FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S.A. on 17 November 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Masivet til AB Science S.A. den 17. november 2008.
English: The tablets are given by mouth, once a day.
Danish: Tabletterne indgives via munden en gang dagligt.
English: It is available as round, orange tablets (50 and 150 mg).
Danish: Det fås som runde, orange tabletter (50 og 150 mg).
English: These reactions are usually mild to moderate and temporary, last for up to four weeks.
Danish: Disse reaktioner er normalt milde til moderate samt forbigående (varer i op til fire uger).
English: A number of studies with Masivet were carried out either in laboratory dogs or in animal patients at veterinary practises in Europe and in the USA.
Danish: Der er foretaget en række undersøgelser med Masivet enten med laboratoriehunde eller med dyrepatienter på dyrlægeklinikker i Europa og USA.
English: The tablets must be administered whole and should not be divided, broken or ground up.
Danish: Tabletterne skal gives hele og må ikke deles, brydes eller knuses.
English: Do not eat, drink or smoke while treating a dog.
Danish: Der må ikke spises, drikkes eller ryges under behandling af hunden.
English: Four to six weeks after starting the treatment with Masivet, the veterinarian should check if the treatment is likely to be successful.
Danish: Fire til seks uger efter påbegyndt behandling med Masivet skal dyrlægen kontrollere, om det er sandsynligt, at behandlingen vil virke.
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Danish: Det betyder, at det blokerer nogle specifikke enzymer, der kaldes tyrosinkinaser.
English: In case of side effects, the veterinarian might decide to lower the dose of Masivet or to discontinue treatment.
Danish: I tilfælde af bivirkninger kan dyrlægen beslutte at nedsætte dosen af Masivet eller at afbryde behandlingen.
English: What is the risk associated with Masivet?
Danish: Hvilken risiko er der forbundet med Masivet?
English: The duration of treatment depends on the dog's response to treatment.
Danish: Behandlingens varighed afhænger af hundens respons på behandlingen.
English: It is only used if the presence of a mutated form of the receptor protein c-kit in the tumours has been confirmed before the start of treatment.
Danish: Det anvendes kun i tilfælde, hvor tilstedeværelsen af en muteret form af c-kit-receptorproteinet i tumorerne er blevet bekræftet inden behandlingsstart.
English: The main study compared the effectiveness of Masivet at the recommended dose of 12.5 mg per kilogramme bodyweight once a day with placebo (a dummy treatment).
Danish: I hovedundersøgelsen sammenlignedes virkningen af Masivet ved den anbefalede dosis på 12,5 mg pr. kg kropsvægt én gang daglig med placebo (en uvirksom behandling).
English: By blocking these receptors, Masivet might help to control cell division, preventing further development of the tumours with this particular mutation.
Danish: Ved at blokere disse receptorer kan Masivet være med til at kontrollere denne celledeling og forebygge yderligere udvikling af tumorerne med denne bestemte mutation.
English: Dogs under Masivet treatment should be regularly monitored for side effects by the veterinarian (at least monthly).
Danish: Hunde, der får behandling med Masivet, skal regelmæssigt undersøges for bivirkninger af en dyrlæge (mindst en gang om måneden).
English: These enzymes can be found in some receptors on the surface of cells, including the c-kit receptor.
Danish: Disse enzymer findes i nogle receptorer på overfladen af celler, heriblandt c-kit-receptoren.
English: If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water.
Danish: Hvis knuste tabletter eller opkast, urin eller afføring fra behandlede hunde kommer i kontakt med huden eller øjnene, skal der omgående skylles med rigeligt vand.
English: Because this disease is a life threatening condition and the overall number of dogs affected is expected to be low, the CVMP guidelines on “Minor-Use-Minor-Species (MUMS) data requirements” were applied when assessing the dossier.
Danish: Da denne sygdom er en livstruende tilstand, og da det samlede antal berørte hunde forventes at være lavt, blev CVMP's retningslinjer for "krav til data for veterinærlægemidler til mindre udbredte sygdomme og mindre arter (MUMS)" anvendt ved udvalgets vurdering af ansøgningsdossieret.
English: Why has Masivet been approved?
Danish: Hvorfor blev Masivet godkendt?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Masivet exceed the risks for the treatment of non-resectable mast cell tumours (grade 2 or 3) that have a confirmed mutated c-kit tyrosine kinase receptor and recommended that Masivet be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Masivet er større end risiciene ved behandling af ikke-resektable mastcelletumorer (grad 2 eller 3) med en bekræftet muteret c-kit tyrosinkinasereceptor, og anbefalede udstedelse af markedsføringstilladelse for Masivet.
English: The active substance in Masivet, masitinib, is a protein-tyrosine kinase inhibitor.
Danish: Det aktive stof i Masivet, masitinib, er en protein-tyrosinkinasehæmmer.
English: In the dogs whose tumours contained mutated c-kit receptors, it took longer for the tumour to get worse when dogs received Masivet (median of 241 days) than in those receiving placebo (median of 83 days).
Danish: Hos de hunde, hvis tumorer indeholdt muterede c-kit-receptorer, varede det længere, før tumorerne blev værre, hvis hundene fik Masivet (gennemsnitligt 241 dage), end hvis de fik placebo (gennemsnitligt 83 dage).
English: The study included dogs of various breeds and both sexes with mast-cell tumours that had come back after surgery or could not be removed with surgery.
Danish: Undersøgelsen omfattede hunde af forskellige racer og af begge køn med mastcelletumorer, som var vendt tilbage efter kirurgi, eller som ikke kunne fjernes med kirurgi.
English: If Masivet is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Danish: Hvis en person utilsigtet kommer til at tage Masivet, skal der straks søges læge, og indlægssedlen eller etiketten skal medbringes og vises til lægen.
English: It must not be used in dogs less than six months of age or less than 4 kg in weight, or bitches that are pregnant or lactating.
Danish: Det må ikke anvendes til hunde, der er yngre end seks måneder eller vejer mindre end 4 kg, eller til drægtige eller diegivende hunhunde.
English: Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably.
Danish: Nogle typer af mastcelletumorer er forbundet med en mutation, som forårsager overaktivitet af c-kit og stimulerer mastcellerne til at dele sig ukontrollabelt.
English: It is used for tumours which are severe in character (grade 2 or 3) and which cannot be removed with surgery.
Danish: Det anvendes mod alvorlige tumorer (grad 2 eller 3), som ikke kan fjernes med kirurgi.
English: Masivet must not be used in dogs with certain kinds of liver or kidney problems, or anaemia (low red blood cell counts) or neutropenia (low white blood cell counts).
Danish: Masivet må ikke anvendes til hunde med visse lever- eller nyreproblemer, anæmi (lavt antal røde blodlegemer) eller neutropeni (lavt antal hvide blodlegemer).
English: What is Masivet?
Danish: Hvad er Masivet?
English: The study population included dogs whose tumours contained mutated or normal (‘wild-type') c-kit receptors.
Danish: Undersøgelsespopulationen omfattede hunde, hvis tumorer indeholdt muterede eller normale ("vildtype")-c-kit-receptorer.
English: Children should not have close contact with treated dogs, or their faeces or vomit.
Danish: Børn må ikke komme i tæt kontakt med behandlede hunde eller med disses afføring eller opkast.
English: Masivet is used to treat dogs with mast-cell tumours (a type of cancer).
Danish: Masivet anvendes til behandling af hunde med mastcelletumorer (en kræfttype).
English: It should not be used in dogs that may be hypersensitive (allergic) to masitinib or any of the other ingredients.
Danish: Masivet må ikke anvendes til hunde, som kan være overfølsomme (allergiske) over for masitinib eller et eller flere af de øvrige indholdsstoffer.
English: The dose depends on the weight of the dog being treated..
Danish: Dosis afhænger af den behandlede hunds vægt.
English: Masivet contains masitinib, which belongs to a class of medicines having an anticancer action.
Danish: Masivet indeholder masitinib, som tilhører gruppen af lægemidler med virkning mod kræft.
English: The most common side effects with Masivet are gastrointestinal reactions (diarrhoea and vomiting) and hair loss.
Danish: De mest almindelige bivirkninger ved Masivet er reaktioner i mave-tarm-kanalen (diarré og opkastning) og hårtab.
English: How has Masivet been studied?
Danish: Hvordan blev Masivet undersøgt?
English: For a full list of all side-effects reported with Masivet, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Masivet fremgår af indlægssedlen.
English: What benefit has Masivet shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Masivet?
English: What is Masivet used for?
Danish: Hvad anvendes Masivet til?
English: How does Masivet work?
Danish: Hvordan virker Masivet?
English: 2nd injection: after 3 weeks
Danish: Anden injektion: efter 3 uger.
English: ATC vet code: QI04AA02.
Danish: ATCvet-kode: QI04AA02
English: Date of last renewal: 18/04/2016
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 18/04/2016
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Danish: *(Cyklusværdi (Ct) ≥ 36 bestemt med en valideret RT-PCR-metode, som ikke indikerede tilstedeværelse af viralt genom)
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af markedsføringstilladelsen skal informere Europa-Kommisionen om planerne for markedsføring af det veterinærlægemidlet, der er godkendt under denne procedure.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 1 år.
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive 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: MARKETING AUTHORISATION NUMBER(S) EU/2/11/131/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/131/001
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2011
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 05/08/2011
English: Aluminium hydroxide (Al3+)
Danish: Adjuvanser: Aluminiumhydroxid (Al3+)
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Danish: Anvendelse af dette veterinærlægemiddel er kun tilladt under de særlige omstændigheder, der er fastsat af EU-lovgivning vedr.
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur very commonly during the 24 hours following vaccination.
Danish: En forbigående stigning i rektaltemperaturen på højst 1,2°C kan forekomme meget almindelig i løbet af de første 24 timer efter vaccination.
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: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Danish: IMMUNOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Inaktiverede virale vacciner - Bluetonguevirus.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis på 2 ml indeholder:
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for bluetonguevirus (BTV).
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 anbrud.
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer)
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal.
Danish: Inaktiveret bluetonguevirus, serotype 1, stamme BTV-1/ALG2006/01 E1 Aluminiumhydroxid, saponin og thiomersal.
English: To stimulate active immunity against Bluetongue Virus, serotype 1 in sheep.
Danish: Til stimulation af aktiv immunitet mod bluetonguevirus, serotype 1 hos får.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton med 1 x 20 ml, 1 x 100 ml og 1 x 240 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1 Ovis suspension for injection for sheep
Danish: VETERINÆRLÆGEMIDLETS NAVN Zulvac 1 Ovis injektionsvæske, suspension, til får
English: No data is available on safety in lactating animals.
Danish: Der foreligger ingen oplysninger om sikkerheden hos diegivende dyr.
English: PACKAGE LEAFLET: Zulvac 1 Ovis suspension for injection for sheep
Danish: INDLÆGSSEDDEL: Zulvac 1 Ovis injektionsvæske, suspension, til får
English: 4.2 Indications for use, specifying the target species For active immunisation of sheep from 1 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotype 1.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af får fra 1,5 måneders-alderen til forebyggelse* af viræmi, som er forårsaget af bluetonguevirus (BTV), serotype 1.
English: The use in lactating animals is therefore not recommended.
Danish: Anvendelse af vaccinen kan derfor ikke anbefales.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 2 ml dose contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver dosis på 2 ml indeholder:
English: STATEMENT OF ACTIVE SUBSTANCES Per dose of 2 ml
Danish: ANGIVELSE AF AKTIVE STOFFER Pr. dosis på 2 ml:
English: Onset of immunity: 21 days after completion of the primary vaccination scheme Duration of immunity: 12 months after completion of the primary vaccination scheme 4.3 Contraindications
Danish: Varighed af immunitet: 12 måneder efter afslutning af basisvaccinationsprogrammet.
English: Cardboard box with one type II glass vial of either 100 ml (containing 50 doses) or 240 ml (containing 120 doses) with a chlorobutyl rubber stopper and aluminium cap.
Danish: Karton med 1 hætteglas af type II glas på 100 ml (indeholdende 50 doser) eller på 240 ml (indeholdende 120 doser) med chlorobutylprop og aluminiumshætte.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstillerne (fremstillerne) ansvarlig for batchfrigivelse
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml and 240 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket på 100 ml og 240 ml hætteglas
English: Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Danish: Karton med 1 hætteglas af type I glas på 20 ml (indeholdende 10 doser) med chlorobutylprop og aluminiumshætte.
English: For active immunisation of sheep from 1 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1.
Danish: Aktiv immunisering af får fra 1,5 måneders-alderen til forebyggelse* af viræmi, som er forårsaget af bluetonguevirus, serotype 1.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Pr. dosis på 2 ml:
English: Marketing authorisation holder Zoetis Belgium SA Rue Laid Burniat 1
Danish: Indehaver af markedsføringstilladelsen: Zoetis Belgium SA
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Vaccination may be followed very commonly by a local reaction at the injection site.
Danish: En lokal reaktion på administrationsstedet efter vaccination er meget almindelig.
English: Adcetris 50 mg Powder for concentrate for solution for infusion
Danish: 50 mg Pulver til koncentrat til infusionsvæske, opløsning i.v.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Holoclar on 17 February 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Holoclar den 17. februar 2015.
English: Holoclar has therefore been given ‘conditional approval'.
Danish: Holoclar har fået en »betinget godkendelse«.
English: Other information about Holoclar
Danish: Andre oplysninger om Holoclar
English: This is a summary of the European public assessment report (EPAR) for Holoclar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Holoclar.
English: Holoclar is intended for a single treatment, although treatment can be repeated if the doctor considers it necessary.
Danish: Holoclar er beregnet til en enkelt behandling, men behandlingen kan gentages, hvis lægen anser det for nødvendigt.
English: A risk management plan has been developed to ensure that Holoclar is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Holoclar anvendes så sikkert som muligt.
English: There were also reductions in patients' symptoms, such as pain and inflammation, and improvements in vision.
Danish: Der var desuden bedring i patienternes symptomer såsom smerter og inflammation, og deres syn var blevet bedre.
English: In the first stage of treatment, a small part of healthy limbal tissue (1−2 mm2 in size) is taken from the patient in hospital and sent to the manufacturer on the same day.
Danish: I det første trin af behandlingen udtages der fra patienten på hospitalet et lille stykke sundt limbalt væv (1−2 mm2), som samme dag sendes til fremstilleren.
English: Educational material will also be provided to patients undergoing treatment.
Danish: Der skal derudover udleveres oplysningsmateriale til de patienter, der modtager behandlingen.
English: Why is Holoclar approved?
Danish: Hvorfor blev Holoclar godkendt?
English: The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study.
Danish: Virksomheden skal fremlægge data om fordelene og risiciene ved Holoclar fra en prospektiv klinisk undersøgelse.
English: Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
Danish: Da Holoclar har fået en betinget godkendelse, skal virksomheden, der markedsfører Holoclar, fremlægge yderligere data om Holoclar.
English: What is Holoclar and what is it used for?
Danish: Hvad er Holoclar, og hvad anvendes det til?
English: Because the number of patients with limbal stem-cell deficiency due to burns to the eyes is low, the disease is considered ‘rare', and Holoclar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Danish: Da antallet af patienter med mangel på limbale stamceller er lavt, betragtes sygdommen som »sjælden«, og Holoclar blev udpeget som »lægemiddel til sjældne sygdomme« den 7. november 2008.
English: As the side effects of Holoclar treatment are generally manageable, the CHMP concluded that Holoclar's benefits outweigh its risks and recommended that it be approved for use in the EU.
Danish: Da bivirkningerne ved behandling med Holoclar sædvanligvis kan behandles, konkluderede CHMP, at fordelene ved Holoclar opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Holoclar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Holoclar?
English: Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine.
Danish: Efter operationen skal patienten have antibiotika og passende antiinflammatorisk medicin.
English: Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed.
Danish: Derefter dyrkes cellerne i vævet i laboratoriet og nedfryses, indtil operationsdagen er fastlagt.
English: The full EPAR and risk management plan summary for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Holoclar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Holoclar.
Danish: Det er ikke en praktisk vejledning i, hvordan Holoclar bør anvendes.
English: Holoclar is a type of advanced therapy product called a ‘tissue engineered product'.
Danish: Holoclar er et lægemiddel til avanceret terapi, som kaldes et »produkt fremstillet ved vævsteknik«.
English: The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid).
Danish: Den hyppigste bivirkning ved Holoclar (som optræder hos mere end 1 ud af 10 patienter) er inflammation af øjenlåget (blefaritis).