FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system disorders Common headache, dizziness, somnolence
Icelandic: Algengar höfuðverkur, sundl, svefnhöfgi
English: • feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence)
Icelandic: • ógleði, niðurgangur, kviðverkur, uppköst, vindgangur
English: Antipsychotics thioridazine
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: gastrointestinal motility disorder includes: gastrointestinal motility disorder, and frequent bowel movements rash includes: rash, rash macular, rash erythematous, rash generalised, rash maculo-papular, rash papular, and urticarial alanine aminotransferase increased includes: alanine aminotransferase increased and hepatocellular injury
Icelandic: Truflanir á þarmahreyfingum ná yfir: truflanir á þarmahreyfingum og tíðar hægðir Útbrot ná yfir: útbrot, dílaútbrot, roðaútbrot, útbreidd útbrot, dröfnuörðuútbrot, örðuútbrot og ofsakláða Aukinn alanín aminótransferasi nær yfir: aukinn alanín aminótransferasa og lifrarfrumuskaða
English: Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline CD4
Icelandic: RNA < 40 eintök/ml samkvæmt upphafsgildi CD4 T frumna (frumur/mm
English: HIV is the virus that causes AIDS (‘acquired immune deficiency syndrome').
Icelandic: HIV er veiran sem veldur alnæmi.
English: The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in T lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Icelandic: Veiruhamlandi virkni tenofovirs gegn rannsóknarstofu- og klínískum HIV-1 stofnum var metin í frumulínum
English: Rare hypomagnesaemia, lactic acidosis*
Icelandic: Mjög sjaldgæfar blóðmagnesíumlækkun, mjólkursýrublóðsýring*
English: Expected:  doravirine (Induction of CYP3A)
Icelandic: Áætlað:  doravirin (CYP3A virkjun)
English: Long-term oral carcinogenicity studies of doravirine in mice and rats showed no evidence of carcinogenic potential at estimated exposures up to 6 times (mice) and 7 times (rats) the human exposures at the RHD.
Icelandic: á doravirini eftir inntöku hjá músum var ekkert sem benti til krabbameinsvaldandi áhrifa við útsetningu sem samsvarar allt að 6 faldri (mýs) og 7 faldri (rottur) útsetningu hjá mönnum við ráðlagða skammta.
English: Antibiotics nafcillin
Icelandic: Eiturverkun á æxlun
English: Rare dermatitis allergic, rosacea, angioedema* Musculoskeletal and connective tissue disorders Common muscle disorders*
Icelandic: Sjaldgæfar vöðvaverkir, liðverkir, rákvöðvalýsa* vöðvamáttleysi*
English: ANNEX I
Icelandic: Annar en B
English: Package leaflet: Information for the user Delstrigo 100 mg/300 mg/245 mg film-coated tablets doravirine/ lamivudine/ tenofovir disoproxil
Icelandic: Delstrigo 100 mg/300 mg/245 mg filmuhúðaðar töflur doravirin/lamivudin/tenofovir disoproxil
English: Following oral dosing, peak plasma concentrations are achieved 2 hours after dosing.
Icelandic: Eftir inntöku er hámarksþéttni náð 2 klst.
English: flatulence
Icelandic: INNIHALDSLÝSING
English: What Delstrigo contains
Icelandic: Delstrigo inniheldur
English: • increased levels of creatine phosphokinase
Icelandic: • aukið magn kreatínkínasa
English: Recommendation Concerning Co-administration with doravirine/lamivudine/tenofo vir disoproxil
Icelandic: Ráðleggingar um gjöf samhliða doravirin/lamivudin/tenofovir disoproxili
English: This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Icelandic: Þessi aukaverkun getur komið fram sem afleiðing af aðlægum píplukvilla í nýrum.
English: Antiviral activity in cell culture
Icelandic: Veiruhamlandi virkni í frumuræktun
English: Resistance
Icelandic: háþrýstingur
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Icelandic: 32(0) 27766211 dpoc_belux@merck.com
English: Expected:  doravirine (Inhibition of CYP3A)
Icelandic: Áætlað:  doravirin (CYP3A hömlun)
English: Impairment of fertility
Icelandic: Geðrofslyf thioridazin
English: Doravirine has an estimated absolute bioavailability of approximately 64 % for the 100 mg tablet.
Icelandic: 64 % fyrir 100 mg töflu.
English: Delstrigo should be discontinued if estimated CrCl declines below 50 mL per minute as dose interval adjustment required for lamivudine and tenofovir disoproxil cannot be achieved with the fixed dose combination tablet (see section 4.2).
Icelandic: því að aðlögun skammtabils sem þarf fyrir lamivudin og tenofovir disoproxil næst ekki með töflu með fastri skammtasamsetningu (sjá kafla 4.2).
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets) Not all pack sizes may be marketed.
Icelandic: - 90 filmuhúðaðar töflur (3 glös með 30 filmuhúðuðum töflum).
English: The efficacy of doravirine is based on the analyses of 96-week data from two randomised, multicentre, double-blind, active controlled Phase 3 trials, (DRIVE-FORWARD and DRIVE-AHEAD) in antiretroviral treatment-naïve, HIV-1 infected subjects (n = 1494).
Icelandic: Verkun doravirins byggist á greiningu á 96 vikna upplýsingum úr tveimur slembuðum, fjölsetra, tvíblindum
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1-infected subjects.
Icelandic: Enginn klínískt marktækur munur er á lyfjahvörfum doravirinsr m.t.t.
English: NA
Icelandic: Kyn
English: But if your next dose is due within
Icelandic: LYFSINS ÞAR SEM VIÐ Á
English: Merck Sharp & Dohme B.V. Tel: 0800 9999000
Icelandic: Tel: 0800 9999000
English: • kidney damage, kidney stones, kidney failure, damage to kidney tubule cells, kidney injury,
Icelandic: • nýrnaskemmdir, nýrnasteinar, nýrnabilun, skemmdir á frumum í nýrnapíplum, nýrnaskaði, mikil þvaglát og þorstatilfinning
English: Co-administration should be avoided.
Icelandic: Helst á að forðast notkun
English: In in vitro studies, doravirine was able to suppress the following NNRTI-associated substitutions; K103N, Y181C, and G190A under clinically relevant concentrations.
Icelandic: K103N, Y181C og G190A við klínískt viðeigandi þéttni.
English: 84 tablets
Icelandic: 84 töflur
English: 17, rue de Pontoise F-95520 Osny France
Icelandic: 17 rue de Pontoise F-95520 Osny Frakkland
English: Study 3a
Icelandic: 3a
English: EU/1/18/1309/001 EU/1/18/1309/002 EU/1/18/1309/003 EU/1/18/1309/004 EU/1/18/1309/005
Icelandic: EU/1/18/1309/003 EU/1/18/1309/004 EU/1/18/1309/005
English: EU/1/18/1309/001 28 tablets EU/1/18/1309/002 84 tablets EU/1/18/1309/003 30 tablets EU/1/18/1309/004 28 tablets EU/1/18/1309/005 84 tablets
Icelandic: EU/1/18/1309/001 28 töflur EU/1/18/1309/002 84 töflur EU/1/18/1309/003 30 töflur EU/1/18/1309/004 28 töflur EU/1/18/1309/005 84 töflur
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Icelandic: LYFJAFORM OG INNIHALD 28 töflur
English: Treatment whilst pregnant might affect your pregnancy (it is not known if Ulipristal Acetate Gedeon Richter might harm your baby or whether can cause miscarriage).
Icelandic: Notkun lyfsins á meðgöngu gæti haft áhrif á meðgönguna (ekki er vitað hvort Ulipristal Acetate Gedeon Richter getur skaðað barnið eða hvort það valdi fósturláti).
English: - If you have liver or kidney disease tell your doctor or pharmacist before taking Ulipristal Acetate Gedeon Richter.
Icelandic: - Ef þú ert með lifrar- eða nýrnasjúkdóm skaltu segja lækninum eða lyfjafræðingi frá því áður en þú notar Ulipristal Acetate Gedeon Richter.
English: If you forget to take Ulipristal Acetate Gedeon Richter If you miss a dose by less than 12 hours, take it as soon as you remember.
Icelandic: Ef gleymist að taka Ulipristal Acetate Gedeon Richter Ef þú gleymir að taka skammt í allt að 12 klst. skaltu taka hann eins fljótt og þú manst eftir því.
English: You should always start taking Ulipristal Acetate Gedeon Richter within the first week of your menstrual period.
Icelandic: Þú skalt ávallt byrja að nota Ulipristal Acetate Gedeon Richter innan fyrstu viku tíðahrings.
English: Your period should generally return within 4 weeks after treatment with Ulipristal Acetate Gedeon Richter is stopped.
Icelandic: Blæðingarnar ættu almennt að byrja aftur innan 4 vikna eftir að meðferð með Ulipristal Acetate Gedeon Richter er hætt.
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Ulipristal Acetate Gedeon Richter.
Icelandic: • upplýsir sjúklinga um hugsanlegar aukaverkanir sem tengjast lifur sem geta verið af völdum notkunar Ulipristal Acetate Gedeon Richter.
English: Ulipristal Acetate Gedeon Richter is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Icelandic: Ulipristal Acetate Gedeon Richter má ekki nota hjá sjúklingum með lifrarsjúkdóm (sjá kafla 4.3 og 4.4).
English: Ulipristal Acetate Gedeon Richter should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Icelandic: Börn undir 18 ára aldri mega ekki nota Ulipristal Acetate Gedeon Richter vegna þess að ekki hefur verið sýnt fram á öryggi og verkun úlipristal asetats fyrir þennan aldurshóp.
English: Gedeon Richter (listed in section 6).
Icelandic: Acetate Gedeon Richter (talin upp í kafla 6).
English: Ulipristal Acetate Gedeon Richter with food and drink
Icelandic: Notkun Ulipristal Acetate Gedeon Richter með mat eða drykk
English: Ulipristal Acetate Gedeon Richter can cause side effects although not everybody gets them.
Icelandic: Ulipristal Acetate Gedeon Richter getur valdið aukaverkunum en það gerist þó ekki hjá öllum.
English: Do not take Ulipristal Acetate Gedeon Richter if you are pregnant.
Icelandic: Notaðu ekki Ulipristal Acetate Gedeon Richter ef þú ert þunguð.
English: Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective (see “Other medicines and Ulipristal Acetate Gedeon Richter”).
Icelandic: Ulipristal Acetate Gedeon Richter er líklegt til að draga úr verkun sumra hormónagetnaðarvarna (sjá „Notkun annarra lyfja samhliða Ulipristal Acetate Gedeon Richter“).
English: • key effects of Ulipristal Acetate Gedeon Richter on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Icelandic: Ulipristal Acetate Gedeon Richter á breytingar á legslímhúð er tengjast prógesterónviðtaka (Progesterone Receptor Modulator Associated Endometrial Changes (PAEC)) og hvernig þær eru frábrugðnar breytingum sem tengjast óhindruðu estrógeni.
English: If you stop taking Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter is to be taken daily during treatment courses of up to 3 months continuously.
Icelandic: Ef hætt er að nota Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter skal taka daglega samfellt í allt að 3 mánaða meðferðartímabilum.
English: Patients with controlled bleedingb,c, d
Icelandic: Sjúklingar með reglulegar blæðingarb, c,
English: SPECIAL STORAGE CONDITIONS Keep the blisters in the outer carton in order to protect from light.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið þynnurnar í ytri öskjunni til varnar gegn ljósi.
English: Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause.
Icelandic: Ulipristal Acetate Gedeon Richter er notað hjá fulltíða konum (eldri en 18 ára) fyrir tíðahvörf.
English: • inform the patients not to take Ulipristal Acetate Gedeon Richter in case of liver problems.
Icelandic: • upplýsir sjúklinga um að nota ekki Ulipristal Acetate Gedeon Richter ef um er að ræða lifrarsjúkdóm.
English: Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Icelandic: Sjúklingar sem voru komnir með eðlilegar blæðingar (PBAC < 75) í 13. viku Miðgildi breytingar á stærð leghnúta (myoma) frá upphafi rannsóknar til 13. vikua a Í rannsókn 1 var breyting frá upphafsgildi á heildarstærð hnúta í legi mæld með segulómun.
English: Stop using Ulipristal Acetate Gedeon Richter and immediately contact a doctor if you experience any of the following symptoms:
Icelandic: Hætta skal notkun Ulipristal Acetate Gedeon Richter og hafa tafarlaust samband við lækninn ef fram koma einhver af eftirfarandi einkennum:
English: If you do become pregnant during Ulipristal Acetate Gedeon Richter treatment, you should stop taking Ulipristal Acetate Gedeon Richter immediately and contact your doctor or pharmacist.
Icelandic: á Ulipristal Acetate Gedeon Richter meðferð stendur skaltu hætta strax að taka Ulipristal Acetate Gedeon Richter og hafa samband við lækninn eða lyfjafræðing.
English: During treatment with Ulipristal Acetate Gedeon Richter, your doctor will carry out regular blood tests to check your liver function.
Icelandic: Meðan á meðferð með Ulipristal Acetate Gedeon Richter stendur, mun læknirinn taka blóðprufur reglulega til að athuga lifrarstarfsemina.
English: Other medicines and Ulipristal Acetate Gedeon Richter Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Icelandic: Notkun annarra lyfja samhliða Ulipristal Acetate Gedeon Richter Látið lækninn eða lyfjafræðing vita um öll önnur lyf sem eru notuð, hafa nýlega verið notuð eða kynnu að verða notuð.
English: If you have been prescribed several courses of Ulipristal Acetate Gedeon Richter 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Icelandic: Ef þér hefur verið ávísað nokkrum þriggja mánaða meðferðartímabilum af Ulipristal Acetate Gedeon Richter skaltu hefja hvert tímabil í fyrsta lagi við aðrar tíðablæðingar eftir að síðasta meðferðartímabili lýkur.
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose,
Icelandic: Í rannsókn 4 voru 61,9% sjúklinga (5 mg skammtur, p=0,032) og 72,7% sjúklinga (10 mg skammtur, p=0,032) með tíðateppu við lok 1. og 2. meðferðartímabils samanlagt; 48,7% og 60,5% voru með tíðateppu eftir öll fjögur meðferðartímabilin samanlagt (5 mg skammtur og 10 mg skammtur, í þeirri röð, p=0,027).
English: What Ulipristal Acetate Gedeon Richter looks like and contents of the pack Ulipristal Acetate Gedeon Richter is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Icelandic: Lýsing á útliti Ulipristal Acetate Gedeon Richter og pakkningastærðir Hvítar til beinhvítar, kringlóttar, kúptar 7 mm töflur merktar með kóðanum „ES5“ á annarri hliðinni.
English: Treatment with Ulipristal Acetate Gedeon Richter usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Icelandic: Meðferð með Ulipristal Acetate Gedeon Richter leiðir yfirleitt til talsvert minni tíðablæðinga eða stöðvar þær jafnvel á fyrstu 10 dögum meðferðar.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Icelandic: SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNA
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).
Icelandic: Tíðnin sem fram kom er í samræmi við samanburðarhópa og algengi sem heimildir greina frá hjá konum fyrir tíðahvörf sem eru með einkenni, í þessum aldurshópi (meðalaldur 40 ár).
English: If you take more Ulipristal Acetate Gedeon Richter than you should Experience with Ulipristal Acetate Gedeon Richter when several doses are taken at once is limited.
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um Reynslan af Ulipristal Acetate Gedeon Richter þegar nokkrir skammtar eru teknir í einu er takmörkuð.
English: Before you start treatment with Ulipristal Acetate Gedeon Richter blood tests will be undertaken to find out how well your liver is working.
Icelandic: - Áður en meðferð með Ulipristal Acetate Gedeon Richter hefst verða teknar blóðprufur til að kanna hvernig lifrarstarfseminni er háttað.
English: The MAH shall ensure that, at launch and thereafter, all prescribers of Ulipristal Acetate Gedeon Richter and pathologists who review samples from Ulipristal Acetate Gedeon Richter-treated patients, as well as patients treated with Ulipristal Acetate Gedeon Richter, are provided with educational material.
Icelandic: Við markaðssetningu og þar á eftir skal markaðsleyfishafi ganga úr skugga um að útvega öllum þeim sem ávísa Ulipristal Acetate Gedeon Richter og meinafræðingum sem greina sýni úr sjúklingum sem meðhöndlaðir eru með Ulipristal Acetate Gedeon Richter, svo og sjúklingum sem eru meðhöndlaðir með Ulipristal Acetate Gedeon Richter, fræðsluefni.
English: Ulipristal Acetate Gedeon Richter may cause mild dizziness (see section 4 “Possible side effects”).
Icelandic: Ulipristal Acetate Gedeon Richter kann að valda vægu sundli (sjá 4. kafla, „Hugsanlegar aukaverkanir“).
English: Therefore, do not breast-feed your baby while taking Ulipristal Acetate Gedeon Richter.
Icelandic: Því skaltu ekki hafa barn á brjósti á meðan þú notar Ulipristal Acetate Gedeon Richter.
English: Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Ulipristal Acetate Gedeon Richter or be affected by Ulipristal Acetate Gedeon Richter: - Certain medicines which are used to treat the heart (e.g. digoxin).
Icelandic: Láttu lækninn eða lyfjafræðing vita ef þú tekur einhver þeirra lyfja sem eru talin upp hér fyrir neðan, því þessi lyf geta haft áhrif á Ulipristal Acetate Gedeon Richter eða orðið fyrir áhrifum af Ulipristal Acetate Gedeon Richter:
English: Frequencies are defined as 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 available data).
Icelandic: (≥1/10), algengar (≥1/100 til <1/10), sjaldgæfar (≥1/1.000 til <1/100), mjög sjaldgæfar (≥1/10.000 til
English: Do not take Ulipristal Acetate Gedeon Richter - if you are allergic to ulipristal acetate or any of the other ingredients of Ulipristal Acetate
Icelandic: Ekki má nota Ulipristal Acetate Gedeon Richter - ef um er að ræða ofnæmi fyrir úlipristal asetati eða einhverju öðru innihaldsefni Ulipristal
English: How to store Ulipristal Acetate Gedeon Richter Contents of the pack and other information
Icelandic: Hvernig geyma á Ulipristal Acetate Gedeon Richter Pakkningar og aðrar upplýsingar
English: Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Ulipristal Acetate Gedeon Richter treatment.
Icelandic: Því er ekki mælt með notkun hormónagetnaðarvarna og þú skalt nota örugga sæðishindrandi getnaðarvörn, t.d. smokk, meðan á Ulipristal Acetate Gedeon Richter meðferð stendur.
English: Depending on the result of these tests, the doctor will decide if treatment with Ulipristal Acetate Gedeon Richter is suitable for you.
Icelandic: Byggt á niðurstöðum þessara blóðprufa mun læknirinn ákveða hvort meðferð með Ulipristal Acetate Gedeon Richter henti þér.
English: In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Ulipristal Acetate Gedeon Richter less effective.
Icelandic: Auk þess eru hormónagetnaðarvarnir og prógestógen (t.d. norethindron eða levonorgestrel) líkleg til að draga úr verkun Ulipristal Acetate Gedeon Richter.
English: What Ulipristal Acetate Gedeon Richter is and what it is used for What you need to know before you take Ulipristal Acetate Gedeon Richter How to take Ulipristal Acetate Gedeon Richter Possible side effects
Icelandic: Í fylgiseðlinum eru eftirfarandi kaflar Upplýsingar um Ulipristal Acetate Gedeon Richter og við hverju það er notað Áður en byrjað er að nota Ulipristal Acetate Gedeon Richter Hvernig nota á Ulipristal Acetate Gedeon Richter Hugsanlegar aukaverkanir
English: What Ulipristal Acetate Gedeon Richter is and what it is used for
Icelandic: Upplýsingar um Ulipristal Acetate Gedeon Richter og við hverju það er notað
English: - If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Ulipristal Acetate Gedeon Richter”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Ulipristal Acetate Gedeon Richter.
Icelandic: - Ef þú ert á hormónagetnaðarvörn (t.d. getnaðarvarnartöflum, þ.e. „pillunni“) (sjá „Notkun annarra lyfja samhliða Ulipristal Acetate Gedeon Richter“) skaltu auk þess nota örugga sæðishindrandi getnaðarvörn (t.d. smokk) á meðan þú notar Ulipristal Acetate Gedeon Richter.
English: • the need to inform the pathologist that patients were treated with Ulipristal Acetate Gedeon Richter if biopsy/surgical samples are to be sent for analysis.
Icelandic: mikilvægi þess að láta meinafræðing vita að sjúklingar voru meðhöndlaðir með Ulipristal Acetate Gedeon Richter ef senda á vefjasýni/sýni úr skurðaðgerð til greiningar.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of ulipristal acetate.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 5 mg úlipristal asetat.
English: Patients in amenorrheab,c
Icelandic: Sjúklingar með tíðateppub, c
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ulipristal Acetate Gedeon Richter in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Icelandic: á Ulipristal Acetate Gedeon Richter hjá öllum undirhópum barna við vöðvaæxli í legi (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: - If you suffer from severe asthma, treatment with Ulipristal Acetate Gedeon Richter may not be suitable for you.
Icelandic: - Ef þú ert með alvarlegan astma kann að vera að meðferð með Ulipristal Acetate Gedeon Richter henti þér ekki.
English: The lining of the uterus may thicken or change as a result of taking Ulipristal Acetate Gedeon Richter.
Icelandic: Legslíman kann að þykkna eða breytast af völdum notkunar á Ulipristal Acetate Gedeon Richter.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Icelandic: NAFN OG HEIMILISFANG MARKAÐSLEYFISHAFA Gedeon Richter Plc.
English: Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective.
Icelandic: Ulipristal Acetate Gedeon Richter er líklegt til að draga úr verkun sumra hormónagetnaðarvarna.
English: How to take Ulipristal Acetate Gedeon Richter
Icelandic: Hvernig nota á Ulipristal Acetate Gedeon Richter
English: 2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Ulipristal Acetate Gedeon Richter treatment)
Icelandic: 5. BLÓÐPRUFA (2- 4 vikum eftir að meðferð með Ulipristal Acetate Gedeon Richter er hætt)
English: You should nonetheless ask your doctor or pharmacist for advice if you take more Ulipristal Acetate Gedeon Richter than you should.
Icelandic: Samt sem áður skal í slíkum tilvikum leita ráða hjá lækninum eða lyfjafræðingi ef tekinn er stærri skammtur af Ulipristal Acetate Gedeon Richter en mælt er fyrir um.
English: Due to the CYP-mediated metabolism, hepatic impairment is expected to alter the elimination of ulipristal acetate, resulting in increased exposure.
Icelandic: Vegna umbrotsins fyrir tilstilli CYP er búist við því að skert lifrarstarfsemi breyti brotthvarfi Ulipristal Acetate Gedeon Richter, sem leiðir til aukinnar útsetningar.
English: ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETS PATIENT CARD
Icelandic: ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TÖFLUR ÖRYGGISKORT SJÚKLINGS
English: Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.
Icelandic: Ulipristal Acetate Gedeon Richter inniheldur virka efnið úlipristal asetat.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter
Icelandic: NAFN MARKAÐSLEYFISHAFA Gedeon Richter
English: 10 mg/day N=107
Icelandic: 10 mg/ dag N=107