natgillin/translations-raw huggingface dataset:
Vaccinen er ikke testet på avlstyre og bør derfor ikke benyttes i avlstyre.
The vaccine has not been tested in breeding bulls and should therefore not be used in breeding bulls.
I enkelte tilfælde hos nyfødte kalve er hudbiopsier fra ører rapporteret positive for BVDV-vaccinestammen ved molekylære diagnostiske tests.
In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests.
Må ikke blandes med lægemidler til dyr undtaget solvens, der leveres til brug med dette veterinærlægemiddel.
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Yderligere laboratorietests til at differentiere vaccinestammens virus fra feltstammer kan rekvireres hos indehaveren af markedsføringstilladelsen.
Additional laboratory tests to differentiate vaccine strain virus from field strain are available upon request from the marketing authorisation holder.
Gelatin
Gelatine
Det anbefales at vaccinere før drægtighed for at sikre beskyttelse mod persistent infektion af fosteret.
It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus.
Dette bør der tænkes på ved vaccaination af besætningen.
This should be considered in case of herd vaccination.
Hensigten med vaccinen er at stimulere udvikling af et aktivt immunrespons mod BVDV-1 og BVDV-2 hos kvæg.
The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle.
Kontrollér, at lyofilisatet er fuldt rekonstitueret inden brug.
Ensure that the lyophilisate is completely reconstituted before use.
Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Solvens:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Langvarig viræmi er observeret efter vaccination, især hos drægtige seronegative kvier (10 dage i et studie).
Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study).
KONTRAINDIKATION
CONTRAINDICATION
Lyofilisat: Off-white uden fremmedlegemer
Lyophilisate: Off-white colour without foreign matter.
Dyr som vaccineres senere end 3 uger før drægtigheden eller i den tidlige drægtighed er ikke nødvendigvis beskyttet mod føtal infektion.
Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection.
Feltstudierne, der blev udført for at vise effekten af vaccinen, blev udført i besætninger hvor persistent inficerede dyr var sat ud.
The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed.
Det anbefales at vaccinere kvæg mindst 3 uger før insemination/parring for at opnå føtal beskyttelse fra undfangelsens første dag.
It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception.
Til aktiv immunisering af kvæg mod BVDV-1 og BVDV-2 for at forebygge kælvning af persistent inficerede kalve forårsaget af transplacental infektion.
For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.
Mens persistent infektion af fosteret forårsaget af vaccinen ikke blev obsereveret, kan en overførsel af vaccinevirus til fosteret forekomme.
While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur.
Vaccinestammerne kan inficere får og svin, når vaccinen er administreret intranasalt, men ingen bivirkninger eller spredning til kontaktdyr er blevet påvist.
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.
Hjørnestenen i udryddelsen af bovin viral diarré (BVD) er identifikation og udsætning af persistent inficerede dyr.
The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals.
Efter rekonstituering indgives en dosis vaccine (2 ml) intramuskulært (i.m.).
After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection.
Affaldshåndtering: Læs indlægssedlen.
Disposal: read package leaflet.
Dette kan resultere i en transplacental transmission af vaccinevirus, men der blev ikke i studierne observeret bivirkninger i foster eller drægtighed.
This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies.
Solvens: Klar, farveløs opløsning
Solvent: Clear, colourless solution.
En dosis (2 ml) indeholder: Lyofilisat:
Each dose (2 ml) contains: Lyophilisate:
FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
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.
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.
5 doser (10 ml) 10 doser (20 ml) 25 doser (50 ml)
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml)
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).
Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies).
Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
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.
Kaliumhydroxid L-glutaminsyre Kaliumdihydrogenphosphat Dikaliumphosphat Natriumchlorid Vand til injektionsvæsker
Potassium hydroxide L-Glutamine acid Potassium dihydrogen phosphate Dipotassium phosphate Sodium chloride Water for injections
Opbevaringstid efter rekonstituering: 8 timer.
Shelf life after reconstitution: 8 hours.
Lyofilisat og solvens til injektionsvæske, suspension Lyofilisat: Off-white uden fremmedlegemer Solvens: Klar, farveløs opløsning
Lyophilisate and solvent for suspension for injection Lyophilisate: Off-white colour without foreign matter.
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.
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.
Indtræden af immunitet: 3 uger efter vaccination.
3 weeks after immunisation.
Ravgule hætteglas (type I-glas) lukket med silikoniseret bromobutylgummiprop med lakeret aluminiumsforsegling.
Type I amber glass vials closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal.
Natriumchlorid Kaliumchlorid Kaliumdihydrogenphosphat Dinatriumhydrogenphosphat Vand til injektionsvæsker
Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
Særlige forholdsregler for personer, som indgiver lægemidlet til dyr:
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Hver dosis (2 ml) indeholder: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50.
Each dose (2 ml) contains: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50.
Bovin viral diarrévirus, type 1: 104.0-106.0 TCID50, Bovin viral diarrévirus, type 2: 104.0-106.0 TCID50.
Bovine viral diarrhoea virus type 1: 104.0-106.0 TCID50, Bovine viral diarrhoea virus type 2: 104.0-106.0 TCID50.
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)
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)
EXP {måned/år} Rekonstitueret vaccine anvendes indenfor: 8 timer.
EXP {month/year} Once reconstituted use within: 8 hours.
HDPE-flaske med solvens lukket med silikoniseret bromobutylgummiprop med lakeret aluminiumsforsegling.
High density polyethylene (HDPE) bottles sof solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal.
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
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
Lyofilisatet rekonstitueres ved at tilsætte hele solvensen, der har stuetemperatur.
Reconstitute the lyophilisate by adding the full content of the solvent at room temperature.
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med solvens: 10 ml, 20 ml, 50 ml, 100 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottles: 10 ml, 20 ml, 50 ml, 100 ml
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med lyofilisat: 5 doser, 10 doser og 25 doser
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vials: 5 doses, 10 doses and 25 doses
EXP {måned/år} Rekonstitueret vaccine anvendes indenfor 8 timer.
EXP {month/year} Once reconstituted use within 8 hours.
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%
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**.
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).
An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies).
Opbevar hætteglassene med lyofilisat og solvens i den ydre karton.
Keep the lyophilisate and the solvent vials in the outer carton.
Opbevar hætteglasset i den ydre karton.
Keep the bottle in the outer carton.
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)
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)
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)
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)
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”).
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”).
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
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
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas med lyofilisat: 50 doser
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Lyophilisate vials: 50 doses
Farmakoterapeutisk gruppe: immunologiske midler til kvæg, levende virale vacciner ATCvet-kode: QI02AD02
Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines.
Desuden var en stigning i legemstemperaturen almindelig i de første 4 timer efter administration, men den faldt spontant inden for 24 timer (se pkt.
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).
INDLÆGSSEDDEL: Bovela, lyofilisat og solvens til injektionsvæske, suspension til kvæg
PACKAGE LEAFLET: Bovela lyophilisate and solvent for suspension for injection for cattle
Lyofilisat til injektionsvæske, suspension
Lyophilisate for suspension for injection
Opbevar hætteglassene i den ydre karton.
Keep the vials in the outer carton.
Bovela, lyofilisat til injektionsvæske, suspension til kvæg
Bovela lyophilisate for suspension for injection for cattle
Bovela, lyofilisat og solvens til injektionsvæske, suspension til kvæg
Bovela lyophilisate and solvent for suspension for injection for cattle
Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
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.
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.
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.
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.
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.
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.
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.
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.
Indgivelsesvej
EU number
Emballage Indhold (koncentration) Pakningsstørrelse EU/1/02/236/001 Ultratard 40 IE/ml Injektionsvæske, suspension Subkutan anvendelse Hætteglas 10 ml (1,4 mg/ml)
Content (concentration) Package size
• demens (tab af intellektuel formåen).
• dementia (loss of intellectual function).
Der scannes 3 til 6 timer efter injektionen.
A scan is taken 3 to 6 hours after the injection.
Lægemidlet anvendes til at diagnosticere følgende sygdomme hos voksne (over 18 år):
The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
Yderligere information om Striascan findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/striascan.
Further information on Striascan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/striascan.
Striascan er et diagnostisk lægemiddel.
Striascan is a diagnostic medicine.
Andre oplysninger om Striascan
Other information about Striascan
En oversigt over Striascan, og hvorfor det er godkendt i EU
An overview of Striascan and why it is authorised in the EU
Striascan må kun håndteres og gives af personer, der har erfaring med sikker håndtering af radioaktive materialer.
Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.
Hvis det sker, reduceres mængden af Striascan, der binder sig til disse nerveceller, betydeligt, hvilket kan ses på skanningen.
If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan.
Da Striascan er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
For mere information om brug af Striascan, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.
Som for alle lægemidler er data vedrørende brug af Striascan løbende overvåget.
As for all medicines, data on the use of Striascan are continuously monitored.
Bivirkninger rapporteret for Striascan vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.
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
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;
• bevægelsesforstyrrelser såsom ved Parkinsons sygdom og andre beslægtede sygdomme, hvor tab af nerveceller fører til tremor (rysten), gangforstyrrelser (problemer med den måde, patienten går på) og muskelstivhed.
• movement disorders such as those in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Striascan er sammenligneligt med DaTSCAN.
The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN.
Hvilke fordele og risici er der forbundet med Striascan?
What are the benefits and risks of Striascan?
Der skal være genoplivningsudstyr til rådighed, før Striascan indgives, hvis patienten skulle få en allergisk reaktion.
Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.
Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Striascan.
As for every medicine, the company provided studies on the quality of Striascan.
Mellem 1-4 timer inden patienterne får Striascan, skal de også tage et andet lægemiddel, f.eks. jodtabletter, for at forhindre det radioaktive jod i Striascan i at trænge ind i skjoldbruskkirtlen.
Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Striascan?
What measures are being taken to ensure the safe and effective use of Striascan?
Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Striascan optages på samme måde som referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
There was no need for ‘bioequivalence' studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Striascan anvendes til at skelne mellem en type demens, der kaldes "Levy body demens" og Alzheimers sygdom.
Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies' and Alzheimer's disease.
Hos patienter med Parkinsons sygdom og beslægtede sygdomme og hos patienter med Lewy body demens sker der typisk et tab af de dopamin-indeholdende nerveceller i striatum.
In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum.
Ioflupan binder sig specifikt til strukturer i nervecelleenderne, som er ansvarlige for transporten af dopamin.
Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.
Striascan udleveres kun efter recept og bør kun anvendes til patienter, der er blevet henvist af en læge med erfaring i håndtering af bevægelsesforstyrrelser eller demens.
Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia.
Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, DaTSCAN, og det er ikke nødvendigt at gentage disse med Striascan.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.
Denne ophobning kan ses ved hjælp af en billedteknik, der kaldes single photon emission computed tomography (SPECT), som opfanger det radioaktive jod-123.
This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
Det betyder, at Striascan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder DaTSCAN.
Striascan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DaTSCAN.
Striascan gives i en vene i en arm ved langsom injektion, der varer mindst 15-20 sekunder.
Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein.
Dette skyldes, at Striascan gives ved injektion i en vene, så det aktive stof ledes direkte ind i blodbanen.
This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Det indeholder et stof, der kaldes ioflupan, som er mærket med 123I (iod-123), en radioaktiv form for jod.
It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of iodine.
Det anvendes til at påvise tab af nerveceller i et område i hjernen kaldet striatum, navnlig de celler, der udsender dopamin, et kemisk signalstof.
It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.