilkynna skuli allar aukaverkanir eða mistök við lyfjagjöf sem fram koma við gjöf á bortezomib
English: Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
Icelandic: Taugakvillar*, útlægur skyntaugakvilli, tilfinningartruflun (dysaesthesia)*, taugaverkur*
English: Then, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m to
Icelandic: Þá má hefja meðferð með bortezomibi að nýju með skammti sem er minnkaður um eitt skammtabil (úr 1,3 mg/m2 í
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Icelandic: Samsett meðferð með dexametasoni og thalidomíði Bortezomib Fresenius Kabi 3,5 mg stungulyfsstofn, lausn er gefið með inndælingu í bláæð eða undir húð í ráðlögðum skammti 1,3 mg/m líkamsyfirborðs, tvisvar í viku í tvær vikur á 1., 4., 8. og 11. degi í 28 daga meðferðarlotu.
English: • Fistula
Icelandic: Taugakerfi
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Icelandic: B veirusýkingar ámeðan samsettri meðferð með rituximabi og bortezomibi stendur, og eftir að meðferð lýkur.
English: Elderly MCL patients
Icelandic: Hjá sjúklingum í III.
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Icelandic: cyclophosphamíð, doxorubicin, vincristin og prednisón; PN = útlægur taugakvilli
English: • seizures
Icelandic: - Útbrot
English: Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Icelandic: Greint hefur verið frá sjaldgæfum tilvikum viðbragða sem mögulega voru vegna ónæmisfléttna t.d. viðbrögðum sem líkjast sermissótt, fjölliðagigt með útbrotum og gauklabólgu með frumufjölgun.
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including thrombocytopenic purpura)
Icelandic: Dreifð blóðstorknun (disseminated intravascular coagulation), blóðflagnafjölgun*, heilkenni ofseigju (hyperviscosity syndrome), blóðflagnakvilli sem ekki er nánara skilgreindur, segasmáæðakvilli (þ.m.t. blóðflagnafæðarpurpuri)
English: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
Icelandic: Hjartatif (þ.m.t. gáttatif), hjartsláttaróregla*, hjartabilun (þ.m.t. vinstri og hægri slegilsbilun)*, hjartavöðvablóðþurrð, vanstarfsemi slegils*
English: n: ITT patients Progression free survival (IRC)
Icelandic: Lifun án versnunar (IRC)a
English: - Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL - Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration - Haemoglobin ≥ 8 g/dL - Non-haematological toxicities should have resolved to grade 1 or baseline.
Icelandic: Blóðflagnafjöldi skal vera ≥ 75.000 frumur/μl hjá sjúklingum með beinmergsíferð eða bindingu í milta (splenic sequestration)
English: Bortezomib intravenous arm
Icelandic: Sjaldgæfar Ofnæmisbjúgur
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids
Icelandic: - Þokusýn - Sýking í ysta lagi augans og innra yfirborði augnloka (tárubólga) - Blóðnasir
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis
Icelandic: Sjaldgæfar Brisbólga (þ.m.t. langvinn)*, blóðuppköst, þroti á vörum*, teppa í meltingarvegi (þ.m.t. teppa í mjógirni, garnastífla)*, óþægindi í kvið, sáramyndun í munni*, garnabólga*, magabólga*, tannholdsblæðing, vélindabakflæðissjúkdómur*, ristilbólga (þ.m.t. vegna clostridium difficile)*, blóðþurrðarristilbólga
English: Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Icelandic: Algengar Hreyfitaugakvilli*, meðvitundarmissir (þ.m.t. aðsvif), sundl*, bragðskynstruflun*, svefnhöfgi, höfuðverkur*
English: • Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
Icelandic: - rauðra blóðkorna, sem getur valdið blóðleysi með einkennum eins og þreytu og fölva - hvítra blóðkorna sem haft getur í för með sér að minna þurfi til að valda sýkingum eða inflúensulíkum einkennum.
English: CR+nCR+PR+MR 146 (46) 108 (35) 66 (52) 45 (41) 80 (43) 63 (31) (35)**
Icelandic: 4,63 (2,61; 8,22); < 0,001a 3,46 (1,90; 6,27); < 0,001a
English: • Respiratory infections, bronchitis, coughing with phlegm, flu like illness
Icelandic: - Öndunarfærasýkingar, berkjubólga, hósti með slímuppgangi, flensulík veikindi
English: * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Icelandic: „Vironeutralising antibody titre after vaccine injection in guinea pigs“.
English: Emulsion for injection
Icelandic: Lyfjaform Dýrategund
English: Target Species Route of administration
Icelandic: Íkomuleið Umbúðir
English: Withdrawal period
Icelandic: Sérheiti Styrkleiki
English: Packaging Content Package Size
Icelandic: Pakkningastærð
English: If this happens to you, do not drive or use machines.
Icelandic: Ef þetta kemur fyrir þig skaltu ekki aka eða stjórna vélum.
English: In case you forget to take a dose, take it as soon as you remember.
Icelandic: Ef þú gleymir að taka einn skammt skaltu taka hann eins fljótt og þú manst.
English: Repso with food, drink and alcohol
Icelandic: Notkun Repso með mat, drykk og áfengi
English: - Dry skin.
Icelandic: Þurr húð.
English: Repso tablets can be taken with or without food.
Icelandic: Repso töflur má taka með eða án matar.
English: Children and adolescents Repso is not recommended for use in children and adolescents below 18 years of age.
Icelandic: Börn og Unglingar Repso á ekki að nota handa börnum og unglingum undir 18 ára aldri.
English: Blisters: 18 months
Icelandic: 18 mánuðir
English: - Weight loss (usually insignificant).
Icelandic: Þyngdartap (oftast óverulegt).
English: If you forget to take Repso
Icelandic: Ef gleymist að taka Repso
English: - The other ingredients are (see section 2 “Repso contains lactose”)
Icelandic: - Önnur innihaldsefni eru (sjá kafla 2 „Repso inniheldur mjólkursykur“)
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel)
Icelandic: Áhrif á getnaðarvarnartöflur (0,03 mg etínýlestradíól og 0,15 mg levonorgestrel)
English: Portugal Teva Pharma - Produtos Farmacêuticos Lda
Icelandic: Teva Pharma - Produtos Farmacêuticos, Lda
English: You will normally take Repso over long periods of time.
Icelandic: Þú munt væntanlega taka Repso í langan tíma.
English: Repso is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Icelandic: Ekki er mælt með notkun Repso hjá sjúklingum yngri en 18 ára þar sem verkun og öryggi við barnaliðagigt (juvenile rheumatoid arthritis) hefur ekki verið staðfest (sjá kafla 5.1 og 5.2).
English: Leflunomide is indicated for the treatment of adult patients with
Icelandic: Leflúnómíð er ætlað til meðferðar á fullorðnum sjúklingum með
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Repso from your body.
Icelandic: Hægt er að stytta þennan tíma í nokkrar vikur með því að nota ákveðin lyf sem hraða því að Repso hverfi úr líkamanum.
English: - Lack or loss of strength (weakness).
Icelandic: Kraftleysi eða minnkaður kraftur (þróttleysi).
English: Before and during treatment with Repso, your doctor will carry out blood tests at regular times.
Icelandic: Áður og meðan á meðferð með Repso stendur, mun læknirinn þinn taka reglulega blóðsýni til rannsóknar.
English: Blisters: 2 years
Icelandic: 2 ár
English: Repso tablets should be swallowed whole with plenty of water.
Icelandic: Repso töflur á að gleypa í heilu lagi með nægu vatni.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Icelandic: Tíðniflokkun er skilgreind á eftirfarandi hátt: mjög algengar (≥1/10); algengar (≥1/100 til <1/10), sjaldgæfar (≥1/1.000 til <1/100); mjög sjaldgæfar (≥1/10.000 til <1/1.000); koma örsjaldan fyrir (<1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: Quinoline Yellow Aluminium lake (E104) Indigo Carmine Aluminium Lake (E132)
Icelandic: Aluminium lake (E104) Indígo karmín Aluminium Lake (E132)
English: - If you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Icelandic: ef þú hefur fengið berkla eða hefur verið í náinni snertingu við einhvern sem er með eða hefur fengið berkla.
English: Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Icelandic: Repso er notað til meðferðar á fullorðnum sjúklingum með virka iktsýki (rheumatoid arthritis) eða með virka sóraliðbólgu (psoriatic arthritis).
English: OPA/Alu/PVC - Aluminium blisters.
Icelandic: OPA/ál/PVC - Álþynnupakking.
English: Pharmacokinetic data in elderly people (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Icelandic: Gögn um lyfjahvörf hjá öldruðum (>65 ár) eru takmörkuð en í samræmi við lyfjahvörf hjá yngri einstaklingum.
English: If you suspect that you are pregnant while taking Repso or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Icelandic: Ef þig grunar að þú sért barnshafandi á meðan þú ert að nota Repso eða innan tveggja ára eftir að meðferð var hætt, átt þú strax að hafa samband við lækni og gera þungunarpróf.
English: Therefore, it is not recommended to drink alcohol during treatment.
Icelandic: Því er ekki ráðlegt að neyta áfengis á meðan á Repso meðferð stendur.
English: If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Icelandic: Ef þú eða einhver annar tekur stóran skammt í einu, eða þú heldur að barn hafi tekið töflu, hafðu strax samband við næsta sjúkrahús, bráðamóttöku eða lækni.
English: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
Icelandic: Slovenská republika TevaTEVA Pharmaceuticals Slovakia s.r.o.
English: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Icelandic: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland /Tel: +49 731 402 02
English: Effect on organic anion transporter 3 (OAT3) substrates
Icelandic: Áhrif á hvarfefni flutningsefnis lífrænna anjóna 3 (OAT3)
English: - If you are woman of child-bearing age and not using effective contraception.
Icelandic: Ef þú ert kona á barnseignaraldri og notar ekki örugga getnaðarvörn.
English: Since Repso can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Icelandic: Þar sem Repso getur valdið hækkuðum blóðþrýstingi mun læknirinn einnig fylgjast reglulega með blóðþrýstingi hjá þér.
English: - Pain, swelling and tenderness most often in the hand, wrist or feet.
Icelandic: Verkur, bólgur og viðkvæmni oftast í hönd, úlnlið eða fótum.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Icelandic: Ítarlegar upplýsingar um þetta lyf eru birtar á heimasíðu Lyfjastofnunar Evrópu http://www.ema.europa.eu/.