FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITH THE BLUE BOX
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR FYRIR FJÖLPAKKNINGAR MEÐ 90 TÖFLUM (3 PAKKNINGAR
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78)
Icelandic: ↓ 60% (↓ 52 til ↓ 68)
English: If
Icelandic: Samkvæmt
English: Recommendation concerning co-administration with efavirenz gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Icelandic: Ráðleggingar varðandi samhliða gjöf ásamt efavírenz ólíklegt að þau keppi um sömu umbrotaensím og brotthvarfsleiðir og efavírenz.
English: Integrase strand transfer inhibitor Raltegravir/efavirenz (400 mg single dose/ -)
Icelandic: Hemlar á flutning við samþættingu strengja Raltegravír/Efavírenz (400 mg einn stakur skammtur/-)
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section
Icelandic: Rannsóknir á lifrarstarfsemi skal gera með reglulegu millibili (sjá kafla 4.2).
English: Weight and metabolic parameters
Icelandic: Lyf við mýkóbakteríum
English: Since efavirenz is highly protein-bound, dialysis is unlikely to remove significant quantities of it from blood.
Icelandic: Þar sem efavírenz er að mestum hluta próteinbundið er ólíklegt að hægt sé að fjarlægja svo mikið magn af lyfinu með blóðskilun, að það hafi þýðingu.
English: - Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy, breast-feeding and fertility).
Icelandic: - Getnaðarvarnarlyf með hormónum, svo sem getnaðarvarnartöflur, getnaðarvarnarlyf til inndælingar (til dæmis Depo-Provera) eða ígræðlings getnaðarvarnarlyf (til dæmis
English: You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with Efavirenz Teva.
Icelandic: Engu að síður hverfa útbrotin í flestum tilfellum án þess að Efavirenz Teva meðferðinni sé breytt.
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Icelandic: Atazanavír/Ritonavír/Efavírenz (400 mg einu sinni á dag/200 mg einu sinni á dag/600 mg einu sinni á dag, allt gefið með mat)
English: Atorvastatin:
Icelandic: Próteasahemlar:
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Icelandic: Atazanavír/Ritonavír/Efavírenz (400 mg einu sinni á dag/100 mg einu sinni á dag/600 mg einu sinni á dag, allt gefið með mat)
English: NNRTIs/efavirenz
Icelandic: Flúoxetín/Efavírenz
English: Azithromycin/efavirenz (600 mg single dose/400 mg once daily)
Icelandic: Azitrómýcín/Efavírenz (600 mg í einum skammti/400 mg einu sinni á dag)
English: - The dose for Efavirenz Teva may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Efavirenz Teva).
Icelandic: Teva skammtinn ef þú ert að taka ákveðin önnur lyf (sjá:
English: Voriconazole/efavirenz (200 mg twice daily/400 mg once daily)
Icelandic: Vorikónazól/Efavírenz (200 mg tvisvar á dag/400 mg einu sinni á dag)
English: Pravastatin/efavirenz (40 mg once daily/600 mg once daily)
Icelandic: Pravastatín/Efavírenz (40 mg einu sinni á dag/ 600 mg einu sinni á dag)
English: AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Icelandic: ↓ 75% (↓ 59 til ↓ 84) Cmax:
English: Plasma HIV-RNA
Icelandic: HIV veirusýkingalyf
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Efavirenz Teva or by other medicines that you are taking at the same time, or by the HIV disease itself.
Icelandic: Þegar HIV sýking er meðhöndluð þá er ekki alltaf hægt að greina hvort aukaverkanir eru vegna Efavirenz
English: Co-administration of simeprevir with efavirenz is not recommended.
Icelandic: Ekki er ráðlagt að nota Efavirenz
English: If you take more Efavirenz Teva than you should
Icelandic: Ef þú tekur inn of mikið af Efavirenz
English: There is no specific antidote for overdose with efavirenz.
Icelandic: Notkun annarra lyfja samhliða Efavirenz Teva).
English: Morning Cmin: ↑ 42% (↑ 9 to ↑ 86)
Icelandic: ↑ 49% (↑ 32 til ↑ 69)
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir,
Icelandic: C (jákvæð prófun fyrir lifrarbólgu C-mótefni, „hepatitis C antibody positive“).
English: Efavirenz Teva film-coated tablets are not recommended for children under the age of 3 years or weighing less than 40 kg.
Icelandic: Teva hjá börnum sem eru yngri en 3 ára eða vega minna en 40 kg.
English: Simvastatin/efavirenz (40 mg once daily/600 mg once daily)
Icelandic: Simvastatín/Efavírenz (40 mg einu sinni á dag/ 600 mg einu sinni á dag)
English: Itraconazole/efavirenz (200 mg q12h/600 mg once daily)
Icelandic: Ítrakónazól/Efavírenz (200 mg q12h/600 mg einu sinni á dag)
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 24 weeks.
Icelandic: Einkenni frá taugakerfi byrja vanalega fljótlega eftir upphaf meðferðar og batna oftast eftir 2-4 vikur.
English: AUC: ↓ 17% Cmax: ↔
Icelandic: ↓ 77% Cmax:
English: CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/efavirenz (240 mg once daily/600 mg once daily)
Icelandic: HJARTA- OG ÆÐALYF Kalsíumgangalokar Diltíazem/Efavírenz (240 mg einu sinni á dag/ 600 mg einu sinni á dag)
English: Voriconazole:
Icelandic: Vorikónazól:
English: Recommendation concerning co-administration with efavirenz immunosuppressants are not anticipated to affect exposure of efavirenz.
Icelandic: Sértækt mótefni gegn efavírenzi er ekki fyrir hendi.
English: (CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Icelandic: Þegar ósýktum sjálfboðaliðum var gefið efavírenz samhliða claritrómýcíni fengu 46 % þeirra útbrot.
English: Reporting of suspected adverse reactions
Icelandic: Einstaka tilkynningar hafa borist eftir
English: Responder rates (NC = F
Icelandic: Natríumglýkólatsterkja (gerð A)
English: Efavirenz Teva may reduce the amount of posaconazole in your blood.
Icelandic: Efavirenz Teva getur minnkað magn posakónazóls í blóði.
English: Valproic acid/efavirenz (250 mg twice daily/600 mg once daily)
Icelandic: Valpróínsýra/Efavírenz (250 mg tvisvar á dag/ 600 mg einu sinni á dag)
English: paranoia, psychosis†, suicide attempt, suicide ideation, catatonia*
Icelandic: sjaldgæfar geðhrif, árásargirni, rugl, sæluvíma, ofskynjanir, oflæti, ofsóknarkennd (paranoia), geðrof†, sjálfsvígstilraunir, sjálfsvígshugleiðingar, geðstjarfi*
English: AUC: ↓71% (↓67 to ↓74) Cmax: ↓51% (↓46 to ↓56) Cmin: ↓91% (↓88 to ↓92)
Icelandic: ↓ 71% (↓ 67 til ↓ 74) Cmax:
English: Efavirenz Teva contains sodium
Icelandic: Hvað inniheldur Efavirenz Teva
English: No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of administered with efavirenz.
Icelandic: lækkun á áætluðu meðalhlutfalli eða ≤25% hækkun á áætluðu meðalhlutfalli.
English: Simeprevir/efavirenz (150 mg once daily /600 mg once daily)
Icelandic: Simeprevir/Efavírenz (150 mg einu sinni á sólarhring /600 mg einu sinni á sólarhring)
English: Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients
Icelandic: Spá um lyfjahvörf efavírenz (hylki/hylkisdreifing) við jafnvægi hjá HIV-sýktum börnum
English: How to store Efavirenz Teva
Icelandic: Akstur og notkun véla Efavirenz
English: If you could get pregnant while receiving Efavirenz Teva, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Icelandic: Teva meðferð stendur skal örugg hindrandi getnaðarvörn (t.d. smokkur) ávallt notuð samhliða öðrum getnaðarvörnum s.s. getnaðarvarnartöflum og öðrum hormónagetnaðarvörnum (s.s. ígræddum getnaðarvörnum og getnaðarvarnarsprautum).
English: Fluconazole/efavirenz (200 mg once daily/400 mg once daily)
Icelandic: Flúkónazól/Efavírenz (200 mg einu sinni á dag/400 mg einu sinni á dag)
English: Eye disorders
Icelandic: Augu sjaldgæfar þokusýn
English: Annex II Conditions to the marketing authorisation(s)
Icelandic: Viðauki II Forsendur fyrir markaðsleyfi (leyfum)
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Icelandic: Markaðsleyfishafi verður að tryggja að framleiðsluaðferðir lyfjaefna sem notuð eru í lyfjavörur sínar séu yfirfarnar vegna hugsanlegrar hættu á myndun Nnítrósamína og breyta eftir þörfum til að lágmarka mengun nítrósamína eins mikið og unnt er.
English: Due date
Icelandic: Skiladagur
English: For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Icelandic: Fyrir N-nítrósodimetýlamín (NDMA) og N-nítrósodietýlamín (NDEA) þarf markaðsleyfishafi að gefa upp eftirfarandi tilgreiningar fyrir innihald lyfsins:
English: 28 months.
Icelandic: 28 mánuðir.
English: See Section 2 Warnings and precautions.
Icelandic: Sjá kafla 2, Varnaðarorð og varúðarreglur.
English: Other important side effects which may occur:
Icelandic: Aðrar mikilvægar aukaverkanir sem geta komið fyrir:
English: Titanium dioxide (E171) Macrogol
Icelandic: Títantvíoxíð (E171) Macrogol
English: Approximately 10-20% is excreted in urine.
Icelandic: Um það bil 10-20% skiljast út í þvagi.
English: It is estimated that 80-90% of the dose is excreted in faeces, although this has not been confirmed in man.
Icelandic: Áætlað er að um 80-90% af skammti skiljist út í hægðum, þó að það hafi ekki verið staðfest hjá mönnum.
English: If this happens, you should not drive or use any tools or machines (see Driving and using machines).
Icelandic: Þeir sem þetta hendir mega hvorki aka bifreið né nota vélar og tæki (sjá Akstur og notkun véla).
English: • if you have liver disease;
Icelandic: ef þú ert með lifrarsjúkdóm
English: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Hungary
Icelandic: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Ungverjaland
English: The (E)-isomer accounts for 95% of the AUC of entacapone.
Icelandic: (E)-ísómerinn svarar til 95% af AUC entacapons.
English: Entacapone can be taken with or without food (see section 5.2).
Icelandic: Taka má entacapon með mat eða án (sjá kafla 5.2).
English: - Phaeochromocytoma.
Icelandic: - Krómfíklaæxli (phaeochromocytoma).
English: Characteristics in patients
Icelandic: Einkenni hjá sjúklingum
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18 % [CI90 11-26%].
Icelandic: Í milliverkanarannsókn hjá heilbrigðum sjálfboðaliðum hafði entacapon þó ekki áhrif á plasmaþéttni S-warfarins en AUC fyrir R-warfarin jókst að meðaltali um 18% [CI90 11-26%].
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section
Icelandic: Entacapon sýndi litla eða enga hömlun hvað varðar önnur P450 ísóensím (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A og CYP2C19) (sjá kafla 4.5).
English: The INR values increased on average by 13% [CI90 6-19%].
Icelandic: INR gildi (international normalized ratio) hækkuðu að meðaltali um 13% [CI90 6-19%].
English: There were corresponding decreases in OFF time.
Icelandic: Samsvarandi minnkun varð á „OFF“ tíma.
English: EU/1/10/665/001 - 30 tablets EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Icelandic: EU/1/10/665/001 - 30 töflur EU/1/10/665/002 - 60 töflur EU/1/10/665/003 - 100 töflur EU/1/10/665/004 - 175 töflur
English: In human plasma the unbound fraction is about 2.0% in the therapeutic concentration range.
Icelandic: Í plasma manna er hlutfall óbundins lyfs um það bil 2,0% á þéttnibili meðferðar.
English: Follow the instructions that your doctor has given you.
Icelandic: Fylgið leiðbeiningum læknisins.
English: The safety and efficacy of Entacapone Teva in children below age 18 have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Entacapone Teva hjá börnum yngri en 18 ára.
English: EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Icelandic: EU/1/10/665/002 - 60 töflur EU/1/10/665/003 - 100 töflur EU/1/10/665/004 - 175 töflur
English: Of the metabolites found in urine only about 1% have been formed through oxidation.
Icelandic: Af þeim umbrotsefnum sem fundust í þvagi hefur aðeins 1% myndast með oxun.
English: Patients with hepatic impairment See section 4.3.
Icelandic: Sjúklingar með skerta lifrarstarfsemi Sjá kafla 4.3
English: - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Icelandic: - Saga um illkynja sefunarheilkenni (neuroleptic malignant syndrome) og/eða rákvöðvalýsu án áverka (non-traumatic rhabdomyolysis).
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Icelandic: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Bretland
English: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Icelandic: Entacapon binst bindiseti II á albumini manna, sem einnig bindur nokkur önnur lyf þ.m.t. diazepam og ibuprofen.
English: 4.5% (0 h 35 min) CI95% 0.93%, 7.97%
Icelandic: CI95% 0,93%, 7,97%
English: Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Icelandic: Gæta skal varúðar þegar þessi lyf eru notuð samtímis entacaponi (sjá einnig kafla 4.3 og 4.4).
English: Do not use this medicine after the expiry date which is stated on the carton and tablet container label after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og á merkimiðanum á töfluílátinu á eftir EXP.
English: Pharmacokinetic interaction with benserazide has not been studied.
Icelandic: Lyfjahvarfamilliverkun við benserazid hefur ekki verið rannsökuð.
English: 1 h 20 min CI95% 45 min, 1 h 56 min
Icelandic: CI95% 45 mín., 1 klst. og 56 mín.
English: Approximately 92% of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Icelandic: Brotthvarf um það bil 92% skammtsins verður í β-fasa með stuttum helmingunartíma brotthvarfs sem er 30 mínútur.
English: Do not drive or operate machinery if you experience these side effects.
Icelandic: Hvorki má aka eða stjórna vélum ef þú finnur fyrir þessum aukaverkunum.
English: Iron oxide yellow (E172) Lecithin (soya) Iron oxide red (E172)
Icelandic: Járnoxíð gult (E 172) Lesitín (soja) Járnoxíð rautt (E 172)
English: The post-marketing data include isolated cases of overdose in which the reported highest daily dose of entacapone has been 16,000 mg.
Icelandic: Í gögnum eftir markaðssetningu er greint frá einangruðum tilfellum ofskömmtunar, þar sem hæsti skráði sólarhringsskammtur af entacaponi er 16.000 mg.
English: In animal studies entacapone was excreted in milk.
Icelandic: Í dýrarannsóknum skildist entacapon út í mjólk.
English: Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Icelandic: Vegna sækni entacapons í cytochrom P450 2C9 in vitro (sjá kafla 5.2), getur entacapon hugsanlega haft áhrif á lyf sem eru umbrotin af þessu ísóensími, t.d. S-warfarin.
English: In single-dose studies in healthy volunteers, no interactions were observed between entacapone and imipramine or between entacapone and moclobemide.
Icelandic: Í rannsóknum á stökum skömmtum hjá heilbrigðum sjálfboðaliðum sáust engar milliverkanir entacapons og imipramins eða entacapons og moclobemids.
English: ** The incidence rates of myocardial infarction and other ischemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2082 patients with end-of-dose motor fluctuations receiving entacapone.
Icelandic: ** Tíðni hjartadreps (0,43%) og annarra tilvika blóðþurrðarsjúkdóms í hjarta (1,54%) er fengið með greiningu á 13 tvíblindum rannsóknum á 2.082 sjúklingum, sem fengu entacapon og höfðu hreyfingatruflanir í lok skammtabils (end-of-dose motor fluctuations).
English: In two phase III double-blind studies in a total of 376 patients with Parkinson's disease and end-ofdose motor fluctuations, entacapone or placebo was given with each levodopa/dopa decarboxylase inhibitor dose.
Icelandic: Í tveimur tvíblindum fasa III rannsóknum hjá samtals 376 sjúklingum með Parkinsonsveiki og hreyfingatruflanir í lok skammtabils (end-of-dose motor fluctuations) var gefið entacapon eða lyfleysa með hverjum skammti levodopa/dopadecarboxylasahemils.
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Icelandic: Samkvæmt in vitro rannsóknum, er þess ekki að vænta að marktækur útruðningur (displacement) verði við meðferðarþéttni lyfjanna.
English: Entacapone is extensively bound to plasma proteins, mainly to albumin.
Icelandic: Entacapon er mikið bundið plasmapróteinum, einkum albumini.
English: In individual cases, only some of these symptoms and/or findings may be evident.
Icelandic: Hjá einstaka sjúklingum verður einungis sumra þessara einkenna og/eða afleiðinga vart.
English: Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Icelandic: Entacapon tilheyrir nýjum lyfjaflokki, cathechol-O-methyltransferasa (COMT) hemlum.
English: If you forget to take the Entacapone Teva tablet with your levodopa dose, you should continue the treatment by taking the next Entacapone Teva tablet with your next levodopa dose.
Icelandic: Ef gleymist að taka Entacapone Teva töflu með skammti af levodopa skal halda meðferðinni áfram með því að taka næstu Entacapone Teva töflu með næsta skammti af levodopa.
English: Entacapone (n=85) Placebo (n=86)
Icelandic: Daglegur „ON“ tími (klst.) Entacapon (n=85) Lyfleysa (n=86)
English: The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
Icelandic: Hámarksþéttni (Cmax) í plasma næst yfirleitt u.þ.b. einni klukkustund eftir inntöku 200 mg entacapon töflu.
English: To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Icelandic: Til að draga úr dopaminvirkum aukaverkunum sem tengjast levodopa, er oft nauðsynlegt að breyta skammti levodopa á fyrstu dögum eða vikum eftir að meðferð með entacaponi hefst, í samræmi við klínískt ástand sjúklings (sjá kafla 4.2 og 4.8).
English: The major part (95%) of the product excreted in urine is conjugated with glucuronic acid.
Icelandic: Meginhluti (95%) lyfsins sem skilst út í þvagi er samtengdur glúkúronsýru.
English: A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Icelandic: Lítið eitt af entacaponi, (E)-ísómerinn, breytist í (Z)-ísómer þess.
English: The total clearance of entacapone is about 800 ml/min.
Icelandic: Heildarúthreinsun entacapons er um 800 ml/mín.
English: Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Icelandic: Hlutfallslegur daglegur „ON“ tími (%) Entacapon (n=103) Lyfleysa (n=102) Mismunur
English: Mogilska 80, 31-546, Krakow Poland
Icelandic: Mogilska 80, 31-546, Krakow Pólland
English: Entacapone decreases the metabolic loss of levodopa to 3O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Icelandic: Entacapon minnkar umbrot levodopa í 3-O-methyldopa (3-OMD) með því að hamla COMT ensíminu.
English: Mogilska 80, 31-546, Krakow, Poland
Icelandic: Mogilska 80, 31-546, Krakow, Pólland
English: Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Icelandic: Til að draga úr dopaminvirkum aukaverkunum sem tengjast levodopa, t.d. hreyfingatregða (dyskinesias), ógleði, uppköstum og ofskynjunum, er því oft nauðsynlegt að breyta skammti levodopa á fyrstu dögum eða vikum eftir að meðferð með entacaponi hefst.
English: Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/benserazide treatment (see also section 4.8).
Icelandic: Þess vegna gætu óæskileg dopaminvirkar aukaverkanir orðið algengari þegar entacaponi er bætt við levodopa/benserazid meðferð (sjá einnig kafla 4.8).
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ~4 μM).
Icelandic: Upplýsingar úr in vitro rannsóknum þar sem notaðar voru lifrarfrymisagnir úr mönnum, benda til þess að entacapon hamli cytochrom P450 2C9 (IC50 ~ 4 µM).
English: If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Icelandic: Ef meðferð með entacaponi er hætt er nauðsynlegt að breyta skömmtum annarra lyfja við Parkinsonsveiki, einkum levodopa, til að ná viðunandi stjórn á einkennum Parkinsonsveikinnar.
English: Skin, hair, beard and nail discolorations
Icelandic: á húð, hári, skeggi og nöglum.
English: Therefore, do not take Entacapone Teva and iron supplements at the same time.
Icelandic: Því má ekki taka járnlyf og Entacapone Teva samtímis.
English: Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
Icelandic: Sumar aukaverkanirnar stafa oft af auknum áhrifum levodopa-meðferðarinnar og algengast er að þær komi fram í upphafi meðferðar.
English: The % change from baseline in OFF time was -24% in the entacapone group and 0% in the placebo group in study I. The corresponding figures in study II were -18% and -5%.
Icelandic: Breyting á hundraðshluta (%) „OFF“ tíma frá upphafsgildi var -24% hjá hópnum sem fékk entacapon og 0% hjá hópnum sem fékk lyfleysu, í rannsókn I. Samsvarandi gildi í rannsókn II voru -18% og -5%.
English: Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Icelandic: Entacapon getur litað þvag rauðbrúnt en þetta er skaðlaust fyrirbæri.
English: The bioavailability of entacapone is about 35% after an oral dose.
Icelandic: Aðgengi entacapons er um 35% eftir inntöku.
English: After taking one of them, wait at least 2 to 3 hours before taking the other.
Icelandic: Látið að minnsta kosti 2 til 3 klst.
English: (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Icelandic: Mjög algengar (≥1/10); algengar (≥1/100 til <1/10); sjaldgæfar (≥1/1.000 til <1/100); mjög sjaldgæfar (≥1/10.000 til <1/1.000); koma örsjaldan fyrir (<1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum, vegna þess að ekki er hægt að draga marktækar ályktanir af klínískum og faraldsfræðilegum rannsóknum).