FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia
Danish: Der foreligger oplysninger om sikkerhed og virkning, der viser, at denne vaccine kan blandes og gives med Merials vaccine uden adjuvans mod felin leukæmi.
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
Danish: Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus, felin calicivirus og Chlamydophila felis.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Danish: Der foreligger oplysninger om sikkerhed og virkning der viser, at denne vaccine kan blandes med Merials vaccine uden adjuvans mod felin leukæmi og/eller anvendes den samme dag men ikke blandes med Merials vaccine med adjuvans mod rabies.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh
Danish: VETERINÆRLÆGEMIDLETS NAVN Purevax RCCh
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection.
Danish: LÆGEMIDDELFORM Lyofilisat og solvens til injektionsvæske, suspension.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
Danish: Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus og Chlamydophila felis.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate and solvent for suspension for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Purevax RCCh, lyofilisat og solvens til injektionsvæske, suspension.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh solvent
Danish: VETERINÆRLÆGEMIDLETS NAVN Purevax RCCh solvens.
English: Use only in healthy animals.
Danish: Vacciner kun raske dyr.
English: ROUTE(S) OF ADMINISTRATION Subcutaneous use
Danish: INDGIVELSESVEJ(E) Subkutan anvendelse.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Purevax RCCh lyofilisat til injektionsvæske.
English: Shelf life after reconstitution: use immediately after reconstitution
Danish: 10. UDLØBSDATO EXP {MM/ÅÅÅÅ} Anvendes umiddelbart efter opløsning.
English: Solvent: Water for injection ....................................................................................................................... q.s.
Danish: Vand til injektion …………… ..................................................... …………………………… q.s 1 ml
English: 29, avenue Tony Garnier F-69007 LYON FRANCE
Danish: 29, avenue Tony Garnier F-69007 LYON FRANKRIG
English: 29, avenue Tony Garnier 69007 LYON FRANCE
Danish: 29, avenue Tony Garnier 69007 Lyon
English: 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Kat
English: Lyophilisate:
Danish: Lyofilisat:
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent
Danish: Æske indeholdende 50 flasker med 1 dosis lyofilisat og 50 flasker med 1 ml solvens.
English: Water for injection ....................................................................................................................... q.s.
Danish: Vand til injektion……… ……………………………………………………………..………..q.s.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gyldige resumé af produktets egenskaber, etikettering og indlægsseddel er de endelige versioner opnået med Koordineringsgruppens procedure.
English: Summary of product characteristics, labelling and package leaflet
Danish: Resumé af produktets egenskaber, etikettering og indlægsseddel
English: Elderly population (> 65 years old)
Danish: Ældre population (> 65 år)
English: Your doctor will want to monitor you closely for at least 16 weeks.
Danish: Lægen vil ønske at overvåge dig nøje i mindst 16 uger.
English: The infusion will take approximately 2 hours.
Danish: Infusionen vil tage omkring 2 timer.
English: The following requirements need to be fulfilled before the product is dispensed:
Danish: De følgende krav skal opfyldes, før præparatet udleveres:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1371/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1371/001
English: Vaccination may further activate complement.
Danish: Vaccination kan aktivere komplement yderligere.
English: Min, max
Danish: Min; maks
English: Ravulizumab should be given to a pregnant woman only if clearly needed.
Danish: Ravulizumab må kun gives til en gravid kvinde, hvis det er klart nødvendigt.
English: Other systemic infections
Danish: Andre systemiske infektioner
English: You should take this into consideration if you are on a controlled sodium diet.
Danish: Du bør tage hensyn til dette, hvis du er på en saltfattig diæt.
English: In pregnant women the use of ravulizumab may be considered following an assessment of the risks and benefits.
Danish: Hos gravide kvinder kan det overvejes at bruge ravulizumab efter en vurdering af risici og fordele.
English: Age (years) at first infusion in study
Danish: Alder (år) ved den første infusion i studiet
English: ≥ 40 to < 60 ≥ 60 to < 100
Danish: ≥ 40 til < 60 ≥ 60 til < 100
English: A risk to infants cannot be excluded.
Danish: En risiko for spædbørn kan ikke udelukkes.
English: Therapeutic steady-state drug concentrations are reached after the first dose.
Danish: Terapeutiske steady-state-lægemiddelkoncentrationer nås efter den første dosis.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, skal navnet og batchnummeret på det administrerede præparat tydeligt registreres.
English: You should also be aware that vaccination may not always prevent this type of infection.
Danish: Du skal også være opmærksom på, at vaccinationen måske ikke altid forebygger denne infektionstype.
English: Do not give this medicine to children under 18 years of age as no data are available on its safety and effectiveness in this group.
Danish: Dette lægemiddel må ikke gives til børn under 18 år, da der ikke foreligger nogen data vedrørende sikkerhed eller virkning for denne gruppe.
English: You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Danish: Du skal stadig huske at tage til lægen hurtigst muligt, selv hvis du får det bedre, efter du har taget antibiotikummet.
English: This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 133 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: The effects of the medicine on an unborn child are not known.
Danish: Lægemidlets virkning på det ufødte barn er ikke kendt.
English: In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Danish: I overensstemmelse med nationale anbefalinger kan lægen anse det for nødvendigt, at der iværksættes ekstra foranstaltninger for at undgå en infektion.
English: Adult patients with PNH
Danish: Voksne patienter med PNH
English: Sex (n, %)
Danish: Køn (n, %)
English: No case of overdose has been reported to date.
Danish: Der er endnu ikke rapporteret tilfælde af overdosering.
English: Aseptic technique must be used.
Danish: Der skal anvendes en aseptisk teknik.
English: The patient should be monitored for one hour following infusion.
Danish: Patienten skal overvåges i en time efter infusionen.
English: o All patients must be monitored for signs of meningitidis.
Danish: o Alle patienterne skal monitoreres for tegn på meningitidis.
English: Ensure that your current meningococcal vaccination is up to date.
Danish: Sørg for, at din nuværende meningokokvaccination stadig dækker.
English: Treatment with any therapeutic protein may induce an immune response.
Danish: Behandling med et hvilket som helst terapeutisk protein kan inducere et immunrespons.
English: This medicine contains sodium (see section 2 “Ultomiris contains sodium”).
Danish: Dette lægemiddel indeholder natrium (se punkt 2 ”Ultomiris indeholder natrium”).
English: Minimum infusion duration minutes (hours)
Danish: Korteste infusionsvarighed minutter (timer)
English: Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use.
Danish: Patienterne skal vaccineres eller revaccineres i henhold til de gældende nationale retningslinjer for brug af vaccinationer.
English: Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.
Danish: Derfor skal patienterne overvåges nøje for sygdomssymptomer efter den anbefalede vaccination.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2019
Danish: Dato for første markedsføringstilladelse: 02 juli 2019
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA43
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, selektive immunsuppressiva, ATC-kode: L04AA43
English: Your doctor will discuss the possible side effects with you and explain the risks.
Danish: Lægen vil diskutere de mulige bivirkninger med dig og forklare dine risici.
English: It is not necessary to protect the diluted solution of Ultomiris from light during administration to the patient.
Danish: Det er ikke nødvendigt at beskytte den fortyndede opløsning af Ultomiris mod lys under administration til patienten.
English: Physicians should advise patients about gonorrhoea prevention.
Danish: Læger skal rådgive patienter om forebyggelse af gonoré.
English: Your first dose is called the loading dose.
Danish: Den første dosis kaldes støddosen.
English: No dose adjustment is required for patients with PNH aged 65 years and over.
Danish: Ingen dosisjustering er nødvendig for patienter med PNH i alderen 65 år og derover.
English: o Enrolment in the PNH registry.
Danish: o Indskrivning i PNH-registret.
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Danish: Patienter, som oplever en overdosering, skal straks have deres infusion afbrudt, og de skal overvåges nøje.
English: It is unknown whether ravulizumab is excreted into human milk.
Danish: Det er ukendt, om ravulizumab udskilles i human mælk.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: The safety and efficacy of ravulizumab in children with PNH aged 0 to < 18 years have not been established.
Danish: Ravulizumabs sikkerhed og virkning hos børn med PNH i alderen 0 til < 18 år er ikke klarlagt.
English: Infusion must be administered through a 0.2 µm filter.
Danish: Infusionen skal administreres via et 0,2 µm filter.
English: It should not be shaken.
Danish: Det må ikke omrystes.
English: Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 UNITED STATES
Danish: Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 USA
English: o The risk of immunogenicity and advice on post-infusion monitoring.
Danish: o Risikoen for immunogenicitet og rådgivning om post-infusions-monitorering.
English: Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
Danish: Vacciner mod serogrupper A, C, Y, W135 og B, hvor det er muligt, anbefales til forebyggelse af de almindeligvis patogene meningokok-serogrupper.
English: The time to maximum observed concentration (tmax) is expected at the end of infusion (EOI) or soon after EOI.
Danish: Tidspunktet for den maksimale observerede koncentration (tmax) forventes at være ved slutningen af infusionen eller hurtigt herefter.
English: Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment.
Danish: Lægen vil diskutere de mulige bivirkninger med dig og forklare risiciene og fordelene ved Ultomiris for dig før din behandling.
English: Please refer to section 4.4 for information on prevention and treatment of suspected meningococcal infection.
Danish: 4.4 for oplysninger om forebyggelse og behandling af mistænkt meningokokinfektion.
English: By attaching to and blocking the C5 protein, this medicine can stop complement proteins from attacking red blood cells and so control symptoms of the disease.
Danish: Ved at binde sig til og blokere C5-proteinet, kan dette lægemiddel forhindre, at komplementproteinerne angriber de røde blodlegemer, og dermed kontrollere symptomerne på sygdommen.
English: 4- Special handling and storage
Danish: 4- Særlig håndtering og opbevaring
English: Ultomiris should not be shaken.
Danish: Ultomiris må ikke omrystes.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Total PNH RBC clone size
Danish: Total PNH RBC-klonstørrelse
English: If you have any of these symptoms, contact your doctor.
Danish: Hvis du har et eller flere af disse symptomer, skal du kontakte lægen.
English: Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data).
Danish: Bivirkningerne er opstillet i henhold til MedDRA-systemorganklasse (SOC) og hyppighed ved anvendelse af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: o The risk of developing antibodies to ravulizumab.
Danish: o Risikoen for at udvikle antistoffer mod ravulizumab.
English: There is no evidence indicating any special precautions are required for treating a geriatric population - although experience with ravulizumab in elderly patients is limited.
Danish: Der er ikke evidens, som indikerer, at særlige forsigtighedsregler er nødvendige ved behandling af en geriatrisk population - dog er erfaring med ravulizumab til ældre patienter begrænset.
English: Vaccination reduces, but does not eliminate, the risk of meningococcal infections.
Danish: Vaccination reducerer, men eliminerer ikke risikoen for meningokokinfektioner.
English: No specific test-article related reproductive toxicities were identified in these studies.
Danish: Der blev ikke identificeret nogen specifikke testartikel-relaterede reproduktionstoksiciteter i disse studier.
English: Because the route of ravulizumab administration is an intravenous infusion and the dosage form is a solution, 100 % of the administered dose is considered bioavailable.
Danish: Da administrationsvejen for ravulizumab er en intravenøs infusion, og doseringsformen er en opløsning, anses 100 % af den administrerede dosis for at være biotilgængelig.
English: Transfer the recommended dose to an infusion bag.
Danish: - Overfør den anbefalede dosis til en infusionspose.
English: Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity.
Danish: Hvis du afbryder eller stopper behandlingen med Ultomiris, kan det få dine PNH-symptomer til at komme tilbage med en større sværhedsgrad.
English: All 3 recovered while continuing treatment with ravulizumab.
Danish: Alle 3 blev raske, mens de fortsatte behandlingen med ravulizumab.
English: These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis).
Danish: Det er en svær infektion i hjernehinderne, som kan sprede sig i hele kroppen og i blodet (sepsis).
English: Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and their signs and symptoms.
Danish: Patienterne skal via indlægssedlen informeres om at øge deres opmærksomhed på mulige alvorlige infektioner og deres tegn og symptomer.
English: Ravulizumab contains only natural occurring amino acids and has no known active metabolites.
Danish: Ravulizumab indeholder kun naturligt forekommende aminosyrer og har ingen kendte aktive metabolitter.
English: However, chemical and physical stability of the diluted product have been demonstrated for up to 24 hours at 2°C-8°C and up to 6 hours at room temperature.
Danish: Kemisk og fysisk stabilitet af det fortyndede lægemiddel er imidlertid blevet vist i op til 24 timer ved 2 °C-8 °C og i op til 6 timer ved stuetemperatur.
English: o Treatment with ravulizumab increases the risk of N. meningitidis infections.
Danish: o Behandling med ravulizumab øger risikoen for N. meningitidis-infektioner.
English: Very common (may affect more than 1 in 10 people): Headache
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer):
English: Two weeks after receiving your loading dose, you will be given a maintenance dose of Ultomiris, and this will then be repeated once every 8 weeks.
Danish: 2 uger efter, du har fået din støddosis, vil du få en vedligeholdelsesdosis af Ultomiris, som vil blive gentaget en gang hver 8. uge.
English: See the leaflet for further information.
Danish: Læs indlægssedlen for yderligere information.
English: In case of infusion reaction, infusion of ravulizumab should be interrupted and appropriate supportive measures should be instituted if signs of cardiovascular instability or respiratory compromise occur.
Danish: I tilfælde af infusionsreaktioner skal ravulizumab-infusionen afbrydes, og der skal iværksættes passende støtteforanstaltninger, hvis der opstår tegn på kardiovaskulær ustabilitet eller respirationshæmning.
English: Administration of ravulizumab may result in infusion reactions.
Danish: Administration af ravulizumab kan føre til infusionsreaktioner.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Alexion Europe SAS
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Alexion Europe SAS
English: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 UNITED STATES
Danish: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 USA
English: Ultomiris is a medicine that contains the active substance ravulizumab and it belongs to a class of medicines called monoclonal antibodies, that attach to a specific target in the body.
Danish: Ultomiris er et lægemiddel, som indeholder det aktive stof ravulizumab, og det tilhører en klasse af lægemidler, der kaldes monoklonale antistoffer, som binder sig til et specifikt mål i kroppen.
English: The prepared solution should be administered immediately following preparation unless it is stored at 2-8°C.
Danish: Den klargjorte opløsning skal administreres straks efter klargøring, medmindre den opbevares ved 2 - 8 °C.
English: There are no clinical data from the use of ravulizumab in pregnant women.
Danish: Der er ingen kliniske data fra anvendelse af ravulizumab til gravide kvinder.
English: If you suspect that you have been accidentally given a higher dose of Ultomiris than prescribed, please contact your doctor for advice.
Danish: Hvis du har mistanke om, at du ved et uheld har fået en højere dosis af Ultomiris end ordineret, skal du kontakte lægen med henblik på rådgivning.
English: Ultomiris must be diluted prior to administration by intravenous infusion over a minimal period of 1.7 to 2.4 hours depending of body weight, see Table 2 below.
Danish: Ultomiris skal fortyndes før administration ved intravenøs infusion over mindst 1,7 til 2,4 timer afhængigt af legemsvægt, se tabel 2 nedenfor.
English: 40 to less than 60 60 to less than 100 above 100
Danish: 60 til under 100
English: For intravenous infusion only.
Danish: Kun til intravenøs infusion.
English: As a result, patients with complement-mediated diseases, including PNH, may experience increased signs and symptoms of their underlying disease, such as haemolysis.
Danish: Som følge heraf kan patienter med komplementmedierede sygdomme, herunder PNH, få flere tegn og symptomer på deres underliggende sygdom, såsom hæmolyse.
English: Ravulizumab preserves the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes.
Danish: Ravulizumab beskytter de tidlige komponenter af komplementaktiveringen, som er essentielle for opsonisering af mikroorganismer og clearance af immunkomplekser.
English: More than 80 % of patients in both treatment groups had a history of transfusion within 12 months of study entry.
Danish: Over 80 % af patienterne i begge behandlingsgrupper havde fået en transfusion inden for 12 måneder, før de indgik i studiet.
English: Ultomiris contains sodium
Danish: Ultomiris indeholder natrium
English: Meningococcal disease due to any serogroup may occur.
Danish: Der kan opstå meningokoksygdom som følge af en hvilken som helst serogruppe.
English: Ravulizumab is a monoclonal antibody IgG2/4K that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the C5b-9.
Danish: Ravulizumab er et monoklonalt antistof IgG2/4K, som binder specifikt til komplementproteinet C5, hvorved det hæmmer spaltningen til C5a (det proinflammatoriske anafylatoksin) og C5b (den initierende subunit af det terminale komplementkompleks [C5b-9]) og forhindrer dannelsen af C5b-9.
English: If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed.
Danish: Hvis du oplever et eller flere af de symptomer, som er beskrevet ovenfor, skal du tage den ordinerede antibiotikakur.
English: Note: LDH = lactate dehydrogenase; CI = Confidence Interval.
Danish: Bemærk: LDH = lactatdehydrogenase, CI = konfidensinterval.
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Danish: Hvis du er i tvivl om, hvad de nedenstående bivirkninger er, skal du bede lægen om at forklare dem for dig.
English: • Submission of written confirmation of the patient`s vaccination against all available meningococcal infection serotypes N. meningitidis and/or prophylactic antibiotic treatment according to national vaccination guideline.
Danish: • Indsendelse af skriftlig bekræftelse af patientens vaccination mod alle tilgængelige N. meningitidis-meningokokinfektionsserotyper og/eller profylaktisk antibiotisk behandling i henhold til nationale retningslinjer for vaccinationer.
English: Prior to launch of Ultomiris in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Ultomiris markedsføres i hvert medlemsland, skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet og det kontrollerede udleveringsprogram, herunder kommunikationsmedier, distributionsmetoder samt alle andre aspekter af programmet.
English: If you stop using Ultomiris
Danish: Hvis du holder op med at bruge Ultomiris