FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: What you need to know before you are given Privigen 3.
Danish: 2 “Det skal du vide, før du begynder at få Privigen”).
English: In patients at risk of acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Danish: IVIg-præparater skal administreres med lavest mulige infusionshastighed og dosering hos patienter, der har risiko for at få akut nyresvigt.
English: Transfusion related acute lung injury
Danish: Ikke almindelig Transfusionsrelateret akut lungesygdom Ikke kendt
English: Replacement therapy in adults, and children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production (see section
Danish: Substitutionsterapi hos voksne samt børn og unge (0-18 år) ved:
English: - If you have any further questions, ask your doctor or healthcare professional.
Danish: - Spørg lægen eller på sundhedspersonalet, hvis der er mere, du vil vide.
English: These include: careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, the testing of each donation and pools of plasma for signs of virus/infections, the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: • testning af hver plasmadonation og -pulje for tegn på virus/infektioner,
English: MedDRA System Organ Class (SOC)
Danish: MedDRAsystemorganklasse
English: CSL Behring AB
Danish: Κύπρος CSL Behring ΕΠΕ
English: Solution for infusion.
Danish: Infusionsvæske, opløsning.
English: - if you are pregnant.
Danish: - hvis De er gravid.
English: - if you have any blood disease.
Danish: hvis De har en blodsygdom.
English: Ask your doctor if you are not sure.
Danish: Spørg lægen, hvis De er usikker.
English: It will be the smallest quantity necessary to get the desired information.
Danish: Det vil være den mindst mulige mængde, der er nødvendig for at få den ønskede information.
English: Individual benefit/risk justification
Danish: Individuel benefit/risk-begrundelse
English: After radiolabelling: 3 hours.
Danish: Efter radiomærkning: 3 timer.
English: Only clear solutions, free of visible particles should be used.
Danish: Kun klare opløsninger, fri for synlige partikler må anvendes.
English: 69115 HEIDELBERG
Danish: 69115 HEIDELBERG TYSKLAND
English: You will not have to store this medicine.
Danish: De får ikke brug for at opbevare dette lægemiddel.
English: Rf from strip cut of
Danish: Rf fra strip udskåret af
English: 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)
Danish: 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).
English: It is not known if the product is excreted in human milk.
Danish: Det vides ikke, om præparatet udskilles i human mælk.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført i afsnit 12.
English: Under nitrogen atmosphere
Danish: Under nitrogenatmosfære
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {MM/ÅÅÅÅ}
English: A single injection into a vein in your arm is sufficient to conduct the test your doctor needs.
Danish: En enkelt indsprøjtning i en vene i armen er tilstrækkelig til udføre den test, som lægen har brug for.
English: If you are pregnant you must not be given Scintimun.
Danish: Hvis De er gravid, må De ikke få Scintinun.
English: Cut the strip in two separate parts at Rf = 0.5.
Danish: Skær strimlen i to dele ved Rf = 0,5.
English: In case of allergic reaction you will receive appropriate treatment from your doctor.
Danish: I tilfælde af en allergisk reaktion vil De modtage relevant behandling af lægen.
English: F-91192 Gif-sur-Yvette Cedex France
Danish: F-91192 Gif-sur-Yvette Cedex Frankrig
English: Interpretation of images
Danish: Fortolkning af billederne
English: This medicine is not recommended for use in patients below 18 years of age because the safety and efficacy of the product have not been established.
Danish: Dette lægemiddel anbefales ikke til brug hos patienter under 18 år, idet sikkerheden og virkningen af lægemidlet ikke er klarlagt.
English: ATC code: V09HA03
Danish: ATC-kode: V09HA03
English: Appropriate aseptic precautions should be taken.
Danish: Passende aseptiske forsigtighedsregler skal tages.
English: Myalgia, arthralgia
Danish: Myalgi, arthralgi
English: Effective Dose 0.00863 mSv / MBq
Danish: Effektiv dosis 0,00863 mSv/MBq
English: - if you have had a scintigraphy with technetium in the last 2 days.
Danish: hvis De har fået en skintigrafisk undersøgelse med technetium inden for de seneste 2 dage.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Danish: For hver patient skal strålingseksponeringen være begrundet med den sandsynlige fordel.
English: Contact your nuclear medicine doctor if you have any questions.
Danish: Kontakt nuklearmedicineren, hvis De har nogen spørgsmål.
English: Swirl carefully to mix the whole solution (DO NOT shake).
Danish: Hvirvl forsigtigt for at blande hele opløsningen (må IKKE omrystes).
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Danish: Præparaternes modtagelse, opbevaring, anvendelse, overførsel og bortskaffelse er underlagt de relevante officielle organisationers retningslinjer og/eller relevante tilladelser.
English: The frequencies are based on the most recent clinical trial and non interventional safety survey.
Danish: Hyppighederne er baseret på det seneste, kliniske forsøg og på ikkeinterventionssikkerhedsundersøgelse.
English: • Serious allergic reaction which causes difficulty in breathing or dizziness
Danish: • Alvorlig, allergisk reaktion, der giver åndedrætsbesvær eller svimmelhed
English: A risk to a breast-fed child cannot be excluded.
Danish: En risiko for et ammet barn kan ikke udelukkes.
English: METHOD OF ADMINISTRATION Not intended for direct application to patients.
Danish: ANVENDELSESMÅDE Ikke beregnet til direkte anvendelse til patienter.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Danish: Den indgivne aktivitet skal i hvert enkelt tilfælde være så lav som det med rimelighed er muligt for at opnå den nødvendige diagnostiske information.
English: Pharmacodynamic effects At the recommended activities, it does not exert any clinically relevant pharmacodynamic effects.
Danish: Farmakodynamisk virkning Ved de anbefalede aktiviteter udøver det ingen klinisk relevant, farmakodynamisk virkning.
English: Quality control
Danish: Kvalitetskontrol
English: This will protect your child from the radiation that may be present in your breast milk.
Danish: Det vil beskytte barnet mod den stråling, der kan være til stede i mælken.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Danish: Der er strenge lovkrav vedrørende brug, håndtering og bortskaffelse af radioaktive lægemidler.
English: Genotoxicity studies conducted to test for potentially genotoxic impurities were also negative.
Danish: Genotoksicitetsforsøg, der blev gennemført for at teste for potentielt genotoksiske urenheder, var også negative.
English: - The final radiolabelled injection solution must be protected from oxygen.
Danish: - Den endelige, radiomærkede injektionsopløsning skal beskyttes mod oxygen.
English: Date of latest renewal: 26 August 2014
Danish: Dato for første markedsføringstilladelse: 11. januar 2010 Dato for seneste fornyelse: 26. august 2014
English: Scintimun should only be used once in a patient's lifetime.
Danish: Scintimun bør kun anvendes én gang i en patients levetid.
English: The DHPC also includes 3 copies of a Patient Alert Card completed by the Healthcare Professional and provided to each patient.
Danish: DHPC-brevet indeholder også 3 kopier af et patientkort, der udfyldes af lægen eller sundhedspersonalet og gives til hver patient.
English: Scintimun should be given to sufficiently hydrated patients.
Danish: Scintimun må kun gives til tilstrækkeligt hydrerede patienter.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The safety and efficacy of Scintimun in children and adolescents have not yet been established.
Danish: Scintimuns sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: Patients who are HAMA positive may have a greater risk for hypersensitivity reactions.
Danish: Patienter, der er HAMA-positive, kan have en forøget risiko for overfølsomhedsreaktioner.
English: This corresponds to the administration of 0.25 to 1 mg of besilesomab.
Danish: Dette svarer til indgivelse af 0,25 til 1 mg besilesomab.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De får denne medicin, da den indeholder vigtige oplysninger.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Danish: Nuklearmedicineren vil informere Dem, hvis De skal tage nogen særlige forholdsregler, efter at De har fået dette lægemiddel.
English: Elderly No dose adjustment is required.
Danish: Ældre Dosisjustering er ikke nødvendig.
English: Table 1: Values of the absorbed doses calculated for the individual male and female of reference.
Danish: Tabel 1: Værdier for absorberede doser, beregnet for den enkelte reference for henholdsvis mænd og kvinder.
English: This may increase the risk of allergic reactions in case of repeated administration of Scintimun.
Danish: Dette kan forøge risikoen for allergiske reaktioner i tilfælde af gentagen indsprøjtning af Scintimun.
English: Scintimun images should be interpreted in the context of other appropriate anatomical and/or functional imaging examinations.
Danish: Scintimun-billeder skal vurderes i sammenhæng med andre egnede, anatomiske og/eller funktionelle billeddannende undersøgelser.
English: An additional acquisition 24 hours after initial injection is recommended.
Danish: En yderligere optagelse 24 timer efter første injektion anbefales.
English: For each organ, or group of organs, the absorbed doses have been calculated using the methodology developed by the MIRD (Medical Internal Radiation Dose).
Danish: For hvert organ eller hver gruppe af organer er de absorberede doser beregnet ved brug af de metoder, der er udviklet af MIRD (Medical Internal Radiation Dose).
English: False results may be obtained in patients with diseases involving neutrophil defects and to patients with haematological malignancies including myeloma.
Danish: Falske resultater kan fås hos patienter med sygdomme, der involverer neutrofile defekter, og hos patienter med hæmatologiske maligne sygdomme, herunder myeloma.
English: Such substances should therefore not be administered together with, or a short time before the injection of Scintimun.
Danish: Sådanne stoffer må derfor ikke indgives sammen med eller kort tid før injektionen af Scintimun.
English: Non pathological unusual accumulations may be observed in the spleen (up to 6 % of the patients), in the bowel (up to 4 % of the patients), in the liver and bone marrow (up to 3 % of the patients), and in the thyroid and kidneys (up to 2 % of patients).
Danish: Ikke-patologiske, ekstraordinære akkumuleringer kan observeres i milten (op til 6 % af patienterne), i tarmen (op til 4 % af patienterne), i leveren og knoglemarven (op til 3 % af patienterne) samt i thyreoidea og nyrerne (op til 2 % af patienterne).
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweights the risk due to radiation.
Danish: Deres læge og nuklearmedicineren har overvejet, om den kliniske fordel, som De vil få af undersøgelsen med det radioaktive lægemiddel, opvejer risikoen på grund af stråling.
English: Package leaflet: information for the patient
Danish: Indlægsseddel: information til patienten
English: This medicinal product should be reconstituted and radiolabelled before administration to the patient.
Danish: Dette lægemiddel skal rekonstitueres og radiomærkes før administration til patienten.
English: EXP Use within 3 hours after radiolabelling.
Danish: EXP Bruges inden 3 timer efter radiomærkning
English: Withdrawals should be performed under aseptic conditions.
Danish: Præparation skal udføres under aseptiske forhold.
English: The frequency listed below is defined using the following convention:
Danish: De nedenfor anførte hyppigheder er defineret efter følgende konvention:
English: You can also report side effects directly via directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Do not store above 25 °C after radiolabelling.
Danish: Må ikke opbevares ved temperaturer over 25 °C efter radiomærkning.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Danish: Procedurerne ved administration skal udføres på en sådan måde, at risikoen for kontaminering af lægemidlet og bestråling af personalet minimeres.
English: Measurement of radioactivity levels in urine shows that up to 14 % of the administered activity is excreted via the bladder during the 24 h post-injection.
Danish: Måling af radioaktivitetsniveauer i urinen viser, at op til 14 % af den indgivne aktivitet udskilles via blæren i løbet af 24 timer efter injektionen.
English: After correcting for the decay of radionuclide, the calculated half-life of the early phase is 0.5 h whereas the late phase shows a half-life of elimination of 16 h.
Danish: Efter korrektion for radionuklidets henfald er den tidlige fases beregnede halveringstid 0,5 h, mens den sene fase viser en halveringstid for eliminering på 16 h.
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Danish: For at gøre det muligt at handle straks i akutte tilfælde skal de nødvendige lægemidler og det nødvendige udstyr såsom endotrakeal tube og respirator være umiddelbart tilgængelige.
English: Without removing the needle, withdraw an equivalent volume of air in order to avoid excess pressure in the vial.
Danish: Uden at fjerne kanylen udtrækkes et tilsvarende volumen luft for at undgå overtryk i hætteglasset.
English: Acquisition can be performed using planar imaging.
Danish: Optagelse kan udføres ved brug af planar scanning.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De kan være gravid, eller planlægger at blive gravid, skal De spørge nuklearmedicineren til råds, før De får dette lægemiddel.
English: Separately count each cut part of the strip and record the obtained values (use an appropriate detection apparatus with a constant counting time, and known geometry and background noise).
Danish: Optæl hver udskåren del af strimlen, og nedskriv de opnåede værdier (anvend et egnet optællingsapparatur med konstant tælletid, kendt geometri og baggrundsstøj).
English: The content of the kit before reconstitution is not radioactive.
Danish: Inden rekonstitution er sættets indhold ikke radioaktivt.
English: About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun.
Danish: Ca. 14 ud af 100 patienter, der har fået denne indsprøjtning, har fået påvist, at de producerer antistoffer i blodet, der reagerer mod det antistof, der er i Scintimun.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/602/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/602/001
English: After injection into your vein, your doctor can obtain pictures (scans) of your organs that give more information about the detection of sites of inflammation and/or infection.
Danish: Efter indsprøjtning i en blodåre kan lægen få billeder (scanninger) af Deres organer, og disse billeder giver flere oplysninger til påvisning af steder for betændelse og/eller infektion.
English: DO NOT let the spot dry.
Danish: Pletten må IKKE udtørre.
English: Data on repeated dosing of Scintimun are very limited.
Danish: Data for gentagen dosering af Scintimun er meget begrænsede.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan påvirke mere end 1 ud af 10 personer):
English: The radiochemical purity of the final radiolabelled preparation can be tested according to the following procedure:
Danish: Det endelige, radiomærkede præparats radiokemiske renhed kan kontrolleres i overensstemmelse med følgende procedure:
English: Specific warnings
Danish: Specifikke advarsler
English: However, based on the investigator's diagnosis after one month of follow-up, Scintimun had a slightly lower specificity (71.8 %) than 99mTc-WBCs (79.5 %).
Danish: Baseret på investigatorens diagnose efter en måneds opfølgning havde Scintimun dog en lidt lavere specificitet (71,8 %) end 99mTc-WBC (79,5 %)
English: Uncommon (may affect up to 1 in 100 people): Allergic reaction, including swelling of the face, hives (urticaria)
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer): Allergisk reaktion, herunder opsvulmen af ansigtet, nældefeber (urticaria)
English: There are currently no criteria to distinguish infection and inflammation by means of Scintimun imaging.
Danish: Der er i øjeblikket ingen kriterier til at skelne mellem infektion og betændelse ved hjælp af Scintimunscanning.
English: If you have been given more Scintimun than you should An overdose is unlikely because injection is prepared as a single dose by the hospital personnel, under strictly controlled conditions.
Danish: En overdosis er usandsynlig, eftersom indsprøjtning forberedes som en enkelt dosis af hospitalspersonalet under strengt kontrollerede forhold.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Danish: Enhver kvinde, hvis menstruation er udeblevet, skal anses for gravid, indtil andet er påvist.
English: Because you could emit radiation especially harmful to young children during the first 12 hours after the injection, you should avoid close contact with young children and pregnant women during this period of time.
Danish: Da De muligvis kan afgive stråling, der især er skadelig for små børn , i løbet af de første 12 timer efter indsprøjtningen, skal De undgå tæt kontakt med små børn og gravide kvinder i denne periode.
English: As the effective dose is about 6.9 mSv when the maximal recommended activity of 800 MBq is administered these adverse reactions are expected to occur with a low probability.
Danish: Da den effektive dosis er ca. 6,9 mSv, når den maksimalt anbefalede aktivitet på 800 MBq indgives, forventes sandsynligheden for, at disse bivirkninger opstår, at være lav.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Eksponering for ioniserende stråling er forbundet med cancerinduktion og risiko for udvikling af arvelige defekter.
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Danish: Dette radioaktive præparat vil afgive lave mængder ioniserende stråling, der forbindes med den laveste risiko for cancer og arvelige abnormiteter.
English: The activity must be between 400 and 1800 MBq depending on the volume of pertechnetate (99mTc).
Danish: Aktiviteten skal være mellem 400 og 1800 MBq, afhængigt af voluminet af pertechnetat (99mTc).
English: Common (may affect up to 1 in 10 people): Low blood pressure
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer): Lavt blodtryk
English: Rf to
Danish: Rf til
English: When the solvent has reached the top of the strip (about 10 minutes), use the forceps to remove the strip and dry in the air.
Danish: Når opløsningsmidlet har nået strippens top (ca. 10 minutter), fjernes strimlen med pincet og tørres i luften.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Danish: Indgivelsen af radioaktive præparater indebærer risiko for andre personer fra ekstern stråling eller kontaminering fra spild af urin, opkast osv.
English: This medicinal product is for use in designated nuclear medicine facilities only, and should only be handled by authorised personnel.
Danish: Dette lægemiddel er alene til brug i designerede, nuklearmedicinske afdelinger og må kun håndteres af autoriseret personale.
English: Pregnancy The use of besilesomab is contraindicated in pregnant women (see section 4.3).
Danish: Graviditet Brug af besilesomab er kontraindiceret hos gravide kvinder (se pkt.
English: The effective dose has been calculated by using the absorbed doses determined for each individual organ, taking into account the weighting factors (radiation and tissue) to use according to the recommendations of the ICRP (International Commission of Radiological Protection, Publication 103).
Danish: Den effektive dosis er beregnet ved brug af de absorberede doser, der bestemmes for hvert enkelt organ, hvor vægtningsfaktorer (stråling og væv) medtages og anvendes i overensstemmelse med anbefalinger fra ICRP (International Commission of Radiological Protection, Publication 103).
English: The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 70 kg is 6.9 mSv.
Danish: Den effektive dosis efter indgivelse af en aktivitet på 800 MBq til en voksen, der vejer 70 kg, er 6,9 mSv.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne angivet efter faldende alvorlighed.
English: If you wish, you can express and store your breast milk before your injection.
Danish: Hvis De ønsker det, kan De udmalke og gemme mælk før indsprøjtningen.
English: After 1 min, check that the content of the vial of Scintimun has completely dissolved.
Danish: Kontrollér efter 1 minut, at indholdet af hætteglasset med Scintimun er fuldstændigt opløst.