FrancophonIA/ELRC3.0 huggingface dataset:
English: For injection of AFSTYLA the provided administration sets are recommended to be used because treatment failure can occur as a consequence of factor VIII adsorption to the internal surface of some injection equipment.
Icelandic: Ráðlagt er að nota lyfjagjafarbúnaðinn sem fylgir með lyfinu til að gefa AFSTYLA, þar sem aðsog storkuþáttar VIII á yfirborð sumra gerða lyfjagjafarbúnaðar getur valdið því að meðferð beri ekki árangur.
English: What you need to know before you use AFSTYLA
Icelandic: Áður en byrjað er að nota AFSTYLA
English: The one-stage clotting assay result underestimates the factor VIII activity level compared to the chromogenic assay result by approximately 45%.
Icelandic: Storknunarpróf í einu skrefi vanmetur virkni storkuþáttar VIII sem nemur u.þ.b. 45%, miðað við litmyndunarprófið.
English: AFSTYLA 2500 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 2500 a.e. stungulyfsstofn og leysir, lausn
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Icelandic: Fargið hettuglasinu undan leysinum með áföstu bláa Mix2Vial millistykkinu..
English: After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 2,5 ml af vatni fyrir stungulyf inniheldur lausnin 200 a.e./ml af rVIII-SingleChain.
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of lonoctocog alfa.
Icelandic: 250 a.e. í hverju hettuglasi; eftir blöndun með 2,5 ml af vatni fyrir stungulyf inniheldur lausnin 100 a.e./ml af lonoktókóg alfa.
English: • chills
Icelandic: • náladofi
English: • If you need a central venous access device (CVAD for injection of AFSTYLA), the risk of complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Icelandic: AFSTYLA þarf læknirinn að íhuga hættu á fylgikvillum, þ.m.t. staðbundnum sýkingum, blóðsýkingu og segamyndun í æðinni þar sem holleggnum er komið fyrir.
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of lonoctocog alfa.
Icelandic: 500 a.e. í hverju hettuglasi; eftir blöndun með 2,5 ml af vatni fyrir stungulyf inniheldur lausnin 200 a.e./ml af lonoktókóg alfa.
English: AFSTYLA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Icelandic: Hvert hettuglas inniheldur 2000 a.e. af einkeðja (single-chain) storkuþætti VIII, framleiddann með raðbrigðaerfðatækni, (rVIII-SingleChain, INN = lonoktókóg alfa).
English: 2500 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 500 IU/ml of lonoctocog alfa.
Icelandic: 2500 a.e. í hverju hettuglasi; eftir blöndun með 5 ml af vatni fyrir stungulyf inniheldur lausnin 500 a.e./ml af lonoktókóg alfa.
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Icelandic: 2000 a.e. í hverju hettuglasi; eftir blöndun með 5 ml af vatni fyrir stungulyf inniheldur lausnin 400 a.e./ml af lonoktókóg alfa.
English: After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 2,5 ml af vatni fyrir stungulyf inniheldur lausnin 100 a.e./ml af rVIII-SingleChain.
English: powder and solvent for solution for injection 1 vial with powder: 3000 IU lonoctocog alfa (600 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Icelandic: 3000 a.e. af lonoktókóg alfa (600 a.e./ml eftir blöndun) 1 hettuglas með 5 ml af vatni fyrir stungulyf
English: AFSTYLA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Icelandic: Hvert hettuglas inniheldur 3000 a.e. af einkeðja (single-chain) storkuþætti VIII, framleiddann með raðbrigðaerfðatækni, (rVIII-SingleChain, INN = lonoktókóg alfa).
English: 1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Icelandic: 1000 a.e. í hverju hettuglasi; eftir blöndun með 2,5 ml af vatni fyrir stungulyf inniheldur lausnin 400 a.e./ml af lonoktókóg alfa.
English: powder and solvent for solution for injection 1 vial with powder: 2500 IU lonoctocog alfa (500 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Icelandic: 2500 a.e. af lonoktókóg alfa (500 a.e./ml eftir blöndun) 1 hettuglas með 5 ml af vatni fyrir stungulyf
English: When reconstituted with 5 ml water for injections the solution contains 500 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 5 ml af vatni fyrir stungulyf inniheldur lausnin 500 a.e./ml af rVIII-SingleChain.
English: powder and solvent for solution for injection 1 vial with powder: 1500 IU lonoctocog alfa (300 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Icelandic: 1500 a.e. af lonoktókóg alfa (300 a.e./ml eftir blöndun) 1 hettuglas með 5 ml af vatni fyrir stungulyf
English: When reconstituted with 5 ml water for injections the solution contains 300 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 5 ml af vatni fyrir stungulyf inniheldur lausnin 300 a.e./ml af rVIII-SingleChain.
English: For intravenous use
Icelandic: Innri umbúðir
English: AFSTYLA 3000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 3000 a.e. stungulyfsstofn og leysir, lausn lonoktókóg alfa (einkeðja (single-chain) storkuþáttur VIII, framleiddur með erfðatækni)
English: AFSTYLA 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Icelandic: Hvert hettuglas inniheldur 2500 a.e. af einkeðja (single-chain) storkuþætti VIII, framleiddann með raðbrigðaerfðatækni, (rVIII-SingleChain, INN = lonoktókóg alfa).
English: When reconstituted with 5 ml water for injections the solution contains 600 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 5 ml af vatni fyrir stungulyf inniheldur lausnin 600 a.e./ml af rVIII-SingleChain.
English: AFSTYLA 250 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 250 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Icelandic: 1 hettuglas með stungulyfsstofni 1 hettuglas með 5 ml af vatni fyrir stungulyf 1 síu/-flutningsbúnað 20/20
English: After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 2,5 ml af vatni fyrir stungulyf inniheldur lausnin 400 a.e./ml af rVIII-SingleChain.
English: AFSTYLA 2500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 2500 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: AFSTYLA 1000 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 1000 a.e. stungulyfsstofn og leysir, lausn
English: AFSTYLA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Icelandic: Hvert hettuglas inniheldur 1500 a.e. af einkeðja (single-chain) storkuþætti VIII, framleiddann með raðbrigðaerfðatækni, (rVIII-SingleChain, INN = lonoktókóg alfa).
English: AFSTYLA 2000 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 2000 a.e. stungulyfsstofn og leysir, lausn.
English: AFSTYLA 2000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 2000 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: AFSTYLA 1500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 1500 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: AFSTYLA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Icelandic: Hvert hettuglas inniheldur 500 a.e. af einkeðja (single-chain) storkuþætti VIII, framleiddann með raðbrigðaerfðatækni, (rVIII-SingleChain, INN = lonoktókóg alfa).
English: When reconstituted with 5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Icelandic: Eftir blöndun með 5 ml af vatni fyrir stungulyf inniheldur lausnin 400 a.e./ml af rVIII-SingleChain.
English: AFSTYLA 250 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 250 a.e. stungulyfsstofn og leysir, lausn.
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the powder vial stopper.
Icelandic: Mix2Vial búnaðinum á hvolf og þrýstið oddinum á gegnsæja endanum á millistykkinu beint niður í gegnum tappa hettuglassins með stofninum.
English: AFSTYLA 1000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 1000 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: AFSTYLA 1500 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 1500 a.e. stungulyfsstofn og leysir, lausn.
English: Administration set
Icelandic: FYRNINGARDAGSETNING
English: AFSTYLA 500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Icelandic: AFSTYLA 500 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: AFSTYLA 3000 IU powder for solution for injection Lonoctocog alfa
Icelandic: AFSTYLA 3000 a.e. stungulyfsstofn og leysir, lausn Lonoktókóg alfa (raðbrigðastorkuþáttur VIII)
English: AFSTYLA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Icelandic: Hvert hettuglas inniheldur 1000 a.e. af einkeðja (single-chain) storkuþætti VIII, framleiddann með raðbrigðaerfðatækni, (rVIII-SingleChain, INN = lonoktókóg alfa).
English: AFSTYLA 3000 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 3000 a.e. stungulyfsstofn og leysir, lausn.
English: AFSTYLA 500 IU powder and solvent for solution for injection
Icelandic: AFSTYLA 500 a.e. stungulyfsstofn og leysir, lausn
English: Blood and lymphatic system disorders
Icelandic: Blæðingarlyf:
English: Cardiovascular events
Icelandic: hitatilfinning
English: Potency assignment is determined using a chromogenic substrate assay.
Icelandic: Lyfið inniheldur snefil af próteinum úr hömstrum.
English: The solvent will automatically flow into the powder vial.
Icelandic: Leysirinn rennur sjálfkrafa niður í hettuglasið með stofninum.
English: Exp. date
Icelandic: A.m.k.
English: ©EMEA 2007
Icelandic: 10 hettuglös©EMEA
English: Packaging Content
Icelandic: Pakkningas tærð
English: Invented name Strength Pharmaceutical Form Route of administration
Icelandic: ESB markaðsleyfisnúmer
English: EU Number
Icelandic: Styrkleik i
English: Date of first authorisation: 22 May 2017
Icelandic: 22. maí 2017
English: Histopathology standard of truth data was available for 99 of the 115 subjects.
Icelandic: Vefjameinafræðileg sanngildisgögn (histopathology standard of truth data) voru tiltæk fyrir 99 af 115 einstaklingum.
English: Talk to your nuclear medicine doctor if you are under 18 years old.
Icelandic: Talaðu við geislalækninn ef þú ert yngri en 18 ára.
English: One injection is usually sufficient to conduct the test that your doctor needs.
Icelandic: Ein inndæling er yfirleitt nóg til að gera þær rannsóknir sem læknirinn þarfnast.
English: Parcelas 1 y 2 La Almunia de Doña Godina 50100 Zaragoza
Icelandic: 2 La Almunia de Doña Godina 50100 Zaragoza
English: Patients with non-surgical therapy were treated at least 2 years before.
Icelandic: Sjúklingar sem fengu meðferð án skurðaðgerðar höfðu fengið meðferð minnst 2 árum áður.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in sections 6.6 and 12.
Icelandic: Ekki má blanda þessu lyfi saman við önnur lyf en þau sem nefnd eru í kafla 6.6 og 12.
English: Activity in the brain is low.
Icelandic: Virkni í heila er lítil.
English: The patient should be positioned supine with arms above the head.
Icelandic: Sjúklingur skal snúa upp með handleggi fyrir ofan höfuð.
English: Typical total scan time is between 20-30 minutes.
Icelandic: Dæmigerður heildartími sneiðmyndatöku er um 20-30 mínútur.
English: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL UK
Icelandic: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL Bretland
English: Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.
Icelandic: Norsk medisinsk syklotronsenter AS, 0372 Oslo, Noregur.
English: Axumin is not intended for use in children and adolescents aged under 18 years.
Icelandic: Axumin er ekki ætlað til notkunar handa börnum og unglingum yngri en 18 ára.
English: The scan will usually start approximately 5 minutes after the Axumin injection is given.
Icelandic: Sneiðmyndatakan hefst yfirleitt um 5 mínútum eftir inndælingu Axumin.
English: If the injection volume is between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used.
Icelandic: Ef inndælingarrúmmálið er milli 0,5 og 1 ml skal aðeins nota sprautur í viðeigandi stærð (1 ml).
English: Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
Icelandic: Gildin voru reiknuð út frá gögnum um líffræðilega dreifingu í mönnum með hugbúnaðinum OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling).
English: The nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine.
Icelandic: Geislalæknirinn mun upplýsa þig um hvort þú þurfir að gera aðrar sérstakar varúðarráðstafanir eftir að þú færð lyfið.
English: Exp{hh:mm}{Time Zone}{DD/MM/YYYY}
Icelandic: Exp{hh:mm}{Tímabelti}{DD/MM/ÁÁÁÁ}
English: You should discuss the results of the test with the doctor that requested the scan.
Icelandic: Þú skalt ræða rannsóknarniðurstöðurnar við lækninn sem hefur beðið um myndatökuna.
English: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria.
Icelandic: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austurríki.
English: Each mL of solution contains 7.7 mg of sodium.
Icelandic: Hver ml lausnar inniheldur 7,7 mg af natríumi.
English: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud France
Icelandic: Advanced Accelerator Applications 3 rue Charles Lauer 92210
English: - Pain or rash at the site of injection, altered taste in the mouth, altered sense of smell.
Icelandic: - Verkur eða útbrot á stungustað, breytt bragðskyn í munni, breytt lyktarskyn.
English: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIA
Icelandic: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf Austurríki
English: If you have previously had treatment for prostate cancer and information from other tests (e.g. prostate specific antigen, PSA) indicates that the cancer may have returned, an Axumin PET scan can help your doctor find the locations where the cancer has come back.
Icelandic: Ef þú hefur áður fengið meðferð við krabbameini í blöðruhálskirtli og ef upplýsingar úr öðrum rannsóknum (t.d. sérstakur mótefnavaki í blöðruhálskirtli eða PSA) benda til þess að krabbameinið geti hafa tekið sig upp á ný, getur Axumin PETsneiðmyndataka hjálpa lækninum að finna þá staði þar sem krabbameinið hefur tekið sig upp aftur.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Icelandic: Móttaka, geymsla, notkun, flutningur og förgun slíkra efna eru háð reglugerðum og/eða viðeigandi leyfum þar til bærra yfirvalda.
English: In clinical studies side effects were reported by less than 1 in 100 patients given the medicine.
Icelandic: Í klínískum rannsóknum tilkynntu færri en 1 af hverjum 100 sjúklingum sem fengu lyfið um aukaverkanir.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Icelandic: Þetta starfsfólk mun gæta þess sérstaklega að lyfið sé notað með öruggum hætti og upplýsa þig um allar aðgerðir sínar.
English: This medicinal product is not intended for regular or continuous administration.
Icelandic: Lyfið er ekki ætlað til reglulegrar eða samfelldrar notkunar.
English: The following information is intended for the specialist only.
Icelandic: Eftirtaldar upplýsingar eru aðeins fyrir sérfræðinginn.
English: Toxicological studies with rats and dogs have demonstrated that with a single intravenous injection no deaths were observed.
Icelandic: Eiturefnafræðilegar rannsóknir hjá rottum og hundum hafa sýnt að engin dauðsföll komu fram með stakri inndælingu í bláæð.
English: It is considered unlikely that Axumin will affect your ability to drive or to use machines.
Icelandic: Talið er ólíklegt að Axumin hafi áhrif á hæfni þína til aksturs eða notkunar véla.
English: The following side effects of Axumin are common (may affect up to 1 in 100 people).
Icelandic: Eftirtaldar aukaverkanir Axumin eru algengar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum).
English: The Healthcare professionals self-training material shall contain the following key elements:
Icelandic: Efnið fyrir sjálfsnám heilbrigðisstarfsfólks skal innihalda eftirfarandi þætti:
English: Uptake by tumours is rapid, with the highest tumour-to-normal tissue contrast between 4 and 10 minutes after injection and continuing for around 30 minutes, with a 61% reduction in mean tumour uptake at 90 minutes after injection.
Icelandic: Upptaka í æxli er hröð, þar sem mesti munur á æxli og eðlilegum vef er milli 4 og 10 mínútur eftir inndælingu og heldur áfram í um 30 mínútur, með 61% lækkun meðalupptöku í æxli 90 mínútum eftir inndælingu.
English: This should be taken into consideration if you are on a controlled sodium diet.
Icelandic: Þetta þarf að taka til greina ef þú ert á natríumsnauðu fæði.
English: Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Icelandic: Advanced Accelerator Applications, 13005 Marseille, Frakklandi Nucleis SA, 4000 Liège, Belgía
English: The MAH shall ensure that in each Member State where Axumin is marketed, all Healthcare professionals who are expected to use Axumin have access to self-training educational material in order to reduce the risk of PET imaging interpretation errors.
Icelandic: Markaðsleyfishafi skal tryggja í hverju landi þar sem Axumin er markaðssett, að allt heilbrigðisstarfsfólk sem gert er ráð fyrir að noti Axumin hafi aðgang að fræðsluefni sem byggir á sjálfsnámi til að draga úr hættu á mistökum í túlkun PET-mynda.
English: Exp: ToC + 8h
Icelandic: Exp: ToC + 8 klst.
English: radioactive
Icelandic: geislavirkt
English: Talk to your nuclear medicine doctor before you are given Axumin if you: - have kidney problems - are on a low sodium diet (see section "Axumin contains sodium").
Icelandic: Ræddu við geislalækninn áður en þér er gefið Axumin ef þú: - ert með nýrnakvilla - ert á natríumsnauðu fæði (sjá kaflann „Axumin inniheldur natríum“).
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Icelandic: Fyrir hvern sjúkling verður útsetning fyrir geislun að vera réttlætanleg með líklegum ávinningi.
English: Washout of activity from most organs and tissues (with the exception of the pancreas) is slow.
Icelandic: Úthreinsun geislavirkni úr flestum líffærum og vefjum (að brisinu undanskildu) er hæg.
English: Fluciclovine (18F) distributes immediately following administration to the liver (14% of administered activity), pancreas (3%), lung (7%), red bone marrow (12%) and heart wall (4%).
Icelandic: Fluciclovine (18F) dreifist strax eftir gjöf til lifrar (14% geislavirkninnar), bris (3%), lungna (7%), rauðs blóðmergs (12%) og hjartaveggjar (4%).
English: Fluciclovine is not metabolised in vivo.
Icelandic: Fluciclovine umbrotnar ekki in vivo.
English: For detection of extraprostatic recurrences (regional lymph node and/or distal metastases) sensitivity was 84.2% (32/38) (95%CI: 68.7-94%) and specificity was 89.7% (78/87) (95%CI: 81.3-95.2%), respectively.
Icelandic: Fyrir greiningu á endurkomu utan blöðruhálskirtlis (nálægum eitlum og/eða fjarlæg meinvörp) var næmi 84,2% (32/38) (95%CI: 68,794%) og sértækni 89,7% (78/87) (95%CI: 81,3-95,2%).
English: The patient should be encouraged to drink sufficient amounts and void as often as possible during the first hours after the scan in order to reduce radiation exposure of the bladder.
Icelandic: Hvetja skal sjúklinginn til að drekka nægilegt vatnsmagn og tæma blöðruna eins oft og hægt er á fyrstu klukkustundum eftir sneiðmyndatökuna til að draga úr útsetningu þvagblöðrunnar fyrir geislun.
English: It will be the smallest quantity necessary to get the desired information.
Icelandic: Notaður verður minnsti skammtur sem nægir til að afla tilætlaðra upplýsinga.
English: This medicine is not indicated for use in women.
Icelandic: Þetta lyf er ekki ætlað til notkunar hjá konum.
English: Exp: ToC + 10h
Icelandic: Exp: ToC + 10 klst.
English: Axumin has no or negligible influence on the ability to drive and use machines.
Icelandic: Axumin hefur engin eða óveruleg áhrif á hæfni til aksturs og notkunar véla.
English: Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Icelandic: Læknir þinn og geislalæknirinn telja að ávinningur af þessari meðferð með geislavirka lyfinu vegi þyngra en hættan sem stafar af geisluninni.
English: In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to facilitate the removal of radioactivity from your body.
Icelandic: Geislalæknirinn sem annast gjöf lyfsins mun einkum beita aðferðum til að auka þvagmyndun og hægðalosun, til að fjarlægja geislavirknina úr líkama þínum.
English: - The active substance is fluciclovine (18F).
Icelandic: - Virka innihaldsefnið er fluciclovine (18F)
English: True positive (%) False positive (%) True negative (%) False negative (%) Sensitivity [95% CI] Specificity [95% CI]
Icelandic: Sönn jákvæð niðurstaða (%) Fölsk jákvæð niðurstaða (%) Sönn neikvæð niðurstaða (%) Fölsk jákvæð niðurstaða (%) Næmi [95% CI] Sértækni [95% CI]
English: The pivotal efficacy data derives from 115 patients recruited into the BED-001 study at Emory
Icelandic: Lykilupplýsingar um verkun eru fengnar frá 115 sjúklingum sem tóku þátt í BED-001 rannsókninni við Emory háskólann.
English: - if you are allergic to fluciclovine (18F) or any of the other ingredients of this medicine (listed in section 6).
Icelandic: - ef um er að ræða ofnæmi fyrir fluciclovine (18F) eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: As a result of the manufacturing process some vials are distributed with punctured rubber stoppers.
Icelandic: Vegna mismunandi framleiðsluferla eru sum hettuglös afgreidd með götuðum gúmmítöppum.
English: Fluciclovine (18F) is not indicated for use in women.
Icelandic: Fluciclovine (18F) er ekki ætlað til notkunar handa konum.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Icelandic: Samt sem áður verður þér veitt viðeigandi meðferð ef þú færð of stóran skammt.