FrancophonIA/ELRC3.0 huggingface dataset:
English: Details of how the PPP will be implemented should be agreed with the Marketing Authorisation Holder and put in place prior to the marketing of the product.
Danish: Detaljer vedrørende måden, hvorpå svangerskabsforebyggelsesprogrammet vil blive implementeret skal aftales med indehaveren af markedsføringstilladelsen og etableres inden produktet markedsføres.
English: The Member States should ensure that the MAH provides the educational materials to the national patients' organisations for review or if such an organisation does not exist or can not be involved, to a relevant patients group.
Danish: Medlemsstaterne skal sikre, at indehaveren af markedsføringstilladelsen udleverer oplysningsmaterialerne til de nationale patientorganisationer til gennemsyn eller, hvis en sådan organisation ikke findes eller ikke kan være involveret, til en relevant patientgruppe.
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
Danish: • Specifikke, nationale krav som skal godkendes af de kompetente, nationale instanser med hensyn til: o Produktdistribution o Procedurer til at sikre at alle relevante forholdsregler er blevet taget, inden thalidomid ordineres
English: The Member States shall report to the EMEA the following information at 6 monthly intervals following the Commission Decision: o The status of implementation of the PPP within their MS o Estimates of usage in their MS
Danish: Medlemsstaterne skal indberette følgende information til EMEA med 6 månedlige intervaller efter kommissionsbeslutningen: o Status for implementeringen af svangerskabsforebyggelsesprogrammet i det respektive land o Vurdering af brug i det respektive land
English: CONDITIONS OR RESTRICTION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE MED HENSYN TIL SIKKER OG EFFEKTIV BRUG AF LÆGEMIDLET.
English: The Member States shall put into place measures to ensure that: o The maximum treatment duration for one prescription shall be 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Prescriptions can only be dispensed within 7 days of the date of the prescription
Danish: Medlemsstaterne skal etablere forholdsregler for at sikre, at: o Den maksimale behandlingsvarighed af en ordination må være 4 uger for kvinder i den fertile alder 12 uger for mænd og kvinder, som ikke er i den fertile alder o Lægemidlet kan kun udleveres inden for 7 dage efter receptens dato
English: The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
Danish: Medlemsstaterne skal sikre, at indehaveren af markedsføringstilladelsen implementerer et svangerskabsforebyggelsesprogram inden for deres område.
English: • The need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
Danish: • Nødvendigheden af effektiv svangerskabsforebyggelse uden afbrydelse 4 uger før behandlingen påbegyndes, under hele behandlingens varighed og 4 uger efter behandlingens afslutning
English: The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below.
Danish: Medlemsstaterne skal være enige om detaljerne vedrørende et kontrolleret distributionssystem med indehaveren af markedsføringstilladelsen i overensstemmelse med de nationale bestemmelser og sundhedssystemer og skal implementere et sådant program nationalt for at sikre, at: o Alle læger og farmaceuter, som har til hensigt at ordinere eller udlevere Thalidomide Celgene, inden lancering modtager et Kære sundhedspersonalebrev som beskrevet nedenfor.
English: The Member State should agree with the Marketing Authorisation Holder prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territory o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
Danish: Medlemsstaterne skal blive enige med indehaveren af markedsføringstilladelsen inden lancering af produktet om: o De mest hensigtmæssige strategier til monitorering af off-labelanvendelse inden for nationale grænser o Indsamling af detaljerede data, der som minimum omfatter patientdemografi og indikation for nøje at monitorere off-label anvendelse på nationalt område o Opstilling af nationale forholdsregler med henblik på at vurdere effektivitet og overholdelse af svangerskabsforebyggelsesprogrammet.
English: Educational healthcare professional's kit The Educational healthcare professional's kit shall contain the following elements:
Danish: Undervisningsmateriale til sundhedspersonale Undervisningsmaterialet til sundhedspersonalet skal indeholde følgende elementer:
English: Not to donate blood during treatment and for one week after treatment ends o Algorithm for Pregnancy Prevention Plan implementation This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
Danish: Ikke at donere blod under behandlingen og i en uge efter behandlingsophør o Algoritme til implementering af planen for svangerskabsforebyggelse Dette skal hjælpe med kategorisering af patienter og bestemmelse af de fornødne forholdsregler vedrørende svangerskabsforebyggelse og graviditetstests.
English: • Pregnancy testing requirements o Advice on suitable tests o Frequency (before commencing, monthly during treatment and after finishing treatment)
Danish: • Krav til graviditetstests o Råd om brugbare prøver o Frekvens (før påbegyndelse af, månedligt under og efter behandling)
English: o Pregnancy Prevention Programme information Definition of women with childbearing potential (WCBP) and actions the prescriber should take if childbearing status is unclear Information on what is effective contraception Safety advice for WCBP
Danish: o Oplysninger om svangerskabsforebyggelsesprogrammet Definition af kvinder i den fertile alder (women of childbearing potential (WCBP)) samt hvorledes den ordinerende læge skal handle, hvis der er uklarhed om graviditetsstatus Oplysninger om hvad effektiv svangerskabsforebyggelse er
English: • The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
Danish: • Nødvendigheden af graviditetstest dvs. før behandling, hver 4. uge under behandlingen og efter behandling
English: • Neuropathy and adverse reaction reporting forms
Danish: • Formularer til indberetning af neuropati og bivirkninger
English: That Thalidomide Celgene must not be given to any other person That the patient should not donate blood during therapy and for one week following discontinuation of thalidomide That the patient should tell their doctor about any adverse events That any unused capsules should be returned to the pharmacist at the end of the treatment o The following information should also be provided in the appropriate booklet Female patient of childbearing potential
Danish: At Thalidomide Celgene ikke må videregives til andre At patienten ikke børe donere blod under behandlingen og i en uge efter thalidomidbehandlingen afsluttes At patienten skal fortælle lægen om alle utilsigtede hændelser At ikke anvendte kapsler skal leveres tilbage til apoteket ved afslutning af behandling o Følgende oplysninger bør også gives i de relevante brochurer: Kvindelig patient i den fertile alder
English: • That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception
Danish: • At hun, hvis hun har brug for at ændre eller stoppe sin svangerskabsforebyggende metode, skal informere - den læge, der ordinerer det svangerskabsforebyggende middel, om at hun er i behandling med thalidomid - den læge, der ordinerer thalidomid, om at hun har stoppet eller ændret sin svangerskabsforebyggende metode
English: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “Educational Healthcare Professional's Kit” (if applicable to a Member State)
Danish: • Brochure til sundhedspersonale o Thalidomids historie, baggrundsoplysninger om Thalidomide Celgene og den godkendte indikation o Dosering o Maksimal varighed af ordinering 4 uger for kvinder i den fertile alder 12 uger for mænd og kvinder, som ikke er i den fertile alder o Teratogenicitet og nødvendigheden af at undgå føtal eksponering o Sundhedspersonalets pligter ved ordinering og salg af Thalidomide Celgene, herunder Nødvendigheden af at yde omfattende vejledning og rådgivning til patienterne At patienterne skal være i stand til at efterkomme krav i forbindelse med sikker anvendelse af thalidomid Nødvendigheden af at udlevere relevant patientoplysningsmateriale Indberetning om graviditet, neuropati eller andre utilsigtede hændelser til Celgene og den lokale sundhedsmyndighed ved brug af formularerne i "Undervisningsmateriale til sundhedspersonale" (hvis relevant i en medlemsstat)
English: o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional's Kit containing the following: Healthcare professional booklet Patient booklets Patient cards Summary of Product Characteristics, Package Leaflet and Labelling
Danish: o Alt sundhedspersonale, som har til hensigt at ordinere (og i overensstemmelse med den nationale, kompetente myndighed udlevere) Thalidomide Celgene, inden ordinationen foretages modtager undervisningsmateriale, der indeholder følgende: Brochure til sundhedspersonale Patientbrochurer Patientkort Produktresumé, indlægsseddel og etikettering
English: • Treatment initiation forms o There should be 3 types of treatment initiation forms: Female patient of childbearing potential Female patient of non-childbearing potential Male patient o All treatment initiation forms should contain the following elements: Teratogenicity warning
Danish: • Formularer til påbegyndelse af behandling o Der bør være 3 formularer til påbegyndelse af behandling: Kvindelig patient i den fertile alder Kvindelig patient, som ikke er i den fertile alder Mandlig patient o Alle formularer, hvor behandling kan påbegyndes, bør indeholde følgende elementer:
English: • That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for male patients should also include: Confirmation that the physician has discussed the following:
Danish: • At hun skal levere kapslerne tilbage til apoteket ved behandlingens afslutning o Formularer til påbegyndelse af behandling for mandlige patienter bør også indeholde: Bekræftelse af, at lægen har talt med patienten om:
English: • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not using effective contraception
Danish: • At thalidomid kan findes i sæd og nødvendigheden at anvende kondom, hvis seksualpartneren er gravid eller er en kvinde i den fertile alder, som ikke bruger et effektivt præventionsmiddel
English: • Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men
Danish: • Nødvendigheden af øjeblikkelig orientering af den behandlende læge ved mistanke om graviditet Sikkerhedsråd til mænd
English: • The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af øjeblikkeligt ophør med anvendelse af Thalidomide Celgene ved mistanke om graviditet
English: • That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for female patients with no childbearing potential should also include: Confirmation that the physician has discussed the following:
Danish: • At hun skal levere kapslerne tilbage til apoteket ved behandlingens afslutning o Formularer til påbegyndelse af behandling for kvinder, som ikke er i den fertile alder, bør også indeholde: Bekræftelse af, at lægen har talt med patienten om:
English: Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
Danish: Bekræftelse af patientens forståelse mht. risikoen for thalidomid og forholdsreglerne i svangerskabsforebyggelsesprogrammet Patientoplysninger, underskrift og dato Ordinerende læge, dennes underskrift samt dato Hensigten med dette dokument, dvs. som formuleret i svangerskabsforebyggelsesprogrammet: "Hensigten med formularen til påbegyndelse af behandling er at beskytte patienterne og eventuelle fostre ved at sikre, at patienterne er fuldstændigt informeret om og forstår risikoen for teratogenicitet og andre bivirkninger forbundet med brugen af thalidomid.
English: • That he should not donate blood or semen during therapy and for one week following discontinuation of thalidomide
Danish: • At han ikke bør donere blod eller sæd under behandlingen og i en uge efter thalidomidbehandlingen afsluttes
English: • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af øjeblikkeligt ophør med anvendelsen af Thalidomide Celgene ved mistanke om graviditet
English: • Education booklets for patients: o The booklets can be of 3 types or a single patient booklet that combines the information for each patient category: Booklet for women of childbearing potential and their partners Booklet for women patients who are not of childbearing potential
Danish: • Oplysningsbrochurer til patienter o Der kan være 3 typer oplysningsbrochurer til patienterne eller en enkelt patientbrochure, som sammenfatter oplysningerne for hver patientkategori: Brochure for kvindelige patienter i den fertile alder og deres partner Brochure for kvindelige patienter, som ikke er i den fertile alder Brochure for mandlige patienter o Alle patientbrochurer bør indeholde følgende oplysninger: At Thalidomide Celgene er teratogent At Thalidomide Celgene kan forårsage thromboemboliske og kardiovaskulære hændelser samt neuropati Beskrivelse af patientkortet og dets anvendelse i den enkelte medlemsstat
English: • Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if female with childbearing potential) o pregnancy test dates and results
Danish: • Patientkort og/eller tilsvarende værktøjer o bekræftelse af, at relevant rådgivning har fundet sted o dokumentation vedrørende muligheden for at blive gravid o boks (el.
English: • That she should not donate blood during therapy and for one week following discontinuation of thalidomide
Danish: • At hun ikke må donere blod under behandlingen og i en uge efter thalidomidbehandlingen afsluttes
English: • That he should not donate semen during therapy and for one week following discontinuation of thalidomide.
Danish: • At han ikke bør donere sæd under behandlingen og i en uge efter thalidomidbehandlingen afsluttes
English: • The need to contact their doctor immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af øjeblikkelig orientering af den behandlende læge ved mistanke om graviditet
English: • That he should not donate semen during therapy and for one week following discontinuation of thalidomide o Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit”
Danish: • At han ikke må donere sæd under behandlingen og i en uge efter thalidomidbehandlingen afsluttes o Krav vedrørende indberetning af graviditet Øjeblikkeligt ophør med indtagelse af Thalidomide Celgene ved mistanke om graviditet
English: Description of the patient card and its use in the individual Member State National or other applicable specific arrangements for a prescription for thalidomide to be dispensed
Danish: Nationale og andre relevante forholdsregler for ordination af Thalidomide Celgene
English: o Treatment initiation forms for female patients with childbearing potential should also include:
Danish: o Formularer til påbegyndelse af behandling for kvindelige patienter i den fertile alder bør også omfatte: Bekræftelse af, at lægen har talt med patienten om:
English: CONTRAINDICATIONS None.
Danish: KONTRAINDIKATIONER Ingen.
English: If such a reaction occurs, appropriate treatment should be administered without delay.
Danish: Hvis der forekommer en sådan reaktion skal passende behandling administreres uden forsinkelse.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/11/2008
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 21/11/2008
English: Vaccination may interfere with existing sero-epidemiological surveys.
Danish: Vaccinationen kan interferere med eksisterende sero-epidemiologiske undersøgelser.
English: In very rare cases transient hyperthermia may occur for up to 2 days.
Danish: I meget sjældne tilfælde kan der forekomme hypertermi i op til 2 dage.
English: Date of last renewal: 12/09/2013
Danish: Dato for seneste fornyelse: 12/09/2013
English: ATCvet code: QI05AA10.
Danish: ATCvet-kode: QI05AA10
English: The vaccine stimulates active immunity against West Nile virus.
Danish: Vaccinen stimulerer aktiv immunitet mod Vestnilvirus.
English: The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Danish: Anvendelse af Equip WNV nedsætter antallet af dyr med viræmi efter naturlig infektion, men forhindrer det ikke nødvendigvis systematisk.
English: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus.
Danish: Men da IgM-respons efter vaccination er sjælden, er et positivt IgM-ELISA-testresultat en stærk indikator for naturlig infektion med Vestnilvirus.
English: • Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
Danish: • Basisvaccination: den første injektion fra 6-måneders alderen, den anden injektion 3-5 uger senere.
English: As with any vaccine rare, occasional hypersensitivity reactions may occur.
Danish: Som med andre vacciner kan der forekomme sjældne, lejlighedsvise overfølsomhedsreaktioner.
English: • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
Danish: • Revaccination: En årlig booster injektion med én enkelt 1 ml dosis bør yde tilstrækkelig beskyttelse, om end denne plan ikke er valideret i tilstrækkelig grad.
English: As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Danish: Som en følge heraf kan det ikke udelukkes, at forbigående immunodepression, som ses under drægtighed, kan interferere med vaccineoptagelse.
English: If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Danish: Hvis der er mistanke om infektion som et resultat af et positivt IgM-respons, er der brug for ekstra analyser for at kunne afgøre, om dyret var inficeret eller vaccineret.
English: SP oil
Danish: SP-olie
English: The excipients (including adjuvants) 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: Hjælpestofferne (inclusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Minimum essential medium (MEM) Phosphate buffered saline
Danish: Minimum essential medium (MEM) Phosphat bufferet NaCl.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/086/004 (2 single-dose glass syringes) EU/2/08/086/005 (4 single-dose glass syringes) EU/2/08/086/006 (10 single-dose glass syringes)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/086/004 (2 enkeltdosis injektionssprøjter af glas) EU/2/08/086/005 (4 enkeltdosis injektionssprøjter af glas) EU/2/08/086/006 (10 enkeltdosis injektionssprøjter af glas)
English: For WNV lineage 2 strains the duration of immunity has not been established.
Danish: For VNV linje 2 stammer er varighed af immuniteten ikke klarlagt.
English: It is therefore recommended not to vaccinate foals of less than 6 months of age.
Danish: Det anbefales derfor, at føl under 6 måneder ikke vaccineres.
English: Name and address of the manufacturer of the biological active substance: Zoetis Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof: Zoetis Inc.
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) At behandling af dyr med veterinærlægemidletgriber 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 fra behandlede dyr ikke er kontamineret,
English: RP* 1.0-2.2 * Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Danish: RP* 1,0- 2,2 *Relativ styrke in vitro sammenlignet med en referencevaccine, der var påvist effektiv til heste.