FrancophonIA/ELRC3.0 huggingface dataset:
English: as triple oral therapy in combination with - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Icelandic: til inntöku í þriggja lyfja meðferð samhliða metformíni og súlfónýlúrea, hjá fullorðnum sjúklingum (sérstaklega of þungum sjúklingum) með ófullnægjandi stjórn á blóðsykri þrátt fyrir að sjúklingur hafi fengið tveggja lyfja meðferð til inntöku.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Icelandic: Lyfjastofnunar Evrópu http://www.ema.europa.eu og á vef Lyfjastofnunar (http://www.serlyfjaskra.is).
English: Glustin contains lactose monohydrate
Icelandic: Glustin inniheldur laktósaeinhýdrat
English: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Icelandic: Í PROactive, langtímarannsókn á áhrifum á hjarta- og æðakerfi, voru 5238 sjúklingar með sykursýki af tegund 2 og alvarlega æðasjúkdóma í stórum æðum, með slembiröðun settir á meðferð í allt að 3,5 ár með pioglitazóni eða lyfleysu, til viðbótar við meðferð með sykursýkilyfjum og hjarta- og æðalyfjum sem var þegar til staðar.
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs; excl. insulins; ATC code: A10BG03.
Icelandic: Lyf notuð gegn sykursýki, blóðsykurslækkandi lyf, önnur en insúlín; ATC-flokkur:
English: Lactose monohydrate Magnesium stearate
Icelandic: Carmellosa kalsíum Hýprólósi Laktósa einhýdrat Magnesíumsterat
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Icelandic: algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum) sýking í loftvegum sjóntruflanir þyngdaraukning dofi sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum) skútabólga erfiðleikar með svefn (svefnleysi)
English: EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010 EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/016 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
Icelandic: EU/1/00/151/001 EU/1/00/151/002 EU/1/00/151/003 EU/1/00/151/004 EU/1/00/151/005 EU/1/00/151/006 EU/1/00/151/007 EU/1/00/151/008 EU/1/00/151/009 EU/1/00/151/010 EU/1/00/151/011 EU/1/00/151/012 EU/1/00/151/013 EU/1/00/151/014 EU/1/00/151/015 EU/1/00/151/017 EU/1/00/151/018 EU/1/00/151/019 EU/1/00/151/020 EU/1/00/151/021 EU/1/00/151/022 EU/1/00/151/023 EU/1/00/151/024
English: What Glustin looks like and contents of the pack
Icelandic: Lýsing á útliti Glustin og pakkningastærðir
English: Musculoskeletal and connective tissue disorders fracture bone4
Icelandic: Stoðkerfi og stoðvefur Beinbrot4
English: Takeda Pharmaceuticals Slovakia s.r.o.
Icelandic: Slove nská re publika Takeda Pharmaceuticals Slovakia s.r.o.
English: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
Icelandic: í einlyfjameðferð hjá fullorðnum sjúklingum (sérstaklega of þungum sjúklingum) þar sem breytt mataræði og líkamsrækt hafa ekki sýnt viðunandi áhrif á blóðsykurstjórn og metformín á ekki við vegna frábendinga eða óþols.
English: - if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
Icelandic: ef þú hefur fengið ketónblóðsýringu af völdum sykursýki (fylgikvilli sykursýki sem veldur skyndilegu þyngdartapi, ógleði eða uppköstum).
English: Environmental Risk Assessment (ERA) No environmental impact is anticipated from the clinical use of pioglitazone
Icelandic: Ekki er gert ráð fyrir neinum áhrifum á lífríkið af klínískri notkun pioglitazóns
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5)
Icelandic: Sýnt hefur verið fram á aukningu á styrk pioglitazóns í plasma þegar það er gefið samhliða gemfibrozili (sem er cýtókróm P450 2C8 hemill), en minnkun á styrk pioglitazóns í plasma þegar það er gefið samhliða rifampicini (P450 2C8 örvi) (sjá kafla 4.5).
English: Glustin 30 mg tablets
Icelandic: Glustin 30 mg töflur
English: Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Glustin in combination with insulin.
Icelandic: Staðbundin bólga (bjúgur) hefur einnig komið mjög oft fyrir (getur komið fyrir hjá fleirum en 1 af hverjum 10 einstaklingum) hjá sjúklingum sem taka Glustin samhliða insúlíni.
English: Frequency of adverse reactions of pioglitazone by treatment regimen Monotherapy
Icelandic: Tíðni aukaverkana pioglitazóns samkvæmt meðferðaráætlun
English: Glustin 45 mg tablets pioglitazone
Icelandic: Glustin 45 mg töflur pioglitazón
English: Takeda GmbH Podružnica Slovenija Tel.+ 386 (0) 59 082 480
Icelandic: Tel.+ 386 (0) 59 082 480
English: Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Glustin in combination with insulin.
Icelandic: Algengt er að hjartabilun hafi komið fyrir (getur komið fyrir hjá allt að 1 af hverjum 10 einstaklingum) hjá sjúklingum sem taka Glustin samhliða insúlíni.
English: Glustin 30 mg
Icelandic: MEÐ BLINDRALETRI Glustin 30 mg
English: Glustin 15 mg tablets
Icelandic: Glustin 15 mg töflur
English: Glustin 45 mg tablets
Icelandic: Glustin 45 mg töflur
English: as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
Icelandic: til inntöku í tveggja lyfja meðferð samhliða metformíni, hjá fullorðnum sjúklingum (sérstaklega of þungum sjúklingum) með ófullnægjandi stjórn á blóðsykri þrátt fyrir að sjúklingur hafi fengið hæstu þolanlega skammta af metformíni í einlyfjameðferð.
English: If you have the impression that the effect of Glustin is too weak, talk to your doctor.
Icelandic: Leitaðu til læknisins ef þér finnst áhrifin af Glustin of lítil.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Glustin.
Icelandic: Ef óþol fyrir sykrum hefur verið staðfest skal hafa samband við lækninn áður en lyfið er tekið inn.
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III
Icelandic: Þegar tekið hefur verið tillit til virkni, þéttni og próteinbindingar eru pioglitazón og umbrotsefni M-III jafn virk.
English: - you are breast-feeding or if you are planning to breast-feed your baby.
Icelandic: þú ert með barn á brjósti eða áformar brjóstagjöf.
English: - Glustin 45 mg tablets are white to off-white, round, flat tablets marked “45” on one face, “AD4” on the other.
Icelandic: Glustin 45 mg töflur eru hvítar til beinhvítar, kringlóttar, flatar og merktar „45“ á annarri hliðinni, „AD4“ á hinni.
English: Glustin 30 mg tablets are white to off-white, round, flat tablets marked “30” on one face, “AD4” on the other.
Icelandic: Glustin 30 mg töflur eru hvítar til beinhvítar, kringlóttar, flatar og merktar „30“ á annarri hliðinni, „AD4“ á hinni.
English: Each Glustin 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Icelandic: Hver Glustin 45 mg tafla inniheldur 45 mg pioglitazón (sem hýdróklóríð).
English: Each Glustin 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Icelandic: Hver Glustin 30 mg tafla inniheldur 30 mg pioglitazón (sem hýdróklóríð).
English: Glustin 45 mg
Icelandic: MEÐ BLINDRALETRI Glustin 45 mg
English: - Glustin 15 mg tablets are white to off-white, round, convex tablets marked “15” on one face, “AD4” on the other.
Icelandic: Glustin 15 mg töflur eru hvítar til beinhvítar, kringlóttar, kúptar og merktar „15“ á annarri hliðinni, „AD4“ á hinni.
English: Sun.
Icelandic: Co.
English: The tablets are white to off-white, round, flat and marked ‘30' on one face, ‘AD4' on the other.
Icelandic: Töflurnar eru hvítar til beinhvítar, kringlóttar, flatar og merktar „30” á annarri hliðinni, AD4 á hinni.
English: Deutschland
Icelandic: Ísland
English: The tablets are white to off-white, round, flat and marked ‘45' on one face, ‘AD4' on the other.
Icelandic: Töflurnar eru hvítar til beinhvítar, kringlóttar, flatar og merktar „45” á annarri hliðinni, AD4 á hinni.
English: Respiratory, thoracic and mediastinal disorders dyspnoea common
Icelandic: Öndunarfæri, brjósthol og miðmæti mæði
English: Each Glustin 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Icelandic: Hver Glustin 15 mg tafla inniheldur 15 mg pioglitazón (sem hýdróklóríð).
English: The tablets are white to off-white, round, convex and marked ‘15' on one face, ‘AD4' on the other.
Icelandic: Töflurnar eru hvítar til beinhvítar, kringlóttar, kúptar og merktar „15” á annarri hliðinni, AD4 á hinni.
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Icelandic: Efnaskipti og næring blóðsykurs-lækkun sjaldgæfar mjög algengar aukin matarlyst sjaldgæfar
English: However, certain medicines are especially likely to affect the amount of sugar in your blood: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these.
Icelandic: rifampicín (notað gegn berklum og öðrum sýkingum) Láttu lækninn eða lyfjafræðing vita ef þú tekur annað hvort þessara.
English: EU/1/00/151/009 14 tablets EU/1/00/151/010 28 tablets EU/1/00/151/020 30 tablets EU/1/00/151/011 50 tablets EU/1/00/151/012 56 tablets EU/1/00/151/021 84 tablets EU/1/00/151/022 90 tablets EU/1/00/151/013 98 tablets
Icelandic: EU/1/00/151/009 14 töflur EU/1/00/151/010 20 töflur EU/1/00/151/020 30 töflur EU/1/00/151/011 50 töflur EU/1/00/151/012 56 töflur EU/1/00/151/021 84 töflur EU/1/00/151/022 90 töflur EU/1/00/151/013 98 töflur
English: EU/1/00/151/008 14 tablets EU/1/00/151/004 28 tablets EU/1/00/151/017 30 tablets EU/1/00/151/005 50 tablets EU/1/00/151/024 56 tablets EU/1/00/151/018 84 tablets EU/1/00/151/019 90 tablets EU/1/00/151/006 98 tablets
Icelandic: EU/1/00/151/008 14 töflur EU/1/00/151/004 20 töflur EU/1/00/151/017 30 töflur EU/1/00/151/005 50 töflur EU/1/00/151/024 56 töflur EU/1/00/151/018 84 töflur EU/1/00/151/019 90 töflur EU/1/00/151/006 98 töflur
English: Package leaflet: Information for the patient Glustin 15 mg tablets
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Glustin 15 mg
English: Renal impairment
Icelandic: liðverkur bakverkur
English: Glustin 30 mg tablets pioglitazone
Icelandic: HEITI LYFS Glustin 30 mg töflur pioglitazón
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Icelandic: Sýkingar af völdum sýkla og sníkjudýra sýking í efri loftvegum berkjubólga skútabólga sjaldgæfar sjaldgæfar sjaldgæfar sjaldgæfar sjaldgæfar
English: EU/1/00/151/007 14 tablets EU/1/00/151/001 28 tablets EU/1/00/151/014 30 tablets EU/1/00/151/002 50 tablets EU/1/00/151/023 56 tablets EU/1/00/151/015 84 tablets EU/1/00/151/016 90 tablets EU/1/00/151/003 98 tablets
Icelandic: EU/1/00/151/007 14 töflur EU/1/00/151/001 20 töflur EU/1/00/151/014/ 30 töflur EU/1/00/151/002 50 töflur EU/1/00/151/023 56 töflur EU/1/00/151/015 84 töflur EU/1/00/151/016 90 töflur EU/1/00/151/003 98 töflur
English: Glustin 15 mg tablets pioglitazone
Icelandic: HEITI LYFS Glustin 15 mg töflur pioglitazón
English: 56 capsules
Icelandic: 56 hylki
English: 30 mg Capsule, hard Oral use bottle (HDPE)
Icelandic: Feraccru 30 mg
English: Feraccru
Icelandic: Styrkleiki
English: Strength Pharmaceutical Form
Icelandic: Styrkur Lyfjaform Dýrategund
English: Adopted at the 5-8 October 2015 PRAC
Icelandic: Samþykkt á fundi PRAC 5.-8. október 2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
Icelandic: 30 Churchill Place ● Canary Wharf ● London E14 5EU ●
English: Anakinra - Thrombocytopenia (EPITT no 18337)
Icelandic: Anakinra - Blóðflagnafæð (EPITT nr. 18337)
English: In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Icelandic: Í klínískum rannsóknum hjá sjúklingum með iktsýki og CAPS hefur verið greint frá blóðflagnafæð hjá 1,9% sjúklinga í meðferð með lyfinu samanborið við 0,3% hjá þeim sem fengu lyfleysu.
English: Summary of Product Characteristics: Section 4.8 - Undesirable effects:
Icelandic: Kafli 4.8 - Aukaverkanir:
English: The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Icelandic: Tilvik blóðflagnafæðar hafa verið væg, þ.e. fjöldi blóðflagna hefur verið >75 x109/l.
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Icelandic: Eftir að lyfið var sett á markað hefur verið greint frá blóðflagnafæð, þ.m.t. einstök tilvik um alvarlega blóðflagnafæð (þ.e. fjöldi blóðflagna <10 x109/l).
English: Thrombocytopenia
Icelandic: Fylgiseðill
English: Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Icelandic: Algengar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum):
English: 1 bag
Icelandic: 1 poki
English: 5-20 x 106 cells/mL
Icelandic: 5-20 x 106 frumur/ml
English: ml
Icelandic: Innihald
English: Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Icelandic: Til notkunar í bláæð Lághitapoki úr etýlen-vínýl-asetati (EVA)
English: Dispersion for infusion
Icelandic: Innrennslislyf, ördreifa
English: AstraZeneca Kft. 1113 Budapest Bocskai út 134-146.
Icelandic: Bocskai út 134-146.
English: AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
Icelandic: S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Icelandic: Listi yfir heiti, lyfjaform, styrkleika lyfjanna, íkomuleið, markaðsleyfishafa í aðildarlöndunum
English: AstraZeneca Oy Luomanportti 3 02200 Espoo Finland
Icelandic: Oy Luomanportti 3 02200 Espoo Finland
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Icelandic: NV AstraZeneca SA Egide Van Ophemstraat
English: Filmtabletten +100mg Filmtabletten +200mg Filmtabletten
Icelandic: Filmtabletten +200mg Filmtabletten
English: Quetiapine XR AstraZeneca 150 mg
Icelandic: AstraZeneca 150 mg
English: Quetiapine XR AstraZeneca 50 mg
Icelandic: AstraZeneca 50 mg
English: Quetiapine XR AstraZeneca 200 mg
Icelandic: AstraZeneca 200 mg
English: Quetiapine XR AstraZeneca 400 mg
Icelandic: AstraZeneca 400 mg
English: Quetiapine XR AstraZeneca 300 mg
Icelandic: AstraZeneca 300 mg
English: EU/1/18/1349/001 DECTOVA
Icelandic: EU/1/18/1349/001
English: Solution for infusion
Icelandic: Innrennslislyf, lausn
English: Pack size
Icelandic: DECTOVA
English: Oral solution bottle (HDPE) 230 ml
Icelandic: Oral solution glas (HDPE)
English: 1 bottle + 1 adapter + 1 oral applicator
Icelandic: 1 glas + 1 millistykki + 1 munngjafaráhald
English: Content (concentration) Package size
Icelandic: Innihald (þéttni)
English: MA (EU) number
Icelandic: ESB
English: EU/1/17/1226/001 LUTATHERA 370 MBq/ml
Icelandic: EU/1/17/1226/001 LUTATHERA
English: 20.5 - 25 ml
Icelandic: Til notkunar í bláæð hettuglas (gler) 20.5 - 25 ml
English: 3 vials
Icelandic: 3 hettuglös
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled pens (multipack)
Icelandic: 1 ml (100 mg/ml) 3 (3 x 1) áfylltar sprautur (fjölpakkning)
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled syringes (multipack)
Icelandic: 1 ml (100 mg/ml) 3 (3 x 1) áfylltir lyfjapennar (fjölpakkning)
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Icelandic: 1 ml (100 mg/ml) 1 áfylltur lyfjapenni
English: 1 ml (100 mg/ml) 1 pre-filled pen
Icelandic: 1 ml (100 mg/ml) 1 áfyllt sprauta
English: Immediate Packaging
Icelandic: Styrkleiki Lyfjaform Íkomuleið Innri umbúðir Innihald (þéttni) Pakkningastærð
English: If this happens, do not drive or use machines.
Icelandic: Ef það gerist, skaltu ekki aka eða nota vélar.
English: Repeatability was 97%.
Icelandic: Endurtekningarnákvæmni var 97%.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1337/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/18/1337/001
English: To ensure that the test results are reliable, you need to follow the rules below:
Icelandic: Til að tryggja að niðurstöður prófsins séu áreiðanlegar, þarftu að fylgja reglunum hér að neðan:
English: Step 1 Weigh the patient.
Icelandic: Skref 1 Vigtið sjúklinginn.
English: You need to stop such treatment at least 1 month before the test.
Icelandic: Þú þarft að hætta á slíkri meðferð a.m.k. 1 mánuði fyrir prófið.
English: It is unknown whether this may affect QTc.
Icelandic: Ekki er vitað hvort þetta geti haft áhrif á QTc.
English: It is a test that helps your doctor to diagnose this condition.
Icelandic: Það er próf sem hjálpar lækninum að greina ástandið.
English: In such a situation, a repetition of the test may be required.
Icelandic: Í slíku tilviki kann að vera þörf á endurtekningu prófsins.
English: It is used when your doctor thinks that you may not have enough growth hormone (adult growth hormone deficiency).
Icelandic: Það er notað þegar læknirinn telur að þú hafir ekki nægilegt vaxtarhormón (vaxtarhormónaskortur hjá fullorðnum).
English: Agreement between the result of the first test and the second test was observed in 31 cases (91.2%).
Icelandic: Samræmi á milli niðurstaðna úr fyrra og seinna prófinu kom fram í 31 tilviki (91,2%).
English: Talk to your doctor or nurse if:
Icelandic: Leitaðu til læknisins eða hjúkrunarfræðingsins ef:
English: Potentially re-test needed in early disease
Icelandic: Hugsanleg endurprófun í upphafi sjúkdóms
English: This is not a treatment for patients who do not have enough growth hormone.
Icelandic: Það er ekki meðferð fyrir sjúklinga sem hafa ekki nægilegt vaxtarhormón.
English: The shelf life of a sachet is 4 years.
Icelandic: Geymsluþol skammtapoka er 4 ár.
English: • Fasting - you must not eat for at least 8 hours before the test, and during the test.
Icelandic: Fasta - þú mátt ekki borða í að minnsta kosti 8 klst. fyrir prófið og meðan á prófinu stendur.
English: The dose is calculated based on the patient´s body weight.
Icelandic: Skammturinn er reiknaður út frá líkamsþyngd sjúklingsins.
English: If you are a woman able to have children, you must use effective contraceptive methods to ensure you are not pregnant at the time of the test.
Icelandic: Ef þú ert kona sem getur átt börn, verður þú að nota örugga getnaðarvörn til að tryggja að þú sért ekki þunguð meðan á prófinu stendur.
English: During the test, the patient needs to stay fasted until the end of the blood sampling.
Icelandic: Sjúklingurinn þarf að vera fastandi meðan á prófinu stendur, þar til töku blóðsýna er lokið.
English: Store in the original package, in order to protect from light and moisture.
Icelandic: Geymið í upprunalegum umbúðum til varnar gegn ljósi og raka.
English: Pharmacotherapeutic group: Diagnostic agents, Tests for pituitary function, ATC code: V04CD06
Icelandic: Sjúkdómsgreiningarefni, lyf til rannsókna á starfsemi heiladinguls, ATC-flokkur: V04CD06
English: In case a patient should be reporting dizziness as side effect, the patient should be instructed to neither drive nor use machines.
Icelandic: Ef sjúklingur tilkynnir um sundl sem aukaverkun, skal sjúklingurinn fá leiðbeiningar um að hann megi hvorki aka né nota vélar.
English: Tell your doctor if you are taking medicines that can alter your heart rhythm, such as:
Icelandic: Láttu lækninn vita ef þú tekur lyf sem geta breytt hjartslættinum, eins og:
English: If occurring, such changes would be timely limited and not last long.
Icelandic: Ef slíkar breytingar koma fyrir, standa þær yfir í takmarkaðan tíma.
English: One hundred and fifty-seven (157) subjects underwent at least one of the two tests in this study, 59% were male, 41% female and 86% of white origin.
Icelandic: Eitt hundrað og fimmtíu og sjö (157) einstaklingar gengust undir a.m.k. eitt af prófunum tveimur í rannsókninni, 59% voru karlar, 41% konur og 86% af hvíta kynþættinum.
English: Macimorelin Aeterna Zentaris must not be used in children and adolescents aged below 18 years, because the safety and effectiveness in these groups have not yet been established.
Icelandic: Ekki má nota Macimorelin Aeterna Zentaris handa börnum og unglingum yngri en 18 ára, vegna þess að ekki hefur verið sýnt fram á öryggi og verkun hjá þessum hópum.
English: These side effects are mostly mild, do not last long, and usually go away quickly without treatment.
Icelandic: Þessar aukaverkanir eru yfirleitt vægar, standa ekki lengi yfir og hverfa venjulega fljótt án meðferðar.
English: Repeatability was tested in a subset of 34 subjects who underwent two MAC tests.
Icelandic: Endurtekningarnákvæmni var prófuð hjá undirhópi 34 einstaklinga sem gengust undir tvö MAC próf.
English: Repeat testing may be warranted in this situation.
Icelandic: Endurtekin próf geta átt rétt á sér við þessar aðstæður.
English: Step 5 Have the patient drink the entire content of the drinking glass within 30 seconds.
Icelandic: Skref 5 Látið sjúklinginn drekka allt innihald drykkjarglassins á innan við 30 sekúndum.
English: Plasma protein binding decreases with increasing concentrations from 78% at 0.1 µM to 62% at 10 µM.
Icelandic: Próteinbinding í plasma minnkar með aukinni þéttni frá 78% við 0,1 µM til 62% við 10 µM.
English: The level of negative and positive agreement between the results of the ITT and the MAC test was used to evaluate the performance of the MAC test.
Icelandic: Fjöldi samræmdra neikvæðra og jákvæðra niðurstaðna úr ITT og MAC prófunum var notaður til að meta árangur af MAC prófinu.
English: Transfer the measured amount to a drinking glass.
Icelandic: Færið mælda magnið í drykkjarglas.
English: The efficacy of macimorelin in patients aged over 65 years has not been established.
Icelandic: Ekki hefur enn verið sýnt fram á verkun masimorelíns hjá sjúklingum eldri en 65 ára.
English: If you are not sure, talk to your doctor or nurse before you are given Macimorelin Aeterna Zentaris.
Icelandic: Ef þú ert ekki viss, skaltu leita ráða hjá lækninum eða hjúkrunarfræðingnum áður en þér er gefið Macimorelin Aeterna Zentaris.
English: You have to drink the complete test dose within 30 seconds.
Icelandic: Þú þarft að drekka alla prófunarskammtinn á innan við 30 sekúndum.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á ytri öskjunni á eftir EXP.
English: Patients with a deficiency affecting hormones other than growth hormone (GH)
Icelandic: Sjúklingar með skort sem hefur áhrif á hormón önnur en vaxtarhormón (GH)
English: As with all GH stimulation tests, also the macimorelin test results should always be interpreted on basis of the outcome of all examinations within the diagnostic work-up for a patient.
Icelandic: Eins og við á um öll GH örvunarpróf, einnig masimorelínpróf, skal ávallt túlka niðurstöðurnar á grundvelli niðurstaðna allra rannsókna sem gerðar hafa verið við mótun greiningar fyrir sjúkling.