FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analyses from studies with the individual components revealed that gender had no clinically relevant effect on the pharmacokinetics of dolutegravir or rilpivirine.
Icelandic: Greining á lyfjahvörfum úr rannsóknum á hvoru virku efni lyfsins fyrir sig gaf ekki til kynna klínísk áhrif sem skipta máli á lyfjahvörf dolutegravirs og rilpivirins með tilliti til kyns.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Juluca with metformin, to maintain glycaemic control.
Icelandic: Íhuga á skammtaaðlögun metformins þegar meðferð með Juluca hefst og þegar henni er lokið til að viðhalda blóðsykursstjórn.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Icelandic: Hver filmuhúðuð tafla inniheldur dolutegravir natríum sem jafngildir 50 mg dolutegravir og rilpivirin hydroklóríð sem jafngildir 25 mg rilpivirin.
English: Steadystate administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine (see section 4.4).
Icelandic: á QTcF bil fyrir lyfleysu eftir leiðréttingu miðað við upphafsgildi, annars vegar 10,7 (15,3) og hins vegar 23,3 (28,4) ms. Gjöf 75 mg skammts og 300 mg skammts af rilpivirini einu sinni á dag við jafnvægi leiddi annars vegar til 2,6-falt og hins vegar til 6,7-falt hærri meðalhámarksþéttni (Cmax) en kom fram við jafnvægi við gjöf ráðlags 25 mg skammts af rilpivirini einu sinni á dag (sjá kafla 4.4).
English: Azole anti-fungals Ketoconazole/ Dolutegravir Ketoconazole/ Rilpivirine1,2
Icelandic: Azól-sveppalyf Ketoconazol/ Dolutegravir
English: • dabigatran etexilate, used to treat or prevent blood clots.
Icelandic: dabigatran etexilat notað til meðferðar á og til að fyrirbyggja blóðtappa.
English: Rifapentine/ Dolutegravir
Icelandic: Rifapentin/ Dolutegravir
English: Considering all of the available in vitro and in vivo data, the following amino acid substitutions, when present at baseline, are likely to affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I or M230L.
Icelandic: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I eða M230L.
English: The PK variability of dolutegravir is low to moderate.
Icelandic: Breytileiki í lyfjahvörfum dolutegravirs er lítill til meðalmikill.
English: Gastrointestinal disorders very common nausea increased pancreatic amylase diarrhoea common abdominal pain vomiting flatulence increased lipase abdominal discomfort upper abdominal pain dry mouth
Icelandic: Meltingarfæri mjög algengar ógleði aukning á amýlasa frá brisi niðurgangur algengar kviðverkur uppköst uppþemba aukning lípasa óþægindi í kvið verkur ofarlega í kvið munnþurrkur
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.
Icelandic: Samt sem áður er ekki hægt að útiloka að útsetning fyrir lyfjafræðilega virku, óbundnu rilpivirini er marktækt meiri hjá sjúklingum með meðalskerta lifrarstarfsemi.
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Icelandic: Valdar staðfestar og fræðilega mögulegar milliverkanir dolutegravirs, rilpivirins og lyfja sem gefin eru samhliða eru taldar upp í töflu 1. (aukning er gefin til kynna sem „↑“, skerðing sem „↓“, engin breyting sem „↔“, flatarmál undir þéttni-tímaferli sem „AUC“, hámarksþéttni sem „Cmax“, þéttni í lok skammtabils sem „Cτ“).
English: Boceprevir/ Rilpivirine
Icelandic: Boceprevir/ Rilpivirin
English: What Juluca contains - The active substances are dolutegravir and rilpivirine.
Icelandic: - Virku innihaldsefnin eru dolutegravir og rilpivirin.
English: No dosage adjustment is required in patients with mild or moderate renal impairment.
Icelandic: Ekki er þörf á skammtaaðlögun hjá sjúklingum með vægt til meðalskerta nýrnastarfsemi.
English: Other medicines and Juluca
Icelandic: Notkun annarra lyfja samhliða Juluca
English: Lamivudine/ Dolutegravir
Icelandic: Lamivudin/ Dolutegravir
English: Co-administration may cause significant decreases in rilpivirine plasma concentrations.
Icelandic: Gjöf samhliða getur valdið verulegri lækkun á plasmaþéttni rilpivirins.
English: Therefore, information regarding drug-drug interactions with other antiretroviral medicinal products is not provided.
Icelandic: Því eru upplýsingar um milliverkanir við önnur andretróveirulyf ekki tilgreindar.
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Icelandic: Hver tafla inniheldur dolutegravir natríum sem jafngildir 50 mg dolutegravir og rilpivirin hydroklóríð sem jafngildir 25 mg rilpivirin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/001
Icelandic: EU/1/18/1282/001 EU/1/18/1282/002
English: Site-directed INI mutant virus
Icelandic: Í greiningunni voru ónæmistengdu stökkbreytingarnar sem tengjast
English: • increase in pancreatic amylase (a digestive enzyme).
Icelandic: • aukning amýlasa frá brisi (meltingarensím).
English: Sofosbuvir / Rilpivirine
Icelandic: Sofosbuvir/ Rilpivirin
English: Calcium supplements, iron supplements or multivitamins must be taken at the same time as Juluca.
Icelandic: Kalk- og járnuppbót eða fjölvítamín verður að taka um leið og Juluca.
English: A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Icelandic: Viðmiðunargildi sem skiptir máli klínískt fyrir svipgerðina (FC samanborið við villigerð veirunnar) hefur ekki verið ákvarðað.
English: If you vomit less than 4 hours after taking Juluca, take another tablet with a meal.
Icelandic: eru liðnar frá því að þú tókst Juluca áttu að taka aðra töflu með máltíð.
English: Immune system disorders uncommon hypersensitivity (see section 4.4) not known immune reconstitution syndrome
Icelandic: Ónæmiskerfi sjaldgæfar ofnæmi (sjá kafla 4.4)
English: → Talk to your doctor for further advice on taking acid-lowering medicines with Juluca.
Icelandic: Fáðu nánari ráðleggingar hjá lækninum um notkun sýrulækkandi lyfja samhliða Juluca.
English: Ribavirin/ Rilpivirine
Icelandic: Ribavirin/ Rilpivirin
English: Antacids should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Icelandic: Sýrubindandi lyf á að taka töluvert fyrir eða eftir gjöf Juluca (minnst 6 klst. fyrir eða 4 klst. eftir).
English: Ledipasvir ↔ AUC ↑ 2%
Icelandic: AUC  2%
English: Simeprevir/ Rilpivirine
Icelandic: Simeprevir/ Rilpivirin
English: If calcium or iron supplements, or multivitamins cannot be taken at the same time as Juluca, these supplements are recommended to be administered 6 hours before or 4 hours after taking Juluca (see section
Icelandic: Ef ekki er unnt að taka kalk- eða járnuppbót eða fjölvítamín samtímis Juluca er ráðlagt er að taka þessi bætiefni 6 klst. fyrir eða 4 klst.
English: Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption due to gastric pH increase).
Icelandic: Gert er ráð fyrir verulegri lækkun á plasmaþéttni rilpivirins (minnkað frásog vegna hækkaðs sýrustigs í maga).
English: H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Icelandic: H2- viðtakablokka á að taka töluvert fyrir eða eftir gjöf Juluca (minnst 4 klst.
English: Male
Icelandic: Skammtar
English: Rilpivirine1,2
Icelandic: 6.2 Ósamrýmanleiki
English: • sleep disorders
Icelandic: • svefnleysi
English: * Adjusted for baseline stratification factors and assessed using a non-inferiority margin of - 8%.
Icelandic: Aðlagað miðað við lagskiptingu við upphaf og metið samkvæmt - 8% jafngildismörkum.
English: AUC ↓ 24% Cmin ↓ 66%
Icelandic: AUC ↓ 24%
English: when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Icelandic: - dexametason (barksteri notaður við ýmsum einkennum t.d. bólgu- og ofnæmisviðbrögðum) til inntöku eða sem stungulyf, nema ef um meðferð með einum skammti er að ræða - vörur sem innihalda jóhannesarjurt (Hypericum perforatum) (jurtalyf notað við þunglyndi).
English: Separate preparations of dolutegravir or rilpivirine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated (see section 4.5).
Icelandic: Lyf sem innihalda dolutegravir eða rilpivirin hvort í sínu lagi eru fáanleg ef hætta á notkun annars virka efnisins eða breyta skammti þess (sjá kafla 4.5).
English: Calcium supplements, iron supplements or multivitamins should be co-administered at the same time as Juluca with a meal.
Icelandic: Kalkuppbót, járnuppbót eða fjölvítamín á að taka samtímis Juluca með máltíð.
English: Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa Juluca samhliða þessum efnaskiptaörvum (sjá kafla 4.3).
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Icelandic: Fylgjast á með klínísku ástandi þ.m.t. lifraramínótransferösum og bilirúbíni.
English: Lamivudine/ Rilpivirine
Icelandic: Lamivudin/ Rilpivirin
English: Absorption
Icelandic: Famotidin
English: In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Icelandic: Í hægðum fannst að meðaltali 25% af gefnum rilpivirin skammti á óbreyttu formi.
English: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Icelandic: Rilpivirin olli ekki litningaskemmdum í in vivo örkjarnaprófi á músum.
English: Carbamazepine/ Rilpivirine
Icelandic: Carbamazepin/ Rilpivirin
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Icelandic: Áhrif rilpivirins eru miðluð af hömlun án samkeppni á HIV-1 bakrita.
English: Sofosbuvir ↔ AUC ↔ Cmax ↑ 21% Sofosbuvir metabolite GS
Icelandic: AUC  Cmin  Cmax  Velpatasvir  AUC  Cmin  Cmax 
English: Osteonecrosis
Icelandic: Erythromycin
English: Co-administration of Juluca with rifapentine is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa Juluca samhliða rifapentini (sjá kafla 4.3).
English: Co-administration of Juluca with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of Juluca.
Icelandic: Gjöf Juluca samhliða lyfjum sem auka sýrustig í maga getur dregið úr plasmaþéttni rilpivirins sem getur hugsanlega dregið úr meðferðaráhrifum Juluca.
English: Oral contraceptives Ethinyl estradiol (EE)1 and Norelgestromin (NGMN)1 / Dolutegravir
Icelandic: og norelgestromin (NGMN) Dolutegravir
English: This may result in loss of therapeutic effect of Juluca.
Icelandic: Þetta getur valdið verkunarleysi Juluca.
English: Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
Icelandic:  Metadon  AUC  2% Cmax  0% C  1%
English: H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) H2 receptor antagonist medicines can stop Juluca being absorbed into your body and make it less effective.
Icelandic: H2 viðtakahemlar (t.d. cimetidin, famotidin, nizatidin, ranitidin)
English: What you need to know before you take Juluca
Icelandic: Upplýsingar um Juluca og við hverju það er notað Áður en byrjað er að nota Juluca Hvernig nota á Juluca
English: AUC ↓ 76% Cmin NA Cmax ↓ 85%
Icelandic: Metformin  AUC  79% Cmin NA Cmax  66%
English: Tenofovir disoproxil / Rilpivirine1,2
Icelandic: Tenofovir disoproxil /
English: gp).
Icelandic: PC:
English: If a patient vomits more than 4 hours after taking Juluca, the patient does not need to take another dose of Juluca until the next regularly scheduled dose.
Icelandic: Juluca þarf hann ekki að taka annan skammt af Juluca fyrr en kemur að næsta áætlaða skammti.
English: If you take too many tablets of Juluca contact your doctor or pharmacist immediately.
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um Leitið ráða hjá lækninum eða lyfjafræðingi ef teknar eru of margar töflur af Juluca.
English: The mechanism for the decrease is unknown.
Icelandic: Verkunarháttur þessarar minnkunar er ekki þekktur.
English: Ethinyl estradiol (EE)1 and Norethindrone1/ Rilpivirine
Icelandic: og norethindron1/ Rilpivirin
English: No relevant effects were seen with dolutegravir on the QTc interval, with doses exceeding the clinical dose by approximately three fold.
Icelandic: Engin marktæk áhrif á QTc-bil komu fram með dolutegraviri með u.þ.b. 3-földum meðferðarskömmtum.
English: • decrease in haemoglobin
Icelandic: • minnkað hemóglóbín
English: HIV-1 RNA <50 copies/mL Treatment Difference* Virologic non response** Reasons Data in window not <50 copies/mL Discontinued for lack of efficacy Discontinued for other reasons while not <50 copies/mL Change in ART No virologic data at Week 48 window Reasons Discontinued study/study drug due to adverse event or death Discontinued study/study drug for other reasons Missing data during window but on study HIV-1 RNA <50 copies/mL by baseline covariates n/N (%)
Icelandic: Engar veirufræðilegar upplýsingar í viku 48 24 (5%) Ástæður Hætt í rannsókninni/notkun rannsóknarlyfs hætt vegna aukaverkunar eða dauðsfalls Hætt í rannsókninni/notkun rannsóknarlyfs hætt af öðrum ástæðum
English: Omeprazole
Icelandic: Aukaverkanir
English: Juluca must be taken with a meal (see section
Icelandic: Juluca á að taka með máltíð (sjá kafla 5.2).
English: AUC ↓ 9% Cmin NA
Icelandic: Rilpivirin AUC ↓ 9% Cmin NA Cmax ↔
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Icelandic: Úthreinsun óbreytts virks efnis um nýru er minniháttar brotthvarfsleið dolutegravirs.
English: (inhibition of intestinal P
Icelandic: (hömlun P-gp í þörmum).
English: common increased bilirubin uncommon hepatitis rare acute hepatic failure**
Icelandic: algengar aukning bilirúbíns sjaldgæfar lifrarbólga mjög sjaldgæfar bráð lifrarbilun**
English: Cmax ↓ 9%
Icelandic: Cmin ↓ 89%
English: Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Icelandic: Líklegt er að samhliða gjöf valdi verulegri lækkun á plasmaþéttni rilpivirins (hömlun CYP3A ensíma).
English: Calcium or iron supplements, or multivitamins should be co-administered at the same time as Juluca, with a meal.
Icelandic: Kalk- eða járnuppbót eða fjölvítamín á að gefa samtímis Juluca samhliða máltíð.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Icelandic: YTRI ASKJA (EINGÖNGU STAKAR PAKKNINGAR)
English: Sildenafil
Icelandic: Segavarnarlyf
English: Antiviral active substances Tenofovir disoproxil / Dolutegravir1
Icelandic: Tenofovir disoproxil / Dolutegravir
English: Recombinant clinical isolates
Icelandic: Samantekt á öryggi lyfsins
English: common decreased white blood cell count decreased haemoglobin decreased platelet count
Icelandic: Blóð og eitlar algengar fækkun hvítra blóðkorna minnkun blóðrauða fækkun blóðflagna
English: Co-infection with Hepatitis B or C
Icelandic: B samhliða eða lifrarbólgu
English: The absolute bioavailability of dolutegravir or rilpivirine has not been established.
Icelandic: Nýting dolutegravirs og rilpivirins hefur ekki verið staðfest.
English: Antacids, to treat indigestion and heartburn, can stop Juluca being absorbed into your body and make it less effective.
Icelandic: Sýrubindandi lyf við meltingartruflunum og brjóstsviða geta komið í veg fyrir upptöku Juluca í líkamann og dregið úr áhrifum þess.
English: Prednisone/ Rilpivirine
Icelandic: Prednison/ Rilpivirin
English: Significant decreases in rilpivirine plasma concentrations are expected.
Icelandic: Gert er ráð fyrir verulegri lækkun á plasmaþéttn rilpivirins.
English: (Not studied, inhibition of CYP3A enzymes).
Icelandic: Rilpivirin ↑ (ekki rannsakað, hömlun CYP3A ensíma).
English: Mannitol (E421)
Icelandic: Ethinyl estradiol (EE)
English: • medicines called antacids, to treat indigestion and heartburn.
Icelandic: • sýrubindandi lyf við meltingartruflunum og brjóstsviða.
English: People may be more likely to get this condition:
Icelandic: Aukin hætta er á þessu hjá þeim sem:
English: Decreased exposure of rilpivirine is expected (induction of CYP3A enzymes).
Icelandic: Gert er ráð fyrir aukinni útsetningu fyrir rilpivirini (hömlun CYP3A ensíma).
English: Fertility
Icelandic: Dofetilid 
English: HMG CO-A reductase inhibitors Atorvastatin/
Icelandic: HMG CO-A redúktasahemlar
English: Paracetamol
Icelandic: Daclatasvir 
English: Cimetidine Nizatidine Ranitidine/ Rilpivirine
Icelandic: Cimetidin Nizatidin Ranitidin/ Rilpivirin
English: No data are available in patients with severe hepatic impairment (Child-Pugh score C); therefore Juluca is not recommended in these patients (see section 5.2).
Icelandic: Því er notkun Juluca ekki ráðlögð hjá þessum sjúklingum (sjá kafla 5.2).
English: Ranitidine/
Icelandic: Rabeprazol
English: (+ 50 mg once daily rilpivirine)
Icelandic: 300 mg einu sinni á dag (+ rilpivirin 50 mg einu sinni á dag)
English: The use of Juluca during pregnancy is not recommended.
Icelandic: Notkun Juluca á meðgöngu er ekki ráðlögð
English: Rilpivirine ↔ AUC ↔
Icelandic: Norethindron  AUC  Cmin 
English: Sofosbuvir/ Velpatasvir/ Dolutegravir1
Icelandic: Sofosbuvir/ Velpatasvir/
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions).
Icelandic: Cmax  35% C24  32% (komplexbinding við fjölgildar jónir).
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
Icelandic: 30 töflur.
English: Dolutegravir and rilpivirine are both primarily metabolized and eliminated by the liver.
Icelandic: Umbrot og brotthvarf dolutegravirs og rilpivirins verður aðallega í lifur.
English: • if their immune systems are very weak
Icelandic: eru með mjög veiklað ónæmiskerfi
English: Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Icelandic: eftir að það er tekið (sjá einnig kafla 3) „Hvernig nota á Juluca“)
English: • increase in cholesterol
Icelandic: • aukning kólesteróls
English: Rilpivirine ↔ AUC ↔ Cmin ↑ 25%
Icelandic: Rifabutin AUC ↔ Cmin ↔ Cmax ↔ 25-O-desacetyl-rifabutin AUC ↔ Cmin ↔ Cmax ↔
English: Rilpivirine studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Icelandic: Ekkert bendir til eiturverkana á fósturvísa eða fóstur eða áhrif á æxlun í rannsóknum á rilpivirini hjá dýrum.
English: Dose dependent decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes).
Icelandic: Gert er ráð fyrir skammtaháðri lækkun á plasmaþéttni rilpivirins (virkjun CYP3A ensíma).
English: Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa Juluca samhliða prótónpumpuhemlum (sjá kafla 4.3).
English: Rilpivirine ↔ Not studied.
Icelandic: Rilpivirin ↓ ekki rannsakað.
English: The combination of Juluca and supplements should be used with particular caution.
Icelandic: Gæta skal sérstakrar varúðar við notkun Juluca samhliða bætiefnum.
English: Anticonvulsants Carbamazepine/ Dolutegravir1
Icelandic: Krampaleysandi lyf Carbamazepin/ Dolutegravir
English: Sofosbuvir metabolite GSAUC ↔
Icelandic: ViiV Healthcare GmbH Tel.:
English: The doctor will choose the smallest amount necessary.
Icelandic: Læknirinn mun velja minnsta skammt sem nauðsynlegur er.
English: Otherwise it should be classified as negative (normal).
Icelandic: Annars ætti hún að vera flokkuð sem neikvæð (eðlileg).
English: The volume of the injection should be not less than 1 mL and not more than 10 mL.
Icelandic: Rúmmál inndælingarinnar á ekki að vera minna en 1 ml og ekki meira en 10 ml.
English: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgium
Icelandic: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgía
English: See section 4.2.
Icelandic: Sjá kafla 4,2.
English: If any one of these regions is clearly positive (abnormal) then the image should be classified as positive (abnormal).
Icelandic: Ef eitthvert þessara svæða er greinilega jákvætt (óeðlilegt) ætti að flokka myndina sem jákvæða (óeðlilega).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GE Healthcare AS
Icelandic: NAFN OG HEIMILISFANG MARKAÐSLEYFISHAFA GE Healthcare AS
English: This is about the same as 14 mL of beer or 6 mL of wine.
Icelandic: Þetta jafngildir u.þ.b 14 ml af bjór eða 6 ml af víni.
English: One injection is sufficient to carry out the scan that your doctor needs.
Icelandic: Ein inndæling nægir til að framkvæma skönnunina sem læknirinn þarf að nota.
English: Nr. 482/2 EZ98 KG 2444 Seibersdorf Austria
Icelandic: 482/2 EZ98 KG 2444 Seibersdorf Austurríki
English: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Italy
Icelandic: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Ítalía
English: This amount may be harmful for those suffering from alcoholism.
Icelandic: Þetta magn getur verið skaðlegt fyrir áfengissjúklinga.
English: Advanced Accelerator Applications S.r.l Via Piero Maroncelli 40/42
Icelandic: S.r.l Via Piero Maroncelli 40/42
English: They will provide you with the necessary information on the procedure.
Icelandic: Þau munu veita þér nauðsynlegar upplýsingar.
English: Volume: xx.x mL
Icelandic: Rúmmál: xx.x ml
English: Tell your doctor straight away if you notice any of the signs above.
Icelandic: Segðu lækninum strax frá því ef þú tekur eftir einhverjum af einkennum hér að framan.
English: The training course for healthcare professionals should contain the following key elements:
Icelandic: Þjálfunarnámskeið fyrir heilbrigðisstarfsfólk skal innihalda eftirfarandi lykilatriði:
English: Cases should be histopathologically confirmed, if possible.
Icelandic: Tilfellin skulu vera meinavefjafræðilega staðfest ef mögulegt er.
English: White matter - p pons and cc corpus callosum.
Icelandic: Hvíta efnið - p brú (pons) og cc hvelatengsl (corpus callosum).
English: Do not use this medicine after the expiry date and time, which are stated on the label after ‘EXP'.
Icelandic: Ekki má nota lyfið eftir fyrningardagsetningu sem tilgreind er á merkimiðanum á eftir ‘EXP'.
English: You should not drive, use machines or engage in other potentially hazardous activities until these effects have completely disappeared.
Icelandic: Ekki keyra, nota vélar eða stunda aðrar hættulegar athafnir fyrr en þessi áhrif hafa horfið.
English: You should discuss the results of the test with the doctor that requested the scan.
Icelandic: Þú ættir að ræða niðurstöður rannsóknarinnar við lækninn sem óskaði eftir skönnuninni.
English: The following adverse reactions are listed in the Table 1 below:
Icelandic: Eftirfarandi aukaverkanir eru taldar upp í töflu 1 hér fyrir neðan:
English: 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) and not known (cannot be estimated from the available data).
Icelandic: 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) og tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: The scan duration should typically be 20 minutes.
Icelandic: Skönnunin tekur yfirleitt um 20 mínútur.
English: The cognitive status of the patients was not determined.
Icelandic: Vitsmunalegt ástand sjúklinga var ekki metið.
English: Remaining organs Effective dose (mSv/MBq)
Icelandic: Virkur skammtur (mSv/MBq)
English: Eight hours from the reference date and time.
Icelandic: Átta klukkustundir frá kvörðunartíma.