FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisations for Prazitel Plus, Exitel Plus, Cazitel Plus and associated names, authorised by MRP IE/V/0241-0243/001/MR (see Annex I) do not need to be amended.
Danish: Det er ikke nødvendigt at ændre markedsføringstilladelserne for Prazitel Plus, Exitel Plus, Cazitel Plus og relaterede navne, der er godkendt ved MRP IE/V/0241-0243/001/MR (se bilag I).
English: Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.
Danish: Den maksimale plasmakoncentration for fenbendazol og oxbendazol i hund, blev opnået ca. 7-9 timer efter administration.
English: 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 and 1000 tablets.
Danish: 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 eller 1000 tabletter.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Danish: Der er tale om syv kopiprodukter med identiske hybride ansøgningsdossierer, der har Drontal Plus (Bayer Animal Health) som referenceprodukt.
English: Special precautions for use in animals
Danish: Særlige forsigtighedsregler for dyret
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus.
Danish: Der er tale om syv ens produkter med identiske hybride ansøgningsdossierer, som Drontal Plus er referenceprodukt for.
English: The products are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Danish: Produkterne er tabletter, der anvendes til hunde og indeholder praziquantel, pyrantelembonat og febantel.
English: Cestodes:
Danish: Cestoder:
English: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Danish: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne er tabletter, der anvendes til hunde og indeholder praziquantel, pyrantelembonat og febantel.
English: The CVMP requested Chanelle Pharmaceuticals Manufacturing Ltd.to justify the claim for efficacy against Echinococcus species and to provide all relevant data in support of the Echinococcus claim, which were presented previously in the dossiers submitted for marketing authorisation, together with comments on the suitability of the documentation to support the extrapolation of efficacy from the reference product to the hybrid product.
Danish: CVMP anmodede Chanelle Pharmaceuticals Manufacturing Ltd. om at dokumentere virkningen mod Echinococcus og fremlægge alle de relevante data, der underbygger virkningen mod Echinococcus og tidligere var fremlagt i dossierer til støtte for markedsføringsgodkendelsen.
English: Overall summary of the scientific evaluation of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne (se bilag I)
English: INN/Strength
Danish: INN/Særnavn
English: Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).
Danish: Spolorm: Toxocara canis, Toxascaris leonina (modne og sene umodne former).
English: Appropriate user safety advice is included in the product literature.
Danish: Produktinformationen indeholder passende sikkerhedsanvisninger til brugeren.
English: 150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.
Danish: 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 og 1000 tabletter.
English: {CARTON FOR PACK SIZES OF 10 TABLETS, AND UPWARDS}
Danish: Æske med 10 tabletter og derover
English: 50mg (equivalent to 144 mg pyrantel embonate)
Danish: 50 mg (svarende til 144 mg pyrantelembonat)
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Evaluation of the benefit - risk balance
Danish: Vurdering af benefit/risk-forholdet
English: The SPCs for these four products does not include indications against Echinococcus granulosus and Echinococcus multilocularis.
Danish: Produktresuméerne for disse fire produkter omfatter ikke indikationer mod Echinococcus granulosus og Echinococcus multilocularis.
English: 4.1 Target species
Danish: 4.1 Dyrearter
English: This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Danish: Dette svarer til 1 tablet/10 kg (22 lbs) legemsvægt.
English: 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.
Danish: 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.
English: 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.
Danish: Desuden anses der i anbefalingerne i produktoplysningerne for at være taget tilstrækkeligt hensyn til risikoen ved produktets anvendelse.
English: 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).
Danish: 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).
English: The SPC for these three products includes indications against Echinococcus granulosus and Echinococcus multilocularis.
Danish: Produktresuméet for disse tre produkter omfatter indikationer mod Echinococcus granulosus og Echinococcus multilocularis.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Perorally administered praziquantel is absorbed almost completely from the intestinal tract.
Danish: Praziquantel absorberes næsten fuldstændigt fra mave-tarmkanalen efter oral indgift.
English: ADVICE ON CORRECT ADMINISTRATION
Danish: Til oral administration
English: Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.
Danish: Må ikke anvendes samtidigt med piperazinforbindelser som anthelmintiske virkninger af pyrantel og piperazin kan modvirkes.
English: 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.
Danish: 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.
English: 6.3 Shelf life of the veterinary medicinal product as packaged for sale
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Pyrantel acts as a cholinergic agonist.
Danish: Pyrantelembonat, et tetrahydropyrimidinderivat.
English: 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.
Danish: 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.
English: Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole.
Danish: I pattedyr, konverteres febantel til fenbendazol og oxfendazol ved ringslutning.
English: 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).
Danish: 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).
English: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
Danish: Bændelorme: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (voksne og umodne stadier).
English: 1 tablet per 10 kg (22 lbs) bodyweight.
Danish: 1 tablet/10 kg (22 lbs) legemsvægt.
English: This veterinary medicinal product does not require any special storage conditions Keep out of the reach and sight of children.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: 50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg/tablet Febantel.
Danish: 50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (svarende til 144 mg pyrantelembonat) og 150 mg/tablet Febantel
English: 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).
Danish: 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).
English: {CARTON FOR PACK SIZES OF 2, 4, 6 AND 8 TABLETS}
Danish: Æske med 2, 4, 6 og 8 tabletter
English: In dogs: Treatment of mixed infections by nematodes and cestodes.
Danish: Hos hund: behandling af infestationer hos hund med rundorm og bændelorm
English: 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.
Danish: 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.
English: 1 pork flavoured tablet contains 50 mg Praziquantel, 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg Febantel.
Danish: 1 tablet med smag af svinekød, indeholder 50 mg praziquantel, 50 mg pyrantel (svarende til 144 mg pyrantelembonat) og 150 mg febantel.
English: Dosage table: Bodyweight (kg)
Danish: Legemsvægt (kg)
English: Nematodes:
Danish: Nematoder:
English: Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats.
Danish: Laboratorieundersøgelser af får og rotter har afsløret teratogene virkninger ved høj dosis febantel.
English: Benefit assessment
Danish: Vurdering af fordele
English: Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate)
Danish: Prazitel Plus tabletter Praziquantel 50 mg Pyrantel 50 mg (svarende til 144 mg pyrantel embonate)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Danish: DATO FOR SENESTE REVISION AF INDLÆGSSEDLEN
English: 6.5 Nature and composition of immediate packaging
Danish: 6.5 Emballage
English: 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.
Danish: Den anbefalede dosis er: 15 mg/kg febantel, 5 mg/kg pyrantel (svarende til 14,4 mg/kg pyrantelembonat) og 5 mg/kg praziquantel.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: In dogs: Treatment of mixed infections by nematodes and cestodes of the following species Nematodes:
Danish: Hos hund: behandling af infestationer hos hund med rundorm og bændelorm af følgende arter:
English: 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.
Danish: Den anbefalede dosis er: 15 mg/kg febantel, 5 mg/kg pyrantel(svarende til 14,4 mg /kg pyrantelembonat) og 5 mg/kg praziquantel.
English: WITHDRAWAL PERIOD
Danish: 10. UDLØBSDATO
English: Marketing authorisation holder
Danish: Indehaver af markedsføring stilladelse
English: In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
Danish: 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.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
English: User Precautions:
Danish: Hjælpestoffer:
English: There is extensive literature for the individual active substances and the combination which supports the safety of this product in younger puppies.
Danish: Produktets sikkerhed hos yngre hvalpe underbygges således af omfattende litteraturdata for hvert af de aktive indholdsstoffer og for kombinationen.
English: Pork flavoured tablets.
Danish: Tabletter med smag af svinekød
English: Prazitel Plus
Danish: Luxembo urg
English: In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.
Danish: Spolorm: Toxocara canis, Toxascaris leonine (Voksne og næsten modne stadier) Hageorm: Uncinaria stenocephala, Ancylostoma caninum(voksne stadier) Piskeorm: Trichuris vulpis (voksne stadier).
English: 1 tablet per 10 kg bodyweight.
Danish: Til oral administration 1 tablet pr. 10 kg legemsvægt
English: MARKETING AUTHORISATION HOLDER Chanelle Pharmaceuticals Manufacturing Limited, Loughrea,
Danish: Chanelle Pharmaceuticals Manufacturing Limited Loughrea
English: Sweden Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Sverige Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Pharmaceutical form
Danish: Lægemiddelform Dyreart
English: Norway Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Norge Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Ungarn Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: 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.
Danish: 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.
English: Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Slovakiet Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Holland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Slovenien Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Germany Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Tyskland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Irland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Litauen Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Iceland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Island Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Spain
Danish: Rumænie
English: Latvia
Danish: Grækenla nd
English: France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Frankrig Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum.
Danish: 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.
English: Cazitel Plus tabletten voor honden
Danish: Cazitel Plus tabletter för hundar
English: Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Italien Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Danish: Polen Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Prazitel Plus tabletten voor honden
Danish: Prazitel Plus tabletter för hundar
English: Section 3.
Danish: Afsnit 3.
English: Annex III Amendments to relevant sections of the product information
Danish: Bilag III Ændringer af de pågældende afsnit i produktinformationen
English: Amendments to relevant sections of the product information of methadone tablets containing low molecular weight povidone (K25 or K30)
Danish: Ændringer i de pågældende afsnit af produktinformationen for metadontabletter indeholdende lavmolekylært povidon (K25 eller K30)
English: Section 6.1 List of excipients [Information about the type of povidone, e.g. K25 or K30, should be included in this section.]
Danish: Afsnit 6.1 Hjælpestoffer [Oplysninger om den pågældende type povidon, f.eks. K25 eller K30, indsættes under dette afsnit.]
English: B. Package Leaflet
Danish: B. Indlægsseddel
English: [The following text should be included in this section] This product is for oral use only, and must not be injected.
Danish: Sådan skal du bruge <særnavn> [Nedenstående tekst indsættes i dette afsnit] Dette lægemiddel er udelukkende til oral brug og må ikke injiceres.
English: A. Summary of Product Characteristics
Danish: A. Produktresumé
English: 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.
Danish: Afsnit 4.2 Dosering og administration [Nedenstående tekst indsættes i dette afsnit]
English: The potential risk for pregnant women is unknown.
Danish: Den potentielle risiko for gravide kvinder er ukendt.
English: May 2017
Danish: 24. maj 2017
English: Immune system disorder Not known:
Danish: Immunsystemet Ikke kendt:
English: The use of this vaccine should be in accordance with official recommendations.
Danish: Denne vaccine skal anvendes i overensstemmelse med officielle anbefalinger.
English: • have a severe infection with a high fever.
Danish: • har en alvorlig infektion med høj feber.