FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er EuropaKommissionen sædvanligvis cirka seks uger om at ajourføre tilladelsen.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Danish: Da CHMP havde vurderet virksomhedens svar på en liste med spørgsmål, var der stadig nogle uafklarede spørgsmål.
English: The application was at day 90 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 90, da virksomheden trak sin ansøgning tilbage.
English: There are no consequences on the use of Zometa in its approved indications, for which the balance of benefits and risks remains positive.
Danish: Det får ingen konsekvenser at anvende Zometa til de godkendte indikationer, for hvilke benefit/riskforholdet fortsat er positivt.
English: What was Zometa expected to be used for?
Danish: Hvad forventedes Zometa anvendt til?
English: The CHMP was also concerned that there was insufficient information to show that the dose of Zometa used in the studies was the most appropriate for these patients.
Danish: CHMP var også betænkelig ved, at der ikke var tilstrækkelige oplysninger til at påvise, at den dosis af Zometa, der blev anvendt i undersøgelserne, var den bedst egnede hos disse patienter.
English: Zometa is a medicine containing the active substance zoledronic acid.
Danish: Zometa er et lægemiddel, der indeholder det aktive stof zoledronsyre.
English: Bone mineral density was measured using a special type of X-ray called ‘dual energy X-ray absorptiometry' (DEXA).
Danish: Knoglemineraltætheden blev målt ved hjælp af en særlig type røntgen, der hedder DEXA (dual energy X-ray absorptiometry).
English: The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zometa, zoledronsyre, er et bisfosfonat.
English: How is Zometa expected to work?
Danish: Hvordan forventes Zometa at virke?
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Zometa had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at der ikke i tilstrækkelig grad var blevet påvist en effekt af Zometa, og at eventuelle fordele ikke opvejede de påviste risici.
English: What are the consequences of the withdrawal for patients in clinical trials using Zometa?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zometa?
English: It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein), and as a concentrate for infusion.
Danish: Det fås som et pulver og en solvens, der anvendes til at lave en opløsning til infusion (drop i en blodåre), og som et koncentrat til infusionsvæske.
English: What is happening for Zometa for the prevention of bone complications and hypercalcaemia?
Danish: Hvad sker der med Zometa, når det anvendes til forebyggelse af knoglekomplikationer og hyperkalcæmi?
English: The CHMP had concerns over the way the two main studies were designed, since they did not look directly at bone fractures.
Danish: CHMP var betænkelig ved den måde, hvorpå de to hovedundersøgelser var bygget op, eftersom det ikke direkte var knoglebrud, der blev undersøgt.
English: The company informed the CHMP that this withdrawal does not have any effect on patients currently included in clinical trials with Zometa.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser har for patienter, der nu deltager i kliniske undersøgelser med Zometa.
English: The company also compared the results of these studies with results from studies of Aclasta, another medicine that also contains zoledronic acid, but which is used to prevent fractures in postmenopausal women with osteoporosis.
Danish: Virksomheden sammenlignede også resultaterne af disse undersøgelser med resultater fra undersøgelser af Aclasta, der er et lægemiddel, som også indeholder zoledronsyre, men som anvendes til at forebygge knoglebrud hos postmenopausale kvinder med osteoporose.
English: The main measure of effectiveness was the change in ‘bone mineral density' (the amount of bone) in the spine, between the start of the study and one year later.
Danish: Det primære mål for virkningen var ændringen i knoglemineraltætheden (knoglemængden) i rygsøjlen fra starten af undersøgelsen til ét år efter.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the prevention of fractures and bone loss in women being treated with aromatase inhibitors.
Danish: På baggrund af gennemgangen af data og virksomhedens svar på CHMP's spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP sine betænkeligheder og var af den foreløbige opfattelse, at Zometa ikke kunne være blevet godkendt til forebyggelse af knoglebrud og -tab hos kvinder i behandling med aromatasehæmmere.
English: Zometa is already approved for use in the prevention of bone complications in patients with advanced cancer that affects the bone.
Danish: Zometa er allerede godkendt til forebyggelse af knoglekomplikationer hos patienter med fremskreden kræft, der påvirker knoglerne.
English: This leads to less bone loss.
Danish: Dermed reduceres knogletabet.
English: On 15 November 2007, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.
Danish: Den 15. november 2007 meddelte Novartis Europharm Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om en ny indikation for Zometa til forebyggelse af knoglebrud og -tab hos postmenopausale kvinder, der har fået konstateret brystkræft på et tidligt stadium, og som behandles med aromatasehæmmere.
English: Although Zometa seemed to reduce bone loss when it was started at the same time as letrozole, the CHMP was not convinced of the relevance of this finding in the absence of adequate information on fractures.
Danish: Selvom behandlingen med Zometa syntes at kunne reducere knogletab, når den blev påbegyndt samtidig med letrozol-behandling, var CHMP ikke overbevist om relevansen af dette resultat, idet der ikke forelå relevante oplysninger om knoglebrud.
English: The effectiveness of Zometa in preventing bone loss was studied in two main studies involving a total of 1,667 postmenopausal women treated for early-stage breast cancer with letrozole (an aromatase inhibitor).
Danish: Virkningen af Zometa til at forebygge knogletab blev undersøgt i to hovedundersøgelser med i alt 1 667 postmenopausale kvinder, der blev behandlet for brystkræft på et tidligt stadium med aromatasehæmmeren letrozol.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Danish: Det virker hæmmende på osteoklasterne, der er de celler i kroppen, som medvirker ved nedbrydningen af knoglevævet.
English: This comparison was intended to provide information on the effect of zoledronic acid on bone fractures in women being treated with aromatase inhibitors.
Danish: Formålet med sammenligningen var at skaffe oplysninger om virkningen af zoledronsyre på knoglebrud hos kvinder, der blev behandlet med aromatasehæmmere.
English: Zometa can also be used to treat the hypercalcaemia caused by tumours.
Danish: Zometa kan også anvendes til at behandle hyperkalcæmi, der skyldes kræft.
English: This includes fractures (broken bones), spinal compression (pressure on the spinal cord), bone disorders needing radiotherapy or surgery, and hypercalcaemia (high levels of calcium in the blood).
Danish: Det omfatter knoglebrud, tryk på rygmarven, knoglelidelser, der kræver strålebehandling eller kirurgisk indgreb, og forhøjet kalciumniveau i blodet (hyperkalcæmi).
English: Both studies looked at the effects of starting Zometa at the same time as starting letrozole treatment, compared with the effects of waiting until there was significant bone loss or evidence of a fracture before starting Zometa.
Danish: I begge undersøgelser så forskerne nærmere på virkningen af at påbegynde behandling med Zometa og letrozol samtidigt sammenlignet med virkningen ved at vente med igangsættelse af behandling med Zometa, indtil der var et betydeligt knogletab eller bevis på knoglebrud.
English: Aromatase inhibitors include anastrozole, letrozole and exemastane, and can cause bone loss and fractures as a side effect.
Danish: Aromatasehæmmere omfatter anastrozol, letrozol og exemestan, og blandt bivirkningerne ved denne type lægemiddel er knoglebrud og -tab.
English: The reduction of bone loss helps to make bones less likely to break, which may be useful in preventing fractures.
Danish: Reduktionen af knogletabet bidrager til at mindske sandsynligheden for knoglebrud.
English: In the new indication, Zometa was expected to be used to prevent fractures and bone loss in postmenopausal women with early-stage breast cancer who were being treated with anticancer medicines called aromatase inhibitors.
Danish: Formålet med den nye indikation var, at Zometa skulle anvendes til at forebygge knoglebrud og -tab hos postmenopausale kvinder, der havde fået konstateret brystkræft på et tidligt stadium, og som var i behandling med en type lægemiddel mod kræft, der kaldes aromatasehæmmere.
English: This was not overcome by providing information on fractures from studies looking at Aclasta in the treatment of osteoporosis.
Danish: Oplysningerne om knoglebrud fra undersøgelserne af Aclasta til behandling af osteoporose kunne ikke fjerne denne betænkelighed.
English: Do not use if your dog
Danish: Må ikke anvendes hvis din hund
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 March 2001
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 13. marts 2001
English: Administer to dogs within 1-2 hours after feeding.
Danish: Administreres til hunde indenfor 1-2 timer efter fodring.
English: The recommended dose should not be exceeded.
Danish: Den anbefalede dosering bør ikke overskrides.
English: Uxbridge UB9 6LS United Kingdom
Danish: Uxbridge UB9 6LS Storbritannien
English: • is hypersensitive to the product
Danish: • er overfølsom overfor produktet
English: The duration of treatment is dependent on clinical response.
Danish: Behandlingens varighed er afhængig af den kliniske respons.
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer Nederlandene
English: Alopecia and erythema may also occur occasionally.
Danish: Alopeci og erythem kan også af og til ses.
English: Do not use after the expiry date, which is stated on the blister.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på blisterkortet.
English: BATCH NUMBER Batch {number}
Danish: BATCHNUMMER Batch {nummer}
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B. V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B. V.
English: Keep the mouth of the dog closed for a few seconds to ensure complete tablet wetting.
Danish: Hold hundens mund lukket et par sekunder for at sikre gennemvædning af tabletten.
English: Pharmacotherapeutic group: Anti-inflammatory Products, Non Steroids ATCvet code: QM01AE92
Danish: Farmakoterapeutisk gruppe: Antiinflammatorisk, non-steroidt ATCvet-kode: QM01AE92
English: Place the tablet in the dog's mouth.
Danish: Tabletten placeres i hundens mund.
English: Vomiting or diarrhoea may occur due to treatment.
Danish: Opkastning eller diarré kan ses som følge af behandling.
English: The oral lyophilisates are available in the following pack sizes:
Danish: Smeltetabletterne findes i følgende pakningsstørrelser:
English: D. STATEMENT OF THE MRLs Not applicable
Danish: D. ANGIVELSE AF MRL-VÆRDIER Ikke relevant
English: Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additional risk.
Danish: Anvendelse til dyr under 6 måneder, under 5 kg eller gamle dyr øger risikoen for bivirkninger.
English: OTHER INFORMATION Not all pack sizes may be marketed.
Danish: ANDRE OPLYSNINGER Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: 1 box containing 1, 3 or 6 blisters.
Danish: 1 æske indeholdende 1, 3 eller 6 blisterkort.
English: In rare cases, particularly in older or in sensitive dogs, these undesirable effects may be serious or fatal.
Danish: I sjældne tilfælde, især hos ældre eller særligt følsomme hunde, kan disse bivirkninger være alvorlige eller fatale.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Tepoxalin
English: When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat.
Danish: Hvis dette ikke er muligt, eller hvis hunden modsætter sig at få tabletten direkte i munden, så placeres tabletten, umiddelbart før den skal indtages, i en lille mængde fugtigt foder eller godbid.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMA) http://www.ema.europa.eu..
English: Special care should be taken when treating dogs with marked renal insufficiency.
Danish: Særlig opmærksomhed skal iagttages ved behandling af hunde med renal insufficiens.
English: If there are such undesirable effects, treatment should be discontinued immediately.
Danish: Hvis sådanne uønskede symptomer er til stede, bør behandlingen straks ophøre.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch {nummer}
English: After a treatment period of 7-10 days, the condition of the dog should be reevaluated in order to establish the need for continuation of treatment.
Danish: Efter en behandlingsperiode på 7-10 dage bør hundens tilstand vurderes igen for at afgøre om fortsat behandling er nødvendig.
English: Each blister contains 10 oral lyophilisates.
Danish: Hvert blisterkort indeholder 10 smeltetabletter.
English: If you notice any other side effects, please inform your veterinary surgeon.
Danish: Hvis De bemærker eventuelle andre bivirkninger, bedes De kontakte Deres dyrlæge.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant
English: The weight of the animal should be accurately determined before start of treatment.
Danish: Dyrets vægt bør kontrolleres, inden behandlingen påbegyndes.
English: If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary.
Danish: Kan brugen i disse dyr ikke undgås, er nøje veterinær overvågning med monitorering af gastrointestinalt blodtab nødvendig.
English: • is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.
Danish: • er dehydreret, hypovolemisk eller hypotensiv da dette medfører en forøget risiko for nyretoxicitet.
English: Ensure the food or treat containing the medication is completely consumed.
Danish: Det skal sikres at foderet eller godbiden med medicinen bliver fuldstændig spist.
English: Other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects.
Danish: NSADs, diuretika, antikoagulanter og andre stoffer med høj proteinbinding, kan konkurrere om bindingen, hvilket kan føre til risiko for forgiftning.
English: 200 mg / oral lyophilisate For a full list of excipients, see section 6.1.
Danish: 200 mg / smeltetablet Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Tepoxalin is rapidly (Tmax of approximately 2 hours) absorbed after oral administration in dogs.
Danish: Tepoxalin absorberes hurtigt efter oral administration til hunde (Tmax ca. 2 timer).
English: WITHDRAWAL PERIOD Not applicable
Danish: 10. TILBAGEHOLDELSESTID Ikke relevant
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Danish: Ubrugte lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.
English: At a therapeutic dose of 10 mg/kg, the Cmax of tepoxalin was 1.08 ± 0.37 μg/ml in dogs fed a low fat meal and 1.19 ± 0.29 μg/ml in dogs fed a high fat meal.
Danish: Ved en terapeutisk dosis på 10 mg/kg, er Cmax af tepoxalin 1.08 ± 0,37 μg/ml hos hunde, fodret med et fedtfattigt måltid og 1,19 ± 0,29 μg/ml hos hunde fodret med et fedtrigt måltid.
English: Long term treatment should be under regular veterinary supervision.
Danish: Langtidsbehandling bør følges regelmæssigt af dyrlægen.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMA) http://www.ema.europa.eu.
English: • is pregnant or lactating or in bitches intended for breeding
Danish: • er drægtig eller lakterende eller til tæver som anvendes i avl
English: • has cardiac or hepatic disease
Danish: • lider af hjerte- eller leversygdom
English: Tepoxalin and its metabolites are excreted in the faeces (99%).
Danish: Tepoxalin og dets metabolitter udskilles i fæces (99%).
English: Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
Danish: Tepoxalin er en dobbelt cyclooxygenase / 5-lipooxygenasehæmmer med antiinflammatorisk aktivitet.
English: In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be sought immediately.
Danish: I tilfælde, hvor mennesker indtager adskillige tabletter, bør der straks søges læge.
English: The acid metabolite is a potent, active cyclooxygenase inhibitor and prolongs the activity of the parent compound.
Danish: Syremetabolitten er en potent, aktiv cyclooxygenasehæmmer, der forlænger aktiviteten af tepoxalin.
English: During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) occurred in 1 out of 10 animals.
Danish: Under klinisk afprøvning af produktet var frekvensen af gastrointestinale bivirkninger (diarré/opkast) 1 ud af 10 dyr.
English: Manufacturer for the Batch Release:
Danish: Fremstiller af batchfrigivelse:
English: Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
Danish: Reduktion af inflammation og lindring af smerter forårsaget af akutte og kroniske muskuloskeletale lidelser.
English: Tepoxalin is extensively converted to its acid metabolite.
Danish: Tepoxalin omdannes i udstrakt grad til dets syremetabolit.
English: Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity.
Danish: Bør ikke anvendes til dehydrerede, hypovolæmiske eller hypotensive hunde, da der er forøget risiko for nyreskader.
English: Plasma concentrations of the acid metabolite are higher than those of the parent compound in the dog.
Danish: Plasmakoncentrationen af syremetabolitten er højere end plasmakoncentrationen af tepoxalin hos hunden.
English: 10 mg/kg once daily.
Danish: 10 mg/kg én gang daglig.
English: Maintain the animal on intravenous fluids and, if necessary, administer whole blood.
Danish: Dyret bør væskebehandles, og om nødvendigt udføres blodtransfusion.
English: If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.
Danish: Hvis smeltetabletten opløses i hånden, vaskes hænderne grundigt.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Aktivt stof
English: Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and leukotriene synthesis.
Danish: Oral administration af 10 mg/kg legemsvægt medfører en inhibering af prostaglandin og leukotrien syntesen.
English: If vomiting continues, administer anti-emetics.
Danish: Hvis opkastning vedvarer behandles med antiemetica.
English: 5.2 Pharmacokinetic properties
Danish: 5.2 Farmakokinetiske oplysninger
English: Tepoxalin and its metabolites are highly protein-bound, more than 98%.
Danish: Både tepoxalin og syremetabolitten har en proteinbinding på over 98%.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER {50 mg}{100 mg}{200 mg}
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS {50 mg}{100 mg}{200 mg}
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Danish: TEKSTEN “TIL DYR” Kun til dyr
English: 10 mg/kg of body weight once daily.
Danish: 10 mg/kg legemsvægt én gang daglig.
English: Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids, diuretics or anticoagulants.
Danish: Tepoxalin bør ikke anvendes samtidigt med andre NSAID's eller smertestillende lægemidler glucocorticoider, diuretika eller antikoagulerende midler.
English: PHARMACEUTICAL FORM Oral lyophilisates
Danish: LÆGEMIDDELFORM Smeltetabletter
English: In the case of overdosage discontinue therapy.
Danish: Ved overdosering bør behandlingen seponeres.
English: Special precautions to be taken by the person administering the medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr
English: The tablet will disintegrate upon contact with moisture.
Danish: Tabletten opløses straks ved kontakt med fugt.
English: Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Bør ikke anvendes samtidigt med andre NSAIDs eller glucocorticoider.
English: During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%.
Danish: Under klinisk afprøvning af produktet var frekvensen af gastrointestinale bivirkninger (opkast/diarrè)
English: 10 mg tepoxalin per kg bodyweight once daily.
Danish: 10 mg tepoxalin pr. kg legemsvægt én gang daglig.
English: NSAID overdosage is characterised by vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and lethargy.
Danish: Bivirkninger ved overdosering med NSAIDs er opkastning, blød fæces/diarré, blod i fæces, nedsat appetit og apati.
English: At doses of 30 mg/kg and above, oral administration of tepoxalin is associated with discoloured faeces ranging in colour from white to yellow, which is the result of unabsorbed drug.
Danish: Ved doser på 30 mg/kg og derover kan der ses hvid til gul misfarvning af fæces, som følge af ikke absorberet lægemiddel.
English: If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.
Danish: Hvis der opstår bivirkninger, bør behandlingen afbrydes,og dyrlægen kontaktes.
English: Absorption of tepoxalin is facilitated via administration to dogs in a fed state.
Danish: Optagelsen af tepoxalin forbedres, hvis det administreres til hunde, der lige er blevet fodret.
English: Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders.
Danish: Almindelige bivirkninger ved behandling med NSAID's er opkastning, blød fæces/diarré, blod i fæces, nedsat appetit, apati og nyrelidelser.