FrancophonIA/ELRC3.0 huggingface dataset:
English: Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)
Danish: Spørgsmål og svar om Rocephin og relaterede navne (ceftriaxon, pulver til injektionsvæske/infusionsvæske, 250 mg, 500 mg, 750 mg, 1 g, 1,5 g, 2 g)
English: The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:
Danish: CHMP konkluderede, at Rocephin bør anvendes hos voksne og børn til følgende infektioner, der allerede var godkendt i flere, men ikke alle, EU-medlemsstater:
English: • bacterial meningitis;
Danish: • bakteriel meningitis
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat.
Danish: Hos voksne og børn over 12 år kan den anbefalede dosis være mellem 1 og 4 g Rocephin én gang dagligt, afhængigt af den behandlede infektion.
English: On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU.
Danish: Den 9. december 2011 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Rocephin i EU.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Rocephin hos voksne og børn.
English: Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.
Danish: Rocephin bør fortrinsvis gives ved injektion i en vene i løbet af 5 minutter eller med drop (infusion) i løbet af mindst 30 minutter, eller ved dyb injektion i en muskel.
English: Ceftriaxone belongs to the group ‘cephalosporins'; it works by attaching to proteins on the surface of bacteria.
Danish: Ceftriaxon tilhører gruppen cefalosporiner og virker ved at bindes til proteiner på bakteriernes overflade.
English: It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.
Danish: Endvidere kan det anvendes til behandling af dissemineret Lyme-borreliose (en bakterieinfektion, der overføres til mennesker gennem inficerede flåter) hos voksne og børn, herunder nyfødte fra 15-dages alderen.
English: It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine).
Danish: Det er et antibiotikum, der anvendes til behandling af en bred vifte af bakterielle infektioner, herunder lungebetændelse (pneumoni) og meningitis (infektion af hinderne omkring hjernen og rygmarven).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: Ud fra de forelagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Rocephin i EU.
English: In children below 12 years of age, the recommended dose of Rocephin depends on body weight and the condition it is used to treat.
Danish: Hos børn under 12 år afhænger den anbefalede dosis af Rocephin af legemsvægten og den behandlede sygdom.
English: • complicated urinary tract infections, including pyelonephritis (kidney infection);
Danish: • komplicerede urinvejsinfektioner, herunder nyrebetændelse (pyelonefritis)
English: Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.
Danish: Rocephin kan anvendes til behandling af patienter, der har for lavt indhold af hvide blodlegemer af typen neutrofile (neutropeni) og desuden har feber, som formodes at skyldes bakteriel infektion, patienter med blodforgiftning (bakteriæmi), der formodes at skyldes en af ovennævnte infektioner, samt til forebyggende behandling af infektioner i operationssår.
English: The CHMP agreed that Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications.
Danish: CHMP fandt, at Rocephin ikke længere burde anvendes til behandling af bihulebetændelse (sinuitis), betændelse i svælget (faryngitis) eller betændelse i blærehalskirtlen (prostatitis), da der ikke findes tilstrækkelige kliniske data til støtte for disse indikationer.
English: Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults.
Danish: Rocephin kan desuden anvendes ved akut forværring af KOL (kronisk obstruktiv lungesygdom) hos voksne.
English: • the sexually transmitted infections gonorrhoea and syphilis;
Danish: • kønssygdommene gonoré og syfilis
English: Rocephin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: CMD(h) (Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human) fandt det nødvendigt at harmonisere Rocephin.
English: • complicated skin and soft tissue infections;
Danish: • komplicerede infektioner i hud og underliggende væv
English: • intra-abdominal infections (infections within the abdomen);
Danish: • betændelser i bughulen (intraabdominale infektioner)
English: • acute otitis media (infection of the middle ear);
Danish: • akut mellemørebetændelse (otitis media)
English: • infections of bones and joints;
Danish: • infektioner i knogler og led
English: • bacterial endocarditis (an infection in the heart).
Danish: • bakteriel hjertehindebetændelse (endokarditis)
English: • hospital- and community-acquired pneumonia (infection of the lungs caught in or outside the hospital);
Danish: • lungebetændelse, der er hospitalserhvervet eller samfundserhvervet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08 July 2005 / 27 July 2010
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 08 juli 2005 / 27 juli 2010
English: 1 dose 5 x 1 dose 10 x 1 dose
Danish: 5 x 1 dosis 10 x 1 dosis
English: potency test
Danish: potency testen
English: Only healthy animals should be vaccinated.
Danish: Kun raske dyr bør vaccineres.
English: Allow the vaccine to reach room temperature before use.
Danish: Lad vaccinen opnå rumtemperatur før brug.
English: Poligono Ind. El Montalvo I
Danish: Poligono El Montalvo I
English: A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
Danish: En tredje vaccination med Equilis Prequenza Te bør gentages mindst 4 uger senere.
English: Concurrent active and passive immunisation (emergency vaccination)
Danish: Sideløbende aktiv og passiv immunisering (nødvaccination)
English: In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Danish: I meget sjældne tilfælde kan en lokal reaktion opstå, som overstiger 5 cm og muligvis vedvarer længere end 2 døgn.
English: Equine influenza virus strains:
Danish: Equin influenzavirus stammer:
English: Store at 2-8°C, protected from light.
Danish: Opbevares ved 2-8°C, beskyttet mod lys.
English: It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine.
Danish: Det anbefales at man kun administrerer en enkel dosis som booster til heste som allerede har modtaget grundvaccination hvor anvendte vacciner indeholder samme type equin influenza virus som er inkluderet i denne vaccine.
English: The second dose of the vaccine (V2) should be administered 4 weeks later.
Danish: Den anden vaccinedosis (V2) bør gives 4 uger senere.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/057/001-004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/05/057/001-004
English: Read package leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: A primary vaccination course may be considered necessary in horses that have not been suitably primed.
Danish: En grundvaccination kan anses for nødvendig hos heste som ikke er blevet hensigtsmæssigt grundvaccineret.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pr. dosis af 1 ml:
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “TIL DYR” OG BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG, om nødvendigt
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inclusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009,
English: Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Danish: Kartonæske(r) med 1, 5 eller 10 præfyldte sprøjter med kanyler.
English: 375 micrograms
Danish: 375 mikrogram
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt af vaccinen ved samtidig brug med andre lægemidler til dyr end dem, der er nævnt ovenfor.
English: This revaccination results in immunity to equine influenza lasting at least 12 months.
Danish: Denne revaccination giver en immunitet mod equin influenza, der varer i mindst 12 måneder.
English: 62.5 micrograms
Danish: 62,5 mikrogram
English: 1 Antigenic units
Danish: 1 Antigen enheder
English: Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Danish: I sjældne tilfælde kan der opstå smerter på injektionsstedet, som kan resultere i forbigående dysfunktion (stivhed).
English: Phosphatidylcholine
Danish: Phosphatidylcholin
English: The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Danish: månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum.
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: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: 125 micrograms
Danish: 125 mikrogram
English: Cardboard box with 10 glass vials of 1 ml.
Danish: Kartonæske med 10 hætteglas af 1 ml.
English: Active substances
Danish: Aktive stoffer
English: In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Danish: I meget sjældne tilfælde kan der forekomme feber, sommetider ledsaget af sløvhed og nedsat ædelyst i et døgn og i usædvanlige tilfælde op til 3 døgn.
English: Lot {number}
Danish: {måneder/år}
English: BATCH NUMBER
Danish: BATCHNUMMER Batch {nummer}
English: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Danish: • Grundvaccination: Første vaccination fra 6 måneders alderen, anden vaccination 4 uger senere.
English: Tetanus toxoid
Danish: Tetanus toksoid
English: Package size:
Danish: Pakningsstørrelse:
English: Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur.
Danish: Flokkulations ækvivalenter; svarende til ≥ 30 IE/ml marsvineserum i Ph.Eur.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later)
Danish: I tilfælde af øget smitterisiko eller utilstrækkelig indtagelse af råmælk, kan der gives en ekstra vaccination ved 4 måneders alderen efterfulgt af et fuldt grundvaccinationsforløb (vaccination ved 6 måneders alderen og 4 uger senere).
English: Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Danish: Føl bør ikke vaccineres, før de er 6 måneder gamle, især ikke hvis hoppen blev revaccineret i de sidste to måneder af drægtigheden, da der er mulighed for interferens med maternelt overførte antistoffer.
English: The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course.
Danish: Den første revaccination (tredje dosis) mod equin influenza gives 5 måneder efter grundvaccinationen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te [a clear pictogram of a horse]
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis Prequenza Te [et tydeligt piktogram af en hest]
English: 4.3 Contraindications None
Danish: 4.3 Kontraindikationer
English: The first revaccination is given not later than 17 months after the primary vaccination course.
Danish: Første revaccination gives ikke senere end 17 måneder efter grundvaccinationen.
English: Intramuscular use
Danish: Intramuskulær anvendelse.
English: Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Danish: Præfyldte sprøjter af type I glas, indeholdende et stempel med en top af halogenobutyl og lukket med en prop af halogenobutyl.
English: C/Zeppelin 6, Parcela 38 37008 Carbajosa de la Sagrada Salamanca
Danish: 37008 Carbajosa de la Sagrada
English: A/equine-2/ South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU), Tetanus toxoid 40 Lf.
Danish: A/equine-2/Sydafrika/4/03 (50 AE), A/equine-2/Newmarket/2/93 (50 AE), Tetanus toksoid 40 Lf.
English: Onset of immunity:
Danish: Immunitetens længde:
English: The second revaccination is given 12 months after the first revaccination.
Danish: Anden revaccination gives 12 måneder efter første revaccination.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 1 ml:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Pr. dosis af 1 ml:
English: PHARMACEUTICAL FORM Clear opalescent suspension for injection
Danish: LÆGEMIDDELFORM Klar opaliserende injektionsvæske, suspension
English: Administer one dose (1 ml), by strict intramuscular injection, according to the following schedule:
Danish: Grundvaccination Indgiv én dosis (1 ml) strikt intramuskulært efter følgende program:
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 4.9).
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som, men ikke blandet med tetanusserum fra Intervet (se afsnit 4.9).
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 8).
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som, men ikke blandet med tetanusserum fra Intervet (se afsnit 8).
English: The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus.
Danish: Vaccinen kan anvendes sammen med tetanusserum fra Intervet til behandling af tilskadekomne heste, der ikke er blevet immuniseret mod tetanus.
English: In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
Danish: I sådanne tilfælde kan første vaccinedosis (V1) gives samtidigt med en behørig profylaktisk dosis af tetanusserum fra Intervet på et andet injektionssted og ved brug af separate sprøjter og kanyler.
English: Store at 2-8 °C, protected from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved 2-8°C, beskyttet mod lys.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis Prequenza Te
English: A/equine-2/ South Africa/4/03
Danish: A/equine-2/Sydafrika/4/03 50 AE1
English: use
Danish: brug
English: A/equine-2/ Newmarket/2/93
Danish: A/equine-2/Newmarket/2/93 50 AE
English: This will lead to a passive protection against tetanus for at least
Danish: Den samtidige administration vil give passiv beskyttelse mod tetanus i mindst 21 dage.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Per dose of 1 ml:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Pr. dosis af 1 ml:
English: Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Danish: Hætteglas af type I glas, lukket med en halogenobutyl gummiprop og forseglet med en aluminiums hætte.
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning Kan anvendes under drægtighed og laktation.
English: 62.5 micrograms For a full list of excipients, see section 6.1.
Danish: 62,5 mikrogram Alle hjælpestoffer er anført under pkt.
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Danish: Vekslende anvendelse, med 12 måneders interval, af en egnet vaccine mod equin influenza indeholdende stammerne A/equine-2/Sydafrika/4/03 og A/equine- 2/Newmarket-2/93 anbefales for at opretholde immunitetsniveauet for influenzakomponenten (se skema).
English: INDICATION(S) Active immunisation of horses against equine influenza and tetanus
Danish: INDIKATION(ER) Aktiv immunisering af heste mod equin influenza og stivkrampe.
English: Thereafter a maximum interval of two years is recommended (see scheme).
Danish: 2 år (se skema).
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift) om nødvendigt
English: A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
Danish: 5 cm i diameter) kan opstå på injektionsstedet, men forsvinder inden for 2 døgn.
English: For animal treatment only - to be supplied only on veterinary prescription.
Danish: Må kun udleveres efter veterinærrecept.
English: Adjuvants: Purified Saponin
Danish: Adjuvans: Renset Saponin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te suspension for injection for horses
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis Prequenza Te, injektionsvæske, suspension til heste
English: INDICATION(S) Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Danish: Aktiv immunisering af heste fra 6 måneders alderen mod equin influenza for at reducere kliniske symptomer og udskillelse af virus efter infektion, samt aktiv immunisering mod tetanus for at forhindre dødelighed.
English: Adjuvant Purified saponin
Danish: Adjuvans Renset Saponin
English: Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Danish: Prequenza Te og tetanusserum fra Intervet kan reducere den aktive immunitet mod tetanus sammenlignet med heste, der er vaccineret med Equilis Prequenza Te men ikke har fået tetanus antitoksinserum.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Intervet International BV
English: Zero days
Danish: 0 døgn.
English: Emil-von-Behring-Str. 76
Danish: Emil-von-Behring-Str. 76 35 041 Marburg Tyskland
English: EXPIRY DATE
Danish: UDLØBSDATO UDL.D.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
Danish: Equilis Prequenza Te, injektionsvæske, suspension til heste NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Danish: Denne samtidige administration vil give passiv beskyttelse mod stivkrampe i mindst 21 dage.
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the sight and reach of children.
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstillerne af de biologisk aktive stof(fer) GSK Vaccines GmbH
English: To stimulate active immunity against Equine influenza and tetanus ATC-vet code: QI05AL01
Danish: ATCvet-kode: QI05AL01
English: 24 months after the first revaccination
Danish: 17 måneder efter grundvaccination 24 måneder efter den første revaccination
English: EXP {month/year}
Danish: UDL.D {måned/år}
English: 4.6 have been observed except for some depression at the day of vaccination
Danish: Efter administration af en dobbelt vaccinedosis er der ikke set andre bivirkninger end dem, der er beskrevet under afsnit 4.6, bortset fra nogen nedstemthed på vaccinationsdagen.
English: 4.11 Withdrawal period(s)
Danish: 4.11 Tilbageholdelsestid 0 døgn
English: PHARMACEUTICAL FORM Suspension for injection
Danish: Injektionsvæske, suspension