FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ualmindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Recommended re-vaccination programme:
Danish: Anbefalet revaccinationsprogram:
English: Therefore, use during pregnancy should only be on a case-by-case basis decided by the responsible veterinarian, taking into consideration e.g. the BVD immunological status of the animal, the time-span between vaccination and mating/insemination, the stage of pregnancy and the risk of infection.
Danish: Derfor bør beslutningen om brug i drægtigheden kun tages med udgangspunkt i det enkelte tilfælde af den ansvarlige dyrlæge, hvor der f.eks. tages hensyn til dyrets immunologiske status for BVD, tiden mellem vaccination og parring/insemination, drægtighedsstadium og risikoen for infektion.
English: To ensure the protection of animals introduced to the herd where BVDV is circulating, vaccination has to be completed 3 weeks before introduction.
Danish: For at sikre at dyr der introduceres til en besætning, hvor BVDV cirkulerer beskyttes, skal vaccinationen være afsluttet 3 uger før introduktionen.
English: 50 doses (100 ml)
Danish: 50 doser (100 ml)
English: Solvent for Bovela
Danish: Solvens til Bovela
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN ”KUN TIL DYR ”SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves.
Danish: Studier har vist, at vaccinevirus kan udskilles i mælk i op til 23 dage efter vaccination i små mængder (~ 10 TCID50/ml), dog ses der ingen serokonvension i disse kalve selvom de fodres med denne mælk.
English: Preparation of vaccine for use (reconstitution):
Danish: Fremstilling af brugsfærdig vaccine (rekonstituering):
English: Shedding of the vaccine virus by body fluids cannot be excluded.
Danish: Udskillelse af vaccinevirus gennem kropsvæsker kan ikke udelukkes.
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 USA
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 USA.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende behandlede dyr ikke er kontamineret,
English: The vaccine has not been tested in breeding bulls and should therefore not be used in breeding bulls.
Danish: Vaccinen er ikke testet på avlstyre og bør derfor ikke benyttes i avlstyre.
English: In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests.
Danish: I enkelte tilfælde hos nyfødte kalve er hudbiopsier fra ører rapporteret positive for BVDV-vaccinestammen ved molekylære diagnostiske tests.
English: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Danish: Må ikke blandes med lægemidler til dyr undtaget solvens, der leveres til brug med dette veterinærlægemiddel.
English: Additional laboratory tests to differentiate vaccine strain virus from field strain are available upon request from the marketing authorisation holder.
Danish: Yderligere laboratorietests til at differentiere vaccinestammens virus fra feltstammer kan rekvireres hos indehaveren af markedsføringstilladelsen.
English: Gelatine
Danish: Gelatin
English: It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus.
Danish: Det anbefales at vaccinere før drægtighed for at sikre beskyttelse mod persistent infektion af fosteret.
English: This should be considered in case of herd vaccination.
Danish: Dette bør der tænkes på ved vaccaination af besætningen.
English: The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle.
Danish: Hensigten med vaccinen er at stimulere udvikling af et aktivt immunrespons mod BVDV-1 og BVDV-2 hos kvæg.
English: Ensure that the lyophilisate is completely reconstituted before use.
Danish: Kontrollér, at lyofilisatet er fuldt rekonstitueret inden brug.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Solvens:
English: Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study).
Danish: Langvarig viræmi er observeret efter vaccination, især hos drægtige seronegative kvier (10 dage i et studie).
English: CONTRAINDICATION
Danish: KONTRAINDIKATION
English: Lyophilisate: Off-white colour without foreign matter.
Danish: Lyofilisat: Off-white uden fremmedlegemer
English: Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection.
Danish: Dyr som vaccineres senere end 3 uger før drægtigheden eller i den tidlige drægtighed er ikke nødvendigvis beskyttet mod føtal infektion.
English: The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed.
Danish: Feltstudierne, der blev udført for at vise effekten af vaccinen, blev udført i besætninger hvor persistent inficerede dyr var sat ud.
English: It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception.
Danish: Det anbefales at vaccinere kvæg mindst 3 uger før insemination/parring for at opnå føtal beskyttelse fra undfangelsens første dag.
English: For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.
Danish: Til aktiv immunisering af kvæg mod BVDV-1 og BVDV-2 for at forebygge kælvning af persistent inficerede kalve forårsaget af transplacental infektion.
English: While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur.
Danish: Mens persistent infektion af fosteret forårsaget af vaccinen ikke blev obsereveret, kan en overførsel af vaccinevirus til fosteret forekomme.
English: The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals has been demonstrated.
Danish: Vaccinestammerne kan inficere får og svin, når vaccinen er administreret intranasalt, men ingen bivirkninger eller spredning til kontaktdyr er blevet påvist.
English: The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals.
Danish: Hjørnestenen i udryddelsen af bovin viral diarré (BVD) er identifikation og udsætning af persistent inficerede dyr.
English: After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection.
Danish: Efter rekonstituering indgives en dosis vaccine (2 ml) intramuskulært (i.m.).
English: Disposal: read package leaflet.
Danish: Affaldshåndtering: Læs indlægssedlen.
English: This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies.
Danish: Dette kan resultere i en transplacental transmission af vaccinevirus, men der blev ikke i studierne observeret bivirkninger i foster eller drægtighed.
English: Solvent: Clear, colourless solution.
Danish: Solvens: Klar, farveløs opløsning
English: Each dose (2 ml) contains: Lyophilisate:
Danish: En dosis (2 ml) indeholder: Lyofilisat:
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERANSVARLIG FOR BATCHFRIGIVELSE
English: For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2.
Danish: og ældre for reducere hypertermi og for at minimere fald i leukocyttallet forårsaget af bovin viral diarrévirus (BVDV-1 og BVDV-2) samt for at mindske udskillelse af virus og viræmi forårsaget af BVDV-2.
English: 5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml)
Danish: 5 doser (10 ml) 10 doser (20 ml) 25 doser (50 ml)
English: Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies).
Danish: Lette hævelser eller knuder på op til 3 cm i diameter er observeret på injektionsstedet, men de forsvandt inden 4 dage efter vaccinationen (kliniske studier).
English: If you notice any side effects, even those not already listed in this package leaflet or think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: Potassium hydroxide L-Glutamine acid Potassium dihydrogen phosphate Dipotassium phosphate Sodium chloride Water for injections
Danish: Kaliumhydroxid L-glutaminsyre Kaliumdihydrogenphosphat Dikaliumphosphat Natriumchlorid Vand til injektionsvæsker
English: Shelf life after reconstitution: 8 hours.
Danish: Opbevaringstid efter rekonstituering: 8 timer.
English: Lyophilisate and solvent for suspension for injection Lyophilisate: Off-white colour without foreign matter.
Danish: Lyofilisat og solvens til injektionsvæske, suspension Lyofilisat: Off-white uden fremmedlegemer Solvens: Klar, farveløs opløsning
English: Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination.
Danish: Lette hævelser eller knuder på op til 3 cm i diameter på injektionsstedet er observeret efter indgift af en 10-dobbelt overdosis, men de forsvandt inden 4 dage efter vaccination.
English: 3 weeks after immunisation.
Danish: Indtræden af immunitet: 3 uger efter vaccination.
English: Type I amber glass vials closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal.
Danish: Ravgule hætteglas (type I-glas) lukket med silikoniseret bromobutylgummiprop med lakeret aluminiumsforsegling.
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
Danish: Natriumchlorid Kaliumchlorid Kaliumdihydrogenphosphat Dinatriumhydrogenphosphat Vand til injektionsvæsker
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler for personer, som indgiver lægemidlet til dyr:
English: Each dose (2 ml) contains: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50.
Danish: Hver dosis (2 ml) indeholder: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50.
English: Bovine viral diarrhoea virus type 1: 104.0-106.0 TCID50, Bovine viral diarrhoea virus type 2: 104.0-106.0 TCID50.
Danish: Bovin viral diarrévirus, type 1: 104.0-106.0 TCID50, Bovin viral diarrévirus, type 2: 104.0-106.0 TCID50.
English: 5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 4 x 5 doses (10 ml) 4 x 10 doses (20 ml) 4 x 25 doses (50 ml) 4 x 50 doses (100 ml) 6 x 5 doses (10 ml) 6 x 10 doses (20 ml) 6 x 25 doses (50 ml) 6 x 50 doses (100 ml) 10 x 5 doses (10 ml) 10 x 10 doses (20 ml) 10 x 25 doses (50 ml) 10 x 50 doses (100 ml)
Danish: 5 doser (10 ml) 10 doser (20 ml) 25 doser (50 ml) 50 doser (100 ml) 4 x 5 doser (10 ml) 4 x 10 doser (20 ml) 4 x 25 doser (50 ml) 4 x 50 doser (100 ml) 6 x 5 doser (10 ml) 6 x 10 doser (20 ml) 6 x 25 doser (50 ml) 6 x 50 doser (100 ml) 10 x 5 doser (10 ml) 10 x 10 doser (20 ml) 10 x 25 doser (50 ml) 10 x 50 doser (100 ml)
English: EXP {month/year} Once reconstituted use within: 8 hours.
Danish: EXP {måned/år} Rekonstitueret vaccine anvendes indenfor: 8 timer.
English: High density polyethylene (HDPE) bottles sof solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal.
Danish: HDPE-flaske med solvens lukket med silikoniseret bromobutylgummiprop med lakeret aluminiumsforsegling.
English: EU/2/14/176/013 50 doses EU/2/14/176/014 4 x 50 doses EU/2/14/176/015 6 x 50 doses EU/2/14/176/016 10 x 50 doses
Danish: EU/2/14/176/013 50 doser EU/2/14/176/014 4 x 50 doser EU/2/14/176/015 6 x 50 doser EU/2/14/176/01610 x 50 doser
English: Reconstitute the lyophilisate by adding the full content of the solvent at room temperature.
Danish: Lyofilisatet rekonstitueres ved at tilsætte hele solvensen, der har stuetemperatur.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottles: 10 ml, 20 ml, 50 ml, 100 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med solvens: 10 ml, 20 ml, 50 ml, 100 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vials: 5 doses, 10 doses and 25 doses
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med lyofilisat: 5 doser, 10 doser og 25 doser
English: EXP {month/year} Once reconstituted use within 8 hours.
Danish: EXP {måned/år} Rekonstitueret vaccine anvendes indenfor 8 timer.
English: Modified live BVDV*-1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50**, Modified live BVDV*-2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50**.
Danish: Modificeret levende BVDV*-1, ikke-cytopatisk, parentalstamme KE-9: 104.0-106.0 TCID50** Modificeret levende BVDV*-2, ikke-cytopatisk, parentalstamme NY-93: 104.0-106.0 TCID50** * Bovin viral diarrévirus ** Vævskulturinfektionsdosis 50%
English: An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies).
Danish: En stigning i legemstemperaturen inden for de fysiologiske grænser er almindelig inden for de første 4 timer efter vaccinationen og temperaturen falder spontant igen inden for 24 timer (kliniske studier).
English: Keep the lyophilisate and the solvent vials in the outer carton.
Danish: Opbevar hætteglassene med lyofilisat og solvens i den ydre karton.
English: Keep the bottle in the outer carton.
Danish: Opbevar hætteglasset i den ydre karton.
English: EU/2/14/176/005 10 doses and 20 ml EU/2/14/176/006 10 doses and 20 ml (4 x) EU/2/14/176/007 10 doses and 20 ml (6 x) EU/2/14/176/008 10 doses and 20 ml (10 x) EU/2/14/176/009 25 doses and 50 ml EU/2/14/176/010 25 doses and 50 ml (4 x) EU/2/14/176/011 25 doses and 50 ml (6 x) EU/2/14/176/012 25 doses and 50 ml (10 x) EU/2/14/176/013 50 doses and 100 ml EU/2/14/176/014 50 doses and 100 ml (4 x) EU/2/14/176/015 50 doses and 100 ml (6 x) EU/2/14/176/016 50 doses and 100 ml (10 x)
Danish: EU/2/14/176/005 10 doser og 20 ml EU/2/14/176/006 10 doser og 20 ml (4 x) EU/2/14/176/007 10 doser og 20 ml (6 x) EU/2/14/176/008 10 doser og 20 ml (10 x) EU/2/14/176/009 25 doser and 50 ml EU/2/14/176/010 25 doser og 50 ml (4 x) EU/2/14/176/011 25 doser og 50 ml (6 x) EU/2/14/176/012 25 doser og 50 ml (10 x) EU/2/14/176/013 50 doser og 100 ml EU/2/14/176/014 50 doser og 100 ml (4 x) EU/2/14/176/015 50 doser og 100 ml (6 x) EU/2/14/176/016 50 doser og 100 ml (10 x)
English: EU/2/14/176/001 5 doses and 10 ml EU/2/14/176/002 5 doses and 10 ml (4 x) EU/2/14/176/003 5 doses and 10 ml (6 x) EU/2/14/176/004 5 doses and 10 ml (10 x)
Danish: EU/2/14/176/001 5 doser og 10 ml EU/2/14/176/002 5 doser og 10 ml (4 x) EU/2/14/176/003 5 doser og 10 ml (6 x) EU/2/14/176/004 5 doser og 10 ml (10 x)
English: Furthermore, a increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section “Adverse reactions”).
Danish: Desuden var en stigning i legemstemperaturen på almindelig i de første 4 timer efter administration, men den faldt spontant inden for 24 timer (se punktet ”Bivirkninger”).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box: 5 doses, 10 doses, 25 doses, 50 doses lyophilisate and 10 ml, 20 ml, 50 ml, 100 ml solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papkartoner: 5 doser, 10 doser, 25 doser, 50 doser lyofilisat og 10 ml, 20 ml, 50 ml, 100 ml solvens
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Lyophilisate vials: 50 doses
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas med lyofilisat: 50 doser
English: Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines.
Danish: Farmakoterapeutisk gruppe: immunologiske midler til kvæg, levende virale vacciner ATCvet-kode: QI02AD02
English: Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section 4.6).
Danish: Desuden var en stigning i legemstemperaturen almindelig i de første 4 timer efter administration, men den faldt spontant inden for 24 timer (se pkt.
English: PACKAGE LEAFLET: Bovela lyophilisate and solvent for suspension for injection for cattle
Danish: INDLÆGSSEDDEL: Bovela, lyofilisat og solvens til injektionsvæske, suspension til kvæg
English: Lyophilisate for suspension for injection
Danish: Lyofilisat til injektionsvæske, suspension
English: Keep the vials in the outer carton.
Danish: Opbevar hætteglassene i den ydre karton.
English: Bovela lyophilisate for suspension for injection for cattle
Danish: Bovela, lyofilisat til injektionsvæske, suspension til kvæg
English: Bovela lyophilisate and solvent for suspension for injection for cattle
Danish: Bovela, lyofilisat og solvens til injektionsvæske, suspension til kvæg
English: Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse Boehringer Ingelheim Vetmedica GmbH
English: 1 lyophilisate vial of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 1 solvent bottle of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Danish: 1 hætteglas med lyofilisat á 10 ml (5 doser), 20 ml (10 doser), 50 ml (25 doser) eller 100 ml (50 doser) og 1 flaske med solvens á 10 ml, 20 ml, 50 ml eller 100 ml pakket sammen i en papkarton.
English: 4 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 4 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Danish: 4 hætteglas med lyofilisat á 10 ml (5 doser), 20 ml (10 doser), 50 ml (25 doser) eller 100 ml (50 doser) og 4 flasker med solvens á 10 ml, 20 ml, 50 ml eller 100 ml pakket sammen i en papkarton.
English: 6 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 6 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Danish: 6 hætteglas med lyofilisat á 10 ml (5 doser), 20 ml (10 doser), 50 ml (25 doser) eller 100 ml (50 doser) og 6 flasker med solvens á 10 ml, 20 ml, 50 ml eller 100 ml pakket sammen i en papkarton.
English: 10 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 10 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
Danish: 10 hætteglas med lyofilisat á 10 ml (5 doser), 20 ml (10 doser), 50 ml (25 doser) eller 100 ml (50 doser) og 10 flasker med solvens á 10 ml, 20 ml, 50 ml eller 100 ml pakket sammen i en papkarton.
English: EU number
Danish: Indgivelsesvej
English: Content (concentration) Package size
Danish: Emballage Indhold (koncentration) Pakningsstørrelse EU/1/02/236/001 Ultratard 40 IE/ml Injektionsvæske, suspension Subkutan anvendelse Hætteglas 10 ml (1,4 mg/ml)
English: • dementia (loss of intellectual function).
Danish: • demens (tab af intellektuel formåen).
English: A scan is taken 3 to 6 hours after the injection.
Danish: Der scannes 3 til 6 timer efter injektionen.
English: The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
Danish: Lægemidlet anvendes til at diagnosticere følgende sygdomme hos voksne (over 18 år):
English: Further information on Striascan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/striascan.
Danish: Yderligere information om Striascan findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/striascan.
English: Striascan is a diagnostic medicine.
Danish: Striascan er et diagnostisk lægemiddel.
English: Other information about Striascan
Danish: Andre oplysninger om Striascan
English: An overview of Striascan and why it is authorised in the EU
Danish: En oversigt over Striascan, og hvorfor det er godkendt i EU
English: Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.
Danish: Striascan må kun håndteres og gives af personer, der har erfaring med sikker håndtering af radioaktive materialer.
English: If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan.
Danish: Hvis det sker, reduceres mængden af Striascan, der binder sig til disse nerveceller, betydeligt, hvilket kan ses på skanningen.
English: Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Striascan er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: For more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Striascan, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: As for all medicines, data on the use of Striascan are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Striascan løbende overvåget.
English: Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Striascan vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Because tremor can also occur in ‘essential tremor' (tremor whose cause is unknown), Striascan can help distinguish between essential tremor and diseases related to Parkinson's disease;
Danish: Da tremor også kan forekomme ved "essentiel tremor" (tremor, hvis årsag er ukendt), kan Striascan være med til at skelne mellem essentiel tremor og sygdomme beslægtede med Parkinsons sygdom