FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/07/386/006 7 prolonged-release tablets EU/1/07/386/007 14 prolonged-release tablets EU/1/07/386/008 28 prolonged-release tablets EU/1/07/386/020 30 prolonged-release tablets EU/1/07/386/009 56 prolonged-release tablets EU/1/07/386/010 98 prolonged-release tablets EU/1/07/386/012 84 prolonged-release tablets EU/1/07/386/018 100 prolonged-release tablets
Icelandic: EU/1/07/386/006 7 forðatöflur EU/1/07/386/007 14 forðatöflur EU/1/07/386/008 28 forðatöflur EU/1/07/386/020 30 forðatöflur EU/1/07/386/009 56 forðaöflur EU/1/07/386/010 98 forðatöflur EU/1/07/386/012 84 forðatöflur EU/1/07/386/018 100 forðatöflur
English: EU/1/07/386/001 7 prolonged-release tablets EU/1/07/386/002 14 prolonged-release tablets EU/1/07/386/003 28 prolonged-release tablets EU/1/07/386/019 30 prolonged-release tablets EU/1/07/386/004 56 prolonged-release tablets EU/1/07/386/005 98 prolonged-release tablets EU/1/07/386/011 84 prolonged-release tablets EU/1/07/386/017 100 prolonged-release tablets
Icelandic: EU/1/07/386/001 7 forðatöflur EU/1/07/386/002 14 forðatöflur EU/1/07/386/003 28 forðatöflur EU/1/07/386/019 30 forðatöflur EU/1/07/386/004 56 forðatöflur EU/1/07/386/005 98 forðatöflur EU/1/07/386/011 84 forðatöflur EU/1/07/386/017 100 forðatöflur
English: Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and medicinal products with anticholinergic properties (e.g. amantadine, tri-cyclic antidepressants, certain neuroleptics) as this may lead to more pronounced therapeutic- and side-effects (e.g. constipation, dry mouth, drowsiness, urinary retention).
Icelandic: Sýna skal varkárni við samhliða gjöf fesóteródíns og annarra lyfja sem hafa andmúskarín- eða andkólínvirka eiginleika (t.d. amantadín, þríhringlaga geðdeyfðarlyf, viss sefandi lyf og hreyfiörvandi lyf) þar sem slíkt getur leitt til sterkari meðferðaráhrifa og aukaverkana (s.s. hægðatregðu, munnþurrk, svefnsækni, þvagteppu).
English: Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Icelandic: Fesóteródín dregur ekki úr hindrun eggloss með hormónagetnaðarvörnum til inntöku.
English: - if you have kidney problems or moderate to severe liver problems and are taking medicines containing any of the following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and nefazodone (used to treat depression)
Icelandic: ef þú ert með nýrnakvilla eða miðlungi alvarlega eða alvarlega lifrarkvilla og tekur lyf sem innihalda einhver eftirtalinna efna: ítrakónazól eða ketókónazól (notuð við sveppasýkingum), ritónavír, atazanavír, indínavír, sakvínavír eða nelfínavír (veirulyf til meðhöndlunar á HIV), klarítrómycín eða telítrómycín (notuð við bakteríusýkingum) og nefazódón (notað við þunglyndi).
English: TOVIAZ 8 mg tablets
Icelandic: TOVIAZ 8 mg töflur
English: The efficacy of fixed doses of fesoterodine 4 mg and 8 mg was evaluated in two Phase 3 randomised, double-blind, placebo-controlled, 12-week studies.
Icelandic: Virkni af föstum 4 mg og 8 mg skömmtum af fesóteródíni var metin í tveimur fasa-III, slembiröðuðum, tvíblindum samanburðarrannsóknum með lyfleysu, sem stóðu í 12 vikur.
English: In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group.
Icelandic: Í klínískum rannsóknum á fesóteródíni komu fram nokkur tilfelli greinilega hækkaðralifrarensíma, en þó ekki oftar en hjá lyfleysuhópnum.
English: • not being able to control when you empty your bladder (called urgency incontinence)
Icelandic: það að hafa ekki stjórn á tæmingu þvagblöðru (nefnt bráðaþvagleki)
English: The maximum daily dose is 8 mg.
Icelandic: Hámarks sólarhringsskammtur er 8 mg.
English: No dose adjustment is recommended in these subpopulations.
Icelandic: Ekki er mælt með skammtaaðlögun hjá þessum undirflokki sjúklinga.
English: • urticaria
Icelandic: • nefþurrkur
English: If you experience any of these effects, do not drive or use any tools or machines.
Icelandic: Akið ekki eða stjórnið hvorki tækjum né vélum ef slík einkenni koma fram.
English: What TOVIAZ contains
Icelandic: TOVIAZ inniheldur
English: Dizziness; Headache
Icelandic: Ofsabjúgur; Ofsakláði
English: • increased heart beat (tachycardia)
Icelandic: • hraðari hjartsláttur (hraðtaktur)
English: Reproduction studies have shown minor embryotoxicity at doses close to maternally toxic ones (increased number of resorptions, pre-implantation and post-implantation losses).
Icelandic: á æxlun sýndu aðeins fram á lítilsháttar eiturverkanir á fósturvísa við skammta sem voru nálægt þeim skömmtum sem höfðu eiturverkandi áhrif á móður (aukinn fjöldi uppsogs-, fyrir hreiðrun- og eftir hreiðrun fósturláta).
English: See section 4.
Icelandic: Grunnviðmið 3,7
English: After oral administration, due to rapid and extensive hydrolysis by non-specific plasma esterases, fesoterodine was not detected in plasma.
Icelandic: Fesóteródín kom ekki fram í plasma eftir inntöku þar sem vatnsrof var hratt og verulegt af völdum ósértækra esterasa í plasma.
English: The effect of fesoterodine 4 mg and 28 mg on the QT interval was thoroughly evaluated in a double-blind, randomised, placebo- and positive-controlled (moxifloxacin 400 mg) parallel group study with once-daily treatment over a period of 3 days in 261 male and female subjects aged 45 to 65 years.
Icelandic: Áhrif fesóteródíns 4 mg og 28 mg á QT bil voru vandlega metin í tvíblindri, slembiraðaðri, samhliða samanburðarrannsókn með lyfleysu og jákvæðu lyfi (moxifloxacín 400 mg).
English: TOVIAZ 4 mg tablets EU/1/07/386/001-005 EU/1/07/386/011 EU/1/07/386/013-014
Icelandic: TOVIAZ 4 mg töflur EU/1/07/386/001-005 EU/1/07/386/011
English: Fesoterodine has been safely administered in clinical studies at doses up to 28 mg/day.
Icelandic: Í klínískum rannsóknum var lyfjagjöf fesóteródíns örugg við skammta allt að 28 mg/sólarhring.
English: Tachycardia; Palpitations
Icelandic: Hraðtaktur; Hjartsláttarónot
English: TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Icelandic: TOVIAZ 8 mg forðatöflur fesóteródín fumarat
English: Pharyngolaryng eal pain; Cough; Nasal dryness
Icelandic: Verkir í koki og barka; Hósti;
English: Uncommon (may affect up to 1 in 100 people)
Icelandic: Sjaldgæfar (geta komið fram hjá allt að1 af hverjum 100)
English: TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
Icelandic: TOVIAZ 4 mg forðatöflur fesóteródín fumarat
English: N=283 N=266
Icelandic: N=266 N=267 N=267
English: In the event of fesoterodine overdose, treat with gastric lavage and give activated charcoal.
Icelandic: Við ofskömmtun af fesóteródíns skal beita magaskolun og gefa lyfjakol.
English: • trouble digesting food (dyspepsia)
Icelandic: • erfiðleikar við meltingu fæðu (meltingartruflanir)
English: Concomitant use with CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.4).
Icelandic: Ekki er mælt með samhliða notkun CYP3A4 hvata (t.d. karbamazepíni, rifampicíni, fenóbarbitali, fenýtóíni, Jóhannesarjurt) (sjá kafla 4.4).
English: Other medicines and TOVIAZ
Icelandic: Notkun annarra lyfja samhliða TOVIAZ
English: • dry throat
Icelandic: • þurrkur í hálsi.
English: Angioedema; Urticaria
Icelandic: LYFJAFORM OG INNIHALD
English: TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre-existing cardiac diseases (e.g. myocardial ischaemia, arrhythmia, congestive heart failure), (see section 4.8).
Icelandic: á QT-lengingu (t.d. blóðkalíumlækkun, hægsláttur og samtímis gjöf lyfja sem vitað er að lengja QT-bil) og með hjartasjúkdóma (t.d. blóðþurrð í hjarta, hjartsláttartruflun, hjartabilun), (sjá kafla 4.8).
English: Each tablet contains 8 mg fesoterodine fumarate
Icelandic: Hver tafla inniheldur 8 mg fesóteródín fumarat
English: Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
Icelandic: Hver forðatafla inniheldur 8 mg fesóteródín fumarat, sem samsvarar 6,2 mg af fesóteródíni.
English: • difficulty in completely emptying the bladder (urinary retention)
Icelandic: • erfiðleikar með að tæma þvagblöðru (þvagteppa)
English: Reporting of side effects
Icelandic: Rannsóknir á áhrifum
English: Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.
Icelandic: Hver forðatafla inniheldur fesóteródín fumarat 8 mg, sem samsvarar 6,2 mg af fesóteródíni.
English: ALT increased; GGT increased
Icelandic: Hækkað gildi ALAT; hækkað gildi GGT
English: Each tablet contains 4 mg fesoterodine fumarate
Icelandic: Hver tafla inniheldur 4 mg fesóteródín fumarat
English: • an uncomfortable feeling in the stomach
Icelandic: • óþægindatilfinning í maga
English: Number of micturitions per 24 hours#
Icelandic: Fjöldi þvagláta á sólarhring #
English: Prolonged-release tablet.
Icelandic: Gefið beta-blokka
English: • extreme tiredness (fatigue)
Icelandic: • mikil þreyta (þróttleysi)
English: You should stop taking TOVIAZ and contact your doctor immediately if you develop swelling of the face, mouth or throat.
Icelandic: Ef vart verður við þrota í andliti, munni eða tungu skaltu hætta notkun TOVIAZ og hafa tafarlaust samband við lækninn.
English: Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity.
Icelandic: Rannsóknir með fesóteródín á dýrum hafa sýnt fram á lítlsháttar skaðleg áhrif á frjósemi.
English: Fesoterodine 8 mg
Icelandic: Fesóteródín 8 mg
English: No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice).
Icelandic: Ekki er ráðlagt að breyta skömmtum þegar lyfið er gefið samhliða meðal öflugum CYP3A4 hemlum (t.d. erýtrómýcíni, flúkónazóli, diltíazemi, verapamíli og greipaldinsafa).
English: Nervous system disorders
Icelandic: Taugakvilla í ósjálfráða taugakerfinu
English: Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
Icelandic: Hver forðatafla inniheldur 4 mg fesóteródín fumarat, sem samsvarar 3,1 mg af fesóteródíni.
English: Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.
Icelandic: Hver forðatafla inniheldur fesóteródín fumarat 4 mg, sem samsvarar 3,1 mg af fesóteródíni.
English: Parameter Placebo Fesoterodine 4 mg
Icelandic: Lyfleysa Fesóteródín 4 mg
English: • sleepiness (somnolence)
Icelandic: syfja (svefnhöfgi)
English: The concomitant use of fesoterodine with a potent CYP3A4 inducer (i.e. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.5).
Icelandic: Ekki er mælt með samhliða notkun fesóteródíns og öflugra CYP3A4 örva (þ.e. karbamazepín, rifampicín, fenóbarbital, fenýtóín, Jóhannesarjurt) (sjá kafla 4.5).
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fram hjá allt að 1 af hverjum 10)
English: Very common (may affect more than 1 in 10 people) You may get a dry mouth.
Icelandic: Mjög algengar (geta komið fram hjá fleiri en 1 af hverjum 10)
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
Icelandic: TOVIAZ 4 mg forðatöflur TOVIAZ 8 mg forðatöflur
English: Fesoterodine treated patients had statistically significant mean reductions in the number of micturitions per 24 hours and in the number of urge incontinence episodes per 24 hours at the end of treatment compared to placebo.
Icelandic: Sjúklingar sem meðhöndlaðir voru með fesóteródíni sýndu fram á tölfræðilega marktæka meðalfækkun á þvaglátum á sólarhring og á bráðaþvagleka á sólahring í lok meðferðar í samanburði við lyfleysu.
English: EU/1/07/386/015 30 prolonged-release tablets EU/1/07/386/016 90 prolonged-release tablets
Icelandic: EU/1/07/386/015 30 forðatöflur EU/1/07/386/016 90 forðatöflur
English: TOVIAZ treats the symptoms of an overactive bladder such as
Icelandic: TOVIAZ er notað til meðferðar við einkennum ofvirkrar þvagblöðru.
English: Hepatic metabolism and renal excretion contribute significantly to the elimination of the active metabolite.
Icelandic: Umbrot í lifur og nýrnaútskilnaður skipta verulegu máli við brotthvarf virka umbrotsefnisins.
English: EU/1/07/386/013 30 prolonged-release tablets EU/1/07/386/014 90 prolonged-release tablets
Icelandic: EU/1/07/386/013 30 forðatöflur EU/1/07/386/014 90 forðatöflur
English: Based on how you respond to the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.
Icelandic: Hugsanlegt er að læknirinn ávísi þér hærri skammti eða einni 8 mg töflu á sólarhring, byggt á svörun þinni við lyfinu.
English: Fesoterodine may not always be suitable for you.
Icelandic: Ekki er víst að fesóteródín henti þér.
English: Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, Cmax and AUC of the active metabolite of fesoterodine increased approximately 19% and 27%, respectively.
Icelandic: Í kjölfar hemlunar á CYP3A4 við samhliða gjöf meðal öfluga CYP3A4 hemilsins flúkónazóls 200 mg tvisvar á sólarhring í 2 sólarhringa, jókst Cmax virks umbrotsefnis fesóteródíns um u.þ.b.
English: • Myasthenia gravis
Icelandic: Vivian Corporation
English: Pharmacological interactions
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: The pharmacokinetics of fesoterodine are not significantly influenced by age and gender.
Icelandic: Aldur og kyn hafa ekki veruleg áhrif á lyfjahvörf fesóteródíns.
English: Soya lecithin
Icelandic: Mjólkursykur
English: TOVIAZ is not recommended during pregnancy.
Icelandic: Ekki er mælt með notkun TOVIAZ á meðgöngu.
English: Пфайзер Люксембург САРЛ, Клон България Тел.
Icelandic: Pfizer Luxembourg SARL, filialas Lietuvoje Tel.
English: Urinary retention may occur uncommonly.
Icelandic: Þvagteppa getur sjaldan komið fyrir.
English: - Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) - Gastrointestinal obstructive disorders (e.g. pyloric stenosis) - Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis - Decreased gastrointestinal motility - Autonomic neuropathy - Controlled narrow-angle glaucoma
Icelandic: Marktæka tæmingarhindrun þvagblöðru (bladder outflow obstruction) og hættu á þvagteppu (t.d. klínískt marktæk stækkun blöðruhálskirtils vegna fjölgunar góðkynja frumna í blöðruhálskirtli sjá kafla 4.3)
English: The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS'.
Icelandic: 4 mg töflurnar eru ljósbláar, sporöskjulaga, tvíkúptar, filmuhúðaðar og merktar „FS“ á annarri hliðinni.
English: CYP3A4 inducers
Icelandic: CYP3A4 hvatar
English: • nasal dryness
Icelandic: A. ÁLETRANIR
English: Hepatic impairment
Icelandic: óreglulegan hjartslátt eða hjartabilun
English: Renal and hepatic impairment
Icelandic: Sundl; Höfuðverkur
English: Please also inform your doctor if you are taking any of the following medicines: - medicines containing any of the following active substances may increase the break-down of fesoterodine and thus decrease its effect: St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
Icelandic: Jóhannesarjurt (St. John´s Wort, náttúrulyf), rifampicín (til meðferðar á bakteríusýkingum), karbamazepín, fenýtóín og fenóbarbital (notað, ásamt öðru, til meðferðar við flogaveiki).
English: The relation to fesoterodine treatment is unclear.
Icelandic: Óljóst er hvert samhengið er við fesóteródín meðferð.
English: TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, filmcoated tablets, and engraved on one side with the letters ‘FS'.
Icelandic: TOVIAZ 4 mg forðatöflur eru ljósbláar, sporöskjulaga, tvíkúptar, filmuhúðaðar töflur, merktar „FS” á annarri hliðinni.
English: There are no adequate data from the use of fesoterodine in pregnant women.
Icelandic: Ekki liggja fyrir neinar fullnægjandi rannsóknaniðurstöður um notkun fesóteródíns á meðgöngu.
English: Cardiac electrophysiology
Icelandic: Raflífeðlisfræðilegar niðurstöður varðandi hjarta
English: The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT'.
Icelandic: TOVIAZ 8 mg forðatöflur eru bláar, sporöskjulaga, tvíkúptar, filmuhúðaðar töflur, merktar „FT” á annarri hliðinni.
English: Dose increases
Icelandic: Setjið upp þvaglegg
English: • Uncontrolled narrow angle glaucoma
Icelandic: United Kingdom Pfizer Limited
English: Paediatric population The pharmacokinetics of fesoterodine have not been evaluated in paediatric patients.
Icelandic: Börn Lyfjahvörf TOVIAZs hafa ekki verið metin hjá börnum.
English: TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated tablets, and engraved on one side with the letters ‘FT'.
Icelandic: TOVIAZ 8 mg töflur 8 mg töflurnar eru bláar, sporöskjulaga, tvíkúptar, filmuhúðaðar og merktar „FT“ á annarri hliðinni.
English: Dyspepsia;
Icelandic: Kviðverkir;
English: Flatulence, Gastroesophage al reflux
Icelandic: Lifur og gall
English: Outer carton 8 mg
Icelandic: Ytri askja 8 mg
English: INSTRUCTIONS ON USE
Icelandic: Getnaðarvarnir til inntöku
English: MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: TOVIAZ prolonged-release tablets contain lactose.
Icelandic: TOVIAZ forðatöflur innihalda mjólkursykur.
English: Lactose monohydrate
Icelandic: Virkt samanburðarlyf
English: Dysgeusia; Somnolence
Icelandic: Truflað bragðskyn; Svefnhöfgi
English: It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Icelandic: Ekki er vitað hvort fesóteródín/umbrotsefni skiljast út í brjóstamjólk.
English: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda Tel: +351 21 423 5500
Icelandic: Pfizer Healthcare Ireland Tel: 1800 633 363(toll free)
English: What you need to know before you take TOVIAZ
Icelandic: Áður en byrjað er að nota TOVIAZ
English: Renal impairment
Icelandic: Töflukjarni Xýlitól
English: Potent CYP3A4 inhibitors
Icelandic: Öflugir CYP3A4 hemlar
English: Outer carton 4 mg
Icelandic: Ytri askja 4 mg
English: Number of urge incontinence episodes per 24 hours
Icelandic: Fjöldi bráðaþvagleka á sólarhring
English: Pharmacotherapeutic group: Urologicals, Urinary antispasmodics, ATC code: G04BD11.
Icelandic: Þvagfæralyf, lyf sem hafa krampalosandi verkun á þvagfæri, ATC flokkur:
English: You should not do both.
Icelandic: Þú skalt ekki gera bæði.
English: Note: You may see an air bubble; this is normal.
Icelandic: Þú gætir séð loftbólu; það er eðlilegt.
English: The injection can take up to 20 seconds.
Icelandic: Inndælingin getur tekið allt að 20 sekúdur.
English: ≥ 2 points on a 0-4 IGA scale.
Icelandic: ≥2 punkta á IGA skala 0-4.
English: Ensure you have the following:
Icelandic: Þú skalt tryggja að þú hafir eftirfarandi:
English: However, there were only 61 patients over 65 years of age included in this analysis.
Icelandic: Hins vegar var aðeins 61 sjúklingur eldri en 65 ára með í þessari greiningu.
English: • Then slowly count to 5.
Icelandic: Teldu þá hægt upp að 5.
English: • You may hear a second click.
Icelandic: Þú gætir heyrt annan smell.
English: It is not known whether this is caused by Dupixent.
Icelandic: Ekki er vitað hvort Dupixent veldur þessu.
English: - if you have recently had or are due to have a vaccination.
Icelandic: - ef þú hefur nýlega fengið eða átt að fá bólusetningu.
English: • Check that the entire window has turned to yellow.
Icelandic: Athugaðu hvort allur glugginn er orðinn gulur.
English: *Items not included in the carton
Icelandic: *Hlutir sem ekki fylgja með í öskjunni
English: • The window will start to turn yellow.
Icelandic: Glugginn byrjar þá að verða gulur.
English: 60 kg or more
Icelandic: 60 kg eða meiri
English: Regeneron Ireland Unlimited Company (U.C.)
Icelandic: Regeneron Ireland Unlimited Company (U.C.) Ballycummin
English: Wash your hands
Icelandic: Þvoið hendurnar
English: Such signs are listed under “Serious side effects” in section 4.
Icelandic: Þessi einkenni eru talin upp undir „Alvarlegar aukaverkanir“ í kafla 4.
English: A caregiver may also give you your Dupixent injection after proper training.
Icelandic: Umönnunaraðili getur einnig gefið þér Dupixent eftir viðeigandi þjálfun.
English: How much Dupixent is given and for how long
Icelandic: Dupixent er gefið og hve lengi
English: and 8ºC.
Icelandic: og 8ºC.
English: less than 60 kg
Icelandic: undir 60 kg
English: If you live in a region where these infections are common or if you are travelling to such a region check with your doctor.
Icelandic: Ef þú býrð á svæði þar sem þessar sýkingar eru algengar eða ef þú ferðast til slíks svæðis skaltu ráðfæra þig við lækninn.
English: • swelling of the face, mouth, and tongue
Icelandic: • þroti í andliti, munni eða tungu
English: Do not use the pre-filled pen if the window is yellow.
Icelandic: Ekki nota áfyllta pennann ef glugginn er gulur.
English: The needle is inside.
Icelandic: Nálin er þar fyrir innan.
English: Do not press or touch the orange needle cover with your fingers.
Icelandic: Ekki þrýsta á eða snerta appelsínugulu nálarhlífina með fingrunum.
English: Similar results were observed in VENTURE.
Icelandic: Hliðstæðar niðurstöður komu fram í VENTURE.
English: A: Prepare A1.
Icelandic: Undirbúið A1.
English: Date of first authorisation: 26 September 2017
Icelandic: 26. september 2017
English: Do not stop using Dupixent without speaking to your doctor first.
Icelandic: Ekki hætta að nota Dupixent nema ræða fyrst við lækninn.
English: This usually, but not always, happens in people who also take a steroid medicine which is being stopped or for which the dose is being lowered.
Icelandic: Þetta gerist venjulega, en þó ekki alltaf, hjá einstaklingum sem einnig taka steralyf sem verið er að hætta töku á eða þegar skammtur þess er minnkaður.
English: C. Give injection C1.
Icelandic: C. Inndæling gefin C1.
English: These effects were sustained throughout treatment.
Icelandic: Þessari verkun var viðhaldið allan meðferðartímann.
English: Subsequent Doses (every other week)
Icelandic: Næstu skammtar (aðra hverja viku)
English: 16-Week Monotherapy Studies (SOLO 1 and SOLO 2)
Icelandic: 16 vikna einlyfjarannsókn (SOLO 1 og SOLO 2)
English: A total of 325 patients were enrolled, with 210 patients who were previously exposed to ciclosporin and 115 patients who have never been exposed to ciclosporin because ciclosporin treatment was medically inadvisable.
Icelandic: Samtals 325 sjúklingar voru skráðir í rannsóknina, með 210 sjúklingum sem voru áður útsettir fyrir ciclosporini og 115 sjúklingum sem aldrei höfðu verið útsettir fyrir ciclosporini vegna þess að meðferð með ciclosporini var ekki ráðlögð af læknisfræðilegum ástæðum.
English: Although no differences in safety or efficacy were observed between older and younger adult atopic dermatitis patients, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.
Icelandic: Þó að enginn munur á öryggi eða verkun hafi sést milli eldri og yngri fullorðinna sjúklinga með bráðaofnæmishúðbólgu er fjöldi sjúklinga á aldrinum 65 ára og eldri ekki nægjanlegur til að ákvarða hvort þeir svari öðruvísi en yngri sjúklingar.
English: Mean age (years) (SD) % Female % White
Icelandic: Meðalaldur (ár) (staðafrávik) % Konur % Hvítir
English: Patients were also permitted to use topical calcineurin inhibitors (TCI).
Icelandic: Sjúklingar máttu einnig nota útvortis calcíneurin hemla (TCI).