FrancophonIA/ELRC3.0 huggingface dataset:
English: - A kidney disorder (nephrotic syndrome) has been reported following high doses of plasma-derived factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Danish: En sygdom i nyrerne (nefrotisk syndrom) har været rapporteret efter høje doser af plasmafremstillet faktor IX hos hæmofili B patienter med faktor IX-inhibitorer og som tidligere har oplevet allergiske reaktioner.
English: BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution (see section 6.6).
Danish: BeneFIX indgives ved intravenøs infusion efter opløsning af det frysetørrede pulver i 0,234% natriumchloridinjektionsvæske (se pkt.
English: 600 IU
Danish: 600 IE
English: BeneFIX is administered by intravenous (IV) infusion after reconstitution of the powder for injection with the supplied solvent (a sodium chloride (salt) solution) in the pre-filled syringe.
Danish: BeneFIX gives som en intravenøs infusion efter opløsning af pulver til injektionsvæske, opløsning med det medfølgende opløsningsmiddel (en natriumchloridopløsning) i den fyldte sprøjte.
English: Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited Tel: +371 670 35 775
Danish: Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
English: Pfizer Luxembourg SARL filialas Lietuvoje
Danish: Pfizer Luxembourg SARL filiāle Latvijā
English: Elimination half-life (h) Recovery (IU/dL per IU/kg)
Danish: Eliminationshalveringstid (timer) Genfinding (IE/dl pr. IE/kg)
English: How to take BeneFIX
Danish: Sådan skal du bruge BeneFIX
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 5 ml of 0.234% sodium chloride solution for injection
Danish: Indeholder 5 ml 0,234% natriumchloridinjektionsvæske.
English: • one pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod
Danish: • en fyldt sprøjte med stempelstang og opløsningsmiddel, 5 ml steril 0,234%
English: BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection
Danish: BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning
English: - Research has shown a link between the occurrence of a factor IX inhibitor and allergic reactions.
Danish: Der har været rapporter i litteraturen, som viser en sammenhæng mellem forekomsten af faktor IX-inhibitor og allergiske reaktioner.
English: Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise.
Danish: Tag sprøjten af adapteren ved forsigtigt at trække og dreje sprøjten mod uret.
English: Sími: + 354 540 8000
Danish: Icepharma hf. Sími: + 354 540 8000
English: - It is recommended that evey time you use BeneFIX, you record the name and batch number of the product.
Danish: Det anbefales, at du noterer navn og batchnummer på lægemidlet, hver gang du bruger BeneFIX.
English: BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
Danish: BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning Nonacog alfa (rekombinant koagulationsfaktor IX)
English: (CYPRUS BRANCH)
Danish: PFIZER ΗΕΛΛΑΣ A.E. (CYPRUS BRANCH)
English: Number of subjects Clearance (mL/h/kg)
Danish: Clearance (ml/time/kg)
English: 1 vial: 500 IU nonacog alfa (approx. 100 IU/ml after reconstitution).
Danish: 1 hætteglas: 500 IE nonacog alfa (ca. 100 IE/ml efter rekonstituering).
English: 1 vial: 2000 IU nonacog alfa (approx. 400 IU/ml after reconstitution).
Danish: 1 hætteglas: 2000 IE nonacog alfa (ca. 400 IE/ml efter rekonstituering).
English: BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
Danish: BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 2000 IE nonacog alfa (rekombinant koagulationsfaktor IX).
English: Ensuring that the syringe plunger rod is still fully depressed, invert the vial.
Danish: Vær sikker på at sprøjtens stempelstang er trykket helt i bund, og vend hætteglasset.
English: BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX).
Danish: BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 250 IE nonacog alfa (rekombinant koagulationsfaktor IX).
English: Please dispose of all unused solution, empty vials and used needles and syringes in an appropriate container for throwing away waste as it may hurt others if not handled properly.
Danish: Bortskaf al ikke anvendt injektionsvæske, tomme hætteglas og anvendte kanyler og sprøjter på forsvarlig vis.
English: Τηλ: +30 210 67 85 800
Danish: PFIZER ΗΕΛΛΑΣ A.E. Τηλ: +30 210 678 5800
English: 1 vial: 1500 IU nonacog alfa (approx. 300 IU/ml after reconstitution).
Danish: 1 hætteglas: 1500 IE nonacog alfa (ca. 300 IE/ml efter rekonstituering).
English: 1 vial: 3000 IU nonacog alfa (approx. 600 IU/ml after reconstitution).
Danish: 1 hætteglas: 3000 IE nonacog alfa (ca. 600 IE/ml efter rekonstituering).
English: However, as with all factor IX products you should be carefully monitored for the development of factor IX inhibitors while being treated with BeneFIX.
Danish: Aktivitets-neutraliserende antistoffer (inhibitorer) er en ikke almindelig hændelse hos tidligere behandlede patienter, som behandles med produkter, der indeholder faktor IX, men som for alle faktor IX-produkter skal du under behandling med BeneFIX omhyggeligt overvåges for udviklingen af faktor IX-inhibitorer.
English: What BeneFIX is and what it is used for What you need to know before you take BeneFIX How to take BeneFIX
Danish: Det skal du vide, før du begynder at bruge BeneFIX Sådan skal du tage BeneFIX Bivirkninger
English: 1 vial: 1000 IU nonacog alfa (approx. 200 IU/ml after reconstitution).
Danish: 1 hætteglas: 1000 IE nonacog alfa (ca. 200 IE/ml efter rekonstituering).
English: BeneFIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU nonacog alfa (recombinant coagulation factor IX).
Danish: BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 3000 IE nonacog alfa (rekombinant koagulationsfaktor IX).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU nonacog alfa (approx. 50 IU/ml after reconstitution).
Danish: 1 hætteglas: 250 IE nonacog alfa (ca. 50 IE/ml efter rekonstituering).
English: Minor:
Danish: Lot:
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use, single use administration only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Life-threatening haemorrhages
Danish: ETIKET TIL HÆTTEGLAS
English: Posology
Danish: 1 gazetampon
English: Cases of peripheral thrombophlebitis (pain and redness of the veins) and deep venous thrombosis (blood clots in the extremities) have also been reported; in most of these cases, BeneFIX was administered via continuous infusion, which is not an approved method of administration.
Danish: Tilfælde af årebetændelse (smerter og rødme af blodårene) med dannelse af blodprop og blodpropper i dybtliggende vener (oftest i benene) er også blevet indberettet.
English: BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
Danish: BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 500 IE nonacog alfa (rekombinant koagulationsfaktor IX).
English: BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX).
Danish: BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1000 IE nonacog alfa (rekombinant koagulationsfaktor IX).
English: BeneFIX 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU nonacog alfa (recombinant coagulation factor IX).
Danish: BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1500 IE nonacog alfa (rekombinant koagulationsfaktor IX).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only the pre-filled syringe of solvent provided in the box for reconstitution.
Danish: Anvend kun solvensen i den fyldte sprøjte, der er vedlagt i pakningen, til rekonstitution.
English: Pfizer
Danish: Pulver
English: Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Danish: Fjern sikkerhedsplastikkappen på sprøjten med opløsningsmiddel ved at brække perforeringen på kappen.
English: Visual impairment e
Danish: Faktor IXhæmning
English: Gastrointestinal disorders
Danish: ETIKET TIL SOLVENSSPRØJTE
English: Tachycardia f
Danish: Takykardi
English: Continuous infusion
Danish: Blodpropper
English: METHOD OF ADMINISTRATION Single use injection.
Danish: Til intravenøs anvendelse, alene som enkeltindgift.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa.
Danish: Efter opløsning i de medfølgende 5 ml (0,234%) natriumchloridinjektionsvæske indeholder 1 ml cirka 50 IE nonacog alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa.
Danish: Efter opløsning i de medfølgende 5 ml (0,234%) natriumchloridinjektionsvæske indeholder 1 ml cirka 100 IE nonacog alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa.
Danish: Efter opløsning i de medfølgende 5 ml (0,234%) natriumchloridinjektionsvæske indeholder 1 ml cirka 200 IE nonacog alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 400 IU nonacog alfa.
Danish: Efter opløsning i de medfølgende 5 ml (0,234%) natriumchloridinjektionsvæske indeholder 1 ml cirka 400 IE nonacog alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 600 IU nonacog alfa.
Danish: Efter opløsning i de medfølgende 5 ml (0,234%) natriumchloridinjektionsvæske indeholder 1 ml cirka 600 IE nonacog alfa
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa.
Danish: Efter opløsning i de medfølgende 5 ml (0,234%) natriumchloridinjektionsvæske indeholder 1 ml cirka 300 IE nonacog alfa.
English: Pfizer Luxembourg SARL, organizačná zložka
Danish: Pfizer Luxembourg SARL filialas
English: It spreads rapidly around the world.
Danish: Den spredes hurtigt over hele verden.
English: However, the relevance for clinical protection is unknown.
Danish: Relevansen for klinisk beskyttelse kendes imidlertid ikke.
English: Date of first authorisation: 19 October 2009 Date of latest renewal: 19 October 2014
Danish: Dato for første markedsføringstilladelse: 19. oktober 2009 Dato for seneste fornyelse: 19. oktober 2014
English: • Format of the simplified PSUR:
Danish: • Format for den forenklede PSUR:
English: - Reporting to be monthly for the first 6 months.
Danish: - Rapportering skal være månedlig de første 6 måneder.
English: AESIs will be defined as follows:
Danish: AESI'er defineres som følger:
English: Results are shown by SRH.
Danish: Resultaterne vises efter SRH.
English: The following principles should be followed when compiling the data:
Danish: Følgende principper bør følges ved dataindsamling:
English: In such cases, the side effects may be more intense).
Danish: I så fald kan bivirkningerne være mere intense.)
English: The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Danish: Følgende aldersgrupperinger anvendes:< 2 år, 2-8 år, > 9 år.
English: Foclivia has been authorised under “Exceptional Circumstances”.
Danish: Foclivia er godkendt under ”særlige omstændigheder”.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Lægerne er opmærksomme på denne mulighed og har nødbehandling til rådighed til brug i disse tilfælde.
English: Visually inspect the suspension prior to administration.
Danish: Kontroller suspensionen visuelt før administration.
English: 1 Based on the assumption that product name will not be provided in a significant proportion of cases.
Danish: 1 Baseret på formodningen om, at produktnavnet ikke vil blive opgivet i de fleste tilfælde.
English: It is important that procedures are in place to avoid injury from faints.
Danish: Det er vigtigt, at de nødvendige procedurer er etableret for at undgå skader i forbindelse med besvimelse.
English: Instructions for administration of the vaccine:
Danish: Anvisninger i administration af vaccinen:
English: It is best to see how Foclivia affects you before you try these activities.
Danish: Det er bedst at se, hvordan Foclivia påvirker dig, inden du forsøger at gøre disse ting.
English: Foclivia should be used in accordance with Official Guidance.
Danish: Foclivia bør anvendes i overensstemmelse med officielle retningslinjer.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Danish: indsnævret SMQ “demyelinering” (eftersom GBS også er inkluderet i denne SMQ, vil der forekomme overlapning i antallet af tilfælde for disse to kategorier).
English: • Supportive data in adult and elderly populations
Danish: • Understøttende data hos populationer af voksne og ældre
English: - All tables will be based on generic and not product-specific data1.
Danish: - Alle tabeller skal baseres på generiske og ikke produktspecifikke data.
English: - A line listing of fatal cases will be provided in an Annex.
Danish: - En opstillling af dødsfald vil blive vedlagt i et bilag.
English: - “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Danish: - “Kumulativt” betyder siden brugen af vaccinen; tilfælde der ikke er rapporteret under den pågældende periode bør ikke være vist i tabellen.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Danish: Disse forbigående falsk positive resultater kan skyldes IgM-produktion som respons på vaccinen.
English: This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det af videnskabelige årsager ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel.
English: Those which have not yet been entered should be reported in the following S-PSUR.
Danish: De data, der ikke er blevet indtastet endnu, skal rapporteres i den følgende S-PSUR.
English: The vaccine contains an ‘adjuvant' (a compound containing squalene) to stimulate a better response.
Danish: Vaccinen indeholder et ‘adjuvans' (et hjælpestof, som indeholder squalen) for at stimulere en bedre reaktion.
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Danish: Yderligere kan en 6-måneders cyklus være for lang til at kunne vurdere vaccinens sikkerhed, når høje eksponeringsniveauer forventes inden for kort tid.
English: • Frequency of submission:
Danish: • Indsendelsesfrekvens:
English: The safety and efficacy of Foclivia in subjects under 18 years of age have not yet been established.
Danish: Foclivias sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: In such cases, the Western blot method is negative.
Danish: I disse tilfælde giver Western Blot-teknikken negativt resultat.
English: Very rare (<1/10,000):
Danish: Meget sjælden (<1/10.000):
English: These reactions usually disappear within 1-2 days without treatment.
Danish: Disse reaktioner forsvinder som regel inden for 1-2 dage uden behandling.
English: Packs of 1 and 10 with or without needle.
Danish: Pakninger med 1 og 10 med eller uden kanyle.
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Danish: - Uret startes fra den første mandag efter afsendelse af den første vaccinebatch.
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Danish: I tilfælde af partikler og/eller usædvanligt udseende skal vaccinen kasseres.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: Hvis den pandemiske situation tillader det, skal immunisering udskydes hos patienter med alvorlig febril sygdom eller akut infektion.
English: The majority of these reactions usually disappear within 1-2 days without treatment.
Danish: De fleste af disse reaktioner forsvinder som regel inden for 1-2 dage uden behandling.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Danish: Derfor vil 6-måneders eller årlige PSUR'er, som falder inden for den pandemiske periode, blive erstattet af månedlige 'simplificerede PSUR'er' (S-PSUR) ledsaget af en oversigt over vaccinedistributionen.
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Danish: Disse antigener kan betragtes som 'nye' antigener og simulerer en situation, hvor målpopulationen for vaccination er immunologisk naive.
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Danish: For at sætte sikkerhedsrapporten i kontekst skal der inkluderes en opsummering over distributionen af vaccine, der indeholder detaljerede oplysninger om antallet af vaccinedoser, der er distribueret til i) EU-medlemsstater i rapporteringsperioden opstillet efter batchnumber, ii) EU-medlemsstater kumulativt og iii) resten af verden.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Danish: Når CHMP har bestemt, at S-PSUR ikke længere er nødvendig, vil en komplet PSUR, der dækker perioden siden “data-lock point” for den sidste rutinemæssige PSUR, blive indsendt inden for en tidsramme, som aftales med Rapporteuren.
English: Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Danish: Tilgængelige data tyder på, at flerdosishætteglas kan anvendes op til maksimalt 72 timer efter første udtrækning, men en sådan forlænget opbevaringsperiode bør ikke udgøre en foretrukket måde.
English: None of the ingredients in the vaccine can cause flu.
Danish: Ingen af stofferne i vaccinen kan give influenza.
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Danish: - S-PSUR fremsendelse til Rapporteur og CHMP-medlemmer på dag 45.
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Danish: Symptomerne på pandemisk influenza ligner symptomerne på almindelig influenza, men de kan være mere alvorlige.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATIONS TO COMPLETE POST AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: BILAG II A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: - Italy Store in a refrigerator.
Danish: - Italien Opbevares i køleskab.
English: Adults and elderly: 0.5 ml at an elected date.
Danish: Adults and elderly: 0.5 ml gives på en udvalgt dato.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Across all ages, low percentages of subjects reported fever.
Danish: På tværs af alle aldre var der en lav procentdel, der rapporterede om feber.
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Danish: Rapporten skal inkludere følgende tabeller med samlet dokumentation (ved at bruge de aftalte skabeloner vedlagt i bilag 2).
English: Your doctor or nurse administers the vaccine in accordance with official recommendations.
Danish: Lægen eller sygeplejersken giver vaccinen i overensstemmelse med de officielle retningslinjer.
English: Foclivia should not be given at the same time as other vaccines.
Danish: Foclivia bør ikke gives samtidig med andre vacciner.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Danish: Det immunologiske respons kan reduceres, hvis patienten behandles med immunsuppressiva.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Danish: Efter indsprøjtning af vaccinen vil kroppens naturlige forsvarssystem (immunsystemet) danne sin egen beskyttelse (antistoffer) mod sygdommen.