FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
Icelandic: Vegna þess að ekki liggja fyrir ítarlegar upplýsingar skal þó íhuga hjartastillingu með rafmagni (non-urgent DC-cardioversion) 24 klst.
English: The antianginal and anti-ischaemic efficacy of ivabradine was studied in five double-blind randomised trials (three versus placebo, and one each versus atenolol and amlodipine).
Icelandic: Verkun ivabradin gegn hjartaöng og blóðþurrð var rannsökuð í fimm tvíblindum slembuðum rannsóknum (í þremur rannsóknum var samanburður við lyfleysu og í hvorri hinna var samanburður við atenolol eða amlodipin).
English: Furthermore as elevated heart rate adversely affects the heart functioning and vital prognosis in patients with chronic heart failure, the specific heart rate lowering action of ivabradine helps to improve the heart functioning and vital prognosis in these patients.
Icelandic: Auk þess hjálpar ivabradin við að bæta hjartastarfsemina og lífshorfur sjúklings með sértækri verkun sem hægir á hjartslætti, því að hraður hjartsláttur hefur neikvæð áhrif á starfsemi hjartans og lífshorfur sjúklinga með langvarandi hjartabilun.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Icelandic: Ef óþol fyrir sykrum hefur verið staðfest skaltu hafa samband við lækninn áður en lyfið er tekið inn.
English: Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Icelandic: - Dauðsfall vegna hjartabilunar - Sjúkrahússinnlögn af öllum orsökum
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Icelandic: ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ:
English: Treatment of chronic heart failure
Icelandic: Meðferð við langvinnri hjartabilun
English: If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily.
Icelandic: Ef hjartsláttartíðni minnkar meðan sjúklingur er á meðferð og er viðvarandi undir 50 slögum á mínútu í hvíld eða ef sjúklingur finnur fyrir einkennum sem tengjast hægslætti, þarf að aðlaga skammtinn niður í næsta lægri skammt hjá sjúklingum sem fá 7,5 mg tvisvar sinnum á sólarhring eða 5 mg tvisvar sinnum á sólarhring.
English: The most common symptom of angina is chest pain or discomfort.
Icelandic: Algengasta einkenni hjartaangar er brjóstverkur eða óþægindi.
English: Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.
Icelandic: Meðferð við einkennum langvarandi áreynsluhjartaangar Ivabradin er ætlað til meðferðar við einkennum langvarandi áreynsluhjartaangar vegna kransæðasjúkdóms hjá fullorðnum með eðlilegan sínustakt og hjartsláttartíðni ≥70 slög/mín.
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Corlentor or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Icelandic: - Lyf sem lengja QT bilið og eru annað hvort notuð við hjartsláttartruflunum eða öðrum sjúkdómum: - kinidin, disopyramid, ibutilid, sotalol, amiodaron (til meðferðar við hjartsláttartruflunum) - bepridil (til meðferðar við hjartaöng) - ákveðnar tegundir lyfja til meðferðar við kvíða, geðklofa eða öðrum geðsjúkdómum (t.d. pimozid, ziprasidon, sertindol) - malaríulyf (t.d. mefloquin eða halofantrin) - erytromycin sem gefið er í bláæð (sýklalyf) - pentamidin (lyf við sníkjudýrum) - cisaprid (við maga-vélindis bakflæði)
English: Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Icelandic: Prótónupumpuhemlar (omeprazol, lansoprazol), sildenafil, HMG CoA reductasahemlar (simvastatin), kalsíumgangalokar af flokki tvíhýdrópýridína (amlodipin, lacidipin), digoxin og warfarin.
English: What Corlentor looks like and contents of the pack Corlentor 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Icelandic: Corlentor 5 mg töflur eru laxableikar, ílangar, filmuhúðaðar töflur með deiliskoru á báðum hliðum, ígrafnar „5“ á annarri hliðinni og á hinni hliðinni.
English: In patients treated with ivabradine the risk of developing atrial fibrillation is increased (see section 4.8).
Icelandic: Hætta á að gáttatif komi fram er aukin hjá sjúklingum sem fá ivabradin (sjá kafla 4.8).
English: At usual recommended doses, heart rate reduction is approximately 10 bpm at rest and during exercise.
Icelandic: Við venjulega ráðlagða skammta lækkar hjartsláttartíðnin um um það bil 10 slög/mín.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB17.
Icelandic: Hjarta-og æðasjúkdómalyf, önnur hjartasjúkdómalyf, ATC flokkur:
English: Grapefruit juice: ivabradine exposure was increased by 2-fold following the co-administration with grapefruit juice.
Icelandic: Útsetning fyrir ivabradini jókst 2-falt í kjölfar samhliða notkunar greipaldinsafa.
English: Glycerol (E 422) Magnesium stearate (E 470 B) Yellow iron oxide (E172) Red iron oxide (E172)
Icelandic: Gult járnoxíð (E172) Rautt járnoxíð (E172)
English: The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation.
Icelandic: Áhrifin á hjartað eru sértæk á sínushnútinn án áhrifa á leiðnitíma innan gátta, milli gátta og slegla eða innan slegla, á samdráttargetu hjartavöðvans eða endurskautun slegla.
English: As ivabradine may cause bradycardia, the resulting combination of hypokalemia and bradycardia is a predisposing factor to the onset of severe arrhythmias, especially in patients with long QT syndrome, whether congenital or substance-induced.
Icelandic: Þar sem ivabradin getur valdið hægslætti, getur sambland af kalíumskorti og hægslætti af völdum lyfjanna aukið hættu á að alvarlegar hjartsláttartruflanir verði sérstaklega hjá sjúklingum með langt QT bil, hvort sem það er meðfætt eða af völdum lyfja.
English: Patients with renal impairment
Icelandic: Sjúklingar með lágþrýsting
English: Special warnings
Icelandic: Sérstök varnaðarorð
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Icelandic: Laxableik, þríhyrningslaga, filmuhúðuð tafla, ígrafin „7.5“ á annarri hliðinni og á hinni hliðinni.
English: The higher than approved dose used in the study did not fully explain these findings.
Icelandic: Þessar niðurstöður voru ekki að fullu útskýrðar með því að notaðir voru stærri skammtar en samþykktir eru.
English: One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Icelandic: Hver filmuhúðuð tafla inniheldur 5 mg ivabradin (samsvarandi 5,390 mg af ivabradini sem hýdróklóríð).
English: In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other antiplatelet medicinal products.
Icelandic: ACE-hemlar (angiotensin converting enzyme inhibitors), angiotensin II blokkar, beta blokkar, þvagræsilyf, aldosterón-hemlar, stutt- og langverkandi nítröt, HMG CoA reductasahemlar, fíbröt, prótónupumpuhemlar, sykursýkislyf til inntöku, acetýlsalicýlsýra og önnur lyf sem hafa áhrif á blóðflögur.
English: If you think that the effect of Corlentor is too strong or too weak, talk to your doctor or pharmacist.
Icelandic: Leitaðu til læknisins eða lyfjafræðings ef þér finnst áhrifin af Corlentor vera of mikil eða of lítil.
English: Do not take Corlentor if you are breast-feeding (see “Do not take Corlentor”).
Icelandic: Konur með barn á brjósti mega ekki nota Corlentor (sjá „Ekki má nota Corlentor“).
English: When treatment modifications are made in chronic heart failure patients treated with ivabradine blood pressure should be monitored at an appropriate interval (see section 4.8).
Icelandic: Þegar breytingar eru gerðar á meðferð hjá hjartabilunarsjúklingum sem fá meðferð með ivabradini, skal fylgjast með blóðþrýstingi með hæfilegu millibili.
English: After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Icelandic: eða minnka skammt í 2,5 mg tvisvar sinnum á sólarhring (hálf 5 mg tafla tvisvar sinnum á sólarhring) ef hjartsláttartíðni í hvíld er viðvarandi undir 50 slögum á mínútu eða ef vart verður við einkenni sem tengjast hægslætti eins og sundl, þreytu eða lágþrýsting.
English: AV 2nd degree block, AV 3rd degree block Sick sinus syndrome
Icelandic: - Alvarlega skert lifrarstarfsemi - Sjúkur sínus (sick sinus syndrome)
English: Measurement of heart rate
Icelandic: Mæling hjartsláttartíðni
English: See package leaflet for the other excipients.
Icelandic: Lesið fylgiseðilinn fyrir notkun.
English: - Renal impairment: the impact of renal impairment (creatinine clearance from 15 to 60 ml/min) on ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20 %) to total elimination for both ivabradine and its main metabolite S 18982 (see section
Icelandic: Í ljósi þess hve óveruleg nýrnaúthreinsun (um 20%) er af heildarúthreinsun bæði fyrir ivabradin og aðalumbrotsefnið S 18982 eru áhrif skertrar nýrnastarfsemi (úthreinsun creatinins frá 15 til 60 ml/mín.)
English: NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets
Icelandic: HEITI LYFS Corlentor 5 mg filmuhúðaðar töflur.
English: NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets
Icelandic: HEITI LYFS Corlentor 7,5 mg filmuhúðaðar töflur.
English: Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
Icelandic: Hætta skal meðferð ef hjartsláttarhraðinn er áfram undir 50 slögum á mínútu eða ef einkenni hægsláttar eru viðvarandi.
English: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).
Icelandic: Ekki þarf að breyta skammti handa sjúklingum með skerta nýrnastarfsemi og úthreinsun kreatinins yfir 15 ml/mín.
English: If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Icelandic: í hvíld meðan á meðferð stendur eða ef sjúklingurinn finnur fyrir einkennum sem tengjast hægslætti, t.d. sundli, þreytu eða lágþrýstingi, á að minnka skammtinn eða hætta meðferð, ef hjartsláttartíðnin helst lægri en 50 slög/mín.
English: Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1.
Icelandic: Hjálparefni með þekkta verkun: 63,91 mg mjólkursykureinhýdrat.
English: Very rare: Irregular heart beats.
Icelandic: Mjög sjaldgæfar* Roðaþot Kláði
English: It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e.g. in case of exacerbated angina, palpitations, irregular pulse).
Icelandic: Gáttatif hefur verið algengara hjá sjúklingum sem nota samtímis amiodarón eða öflug lyf gegn hjartsláttartruflunum í flokki I. Mælt er með reglulegu klínísku eftirliti með sjúklingum sem nota ivabradin, með tilliti til gáttatifs (viðvarandi eða tilfallandi) og ef við á skal einnig taka hjartalínurit (t.d. við versnandi hjartaöng, hjartsláttarónot, óreglulegan púls).
English: ECG prolonged QT interval * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Icelandic: *Tíðni reiknuð út frá tilkynningum um aukaverkanir í klínískum rannsóknum
English: Przedsiebiorstwo Farmaceutyczne ANPHARM S.A. ul.
Icelandic: Laboratorios Farmacéuticos Rovi, S.A. Tel:
English: After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerated and if resting heart rate remains above 60 bpm, the dose may be increased to the next higher dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Icelandic: Eftir þriggja til fjögurra vikna meðferð má auka skammtinn í næstu skammtastærð hjá sjúklingum sem fá 2,5 mg tvisvar sinnum á sólarhring eða 5 mg tvisvar sinnum á sólarhring ef sjúklingurinn hefur enn einkenni, upphafsskammtur þolist vel og hjartsláttartíðni í hvíld helst hærri en 60 slög/mín.
English: Severe bradycardia should be treated symptomatically in a specialised environment.
Icelandic: Veita á meðferð við alvarlegum hægslætti í samræmi við einkenni og í sérhæfðu umhverfi.
English: NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets ivabradine
Icelandic: Corlentor 5 mg filmuhúðaðar töflur ivabradin
English: NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets ivabradine
Icelandic: Corlentor 7,5 mg filmuhúðaðar töflur ivabradin
English: Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Icelandic: Því má ekki nota ivabradin á meðgöngu (sjá kafla 4.3).
English: Ivabradine should therefore be used with precaution in this population.
Icelandic: Gæta skal varúðar við notkun ivabradins hjá þessum sjúklingahópi.
English: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Icelandic: Hver filmuhúðuð tafla inniheldur 7,5 mg ivabradin (samsvarandi 8,085 mg af ivabradini sem hýdróklóríð).
English: Hypertensive patients requiring blood pressure treatment modifications.
Icelandic: Þegar blóðþrýstingslyfjameðferð er breytt hjá sjúklingum með háþrýsting.
English: Syncope, possibly related to bradycardia
Icelandic: Sundl, líklega tengt hægslætti
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 5 mg ivabradin (jafngildir 5,39 mg sem ivabradinhýdróklóríð)
English: Atrial fibrillation - Cardiac arrhythmias
Icelandic: - Sjúklingar sem eru háðir gangráði (hjartsláttartíðni ákvarðast eingöngu af gangráði) - Hvikul hjartaöng
English: Very rare
Icelandic: Mjög sjaldgæfar:
English: Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Icelandic: Ábendingar ivabradin meðferðar eru: - fyrir fullorðna sem þola ekki beta blokka eða mega ekki nota beta blokka.
English: Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (e.g. myocardial infarction or cardiovascular death ) (see section 5.1).
Icelandic: Ivabradin er eingöngu ætlað til meðferðar við einkennum langvarandi áreynsluhjartaangar þar sem ivabradin hefur engin jákvæð áhrif á afleiðingar kransæðasjúkdóma (t.d. hjartadrep eða dauðsfall af völdum hjarta- og æðasjúkdóms ) (sjá kafla 5.1).
English: Corlentor with food and drink Avoid grapefruit juice during treatment with Corlentor.
Icelandic: Forðast skal neyslu greipaldinsafa þann tíma sem meðferð með Corlentor varir.
English: Phosphenes were generally reported to be of mild to moderate intensity.
Icelandic: Yfirleitt voru ljóssýnir sem greint var frá vægar til í meðallagi slæmar.
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Icelandic: Ivabradin hefur ekki áhrif á leiðni innan hjartans, samdráttargetu (engin neikvæð inotropic áhrif) eða endurskautun slegla:
English: Diplopia Visual impairment
Icelandic: Ógleði Hægðatregða Niðurgangur
English: Uncommon*
Icelandic: Kviðverkur*
English: The main efficacy criterion was the composite of cardiovascular death or non-fatal MI.
Icelandic: Samsettur aðalendapunktur fyrir virkni var dauðsfall af völdum hjarta- og æðasjúkdóms og tilvik hjartadreps sem ekki leiddi til dauða.
English: Eosinophilia
Icelandic: B. FYLGISEÐILL
English: The reduction in the primary endpoint was observed consistently irrespective of gender, NYHA class, ischaemic or non-ischaemic heart failure aetiology and of background history of diabetes or hypertension.
Icelandic: Lækkun í tíðni aðalendapunkts rannsóknarinnar kom ávallt fram óháð kyni, NYHA flokki, hvort hjartabilun var vegna blóðþurrðar eða annarra orsaka eða hvort undirliggjandi var saga um sykursýki eða háþrýsting.
English: Temporary cardiac electrical pacing may be instituted if required.
Icelandic: Ef þess gerist þörf má hefja tímabundna notkun hjartagangráðs.
English: Animal studies indicate that ivabradine is excreted in milk.
Icelandic: Dýrarannsóknir benda til að ivabradin skiljist út í brjóstamjólk.
English: Special population
Icelandic: Aldraðir einstaklingar
English: If heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Icelandic: Ef hjartsláttartíðni eykst hjá sjúklingum sem fá 2,5 mg tvisvar sinnum á sólarhring eða 5 mg tvisvar sinnum á sólarhring og er viðvarandi yfir 60 slögum á mínútu í hvíld, má aðlaga skammtinn upp í næstu efri skammtamörk.
English: Under triggering circumstances (e.g. rapid changes in luminosity), partial inhibition of Ih by ivabradine underlies the luminous phenomena that may be occasionally experienced by patients.
Icelandic: Hlutahömlun Ih af völdum ivabradins liggur að baki ljósfyrirbæris sem sjúklingar geta stöku sinnum orðið varir við, við aðstæður sem framkalla þessi viðbrögð (t.d. skyndileg breyting á birtu).
English: Corlentor 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 7,5 mg ivabradin (jafngildir 8,085 mg ivabradinhýdróklóríð)
English: Cardiac disorders
Icelandic: Hjartsláttartruflanir
English: Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Icelandic: - Hjá sjúklingum með skerta starfsemi vinstri slegils (útfallsbrot vinstri slegils (left ventricular ejection fraction (LVEF) á milli 30 og 45%) hafði ivabradin engin skaðleg áhrif á LVEF.
English: Palpitations, supraventricular extrasystoles
Icelandic: Öndunarfæri, brjósthol og miðmæti
English: Servier Pharma SRL Tel: +4 021 528 52 80
Icelandic: Сервие Медикал ЕООД Тел.: +359 2 921 57 00
English: Laboratorios Servier, S.L.
Icelandic: Servier Laboratories (Ireland) Ltd.
English: Asthenia, possibly related to bradycardia Fatigue, possibly related to bradycardia
Icelandic: Þróttleysi, líklega tengt hægslætti Þreyta, líklega tengt hægslætti Mjög sjaldgæfar* Lasleiki, líklega tengt hægslætti
English: Dizziness, possibly related to bradycardia
Icelandic: Yfirlið, líklega tengt hægslætti
English: It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.
Icelandic: Hvorki ætti að hefja né breyta meðferð nema fyrir liggi endurteknar mælingar á hjartsláttarhraða, hjartarafrit eða sólarhrings hjartasíritun.
English: Excipient with known effect: 61.215 mg lactose monohydrate For the full list of excipients, see section 6.1.
Icelandic: 61,215 mg mjólkursykureinhýdrat.
English: Vascular disorders
Icelandic: Ofsabjúgur Útbrot
English: Dyspnoea
Icelandic: Taugakerfi
English: Contra-indication of concomitant use
Icelandic: Samsettur aðalendapunktur rannsóknar
English: Excretion of metabolites occurs to a similar extent via faeces and urine.
Icelandic: Útskilnaður umbrotsefna er í svipuðum mæli í hægðum og þvagi.
English: In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous betastimulating medicinal products such as isoprenaline may be considered.
Icelandic: Hafa má í huga að ef hægsláttur kemur fram með lágu útfalli hjartans getur meðferð við einkennum m.a. falið í sér notkun betaörvandi lyfs t.d. isoprenalins í bláæð.
English: ANNEX II
Icelandic: 4.2 Ábendingar
English: Vaccinate only healthy animals.
Icelandic: Bólusetjið eingöngu heilbrigð dýr.
English: ATC vet code : QI07AO01.
Icelandic: QI07AO01.
English: Allergic-type reactions are rare.
Icelandic: Ofnæmisviðbrögð eru mjög sjaldgæf.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Icelandic: Samkvæmt ákvæðum 71. greinar í tilskipun Evrópuráðsins og þingsins 2001/82/EB með viðaukum bannar viðkomandi land eða getur bannað innflutning, sölu, birgðahald og/eða notkun dýralyfsins á ákveðnu landssvæði eða öllu landinu ef sýnt er fram á að:
English: Duration of immunity: 1 year after the last (re-)vaccination.
Icelandic: 1 ár eftir síðustu (endur-)bólusetningu.
English: 13th Klm National Road Athens-Lamia 14452 Metamorfosi Athens - GREECE
Icelandic: 13th Klm National Road Athens-Lamia 14452
English: Marketing authorisation holder and manufacturer:
Icelandic: Markaðsleyfishafi og framleiðandi:
English: Sodium chloride 9 mg/ml (0.9%)
Icelandic: Natríumklóríð 9 mg/ml (0,9%)