FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance is a protein that attaches to and blocks the actions of another protein called human interleukin-1 alpha, which is involved in many activities in the body including some that aid the
Danish: Det aktive stof er et protein, der bindes til og blokerer for virkningerne af et andet protein, humant interleukin-1-alfa, som er involveret i mange aktiviteter i kroppen, hvoraf nogle fremmer kræftcellers
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech', intended for intended for treating debilitating symptoms of advanced colorectal cancer.
Danish: Den 18. maj 2017 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech til behandling af svækkende symptomer på fremskreden kolorektal kræft.
English: It was to be available as a concentrate to be made up into a solution for infusion.
Danish: Det var meningen, at det skulle kunne fås som et koncentrat til fremstilling af en injektionsvæske, opløsning.
English: What is Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
Danish: Hvad er Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
English: Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care.
Danish: For det andet syntes der på det tidspunkt at være øget risiko for infektioner hos patienter, der fik lægemidlet.
English: This is a medicine containing the active substance human IgG1 monoclonal antibody specific for human interleukin-1 alpha.
Danish: Dette lægemiddel indeholder det aktive stof humant IgG1 monoklonalt antistof specifikt for humant interleukin-1 alfa.
English: Wash hands after administration.
Danish: Vask hænder efter administrationen.
English: The maximum dose should not be exceeded.
Danish: Den maksimale dosis bør ikke overstiges.
English: Dog's weight
Danish: Hundens vægt
English: Over 80% of male dogs above 5 years of age are affected.
Danish: Mere end 80% af alle hanhunde over 5 år er påvirkede.
English: *No data are available for dogs less than 3 kg bodyweight
Danish: *Der er ikke tilgængelige data for hunde under 3 kg legemsvægt.
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 denne markedsføringstilladelse skal informere Europakommissionen om markedsføringsplanerne for dette lægemiddel, som er autoriseret med denne beslutning.
English: Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/2011
Danish: Dato for første markedsføringstilladelse: 11/01/2007 Dato for seneste fornyelse af markedsføringstilladelse: 19/12/2011
English: No adverse effects on semen quality have been observed.
Danish: Der er ikke observeret negativ virkning på sædkvalitet.
English: There was no clinical effect.
Danish: Der var ingen kliniske symptomer.
English: This binding is reversible and not affected by other substances known to specifically bind to albumin.
Danish: Denne binding er reversibel og upåvirket af andre substanser med kendt binding til albumin.
English: Tablets can be given either directly into the mouth or with food.
Danish: Tabletten kan gives enten direkte i munden eller i foderet.
English: The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Danish: Responsen på en ATCH stimulationstest kan også blive undertrykt i flere uger efter administrationen af osateron.
English: Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism.
Danish: Der bør implementeres passende monitorering hos hunde med stress (f.eks. postoperativ) eller med hypoadrenocorticisme.
English: A transient reduction in plasma cortisol occurs in most treated animals.
Danish: Der forekommer forbigående reduktion i plasmakortisol hos de fleste behandlede dyr.
English: Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine.
Danish: Osateron elimineres i løbet af 14 dage, hovedsageligt i faeces via galdeekskretion (60%) og i mindre grad (25%) i urinen.
English: PHARMACEUTICAL FORM Tablet.
Danish: LÆGEMIDDELFORM Tablet.
English: ATC vet code : QG04C X
Danish: ATCvet-kode: QG04C X
English: Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin.
Danish: Osateronacetat og dens metabolit bindes til plasmaprotein (omkring 90% og 80% respektivt), hovedsageligt albumin.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch : {nummer}
English: If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Danish: Hvis den kliniske respons er betydeligt kortere end forventet, er en revurdering af diagnosen nødvendig.
English: Elimination is slow with a mean half-life (T½) of about 80 hours.
Danish: Elimineringen er langsom med en gennemsnitlig T½ på omkring 80 timer.
English: Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials.
Danish: Bør anvendes med forsigtighed hos hunde med tidligere leverproblemer, fordi sikkerheden ved brugen hos disse hunde ikke er blevet grundigt undersøgt, og fordi behandlingen hos nogle hunde med leversygdomme har resulteret i reversibel forhøjelse af ALT og ALP i kliniske afprøvninger.
English: After oral administration with food in dogs, osaterone acetate is rapidly absorbed (Tmax about 2 hours) and undergoes a first-pass effect mainly in the liver.
Danish: Efter oral administration i foder til hunde absorberes osateronacetatet hurtigt (Tmax er omkring 2 timer), og undergår hovedsageligt en ”first-pass”-effekt i leveren.
English: This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.
Danish: Dette fører til forskellige ikke specifikke kliniske symptomer som mavesmerter og vanskeligheder med afføring og urinering, blod i urinen og bevægelseshæmning.
English: Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l.
Danish: Femten dage efter den sidste administration er den gennemsnitlige plasmakoncentration omkring 6,5 μg/l.
English: In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Danish: I kliniske afprøvninger blev behandlingen med det veterinære lægemiddel ikke afbrudt, og alle hunde normaliseredes uden nogen specifik behandling.
English: The onset of clinical response to treatment is usually seen within 2 weeks.
Danish: Starten på den kliniske respons ses normalt inden for 2 uger.
English: It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate.
Danish: Det hæmmer kompetitivt binding af androgener til deres receptorer i prostata og blokerer transporten af testosteron ind i prostata.
English: PACKAGE SIZE 7 tablets.
Danish: PAKNINGSSTØRRELSE 7 tabletter.
English: Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active.
Danish: Osateronacetat omsættes til sin væsentligste, 15β-hydroxylerede metabolit, som også er farmakologisk aktiv.
English: Osaterone acetate
Danish: Osateronacetat
English: An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration.
Danish: I en studie med op til 1,25 mg/kg legemsvægt i 10 dage, som blev gentaget efter én måneds varighed, forekom der ingen uønskede virkninger, bortset fra et fald i kortisolplasmakoncentrationen.
English: Behavioural changes such as modification of dog's activity or more social behaviour are common.
Danish: Adfærdsmæssige forandringer, som ændring af hundens aktivitetsniveau eller en mere social adfærd, er almindelige.
English: Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
Danish: Rund, hvid, bikonveks tablet på 5,5 mm, 7 mm, 9 mm og 12 mm.
English: Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare).
Danish: Der kan forekomme forbigående ændringer af appetitten, enten øget (meget almindeligt) eller nedsat (meget sjældent).
English: After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 34 without change in the rates of absorption or elimination.
Danish: Efter gentagne administrationer af osateronacetat på 0,25 mg/kg/dag i 7 dage er akkumulationsfaktoren omkring 3-4 gange, uden at raterne for absorption og elimination ændres.
English: After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l.
Danish: Efter en dosis på 0,25mg/kg/dag var maksimumkoncentrationen (Cmax) i plasma omkring 69 μg/l.
English: Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane.
Danish: Forbigående ændringer i pels, så som hårtab eller forandring af pelsen kan forekomme i meget sjældne tilfælde efter administration af Ypozane.
English: All these adverse reactions are reversible without any specific treatment.
Danish: Alle disse bivirkninger er forbigående og forsvinder uden nogen specifik behandling.
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription.
Danish: UDLEVERING OG BRUG, OM NØDVENDIGT Kun til dyr - må kun udleveres efter veterinærrecept.
English: Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity.
Danish: Osateronacetat er et steroidt kemikalium, der er beslægtet med progesteron og har potent progestagen og anti-androgen aktivitet.
English: Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly.
Danish: Andre bivirkninger, inklusive forbigående opkastninger og/eller diarre, polyuria/polydipsia eller lethargi forekommer sjældent.
English: In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions.
Danish: Hos tæver laboratoriedyr forårsagede osateronacetat alvorlige bivirkninger med påvirkning af reproduktionsevnen.
English: Do not use after the expiry date stated on the blister after “EXP”
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på blisterpakningen efter UDL.
English: BPH is a development and enlargement of the prostate due to the male hormone testosterone.
Danish: BPH er en udvikling og forstørrelse af prostata, der er forårsaget af det mandlige kønshormon testosteron.
English: In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Ved utilsigtet indtagelse hos en person skal vedkommende omgående søge læge og forevise indlægssedlen eller pakningen til lægen.
English: Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms.
Danish: Osateronacetat hæmmer den virkningen af et overskud af mandligt kønshormon (testosteron) via forskellige mekanismer.
English: Benign prostatic hypertrophy (BPH) is a natural consequence of ageing.
Danish: Benign prostata hypertrofi (BPH) er en naturlig konsekvens af alderdom.
English: YPOZANE tablets to be administered
Danish: YPOZANE-tabletter, som skal tildeles
English: The clinical response persists for at least 5 months after treatment.
Danish: Den kliniske respons persisterer i mindst 5 måneder efter behandlingen.
English: The enlargement of mammary glands occurs less commonly and can be associated with lactaction in very rare cases.
Danish: Mælkekirtelhyperplasi forekommer sjældent og kan forbindes med laktation i meget sjældne tilfælde.
English: The most commonly reported adverse reactions are mild and transient modifications of appetite, either increased (very common) or decreased (very rare).
Danish: De hyppigst sete bivirkninger er milde og forbigående ændringer af appetitten, enten øget (meget almindeligt) eller nedsat (meget sjældent).
English: Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).
Danish: Osateron er et steroidt antiandrogen, som hæmmer virkningen af en overskydende produktion af maskulint hormon (testosteron).
English: A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days.
Danish: Én enkelt dosis på 40 mg osateronacetat hos mænd blev efterfulgt af sporadisk fald i FSH, LH og testosteron.
English: Re-evaluation by the veterinarian should take place 5 months after treatment, or earlier if clinical signs recur.
Danish: Veterinær reevaluering bør ske 5 måneder efter behandlingen, eller tidligere hvis kliniske symptomer genopstår.
English: Dogs (male)
Danish: Hund (Hanhunde).
English: Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly.
Danish: Andre bivirkninger, som opkastning og/eller diarre, forøget tørst eller lethargi er mindre almindelige.
English: Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common.
Danish: Forbigående adfærdsændringer, som forøget eller nedsat aktivitet eller en mere social adfærd, er almindelige.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Also, the major metabolite of osaterone acetate (15β-hydroxylatedosaterone acetate) has anti-androgenic activity.
Danish: Desuden har den væsentligste metabolit af osateronacetat (15βhydroxyleret-osateronacetat) anti-androgene egenskaber.
English: Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Danish: Tildel 0,25 - 0,5 mg osateronacetat pr. kg legemsvægt én gang dagligt i 7 dage, som angivet i nedenstående skema:
English: 6.5 Nature and composition of immediate packaging Carton box containing one aluminium/aluminium blister with 7 tablets.
Danish: Kartonæske, der indeholder én aluminium/aluminium blisterpakning med 7 tabletter.
English: Use with caution in dogs with a history of liver disease.
Danish: Skal anvendes med forsigtighed hos hunde med tidligere leverproblemer.
English: SPECIAL STORAGE CONDITIONS Not applicable
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Ikke relevant.
English: Number of tablets per day
Danish: Antal tabletter pr. dag Behandlingens varighed
English: Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Danish: Derfor bør kvinder i den reproduktive alder undgå kontakt med produktet eller anvende éngangshandsker, når det administreres.
English: Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy.
Danish: Farmakoterapeutisk gruppe: Lægemiddel til brug ved benign prostatahypertrofi.
English: A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product.
Danish: En beslutning om at gentage behandlingen efter 5 måneder eller tidligere bør bero på en veterinær undersøgelse samt på en vurdering af produktets risk/benefit-profil.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: WITHDRAWAL PERIOD(S) Not applicable
Danish: TILBAGEHOLDELSESTID(er) Ikke relevant.
English: YPOZANE 1.875 mg tablets for dogs YPOZANE 3.75 mg tablets for dogs YPOZANE 7.5 mg tablets for dogs YPOZANE 15 mg tablets for dogs
Danish: YPOZANE 1,875 mg tablet til hund YPOZANE 3,75 mg tablet til hund YPOZANE 7,5 mg tablet til hund YPOZANE 15 mg tablet til hund
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED :
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate INDICATION(S)
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Tabletter á 1,875 mg, 3,75 mg, 7,5 mg eller 15 mg osateronacetat
English: In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
Danish: Hos hunde er BPH associeret med prostatitis.
English: Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients:
Danish: Tabletter á 1,875 mg, 3,75 mg, 7,5 mg eller 15 mg osateronacetat
English: Name and address of the manufacturer responsible for batch release Virbac S.A.
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig for batchfrigivelse VIRBAC S.A.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: : {måneder/år} BATCHNUMMER Batch : {nummer} TEKSTEN ”TIL DYR” Kun til dyr.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 1.875 mg
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - 1,875 mg
English: 1ère avenue - 2065 m - LID 06516 Carros France
Danish: 1ère avenue - 2065 m - LID 06516 Carros Frankrig
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 1.875 mg osaterone acetate.
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 1,875 mg osateronacetat.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 1.875 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister - 1,875 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 15 mg
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - 15 mg
English: INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs.
Danish: INDIKATION(ER) Behandling af benign prostata hypertrofi hos hanhunde.
English: A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration.
Danish: En forbigående reduktion af plasmat kortisolkoncentrationen kan forekomme.
English: 1ère avenue 2065 m LID 06516 Carros
Danish: 1ère avenue 2065 m LID 06516 Carros France
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Danish: A. INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR
English: 30 to 60 kg
Danish: 30 til 60 kg
English: 15 to 30 kg
Danish: 15 til 30 kg
English: MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VIRBAC S.A.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 15 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister - 15 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 3.75 mg
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - 3,75 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 7.5 mg
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - 7,5 mg
English: 7.5 to 15 kg
Danish: 7,5 til 15 kg
English: Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Danish: Behandling af benign prostata hypertrofi hos (BPH) hanhunde.
English: 3 to 7.5 kg
Danish: 3 til 7,5 kg
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 15 mg osaterone acetate
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 15 mg osateronacetat.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 7.5 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister - 7,5 mg
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Virbac S.A.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VIRBAC S.A.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 3.75 mg
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister - 3,75 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 1.875 mg tablets for dogs Osaterone acetate
Danish: VETERINÆRLÆGEMIDLETS NAVN YPOZANE 1,875 mg tablet til hund Osateronacetat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate
Danish: VETERINÆRLÆGEMIDLETS NAVN YPOZANE 15 mg tablet til hund Osateronacetat.
English: NAME OF THE MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VIRBAC S.A.
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
Danish: C. BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE SALG, UDLEVERING OG BRUG Ikke relevant
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 3.75 mg osaterone acetate
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 3,75 mg osateronacetat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate
Danish: VETERINÆRLÆGEMIDLETS NAVN YPOZANE 7,5 mg tablet til hund Osateronacetat.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate
Danish: VETERINÆRLÆGEMIDLETS NAVN YPOZANE 3,75 mg tablet til hund Osateronacetat.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 7.5 mg osaterone acetate
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 7,5 mg osateronacetat.
English: EU/2/06/068/001 EU/2/06/068/002 EU/2/06/068/003 EU/2/06/068/004
Danish: EU/2/06/068/002
English: Lactose monohydrate
Danish: Laktosemonohydrat Pregelatineret stivelse Carboxymethylcellulosekalcium Majsstivelse
English: VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrance
Danish: 2065 m - LID06516 CarrosFrankrig
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/068/001
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/068/002
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/068/004
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/068/003
English: Treatment duration
Danish: INDLÆGSSEDDEL
English: RELEASE
Danish: BATCHFRIGIVELSE
English: It was also considered that no restrictive use could be adequately substantiated.
Danish: Desuden var det opfattelsen, at ingen begrænset anvendelse kunne underbygges tilstrækkeligt.
English: In parallel, on 1 July 2011, France triggered a referral under Article 31of Directive 2001/83/EC, as amended.
Danish: Sideløbende indledte Frankrig den 1. juli 2011 en indbringelse i medfør af artikel 31 i direktiv 2001/83/EF, som ændret.
English: Positive rechallenge was noted in some cases.
Danish: I nogle tilfælde blev der beskrevet positiv reeksponering.