FrancophonIA/ELRC3.0 huggingface dataset:
English: ADVICE ON CORRECT ADMINISTRATION Aseptically reconstitute the lyophilisate with the solvent.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Rekonstituer lyofilisat med solvens aseptisk.
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
Danish: − for at forebygge kliniske symptomer (næse- og øjenudflåd) og begrænse virusudskillelse forårsaget af hundeparainfluenzavirus.
English: − to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,
Danish: − for at forebygge kliniske symptomer og begrænse virusudskillelse forårsaget af hundeadenovirus type 2
English: Aseptically reconstitute the lyophilisate with the solvent.
Danish: Rekonstituer lyofilisat med solvens aseptisk.
English: SPECIAL WARNING(S)
Danish: INDIKATION(ER)
English: Reconstituted vaccine: whitish to yellowish colour with a slight opalescence.
Danish: Rekonstitueret vaccine: hvidlig eller gullig farve med let opalisering.
English: − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, and
Danish: − for at forebygge kliniske symptomer, leukopeni og virusudskillelse forårsaget af hundeparvovirus og
English: Lyophilisate and solvent for suspension for injection.
Danish: Lyofilisat og solvens til injektionsvæske, suspension.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Danish: LÆGEMIDDELFORM Lyofilisat og solvens til injektionsvæske, suspension
English: Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence.
Danish: Efter blanding bør indholdet i hætteglasset have en hvidlig eller gullig farve med let opalisering.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi lyofilisat og solvens til injektionsvæske, suspension til hund
English: PACKAGE LEAFLET: Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus DHPPi lyofilisat og solvens til injektionsvæske, suspension til hund
English: The visual appearance is as follows:
Danish: Udseende:
English: − to prevent mortality and clinical signs caused by canine distemper virus,
Danish: − for at forebygge mortalitet samt de kliniske symptomer forårsaget af hundesygevirus
English: At least one year following the primary vaccination course for canine parainfluenza virus.
Danish: Mindst 1 år efter basisvaccination for CPiV.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi - lyofilisat til hund
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi solvent for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi - solvens til hund
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN ”TIL DYR”
English: VIAL (1 ML SOLVENT)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER HÆTTEGLAS (SOLVENS, 1 ML)
English: Canine distemper virus
Danish: Hundesygevirus
English: MA (EU) Number (Invented) name
Danish: MF (EU)-nummer
English: It tells you about your medicine.
Danish: Den fortæller dig om din medicin.
English: Repeat administration must be avoided.
Danish: Gentagen administration skal undgås.
English: The MAM should be prepared fresh daily.
Danish: MAM bør være frisk fremstillet dagligt.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: A separate cannula should be used.
Danish: En separat kanyle skal anvendes.
English: A value of at least 90% should be obtained in a satisfactory preparation.
Danish: En værdi på mindst 90% bør opnås i en tilfredsstillende opløsning.
English: However PET is not
Danish: Imidlertid er PET ikke almindeligt
English: Continue until a solid residue remains.
Danish: Fortsæt indtil der forbliver fast stof tilbage.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
English: Appropriate treatment and equipment should be readily available.
Danish: Egnede præparater og udstyr bør være umiddelbart tilgængelige.
English: Alternative techniques, which do not involve ionising radiation, should be considered.
Danish: Alternative teknikker, der ikke involverer ioniserende stråling, skal overvejes.
English: See section 4.4
Danish: Se punkt 4.4.
English: Higher doses might be justified in some clinical
Danish: Højere doser kan være berettigede i nogle
English: The peptide itself has a lower affinity for these receptors.
Danish: Selve peptidet har en lavere affinitet for disse receptorer.
English: Count each strip section in a dose calibrator and interpret the results as follows:
Danish: Tæl hver sektion i en dosis kalibrator og fortolk resultaterne som følger:
English: The ammonium acetate solution can be used for up to one month.
Danish: Ammonium acetat opløsningen kan anvendes i op til en måned.
English: Do not use NeoSpect after the expiry date which is stated on the label.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på etiketten.
English: Swirl gently for 10 seconds in order to ensure complete dissolution of the powder.
Danish: Bland forsigtigt i 10 sekunder for at sikre fuldstændig opløsning af pulveret.
English: The product label includes the appropriate storage conditions and the expiry date for the product.
Danish: Produktets etiket indeholder de hensigtsmæssige opbevaringsforhold og udløbsdatoen for lægemidlet.
English: All were uncommon (0.1%-1%) in occurrence.
Danish: Alle var sjældent (0,1% - 1%) forekomne.
English: Use aseptic technique throughout.
Danish: Anvend aseptisk teknik gennem hele proceduren.
English: It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Danish: Det vil kun blive anvendt og administreret af personer, som er uddannet og kvalificeret i sikker håndtering af radioaktivt materiale.
English: Instructions for reconstitution, handling and disposal are given in section 12.
Danish: Instruktioner om rekonstitution, håndtering og bortskaffelse er anført under punkt 12.
English: No case of overdose has been reported.
Danish: Der er ingen meddelelser om tilfælde af overdosering.
English: Estimated absorbed radiation dose Target Organ mGy/MBq
Danish: Estimerede absorberede radioaktive doser Mål organ mGy/MBq
English: Percent 99mTc-depreotide: 100 - (A + B).
Danish: Procent 99mTc-depreotid: 100 - (A + B).
English: You should tell your doctor if there is any possibility that you are pregnant, or if you are breast
Danish: Du skal fortælle din læge, hvis der er en mulighed for, at du er gravid eller hvis du ammer.
English: Label the solution with a one month expiration date.
Danish: Mærk opløsningen med en måneds udløbsdato.
English: Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No. 1 rev., Soc. Nucl.
Danish: Dosis beregninger blev udført efter standard MIRD metoden (MIRD Pamphlet No. 1 rev., Soc. Nucl.
English: Toxic effects observed in the animal studies were not considered to be relevant in clinical use in humans.
Danish: Toksiske påvirkninger set i dyreforsøgene anses ikke for at være relevante for klinisk anvendelse til mennesker.
English: If any of the above mentioned conditions are applicable to you, you should inform your doctor.
Danish: Hvis nogen af de ovennævnte tilstande passer på dig, skal du informere din læge.
English: Re-administration: Clinical data reflecting safety and efficacy of multiple injections are only available in 13 patients.
Danish: Gentagen administration: Kliniske data vedrørende sikkerhed og effektivitet ved gentagne injektioner, er kun tilgængelige for 13 patienter.
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals.
Danish: Tilfredsstillende aseptiske forholdsregler bør tages i henhold til kravene for Good Manufacturing Practice (GMP) for lægemidler.
English: Please read this leaflet carefully.
Danish: Læs hele denne indlægsseddel omhyggeligt.
English: Treatment of an overdose should be directed towards the support of vital functions.
Danish: Behandling af overdosering skal rettes mod opretholdelse af vitale funktioner.
English: In view of the false negative rate of FNA (5-8% false negative rate reported), thoracotomy is considered to be the gold standard.
Danish: I lyset af den falsk negative procent i forbindelse med FNA (rapporter om 5-8% falsk negative) anses thoracotomi som guldstandard.
English: Trained hospital staff will ensure the correct storage of NeoSpect.
Danish: Trænet hospitalspersonale vil sørge for at NeoSpect bliver opbevaret korrekt.
English: Studies have not been conducted to evaluate carcinogenic potential or effects on fertility.
Danish: Studier er ikke blevet udført for at kortlægge carcinogenisk potentiale eller effekt på fertilitet.
English: 91192 GIF sur YVETTE cedex FRANCE
Danish: 91192 GIF sur YVETTE cedex FRANKRIG
English: Unlabelled NeoSpect should not be administered directly to the patient.
Danish: Ikke-mærket NeoSpect må ikke administreres direkte til patienten.
English: The scanning may take place 2-4 hours after injection of NeoSpect.
Danish: Scanningen kan foretages 2 - 4 timer efter indsprøjtningen med NeoSpect.
English: However, it is not considered likely that NeoSpect will affect your ability to drive or to operate
Danish: Det anses dog ikke for sandsynligt at NeoSpect vil have indvirkning på din evne til at køre eller
English: See Cautionary notes 1 and 2
Danish: Se nedenstående advarselsbemærkninger punkt 1 og 2.
English: Pregnancy and lactation.
Danish: Graviditet og amning.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt den
English: This scan will show exactly the distribution of the radioactivity within the body.
Danish: Dette scanningsbillede vil præcist vise, fordelingen af radioaktiviteten i kroppen.
English: For each patient, exposure to ionising radiation must be justifiable on the basis of the likely benefit.
Danish: For hver patient, skal eksponeringen for ioniserende stråling retfærdiggøres på basis af forventet fordel.
English: One to 18% of the injected dose of radioactivity appeared in the urine at 4 hours after injection.
Danish: En til 18% af den injicerede radioaktive dosis viste sig i urinen 4 timer efter injektionen.
English: NeoSpect 47 micrograms.
Danish: NeoSpect 47 mikrogram.
English: External whole-body gamma scintigraphy showed highest location of radioactivity in the abdomen.
Danish: Ydre helkrops gamma scintigrafi viste størst lokalisation af radioaktivitet i abdomen.
English: The radioactive amount of the diluted generator eluate must not exceed 1.8 GBq when it is added to the vial.
Danish: Den radioaktive mængde i det fortyndede generatoreluat må ikke overstige 1,8 GBq, når det tilsættes hætteglasset.
English: (The saturated sodium chloride solution can be reused.
Danish: (Den mættede natriumklorid opløsning kan genbruges.
English: Any 99mTc-depreotide which remains in your body, will naturally lose its radioactivity within 2-3 days.
Danish: Det 99mTc-depreotid, som forbliver i din krop, vil af sig selv miste sin radioaktivitet indenfor 2-3 dage.
English: There is only limited data available regarding interactions with other products.
Danish: Der er kun begrænsede data til rådighed omhandlende interaktioner med andre lægemidler.
English: This can give the doctor valuable information such as the location of a tumour.
Danish: Dette kan give lægen værdifuld information, som for eksempel lokalisering af kræftvæv.
English: A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a particular part of the body (for example a tumour).
Danish: Et radioaktivt lægemiddel til diagnostisk anvendelse er et produkt, der, når det injicéres, midlertidigt samler sig i en bestemte del af kroppen (for eksempel i en tumor).
English: The radiation dose from 18FDG-PET (Fluorodeoxyglucose - Positron Emission Tomography) is lower than that from NeoSpect, whilst still achieving high sensitivity and specificity.
Danish: Strålingsdosis fra 18FDG-PET (Fluorodeoxyglucose - Positron Emission Tomography) er lavere end fra NeoSpect , med opnåelse af høj sensitivitet og specificitet.
English: In the same prevalence range the positive predictive value was in the range 52-72%.
Danish: I samme prævalens område var positiv prædiktiv værdi (PPV)i området 52-72%.
English: Total clearance averaged 2 to 4 ml/min/kg.
Danish: Total clearance er gennemsnitlig 2 til 4 ml/min/kg.
English: Experience from clinical trials indicates that no dose adjustment is required.
Danish: Erfaringer fra kliniske studier viser, at dosisjustering ikke er nødvendig.
English: The vial should not be cooled under running water, as this may impede labelling.
Danish: Hætteglasset bør ikke afkøles under rindende vand, da dette kan hindre den radioaktive mærkning.
English: Renal clearance averaged about 0.3 ml/min/kg.
Danish: Renale clearance er gennemsnitlig omkring 0,3 ml/min/kg.
English: Familiarity with the practice and technique of resuscitation and treatment of anaphylaxis is essential.
Danish: Kendskab til procedurer og teknik ved genoplivning og behandling af anafylaksi er nødvendig.
English: Because there are strict laws covering the use, handling and disposal of radioactivity, NeoSpect will always be used in a hospital or a similar setting.
Danish: Da der er strenge love vedrørende anvendelse, håndtering og bortskaffelse af radioaktivitet, anvendes NeoSpect altid kun på hospitaler eller i tilsvarende omgivelser.
English: It is essential that the user follows the directions carefully and adheres to aseptic procedures during the preparation of the radiopharmaceutical.
Danish: Det er vigtigt, at brugeren følger instruktionerne omhyggeligt og følger aseptiske procedurer under fremstilling af det radioaktive lægemiddel.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Danish: Hvis en menstruation er udeblevet, skal kvinden anses for at være gravid, indtil andet er bevist.
English: After use, the container and any unused material must be disposed of as radioactive waste in
Danish: Efter brug skal beholderen og alt ubenyttet materiale bortskaffes som radioaktivt affald i
English: NeoSpect is for use in patients over the age of 18 years.
Danish: NeoSpect er til anvendelse hos patienter over 18 år.
English: For most diagnostic investigations using nuclear medicine procedures, the radiation dose delivered (effective dose equivalent) is less than 20 mSv.
Danish: Ved de fleste diagnostiske undersøgelser, hvor nuklearmedicinske procedurer anvendes, er den givne stråledosis (effektiv dosis ækvivalent) mindre end 20 mSv.
English: The area where the radioactive compound is collected, will light up on the picture and give information on the location of the tumour.
Danish: Det område, hvor radioaktiviteten har samlet sig, vil lyse op på billedet og give information om lokalisering af svulsten.
English: For this product, the effective dose resulting from an administered activity of 555-740 MBq is typically 8.88-11.84 mSv for a 70 kg individual.
Danish: For dette produkt, er den effektive dosis efter administration af en aktivitet på 555 - 740 MBq typisk 8,88-11,84 mSv for en person på 70 kg.
English: Diagnostic agent for scintigraphic imaging.
Danish: Diagnostisk præparat til scintigrafisk billedfremstilling.
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radioaktive lægemidler bør behandles af brugeren på en måde, som tilfredsstiller både strålehygiejne og farmaceutiske kvalitetskrav.
English: Following reconstitution and radiolabelling, the material must be used within 5 hours as radiochemical purity and stability have been demonstrated for 5 hours at 25°C.
Danish: Efter rekonstitution og radioaktiv mærkning, skal materialet anvendes inden 5 timer, idet radiokemisk renhed og stabilitet er påvist i 5 timer ved 25 oC.
English: As with all injectable medicinal products, anaphylactic or anaphylactoid reactions may occur after administration.
Danish: Som med alle injektionspræparater kan anafylaktiske og anafylaktoide reaktioner forekomme efter administrationen.
English: The vial contains no bacteriostatic preservative.
Danish: Hætteglasset indeholder intet bakteriostatisk konserveringsmiddel.
English: In a clinical study examining the pharmacodynamic effects of the recommended dose of the peptide in human volunteers during an oral GTT (Glucose Tolerance Test), no effects were observed other than the normal physiologic response to oral glucose challenge.
Danish: I et klinisk studie, der undersøgte den farmakodynamiske effekt af den anbefalede dosis af peptidet hos frivillige personer under oral GTT (Glukose Tolerance Test), observeredes ingen andre påvirkninger end det normale fysiologiske respons på oral glucosebelastning.
English: Name and address of the manufacturer responsible for batch release CIS bio international
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse CIS bio international
English: Like all medicines, NeoSpect can cause side effects, although not everybody gets them.
Danish: HVILKE MULIGE BIVIRKNINGER NeoSpect HAR Som alle andre lægemidler kan NeoSpect have bivirkninger, selvom ikke alle får bivirkninger.
English: - If you have any further questions, ask your doctor.
Danish: - Kontakte Deres læge, hvis De har yderligere spørgsmål.
English: The majority of the radioactivity excreted in urine is in parent form.
Danish: Størstedelen af radioaktiviteten udskilles i urinen i den oprindelige form.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Udsættelse for ioniserende stråling er forbundet med induktion af cancer og risiko for udvikling af arvelige defekter.
English: If overdose is suspected, symptomatic treatment will be administered.
Danish: Hvis der er mistanke om overdosering, vil behandlingen rette sig efter symptomerne.
English: After use, dispose of as radioactive waste.
Danish: Efter brug, bortskaffelse som radioaktivt affald.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit: visually inspect the reconstituted solution at a safe distance through leaded glass.
Danish: Parenterale lægemidler bør undersøges visuelt for partikler og misfarvning før administrationen, når opløsning og beholder tillader det: Undersøg visuelt den fremstillede opløsning i en sikker afstand bag blyholdigt glas.
English: Allow the solvent front to move to the top of the strip.
Danish: Tillad væskefronten at løbe til toppen af strippen.
English: The medicinal product is for hospital use or in designated Nuclear Medicine Facilities only, by persons experienced in radioisotope diagnostic imaging.
Danish: Lægemidlet er kun til brug på hospitaler eller steder med nuklearmedicinske faciliteter af personer med erfaring i diagnostisk radioisotopisk billedfremstilling.
English: Most of the side effects reported were transient and of mild intensity.
Danish: De fleste af de rapporterede bivirkninger var forbigående og af mild intensitet.
English: This medicinal product is for diagnostic use only.
Danish: Dette lægemiddel er udelukkende til diagnostisk anvendelse.
English: Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive
Danish: Opbevaring af radioaktive lægemidler skal ske i overensstemmelse med nationale krav for radioaktivt
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke lavet undersøgelser vedrørende påvirkningen af evnen til at føre bil eller betjene maskiner.
English: Do not use if the solution is not clear or if it contains visible particulate matter.
Danish: Brug ikke opløsningen, hvis den er uklar eller, hvis den indeholder
English: Observed changes in the laboratory parameters are: increased WBC count, basophils, eosinophils, monocytes and neutrophils, AST, ALT, LDH, total bilirubin and total protein; lowered RBC count and
Danish: Observerede forandringer i laboratorieværdier er stigning i leukocytter, basofile, eosinofile, monocytter og neutrofile, ASAT, ALAT, LDH, total bilirubin og total protein; fald i erythrocytter og
English: Because the substance contains a small amount of radioactivity it can be detected from outside the body using special cameras, and a picture, known as a scan, can be taken.
Danish: Da lægemidlet indeholder en lille mængde radioaktivitet, kan det registreres udvendigt på kroppen ved anvendelse af specielle kameraer, og der kan fremstilles et scanningsbillede.
English: White powder for solution for injection.
Danish: Hvidt pulver til injektionsvæske
English: NeoSpect is a powder for solution for injection that has to be dissolved and labelled with radioactive technetium before use.
Danish: NeoSpect er et pulver til injektionsvæske, som skal opløses i og mærkes med radioaktivt technetium før anvendelse.
English: Studies in healthy volunteers have demonstrated that the tracer confers three-compartment pharmacokinetic characteristics with a distribution half-life of less than 5 minutes and a terminal halflife of about 20 hours, and a steady-state volume of distribution of 1.5 to 3 l/kg.
Danish: Studier på raske frivillige har med tracer vist en tre-kompartment farmakokinetiske karakteristika med en fordelings halveringstid på mindre end 5 minutter og en eliminationshalveringstid på omkring 20 timer, samt et steady-state fordelingsvolume på 1,5 til 3 l/kg.
English: Care should be exercised in patients with impaired renal function, due to lower renal excretion and probable increase in exposure to radioactivity.
Danish: Forsigtighed bør udvises hos patienter med nedsat nyrefunktion, på grund af nedsat renal udskillelse og mulig stigning i eksponeringen for radioaktivitet.
English: The effective dose (ED) calculated in accordance with ICRP Publication 60 (Pergamon Press, 1991) gave a value of 0.016 mSv/MBq, corresponding to 11.84 mSv after
Danish: Effektiv dosis (ED) udregnet i henhold til ICRP Publikation 60, Pergamon Press, 1991 gav en værdi på 0,016 mSv/MBq, svarende til 11,84 mSv efter indgift af 740 MBq.
English: This solution is ready for injection into a vein.
Danish: Denne opløsning er klar til injektion i en vene.
English: This radiopharmaceutical may be handled only by authorised persons in designated clinical settings.
Danish: Dette radioaktive lægemiddel må kun håndteres af autoriseret personale i dertil indrettede lokaler.
English: The values are listed in descending order as mGy/MBq and assume urinary bladder emptying at 4.8 hours.
Danish: Værdierne er opstillet efter faldende værdier af mGy/MBq, og antaget blæretømning efter 4,8 timer.
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Danish: Isotop undersøgelser udført på gravide kvinder medfører også stråledoser til fosteret.
English: The amount of radioactivity is calculated according to the planned time of injection to the patient, to obtain a single patient dose of 555 - 740 MBq from the entire
Danish: Mængden af radioaktivitet beregnes i relation til det planlagte tidspunkt for injektion, for at opnå en enkelt patientdosis på 555 - 740 MBq fra det rekonstituerede