FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not store Epivir above 30
Danish: Tag ikke Epivir
English: • general feeling of being unwell
Danish: • almen utilpashed
English: Pregnancy There are no or limited amount of data from the use of ivabradine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ivabradin til gravide kvinder.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Corlentor in children aged 0 to less than 6 months for the treatment of chronic heart failure.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Corlentor til børn i alderen 0 til under 6 måneder til behandling af kronisk hjerteinsufficiens.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Corlentor in all subsets of the paediatric population for the treatment of angina pectoris.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Corlentor i alle undergrupper af den pædiatriske population med angina pectoris.
English: AV 2nd degree block, AV 3rd degree block Sick sinus syndrome
Danish: Meget sjælden AV-blok af 2. grad, AV-blok af 3. grad Syg sinus-syndrom
English: Corlentor 5 mg film-coated tablets EU/1/05/317/001-007
Danish: Corlentor 5 mg filmovertrukne tabletter EU/1/05/317/001-007
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Corlentor.
Danish: Tal med lægen, hvis De ammer eller ønsker at amme, da amning skal ophøre, hvis De tager Corlentor.
English: Corlentor 7.5 mg film-coated tablets EU/1/05/317/008-014
Danish: Corlentor 7,5 mg filmovertrukne tabletter EU/1/05/317/008-014
English: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3[ years, [3-18[ years and <40 kg and [3-18[
Danish: De gennemsnitlige ivabradindoser som muliggør opnåelse af 20 % reduktion i hjertefrekvens, var hhv.0,13 ± 0,04 mg/kg to gange dagligt; 0,10 ± 0,04 mg/kg to gange dagligt og 4,1 ± 2,2 mg to gange dagligt i aldersgrupperne [1-3[ år, [3-18[ år og <40 kg og [3-18[ år og ≥ 40 kg.
English: nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Danish: Anvendelse til patienter med 2. grads AV-blok Ivabradin kan ikke anbefales til patienter med 2. grads AV-blok.
English: There was an improvement in NYHA class in 37.7% of ivabradine patients versus 25.0% in the placebo group.
Danish: Der var en forbedring i NYHA- klasse hos 37,7% af patienterne i ivabradingruppen mod 25,0 % i placebogruppen.
English: ElderlyIn patients aged 75 years or more, a lower starting dose should be considered (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.
Danish: Hos patienter på 75 år og derover bør det overvejes at starte med en lavere dosis hos disse patienter (2,5 mg to gange daglig, dvs. en halv 5 mg tablet to gange daglig), før dosis om nødvendigt øges.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Corlentor 5 mg film-coated tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Corlentor 5 mg filmovertrukne tabletter
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).
Danish: Det er vigtigt, at De fortæller det til Deres læge, hvis De tager nogle af følgende lægemidler, da det kan blive nødvendigt at justere dosis af Corlentor eller kontrollere Dem nøjere: - fluconazol (mod svampeinfektioner) - rifampicin (antibiotikum) - barbiturater (for søvnforstyrrelser eller epilepsi) - phenytoin (for epilepsi) - Hypericum perforatum eller perikon (naturmedicin for depression) - medicin, der forlænger QT-intervallet i ekg til behandling af enten hjerterytmeforstyrrelser eller andre sygdomme, som f.eks.: - quinidin, disopyramid, ibutilid, sotalol, amiodaron (til behandling af forstyrrelser af hjertets rytme) - bepridil (til behandling af angina pectoris) - visse lægemidler til behandling af angst, skizofreni eller andre alvorlige sindslidelser (fx pimozid, ziprasidon og sertindol) - malariamidler (fx mefloquin eller halofantrin) - intravenøs erythromycin (et antibiotikum) - pentamidin (et lægemiddel mod parasitter) - cisaprid (mod mavesyre-reflux fra mavesæk til spiserør) - nogle typer vanddrivende medicin (diuretika), der kan medføre nedsat kaliumniveau i blodet, såsom furosemid, hydrochlorthiazid, indapamid (anvendt til at behandle ødemer og højt blodtryk).
English: Talk to your doctor or pharmacist before taking Corlentor - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Corlentor - hvis De lider af forstyrrelser i hjertets rytme (uregelmæssig puls, hjertebanken, smerter i brystkassen) eller vedvarende hjerteflimmer (hurtig, meget uregelmæssig puls) eller en abnormitet i elektrokardiogrammet (ekg) kaldet ”lang QT-syndrom” - hvis De har symptomer som træthed, svimmelhed eller kortåndethed (det kan betyde, at Deres hjerte slår for langsomt) - hvis De lider af symptomer på artrieflimren (hvilepulsen er usædvanlig høj (over 110 slag i minuttet) eller uregelmæssig uden nogen tydelig grund, hvilket gør det vanskeligt at måle pulsen) - hvis De for nylig har haft et slagtilfælde (blodprop i hjernen/hjerneblødning) - hvis De lider af lavt blodtryk i let til moderat grad - hvis Deres blodtryk ikke er under kontrol - især efter en ændring i Deres blodtryksbehandling - hvis De lider af alvorligt hjertesvigt eller hjertesvigt med en abnormitet i ekg kaldet ”grenblok” - hvis De lider af en kronisk nethindesygdom i øjet - hvis De lider af moderate leverproblemer - hvis De lider af svære problemer med nyrerne Hvis noget af ovenstående gælder for Dem, skal De straks tale med Deres læge om det, før eller mens De tager Corlentor.
English: Package leaflet: information for the patient Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets ivabradine
Danish: Indlægsseddel: Information til patienten Corlentor 5 mg filmovertrukne tabletter Corlentor 7,5 mg filmovertrukne tabletter ivabradin
English: Corlentor 7.5 mg film-coated tablets
Danish: Corlentor 7,5 mg filmovertrukne tabletter
English: Corlentor 5 mg film-coated tablets
Danish: Corlentor 5 mg filmovertrukne tabletter
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heartbeat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Danish: Tag ikke Corlentor - hvis De er allergisk over for ivabradin eller et af de øvrige indholdsstoffer i Corlentor (angivet i punkt 6) - hvis Deres hjertefrekvens i hvile før behandlingen er for langsom (under 70 slag i minuttet) - hvis De lider af kardiogent shock (en hjertesygdom, som skal behandles på hospital) - hvis De lider af forstyrrelser i hjertets rytme - hvis De får et hjerteanfald - hvis De lider af meget lavt blodtryk - hvis De lider af ustabil hjertekrampe (en alvorlig form med hyppige brystsmerter, der opstår både under hvile og anstrengelse) - hvis De lider af hjertesvigt, og Deres tilstand for nylig er forværret - hvis Deres hjerterytme udelukkende styres af en pacemaker - hvis De lider af svære leverproblemer - hvis De allerede tager medicin til behandling af svampeinfektioner (fx ketoconazol,
English: In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
Danish: [0,74;1,28]) eller på de sekundære endepunkter inklusive indlæggelse for tiltagende hjerteinsufficiens (hazard ratio: 0,79; 95 % KI [0,56;1,10]) eller død pga. hjerteinsufficiens (hazard ratio: 0,69; 95% KI [0,31;1,53]).
English: Ventricular extrasystoles Atrial fibrillation
Danish: Ventrikulære ekstrasystoler
English: The starting dose should not exceed one tablet of Corlentor 5 mg twice daily.
Danish: Hvis De bliver behandlet for stabil angina pectoris Startdosis bør ikke være mere end en Corlentor-tablet på 5 mg to gange dagligt.
English: Corlentor 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Danish: Corlentor indeholder: - Aktivt stof: ivabradin (som hydrochlorid) Corlentor 5 mg: En filmovertrukket tablet indeholder 5 mg ivabradin (hvilket svarer til 5,390 mg ivabradin som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Corlentor 5 mg filmovertrukne tabletter Corlentor 7,5 mg filmovertrukne tabletter
English: In such cases, an appropriate symptomatic treatment should be administered.
Danish: I sådanne tilfælde bør en passende symptomatisk behandling administreres.
English: The animal should be revaccinated 3 weeks later with the same dose.
Danish: Dyret bør revaccineres 3 uger senere med samme dosis.
English: Recommended vaccination programme:
Danish: Anbefalet vaccinationsplan:
English: Vaccination might very rarely cause hypersensitivity reactions.
Danish: Vaccination kan meget sjældent forårsage overfølsomhedsreaktioner.
English: Cattle (calves and adult cows).
Danish: Kvæg (kalve og voksent kvæg).
English: This transient rise in temperature is spontaneously resolved within 48 hours without treatment and it is not related to a febrile process.
Danish: Denne forbigående temperaturstigning forsvinder spontant inden for 48 timer uden behandling og er ikke relateret til en febril proces.
English: This slight swelling lasts for less than 24 hours in most cases.
Danish: Denne lette hævelse varer i de fleste tilfælde mindre end 24 timer.
English: Diagnostic tools designed to detect gE antibodies should be suitable for this purpose.
Danish: Diagnostiske redskaber beregnet til detektering af gE-antistoffer bør være egnede til dette formål.
English: Date of first authorisation: 27/01/2011 Date of last renewal: 06/11/2015
Danish: Dato for første markedsføringstilladelse: 27/01/2011 Dato for seneste fornyelse af markedsføringstilladelse: 06/11/2015
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Danish: Det aktive stof, der principielt er af biologisk oprindelse, der skal fremkalde en aktivitet, er ikke i anvendelsesområdet for forordning (EC) 470/2009.
English: The manufacture, import, possession, sale, supply and/or use of HIPRABOVIS IBR MARKER LIVE may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af HIPRABOVIS IBR MARKER LIVE er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: Avoid the introduction of contamination during reconstitution and use.
Danish: Undgå kontaminering under rekonstitution og anvendelse.
English: A slight increase in body temperature up to 1 °C is common within 4 days following vaccination.
Danish: En let stigning i kropstemperatur på op til 1 °C er almindelig inden for 4 dage efter vaccinationen.
English: The tk deletion is related to reduced viral neurotropism and reduced establishment of latency.
Danish: Tk-deletion er relateret til reduceret viral neurotropisme og reduceret etablering af latens.
English: Do not use after the expiry date (EXP) stated on the box and the label.
Danish: Må ikke anvendes efter den udløbsdato, der er angivet på boks og etiketten.
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 product.
Danish: De hjælpestoffer,der er anført i punkt 6.1 i produktresumeet er enten tilladte stoffer for hvilke Tabel 1 i annexet til Kommission Regulativ (EU) Nr. 37/2010 indikerer, at der ikke kræves nogen MRL eller anses for ikke at være omfattet af Regulativ (EC) Nr. 470/2009, når det er anvendt som i dette produkt.
English: Thereafter a single booster dose of 2 ml should be administered every six months.
Danish: Derefter bør en enkelt booster-dosis à 2 ml indgives hver sjette måned.
English: Any person intending to manufacture, import, possess, sell, supply and/or use of HIPRABOVIS IBR MARKER LIVE must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende HIPRABOVIS IBR MARKER LIVE, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: Keep the bottles in the box in order to protect from light.
Danish: Hætteglassene opbevares i den boks beskyttet mod lys.
English: 10 ml 50 ml 60 ml
Danish: 50 ml 60 ml
English: A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination.
Danish: Forbigående betændelse på injektionsstedet er almindelig hos kvæg i op til 72 timer efter vaccination.
English: The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal.
Danish: Anbefalet startdosis er 1 injektion à 2 ml rekonstitueret vaccine pr. dyr.
English: BATCH NUMBER
Danish: Batch nummer
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Danish: Må ikke blandes med andre lægemidler til dyr, undtagen med den medfølgende solvens til brug sammen med lægemidlet.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller ét eller flere af hjælpestofferne.
English: Use only sterile needles and syringes for administration.
Danish: Brug kun sterile nåle og sprøjter til indgivelse.
English: Cattle: from the age of 3 months onwards.
Danish: Kvæg: fra 3 måneder og derover.
English: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPAIN
Danish: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPANIEN
English: Commonly, an increase in rectal temperature up to 1.63 ºC in adult cows and up to 2.18 ºC in calves may be observed.
Danish: Der kan almindeligt observeres en rektal temperaturstigning på op til 1,63 ºC hos voksent kvæg og op til 2,18 ºC hos kalve.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr: Kun raske dyr bør vaccineres.
English: 5 doses 25 doses 30 doses
Danish: 5 doser 25 doser 30 doser
English: Shelf-life after reconstitution according to directions: 6 hours.
Danish: Opbevaringstid efter rekonstitution i henhold til anvisningerne: 6 timer.
English: Very rare adverse reactions:
Danish: Meget sjælden bivirkninger:
English: Cattle from the age of 3 months onwards.
Danish: Kvæg fra 3 måneder og derover.
English: Solvent: Colourless type I glass bottle (10 ml) or Type II glass bottle (50 ml or 100 ml containing 60 ml of solvent) or PET bottles (10, 50 or 100 ml containing 60 ml of solvent) closed with a bromobutyl rubber closure and an aluminium cap.
Danish: Solvens: Farveløse type I-hætteglas (10 ml) eller Type II-hætteglas (50 ml) eller 100 ml indeholdende 60 ml af solvens) af PET flasker (10, 50 af 100 ml indeholdende 60 ml af solvens) med brombutylgummiprop og aluminiumskapsel.
English: To stimulate active immunity against bovine herpesvirus type 1 (BoHV-1) in cattle.
Danish: Til stimulering af aktiv immunitet mod bovint herpesvirustype 1 (BoHV-1) hos kvæg.
English: The absence of the gene coding for the gE surface protein entails that the vaccine does not elicit antibodies to glycoprotein E of BoHV-1 (marker vaccine).
Danish: .Fravær af genet, der koder for gE-overfladeproteinet indebærer, at vaccinen ikke eliminerer antistoffer mod glycoprotein E af BoHV-1 (markør-vaccine).
English: The vaccine contains a BoHV-1 strain (CEDDEL strain) that is double deleted within the genes coding for the gE surface protein and the tk enzyme.
Danish: Vaccinen indeholder en BoHV-1-stamme (CEDDEL-stamme), der er dobbelt-deleteret i generne, der koder for gE-overfladeproteinet og tk-enzymet.
English: Reconstitute the lyophilisate with the entire contents of the supplied solvent to obtain a suspension for injection.
Danish: Den lyofilisat rekonstitueres med hele indholdet af den medfølgende solvens for at opnå en suspension til injektion.
English: This enables discrimination between cattle vaccinated with this vaccine and cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines.
Danish: Dette muliggør skelnen mellem kvæg, der er vaccineret med denne vaccine, og kvæg, der er inficeret med BoHV-1naturligt forekommende virus eller vaccineret med konventionelle ikke-markør BoHV-1-vacciner.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 5 AND 25 DOSES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTONÆSKE: 5 OG 25 DOSER
English: Solvent of 30 doses: Do not store and transport above 25 ºC.
Danish: Solvens af 30 doser: Må ikke Opbevares og transporteres opbevares over 25°C.
English: Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus.
Danish: Vaccinerede dyr kan adskilles fra dyr, der er inficerede med naturligt forekommende virus, ved markørdeletion (gE-) ved hjælp af kommercielle diagnostiske kits, medmindre dyrene tidligere er vaccinerede med en konventionel vaccine eller inficerede med naturligt forekommende virus.
English: Solvent for HIPRABOVIS IBR MARKER LIVE
Danish: Solvens til HIPRABOVIS IBR MARKER LIVE
English: Tel. +34 972 430660
Danish: Tel. +34 972 43 06 60 Fax.
English: Duration of immunity: 6 months after completion of the basic vaccination.
Danish: Varighed af immunitet: 6 måneder efter afslutning af den grundlæggende vaccination.
English: Onset of immunity: 21 days after completion of the basic vaccination scheme.
Danish: Indtræden af immunitet: 21 dage efter afslutning af den grundlæggende vaccinationsplan.
English: The solvent should be allowed to warm to a temperature between 15 ºC and 20 ºC before reconstitution of the lyophilisate.
Danish: Solvensen bør opvarmes til en temperatur på mellem 15 ºC og 20 ºC før rekonstitution af den lyofilisat.
English: Solvent: Phosphate buffer solution.
Danish: Solvens: Phosphatbufferopløsning
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles.
Danish: Der indgives en dosis på 2 ml ved intramuskulær injektion i halsmusklerne.
English: Animals exposed to gE surface protein will test positive (i.e. cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) but unexposed animals will test negative (i.e. non-infected animals, including those vaccinated with HIPRABOVIS IBR MARKER LIVE).
Danish: Dyr eksponeret for gE-overfladeproteinet vil blive testet positive (dvs. kvæg, der er inficeret med BoHV-1naturligt forekommende virus eller vaccineret med konventionelle ikke-markør BoHV-1-vacciner), men ikke-eksponerede dyr vil blive testet negative (dvs. ikke-inficerede dyr, herunder dyr vaccineret med Hiprabovis IBR Marker Live).
English: The solvent should be allowed to warm to a temperature between 15 and 20 ºC before reconstitution of the lyophilisate.
Danish: Solvensen bør opvarmes til en temperatur på mellem 15 og 20 ºC før rekonstitution af den lyofilisat.
English: Duration of immunity: 6 months after completion of the basic vaccination scheme.
Danish: Varighed af immunitet: 6 måneder efter afslutning af den grundlæggende vaccinationsplan.
English: Animals vaccinated with HIPRABOVIS IBR MARKER LIVE will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of antibodies to any other BoHV-1 antigens.
Danish: Dyr vaccineret med Hiprabovis IBR Marker Live vil blive testet positive (sammen med kvæg, der er inficeret med BoHV-1-naturligt forekommende virus eller vaccineret med konventionelle ikke-markør BoHV-1-vacciner), når prøver analyseres i test baseret på identifikation af antistoffer mod et hvilket som helst andet BoHV-1-antigen.
English: Abbreviations: gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose
Danish: Forkortelser: gE: deleteret glycoprotein E, tk: deleteret thymidin kinase, CCID: infektions dosis i cellekultur
English: Do not store and transport above 25°C).
Danish: Må ikke Opbevares og transporteres opbevares over 25°C.
English: Lyophilisate: Colourless type I glass bottle closed with a bromobutyl rubber closure and an aluminium cap.
Danish: Lyofilisat: Farveløse type I-hætteglas med brombutylgummiprop og aluminiumskapsel.