FrancophonIA/ELRC3.0 huggingface dataset:
English: From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Icelandic: Sjúklingurinn skal taka tvær 10 mg filmuhúðaðar töflur (20 mg) eða eina 20 mg filmuhúðaða töflu á dag.
English: The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in clear PVC-PVdC film with push through aluminium foil lidding perforated unit dose blisters.
Icelandic: Pakkningastærðirnar 28 × 1, 56 × 1, 98 × 1 og 100 × 1 fyrir filmuhúðaðar töflur eru í glærri PVC-PVdC filmu með álþynnuloki sem hægt er að þrýsta í gegnum, rifgötuðum stakskammtaþynnum.
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Icelandic: Í annarri slembiraðaðri rannsókn á einlyfjameðferð á vægum til miðlungs Alzheimers-sjúkdómi tóku 470 sjúklingar þátt (MMSE heildarstigatala á grunnlínu 11 - 23).
English: Memantine Mylan is used for the treatment of patients with moderate to severe Alzheimer's disease.
Icelandic: Mylan er notað við meðferð sjúklinga sem haldnir eru miðlungs til alvarlegum Alzheimers-sjúkdómi.
English: Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Icelandic: Rétt er að forðast samhliða notkun N-metýl-D-aspartat (NMDA) blokka á borð við amantadín, ketamín eða dextrómetorfan.
English: Additional for 10 mg film-coated tablets:
Icelandic: Til viðbótar fyrir 10 mg filmuhúðaðar töflur:
English: 56 x 1 film-coated tablets 60 film-coated tablets
Icelandic: 56 × 1 filmuhúðaðar töflur 60 filmuhúðaðar töflur
English: 28 x 1 film-coated tablets 30 film-coated tablets
Icelandic: 28 × 1 filmuhúðaðar töflur 30 filmuhúðaðar töflur
English: Breast-feeding Women taking Memantine Mylan should not breast-feed.
Icelandic: Konur sem taka Memantine Mylan ættu ekki að hafa barn á brjósti.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Mylan reassessed by your doctor on a regular basis.
Icelandic: Sé svo þarf að fylgjast grannt með meðferðinni og læknirinn þarf að meta reglulega klínískan ábata af töku Memantine Mylan.
English: EU/1/13/827/008 EU/1/13/827/009 EU/1/13/827/010 EU/1/13/827/011 EU/1/13/827/012 EU/1/13/827/013 EU/1/13/827/014 EU/1/13/827/015 EU/1/13/827/016 EU/1/13/827/017 EU/1/13/827/018 EU/1/13/827/019 EU/1/13/827/020 EU/1/13/827/021 EU/1/13/827/022 EU/1/13/827/023 EU/1/13/827/024 EU/1/13/827/025 EU/1/13/827/026 EU/1/13/827/027 EU/1/13/827/028 EU/1/13/827/029 EU/1/13/827/030 EU/1/13/827/031 EU/1/13/827/032 EU/1/13/827/033 EU/1/13/827/034 EU/1/13/827/035 EU/1/13/827/036
Icelandic: EU/1/13/827/019 EU/1/13/827/020 EU/1/13/827/021 EU/1/13/827/022 EU/1/13/827/023 EU/1/13/827/024 EU/1/13/827/025 EU/1/13/827/026 EU/1/13/827/027 EU/1/13/827/028 EU/1/13/827/029 EU/1/13/827/030 EU/1/13/827/031 EU/1/13/827/032 EU/1/13/827/033 EU/1/13/827/034 EU/1/13/827/035 EU/1/13/827/036
English: one and a half 10 mg tablets week 4 and beyond one 20 mg tablet once a day
Icelandic: ein og hálf 10 mg tafla vika 4 og eftir það ein 20 mg tafla einu sinni á dag
English: Very rare (may affect up to 1 in 10,000 people): • Seizures
Icelandic: Koma örsjaldan fyrir (geta komið fyrir hjá allt að 1 af hverjum 10.000 einstaklingum): • Krampar
English: If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Icelandic: Ef þú ert með skerta nýrnastarfsemi (nýrnakvilla) þarf læknirinn að fylgjast vel með nýrnastarfseminni og aðlaga memantínskammtinn í samræmi við það ef það reynist nauðsynlegt.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Icelandic: Við 20 mg dagskammt memantíns er magn í mænuvökva (CSF) í samræmi við ki-gildi (ki = hömlunarfasti) memantíns, sem er 0,5 µmól í framanverðum heilaberki manna.
English: Italia Mylan S.p.A
Icelandic: Mylan S.p.A Tel:
English: The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blisters.
Icelandic: Pakkningastærðirnar 28 × 1, 56 × 1, 98 × 1 og 100 × 1 fyrir filmuhúðaðar töflur koma í stakskammtaþynnum.
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity Uncommon (may affect up to 1 in 100 people):
Icelandic: Höfuðverkur, syfja, hægðatregða, hækkun lifrarprófa, sundl, jafnvægistruflanir, mæði, háþrýstingur og ofnæmi fyrir lyfinu Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum):
English: Administration of Memantine Mylan is not recommended in patients with severe hepatic impairment.
Icelandic: Ekki er mælt með lyfjagjöf Memantine Mylan hjá sjúklingum með alvarlega skerta lifrarstarfsemi.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), titanium dioxide (E171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide yellow (E172), macrogol 400 (E1521), macrogol 8000, indigo carmine aluminium lake (E132) and iron oxide red (E172), all in the tablet coating.
Icelandic: - Önnur innihaldsefni eru örkristallaður sellulósi, natríumkroskarmellósi, magnesíumsterat, talkúm og vatnsfrí kísilkvoða, allt í töflukjarna; pólýdextrósi (E1200), hýprómellósi 3cP (E464), hýprómellósi 6cP (E464), hýprómellósi 50cP (E464), gult járnoxíð (E172), makrógól 400 (E1521), makrógól 8000, indigókarmín állitur (E132), rautt járnoxíð (E172), allt í töfluhúðinni.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (E172), macrogol 400 (E1521), macrogol 8000, all in the tablet coating.
Icelandic: - Önnur innihaldsefni eru örkristallaður sellulósi, natríumkroskarmellósi, magnesíumsterat, talkúm og vatnsfrí kísilkvoða, allt í töflukjarna; pólýdextrósi (E1200), hýprómellósi 3cP (E464), hýprómellósi 6cP (E464), hýprómellósi 50cP (E464), rautt járnoxíð (E172), makrógól 400 (E1521), makrógól 8000, allt í töfluhúðinni.
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Icelandic: Í einskammta lyfjahvarfarannsóknum hjá ungum, heilbrigðum einstaklingum komu ekki fram neinar milliverkanir sem máli skipta milli virku efnanna memantíns og glýbúríðs/metformíns eða dónezepíls.
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Icelandic: stigs, 6 mánaða rannsóknunum sex, með samanburði við lyfleysu (þar með talið einlyfjameðferðar rannsóknir og rannsóknir þar sem sjúklingarnir voru á óbreyttum skammti acetýlkólínesterasa hemla) komu í ljós tölfræðilega marktækt meiri áhrif hjá memantínmeðhöndluðum sjúklingum á skilvits-, heildar- og starfrænt svið.
English: INFORMATION IN BRAILLE Memantine Mylan 20 mg
Icelandic: MEÐ BLINDRALETRI Memantine Mylan 20 mg
English: Also, Memantine Mylan may change your reactivity, making driving or operating machinery inappropriate.
Icelandic: Memantine Mylan og getur þannig dregið úr hæfni til aksturs og stjórnunar véla.
English: In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme.
Icelandic: Til þess að draga úr hættu af aukaverkunum er farið upp í þennan skammt með því að fylgja eftirfarandi meðferðarskema.
English: Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist.
Icelandic: Memantín er spennuháður NMDA-viðtakablokki með hóflega sækni án samkeppni.
English: INFORMATION IN BRAILLE Memantine Mylan 10 mg
Icelandic: MEÐ BLINDRALETRI Memantine Mylan 10 mg
English: You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Icelandic: Rétt er að láta lækni vita ef ætlunin er að breyta verulega um mataræði eða ef því hefur verið breytt nýlega (t.d. ef venjulegu mataræði er hætt og tekið upp strangt jurtafæði) eða ef maður þjáist af nýrnapíplublóðsýringu
English: A red film-coated, oval, biconvex, bevelled edge tablet debossed with “ME” on one side of the tablet and “20” on the other side.
Icelandic: Rauð, filmuhúðuð, egglaga, tvíkúpt tafla með skáskorinni brún og merkt með „ME“ á annarri hliðinni og „20“ á hinni hliðinni.
English: Iron oxide yellow (E172)
Icelandic: Gult járnoxíð (E172) Indigókarmín állitur (E132)
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Icelandic: Höfuðverkur, syfja, hægðatregða, hækkun lifrarprófa, sundl, jafnvægistruflanir, mæði, háþrýstingur og ofnæmi fyrir lyfinu
English: Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Icelandic: Hver filmuhúðuð tafla inniheldur 20 mg af memantínhýdróklóríði, samsvarandi 16,62 mg af memantíni.
English: Silica, colloidal anhydrous
Icelandic: Sellulósi, örkristallaður
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg per day.
Icelandic: Hjá sjúklingum með miðlungs skerta nýrnastarfsemi (kreatínín úthreinsun 30 - 49 ml/mín.)
English: Memantine Mylan 10 mg film-coated tablets
Icelandic: Memantine Mylan 10 mg filmuhúðaðar töflur.
English: OTHER Mon → Tue → Wed → Thu → Fri → Sat → Sun
Icelandic: Fim → Fös → Lau → Sun
English: Fertility No adverse reactions of memantine were noted on male and female fertility.
Icelandic: Frjósemi Engar aukaverkanir komu fram á frjósemi karla og kvenna vegna memantíns.
English: Memantine Mylan acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Icelandic: Mylan hefur áhrif á NMDA-viðtakana og bætir sendingu taugaboða ásamt minni.
English: How to store Memantine Mylan
Icelandic: Memantine Mylan
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Icelandic: 7 - 9 falt (sjá kafla 4.4).
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Icelandic: Lykilrannsókn á einlyfjameðferð með memantíni var gerð hjá 403 sjúklingum með vægan til miðlungs Alzheimers-sjúkdóm (MMSE heildarstigatala á grunnlínu 10 - 22).
English: In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
Icelandic: Hjá sjúklingum með mjög skerta nýrnastarfsemi (kreatínín úthreinsun 5 - 29 ml/mín.)
English: EU/1/13/827/033 98 x 1 film-coated tablets EU/1/13/827/034 100 film-coated tablets EU/1/13/827/035 100 x 1 film-coated tablets EU/1/13/827/036 112 film-coated tablets
Icelandic: EU/1/13/827/033 98 × 1 filmuhúðaðar töflur EU/1/13/827/034 100 filmuhúðaðar töflur EU/1/13/827/035 100 × 1 filmuhúðaðar töflur EU/1/13/827/036 112 filmuhúðaðar töflur
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Icelandic: Lykilrannsókn á einlyfjameðferð var gerð hjá samtals 252 sjúklingum utan stofnana með miðlungs til alvarlegan Alzheimers-sjúkdóm (heildarstigatala vitræns mats (MMSE) við grunngildi 3 - 14).
English: A dark yellow film-coated, tapered oblong shaped, biconvex tablet debossed with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side.
Icelandic: Dökkgul, filmuhúðuð og aflöng, tvíkúpt tafla, mjókkandi í annan endann, með „ME“ ígreypt vinstra megin við deiliskoruna og „10“ hægra megin á annarri hlið töflunnar og deiliskoru á hinni hliðinni.
English: Memantine Mylan 20 mg film-coated tablets
Icelandic: Mylan 20 mg filmuhúðaðar töflur
English: How to take Memantine Mylan
Icelandic: Áður en byrjað er að nota Memantine Mylan
English: In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure.
Icelandic: Í rottum varð vart minni fósturvaxtar við skammta sem gáfu svipaða útsetningu við notkun hjá mönnum.
English: EU/1/13/827/015 98 x 1 film-coated tablets EU/1/13/827/016 100 film-coated tablets EU/1/13/827/017 100 x 1 film-coated tablets EU/1/13/827/018 112 film-coated tablets
Icelandic: EU/1/13/827/015 98 × 1 filmuhúðaðar töflur EU/1/13/827/016 100 filmuhúðaðar töflur EU/1/13/827/017 100 × 1 filmuhúðaðar töflur EU/1/13/827/018
English: EU/1/13/827/001 EU/1/13/827/002 EU/1/13/827/003 EU/1/13/827/004 EU/1/13/827/005 EU/1/13/827/006 EU/1/13/827/007
Icelandic: EU/1/13/827/001 EU/1/13/827/002 EU/1/13/827/003 EU/1/13/827/004 EU/1/13/827/005 EU/1/13/827/006 EU/1/13/827/007 EU/1/13/827/008 EU/1/13/827/009 EU/1/13/827/010 EU/1/13/827/011 EU/1/13/827/012 EU/1/13/827/013 EU/1/13/827/014 EU/1/13/827/015 EU/1/13/827/016 EU/1/13/827/017 EU/1/13/827/018
English: Macrogol 8000 (E1521)
Icelandic: Pólýdextrósi (E1200)
English: What Memantine Mylan looks like and contents of the pack A dark yellow film-coated, tapered oblong shaped, biconvex tablet marked with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side.
Icelandic: Dökkgul, filmuhúðuð og aflöng, tvíkúpt tafla, mjókkandi í annan endann, merkt með „ME“ vinstra megin við deiliskoruna og „10“ hægra megin á annarri hlið töflunnar og deiliskoru á hinni hliðinni.
English: EU/1/13/827/007 42 film-coated tablets
Icelandic: EU/1/13/827/007 42 filmuhúðaðar töflur
English: EU/1/13/827/025 42 film-coated tablets
Icelandic: EU/1/13/827/025 42 filmuhúðaðar töflur
English: EU/1/13/827/022 28 film-coated tablets
Icelandic: EU/1/13/827/022 28 filmuhúðaðar töflur
English: See section 4.
Icelandic: Frá 4. viku:
English: EU/1/13/827/032 98 film-coated tablets
Icelandic: EU/1/13/827/032 98 filmuhúðaðar töflur
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Icelandic: Mylan og pakkningastærðir
English: EU/1/13/827/030 70 film-coated tablets
Icelandic: EU/1/13/827/030 70 filmuhúðaðar töflur
English: EU/1/13/827/020 10 film-coated tablets
Icelandic: EU/1/13/827/020 10 filmuhúðaðar töflur
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Icelandic: VIRKT EFNI Hver filmuhúðuð tafla inniheldur 10 mg af memantínhýdróklóríði, samsvarandi 8,31 mg af memantíni.
English: EU/1/13/827/019 7 film-coated tablets
Icelandic: EU/1/13/827/019 7 filmuhúðaðar töflur
English: EU/1/13/827/010 56 x 1 film-coated tablets EU/1/13/827/011 60 film-coated tablets
Icelandic: EU/1/13/827/010 56 × 1 filmuhúðaðar töflur EU/1/13/827/011 60 filmuhúðaðar töflur
English: Paediatric population No data available.
Icelandic: Börn Engar upplýsingar liggja fyrir.
English: EU/1/13/827/009 56 film-coated tablets
Icelandic: EU/1/13/827/009 56 filmuhúðaðar töflur
English: EU/1/13/827/023 28 x 1 film-coated tablets EU/1/13/827/024 30 film-coated tablets
Icelandic: EU/1/13/827/023 28 × 1 filmuhúðaðar töflur EU/1/13/827/024 30 filmuhúðaðar töflur
English: EU/1/13/827/008 50 film-coated tablets
Icelandic: EU/1/13/827/008 50 filmuhúðaðar töflur
English: Memantine Mylan 20 mg film-coated tablets memantine hydrochloride
Icelandic: Mylan 20 mg filmuhúðaðar töflur memantínhýdróklóríð
English: EU/1/13/827/005 28 x 1 film-coated tablets EU/1/13/827/006 30 film-coated tablets
Icelandic: EU/1/13/827/005 28 × 1 filmuhúðaðar töflur EU/1/13/827/006 30 filmuhúðaðar töflur
English: EU/1/13/827/031 84 film-coated tablets
Icelandic: EU/1/13/827/031 84 filmuhúðaðar töflur
English: Tablet coat for 10/20 mg film-coated tablets: Polydextrose (E1200)
Icelandic: Töfluhúð fyrir 10/20 mg filmuhúðaðar töflur:
English: EU/1/13/827/021 14 film-coated tablets
Icelandic: EU/1/13/827/021 14 filmuhúðaðar töflur
English: EU/1/13/827/027 56 film-coated tablets
Icelandic: EU/1/13/827/027 56 filmuhúðaðar töflur
English: EU/1/13/827/026 50 film-coated tablets
Icelandic: EU/1/13/827/026 50 filmuhúðaðar töflur
English: EU/1/13/827/028 56 x 1 film-coated tablets EU/1/13/827/029 60 film-coated tablets
Icelandic: EU/1/13/827/028 56 × 1 filmuhúðaðar töflur EU/1/13/827/029 60 filmuhúðaðar töflur
English: EU/1/13/827/004 28 film-coated tablets
Icelandic: EU/1/13/827/004 28 filmuhúðaðar töflur
English: EU/1/13/827/002 10 film-coated tablets
Icelandic: EU/1/13/827/002 10 filmuhúðaðar töflur
English: If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Icelandic: Skammtur hjá sjúklingum með skerta nýrnastarfsemi Sé sjúklingur með skerta nýrnastarfsemi ákveður læknirinn hvaða skammtur hæfir best.
English: EU/1/13/827/014 98 film-coated tablets
Icelandic: EU/1/13/827/014 98 filmuhúðaðar töflur
English: Memantine Mylan 10 mg film-coated tablets memantine hydrochloride
Icelandic: Mylan 10 mg filmuhúðaðar töflur memantínhýdróklóríð
English: EU/1/13/827/012 70 film-coated tablets
Icelandic: EU/1/13/827/012 70 filmuhúðaðar töflur
English: EU/1/13/827/001 7 film-coated tablets
Icelandic: EU/1/13/827/001 7 filmuhúðaðar töflur
English: Venous thrombosis/thromboembolism
Icelandic: Mylan bvba/sprl
English: Constipation
Icelandic: Háþrýstingur
English: EU/1/13/827/003 14 film-coated tablets
Icelandic: EU/1/13/827/003 14 filmuhúðaðar töflur
English: Elderly
Icelandic: Ungverjaland
English: What Memantine Mylan contains - The active substance is memantine.
Icelandic: - Virka innihaldsefnið er memantín.
English: In post-marketing experience these reactions have been reported in patients treated with memantine.
Icelandic: Slíkar aukaverkanir hafa verið tilkynntar hjá sjúklingum í meðferð með memantíni eftir að lyfið kom á markað.
English: Dosage in patients with impaired kidney function
Icelandic: Notkun annarra lyfja samhliða
English: Pharmacokinetic/pharmacodynamic relationship
Icelandic: Pharmaceutical Trading Co.
English: Hungary
Icelandic: Bretland
English: If you forget to take Enviage
Icelandic: Ef gleymist að taka Enviage
English: Taking Enviage with food and drink
Icelandic: Ef Enviage er tekið með mat eða drykk
English: Always take Enviage exactly as your doctor has told you.
Icelandic: Notið Enviage alltaf eins og læknirinn hefur sagt til um.
English: Enviage has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Icelandic: Enviage hefur verið rannsakað hjá 1.864 sjúklingum 65 ára og eldri og 426 sjúklingum 75 ára og eldri.
English: There are no special dose recommendations for patients aged 65 years or older.
Icelandic: Það eru engar sérstakar ráðleggingar varðandi skammta handa sjúklingum sem eru 65 ára eða eldri.
English: • At the request of the EMEA.
Icelandic: Ef EMEA óskar eftir því.
English: Enviage was secreted in the milk of lactating rats.
Icelandic: Enviage skildist út í mjólk hjá mjólkandi rottum.
English: Enviage was not teratogenic in rats or rabbits (see section 5.3).
Icelandic: Enviage hafði ekki fósturskemmandi áhrif hjá rottum eða kanínum (sjá kafla 5.3).
English: Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Icelandic: Ekki er mælt með notkun Enviage fyrir börn og unglinga yngri en 18 ára þar sem engar upplýsingar liggja fyrir um öryggi og verkun (sjá kafla 5.2).
English: Like all medicines, Enviage can cause side effects, although not everybody gets them.
Icelandic: Eins og við á um öll lyf getur Enviage valdið aukaverkunum en það gerist þó ekki hjá öllum.
English: Enviage belongs to a new class of medicines called renin inhibitors.
Icelandic: Enviage tilheyrir nýjum lyfjaflokki sem kallast renínhemlar.
English: Enviage has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Icelandic: Enviage hefur verið metið með tilliti til öryggis hjá fleiri en 7.800 sjúklingum, þar á meðal voru 2.300 meðhöndlaðir lengur en 6 mánuði og fleiri en 1.200 lengur en 1 ár.
English: In this leaflet: What Enviage is and what it is used for
Icelandic: UM ENVIAGE OG VIÐ HVERJU ÞAÐ ER NOTAÐ
English: PA/Alu/PVC blisters
Icelandic: PA/Ál/PVC þynnur
English: You should take Enviage with a light meal once a day, preferably at the same time each day.
Icelandic: Enviage á að taka ásamt léttri máltíð einu sinni á sólarhring, helst alltaf á sama tíma sólarhringsins.
English: The use of Enviage in children and adolescents is not recommended.
Icelandic: Ekki er mælt með notkun Enviage handa börnum og unglingum.
English: Do not use Enviage after the expiry date which is stated on the carton and blister.
Icelandic: Ekki skal nota Enviage eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnu.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Icelandic: Markaðsleyfishafi skal tryggja að kerfi fyrir lyfjagát, eins og lýst er í útgáfu 8.0, sem er í kafla 1.8.1. í markaðsleyfisumsókninni, hafi verið komið á fót og sé virkt áður en og á meðan lyfið er á markaði.
English: - during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and
Icelandic: - síðustu 6 mánuði meðgöngu eða ef þú ert með barn á brjósti, sjá kaflann „Meðganga og brjóstagjöf“.
English: However, CYP3A4 inhibitors often also affect P-gp.
Icelandic: Aftur á móti hafa CYP3A4 hemlar oft áhrif á P-gp.
English: Cases of angioedema have also been reported in post-marketing experience (frequency unknown).
Icelandic: Einnig hefur verið greint frá tilvikum um ofsabjúg eftir markaðssetningu (tíðni ekki þekkt).
English: - ketoconazole, a medicine used to treat fungal infections.
Icelandic: - Ketoconazol, lyf sem notað er við sveppasýkingum.
English: Co-administration of aliskiren with either valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Enviage.
Icelandic: Notkun aliskirens samhliða valsartani (↓28%), metformini (↓28%), amlodipini (↑29%) eða cimetidini (↑19%) orsakaði 20% til 30% breytingu á Cmax eða AUC fyrir Enviage.
English: Warfarin The effects of Enviage on warfarin pharmacokinetics have not been evaluated.
Icelandic: Warfarin Áhrif Enviage á lyfjahvörf warfarins hafa ekki verið metin.
English: If co-medication is considered necessary, caution is advisable.
Icelandic: Ef samhliða lyfjagjöf er talin nauðsynleg er ráðlegt að gæta varúðar.
English: Not known (frequency cannot be estimated from the available data): Kidney problems.
Icelandic: Tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum):
English: Enviage has negligible influence on the ability to drive and use machines.
Icelandic: Enviage hefur óveruleg áhrif á hæfni til aksturs og notkunar véla.