FrancophonIA/ELRC3.0 huggingface dataset:
English: In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN during treatment, but one case of hepatitis occurred 3 days after the end of bosentan treatment.
Icelandic: Í rannsókn FUTURE-4 þar sem 13 nýburar með langvinnan lungnaháþrýsting fengu 2 mg/kg af bósentani tvisvar á dag í styttri tíma en 10 daga (á bilinu 0,5-10,0 dagar) voru engin tilvik um lifraramínótransferasa ≥
English: Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Icelandic: Ekki má gefa Tracleer og cíklósporín A (kalsíneurínhemil) samhliða (sjá kafla 4.3).
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with Tracleer.
Icelandic: sírólímus eða takrólímus sem eru lyf sem notuð eru eftir ígræðslu, þar sem ekki er mælt með að nota þau með Tracleer.
English: If the aminotransferase levels return to pre-treatment values reintroducing Tracleer according to the conditions described below should be considered.
Icelandic: Ef amínótransferasagildi breytast aftur í sömu gildi og fyrir meðferð skal íhuga að hefja aftur Tracleer meðferð í samræmi við þau skilyrði sem lýst er hér að neðan.
English: Mar ______
Icelandic: Mars ______
English: In a pharmacokinetic crossover study (AC-052-116), 16 healthy adult subjects received 62.5 mg bosentan using the 62.5 mg film-coated tablet formulation or 64 mg bosentan using the 32 mg dispersible tablet formulation.
Icelandic: 16 heilbrigðir einstaklingar 62,5 mg af bósentani annaðhvort með 62,5 mg í filmuhúðuðu töfluformi eða með 64 mg í 32 mg dreifitöfluformi.
English: Concomitant use of rifampicin and Tracleer is not recommended.
Icelandic: Ekki er mælt með samhliða notkun á rífampícíni og Tracleer.
English: What Tracleer looks like and contents of the pack
Icelandic: Lýsing á útliti Tracleer og pakkningastærðir
English: Discontinuation of treatment
Icelandic: Áhrif meðferðar
English: Cartons contain 14, 56 or
Icelandic: Öskjur með 14, 56 eða 112
English: Consequently, should signs of pulmonary oedema occur when Tracleer is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.
Icelandic: Ef einkenni lungnabjúgs koma fram þegar Tracleer er gefið sjúklingum með lungnaháþrýsting á því að íhuga möguleika á tengdum teppusjúkdómi í lungnabláæðum.
English: In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases ≥ 3 × ULN were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients.
Icelandic: Í heildarniðurstöðum úr 20 samanburðarrannsóknum með lyfleysu kom fram aukning á lifraramínótransferösum ≥ 3 sinnum efri eðlileg mörk (ULN, upper limit of normal) í 11,2% af sjúklingum meðhöndluðum með bósentani, miðað við 2,4% af sjúklingum sem fengu lyfleysu.
English: Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Icelandic: Tracleer 62,5 mg filmuhúðaðar töflur eru appelsínugular-hvítar, kringlóttar, filmuhúðaðar töflur, með „62,5” á annarri hliðinni.
English: Cartons contain 14, 56 or 112 film-coated tablets.
Icelandic: 14, 56 eða 112 filmuhúðaðar töflur.
English: CARTON WITH 56 TABLETS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 56 TÖFLUM
English: Jul ______
Icelandic: Júlí ______
English: There is limited experience with abrupt discontinuation of Tracleer in patients with PAH.
Icelandic: Takmörkuð reynsla er af því að hætta skyndilega meðferð með Tracleer hjá sjúklingum með lungnaháþrýsting.
English: The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant Tracleer treatment.
Icelandic: Aðlaga getur þurft skammta þessara lyfja eftir að samhliða meðferð með Tracleer er hafin, skammti breytt eða henni hætt.
English: Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets
Icelandic: Tracleer 62,5 mg filmuhúðaðar töflur Tracleer 125 mg filmuhúðaðar töflur
English: How to take Tracleer.
Icelandic: Hvernig nota á Tracleer
English: There are no studies to demonstrate beneficial effects of Tracleer treatment on survival.
Icelandic: Ekki hefur verið sýnt fram á með rannsóknum að meðferð með Tracleer hafi jákvæð áhrif á lifun.
English: Therefore, you must not take Tracleer if you are pregnant and you must also not become pregnant while taking Tracleer.
Icelandic: Tracleer ef þú ert þunguð og þú mátt ekki heldur verða þunguð á meðan þú tekur Tracleer.
English: The efficacy of Tracleer has not been established in patients with severe PAH.
Icelandic: Virkni Tracleer hefur ekki verið staðfest í sjúklingum með háþrýsting í lungnaslagæð á alvarlegu stigi.
English: film-coated tablets (Tracleer 125 mg film-coated tablets).
Icelandic: filmuhúðuðum töflum (Tracleer 125 mg filmuhúðaðar töflur).
English: • if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis) If any of these apply to you, tell your doctor.
Icelandic: ef þú tekur cíklósporín A (lyf sem notað er eftir ígræðslu eða til að meðhöndla psóríasis)
English: Tracleer 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Icelandic: Tracleer 125 mg filmuhúðaðar töflur eru appelsínugular-hvítar, sporöskjulagaðar, filmuhúðaðar töflur, með „125” á annarri hliðinni.
English: Tracleer contains sodium
Icelandic: Tracleer inniheldur natríum
English: If you take more Tracleer than you should
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 14, 56 AND 112 TABLETS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 14, 56 OG 112 TÖFLUM
English: If you stop taking Tracleer
Icelandic: Ef hætt er að nota Tracleer
English: In adult patients, Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Icelandic: Hjá fullorðnum sjúklingum skal hefja meðferð með Tracleer með 62,5 mg skammti tvisvar á dag í 4 vikur og síðan auka í viðhaldsskammt, 125 mg tvisvar á dag.
English: Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Icelandic: Öskjur sem innihalda 56 filmuhúðaðar töflur (Tracleer 62,5 mg filmuhúðaðar töflur).
English: Tracleer 62.5 mg tablets bosentan
Icelandic: Tracleer 62,5 mg töflur bósentan
English: Your monthly liver blood test schedule:
Icelandic: Áætlun um mánaðarlegar blóðprufur til að kanna lifrarástand
English: Cartons contain 56 or 112 film-coated tablets.
Icelandic: 56 eða 112 filmuhúðaðar töflur.
English: 112 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Icelandic: filmuhúðuðum töflum (Tracleer 62,5 mg filmuhúðaðar töflur).
English: Contents of the pack and other information What Tracleer contains
Icelandic: Hugsanlegar aukaverkanir Hvernig geyma á Tracleer Pakkningar og aðrar upplýsingar
English: Cartons contain 56 film-coated tablets (Tracleer 125 mg film-coated tablets).
Icelandic: Öskjur sem innihalda 56 filmuhúðaðar töflur (Tracleer 125 mg filmuhúðaðar töflur).
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Icelandic: Einungis læknir með reynslu af meðferð herslismeina skal hefja og hafa eftirlit með meðferð.
English: Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Icelandic: Meðferð með Tracleer skal hafin með 62,5 mg skammti tvisvar á dag í 4 vikur og síðan auka í viðhaldsskammt, 125 mg tvisvar á dag.
English: Tracleer 125 mg tablets bosentan
Icelandic: Tracleer 125 mg töflur bósentan
English: When the tablet has fully dissolved, give the liquid to the patient.
Icelandic: Gefið sjúklingnum vökvann þegar taflan er að fullu uppleyst.
English: No dose adjustment of Tracleer is considered necessary.
Icelandic: Ekki er talin þörf á skammtaaðlögun Tracleer.
English: Breast-feeding is not recommended during treatment with Tracleer.
Icelandic: Brjóstagjöf er ekki ráðlögð samhliða Tracleer meðferð.
English: Systemic sclerosis with ongoing digital ulcer disease Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Icelandic: Einungis læknir með reynslu af meðferð lungnaháþrýstings skal hefja og hafa eftirlit með meðferð.
English: Package leaflet: Information for the user Tracleer 32 mg dispersible tablets
Icelandic: Upplýsingar fyrir notanda lyfsins Tracleer 32 mg dreifitöflur
English: For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C.
Icelandic: Fyrir PVC/PE/PVDC/álþynnupakkningar:
English: The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Icelandic: Samhliða gjöf simvastatíns hafði ekki áhrif á blóðvökvasþéttni bósentans.
English: Treatment with Tracleer should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Icelandic: Einungis læknir með reynslu af meðferð lungnaháþrýstings eða herslismeins skal hefja og hafa eftirlit með meðferð með Tracleer.
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with Tracleer should be avoided (see section 4.5).
Icelandic: Forðast skyldi samhliða gjöf Tracleer og bæði CYP3A4 hemils og CYP2C9 hemils (sjá kafla 4.5).
English: Tracleer 125 mg film-coated tablets bosentan
Icelandic: Tracleer 125 mg filmuhúðaðar töflur bósentan
English: Comparison between formulations
Icelandic: Samanburður á töfluformum
English: • Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function) Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Icelandic: Einnig hefur verið tilkynnt um þokusýn en tíðni hennar er óþekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: If necessary the dispersible tablet can be divided along the break-marks.
Icelandic: Ef nauðsyn krefur má skipta dreifitöflunni eftir brotalínunum.
English: Each dispersible tablet contains 32 mg of bosentan (as monohydrate).
Icelandic: Hver dreifitafla inniheldur 32 mg af bósentani (sem einhýdrat).
English: Tracleer 62.5 mg film-coated tablets bosentan
Icelandic: Tracleer 62,5 mg filmuhúðaðar töflur bósentan
English: OUTER CARTON & BOTTLE LABEL/ BOTTLES
Icelandic: YTRI ASKJA OG MERKIMIÐI Á GLÖSUM/ GLÖS
English: Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica colloidal anhydrous Tartaric acid
Icelandic: Örkristallaður sellulósi Vatnsfrítt kalsíumhýdrógenfosfat
English: Each dispersible tablet contains 32 mg bosentan (as monohydrate)
Icelandic: Hver dreifitafla inniheldur 32 mg bósentan (sem einhýdrat)
English: Package leaflet: Information for the user Tracleer 62.5 mg film-coated tablets
Icelandic: Upplýsingar fyrir notanda lyfsins Tracleer 62,5 mg filmuhúðaðar töflur
English: Frequency
Icelandic: Heildarbreyting
English: Tracleer is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Icelandic: Lyfjahvörf bósentans hafa ekki verið rannsökuð hjá sjúklingum með skerta lifrarstarfsemi í Child-Pugh flokki C. Ekki má nota Tracleer hjá sjúklingum með í meðallagi skerta eða alvarlega skerta lifrarstarfsemi, þ.e. Child-Pugh flokk B eða C (sjá kafla 4.3).
English: Тел.
Icelandic: Okt.
English: Package leaflet: Information for the user Tracleer 125 mg film-coated tablets
Icelandic: Upplýsingar fyrir notanda lyfsins Tracleer 125 mg filmuhúðaðar töflur
English: Cartons contain 56 dispersible tablets.
Icelandic: Öskjur sem innihalda 56 dreifitöflur.
English: Recommendations in the event of ALT/AST elevations
Icelandic: Ráðlögð viðbrögð við ALAT/ASAT aukningu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 TABLETS
Icelandic: YTRI UMBÚÐUM OG INNRI UMBÚÐUM ASKJA MEÐ 56 TÖFLUM
English: Blood tests for liver function
Icelandic: Blóðrannsóknir til að kanna lifrarstarfsemi
English: Tracleer 32 mg dispersible tablets bosentan
Icelandic: Tracleer 32 mg dreifitöflur bósentan
English: Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets.
Icelandic: Fletti-þrýstiþynnur sem innihalda 14 dreifitöflur, öskjur innihalda 56 dreifitöflur.
English: The PAH for which Tracleer is indicated can be:
Icelandic: Tracleer er ætlað fyrir lungnaháþrýsting sem getur verið:
English: Tracleer 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Icelandic: Appelsínugular-hvítar, sporöskjulaga, tvíkúptar, filmuhúðaðar töflur, stimplaðar með „125” öðrum megin.
English: Jun ______
Icelandic: Júní ______
English: Tracleer 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Icelandic: Appelsínugular-hvítar, kringlóttar, tvíkúptar, filmuhúðaðar töflur, stimplaðar með „62,5” öðrum megin.
English: Tracleer 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 125 mg bósentani (sem einhýdrat).
English: The pharmacokinetics of bosentan have not been studied in patients with Child-Pugh class C hepatic impairment.
Icelandic: Lyfjahvörf bósentans hafa ekki verið rannsökuð hjá sjúklingum með skerta lifrarstarfsemi í ChildPugh flokki C. Ekki má nota Tracleer hjá sjúklingum með í meðallagi skerta eða alvarlega skerta lifrarstarfsemi, þ.e. Child-Pugh flokk B eða C (sjá kafla 4.3).
English: Tracleer 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 62,5 mg bósentani (sem einhýdrat).
English: Baseline (BL); mean (SD) Change from BL; mean (SD) Treatment effects 95% CL
Icelandic: Breyting frá GG; meðaltal (SD)
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking Tracleer.
Icelandic: Notaðu örugga tegund getnaðarvarna meðan þú tekur Tracleer, ef þú getur mögulega orðið þunguð.
English: Tracleer 32 mg dispersible tablets
Icelandic: Tracleer 32 mg dreifitöflur
English: ALT/AST levels
Icelandic: YTRI ASKJA/ÞYNNUR
English: Dispersible tablet:
Icelandic: Húð á töflu:
English: • Gastrooesophageal reflux disease (acid reflux)
Icelandic: Skorpulifur, lifrarbilun (alvarleg truflun á lifrarstarfsemi)
English: This may be harmful for people with phenylketonuria.
Icelandic: Getur verið skaðlegt þeim sem hafa fenýlketónmigu.
English: Perlinring 0,120 mg/0,015 mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer
Icelandic: 0,120 mg/0,015 mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer
English: Pirlinring 0,120 mg/0,015 mg for cada 24 horas, sistema de liberación vaginal
Icelandic: 0,120 mg/0,015 mg for cada 24 horas, sistema de liberación vaginal
English: Perlinring 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
Icelandic: 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik
English: Perlinring 0,120 mg/0,015 mg pro 24 Stunden - Vaginalring
Icelandic: Perlinring 0,120 mg/0,015 mg pro 24 StundenVaginalring
English: Annex I List of medicinal products and presentations
Icelandic: Viðauki I Listi yfir landsvísu leyfi lyfja.
English: EU/2/19/239/001 Baycox Iron
Icelandic: EU/2/19/239/001 Baycox Iron 36 mg/ml / 182 mg/ml
English: Vial (glass) 100 ml
Icelandic: 100 ml hettuglas
English: Meat and offal: 53 days
Icelandic: 53 dagar
English: Piglets
Icelandic: Sérheiti
English: Immediate packaging
Icelandic: Umbúðir Innihald Pakkningastærð
English: Intramuscular use
Icelandic: Stungulyf, dreifa Grísir
English: EU/1/11/741/001 Levetiracetam SUN 100 mg/ml
Icelandic: EU/1/11/741/001
English: Intravenous use vial (glass) 5 ml
Icelandic: 5 ml
English: Wash hands after use.
Icelandic: Hendur skal þvo eftir notkun.
English: Date of first authorisation: 09/12/2015
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 09/12/2015
English: Velactis reduces milk production.
Icelandic: Velactis minnkar mjólkurframleiðslu.
English: More than 74% of cabergoline is bound to plasma protein.
Icelandic: Próteinbinding cabergolins í plasma er yfir 74%.
English: Liver Kidney Muscle Milk
Icelandic: Fita Lifur Nýru Vöðvi Mjólk
English: Do not use after the expiry date which is stated on the carton after EXP.
Icelandic: Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni á eftir EXP.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/192/001-004
Icelandic: MARKAÐSLEYFISNÚMER EU/2/15/192/001-004
English: - 4 days (8 milkings) after calving when the dry period length is less than 32 days
Icelandic: - 4 dagar (8 mjaltir) eftir burð þegar geldstöðutímabilið er innan við 32 dagar.
English: Only use a dry sterile needle and avoid the introduction of humidity/water during use.
Icelandic: Aðeins skal nota þurra sæfða nál og forðast raka-/vatn við notkun.
English: Active substance: Cabergoline ....................................................................... 1.12 mg
Icelandic: Cabergolin.........................................................................1,12 mg Hjálparefni:
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use
Icelandic: SÉRSTÖK VARNAÐARORÐ, EF ÞÖRF KREFUR Lesið fylgiseðilinn fyrir notkun
English: Cabergoline should not enter surface waters as it has harmful effects on aquatic species.
Icelandic: Cabergolin má ekki komast í snertingu við yfirborðsvatn vegna þess að það hefur skaðleg áhrif á vatnalífverur.
English: This was observed following 1.5-2 times of the recommended dose and was more pronounced at higher doses.
Icelandic: Þetta kom fram eftir gjöf á 1,5-2 földum ráðlögðum skammti og var greinilegra við stærri skammta.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS Ítarlegar upplýsingar um þetta dýralyf eru birtar á heimasíðu Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Icelandic: Tíðni aukaverkana er skilgreind samkvæmt eftirfarandi: - mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10 dýrum í hverri meðferð) - algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100 dýrum) - sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 1.000 dýrum) - mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum) - koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000 dýrum, þ.m.t. einstök tilvik)
English: Cattle (dairy cows)
Icelandic: Nautgripir (mjólkurkýr)
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Icelandic: Hjálparefnin sem talin eru upp í kafla 6.1 í samantekt á eiginleikum lyfsins eru ýmist leyfð innihaldsefni sem ekki þurfa gildi fyrir hámark lyfjaleifa samkvæmt töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010 eða talin falla utan reglugerðar (EB) nr. 470/2009 þegar þau eru notuð eins og í þessu dýralyfi.
English: (There are no data on pregnancy outcome in humans following injection of cabergoline, but studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.)
Icelandic: (Engar upplýsingar um áhrif cabergolins á meðgöngu hjá konum í kjölfar inndælingar með cabergolini liggja fyrir, en hætta á fósturdauða hefur komið fram í dýrarannsóknum eftir endurtekna útsetningu fyrir cabergolini eftir inntöku.)
English: Brown glass vials closed by bromobutyl stoppers and crimped with aluminium and plastic flip capsules.
Icelandic: Brún hettuglös úr gleri, lokuð með brómóbútýltöppum og álhettum með plastflipa.
English: Cabergoline is a synthetic ergot derivative, which is a potent dopamine receptor agonist on D2 receptors.
Icelandic: Cabergolin er samtengd ergotafleiða, sem er öflugur dópamínviðtakaörvi fyrir D2 viðtaka.
English: Excipients: For the full list of excipients, see section 6.1
Icelandic: Sjá lista yfir öll hjálparefni í kafla 6.1.
English: Three consecutive administrations of 1, 3 or 5 times the recommended dose may result in transient and reversible slight elevation of plasma glucose levels.
Icelandic: Þrjár gjafir í röð af 1, 3 eða 5 földum ráðlögðum skammti geta valdið svolítilli, skammvinnri og afturkræfri hækkun á plasmaþéttni glúkósa.
English: Cardboard box with 1 vial of 5 ml, 25 ml or 50 ml, or 5 vials of 5 ml.
Icelandic: Pappaaskja með 1 hettuglasi með 5 ml, 25 ml eða 50 ml eða 5 hettuglösum með 5 ml.
English: WITHDRAWAL PERIOD Withdrawal period: See box
Icelandic: BIÐTÍMI FYRIR AFURÐANÝTINGU Biðtími: Sjá öskju
English: This could theoretically decrease the metabolisation of cabergoline, and prolong its persistence in plasma from cows treated concomitantly with Velactis and such products.
Icelandic: Þetta gæti fræðilega séð skert umbrot cabergolins og lengt tímann sem það er til staðar í plasma hjá kúm í meðferð með Velactis og slíkum lyfjum samhliða.
English: Cabergoline Bovine 0.10 µg/kg 0.25 µg/kg
Icelandic: 0,10 µg/kg 0,25 µg/kg 0,50 µg/kg 0,15 µg/kg 0,10 µg/kg
English: The difference between groups was 13.7% (95% confidence interval 6.4-21%).
Icelandic: Munurinn á milli hópanna var 13,7% (95% öryggisbil 6,4-21%).
English: The active substance in Velactis is cabergoline, an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Icelandic: DÝRALYFJALEIFA Virka efnið í Velactis cabergolin, er leyft innihaldsefni samkvæmt lýsingu í töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010:
English: Velactis should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Icelandic: Velactis má ekki berast í vötn, ár eða læki þar sem það kann að vera skaðlegt fiski eða öðrum vatnalífverum.
English: The difference between groups was 8.7% (95% confidence interval 4.9-12.6%).
Icelandic: Munurinn á milli hópanna var 8,7% (95% öryggisbil 4,9-12,6%).
English: The product should be injected within 4 hours after the last milking.
Icelandic: Lyfið skal gefa innan 4 klst. frá síðustu mjöltum.
English: Meat and offal: 23 days
Icelandic: 23 dagar Mjólk:
English: The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of solution for injection) per animal in one single injection at the day of drying-off after the last milking.
Icelandic: Ráðlagður skammtur er 5,6 mg af cabergolini (samsvarar 5 ml af stungulyfi, lausn) fyrir hvert dýr í einni stakri inndælingu eftir síðustu mjaltir á fyrsta degi geldstöðu.
English: Due to its pharmacological effect (inhibition of lactation) breastfeeding women should avoid contact with the product.
Icelandic: Vegna lyfjafræðilegra áhrifa lyfsins (hindrun mjólkurframleiðslu) skulu konur með barn á brjósti forðast snertingu við það.
English: The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of Velactis) per animal in one single injection at the day of drying-off after the last milking.
Icelandic: Ráðlagður skammtur er 5,6 mg af cabergolini (samsvarar 5 ml af Velactis) fyrir hvert dýr í einni stakri inndælingu eftir síðustu mjaltir á fyrsta degi geldstöðu.
English: Cabergoline is rapidly metabolized principally by liver, and is eliminated with a mean half-life of about 20 h.
Icelandic: Cabergolin umbrotnar hratt, aðallega í lifur og hverfur brott með meðalhelmingunartíma sem er u.þ.b. 20 klst.