FrancophonIA/ELRC3.0 huggingface dataset:
English: In male dogs administered 10 times the upper recommended therapeutic dose, diffuse atrophy of seminiferous tubules in the testes and associated decreased sperm counts were seen.
Danish: Ved administrering af ti gange den højest anbefalede terapeutiske dosis, er der set diffus atrofi af sædkanaler i testiklerne og dertil hørende reduceret sædtal.
English: Pexion 100 mg tablets for dogs Pexion 400 mg tablets for dogs
Danish: Pexion 100 mg tabletter til hunde Pexion 400 mg tabletter til hunde
English: Number of tablets (to be given twice daily) for noise phobia treatment: Dose: 30 mg/kg twice daily
Danish: Antal tabletter (der skal gives to gange dagligt) med henblik på behandling for støjfobi: Dosis: 30 mg/kg to gange dagligt
English: For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
Danish: Til reduktion af hyppigheden af generaliserede anfald som følge af idiopatisk epilepsi hos hunde.
English: No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section “Interactions”).
Danish: Ingen definitive konklusioner kan drages omkring imepitoins effekt, som supplerende terapi til phenobarbital, kaliumbromid og/eller levetiracetam, baseret på det begrænset antal af tilgængelige kliniske forsøg (se også punktet ”Interaktion”).
English: PACKAGE SIZE 30 tablets 100 tablets 250 tablets
Danish: 30 tabletter 100 tabletter 250 tabletter
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Danish: TEKSTEN "OPBEVARES UTILGÆNGELIGT FOR BØRN"
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Boehringer Ingelheim Vetmedica GmbH
English: ADVICE ON CORRECT ADMINISTRATION Each tablet can be halved for accurate dosing according to the individual bodyweight of the dog.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Hver tablet kan halveres for at opnå en nøjagtig dosering, der passer til hver enkelt hunds legemsvægt.
English: The use of the veterinary medicinal product is not recommended in male breeding dogs or in female dogs during pregnancy and lactation.
Danish: Anvendelse af veterinærlægemidlet frarådes hos hanhunde, som bruges til avl og til tæver under drægtighed og diegivning.
English: 116 animals in the imepitoin group and 110 animals in the phenobarbital group).
Danish: Sikkerheden af begge behandlinger blev evalueret i det fulde analysedatasæt ( eller sikkerhedsdatasæt, dvs. 116 dyr i imepitoin-gruppen og 110 dyr i phenobarbital-gruppen).
English: Oral administration at a dose of 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart.
Danish: Oral administration med en dosis på 30 mg imepitoin pr. kg legemsvægt to gange dagligt med ca. 12 timers mellemrum.
English: in the imepitoin group and 8% (4 dogs out of 52; 95% CI [0.004; 0.149]) in the placebo group.
Danish: Andelen af hunde, der var frie for generaliserede anfald, var 21% (21 hunde ud af 99; 95 % CI [0.131; 0.293]) i imepitoin gruppen og 8% (4 hunde ud af 52; 95% CI [0.004; 0.149]) i placebo gruppen.
English: 250 tablets
Danish: 100 tabletter 250 tabletter
English: Ingestion of this product may cause dizziness, lethargy and nausea.
Danish: Særlige forsigtighedsregler for personer, der administrerer lægemidlet til dyr Indtagelse af dette produkt kan medføre svimmelhed, sløvhed og kvalme.
English: Imepitoin 400 mg
Danish: Imepitoin 100 mg Imepitoin 400 mg
English: Special precautions for use in animals
Danish: Særlige forsigtighedsregler vedrørende brugen
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 30 tablets (100 and 400 mg) and 100 tablets (100 mg)
Danish: Beholder med 30 tabletter (100 og 400 mg) og 100 tabletter (100 mg)
English: BATCH NUMBER Lot {number}
Danish: Lot {nummer}
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia, emesis, polyphagia at the beginning of treatment, somnolence (very common); hyperactivity, apathy, polydipsia, diarrhoea, disorientation, anorexia, hypersalivation, polyuria (common); prolapsed nictitating membrane and decreased sight (isolated reports).
Danish: Følgende milde og generelt forbigående bivirkninger er blevet observeret i prækliniske og kliniske studier af behandling af epilepsi indikationen i rækkefølge efter faldende hyppighed: ataksi, emesis, polyfagi i begyndelse af behandlingen, døsighed (meget almindelig), hyperaktivitet, apati, polydipsi, diarré, desorientering, anoreksi hypersalivation, polyuri (almindelig), blinkhindefremfald og nedsat syn (isolerede rapporter).
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OGBRUG
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia, increased appetite, lethargy (very common); emesis, aggression (see section 4.5) (common); hyperactivity, somnolence, hypersalivation (uncommon).
Danish: Følgende bivirkninger er observeret under prækliniske og kliniske studier, som er udført for at støtte støjfobiindikationen: ataksi, øget appetit, letargi (meget almindelig), emesis, aggression (se punkt 4.5) (almindelig), hyperaktivitet, døsighed, hypersalivation (ikke almindelig).
English: Oral administration at a dose range of 10 mg to 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart.
Danish: Oral indgivelse i et dosisinterval på 10 mg til 30 mg imepitoin pr. kg legemsvægt to gange dagligt, med ca. 12 timers mellemrum.
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia (loss of coordination), emesis (vomiting), polyphagia (increased appetite) at the beginning of treatment, somnolence (drowsiness) (very common); hyperactivity (much more active than usual), apathy, polydipsia (increased thirst), diarrhoea, disorientation, anorexia (loss of appetite), hypersalivation (increased saliva production), polyuria (increased urine production) (common); prolapsed nictitating membrane (visible third eyelid) and decreased sight (isolated reports).
Danish: Følgende milde og generelt forbigående bivirkninger er blevet observeret i prækliniske og kliniske studier af behandling af epilepsiindikationen i rækkefølge efter faldende hyppighed: ataksi (usikre bevægelser), emesis (opkastning), polyfagi (øget appetit) set ved behandlingens start, somnolens (døsighed) (meget almindelig), hyperaktivitet (rastløshed), apati, polydipsi (øget tørst), diarré, desorientering, anoreksi (mistet appetit), hypersalivation (øget spytsekretion), polyuri (øget udskillelse af urin) (almindelig), blinkhindefremfald (tydeligt tredje øjenlåg) og nedsat syn (isolerede rapporter).
English: EU/2/12/147/004 250 tablets (400 mg)
Danish: EU/2/12/147/002 250 tabletter (100 mg) EU/2/12/147/003 100 tabletter (400 mg) EU/2/12/147/004 250 tabletter (400 mg)
English: Pexion 400 mg tablets for dogs imepitoin
Danish: Pexion 100 mg tabletter til hunde Pexion 400 mg tabletter til hunde imepitoin
English: 100 tablets
Danish: 30 tabletter 100 tabletter
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia (loss of coordination), increased appetite, lethargy (very common); emesis (vomiting), aggression (see section “Special warnings”) (common); hyperactivity, somnolence (drowsiness), hypersalivation (uncommon).
Danish: Følgende bivirkninger er observeret under prækliniske og kliniske studier, som er udført for at støtte støjfobiindikationen: ataksi (mindsket koordinationsevne), øget appetit, letargi (meget almindelig), emesis (opkastning), aggression (se punktet ”Særlige advarsler”) (almindelig), hyperaktivitet, somnolens (døsighed), hypersalivation (øget spytsekretion) (ikke almindelig).
English: PACKAGE LEAFLET:
Danish: En tablet indeholder:
English: Date of last renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse af markedføringstilladelse:
English: In a US field trial that compared the efficacy of imepitoin at a fixed dose of 30 mg/kg twice daily to a placebo in 151 dogs with idiopathic epilepsy during a treatment period of 84 days, the proportion of generalized seizure-free dogs was 21% (21 dogs out of 99; 95 % CI [0.131; 0.293])
Danish: I et feltforsøg i USA, sammenlignedes effekten af imepitoin som fast dosis på 30 mg/kg 2 gange daglig, i forhold til placebo hos 151 hunde med idiopatisk epilepsi gennem en behandlingsperiode på 84 dage.
English: ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 30, 100 and 250 tablets
Danish: Æske til 30, 100 og 250 tabletter
English: Noise phobia
Danish: Støjfobi
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suprelorin on 10/07/2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suprelorin den 10. juli 2007.
English: There can also some be some local reaction (e.g. inflammation, hardening) for up to three months after implantation.
Danish: Der kan desuden forekomme lokalreaktioner (f.eks. inflammation, hårdhed) indtil tre måneder efter implantationen.
English: It is presented in a pre-loaded applicator.
Danish: Det fås i en fyldt applikator.
English: The return to normal fertility after the end of the treatment has not been investigated in ferrets.
Danish: Tilbagevenden til normalt fertilitet efter afsluttet behandling er ikke blevet undersøgt hos fritter.
English: Pregnant women should not administer the product.
Danish: Gravide kvinder bør ikke udføre implantationen.
English: In case of accidental self-injection, medical advice should be sought immediately and the Package Leaflet or the label shown to the doctor.
Danish: I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The effect continues for six months in the case of the 4.7 mg implant for dogs and 12 months in the case of the 9.4 mg implant for dogs (16 months for ferrets) after which the dog and ferret can be re-implanted if necessary.
Danish: Virkningen fortsætter i seks måneder i tilfælde af 4,7 mg implantatet hos hunde og 12 måneder i tilfælde af 9,4 mg implantatet hos hunde (16 måneder hos fritter), hvorefter hunden og fritten om nødvendigt kan få indsat et nyt implantat.
English: The active substance in Suprelorin, deslorelin, acts like the natural hormone gonadotropinreleasing hormone (GnRH) which controls the secretion of other hormones involved in fertility.
Danish: Det aktive stof i Suprelorin, deslorelin, virker på samme måde som det naturlige gonadotropinfrigørende hormon (GnRH), der styrer sekretionen af andre hormoner med betydning for frugtbarheden.
English: Suprelorin is an implant containing the active substance deslorelin.
Danish: Suprelorin er et implantat, der indeholder det aktive stof deslorelin.
English: Suprelorin is given as an implant that slowly releases a continuous low dose of deslorelin.
Danish: Suprelorin gives som et implantat, der langsomt afgiver en konstant lav dosis deslorelin.
English: This veterinary medicine has been developed especially for dogs and ferrets and is not for use in humans.
Danish: Dette veterinærlægemiddel er specielt udviklet til hunde og fritter og er ikke beregnet til mennesker.
English: The implant is inserted subcutaneously, under the loose skin on the back between the lower neck and the lumbar area in dogs and between the shoulder blades in ferrets.
Danish: Implantatet indsættes subkutant under den løstsiddende hud på ryggen mellem nederste del af nakken og lænden hos hunde og mellem skulderbladene hos fritter.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suprelorin outweigh its risks for the induction of temporary infertility in healthy, entire, sexually mature male dogs and ferrets and recommended that Suprelorin be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Suprelorin opvejer risiciene ved fremkaldelse af midlertidig sterilitet hos raske, fuldt kønsmodne hanhunde og fritter, og anbefalede udstedelse af markedsføringstilladelse for Suprelorin.
English: This suppresses (blocks) the production of follicle stimulating hormone (FSH) and luteinising hormone (LH).
Danish: Derved blokeres produktionen af follikelstimulerende hormon (FSH) og luteiniserende hormon (LH).
English: In some of these studies, the dogs and ferrets received Suprelorin more than once and were observed for up to a year after receiving the final implant.
Danish: I nogle af undersøgelserne fik hundene og fritterne Suprelorin flere gange og blev observeret i indtil et år efter at have fået det sidste implantat.
English: Ferrets can have transient moderate swelling, itching and redness at the implant site.
Danish: Fritter kan have forbigående, moderat hævelse, kløe og rødme på implantationsstedet.
English: Other information about Suprelorin:
Danish: Andre oplysninger om Suprelorin
English: The majority of dogs regained normal semen characteristics approximately one year after the last treatment and dogs have been able to successfully mate with bitches, after treatment with Suprelorin was stopped.
Danish: Hos størstedelen af hundene fik sæden igen normale egenskaber ca. et år efter den sidste behandling, og hundene har været i stand til at gennemføre vellykket parring med tæver efter ophør af behandlingen med Suprelorin.
English: What is the risk associated with Suprelorin?
Danish: Hvilken risiko er der forbundet med Suprelorin?
English: Suprelorin is not recommended for use in dogs and ferrets that have not yet reached puberty, as it has not been investigated in these animals.
Danish: Suprelorin anbefales ikke til brug hos hunde og fritter, der endnu ikke er kønsmodne, da der ikke er foretaget undersøgelser på sådanne dyr.
English: Although skin contact with the product is unlikely, if this occurs the exposed area should be washed immediately, as these types of substances may be absorbed through the skin.
Danish: Skulle det alligevel ske, skal det pågældende område straks afvaskes, da stoffer af denne art kan optages gennem huden.
English: Suprelorin has been studied under field conditions in dogs weighing between 10 and 25 kg which were implanted before being followed up for up to a year and in ferrets weighing between 1 and 1.7 kg which were implanted at the beginning of the breeding season before being followed up for up to 6 months.
Danish: Suprelorin blev undersøgt under feltforhold hos hunde, som vejede mellem 10 og 25 kg, og som fik opsat et implantat inden opfølgningen i op til et år, og hos fritter, som vejede mellem 1 og 1,7 kg, og som fik opsat et implantat i begyndelsen af yngletiden inden opfølgningen i op til 6 måneder.
English: Why has Suprelorin been approved?
Danish: Hvorfor blev Suprelorin godkendt?
English: In more than 95% of dogs, these effects started at six weeks after implantation and between 5 and 14 weeks in treated ferrets after implantation.
Danish: Hos over 95 % af hundene startede virkningen seks uger efter implantationen og efter 5 til 14 uger hos behandlede fritter efter implantationen.
English: It is used in healthy, sexually-mature dogs and ferrets that have not been neutered.
Danish: Det anvendes hos raske, kønsmodne hunde og fritter, der ikke er blevet kastreret.
English: Dogs can have some moderate swelling at the implant site in the two weeks after implantation.
Danish: Der kan forekomme moderat hævelse på implantationsstedet de første to uger efter implantationen.
English: Suprelorin starts being effective after about six weeks in dogs and between 5 to 14 weeks in ferrets.
Danish: Suprelorin begynder at virke efter ca. seks uger hos hunde og mellem 5 til 14 uger hos fritter.
English: Suprelorin is used for male dogs and male ferrets to make them temporarily infertile.
Danish: Suprelorin anvendes til at gøre hanhunde og hanfritter midlertidigt sterile.
English: The studies looked at the effect of Suprelorin on blood testosterone levels and the size of the testicles for dogs and ferrets and the ability of the dogs to produce semen for collection.
Danish: I undersøgelserne registreredes Suprelorins virkning på blodets testosteronindhold, testiklernes størrelse for hunde og fritter og hundes evne til at producere sæd til opsamling.
English: The safety of Suprelorin was studied after giving dogs more than 10 times and ferrets more than 6 times the recommended dose rate.
Danish: Sikkerheden af Suprelorin blev undersøgt hos hunde efter indgift med en dosishyppighed på over 10 gange og hos fritter over seks gange den anbefalede dosishyppighed.
English: If a dog or a ferret under treatment with Suprelorin were to mate with a female dog (“bitch”) or female ferret (“jill”) on heat, the chance of the bitch or jill becoming pregnant would be extremely low.
Danish: Hvis en hund eller en fritte, der er i behandling med Suprelorin, parrer sig med en tæve eller hunfritte i løbetid, er der kun en yderst ringe risiko for, at tæven eller hunfritten bliver drægtig.
English: Any swelling or local reaction resolves naturally.
Danish: Hævelse og reaktioner svinder af sig selv.
English: How has Suprelorin been studied?
Danish: Hvordan blev Suprelorin undersøgt?
English: What is Suprelorin?
Danish: Hvad er Suprelorin?
English: What is Suprelorin used for?
Danish: Hvad anvendes Suprelorin til?
English: As a result in male dogs and ferrets less testosterone circulates in the blood, the dog and ferret stop producing sperm and its libido is reduced.
Danish: Dette nedsætter hanhundens og frittens testosteronindhold i blodet, så hunden og fritten ophører med at producere sæd, og dens brunst mindskes.
English: What benefit has Suprelorin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Suprelorin?
English: All studies showed a reduction of testosterone levels in the blood, a reduction in the size of the testicles, decreased libido and decreased spermatogenesis (when fewer sperm are produced by the testicles).
Danish: I alle undersøgelserne faldt blodets testosteronindhold, testiklerne formindskedes, brunsten aftog, og sædproduktionen i testiklerne blev nedsat.
English: How does Suprelorin work?
Danish: Hvordan virker Suprelorin?
English: The size of the testicles will decrease during treatment.For a full list of all side effects reported with Suprelorin, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Suprelorin fremgår af indlægssedlen.
English: When administering the product, care should be taken to avoid accidental self-injection by ensuring that animals are suitably restrained and that the application needle is shielded until the moment of implantation.
Danish: Når produktet gives, skal der udvises forsigtighed for at undgå utilsigtet selvinjektion.
English: It is most important to increase the dose gradually.
Danish: Det er yderst vigtigt at øge dosen gradvist.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Danish: • Udvalget behandlede indbringelsen i medfør af artikel 30 i direktiv 2001/83/EF.
English: The therapeutic effect is normally seen after 2-4 weeks of dosing.
Danish: Den terapeutiske virkning ses normalt efter 2-4 ugers behandling.
English: Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
Danish: Regelmæssig revurdering anbefales for at bekræfte, at fortsat behandling er hensigtsmæssig for patienten.
English: In addition, as treatment is symptomatic it should be continued for an appropriate length of time.
Danish: Da behandlingen er symptomatisk, bør den desuden fortsættes i tilstrækkeligt lang tid.
English: In many patients, therapy for neuropathic pain may be needed for several years.
Danish: Hos mange patienter kan behandlingen af neuropatiske smerter være nødvendig i flere år.
English: It is authorised in the following Member States: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO and SE. Other amitriptyline containing products are also authorised under different brand names in the EU.
Danish: Det er godkendt i følgende medlemsstater: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO og SE. Andre amitriptylinholdige produkter er under forskellige handelsnavne også godkendt i EU.
English: Amitriptyline is not recommended during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.
Danish: Amitriptylin anbefales ikke under graviditet, medmindre det er tvingende nødvendigt og da kun efter omhyggelig overvejelse af benefit/riskforholdet.
English: Amitriptyline is authorised worldwide in more than 56 countries.
Danish: Amitriptylin er godkendt i flere end 56 lande verden over.
English: Amitriptyline was first approved by the US in 1961.
Danish: Amitriptylin blev godkendt første gang i USA i 1961.
English: In addition, treatment duration should not to exceed a period of 3-months and ECG should be performed prior to initiating therapy to exclude long QT syndrome.
Danish: Desuden bør behandlingsvarigheden ikke overstige tre måneder, og der bør udføres ekg før iværksættelse af behandlingen for at udelukke langt QT-syndrom.
English: The posology schemes cannot be achieved with every available formulation/strength and a suitable formulation/strength should be sought for a specific dose.
Danish: Den planlagte dosering kan ikke opnås med alle tilgængelige formuleringer/styrker, og det bør derfor tilstræbes at finde en formulering/styrke, der passer til den specifikke dosis.
English: In this patient population doses above 75 mg should be used with caution.
Danish: I denne patientpopulation bør doser over 75 mg anvendes med forsigtighed.
English: In the EU the originator product for amitriptyline is marketed as Saroten (and associated names including Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex and Redomex Diffucaps).
Danish: Originalpræparatet for amitriptylin markedsføres i EU som Saroten (og relaterede navne, herunder Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex og Redomex Diffucaps).
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen, hvor det var relevant, dog blev de fleste punkter overladt til national udarbejdelse.
English: • the scope of the referral was the harmonisation of the product information,
Danish: • Formålet med henvisningen var at harmonisere produktinformationen.
English: The maintenance dose is the lowest effective dose and doses above 150 mg daily are not recommended.
Danish: Vedligeholdelsesdosen er den laveste effektive dosis, og doser over 150 mg dagligt anbefales ikke.
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Danish: Den maksimale daglige dosis på 150 mg amitriptylin givet som injektion/infusion bør ikke overskrides.
English: It is also available as solution for injection (2ml, 50 mg).
Danish: Det fås også som injektionsvæske, opløsning (2 ml, 50 mg).