FrancophonIA/ELRC3.0 huggingface dataset:
English: Potential ↑in plasma concentrations of sildenafil
Icelandic: Möguleg ↑ þéttni sildenafíls í plasma
English: Adjustment of the posology
Icelandic: Kutno Pólland
English: Uncommon side effects (may affect up to 1 in 100 people):
Icelandic: Sjaldgæfar aukaverkanir (geta komið fram hjá allt að 1 af hverjum 100 einstaklingum) :
English: Other medicinal products and Ketoconazole HRA
Icelandic: Notkun annarra lyfja samhliða Ketoconazole HRA
English: Pharmacotherapeutic group: Antimycotics for systemic use, imidazole derivatives, ATC code: J02AB02
Icelandic: Sveppalyf (antimycotica) til altækrar notkunart, imidazól afleiður, ATC-flokkur:
English: Dose of edoxaban needs to be reduced when used concomitantly, please consult edoxaban SmPC.
Icelandic: Minnka þarf skammt edoxabans þegar það er notað samhliða, sjá samantekt á eiginleikum lyfs fyrir edoxaban.
English: In the case an increase of liver enzymes is detected which is less than 3 times the upper limit of normal, closer monitoring of liver function should be performed and the daily dose should be decreased by at least 200 mg.
Icelandic: Ef fram kemur hækkun lifrarensíma sem er innan við þrisvar efri eðlileg mörk, skal hafa nánara eftirlit með lifrarstarfsemi og dagskammturinn minnkaður um a.m.k.
English: AUC: ↑ 3.6-fold
Icelandic: ↑ 2,6-falt
English: Preclinical data show that ketoconazole crosses the placenta and is teratogenic.
Icelandic: Forklínískar upplýsingar sýna að ketókónazól berist í fylgju og er vansköpunarvaldandi.
English: Dyspepsia, flatulence, tongue discoloration, dry mouth, dysgeusia
Icelandic: Meltingartruflanir, vindgangur, litabreytingar á tungu, munnþurrkur, truflað bragðskyn
English: Escape phenomenon
Icelandic: Geðræn vandamál
English: Potential ↑in plasma concentrations of warfarin
Icelandic: Möguleg ↑ þéttni warfaríns í plasma Náið eftirlit
English: Contraindicated due to the risk of serious cardiovascular events including QT prolongation (see section 4.3).
Icelandic: Má ekki nota vegna aukinnar hættu á alvarlegum hjarta- og æðasjúkdómum, m.a. QT lengingu (sjá kafla 4.3).
English: Ketoconazole can be reintroduced thereafter at a lower dose (see section 4.4); - Treatment with ketoconazole can be stopped abruptly without a need for progressive dose decrease where a change in the therapeutic strategy (e.g. surgery) is desired.
Icelandic: - Hægt er að hætta meðferð með ketókónazól skyndilega án þess að minnka skammta smám saman þegar breyta þarf meðferðaráætlun (t.d. við skurðaðgerð).
English: Józefów 9, 99-300 Kutno Poland
Icelandic: Józefów 9,
English: - The active substance is ketoconazole.
Icelandic: - Virka innihaldsefnið er ketókónazól.
English: Elderly patients
Icelandic: Upplýsingar fyrir sjúkling
English: Contraindicated due to the large increase in these medicinal products concentrations (see section 4.3).
Icelandic: Má ekki nota vegna mikillar aukinnar þéttni þessara lyfja (sjá kafla 4.3).
English: Potential ↑in plasma concentrations of ergot alkaloids
Icelandic: Möguleg ↑ þéttni korndrjóla alkaloíða í plasma
English: Blood and lymphatic system disorders
Icelandic: Blóðþynningarlyf og blóðflagnahemjandi lyf Dabigatran
English: Temsirolimus
Icelandic: Temsirólímus
English: Fesoterodine and solifenacin are contraindicated in patients with renal impairment (see section 4.3).
Icelandic: Ekki má nota fesóteródín og sólifenasín hjá sjúklingum með skerta nýrnastarfsemi (sjá kafla 4.3).
English: Table 1 Interactions and recommendations for co-administration.
Icelandic: Tafla 1 Milliverkanir og ráðleggingar um samtímis lyfjagjöf.
English: • Nervousness
Icelandic: Taugaveiklun
English: Isavuconazole
Icelandic: Isavukónazól
English: • Distortion of the sense of taste
Icelandic: Brenglað bragðskyn
English: Common side effects (may affect up to 1 in 10 people):
Icelandic: Algengar aukaverkanir (geta komið fram hjá allt að 1 af hverjum 10 einstaklingum) :
English: Dose adjustment of these medicinal products may be required.
Icelandic: Þörf getur verið á skammtaaðlögun þessara lyfja.
English: AUC: ↑ 5.5-fold
Icelandic: ↑ 5,5-falt
English: Acute hepatocellular injury has been primarily observed as has cholestatic injury or a mixed pattern of toxicity.
Icelandic: Bráður áverki í lifrarþekjuvef hefur aðallega komið fram sem gallteppuáverki eða blönduð eiturverkun.
English: Dose adjustment of paclitaxel may be required.
Icelandic: Þörf getur verið á aðlögun paclitaxel þessara lyfja.
English: Serious hepatotoxicity, including jaundice, hepatitis, hepatic necrosis, hepatic cirrhosis, hepatic failure including cases necessitating transplantation or resulting in death.
Icelandic: Alvarleg eiturverkun í lifur, þ.m.t. gula, lifrarbólga, lifrardrep, skorpulifur, lifrarbilun, m.a. tilvik sem kalla á ígræðslu eða valda dauða.
English: Midazolam IV
Icelandic: Jozefow 9
English: Indinavir (600mg TID): AUC= 0.8-fold
Icelandic: Indinavír (600 mg þrisvar á dag):
English: Not recommended due to increased risk of isavuconazole adverse reactions, please consult isavuconazole SmPC
Icelandic: Ekki mælt með notkun lyfsins vegna aukinnar hættu á aukaverkunum isavukónazóls, sjá samantekt á eiginleikum lyfs fyrir isavukónazól.
English: Specific dosing regimen
Icelandic: Sérstakar skammtaáætlanir
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURs)
Icelandic: Rannsókn á öryggi lyfsins eftir markaðssetningu (PASS):
English: If you take more Ketoconazole HRA than you should
Icelandic: Ef notaður er stærri skammtur af Ketoconazole HRA en mælt er fyrir um
English: However in patients with adrenal cortical carcinoma, improvement of hypercortisolism on ketoconazole was limited in some cases.
Icelandic: Hins vegar var bati offramleiðslu kortisóls takmarkaður í sumum tilvikum hjá sjúklingum með þekjuvefskrabbamein í nýrnahettuberki.
English: Mean peak plasma concentrations of approximately 3.5 μg/ml are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal.
Icelandic: U.þ.b. 3,5 μg/ml meðal hámarksplasmaþéttni næst innan 1 til 2 klst.
English: Antidiabetics Repaglinide
Icelandic: Ópíóíð verkjalyf
English: • Loss of appetite or increased appetite
Icelandic: Lystarleysi eða aukin matarlyst
English: Ketoconazole should be discontinued without any delay if clinical symptoms of hepatitis develop.
Icelandic: Hætta skal notkun ketókónazól án tafar ef fram koma klínísk einkenni lifrarbólgu.
English: Dose adjustment of risperidone may be required.
Icelandic: Þörf getur verið á aðlögun risperidón skammta.
English: AUC: ↑ 1.5-fold Cmax: ↑ 1.5-fold
Icelandic: ↑ 1,5-falt Cmax:
English: microcrystalline cellulose, silica colloidal, magnesium stearate
Icelandic: Alkóhólóþol, lystarstol, aukin matarlyst
English: You should not take antacids (eg aluminium hydroxide) or other medicines for acid indigestion for at least 2 hours after the intake of Ketoconazole HRA (see section Warning and Precautions).
Icelandic: Þú skalt ekki nota sýrubindandi lyf (s.s. álhýdroxíð) eða önnur lyf við of háum magasýrum í minnst 2 klst.
English: Monitoring of adrenal function
Icelandic: Eftirlit með nýrnastarfsemi
English: ↑in plasma concentrations of docetaxel have been observed Potential ↑in plasma concentrations of busulfan
Icelandic: Möguleg ↑ þéttni rífabútíns í plasma Gert er ráð fyrir mögulegri ↓ þéttni ketókónazóls í plasma.
English: ↑in plasma concentrations of colchicine have been observed
Icelandic: ↑ þéttni kolkisíns í plasma hefur komið fram
English: Not recommended due to the increased risk of QT prolongation and extrapyramidal symptoms.
Icelandic: Ekki er mælt með notkun lyfsins vegna aukinnar hættu á QT lengingu og utanstrýtueinkenna.
English: What Ketoconazole HRA looks like and contents of the pack
Icelandic: Lýsing á útliti Ketoconazole HRA og pakkningastærðir
English: AUC: ↑ 15.3-fold Cmax: ↑ 4.1-fold
Icelandic: ↑ 15,3-falt Cmax:
English: Microcrystalline cellulose Silica colloidal Magnesium stearate
Icelandic: kísilkvoðulausn, magnesíumsterat
English: Tolbutamide
Icelandic: Tolbútamíð
English: Dose adjustment of dihydropyridines and verapamil may be required.
Icelandic: Þörf getur verið á aðlögun díhýdrópýrídín og verapamíl skammta.
English: Temsirolimus:
Icelandic: Temsirólímus:
English: isavuconazole - certain antidiabetics: repaglinide, saxagliptin, tolbutamide - certain medicines used for mental disorders: buspirone, aripipazole, haloperidol, reboxetine, risperidone - certain heart medicines - verapamil, digoxin, nadolol, aliskiren - certain anticonvulsivants: carbamazepine, phenitoin - certain glucocorticoids - such as budesonide, fluticasone, dexamethasone, methylprednisolone, ciclesonide - certain stong painkillers (narcotics) - such as alfentanyl, fentanyl, buprenorphine (injection and sublingual),
Icelandic: dabrafenib, cabazitaxel, crizotinib, ibrutinib - lyf notuð við sýkingum: rifabútín, telitrómýsín, rifampisín, ísóníasíð, klaritrómýsín, isavukónazól - lyf við sykursýki: repagliníð, saxagliptín, tolbútamíð - lyf notuð við geðröskunum: búsiprón, aripipazól, halóperidól, reboxetín, risperidón - hjartalyf - verapamíl, digoxín, nadólól, aliskiren - krampalyf; karbamazepín, fenýtóín - barksterar- s.s. búdesóníð, flutíkasón, dexametasón, metýlprednisólón, ciclesóníð - sterk verkjalyf - s.s. alfentanýl, fentanýl, búprenorfín (í æð og undir tungu), oxýkodón - lyf við ógleði og uppköstum: domperidón, aprepitant - naloxegól (lyf notað við meðferð hægðatregðu, sérstaklega af völdum sterkra verkjalyfja) - solifenasín, fesóseteródín hjá sjúklingum með skerta nýrnastarfsemi - önnur lyf: sildenafíl, tolteródín, mítítan, praziquantel, eletriptan, salmeteról, bósentan, midazólam (í æð), tadalafíl, vardenafíl, temsirólímus, cinalcacet, takrólímus, ebastín, ciclosporín, kolkisín
English: AUC: ↑ 1.3-fold
Icelandic: ↑ 1,3-falt Cabozantinib
English: AUC: ↑ 24-fold Cmax: ↑ 29-fold
Icelandic: ↑ 24-falt Cmax:
English: Ritonavir
Icelandic: LOTUNÚMER
English: - Prior to the start of ketoconazole - Within one week after the beginning of the treatment - As clinically indicated thereafter.
Icelandic: - Innan viku frá upphafi meðferðar
English: Nausea, abdominal pain, vomiting, diarrhoea
Icelandic: Geðlyf, kvíðalyf og svefnlyf
English: Aripiprazole dose should be reduced to approximatively one-half of its prescribed dose.
Icelandic: Minnka skal skammta aripiprazóls um u.þ.b. helming miðað við ávísaðan skammt.
English: See section 4.
Icelandic: ↑ 1,4-falt
English: AUC: ↑ 10-fold Cmax: ↑ 4-fold
Icelandic: ↑ 10-falt Cmax:
English: Photosensitivity, erythema multiforme, dermatitis, erythema, , xeroderma
Icelandic: Ljósnæmi, regnbogaroðasótt, húðbólga, roði í húð, húðþurrkur
English: Posology
Icelandic: Ritonavír
English: Therefore, ketoconazole is an inhibitor of cortisol and aldosterone synthesis.
Icelandic: Þar af leiðandi hamlar ketókónazól kortísól og aldósterónmyndun.
English: In most of the publications the maintenance dose varied between 600 mg/day and 800 mg/day; - When the effective dose of ketoconazole is established, monitoring of urinary free cortisol and/or plasma cortisol levels may be performed every 3 to 6 months (see section 4.4); - In the case of adrenal insufficiency and depending on the severity of the event, the dose of ketoconazole should be decreased by at least 200 mg/day or the treatment should be temporarily discontinued and/or a corticosteroid therapy should be added until the resolution of the event.
Icelandic: - Við skerta nýrnastarfsemi allt eftir alvarleika ástandsins, skal minnka ketókónazól skammtinn um minnst 200 mg/dag eða hætta skal meðferðinni tímabundið og/eða bæta við meðferð með barksterum þar til ástandið leysist.
English: AUC: ↑ 10.9-fold Cmax: ↑ 4.4-fold
Icelandic: ↑ 10,9-falt Cmax:
English: Reboxetine: AUC: ↑ 1.5-fold of both enantiomers
Icelandic: ↑ 1,5-falt fyrir báðar handhverfur
English: Telithromycine:
Icelandic: Tolbútamíð:
English: Urological Drugs Fesoterodine Tolterodine Solifenacin
Icelandic: Þvagfæralyf Fesóteródín Tolteródín Solifenasín
English: AUC: ↑ 5-fold Cmax: ↑ 3.4-fold
Icelandic: ↑ 1,4-falt Cmax:
English: - if you are allergic to ketoconazole and/or to any imidazole antifungal medicine, or to any of the other ingredients of this medicine (listed in section 6) - if you have liver problems - if you are pregnant - if you are breastfeeding - if you have a history of an irregular heart beat - if you are taking any of the following medicines:
Icelandic: - ef um er að ræða ofnæmi fyrir ketókónazóli og/eða sveppalyfjum sem innihalda imidasól, eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: Clinical efficacy
Icelandic: Samhliða meðferð
English: Potential ↑in plasma concentrations of disopyramide and quinidine
Icelandic: Möguleg ↑ þéttni disópýramíðs og kínidíns í plasma
English: AUC: ↑ 2.7-fold Cmax:↑ 1.5-fold
Icelandic: ↑ 2,5-falt Cmax:
English: Fesoterodine active metabolite:
Icelandic: Nevirapín: styrkur í plasma:
English: AUC: ↑ 1.9-fold Cmax: ↑ 1.7-fold
Icelandic: ↑ 1,9-falt Cmax:
English: AUC: ↑ 1.2-fold Cmax: ↑ 1.2-fold
Icelandic: ↑ 1,2-falt Cmax:
English: ↑in plasma concentrations of tolterodine have been observed
Icelandic: ↑ 3,0-falt ↑ þéttni tolteródíns í plasma hefur komið fram
English: Gastrointestinal Drugs Aprepitant
Icelandic: Lyf gegn sýkingum Rifabútín
English: Epistaxis
Icelandic: Veirulyf
English: Medicinal products affecting the absorption of ketoconazole
Icelandic: Lyf sem hafa áhrif á frásog ketókónazóls
English: Oedema peripheral, malaise, hot flush
Icelandic: Ógleði, kviðverkur, uppköst, niðurgangur
English: Potential ↑in plasma concentrations of haloperidol.
Icelandic: Möguleg ↑ þéttni halóperidóls í plasma.
English: Each tablet contains 200 milligram ketoconazole - The other ingredients are maize starch, lactose monohydrate (see section 2), povidone,
Icelandic: - Önnur innihaldsefni eru maíssterkja, laktósaeinhýdrat (sjá kalfa 2), póvidon, örkristallaður sellulósi,
English: Potential ↑in plasma concentrations of buspirone.
Icelandic: Möguleg ↑ þéttni busúlfans í plasma
English: ↑in plasma concentrations of tolvaptan have been observed
Icelandic: ↑ þéttni tolvaptans í plasma hefur komið fram
English: Contraception
Icelandic: Lifrarsjúkdómur
English: AUC: ↑ 2-fold
Icelandic: P-gp: hömlun
English: Dose adjustment of aprepitant may be required
Icelandic: Þörf getur verið á aðlögun aprepitant skammta.
English: • Skin redness, drying, itching
Icelandic: Roði í húð, þukkur, kláði
English: Ketoconazole dose should be adjusted accordingly.
Icelandic: Aðlaga skal skammta ketókónazóls í samræmi við það.
English: Contraindicated due to an increase risk of edema and congestive heart failure (see section 4.3).
Icelandic: Má ekki nota vegna aukinnar hættu á blóðkalíumhækkun og lágþrýstingi (sjá kafla 4.3).
English: Cmax: ↑ 6 fold
Icelandic: ↑1,6-falt
English: • Diarrhoea • Skin reactions (pruritus, rash)
Icelandic: Viðbrögð í húð (kláði, útbrot)
English: AUC: ↑2.2-fold Cmax: ↑1.7-fold
Icelandic: ↑ 6,2-falt Cmax:
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Icelandic: 5.1 Lyfjahvörf
English: Cabozantinib
Icelandic: Dasatinib
English: Ketoconazole HRA contains lactose
Icelandic: Ketoconazole HRA inniheldur laktósa
English: Observed teratogenic effects were mainly skeletal anomalies, including cleft palate, brachydactylia, ectrodactylia and syndactylia.
Icelandic: Vansköpunaráhrif sem fram komu voru aðallega frávik í beinagrind, m.a. klofinn gómur, stuttfingrun, vanfingrun og samfingrun.
English: Press down at 1 and at the same time pull at 2.
Icelandic: Þrýstið niður á 1 og togið á sama tíma í 2.
English: The relevance of these findings for humans is not known.
Icelandic: Mikilvægi þessara niðurstaðna fyrir menn er ekki þekkt.
English: Take one capsule in the morning and one capsule at night.
Icelandic: Taktu eitt hylki að morgni og eitt hylki að kvöldi.
English: EU/1/14/974/001 56 capsules EU/1/14/974/002 196 capsules EU/1/14/974/003 14 capsules
Icelandic: EU/1/14/974/001 56 hylki EU/1/14/974/002 196 hylki EU/1/14/974/003 14 hylki
English: Continue taking Cerdelga every day for as long as your doctor tells you.
Icelandic: Haltu áfram að taka Cerdelga á hverjum degi eins lengi og læknirinn segir fyrir um.
English: Do not give this medicine to children or adolescents.
Icelandic: Ekki gefa börnum eða unglingum lyfið.
English: Cerdelga has not been tested in children and adolescents under 18 years of age.
Icelandic: Cerdelga hefur ekki verið prófað á börnum og unglingum undir 18 ára aldri.
English: Not all packs may be marketed in your country.
Icelandic: Ekki víst að allar pakkningastærðir séu markaðssettar í þínu landi.
English: It may be taken with or without food.
Icelandic: Það má taka með eða án matar.
English: • have had a heart attack or heart failure.
Icelandic: • hefur fengið hjartaáfall eða hjartabilun
English: Information for the patient:
Icelandic: Upplýsingar fyrir sjúklinginn:
English: Take one capsule at the same time every day.
Icelandic: Takið eitt hylki daglega, alltaf á sama tíma.
English: The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened.
Icelandic: Hylkin á að gleypa í heilu lagi, helst með vatni, og þau má ekki mylja, leysa upp eða opna.
English: Do not open, crush, dissolve, or chew the capsule before swallowing it.
Icelandic: Ekki opna, mylja, leysa upp eða tyggja hylkin áður en þú gleypir þau.
English: The size of the capsule is ‘size 2' (dimensions 18.0 x 6.4 mm).
Icelandic: Stærð hylkisins er „stærð 2“ (mál 18,0 x 6,4 mm).
English: a Cerezyme/Cerdelga - Originally Randomized to Cerezyme b Cerdelga - Originally Randomized to Cerdelga
Icelandic: a Cerezyme/Cerdelga - upphaflega slembiraðað á Cerezyme b Cerdelga - upphaflega slembiraðað á Cerdelga
English: Your doctor will determine if Cerdelga is suitable for you before you start taking it, using a simple laboratory test.
Icelandic: Læknirinn mun ákvarða hvort Cerdelga sé hentugt fyrir þig áður en þú byrjar að taka það með því að nota einfalt próf.
English: In turn this helps your affected organs to work better.
Icelandic: Þetta hjálpar þar með líffærunum að vinna betur.
English: Information for healthcare professionals:
Icelandic: Upplýsingar fyrir heilbrigðisstarfsfólk:
English: Eighteen patients completed 8 years of treatment.
Icelandic: Átján sjúklingar luku 8 ára meðferð.
English: Gaucher disease type 1 is a lifelong condition and you must continue to take this medicine as prescribed by your doctor to gain the maximum benefit from your medicine.
Icelandic: Gaucher-sjúkdómur af gerð 1 er ævilangt ástand og þú verður að halda áfram að taka lyfið eins og læknirinn hefur sagt til um til að hafa sem mest gagn af lyfinu.
English: The build-up prevents these organs from working properly.
Icelandic: Uppsöfnunin kemur í veg fyrir að þessi líffæri virki rétt.
English: Reports from the subregistry are to be submitted with each PSUR.
Icelandic: Skýrslur úr sér skránni skal leggja fram með hverri PSUR.
English: Do not use this medicine after the expiry date which is stated on the carton, sleeve and blister after ‘EXP'.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni, slíðrinu og þynnunni á eftir „EXP“.
English: Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.
Icelandic: Hann ákveður hvaða lyf er hægt að nota eftir því hve hratt líkaminn brýtur niður eliglustat.
English: o Always consult the doctor who prescribed eliglustat before you start using other medicines.
Icelandic: o Ráðfærðu þig ávallt við lækninn sem ávísaði eliglustati áður en þú byrjar að nota önnur lyf.
English: Talk to your doctor or pharmacist before taking Cerdelga, if you:
Icelandic: Leitið ráða hjá lækninum eða lyfjafræðingi áður en Cerdelga er notað, ef þú:
English: Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in plasma.
Icelandic: Eliglustat er miðlungsmikið bundið plasmapróteinum manna (76 til 83%) og dreifist að mestu í plasma.
English: Dry skin, urticaria*
Icelandic: Þurr húð, ofsakláði*
English: • have any other heart problems.
Icelandic: • ert með önnur hjartavandamál
English: If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Icelandic: Ef gleymist að taka skammt skal taka næsta skammt á venjulegum tíma, ekki skal tvöfalda næsta skammt.
English: No significant differences were found in the efficacy and safety profiles of elderly patients and younger patients.
Icelandic: Enginn marktækur munur kom fram á verkun og öryggi aldraðra sjúklinga og yngri sjúklinga.
English: The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Cerdelga hjá börnum og unglingum yngri en 18 ára.
English: A limited number of patients aged 65 years (n=10) and over were enrolled in clinical trials.
Icelandic: Takmarkaður fjöldi sjúklinga 65 ára (n=10) og eldri tók þátt í klínískum rannsóknum.
English: Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford Ireland
Icelandic: Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford Írland
English: Gender, body weight, age, and race
Icelandic: Kyn, líkamsþyngd, aldur og kynþáttur
English: At 2 and 24 hours post-dose, 0.034 % and 0.013 % of labelled dose was detected in foetal tissue, respectively.
Icelandic: Tveimur og 24 klukkustundum eftir lyfjagjöf kom 0,034% og 0,013% af merktum skammti fram í vefjum fósturs, í þeirri röð.
English: As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond.
Icelandic: Þess vegna getur magn lyfsins í blóði verið mismunandi eftir sjúklingum sem gæti haft áhrif á svörun sjúklings.
English: 5% (40.57%) [n=39], 74.6% (49.57%) [n=35], and 86.8% (54.20%) [n=12]; mean reduction in spleen volume (MN) 46.5% (9.75%) [n=38], 54.2% (9.51%) [n=32], and 65.6% (7.43%) [n=13]; and mean reduction in liver volume (MN) 13.7% (10.65%) [n=38], 18.5% (11.22%) [n=32], and 23.4% (10.59%) [n=13].
Icelandic: 3) 58,5% (40,7%) [n=39], 74,6% (49,57%) [n=35], og 86,8% (54,20%) [n=12]; meðaltals minnkun á rúmmáli milta (MN) 46,5% (9,75%) [n=38], 54,2% (9,51%) [n=32], og 65,6% (7,43%) [n=13]; og meðaltals minnkun á rúmmáli lifrar (MN) 13,7% (10,65%) [n=38], 18,5% (11,22%) [n=32], og 23,4% (10,59%) [n=13].
English: Please speak to your doctor regarding these medicines before you start taking Cerdelga.
Icelandic: Þú skalt ræða við lækninn um þessi lyf áður en þú byrjar að nota Cerdelga.
English: In these four studies a total of 393 patients between the ages of 16-75 years received eliglustat for a median duration of 3.5 years (up to 9.3 years).
Icelandic: Í þessum fjórum rannsóknum fengu alls 393 sjúklingar á aldrinum 16-75 ára eliglustat í 3,5 ár (miðgildi) (allt að 9,3 ár).
English: Do not stop taking Cerdelga without talking to your doctor.
Icelandic: Ef hætt er að nota Cerdelga Ekki hætta að taka Cerdelga án þess að tala við lækninn.
English: Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Icelandic: Framleiðandi Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
English: Effects of eliglustat in toxicology studies were reversible and exhibited no evidence of delayed or recurring toxicity.
Icelandic: Áhrif eliglustats í rannsóknum á eiturverkunum voru afturkræf og sýndu engin merki um seinkaðar eða endurteknar eiturverkanir.
English: People differ in the speed that their body breaks down this medicine.
Icelandic: Það er mismunandi hversu hratt líkami fólks brýtur lyfið niður.
English: 14 hard capsules 56 hard capsules 196 hard capsules
Icelandic: 14 hörð hylki 56 hörð hylki 196 hörð hylki
English: Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure (based on AUC).
Icelandic: Þroski fósturvísa og fóstra hjá rottum og kanínum varð ekki fyrir áhrifum upp að klínískt viðeigandi útsetningu (samkvæmt AUC).