FrancophonIA/ELRC3.0 huggingface dataset:
English: In the context of this review, limited information on the gastrointestinal toxicity profile of nimesulide in comparison to other NSAIDs, and the possible consequences of switching to other NSAIDs with a higher gastrointestinal toxicity risk was considered.
Danish: Under denne gennemgang blev der taget højde for de begrænsede oplysninger om nimesulids gastrointestinale sikkerhedsprofil sammenlignet med andre NSAID'er og de mulige konsekvenser ved at skifte til andre NSAID'er med en højere risiko for gastrointestinal toksicitet.
English: • The Committee considered that evidence of the clinically efficacy of nimesulide-containing products for systemic use in the indications for short-term treatment has been shown.
Danish: • Udvalget vurderede, at der er påvist en klinisk virkning af lægemidler til systemisk brug, der indeholder nimesulid, i indikationerne på kortvarig behandling.
English: The recommended dosage is 100 mg twice daily and the maximum duration of treatment is 15 days with the shortest duration of treatment recommended to minimise the occurrence of side effects.
Danish: Den anbefalede dosis er 100 mg to gange dagligt, og behandlingsvarigheden er maks.
English: Overall, gastrointestinal toxicity of nimesulide is regarded to be comparable to other available NSAIDs.
Danish: Generelt anses nimesulids gastrointestinale toksicitet for at være sammenlignelig med andre NSAID'er på markedet.
English: The reported cases showed an association with non-A non-B non-paracetamol-related fulminant hepatic failure requiring liver transplantation in Ireland higher with nimesulide than with any other medicinal product.
Danish: De indberettede sager viste, at der i Irland var en forbindelse med fulminant leversvigt, som ikke skyldtes hepatitis A, hepatitis B eller paracetamol, som krævede en levertransplantation.
English: The combined safety profile in terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse than some other alternative NSAIDs such as diclofenac and naproxen.
Danish: Den kombinerede sikkerhedsprofil for nimesulid, hvad angår risikoen for hepatoksicitet og gastrointestinal toksicitet, er ringere end nogle andre NSAID'er som diclofenac og naproxen.
English: When combining both liver injury and GI toxicity nimesulide falls in the mid range of the other NSAIDs.
Danish: Ved en kombination af både leverskader og gastrointestinal toksicitet placerer nimesulid sig i mellemklassen i forhold til de andre NSAID'er.
English: The safety profile in terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse than alternative NSAIDs such as diclofenac and naproxen.
Danish: Det er påvist, at sikkerhedsprofilen for nimesulid, hvad angår risikoen for hepatoksicitet og gastrointestinal toksicitet, er ringere end andre NSAID'er som diclofenac og naproxen.
English: Based on available data, it is concluded that the proven efficacy of nimesulide in short-term clinical studies is consistent with the indication for short-term use only (i.e. maximum 15 days of treatment) as previously restricted to minimise the risks for hepatoxicity.
Danish: På baggrund af de tilgængelige data konkluderes det, at nimesulids dokumenterede virkning i kortvarige kliniske undersøgelser er i overensstemmelse med indikationen for, at lægemidlet kun må anvendes kortvarigt (dvs. maks.
English: Grounds for amendment of the summary of product characteristics and package leaflet
Danish: Begrundelser for ændring af produktresumé og indlægsseddel ud fra følgende betragtninger:
English: Nimesulide efficacy is proven in short-term clinical studies which is consistent with the indication for short-term use (i.e. maximum 15 days of treatment) previously introduced to minimise the risks for hepatoxicity.
Danish: Nimesulids virkning er dokumenteret i kortvarige kliniske undersøgelser, som er i overensstemmelse med indikationen for, at lægemidlet kun må anvendes kortvarigt (dvs. maks.
English: • The Committee, in light of the above, considered that there is a risk of chronic use of nimesulide in “symptomatic treatment of painful osteoarthritis” and concludes that the riskbenefit balance of nimesulide-containing medicinal products for systemic use is no longer favourable in this indication.
Danish: • Ud fra ovenstående vurderede udvalget, at der er en risiko ved kronisk brug af nimesulid til "symptomatisk behandling af smertefuld osteoartritis".
English: • Considering the maximum duration of 15 days of treatment to minimise the risk for hepatotoxicity and aiming a further minimisation of the risks associated with nimesulide, the Committee considered that nimesulide use should be restricted to acute conditions only i.e. treatment of acute pain and primary dysmenorrhoea.
Danish: Dette skal ses i lyset af begrænsningen om, at behandlingen maksimalt må vare i 15 dage for at minimere risikoen for hepatotoksicitet, og i lyset af bestræbelserne på yderligere at minimere de risici, der er forbundet med nimesulid.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: APPENDIKS BETINGELSER ELLER BEGRÆNSNINGER FOR SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
English: - That the dose of caffeine expressed as caffeine base is one half the dose of caffeine expressed as caffeine citrate (20mg caffeine citrate is equivalent to 10mg caffeine base) and that prescriptions should clearly indicate that caffeine citrate is to be administered.
Danish: - En koffeindosis udtrykt som koffeinbase er det halve af en koffeindosis udtrykt som koffeincitrat (20 mg koffeincitrat svarer til 10 mg koffeinbase), og ordineringer skal tydeligt angive, at der skal administreres koffeincitrat.
English: - That the product should be used immediately after opening the ampoule and unused portions left in the ampoule should be discarded - That baseline plasma levels may need measuring because of an increased risk of toxicity if o The neonate has been previously treated with theophylline o The mother has been consuming large amounts of caffeine prior to delivery or breast feeding - That caffeine and theophylline should not be used concurrently - That if caffeine and doxapram are used concurrently, the patient should be closely monitored - That additional plasma caffeine monitoring and dosage adjustment may be necessary in at risk situations such as preterm infants: o With cholestatic hepatitis o With significant renal impairment o With seizure disorders o With cardiac disease o less than 28 weeks gestational age and/or body weight <1000g particularly when receiving parenteral nutrition o with co-administration of medicinal products known to interfere with caffeine metabolism - That cardiac disorders (including arrhythmias) may arise in neonates with pre-existing cardiac disease - That all suspected adverse reactions should be reported in accordance with national reporting requirements - In particular, if convulsions, seizures, necrotising enterocolitis, symptoms and signs of caffeine withdrawal, medically abnormal decrease in infant weight gain or interactions with other medicines are suspected as being associated with the use of caffeine citrate, these should be reported to <insert local name and address of Chiesi Farmaceutici S.p.A.
Danish: - Produktet skal anvendes med det samme efter åbning af ampullen, og ubrugte portioner i ampullen skal bortskaffes - Baseline plasmaniveauerne skal måles på grund af en øget risiko for forgiftning, hvis o Det nyfødte barn tidligere er behandlet med teofyllin o Moderen har indtaget store mængder koffein forud for fødslen eller amning - Koffein og teofyllin må ikke anvendes sideløbende - Patienten skal monitoreres tæt, hvis koffein og doxapram anvendes sideløbende - Yderligere monitorering af koffein i plasma og justering af dosis kan være nødvendig i risikosituationer, f.eks. i forbindelse med præmature nyfødte børn: o Med kolestatisk hepatitis o Med signifikant nedsat nyrefunktion o Med krampeanfald o Med en hjertesygdom o Med mindre end 28 ugers gestatiosnalder og/eller en kropsvægt på <1000 g, især hvis barnet får parental ernæring o Med samtidig administration af medicinsk produkter, der vides at interferere med koffeinmetabolisme - Der kan opstå hjerteproblemer (herunder arytmi) hos nyfødte børn med en eksisterende hjertesygdom - Alle mistænkte uønskede virkninger skal oplyses i overensstemmelse med de nationale krav - Hvis der er mistanke om især kramper, krampeanfald, nekrotiserende enterocolitis, symptomer og tegn på koffeinabstinenser, medicinsk unormal nedsat vægtøgning eller interaktion med andre lægemidler i forbindelse med anvendelsen af koffeincitrat, skal dette indberettes til <indsæt det lokale navn og den lokale adresse på Chiesi Farmaceutici S.p.A.>
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES The Member States shall agree with the Marketing Authorisation Holder the final text of a card suitable for display in neonatal intensive care units.
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE Medlemsstaterne skal komme overens med indehaveren af markedsføringstilladelsen om den endelige tekst til et kort, der egner sig til neonatale intensivafdelinger.
English: The Member States shall ensure that the card contains the following key elements and is provided by the Marketing Authorisation Holder to all neonatal intensive care units where the product is likely to be used at launch of the product: - That Peyona is for the treatment of primary apnoea - That treatment with Peyona must be provided in a neonatal intensive care unit and initiated and supervised by a physician experienced in neonatal intensive care - Details of the loading and maintenance dosages and that caffeine may accumulate in premature neonates because of its long half-life.
Danish: Medlemsstaterne skal sikre, at kortet indeholder følgende hovedelementer og leveres af indehaveren af markedsføringstilladelsen til alle neonatale intensivafdelinger, hvor der er sandsynlighed for, at lægemidlet vil blive brugt, i forbindelse med lanceringen af produktet: - Peyona er beregnet til behandling af primær apnø - Behandling med Peyona skal foregå i en neonatal intensivafdeling og initieres og superviseres af en læge med erfaring i neonatal intensiv behandling - Detaljer om loading- og vedligeholdelsesdoser, og oplysninger om, at koffein kan akkumuleres i præmature nyfødte børn på grund af den lange halveringstid.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen.
English: This overview was last updated in April 2018.
Danish: Denne oversigt blev sidst ajourført i april 2018.
English: The dose depends on the animal's weight.
Danish: Dosen afhænger af dyrets vægt.
English: Further information on Credelio can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere oplysninger om Credelio findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Credelio
Danish: Andre oplysninger om Credelio
English: Credelio received a marketing authorisation valid throughout the EU on 25 April 2017.
Danish: Credelio modtog en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 25. april
English: It contains the active substance lotilaner.
Danish: Det indeholder det aktive stof lotilaner.
English: The European Medicines Agency decided that Credelio's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Credelio opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It blocks the normal movement of charged particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Danish: Det blokerer den normale transport af ladede partikler ind og ud af nervecellerne, navnlig dem, der er forbundet med gammaaminosmørsyre (GABA) og glutamat, som begge er stoffer, der overfører signaler mellem nerverne (neurotransmittere).
English: Credelio is effective for one month and treatment can be repeated every month.
Danish: Credelio virker i en måned, og behandlingen kan gentages én gang om måneden.
English: This means that it kills parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Danish: Det vil sige, at det dræber parasitter, der lever på dyrets hud eller i pelsen, f.eks. lopper og flåter.
English: An overview of Credelio and why it is authorised in the EU
Danish: Oversigt over Credelio, og hvorfor det er godkendt i EU
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Hvis en person utilsigtet indtager lægemidlet, bør der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Why is Credelio authorised in the EU?
Danish: Hvorfor blev Credelio godkendt i EU?
English: The active substance in Credelio, lotilaner, acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i Credelio, lotilaner, er et såkaldt ektoparasiticid.
English: Credelio is available as chewable tablets in seven different strengths (the lowest two strengths for cats, the rest for dogs) which are given to the animals with food or within 30 minutes after feeding.
Danish: Credelio fås som tyggetabletter i syv forskellige styrker (de to laveste styrker til katte og de resterende til hunde) og gives til dyret sammen med mad eller inden for 30 minutter efter et måltid.
English: What is Credelio and what is it used for?
Danish: Hvad er Credelio, og hvad anvendes det til?
English: Lotilaner kills these parasites that have ingested the blood by acting on their nervous system.
Danish: Lotilaner dræber de parasitter, der har indtaget dyrets blod, ved at påvirke deres nervesystem.
English: Lotilaner kills fleas before they can lay eggs and so helps to reduce contamination of the animal's environment.
Danish: Lotilaner dræber lopper, før de kan lægge æg, og nedsætter derved spredning til dyrets omgivelser.
English: Because ticks must start feeding on the animal in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.
Danish: Da lopper og flåter skal begynde at suge næring fra dyret for at blive dræbt af medicinen, kan det ikke udelukkes, at de kan overføre eventuelle sygdomme.
English: For more information about using Credelio, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Credelio, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What are the risks associated with Credelio?
Danish: Hvilke risici er der forbundet med Credelio?
English: In order to be exposed to the active substance, fleas and ticks must have attached to the skin and commenced feeding on the animal's blood.
Danish: For at lopper og flåter kan blive udsat for det aktive stof, skal de først hægte sig fast i huden og begynde at tage næring fra dyrets blod.
English: Credelio is a veterinary medicine used to treat flea and tick infestations in dogs and cats.
Danish: Credelio er et lægemiddel, der anvendes til behandling af angreb af lopper og flåter hos hunde og katte.
English: In all studies below animals had natural infestations.
Danish: I alle nedennævnte studier havde dyrene naturlige loppe- og/eller flåtangreb.
English: After being given to dogs, Credelio kills fleas within 4 hours and ticks within 48 hours of attachment.
Danish: Efter indgift hos hunde dræber Credelio lopper i løbet af 4 timer og flåter i løbet af 48 timer efter et angreb.
English: Credelio reduced flea counts by 97% over one month and was as effective as the other medicine.
Danish: Credelio reducerede antallet af lopper med 97 % i løbet af en måned og var lige så effektivt som det andet lægemiddel.
English: Credelio can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Credelio kan anvendes som led i behandlingen af hudbetændelse ved overfølsomhed for loppebid (loppebetinget allergisk dermatitis).
English: After being given to cats, Credelio kills fleas within 12 hours and ticks within 24 hours of attachment.
Danish: Efter indgift hos katte dræber Credelio lopper i løbet af 12 timer og flåter i løbet af 24 timer efter et angreb.
English: How does Credelio work?
Danish: Hvordan virker Credelio?
English: How is Credelio used?
Danish: Hvordan anvendes Credelio?
English: What benefits of Credelio have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Credelio?
English: In a small field study involving dogs with ticks, 47 dogs were treated once with Credelio and 35 dogs were treated with a spot-on medicine containing fipronil and another active substance, (s)-methoprene.
Danish: I et lille feltstudie hos hunde med flåter blev 47 hunde behandlet én gang med Credelio, mens 35 hunde blev behandlet med et spot-on lægemiddel indeholdende fipronil og et andet aktivt stof, (S)-methopren.
English: Credelio was as effective as the other medicine in reducing tick counts and reduced ticks by 99% during the study.
Danish: Credelio var lige så effektivt som det andet lægemiddel til at nedsætte antallet af flåter, og det nedsatte antallet af flåter med 99 % i løbet af studiet.
English: The study showed Credelio to be as effective as the other medicine in reducing tick counts over four weeks and tick counts were reduced by 100% for Credelio treated dogs.
Danish: Studiet viste, at Credelio var lige så effektivt som det andet lægemiddel til at nedsætte antallet af flåter i løbet af fire uger, og hundene fik ved behandling med Credelio nedsat antallet af flåter med 100 %.
English: A second larger field study of dogs with ticks involved 127 dogs treated with Credelio monthly for 3 months whilst 68 dogs were treated with a spot-on medicine containing fipronil and (s)-methoprene.
Danish: Et andet, større feltstudie hos hunde med flåter omfattede 127 hunde, der blev behandlet med Credelio i 3 måneder, mens 68 hunde blev behandlet med et spot-on lægemiddel indeholdende fipronil og (S)-methopren.
English: The study showed Credelio to be as effective as the other medicine in reducing the flea counts over the 12 weeks and dogs treated with Credelio had flea counts reduced by 99%.
Danish: Studiet viste, at Credelio var lige så effektivt som det andet lægemiddel til at nedsætte antallet af lopper i løbet af de 12 uger, og ved behandling med Credelio fik hundene nedsat antallet af lopper med 99 %.
English: In a 12-week field study involving dogs with fleas, 128 dogs were treated with Credelio every four weeks and 64 dogs with a spot-on medicine containing fipronil, another medicine to treat flea infestation.
Danish: I et 12-ugers feltstudie hos hunde med lopper blev 128 hunde behandlet med Credelio hver fjerde uge, og 64 hunde blev behandlet med et spot-on produkt indeholdende fipronil, et andet lægemiddel til behandling af loppeangreb.
English: In a one month study involving cats with fleas, 121 cats were treated with Credelio and 61 cats with a spot-on medicine containing fipronil and (s)-methoprene.
Danish: I et månedlangt studie hos katte med lopper blev 121 katte behandlet med Credelio, mens 61 katte blev behandlet med et spot-on lægemiddel indeholdende fipronil og (S)-methopren.
English: In a further three month study involving cats with ticks, 112 cats were treated with Credelio every month and 57 cats with a spot-on medicine containing fipronil.
Danish: I et andet tremåneders studie hos katte med flåter blev 112 katte behandlet med Credelio én gang om måneden, mens 57 katte blev behandlet med et spot-on lægemiddel indeholdende fipronil.
English: Pack size blister (alu/alu) 30 tablets blister (alu/alu) 90 (3 x 30) tablets (multipack)
Danish: Oral anvendelse blister (alu/alu) 90 (3 x 30) tabletter (multipakke)
English: You should take your medicine regularly at the same time each day.
Danish: Medicinen tages regelmæssigt og på samme tid hver dag.
English: The following side effects have been reported.
Danish: De følgende bivirkninger er blevet indberettet.
English: Very rare, not known*
Danish: Sjælden Meget sjælden, ikke kendt
English: Some of the side effects may be serious.
Danish: Nogle af bivirkningerne kan være alvorlige.
English: • Your doctor may order blood tests
Danish: • kan din læge bede om blodprøver
English: Store in the original package to protect from light.
Danish: Opbevares i original emballage for at beskytte mod lys.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/649/001-016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/649/001-016
English: Changes in levels of certain substances in your blood or urine.
Danish: • Ændringer i niveauer af visse stoffer i dit blod eller din urin.
English: See section 4
Danish: Se afsnit 4.
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Danish: Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i outcome med poor metabolisers.
English: eptifibatide or tirofiban.
Danish: eptifibatid eller tirofiban.
English: Posology: • Adults and older people
Danish: • Voksne og ældre personer
English: The other side of the tablet is plain.
Danish: Den anden side af tabletten er glat.
English: Prevention of atherothrombotic events Clopidogrel is indicated in:
Danish: Forebyggelse af aterotrombotiske hændelser Clopidogrel er indiceret hos:
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) , not known (cannot be estimated from the available data).
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden <1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you suffer from any of the following symptoms you should contact your doctor immediately:
Danish: Hvis du lider af nogen af de følgende symptomer, skal du straks kontakte din læge:
English: • You have had an allergy or reaction to any medicine used to treat your disease.
Danish: • hvis du har haft allergi over for eller en reaktion på et lægemiddel, der anvendes til at behandle din sygdom.
English: Magyarország Teva Gyógyszergyár Zrt.
Danish: Teva Gyógyszergyár Zrt
English: This may be detectable via blood or urine tests.
Danish: Dette kan ses i blodprøver eller urinprøver.
English: Push the tablet out
Danish: Tryk tabletten ud
English: Warnings and precautions Tell your doctor before you start to take this medicine if:
Danish: Advarsler og forsigtighedsregler Fortæl det til din læge inden du begynder at tage denne medicin, hvis:
English: You should not breastfeed while taking this medicine.
Danish: Du må ikke amme, når du tager denne medicin.
English: Put the tablet in your mouth and swallow with water or another liquid.
Danish: Put tabletten i munden og synk den med vand eller en anden væske
English: These may be the signs of an allergic reaction.
Danish: Dette kan være tegn på en overfølsomhedsreaktion (allergisk reaktion)
English: You can take it with or without food.
Danish: Du kan tage den med eller uden mad.
English: One side of the tablet is debossed with “C75”.
Danish: Den ene side af tabletten er præget med "C75".
English: • moclobemide, medicine to treat depression.
Danish: • moclobemid, medicin mod depression.