FrancophonIA/ELRC3.0 huggingface dataset:
English: To stimulate active immunity against bluetongue virus, serotypes 1 and 8 in cattle.
Danish: Til stimulation af aktiv immunitet mod bluetongue-virus, serotype 1 og 8 hos kvæg.
English: Avoid multiple vial broaching.
Danish: Undgå anbrud af hætteglas gentagne gange.
English: Off-white or pink liquid
Danish: Råhvid eller lyserød væske.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus ATCvet code: QI02AA08.
Danish: IMMUNOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Inaktiverede virale vacciner - bluetongue-virus ATCvet-kode: QI02AA08
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Danish: For at undgå utilsigtet kontaminering af vaccinen under brug, anbefales det at anvende et multiinjektions-vaccinationssystem, når der anvendes større doser.
English: Special warnings for each target species:
Danish: Særlig advarsel for hver dyreart.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær anvendelse.
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): Zero days.
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid(er): 0 dage.
English: Shelf life after first opening the immediate packaging: use immediately after broaching.
Danish: Opbevaringstid efter første åbning af den indre emballage: anvendes umiddelbart efter åbning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20 ml, 1 x 100 ml or 240 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske med 1 x 20 ml, 1 x 100 ml og 1 x 240 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket på 20 ml hætteglas
English: Name and address of the manufacturer of the biological active substance Zoetis Manufacturing & Research Spain, S.L.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Zoetis Manufacturing & Research Spain, S.L.
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose.
Danish: En forbigående stigning i rektaltemperaturen, der ikke overstiger 2°C kan forekomme hos 10 % af dyrene i løbet af 24 timer efter administration af en 2-fold overdosis.
English: Pack of 1 bottle of 10 doses (20 ml).
Danish: Pakke med 1 flaske med 10 doser (20 ml).
English: 4.2 Indications for use, specifying the target species For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af kvæg fra 3 måneders alderen til forebyggelse* af viræmi, som er forårsaget af bluetongue-virus (BTV), serotype 1 og 8.
English: PACKAGE LEAFLET: Zulvac 1+8 Bovis Suspension for injection for cattle
Danish: INDLÆGSSEDDEL: Zulvac 1+8 Bovis Injektionsvæske, suspension til kvæg
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml:
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) En dosis med 2 ml indeholder:
English: Adjuvants: Aluminium hydroxide
Danish: Adjuvanser: Aluminiumhydroxid
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Danish: PAKNINGSSTØRRELSE 20 ml (10 doser) 100 ml (50 doser) 240 ml (120 doser)
English: PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
Danish: PAKNINGSSTØRRELSE 100 ml (50 doser) 240 ml (120 doser)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Bovis suspension for injection for cattle
Danish: VETERINÆRLÆGEMIDLETS NAVN Zulvac 1+8 Bovis injektionsvæske, suspension, til kvæg
English: Onset of immunity: 21 days after completion of the primary vaccination course Duration of immunity: 12 months after completion of the primary vaccination course.
Danish: Indtræden af immunitet: 21 dage efter basisvaccinationsprogrammet Varighed af immunitet: 12 måneder efter basisvaccinationsprogrammet.
English: Pack of 1 bottle of 120 doses (240 ml).
Danish: Pakke med 1 flaske med 120 doser (240 ml).
English: Pack of 1 bottle of 50 doses (100 ml).
Danish: Pakke med 1 flaske med 50 doser (100 ml).
English: Adjuvant(s): Aluminium hydroxide
Danish: Adjuvans (Adjuvanser): Aluminiumhydroxid
English: EXPIRY DATE EXP {month/year} Once broached use immediately.
Danish: 10. UDLØBSDATO EXP {måneder/år} Anvendes umiddelbart efter anbrud.
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Danish: Varighed af immunitet: 12 måneder efter basisvaccinationsprogrammet.
English: Name and address of the manufacturer responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Zoetis Manufacturing & Research Spain, S.L.
English: For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
Danish: Aktiv immunisering af kvæg fra 3 måneders alderen til forebyggelse* af viræmi, som er forårsaget af bluetongue-virus, serotype 1 og 8.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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: − Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)
English: Official control authority batch release is required for this product.
Danish: Officiel batch frigivelse.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dihydrate Sodium chloride
Danish: Kaliumdihydrogenphosphat Dinatriumhydrogenphosphatdihydrat Natriumchlorid
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket på 100 ml og 240 ml hætteglas
English: Per dose of 2 ml:
Danish: Hver dosis på 2 ml indeholder:
English: Active substance(s):
Danish: Aktivt stof (Aktive stoffer):
English: A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Danish: I et sikkerhedsstudie, blev der almindeligvis observeret en forbigående stigning i rektaltemperaturen, som ikke oversteg 2,7 ºC i løbet af 48 timer efter vaccinationen.
English: Do not use after the expiry date which is stated on the carton and label after EXP. Once broached use immediately.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001 (20 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/12/139/001 (20 ml)
English: EU/2/12/139/002 (100 ml) EU/2/12/139/003 (240 ml)
Danish: EU/2/12/139/003 (240 ml)
English: Onset of immunity: 21 days after completion of the primary vaccination course.
Danish: Indtræden af immunitet: 21 dage efter basisvaccinationsprogrammet..
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Danish: Lokale reaktioner på < 5 cm blev meget almindeligt observerets, reaktioner på >5 cm observeres almindeligt efter injektion af den anden enkeltdosis.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/12/139/002
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/12/139/001
English: Excipient(s): Thiomersal
Danish: Hjælpestof (Hjælpestoffer): Thiomersal
English: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1, Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02.
Danish: Inaktiveret bluetongue-virus, serotype 1, stamme BTV-1/ALG2006/01 E1 Inaktiveret bluetongue-virus, serotype 8, stamme BTV-8/BEL2006/02
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Danish: Inaktiveret bluetonguevirus, serotype 8, stamme BTV-8/BEL2006/02 Inaktiveret bluetongue-virus, serotype 8, stamme BTV-8/BEL2006/02
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5cm diameter were commonly observed after administration of a single dose in field safety studies.
Danish: Lokale reaktioner på < 5 cm blev meget almindelige observeres, reaktioner på >5 cm observeres almindelige efter injektion af den anden enkeltdosis.
English: WITHDRAWAL PERIOD(S) Zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 dage.
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Danish: Efter administration er forekomst af lokale reaktioner på < 2 cm meget almindelig, mens der lejlighedsvis kan almindelige forekomme reaktioner på op til 5 cm, disse forsvinder inden for højst 25 dage.
English: Invented name
Danish: Indgivelsesv ej
English: All active substances are authorised at the level of the Member States.
Danish: Alle aktive stoffer er godkendt i de enkelte medlemsstater.
English: • For bromocriptine: Restriction of the maximum dose to 30 mg per day.
Danish: • For bromocriptin: Begrænsning af den maksimale dosis til 30 mg/dag.
English: This warning includes recommendations for the monitoring of patients for signs of fibrosis during treatment.
Danish: Denne advarsel omfatter anbefalinger for monitorering af patienterne for tegn på fibrose under behandlingen.
English: This has been subject to previous reviews leading to risk minimisation measures at national level.
Danish: Dette er tidligere undersøgt, hvilket har ført til nationale tiltag til risikominimering.
English: The majority of reported fibrotic events were not completely reversible although symptomatic improvement occurs for various reasons and indeed occasionally fibrosis may regress.
Danish: Hovedparten af de rapporterede fibrotiske hændelser var ikke fuldstændig reversible, selvom om der af forskellige årsager sker en symptomlindring, og fibrosen kan af og til faktisk aftage.
English: The mechanism of fibrotic reaction induced by ergot alkaloids has not been completely clarified yet.
Danish: Mekanismerne bag fibrotisk reaktion induceret af ergotalkaloider er endnu ikke fuldstændig klarlagt.
English: A warning on the possible risk of fibrosis in patients taking these medicines at high doses for long periods.
Danish: En advarsel om den potentielle risiko for fibrose hos patienter, der tager disse lægemidler ved høje doser gennem længere tid.
English: Whether this mechanism also applies to the non-cardiac fibrotic events is unclear.
Danish: Det er uklart, om denne mekaniske også gør sig gældende ved non-kardielle fibrotiske hændelser.
English: The stimulation of the 5-HT2B receptor agonists is considered the most plausible mechanism that induces cardiac valvulopathy, although other mechanisms may be involved.
Danish: Stimulering af 5-HT2B-receptoragonisterne anses som den mest sandsynlige mekaniske bag inducering af hjerteklapbeskadigelse, selvom andre mekanismer muligvis også er involveret.
English: Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
Danish: Fire observationelle hovedundersøgelser havde til formål at undersøge risikoen for hjerteklapbeskadigelse hos patienter, der fik behandling med dopaminagonister mod Parkinsons sygdom (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BROMOCRIPTINE, DIHYDROERGOCRYPTINE AND LISURIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF BROMOCRIPTIN, DIHYDROERGOCRYPTIN OG LISURID OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Spontaneous cases of fibrotic reactions were reported for all ergot derived dopamine agonists, especially at high doses and after long period of treatment.
Danish: Der var rapporteret spontane tilfælde af fibrotiske reaktioner for alle ergotderiverede dopaminagonister, især ved høje doser efter længere tids behandling.
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Danish: Den 21. juni 2007 anmodede Det Forenede Kongerige i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, CHMP om at undersøge risikoen for fibrose og hjerteklapbeskadigelse i forbindelse med brug af ergotderiverede dopaminagonister og afgive en udtalelse om, hvorvidt markedsføringstilladelserne for alle produkter i denne lægemiddelgruppe bør opretholdes, ændres, suspenderes eller trækkes tilbage.
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for cabergoline and pergolide.
Danish: I lyset af forskellene i risikoniveauet blandt ergotderiverede dopaminagonister anbefalede CHMP, at der afgives en separat udtalelse om cabergolin og pergolid.
English: Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Danish: Ergotderiverede dopaminagonister anvendes primært til behandling af Parkinsons sygdom, enten som monoterapi eller i kombination med andre lægemidler.
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
Danish: CHMP gennemgik alle de oplysninger, som indehaverne af markedsføringstilladelserne havde indsendt om risikoen for fibrose og hjerteklapbeskadigelse fra kliniske undersøgelser, observationelle undersøgelser og spontane rapporteringer.
English: A contraindication for patients treated for a long period and with pre-existing cardiac valulopathy .
Danish: En kontraindikation for patienter i langtidsbehandling og med en anamnese med hjerteklapbeskadigelse.
English: As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Danish: Det har resulteret i, at lægemidler indeholdende pergolid kun er indiceret som andetvalgspræparater ved behandling af Parkinsons sygdom, og brugen af disse er kontraindiceret til patienter, der viser symptomer på hjerteklapproblemer.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER OG INDLÆGSSEDLER
English: - In view of the available data, the Committee concluded that the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Danish: - På baggrund af de tilgængelige data konkluderede udvalget, at risikoen for fibrotiske hændelser, heriblandt hjerteklapbeskadigelse, ikke er ens for alle ergotderiverede dopaminagonister.
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Danish: På sit møde i juni 2008 konkluderede CHMP, at mængden af videnskabelige data om risikoen for fibrotiske hændelser, heriblandt hjerteklapbeskadigelse, ikke er ens for alle ergotderiverede dopaminagonister.
English: • For bromocriptine and dihydroergocryptine:
Danish: • For bromocriptin og dihydroergocryptin:
English: Overall, data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Danish: Samlet set indikerer data fra spontane rapporteringer, at patienter, som tager carbergolin og pergolid, har større risiko for fibrotiske hændelser og hjerteklapbeskadigelse end patienter, som tager bromocriptin, lisurid eller dihydroergocryptin.
English: They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Danish: De anvendes også til behandling af blandt andet hyperprolaktinæmi og prolaktinomer samt til forebyggelse af laktation og migræne.
English: Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Danish: Ergotderiverede dopaminagonister har været forbundet med en øget risiko for fibrotiske lidelser og hjerteklapfejl.
English: In view of the above, the CHMP recommended the maintenance of the marketing authorisation for bromocriptine, dihydroergocryptine and lisuride containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Danish: På baggrund af ovennævnte anbefalede CHMP opretholdelse af markedsføringstilladelsen for lægemidler indeholdende bromocriptin, dihydroergocryptin og lisurid med de ændringer i produktinformationen (produktresuméet og indlægssedlen), der er beskrevet nedenfor.
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Danish: - CHMP behandlede indbringelsen i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende bromocriptin, cabergolin, dihydroergocryptin, lisurid og pergolid.
English: For carbergoline and pergolide an increased risk of fibrotic events is considered well established.
Danish: For carbergolin og pergolid anses det for veldokumenteret, at der er en øget risiko for fibrotiske hændelser.
English: However, cases of valvulopathy were reported for bromocriptine, cabergoline, dihydroergocryptine and pergolide, but not for lisuride.
Danish: Der var dog rapporteret om tilfælde af hjerteklapbeskadigelse for bromocriptin, cabergolin, dihydroergocryptin og pergolid, men ikke for lisurid.
English: Bromocriptine, dihydroergocryptine and lisuride belong to the class of ergot derived dopamine agonists, which also comprises cabergoline and pergolide.
Danish: Bromocriptin, dihydroergocryptin og lisurid tilhører gruppen af ergotderiverede dopaminagonister, som også omfatter cabergolin og pergolid.
English: • For bromocriptine, dihydroergocryptine and lisuride:
Danish: • For bromocriptin, dihydroergocryptin og lisurid:
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin Neuropharmacol, 2006).
Danish: Graden af 5-HT2B-receptoragonisme varierer mellem de ergotderiverede dopaminagonister og stemmer godt overens med forskellene i incidensrater af fibrotiske hændelser for de forskellige ergot-præparater (C.
English: - The CHMP, as a consequence, recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets for the medicinal products containing bromocriptine, dihydroergocryptine and lisuride (see Annex III).
Danish: - anbefalede CHMP, at der blev foretaget ændringer i de relevante dele af produktresuméerne og indlægssedlerne for lægemidler indeholdende bromocriptin, dihydroergocryptin og lisurid (se bilag III).
English: For bromocriptine, dihydroergocryptine and lisuride, an increased risk of fibrosis, including cardiac valvulopathy, cannot be excluded.
Danish: For bromocriptin, dihydroergocryptin og lisurid kan det ikke udelukkes, at der er en øget risiko for fibrose, herunder hjerteklapbeskadigelse.
English: For bromocriptine, dihydroergotamine and lisuride, no fibrotic events have been reported by MAHs from clinical trials or observational studies.
Danish: Med hensyn til bromocriptin, dihydroergotamin og lisurid har indehaverne af markedsføringstilladelserne ikke rapporteret om fibrotiske hændelser fra kliniske undersøgelser eller observationelle undersøgelser.
English: For bromocriptine, dihydroergocryptine and lisuride an increased risk cannot be excluded based on the amount of evidence available.
Danish: For bromocriptin, dihydroergocryptin og lisurid kan det ikke udelukkes, at der er en øget risiko, på baggrund af de tilgængelige videnskabelige data.
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline and pergolide, compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Danish: Fra Schade-undersøgelsen rapporteredes en højere justeret incidensrate-ratio (IRR) for symptomatiske utætheder i hjerteklapper (regurgitation) for cabergolin og pergolid,
English: 13 days.
Danish: 13 dage.
English: The marketing authorisation was renewed on 29 October 2004.
Danish: Markedsføringstilladelsen blev fornyet den 29. oktober 2004.
English: This summary was last updated in June 2007.
Danish: Dette sammendrag blev sidst ajourført i 06-2007.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
English: Information on the prescription status of this product may be found on the label of the bottle.
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på flaskeetiketten.
English: Any unused product or waste materials should be disposed of in accordance with local requirements.
Danish: En eventuel uanvendt del af produktet og affald herfra skal bortskaffes i henhold til lokale retningslinjer.
English: Other information about Halocur:
Danish: Andre oplysninger om Halocur:
English: The benefit-risk balance may be found in module 6 of this EPAR.
Danish: En afvejning af fordele og risici fremgår af modul 6 i denne EPAR.
English: Not applicable since the product is only to be used in newborn calves.
Danish: Ikke relevant, da produktet udelukkende er til brug hos nyfødte kalve.