natgillin/translations-raw huggingface dataset:
50 mg (svarende til 144 mg pyrantelembonat) 
50mg (equivalent to 144 mg pyrantel embonate)
Som konklusion godtages det på grundlag af en samlet vurdering af de fremlagte data, at det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og relaterede navne) er effektivt (op til 100 %) til behandling af umodne og modne former af E. granulosus og E. multilocularis hos hunde. 
In conclusion, based on the totality of data presented, it is accepted that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) will be effective (up to 100%) in the treatment of immature and mature forms of E. granulosus and E. multilocularis in the dog.
konkluderede CVMP, at det overordnede benefit/risk-forhold for disse produkter fortsat er positivt, forudsat at der foretages de anbefalede ændringer i produktinformationen for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus og relaterede navne, som er godkendt ved MRP IE/V/0272-0275/001/MR med Irland som referencemedlemsstat og Frankrig som berørt medlemsstat. 
the CVMP, concluded that the overall benefit/risk balance for these products remains positive subject to the recommended changes in the product information for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State.
Vurdering af benefit/risk-forholdet 
Evaluation of the benefit - risk balance
Produktresuméerne for disse fire produkter omfatter ikke indikationer mod Echinococcus granulosus og Echinococcus multilocularis. 
The SPCs for these four products does not include indications against Echinococcus granulosus and Echinococcus multilocularis.
4.1 Dyrearter 
4.1 Target species
Dette svarer til 1 tablet/10 kg (22 lbs) legemsvægt. 
This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Milaxyn Plus, Strantel Plus, Prazical Plus og Voxical Plus blev efterfølgende godkendt ved den gensidige anerkendelsesprocedure MRP IE/V/0272-0275/001/MR som hybride ansøgninger i henhold til artikel i 13, stk. 3, i direktiv 2001/82/EF som ændret, med Irland som referencemedlemsstat og Frankrig som berørt medlemsstat. 
Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus were authorised subsequently by MRP IE/V/0272-0275/001/MR as hybrid applications under Article 13(3) of Directive 2001/82/EC, as amended involving Ireland as reference Member State and France as concerned Member State.
Desuden anses der i anbefalingerne i produktoplysningerne for at være taget tilstrækkeligt hensyn til risikoen ved produktets anvendelse. 
Further, it is considered that use of this product, in accordance with label recommendations in the product literature, sufficiently manages the risk associated with its use.
CVMP anbefalede derfor ændring af de markedsføringstilladelser, for hvilke produktresuméerne, etiketteringen og indlægssedlen fremgår af bilag III, for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus og relaterede navne, som er godkendt ved MRP IE/V/0272-0275/001/MR med Irland som referencemedlemsstat og Frankrig som berørt medlemsstat (se bilag I). 
Therefore the CVMP has recommended the variation of the marketing authorisations for which the summaries of product characteristics, labelling and package leaflet are set out in Annex III for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State (see Annex I).
Produktresuméet for disse tre produkter omfatter indikationer mod Echinococcus granulosus og Echinococcus multilocularis. 
The SPC for these three products includes indications against Echinococcus granulosus and Echinococcus multilocularis.
Indikationen behandling af infestation med umodne og modne former af E. granulosus og E. multilocularis kan godtages for det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne). 
The indication for the treatment of immature and mature forms of E. granulosus and E. multilocularis can be accepted for the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Pyrantel virker som en kolinerg agonist, der stimulerer parasittens nikotine kolinerge receptorer og dermed inducerer spastisk paralyse af nematoderne, hvilket medfører parasittens udstødning fra mave-tarmkanalen. 
Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.
Praziquantel absorberes næsten fuldstændigt fra mave-tarmkanalen efter oral indgift. 
Perorally administered praziquantel is absorbed almost completely from the intestinal tract.
Til oral administration 
ADVICE ON CORRECT ADMINISTRATION
Må ikke anvendes samtidigt med piperazinforbindelser som anthelmintiske virkninger af pyrantel og piperazin kan modvirkes. 
Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.
Produkterne Prazitel Plus, Exitel Plus, Cazitel Plus og relaterede navne er i mange EU- og EØSmedlemsstater godkendt ved den gensidige anerkendelsesprocedure (MRP) IE/V/0241-0243/001/MR efter enslydende hybride ansøgninger i henhold til artikel 13, stk. 3, i direktiv 2001/82/EF, som ændret. 
The marketing authorisation holder for the concerned product is Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus, Exitel Plus, Cazitel Plus and associated names were authorised in many Member States (EU/EEA) by mutual recognition procedure (MRP) IE/V/0241-0243/001/MR as duplicate hybrid applications under Article 13(3) of Directive 2001/82/EC as amended.
Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år 
6.3 Shelf life of the veterinary medicinal product as packaged for sale
Dataene er fyldestgørende som bro mellem den dokumenterede virkning af referenceproduktet (Drontal Plus) og af det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og relaterede navne). 
These data are adequate as a bridge between the documented efficacy of the reference product (Drontal Plus) and the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Når produkternes svarer til hinanden med hensyn til systemisk tilgængelighed (absorptionsgrad), antages de imidlertid også at svare til hinanden med hensyn til deres optræden lokalt i mave-tarmkanalen efter administration. 
While plasma concentrations are not a direct measure of the concentrations of active available locally in the gastro intestinal tract, it is considered that similar systemic availability (similar extent of absorption) is indicative of similar behaviour locally in the gastro intestinal tract following product administration.
Pyrantelembonat, et tetrahydropyrimidinderivat. 
Pyrantel acts as a cholinergic agonist.
På grundlag af sikkerhedsundersøgelsen i måldyrearten fandt udvalget det usandsynligt, at anvendelse til hvalpe under 9 uger og hunde under 2,5 kg vil medføre sikkerhedsmæssige betænkeligheder. 
The Committee considered on basis of a target animal safety study that the use of the concerned product in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern and therefore a restriction on use in such animals is unnecessary.
I pattedyr, konverteres febantel til fenbendazol og oxfendazol ved ringslutning. 
Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole.
En del vedrørte dog virkningen af praziquantel dispenseret som andre lægemiddelformer (injektionspræparat, pasta, pulver) og/eller administreret ad andre indgivelsesveje (intramuskulært, subkutant) og/eller kombineret med andre aktive indholdsstoffer (f.eks. Drontal Plus, Bayer Animal Health). 
While the majority of references cited by Chanelle Pharmaceuticals Manufacturing Ltd.reported on the efficacy of praziquantel when presented as a monosubstance tablet (Droncit, Bayer Animal Health), a number of the references reported on the efficacy of praziquantel when presented in other pharmaceutical forms (injectable, paste, powder) and/or for administration by other routes (intramuscular, subcutaneous) and/or when combined with other active substances (e.g. Drontal Plus, Bayer Animal Health).
Bændelorme: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (voksne og umodne stadier). 
Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
1 tablet/10 kg (22 lbs) legemsvægt. 
1 tablet per 10 kg (22 lbs) bodyweight.
Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen. 
This veterinary medicinal product does not require any special storage conditions Keep out of the reach and sight of children.
50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (svarende til 144 mg pyrantelembonat) og 150 mg/tablet Febantel 
50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg/tablet Febantel.
Chanelle Pharmaceuticals Manufacturing Ltd. har ekstrapoleret de offentligt tilgængelige data vedrørende virkning for produkter fra Bayer Animal Health (Droncit og Drontal Plus) til det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og relaterede navne). 
Chanelle Pharmaceuticals Manufacturing Ltd.has extrapolated the efficacy data available in the public domain for the Bayer Animal Health products (Droncit and Drontal Plus) to the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) by presenting a comparative pharmacokinetic study conducted with the concerned product and Drontal Plus (Bayer Aniamal Health).
Æske med 2, 4, 6 og 8 tabletter 
{CARTON FOR PACK SIZES OF 2, 4, 6 AND 8 TABLETS}
Hos hund: behandling af infestationer hos hund med rundorm og bændelorm 
In dogs: Treatment of mixed infections by nematodes and cestodes.
På grundlag af denne undersøgelse kan testog referenceprodukterne anses for at være ækvivalente med hensyn til AUCinf for praziquantel, hvorfor produkternes systemiske tilgængelighed kan antages at være ens. Plasmakoncentrationen er ikke et direkte mål for den koncentration af det aktive indholdsstof, der lokalt er tilgængelig i mave-tarmkanalen. 
Based on the findings of this study, the test and reference products can be considered equivalent with respect to AUCinf of praziquantel; therefore similar systemic availability can be assumed.
1 tablet med smag af svinekød, indeholder 50 mg praziquantel, 50 mg pyrantel (svarende til 144 mg pyrantelembonat) og 150 mg febantel. 
1 pork flavoured tablet contains 50 mg Praziquantel, 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg Febantel.
Legemsvægt (kg) 
Dosage table: Bodyweight (kg)
Nematoder: 
Nematodes:
Laboratorieundersøgelser af får og rotter har afsløret teratogene virkninger ved høj dosis febantel. 
Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats.
Vurdering af fordele 
Benefit assessment
Prazitel Plus tabletter Praziquantel 50 mg Pyrantel 50 mg (svarende til 144 mg pyrantel embonate) 
Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate)
DATO FOR SENESTE REVISION AF INDLÆGSSEDLEN 
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
6.5 Emballage 
6.5 Nature and composition of immediate packaging
Den anbefalede dosis er: 15 mg/kg febantel, 5 mg/kg pyrantel (svarende til 14,4 mg/kg pyrantelembonat) og 5 mg/kg praziquantel. 
The recommended dose rates are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE 
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Hos hund: behandling af infestationer hos hund med rundorm og bændelorm af følgende arter: 
In dogs: Treatment of mixed infections by nematodes and cestodes of the following species Nematodes:
Den anbefalede dosis er: 15 mg/kg febantel, 5 mg/kg pyrantel(svarende til 14,4 mg /kg pyrantelembonat) og 5 mg/kg praziquantel. 
The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
10. UDLØBSDATO 
WITHDRAWAL PERIOD
Indehaver af markedsføring stilladelse 
Marketing authorisation holder
Særlige forsigtighedsregler for personer, der administrerer lægemidlet I tilfælde af indtagelse af tabletterne ved hændeligt uheld, skal der straks søges lægehjælp, og indlægssedlen vises til lægen. 
In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Hjælpestoffer: 
User Precautions:
Produktets sikkerhed hos yngre hvalpe underbygges således af omfattende litteraturdata for hvert af de aktive indholdsstoffer og for kombinationen. 
There is extensive literature for the individual active substances and the combination which supports the safety of this product in younger puppies.
Tabletter med smag af svinekød 
Pork flavoured tablets.
Luxembo urg 
Prazitel Plus
Spolorm: Toxocara canis, Toxascaris leonine (Voksne og næsten modne stadier) Hageorm: Uncinaria stenocephala, Ancylostoma caninum(voksne stadier) Piskeorm: Trichuris vulpis (voksne stadier). 
In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.
Til oral administration 1 tablet pr. 10 kg legemsvægt 
1 tablet per 10 kg bodyweight.
Sverige Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Sweden Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Lægemiddelform Dyreart 
Pharmaceutical form
Norge Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Norway Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Ungarn Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
I denne kombination virker pyrantel og febantel imod alle relevante rundorme (spolorm, hageorme og piskeorme) i hunde, dog særligt imod Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum og Trichuris vulpis. 
Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs.
Slovakiet Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Holland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Slovenien Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Tyskland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Germany Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Irland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Litauen Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Island Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Iceland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Rumænie 
Spain
Grækenla nd 
Latvia
Frankrig Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Lopper tjener som værtsdyr for en af de almindelige bændelorm - Dipylidium caninum Angreb med bændelorm kan indtræffe igen, medmindre der foretages kontrol af mellemværter såsom lopper, mus etc. 
Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum.
Italien Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Polen Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea 
Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Afsnit 3. 
Section 3.
Bilag III Ændringer af de pågældende afsnit i produktinformationen 
Annex III Amendments to relevant sections of the product information
Ændringer i de pågældende afsnit af produktinformationen for metadontabletter indeholdende lavmolekylært povidon (K25 eller K30) 
Amendments to relevant sections of the product information of methadone tablets containing low molecular weight povidone (K25 or K30)
Afsnit 6.1 Hjælpestoffer [Oplysninger om den pågældende type povidon, f.eks. K25 eller K30, indsættes under dette afsnit.] 
Section 6.1 List of excipients [Information about the type of povidone, e.g. K25 or K30, should be included in this section.]
B. Indlægsseddel 
B. Package Leaflet
Sådan skal du bruge <særnavn> [Nedenstående tekst indsættes i dette afsnit] Dette lægemiddel er udelukkende til oral brug og må ikke injiceres. 
[The following text should be included in this section] This product is for oral use only, and must not be injected.
A. Produktresumé 
A. Summary of Product Characteristics
Afsnit 4.2 Dosering og administration [Nedenstående tekst indsættes i dette afsnit] 
Section 4.2 Posology and method of administration [The following text should be included in this section] This product is for oral use only, and must not be injected.
Den potentielle risiko for gravide kvinder er ukendt. 
The potential risk for pregnant women is unknown.
24. maj 2017 
May 2017
Immunsystemet Ikke kendt: 
Immune system disorder Not known:
Denne vaccine skal anvendes i overensstemmelse med officielle anbefalinger. 
The use of this vaccine should be in accordance with official recommendations.
• har en alvorlig infektion med høj feber. 
• have a severe infection with a high fever.
Vaccinen virker ved at hjælpe kroppen med at danne antistoffer (kroppens naturlige forsvar), som beskytter dig eller dit barn mod denne sygdom. 
The vaccine works by helping the body to make antibodies (the body's natural defences) which protect you or your child against this disease.
Vaccinen må ikke anvendes, hvis den ikke kan re-suspenderes. 
Do not use the vaccine if it cannot be re-suspended.
Resultater fra gruppe 2 og 3 er ikke medtaget, da kun 2 repræsentative stammer blev evalueret. 
Results from Groups 2 and 3 are not presented, as only 2 representative strains were evaluated.
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) 
Not known (cannot be estimated from available data)
Vaccinen indeholder to vigtige bestanddele fra bakteriens overflade. 
The vaccine contains two important components from the surface of the bacteria.
Personer på 10 år og derover 
Individuals 10 years and older
• har haft problemer efter en dosis Trumenba, f.eks. en allergisk reaktion eller vejrtrækningsproblemer. 
• have had any problems after any dose of Trumenba such as an allergic reaction or problems with breathing.
Serum blev udtaget ca. 1 måned efter vaccination. 
Serum was obtained approximately 1 month after vaccination.
Trumenba må ikke gives: - hvis du eller dit barn er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6). 
Trumenba should not be given: - if you or your child are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
I tilfælde af overdosering anbefales det at overvåge vitale funktioner og muligvis give symptomatisk behandling. 
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Der er begrænset erfaring med overdosering. 
Experience of overdose is limited.
Eftersom bivirkningen er indberettet spontant, kan hyppigheden ikke fastsættes og anses derfor som ikke kendt. 
Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.
Feber ≥ 38 °C (pyreksi) 
Fever ≥ 38 °C (Pyrexia)
Meget almindelig (≥1/10) 
Very common (≥ 1/10)
Persistens af immunitet og respons på booster-vaccination 
Persistence of immunity and response to booster vaccination
Ud af de 1.713 randomiserede forsøgspersoner, var 427 i gruppe 1, 430 var i gruppe 2, 427 var i gruppe 3, 286 var i gruppe 4, og 143 var i gruppe 5. 
Of the 1,713 subjects randomised, 427 were in Group 1, 430 were in Group 2, 427 were in Group 3, 286 were in Group 4, and 143 were in Group 5.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får Trumenba. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Trumenba is given.
Besvimelse, mathed eller andre stressrelaterede reaktioner kan forekomme som reaktion på enhver indsprøjtning. 
Fainting, feeling faint, or other stress-related reactions can occur as a response to any needle injection.
Din læge vil måske stadig anbefale, at du får Trumenba, hvis du er i risiko for at få meningokoksygdom. 
Your doctor may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Alligevel bør vaccination ikke undlades, hvis der er klar risiko for eksponering for meningokokinfektion. 
Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Bivirkninger rapporteret i kliniske studier er anført efter faldende hyppighed og sværhedsgrad i henhold til følgende hyppighedsgrupper: 
Adverse reactions reported in clinical studies are listed in decreasing order of frequency and seriousness according to the following frequency categories:
Hyppighed ikke kendt (kan ikke vurderes ud fra tilgængelige data) - Allergiske reaktioner 
Not known (cannot be estimated from available data) - Allergic reactions
60 mikrogram 
60 micrograms
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler. 
The requirements for submission of periodic safety update repots for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Denne vaccine kan som alle andre vacciner give bivirkninger, men ikke alle får bivirkninger. 
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Farmakoterapeutisk klassifikation: vacciner, ATC-kode: J07AH09 
Pharmacotherapeutic group: vaccines; ATC code: J07AH09
Relevant medicinsk behandling og overvågning skal altid være umiddelbart tilgængelig i tilfælde af en anafylaktisk reaktion efter administration af vaccinen. 
Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Prækliniske data viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet. 
Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and reproduction and developmental toxicity.