natgillin/translations-raw huggingface dataset:
Der skulle ikke forekomme nogen bemærkelsesværdige virkninger, hvis De holder op med at tage Rapinyl, men mulige abstinenssymptomer er angst, rysten, svedudbrud, bleghed, kvalme og opkastning. 
There should be no noticeable effects if you stop taking Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
På grund af det lille antal patienter, der er blevet eksponeret i længere i tid, skal de endelige resultater af forsøg EN3267-005 og EN3267-007 fremsendes som betingelse for markedsføringstilladelserne. 
Due to the low number of patients exposed for a long time, the final results of the studies EN3267-005 and EN3267-007 should be provided as conditions to the Marketing Authorisations.
Ældre, kakektiske eller debile patienter kan have en nedsat fenatylclearance, som kan medføre en længere terminal halveringstid af stoffet (se pkt. 
Elderly, cachectic or generally impaired patients may have a lower fentanyl clearance, which could cause a longer terminal half-life for the compound (see sections 4.2 and 4.4).
• hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer 
• if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Rapinyl • if you have severe breathing problems
• Almindelige bivirkninger (påvirker mellem 1 og 10 ud af 100 brugere): forvirring, angst eller nervøsitet, hallucinationer, unormal tankegang, muskeltrækninger, søvnbesvær, underlige drømme, tunge- eller smagsproblemer, blussen, sår/blærer i munden, tarmblokering, synkebesvær, tilbøjelighed til at komme galt afsted 
• Common side effects (affects 1 to 10 users in 100): feeling confused, feeling anxious or nervous, hallucinations, abnormal thinking, muscle twitching, difficulty sleeping, strange dreams, tongue or taste problems, flushing, mouth ulcers/blisters, blockage of the gut, difficulty swallowing, being accident-prone
Indehaver af markedsføringstilladelsen: [Se bilag I - udfyldes nationalt] (Navn og adresse) <{tlf}> <{fax}> <{e-mail}> 
Marketing authorisation holder: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL 
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
• hvis De har alvorlige vejrtrækningsproblemer Inden De påbegynder behandlingen med Rapinyl, skal De regelmæssigt have taget eller brugt et ordineret, stærkt smertestillende lægemiddel, som kaldes et opioid, til at kontrollere Deres vedvarende smerter. 
Before you start treatment with Rapinyl, you must have been regularly taking or using a prescribed strong pain-relieving medicine, called an opioid, to control your persistent pain.
Fentanyl er et særdeles lipofilt lægemiddel, der absorberes meget hurtigt via den orale mukosa og langsommere via mave-tarmkanalen. 
Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
I dette forsøg ser de valgte primære kriterier (SPID) og tiden, der er valgt til vurdering af effekt (30 min.), ikke ud til at være passende til at vurdere effekten af en behandling på BTP-episoder, som er kendt for at have en middelvarighed på 30 min. CHMP var af den mening, at ansøgeren skulle fremlægge en analyse af 30% og 50% af de responderende efter 10 og 15 minutter for bedre at kunne vurdere den klinisk relevante profil for tid-effekt. 
In this study, the primary criteria chosen (SPID) and the time chosen for assessment of efficacy (30 min) do not seem appropriate to evaluate the efficacy of a treatment on BTP episodes, which are known to present a median duration of 30 min.
• Visse typer medicin mod virus, der bruges til at behandle infektioner, der er forårsaget af vira (såkaldte proteasehæmmere, f.eks. ritonavir). 
• Certain types of antiviral medicines used to treat infections caused by viruses (called protease inhibitors, containing e.g. ritonavir).
Behandling af gennembrudssmerter hos voksne patienter, der er i opioidbehandling for kroniske cancersmerter. 
Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Rapinyl er en hurtigtopløsende sublingual tablet, der er beregnet til hurtigt og forudsigeligt at frigive fentanyl via slimhinden i munden. 
Rapinyl is a rapidly disintegrating sublingual tablet designed to rapidly and predictably deliver fentanyl through the oral mucosa.
Rapinyl og tilhørende navne (se bilag I) 50 mikrogram sublinguale resoribletter [Se bilag I - udfyldes nationalt] 
Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally]
• snue eller tilstoppet næse, mundtørhed, ondt i halsen, hudkløe, hududslæt, irritation under tungen 
• runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
CHMP anså den lave uønskede incidens inden for spektret hos opioidtolerante patienter for at være acceptabel og registrerede bemærkningen i produktresuméet om dosistitrering. 
The CHMP considered the low adverse spectrum incidence in opioid-tolerant patients reassuring and noted the statement in the SPC on dose titration.
Rapinyl og tilhørende navne (se bilag I) 50 µg sublinguale resoribletter [Se bilag I - udfyldes nationalt] 
Rapinyl and associated names (see Annex I) 50 µg sublingual tablets [See Annex I - To be completed nationally]
Som alle µ-opioidreceptoragonister fremkalder fentanyl dosisafhængig respirationsdepression. 
Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
• Ualmindelige bivirkninger (påvirker mellem 1 og 10 ud af 1.000 brugere): rastløshed, isolationsfornemmelse, humørsvingninger, rysten, talebesvær, glemsomhed, tab af koordinationsevne, svimmelhed, langsomme eller hurtige hjerteslag, højt blodtryk, vejrtrækningsbesvær, langsom eller overfladisk vejrtrækning, astma, oppustethed, luft i tarmen, tørst, afføringsbesvær, ændringer i hyppigheden af toiletbesøg, utilpashed 
• Uncommon side effects (affects 1 to 10 users in 1,000): feeling restless, feeling detached, moodswings, trembling, difficulty speaking, being forgetful, loss of coordination, vertigo, slow or fast heartbeat, high blood pressure, difficulty breathing, slow or shallow breathing, asthma, bloating, wind, thirst, difficulty going to the toilet, change in frequency of going to the toilet, feeling unwell
LÆGEMIDDELFORM OG INHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Sublingual resoriblet 
PHARMACEUTICAL FORM AND CONTENTS Sublingual tablet
Rapinyl e beregnet til behandling af personer, som allerede regelsmæssigt tager stærke, smertelindrede lægemidler (oipoider) mod vedvarende cancersmerter, men som kræver behandling af gennembrudssmerter. 
Rapinyl is a treatment for people who must already regularly be taking strong pain-relieving medicine (opioids) for their persistent cancer pain, but require treatment for their breakthrough pain.
Der forventes ingen mærkbare virkninger ved seponering af behandling med Rapinyl, men mulige abstinenssymptomer er angst, tremor, svedudbrud, bleghed, kvalme og opkastning. 
There should be no noticeable effects on cessation of treatment with Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Almindelig: Myoclonus, insomni, smagsforstyrrelser Ikke almindelig: Unormal gang/koordination, vertigo, amnesi, taleforstyrrelser, tremor Luftveje, thorax og mediastinum 
Common: Myoclonus, insomnia, taste disorders Uncommon: Abnormal gait/coordination, vertigo, amnesia, speech disorders, tremor
Rapinyl er beregnet til behandlingen af gennembrudssmerter hos patienter, der er i opioidbehandling for kroniske cancersmerter. 
Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Fentanyl bør kun administreres til ammende kvinder, hvis fordelene helt klart opvejer de potentielle risici for både moder og barn. 
Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed child. Fentanyl should only be used by breast-feeding women if the benefits clearly outweigh the potential risks for both mother and child.
• lavt blodtryk, blussen/varmefølelse, langsom overfladisk vejrtrækning, svaghed, fornemmelse af at være ved at besvime, nedsat følsomhed over for berøring, følelsesløshed eller snurren 
• low blood pressure, flushing/feeling hot, slow shallow breathing, feeling weak, feeling faint,
Blisterkort 
Carton Label
Er De i tvivl, så spørg lægen eller apoteket. 
• If you have any further questions, ask your doctor or pharmacist.
Almindelig: Gastrointestinal okklusion, dysfagi, mundsår/stomatitis, tungelidelse Ikke almindelig: Forstørret abdomen, flatulens, tørst Sjælden: Hikke 
Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups
• opkastning, diaré, forstoppelse, mavepine, oppustet fornemmelse, fordøjelsesbesvær, 
• vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite
50 mikrogram subingual resoriblet er en hvid femkantet tablet 100 mikrogram sublingual resoriblet er en hvid, rund tablet 200 mikrogram sublingual resoriblet er en hvid, oval tablet 300 mikrogram sublingual resoriblet er en hvid, trekantet tablet 400 mikrogram sublingual resoriblet er en hvid, diamantformet tablet 600 mikrogram sublingual resoriblet er en hvid ”D”-formet tablet 800 mikrogram sublingual resoriblet er en hvid, kapselformet tablet 
50 microgram sublingual tablet is a white pentagon-shaped tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet
Må ikke synkes. 
Do not swallow
På grund af det temmelig lille antal patienter, der er blevet eksponeret i længere i tid, skal de endelige resultater fra forsøg EN3267-005 og EN3267-007 samt data fra den komplette sikkerhedsanalyse om alvorlige uønskede hændelser imidlertid fremsendes som betingelse for markedsføringstilladelserne. 
However, due to the quite low number of patients exposed for a long time, the Applicant was asked to provide the final results of the studies EN3267-005 and EN3267-007 and the full safety analysis data on SAEs as conditions to the Marketing Authorisations.
Anvendelsen af Rapinyl er kontraindiceret til opioidnaive patienter på grund af risikoen for livstruende respirationsdepression. 
Opioid-naïve patients because of the risk of life-threatening respiratory depression.
BILAG III PRODUKTRESUME ETIKETTERING OG INDLÆGSSEDDEL 
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
De har tendens til at aftage i intensitet ved fortsat brug. 
Undesirable effects typical of opioids are to be expected with Rapinyl; they tend to decrease in intensity with continued use.
Rapinyls udseende og pakningsstørrelse 
What Rapinyl looks like and contents of the pack
Desuden blev der påvist en klinisk relevant profil for tideffekt, der var passende for en episode med gennembrudssmerter og betydningsfulde kliniske fordele for patienterne. 
In addition, a clinically relevant time-effect profile appropriate for an episode of breakthrough painl and meaningful clinical benefits for the patients were shown; patients could identify an effective dose of Rapinyl and use it successfully to control multiple episodes of breakthrough pain.
Almindelig: Vasodilatation 
Vascular disorders Common: Vasodilation
Indehaveren af markedsføringstilladelsen og fremstiller 
Marketing Authorisation Holder and Manufacturer:
Dataene viste, at de farmakokinetiske parametre hos patienter ikke var forskellige fra parametrene hos raske frivillige med en lignende farmakokinetisk variabilitet. 
The Applicant provided data from a study investigating the pharmacokinetics of Rapinyl in 8 opioid tolerant cancer patients, which demonstrated that the pharmacokinetic parameters in patients were not different from those in healthy volunteers, with a similar pharmacokinetic variability.
Almindelig: Hallucinationer, konfusion, angst, nervøsitet, unormal tankegang, unormale drømme 
Common: Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon: Agitation, depersonalisation, emotional lability
50 mikrogram resoribletten er en hvid, femkantet tablet 100 mikrogram resoribletten er en hvid, rund tablet 200 mikrogram resoribletten er en hvid, oval tablet 300 mikrogram resoribletten er en hvid, trekantet tablet 400 mikrogram resoribletten er en hvid, diamantformet tablet 600 mikrogram resoribletten er en hvid, ”D”-formet tablet 800 mikrogram resoribletten er en hvid, kapselformet tablet 
The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “D”-shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
Ikke almindelig: Urinretention, miktionsforstyrrelser Meget sjælden: Blærespasmer, oliguri 
Renal and urinary disorders Uncommon: Urinary retention, change in urinary frequency Very rare: bladder spasm, oliguria
ATC-kode: N02AB03 
Pharmacotherapeutic group: Phenylpiperidine derivatives, ATC code: N02ABO3
• Visse typer stærke smertestillende lægemidler, der f.eks. indeholder buprenorphin eller pentazocin 
The following medicines may reduce the effects of Rapinyl: • Certain types of strong pain killers containing e.g. buprenorphine or pentazocine
Godkendelse af navn under behandling 
DATE OF REVISION OF THE TEXT
Spørg lægen eller apoteket, hvis der er noget De er i tvivl om eller føler Dem usikker på. 
You should check with your doctor or pharmacist if you are not sure.
Desuden skal ansøgeren fremsende en komplet sikkerhedsanalyse, selv om de af ansøgeren angivne årsager til kun at analysere alvorlige uønskede hændelser på dette stadie accepteres, og selv om de manglende nye væsentlige sikkerhedsproblemer af CHMP anses for at være acceptable. 
Applicant for analyzing only SAEs at this stage are endorsed, and the absence of new important safety issues was considered re-assuring by the CHMP, a full safety analysis should be provided by the Applicant.
Hver sublingual resoriblet indeholder 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat) 
Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Seponering af behandling: 
Discontinuation of therapy:
En sublingual resoriblet indeholder: 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat) 
One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Rapinyl 100 mikrogram sublinguale resoribletter, Rapinyl 200 mikrogram sublinguale resoribletter Rapinyl 300 mikrogram sublinguale resoribletter Rapinyl 400 mikrogram sublinguale resoribletter Rapinyl 600 mikrogram sublinguale resoribletter Rapinyl 800 mikrogram sublinguale resoribletter 
Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Afslutningsvis bemærkede CHMP, at der ikke blev fremlagt nye data af ansøgeren under proceduren, men var uenig med ansøgeren i, at yderligere data om klinisk effekt og sikkerhed ikke er nødvendige. 
In conclusion, the CHMP noted that no new data was provided by the Applicant during the procedure but disagreed with the Applicant point of view that further clinical efficacy and safety data are not needed, indeed the justification relies entirely on a bridging strategy that assumes that the bioavailability obtained with Rapinyl is twice higher than that obtained with Actiq at the same molar dose.
Almindelig: Opkastning, mavesmerter, diaré, obstipation, mavegener, dyspepsi, xerostomi 
Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth
Rapinyl 800 µg sublinguale resoribletter 
Rapinyl 800 µg sublingual tablets
Vedligeholdelsesbehandling: 
Maintenance therapy:
Indtagelse af medicinen 
Taking the medicine
SÅDAN SKAL DE TAGE RAPINYL 
HOW TO TAKE RAPINYL
Vær ekstra forsigtig med at tage Rapinyl 
Take special care with Rapinyl
Rapinyl 400 µg sublinguale resoribletter 
Rapinyl 400 µg sublingual tablets
SÅDAN OPBEVARER DE RAPINYL 
HOW TO STORE RAPINYL
Rapinyl 600 µg sublinguale resoribletter 
Rapinyl 600 µg sublingual tablets
Rapinyl 600 mikrogram sublinguale resoribletter 
Rapinyl 600 microgram sublingual tablets
Ikke almindelig: Hypoventilation, astma, dyspnø 
Respiratory thoracic and mediastinal disorders Uncommon: Hypoventilation, asthma, dyspnoea, Very rare: Apnoea, haemoptysis
Rapinyl 100 µg sublinguale resoribletter 
Rapinyl 100 µg sublingual tablets
Rapinyl 800 mikrogram sublinguale resoribletter 
Rapinyl 800 microgram sublingual tablets
Rapinyl 300 µg sublinguale resoribletter 
Rapinyl 300 µg sublingual tablets
Rapinyl 400 mikrogram sublinguale resoribletter 
Rapinyl 400 microgram sublingual tablets
Hjerte 
Whereas
Rapinyl 200 µg sublinguale resoribletter 
Rapinyl 200 µg sublingual tablets
Hud og subkutane væv 
Skin and subcutaneous tissue disorders Very common: Sweating
800 mikrogram fentanyl (som citrat) 
800 micrograms fentanyl (as citrate)
Almindelig: Udslæt, pruritus 
Skin and subcutaneous tissue disorders Common: Rash, pruritus
200 mikrogram fentanyl (som citrat) 
200 micrograms fentanyl (as citrate)
Aktivt stof: Fentanyl. 
The active substance is fentanyl.
300 mikrogram fentanyl (som citrat) 
300 micrograms fentanyl (as citrate)
400 mikrogram fentanyl (som citrat) 
400 micrograms fentanyl (as citrate)
600 mikrogram fentanyl (som citrat) 
600 micrograms fentanyl (as citrate)
Resoriblet, sublingual 
Sublingual use.
Medlemsstat Indehaver af marketingsgodkendelse 
Marketing Authorisation Holder
Rapinyl 200 mikrogram sublinguale resoribletter 
Rapinyl 200 microgram sublingual tablets
Ikke almindelig: Uro, depersonalisation, emotionel labilitet 
Psychiatric disorders Common: Depression, anorexia, concentration impaired, euphoria
Rapinyl 300 mikrogram sublinguale resoribletter 
Rapinyl 300 microgram sublingual tablets
Rapinyl 100 mikrogram sublinguale resoribletter 
Rapinyl 100 microgram sublingual tablets
Lad derfor være med at give Rapinyl til andre. 
Do not pass it on to others.
EU-nummer (markedsføringstilla delsesnummer) 
EU (MA) Number
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, administyrationsvej, indehavere af markedsføringstilladelser i medlemsstaterne 
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Sanofi-Aventis Netherlands B.V. 
Netherlands Sanofi-Aventis Netherlands B.V.
Kampenringweg 45 D-E Gouda Holland 
Kampenringweg 45 D-E Gouda Netherlands
Der blev gennemført fem hovedstudier. 
Five main studies were carried out.
Hvert år gennemgår agenturet alle nye oplysninger, der måtte foreligge, og opdaterer om nødvendigt denne oversigt. 
Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Det vides endnu ikke, hvor længe beskyttelsen varer. 
It is not yet known how long the protection will last.
Imvanex fik en markedsføringstilladelse med gyldighed i hele EU den 31. juli 2013. 
Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Kopper blev officielt erklæret udryddet i 1980 med det sidst kendte tilfælde af sygdommen i 1977. 
Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Imvanex er blevet godkendt under "særlige omstændigheder". 
Imvanex has been authorised under ‘exceptional circumstances'.
Yderligere information om Imvanex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/imvanex. 
Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Vaccinen fås kun på recept. 
The vaccine can only be obtained with a prescription.
Det vides dog ikke, hvor længe beskyttelsen varer. 
However, the duration of protection is not known.
Denne vaccine vil blive anvendt, når det skønnes nødvendigt for at beskytte mod kopper i henhold til de officielle anbefalinger. 
This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.
Når personen igen kommer i kontakt med dette eller et lignende virus, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe viraene og hjælpe med at beskytte mod sygdommen. 
When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Vacciner virker ved at "lære" immunsystemet, hvordan det skal forsvare sig mod en sygdom. 
Vaccines work by ‘teaching' the immune system how to defend itself against a disease.
Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Imvanex, fordi sygdommen er sjælden. 
This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease.
Imvanex (levende modificeret vaccinia Ankara-virus) 
Imvanex (live modified vaccinia ankara virus)
Som for alle lægemidler bliver data vedrørende brugen af Imvanex løbende overvåget. 
As for all medicines, data on the use of Imvanex are continuously monitored.
De hyppigste bivirkninger ved Imvanex (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, kvalme, muskelsmerter (myalgi), træthed og reaktioner på injektionsstedet (smerte, rødme, hævelse, hærdning og kløe). 
The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Studierne omfattede over 2.000 voksne, herunder patienter med hiv og atopisk dermatitis (en kløende hudlidelse forårsaget af et overaktivt immunsystem) og personer, der tidligere var blevet vaccineret mod kopper. 
The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Da Imvanex er blevet godkendt under særlige omstændigheder, vil den virksomhed, der markedsfører Imvanex, fremskaffe data om vaccinens fordele og risici ved at gennemføre observationsstudier med patienter, der får vaccinen, samt hvis der skulle komme et udbrud af sygdommen i fremtiden. 
Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
I to af studierne blev der specifikt set på effektiviteten af Imvanex som booster. 
Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
Imvanex må ikke anvendes til patienter, der er overfølsomme (allergiske) over for det aktive stof eller et af de øvrige stoffer, der findes på sporstofniveau, såsom kyllingeprotein, benzonase og gentamicin. 
Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
En oversigt over Imvanex, og hvorfor det er godkendt i EU 
An overview of Imvanex and why it is authorised in the EU