FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: 6.1 i Produktresuméet er enten tilladte stoffer som ifølge tabel 1 i Annex til Kommisionens Forordning (EF) nr. 37/2010 ikke kræver MRL, eller stofferne anses ikke for at falde ind under reglerne i Forordning (EF) nr. 470/2009 når de anvendes som i dette veterinære lægemiddel.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinære lægemiddel er tilgængeligt på det Europæiske Medicinagenturs hjemmeside: http://www.ema.europa.eu/
English: EXP {month/year} Once broached, use within 10 hours.
Danish: Efter anbrud, anvend inden 10 timer.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Holdbarhed for dette veterinære lægemiddel i salgspakning: 2 år.
English: Two doses should be given subcutaneously with an interval of 3 weeks.
Danish: To doser gives subkutant med et interval på 3 uger.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstiller af det biologisk aktive stof
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: I henhold til Artikel 71 i Rådets direktiv 2001/82/EC kan et medlemsland i henhold til nationale regler, forbyde fremstilling, import, forarbejdning, salg, levering og/eller brug af immunologiske veterinære lægemidler i hele, eller dele af, territoriet hvis følgende er opfyldt:
English: Lactation: In cattle and goats the vaccine can be used during lactation.
Danish: Laktation: Hos kvæg og geder kan vaccinen anvendes under laktation.
English: Vaccination of animals already infected at the time of vaccination will have no adverse effect.
Danish: Vaccination af dyr der er inficerede på vaccinationstidspunktet, giver ingen bivirkninger.
English: > 72 QF Units/ml
Danish: ≥72 QF enheder/ml
English: Whitish, opalescent, homogeneous suspension.
Danish: Hvidlig, opaliserende, homogen suspension.
English: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Danish: CEVA Santé Animale 10 avenue de la Ballastière 33500 Libourne FRANKRIG
English: Cattle from 3 months of age:
Danish: Kvæg fra 3 måneder:
English: Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.
Danish: Under normale omstændigheder planlægges vaccinationen så basisvaccination er fuldført 3 uger før artificiel insemination eller parring.
English: Duration of immunity: one year after completion of the primary vaccination course.
Danish: Varighed af immunitet: 1 år efter afslutning af basisvaccination.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Uforligeligheder: Må ikke blandes med andre veterinære lægemidler.
English: > 72 QF Units* *QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Danish: ≥72 QF enheder* *QF (Q-feber) enhed: relativ styrke af fase-I antigen målt ved ELISA i forhold til en referenceværdi.
English: Shelf life after first opening the immediate packaging: 10 hours.
Danish: Holdbarhed efter første åbning af indre emballage: 10 timer.
English: SC Read the package leaflet before use.
Danish: SC Læs indlægssedlen før brug.
English: Lactation: The vaccine can be used during lactation.
Danish: Laktation: Vacinen kan anvendes under laktation.
English: Re-vaccination: One dose should be given yearly.
Danish: Revaccination: 1 dosis gives årligt.
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet (2 °C-8 °C).
English: Diarrhoea has been observed rarely in post marketing safety experience.
Danish: Diarré er observeret i sjældne tilfælde i sikkerhedsovervågning efter markedsføringen.
English: In the case that it is decided to vaccinate the whole herd, it is advisable to vaccinate the male animals at the same time.
Danish: I tilfælde hvor det besluttes at vaccinere hele besætningen, anbefales at vaccinere handyr samtidigt.
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Water for injections
Danish: Natriumklorid Dinatriumhydrogenfosfat Kaliumdihydrogenfosfat Vand til injektionsvæsker.
English: Under field conditions, vaccination with COXEVAC has commonly been followed by a decrease in milk production in goats.
Danish: Under praksisforhold er vaccination med COXEVAC ofte ledsaget af en nedgang i mælkeydelse hos geder.
English: Inactivated Coxiella burnetii, strain Nine Mile
Danish: Inaktiveret Coxiella burnetii, stamme Nine Mile
English: For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when nonpregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.
Danish: Til aktiv immunisering af kvæg, for at mindske risikoen for at ikke-inficerede dyr, der vaccineres som ikke-drægtige, bliver bakterie-udskillere (5-gange mindre sandsynligt i forhold til dyr vaccineret med placebo), og for at reducere udskillelsen af Coxiella burnetii i mælk og vaginalslim fra disse dyr.
English: Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.
Danish: Systemiske symptomer som sløvhed, utilpashed og/eller nedsat appetit er ualmindeligvis observeret i sikkerhedsovervågning efter markedsføringen.
English: Special precautions for use in animals:
Danish: Særlige forholdsregler til brug hos dyr::
English: Manufacturer responsible for batch release: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
Danish: Fremstiller ansvarlig for batchfrigivelse: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
English: Suspension for injection.
Danish: LÆGEMIDDELFORM Suspension til injektion.
English: Duration of immunity: 280 days after completion of the primary vaccination course.
Danish: Varighed af immunitet: 280 dage efter afslutning af basisvaccination.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA.
English: Veterinary medicinal product subject to prescription.
Danish: Veterinært lægemiddel som kræver recept.
English: MANUFACTURER'S BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Batch {nummer}
English: Suspension for injection
Danish: LÆGEMIDDELFORM Suspension til injektion
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: Beslutning om samtidig anvendelse af andre vacciner eller veterinære lægemidler må derfor ske fra sag til sag.
English: It is advisable to vaccinate all the animals in the herd at the same time.
Danish: Det anbefales at vaccinere alle dyr i besætningen på samme tid.
English: Each container is closed with a 20 mm bromobutyl rubber stopper and a central tear-off aluminiumplastic cap.
Danish: Hvert hætteglas er lukket med en 20 mm bromobutyl gummiprop og en aluminium-plasthætte.
English: Goats from 3 months of age:
Danish: Geder fra 3 måneder:
English: There are no benefits of the vaccine (as described in the indications for cattle), when used in infected and/or pregnant cows.
Danish: Der er ingen fordele ved vaccination af inficerede og/eller drægtige køer (som beskrevet under indikationer for kvæg).
English: Goats: 2 ml in the neck region.
Danish: Geder: 2 ml i halsregionen
English: Date of first authorisation: 30/09/2010.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 30/09/2010.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende dette veterinære lægemiddel skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: Marketing authorisation holder: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Danish: Indehaver af markedsføringstilladelsen: CEVA Santé Animale 10 avenue de la Ballastière 33500 Libourne
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de lokale krav.
English: Cattle and goats
Danish: Kvæg og geder.
English: For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.
Danish: Til aktiv immunisering af geder for at reducere antallet af aborter forårsaget af Coxiella burnetii, og for at reducere bakterieudskillelsen i mælk, vaginalslim, fæces og i placenta.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre vacciner eller veterinære lægemidler.
English: It was very common to observe in laboratory trials a slight increase of rectal temperature for 4 days post-vaccination.
Danish: I laboratorieforsøg var det meget almindeligt at observere en let stigning i rektaltemperatur i op til 4 dage efter vaccination.
English: The manufacture, import, possession, sale, supply and/or use of COXEVAC may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af COXEVAC er, eller kan være, forbudt i visse medlemsstater på dele af eller hele deres område.
English: Inactivated Coxiella burnetii, strain Nine Mile > 72 QF Units/ml
Danish: Inaktiveret Coxiella burnetii, stamme Nine Mile………≥72 QF Unit/ml
English: Active substance:
Danish: Aktivt stof
English: Each ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml indeholder:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDANSVARLIG FOR BATCHFRIGIVELSE
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstiller ansvarlig for batchfrigivelse
English: However, in safety laboratory trials, the use of COXEVAC in males proved to be safe.
Danish: Imidlertid har sikkerhedsforsøg i laboratorium vist, at brugen af Coxevac i handyr er sikkert.
English: Re-vaccination: Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Danish: Revaccination: 1 dosis subkutant hver 9. måned, baseret på en varighed af immunitet på 280 dage.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til subkutan injektion.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: The vaccine contains phase I Coxiella burnetii as active ingredient inducing active immunity against Q fever in cattle and goats.
Danish: Vaccinen indeholder fase-I Coxiella burnetii som aktiv substans, der inducerer aktiv immunitet mod Qfeber i kvæg og geder.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX for 40 ml or 100 ml plastic bottle
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med 40 ml eller 100 ml plastflaske
English: Meat, milk and offal: Zero days.
Danish: TILBAGEHOLDELSESTID(er) Slagtning og mælk: 0 døgn.
English: EU/2/10/110/002
Danish: EU/2/10/110/002 100 ml
English: Pack sizes: 40 ml or 100 ml in a plastic LDPE bottle.
Danish: Pakningsstørrelser: 40 ml og 100 ml plastik hætteglas.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: 6.1 Fortegnelse over hjælpestoffer
English: Administer the vaccine as follows: Cattle: 4 ml in the neck region.
Danish: Dosering og administration: Kvæg: 4 ml i halsregionen Geder: 2 ml i halsregionen
English: Carton box with 1 plastic (LDPE) bottle, containing 40 ml of suspension.
Danish: Papæske indeholdende 1 plasthætteglas (LDPE) med 40 ml suspension.
English: No efficacy data are available concerning the use of COXEVAC in male animals.
Danish: Der findes ingen data for virkningen af vaccination med Coxevac i handyr.
English: Specific pharmacovigilance requirement(s): The MAH should provide an additional PSUR.
Danish: Indehaveren af markedsføringstilladelsen bør udfærdige en yderligere PSUR.
English: Carton box with 1 plastic (LDPE) bottle, containing 100 ml of suspension.
Danish: Papæske indeholdende 1 plasthætteglas (LDPE) med 100 ml suspension.
English: However, in safety laboratory trials, the use of the vaccine in males proved to be safe.
Danish: Imidlertid har sikkerhedsforsøg i laboratorium vist, at brugen af COXEVAC i handyr er sikkert.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Søg straks læge i tilfælde af utilsigtet selvinjektion, og vis indlægsseddel eller etiket til lægen.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Danish: TEKSTEN “ TIL DYR” Til dyr.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 ml plastic bottle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER 40 ml hætteglas
English: EU/2/10/110/001 (40 ml) EU/2/10/110/002 (100 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/110/001 40 ml
English: With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site, lasting for 16 days.
Danish: Ved anvendelse af dobbelt dosis kunne en palperbar hævelse med maksimal diameter på 10 cm erkendes på injektionsstedet, med en varighed på 16 dage.
English: PHARMACEUTICAL FORM
Danish: FARMACEUTISKE OPLYSNINGER
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJE(E)
English: Goats:
Danish: Geder:
English: Shake well before use.
Danish: Ryst flasken grundigt før anvendelse.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver ml indeholder:
English: With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site, lasting for 4 days.
Danish: Ved anvendelse af dobbelt dosis blev observeret en moderat palperbar hævelse på injektionsstedet med en diameter på 4-5 cm med en varighed på op til 4 dage.
English: Withdrawal period(s): zero days.
Danish: 10. TILBAGEHOLDELSESTID Slagtning: 0 døgn.
English: To be supplied only on veterinary prescription.
Danish: Kun til dyr - kræver recept.
English: CLINICAL PARTICULARS 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til
English: Store and transport refrigerated.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet.
English: PACKAGE LEAFLET: COXEVAC suspension for injection for cattle and goats
Danish: VETERINÆRLÆGEMIDLETS NAVN COXEVAC injektionsvæske, suspension til kvæg og geder
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Danish: IMMUNOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Immunologiske produkter til drøvtyggere, inaktiverede, ATCvet-kode: QI02AB.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml plastic bottle
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 100 ml HÆTTEGLAS
English: COXEVAC suspension for injection for cattle and goats
Danish: INDLÆGSSEDDEL COXEVAC injektionsvæske, suspension til kvæg og geder.
English: Disposal: read package leaflet.
Danish: Indholdsstofferne anført i pkt.
English: It was very common to see in laboratory trials a palpable reaction of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days.
Danish: I laboratorieforsøg var det meget almindeligt at se en palperbar hævelse med en maksimal diameter på 910 cm på injektionsstedet.
English: The reaction reduces and disappears without need for treatment.
Danish: Reaktionen forsvinder uden yderligere behov for behandling.
English: Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende COXEVAC, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: No efficacy data are available concerning the use of the vaccine in male animals.
Danish: Der findes ingen data for virkningen af vaccination med COXEVAC i handyr.
English: It was very common to see in laboratory trials a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
Danish: I laboratorieforsøg var det meget almindeligt at se en palperbar hævelse med en diameter på 3-4 cm på injektionsstedet.
English: The reaction gradually reduced and disappeared without need for treatment.
Danish: Hævelsen aftog gradvist og forsvandt uden yderligere behandling.
English: The reaction gradually reduces and disappears without need for treatment.
Danish: Reaktionen forsvinder gradvist uden yderligere behandling.
English: EU/2/10/110/001-002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/10/110/001-002
English: 100 ml
Danish: PAKNINGSSTØRRELSE 100 ml
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: Kontakt din dyrlæge, hvis du observerer bivirkninger.
English: Fluodeoxyglucose (
Danish: Fluordeoxyglukose (
English: The European Commission issued a decision on 29 May 2009.
Danish: Europa-Kommissionen traf en afgørelse den 29. maj 2009.
English: This means that it will be absorbed differently by cells depending on their state.
Danish: Dette betyder, at det optages forskelligt af cellerne afhængigt af deres tilstand.
English: Ref. EMEA/CHMP/342694/2009 EMEA/H/A-29/1123
Danish: EMEA/CHMP/356650/2009 EMEA/H/A-29/1123
English: F) is already authorised via national procedures in the Czech Republic, Ireland and the
Danish: F) er allerede godkendt efter nationale procedurer i Den Tjekkiske Republik, Irland og Det Forenede Kongerige.
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Danish: Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på grund af alvorlig risiko for folkesundheden.
English: What is Gluscan 500?
Danish: Hvad er Gluscan 500?
English: This is a procedure when one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance are Germany, Poland, Portugal and Spain)2.
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Frankrig) bedømmer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som har gyldighed i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Tyskland, Polen, Portugal og Spanien)2.
English: However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 30 January 2009.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den franske lægemiddelkontrolmyndighed indbragte den 30. januar 2009 sagen for CHMP med henblik på voldgift.
English: Why was Gluscan 500 reviewed?
Danish: Hvorfor blev Gluscan 500 vurderet?
English: Gluscan 500 can be used: - in cancer medicine to help detect the location of tumours, as cancer cells use a lot of energy and will absorb more fluodeoxyglucose than non-cancerous cells; - in cardiac medicine to help locate areas of the heart that are not taking up as much glucose as expected because of ischaemia (reduced blood supply); - in neurology to detect specific areas within the brain of epileptic patients before surgery; - and to locate areas of the body where there are abnormally high numbers of white blood cells (such as the sites of deep-seated infections or inflammation).
Danish: Gluscan 500 kan anvendes: - inden for kræftmedicin til at hjælpe med at lokalisere tumorer, da kræftceller bruger stor energi og vil optage mere fluordeoxyglukose end andre celler - inden for hjertemedicin til at hjælpe med at lokalisere områder af hjertet, der ikke optager så meget glukose som forventet på grund af iskæmi (nedsat blodforsyning) - inden for neurologi til at påvise specifikke områder i hjernen hos patienter med epilepsi inden kirurgiske indgreb - og til at lokalisere områder af kroppen, hvor der findes et unormalt højt antal hvide blodlegemer (som f.eks. dybtliggende infektioner eller inflammation).
English: The review was carried out under an ‘Article 29' referral1.
Danish: Undersøgelsen blev gennemført som følge af en indbringelse i henhold til artikel 291.
English: Once in the cell, the radioactivity remains trapped, and can be seen on scans such as those obtained using a ‘PET' (positron emission tomography) scanner.
Danish: Når stoffet er optaget i cellen, er radioaktiviteten fanget og kan ses ved scanninger som dem, der opnås ved hjælp af en "PET"-scanner (positronemissionstomografi).
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Gluscan 500.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure efter uenighed mellem forskellige af Den Europæiske Unions medlemsstater om markedsføringstilladelsen for lægemidlet Gluscan 500.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Gluscan 500 outweigh its risks, and the marketing authorisation can be granted in France and in the following Member States of the European Union Germany, Poland, Portugal and Spain.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at den gavnlige virkning af Gluscan 500 er større end risiciene, og at der kan udstedes markedsføringstilladelse i Frankrig samt i følgende EU-medlemsstater: Tyskland, Polen, Portugal og Spanien.
English: It contains a substance, fluodeoxyglucose, that has been labelled with 18F (fluoride-18), a radioactive form of the chemical element fluorine.
Danish: Det indeholder et stof, fluordeoxyglukose, som er blevet mærket med 18F (fluor 18), en radioaktiv form af det kemiske grundstof fluor.