FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Vyndaqel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vyndaqel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vyndaqel.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Vyndaqel skal anvendes.
English: In 45% of patients taking Vyndaqel, nerve function either improved or stabilised, compared with 30% of patients taking placebo.
Danish: Hos 45 % af de patienter, der fik Vyndaqel, enten forbedredes eller stabiliseredes nervefunktionen sammenlignet med 30 % hos de patienter, der fik placebo.
English: The full EPAR for Vyndaqel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Vyndaqel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Vyndaqel, tafamidis, is a transthyretin stabilizer.
Danish: Det aktive stof i Vyndaqel, tafamidis, er en transthyretin-stabilisator.
English: What measures are being taken to ensure the safe and effective use of Vyndaqel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vyndaqel?
English: The CHMP therefore concluded that the benefits of Vyndaqel are greater than its risks and recommended that it be granted marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Vyndaqel opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The company that makes Vyndaqel will carry out a study on the effects of the medicine in a subgroup of patients with certain genetic mutations.
Danish: Virksomheden, som fremstiller Vyndaqel, skal gennemføre en undersøgelse af virkningerne af lægemidlet i en undergruppe af patienter med visse genetiske mutationer.
English: Vyndaqel is used in adult patients with the early stage of nerve disease (stage 1).
Danish: Vyndaqel anvendes til voksne patienter med nervesygdommen i et tidligt stadium (stadie 1).
English: Other information about Vyndaqel
Danish: Andre oplysninger om Vyndaqel
English: It attaches to transthyretin, which prevents the protein from breaking up, thereby stopping the formation of amyloid and slowing down the progression of the nerve disease.
Danish: Det binder sig til transthyretin, hvilket forhindrer, at proteinet går i stykker, hvorved det bringer dannelsen af amyloid til ophør og forhaler nervesygdommens progression.
English: Vyndaqel is a medicine that contains the active substance tafamidis.
Danish: Vyndaqel er et lægemiddel, der indeholder det aktive stof tafamidis.
English: The company that markets Vyndaqel will provide educational material to all doctors expected to prescribe Vyndaqel.
Danish: Virksomheden, som markedsfører Vyndaqel, skal udlevere oplysningsmateriale til alle læger, som forventes at ordinere Vyndaqel.
English: Because the number of patients with transthyretin amyloidosis is low, the disease is considered ‘rare', and Vyndaqel was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 August
Danish: Da antallet af patienter med transthyretin amyloidose er lavt, anses sygdommen for at være "sjælden", og Vyndaqel blev udpeget som "lægemiddel til sjældne sygdomme" den 28. august 2006.
English: The most common side effects with Vyndaqel (seen in more than 1 patient in 10) are urinary tract infection (infection of the structures that carry urine), vaginal infection, upper abdominal pain (stomach ache) and diarrhoea.
Danish: De hyppigste bivirkninger ved Vyndaqel (som optræder hos mere end 1 ud af 10 patienter) er urinvejsinfektioner, vaginal infektion, mavesmerter og diarré.
English: In patients with transthyretin amyloidosis, a blood protein called transthyretin is defective and breaks easily.
Danish: Hos patienter med transthyretin amyloidose fungerer et blodprotein kaldet transthyretin ikke rigtigt og bliver let ødelagt.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vyndaqel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Vyndaqel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The broken protein forms a fibrous substance called amyloid that is deposited in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Danish: Det ødelagte protein danner et fibrøst stof kaldet amyloid, som deponeres i væv og organer rundt om i kroppen, herunder også rundt om nerverne, hvor det forstyrrer deres normale funktion.
English: For the full list of all side effects and restrictions with Vyndaqel, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Vyndaqel fremgår af indlægssedlen.
English: Vyndaqel was compared with placebo (a dummy treatment) in 128 patients with transthyretin amyloidosis.
Danish: Vyndaqel blev sammenlignet med placebo (en uvirksom behandling) hos 128 patienter med transthyretin amyloidose.
English: Vyndaqel is used to delay nerve damage caused by transthyretin amyloidosis, a hereditary disease in which fibres called amyloid build up in tissues around the body including around the nerves.
Danish: Vyndaqel anvendes til at udskyde beskadigelsen af nerverne som følge af transthyretin amyloidose, en arvelig sygdom, hvorunder der opbygges fibre kaldet amyloid i vævene rundt om i kroppen, herunder også rundt om nerverne.
English: What information is still awaited for Vyndaqel?
Danish: Hvilke oplysninger afventes der stadig for Vyndaqel?
English: Vyndaqel was more effective than placebo at treating patients with transthyretin amyloidosis.
Danish: Vyndaqel var mere effektivt end placebo til behandling af patienter med transthyretin amyloidose.
English: What is the risk associated with Vyndaqel?
Danish: Hvilken risiko er der forbundet med Vyndaqel?
English: Why has Vyndaqel been approved?
Danish: Hvorfor blev Vyndaqel godkendt?
English: What is Vyndaqel?
Danish: Hvad er Vyndaqel?
English: This means that because transthyretin amyloidosis is rare, for scientific reasons, it has not been possible to obtain complete information about Vyndaqel.
Danish: Det betyder, at det af videnskabelige årsager ikke har været muligt at indhente fyldestgørende oplysninger om Vyndaqel, fordi transthyretin amyloidose er en sjælden sygdom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vyndaqel have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Vyndaqel.
English: What is Vyndaqel used for?
Danish: Hvad anvendes Vyndaqel til?
English: The CHMP noted that, apart from in patients who left the study because they needed a liver transplant, Vyndaqel was more effective than placebo in delaying nerve damage in patients with transthyretin amyloidosis.
Danish: CHMP bemærkede, at Vyndaqel var mere effektivt end placebo til at udskyde nervebeskadigelse hos patienter med transthyretin amyloidose, bortset fra hos de patienter, som forlod undersøgelsen, fordi de havde behov for en levertransplantation.
English: How has Vyndaqel been studied?
Danish: Hvordan blev Vyndaqel undersøgt?
English: How is Vyndaqel used?
Danish: Hvordan anvendes Vyndaqel?
English: What benefit has Vyndaqel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vyndaqel?
English: EU/1/09/537/001 Mozobil
Danish: EU/1/09/537/001
English: 20 mg/ml Solution for injection
Danish: 20 mg/ml injektionsvæske, opløsningSubkutan anvendelse
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: 1 vial
Danish: Mozobil
English: Annex A
Danish: MF (EU)-nummer
English: Invented name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: _*_One 2-ml dose contains: rotavirus serotype* G1
Danish: *En 2-ml dosis indeholder: Rotavirus serotype* G1
English: 2 As lower confidence limit (p = 0.95)
Danish: 1Infektiøse enheder 2Som nedre konfidensgrænse (p= 0,95)
English: not less than 2.3 x 106 IU1, 2 * human-bovine rotavirus reassortants (live), produced in Vero cells.
Danish: * human-bovine rotavirus-reassortanter (levende) fremstillet i Vero-celler.
English: The method of administration is as follows:
Danish: Metoden for administration er som følger:
English: Gonazon for fish:
Danish: Gonazon til fisk:
English: Operators should wash their hands after use of the product.
Danish: Operatøren bør vaske hænder efter brug af produktet.
English: No antidotes are available.
Danish: Der findes ingen antidoter.
English: The recommended dose is 32 µg/kg body weight.
Danish: Den anbefalede dosis er 32 g/kg legemsvægt.
English: It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
Danish: Det anbefales at stryge fisk efter behandling med intervaller på ca. 50-100 graddage.
English: In some cases this can be related to the use of the compound too early in the spawning season.
Danish: I nogle tilfælde kan dette hænge sammen med brugen af produktet for tidligt i gydeperioden.
English: After first opening the container, the solvent may be stored for 28 days.
Danish: Efter første åbning af beholder kan solvensen opbevares i 28 dage.
English: The transition between the stimulatory and inhibitory effects is completed within approximately one month.
Danish: Inden for cirka en måned er overgangen mellem stimulerende og inhiberende effekt afsluttet.
English: As a consequence, there is no follicular follicle growth (hence no oestrus is observed) and no ovulation.
Danish: Som konsekvens er der ingen follikulær vækst (siden ingen østrus er observeret) og ingen ovulation.
English: Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally.
Danish: Anvend ikke Gonazon før ca. 10% af avlsfiskene har haft naturlig ovulation.
English: Total kg of fish to be injected 50 kg
Danish: Totale antal kg fisk, der skal behandles 50 kg
English: The product should not be used in fish maintained in water temperatures that would normally inhibit ovulation as this can result in a decrease in egg quality.
Danish: Produktet bør ikke bruges til fisk der holdes ved vandtemperaturer, der normalt vil blokere ovulation, da dette kan resultere i forringet ægkvalitet.
English: At the end of a one year treatment, it may not be possible to locate and remove the implant in approximately 10% of cases.
Danish: I slutningen af et års behandling, er det ikke muligt at lokalisere og fjerne implantatet i omkring 10 % af tilfældene.
English: A reduction in the egg quality is seen after administration of doses above the recommended therapeutic dose.
Danish: Der er set en reduktion i ægkvaliteten efter administration af doser over den anbefalede terapeutiske dosis.
English: For Arctic charr, injections should be given only if the water temperature is < 8°C.
Danish: Fjeldørreder bør kun behandles, hvis vandtemperaturen er < 8C.
English: This brief phase may result in induced heat within one to four weeks following the first administration of the implant (see section 4.5).
Danish: Denne korte fase kan resultere i induceret brunst inden for én til fire uger efter første injektion af implantatet (se punkt 4.5).
English: Fish should be anaesthetised.
Danish: Fiskene bør være bedøvede.
English: REMOVAL:
Danish: FJERNELSE:
English: However, interactions with other medicinal products have not been investigated.
Danish: Imidlertid er interaktioner med andre lægemidler ikke blevet undersøgt.
English: The risk of inducing a fertile heat is low in metoestrus (5%).
Danish: Risikoen for at inducere fertil brunst er lav i metøstrus (5%).
English: An overdose will not accelerate the onset or increase the degree of ovulation.
Danish: En overdosering vil ikke fremme tidspunktet for eller graden af ovulation.
English: Preferred injection volume per kg fish (depending on fish
Danish: Foretrukket injektionsvolumen pr. kg fisk (afhængig af fiskenes
English: The recommended dose is one implant per bitch.
Danish: Den anbefalede dosering er ét implantat pr. tæve.
English: Gonazon for dogs: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Danish: Gonazon til hund: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Østrig
English: There are no data available for animals treated on more than two occasions.
Danish: Der er ingen data til rådighed på dyr, der er behandlet mere end to gange.
English: ATC vet code: QH01CA
Danish: ATCvet kode: QH01CA
English: Gonazon implant is a solid, off white, 14x3x1 mm implant.
Danish: Gonazon implantat er et fast, grålighvidt, 14x3x1 mm implantat.
English: Do not use after the expiry date which is stated on the label ‘EXP' Do not store above 25C.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten 'EXP' Må ikke opbevares over 25
English: Subcutaneous administration.
Danish: Subkutan administration.
English: Inability to locate and remove Gonazon will not have serious effects on the general health of the dog.
Danish: Manglende evne til at lokalisere og fjerne Gonazon, vil ikke have alvorlige effekter på hundens generelle helbredstilstand.
English: In addition, the frequency of induced heat is lower in younger bitches than in older bitches.
Danish: Yderligere er hyppigheden af induceret brunst lavere i yngre tæver end i ældre tæver.
English: Position the bitch on her back.
Danish: Anbring tæven på ryggen.
English: * this volume will be minimized for the species with the largest body weights.
Danish: * Dette volumen vil blive minimeret i forhold til arten med den højeste legemsvægt.
English: The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction in the numbers of live pups at whelping and weaning compared to an untreated control group.
Danish: Produktet er kontraindiceret til tæver der er beregnet til avl (voksne og præpuberale), da laboratorieforsøg med hunde, som modtog 3 samtidige implantater i en periode på 12 måneder, viste en reduktion i antallet af levende hvalpe ved fødslen og ved fravænning sammenlignet med den ubehandlede kontrolgruppe.
English: Treatment in proestrus will not suppress that particular heat (proestrus and oestrus).
Danish: Behandling i proøstrus vil ikke undertrykke denne særlige brunst (proøstrus og østrus).
English: The implant may be administered to bitches from the age of four months.
Danish: Implantatet kan administreres til tæver fra 4-måneders alderen.
English: Administration of Gonazon at other stages of the cycle may induce heat that may be fertile.
Danish: Indgivelse af Gonazon på andre stadier i cyklus kan inducere brunst, som kan være fertil.
English: Simultaneous administration of five implants during a oneyear period was well tolerated.
Danish: Samtidig administration af 5 implantater i en periode på et år kunne tåles uden problemer.
English: In case of accidental contact with either the skin or the eyes, rinse thoroughly with water.
Danish: I tilfælde af kontakt med hud eller øjne ved hændeligt uheld skylles grundigt med vand.
English: Do not mix with other medicinal products.
Danish: Bland ikke med andre lægemidler.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http://www.emea.europa.eu/.
English: Additional sterile vials will be supplied on request.
Danish: Yderligere sterile hætteglas kan leveres efter anmodning.
English: Position the dog as described for administration of the implant.
Danish: Anbring hunden som beskrevet ved administration af implantatet.
English: GnRH is synthesised by neurones in the hypothalamus in all vertebrate species.
Danish: GnRH er syntetiseret af neuroner i hypothalamus hos alle arter af hvirveldyr.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http://www.emea.europa.eu
English: To minimise this problem, caution needs to be exercised to ensure that the implant is administered by subcutaneous injection, particularly in dogs with pronounced depots of subcutaneous fat.
Danish: For at mindske dette problem, skal der udvises forsigtighed for at sikre, at implantatet er administreret ved subkutan injektion, særligt i hunde med udtalte depoter af subkutant fedt.
English: If the implant cannot be palpated in the month following administration, the owner is encouraged to seek veterinary advice as efficacy cannot be ensured in these cases.
Danish: Hvis implantatet ikke kan føles under den første måned efter administration, skal ejeren opfordres til at søge dyrlæge, da der i disse tilfælde ikke kan garanteres effekt.
English: Induction and synchronisation of ovulation for the production of eyed-eggs and fry.
Danish: Induktion og synkronisering af ovulation for produktion af øjenæg og blommesæklarver.
English: Therefore, drug interactions would not be expected to occur.
Danish: Derfor forventes der ingen interaktioner.
English: A proportion of bitches that show induced heat may subsequently develop pseudopregnancy.
Danish: En del af de tæver, som viser induceret brunst, kan efterfølgende udvikle pseudodrægtighed.
English: The frequency of induced heat is lower when the first treatment is administered in metoestrus (32%) than in anoestrus (84%).
Danish: Frekvensen af induceret brunst er lavere, når første behandling er givet i metøstrus (32%) end i anøstrus (84%).
English: Cured elastomer, resulting from the polymerisation of polydimethylsiloxane and tetrapropylorthosilicate in the presence of stannous octoate.
Danish: Hærdet elastomer, som resultat fra polymerisering af polydimethylsiloxan og tetrapropylorthosilicat i tilstedeværelsen af tinoctoat.
English: Absorption: Following subcutaneous administration of a single implant to dogs (approximate weight of 10 kg), maximum serum concentrations (0.13 µg/ml) of azagly-nafarelin are reached around 3.5 hours.
Danish: Absorption: Efter subkutan administration af et enkelt implantat til hunde (omtrentlig vægt på 10 kg), nås den maksimale serumkoncentrationen (0,13 µg/ml) af azagly-nafarelin efter cirka 3,5 timer.
English: Medical advice should be sought immediately in cases in which the concentrated solution or several ml of the diluted solution are spilled onto the skin or into the eyes or in the case of accidental self-injection.
Danish: Søg straks lægehjælp hvis den koncentrerede solvens eller adskillige ml af det opløste solvens spildes på huden eller kommer i øjnene, eller i tilfælde af utilsigtet selvinjektion.
English: Owing to their pharmacological activity (inhibition of the production of sex steroids), administration of GnRH agonists to bitches might be associated with vaginitis.
Danish: På grund af deres farmakologiske aktivitet (hæmning af dannelsen af kønshormoner), kan administration af GnRH-agonister til tæver være forbundet med vaginitis.
English: No information on interactions with other veterinary medicinal products is available.
Danish: Der findes ingen tilgængelig information om interaktion med andre veterinære lægemidler.
English: However, based on field trial data, the incidence of pseudopregnancy in treated bitches is not greater than in control (untreated) bitches.
Danish: Imidlertid viser data fra feltforsøg, at hyppigheden af pseudodrægtighed hos behandlede tæver ikke er større end i kontrol tæver (ubehandlede).
English: <Batch> <Lot> <BN> {number}
Danish: <Batch>, >Lot>, <BN> {nummer}
English: Prepare the site for an
Danish: Forbered stedet til en aseptisk
English: Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes.
Danish: Azagly-nafarelin er et peptid, som hovedsagelig nedbrydes af peptidaser og ikke af cytochrom P-450enzymer.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette veterinære lægemiddel ikke blandes med andre veterinære lægemidler.
English: Record the date of treatment in the clinical records of the animals.
Danish: Registrer dato for behandlingen i dyrets optegnelser.
English: These maximal azagly-nafarelin concentrations are followed by a slow decline in circulating azagly-nafarelin concentrations lasting up to 12 months.
Danish: Denne maksimale azagly-nafarelin-koncentration efterfølges af et langsomt fald i den cirkulerende azaglynafarelin-koncentration, som varer op til 12 måneder.
English: The package insert or the label should be shown to the physician
Danish: Indlægssedlen eller etiketten bør vises til lægen.
English: Gonazon 18.5 mg implant for dogs
Danish: Gonazon 18,5 mg implantat til hunde
English: Make a stab incision, approximately 5 mm long, along the elevated near end of the implant.
Danish: Lav et snit, cirka 5 mm langt, langs den hævede ende af implantatet.
English: Personal protective equipment, consisting of gloves, should be worn when handling the veterinary medicinal product.
Danish: Personligt beskyttelsesudstyr i form af handsker bør anvendes ved håndtering af lægemidlet.
English: The long term effects of azagly-nafarelin on treated broodstock fish have not been studied.
Danish: Langtidseffekten af azagly-nafarelin på behandlede avlsfisk er ikke undersøgt.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: One implant.
Danish: Et implantat.
English: Store and transport at 2C - 8C (in a refrigerator).
Danish: Opbevares og transporteres ved 2C - 8C (i køleskab).
English: Unlike liquid injections, there is no need to remove air bubbles as attempts to do so may displace the implant from the needle.
Danish: I modsætning til normale injektioner er det ikke nødvendigt at fjerne luftbobler, da forsøg herpå kan fjerne implantatet fra kanylen.
English: The empty, sterile vial is intended to be used for mixing the concentrate and solvent.
Danish: Det tomme sterile hætteglas er beregnet til brug ved blanding af koncentrat og solvens.
English: No data are available on repeat treatments in prepubertal bitches.
Danish: Ingen data foreligger om gentagen behandling i præpuberale tæver.
English: In a limited laboratory study, co-administration of Gonazon and short-acting progestagens has been shown to be well tolerated.
Danish: I et begrænset laboratoriestudie er det vist, at samtidig administration af Gonazon og korttidsvirkende progestagener er uden problemer.
English: Benzyl alcohol (1%)
Danish: Hjælpestoffer: Benzylalkohol (1%)
English: Operators should wear gloves when mixing the concentrate solution with the solvent.
Danish: Operatøren bør anvende handsker, når koncentrat og solvens blandes.