FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Siklos?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Siklos?
English: The 1,000 mg tablet has special score lines so that it can be easily divided into four equal parts.
Danish: 1 000 mg-tabletten har særlige delekærve, så den let kan deles i fire lige store dele.
English: There were also fewer admissions into hospital, and fewer days spent in hospital.
Danish: Der var også færre hospitalsindlæggelser og færre indlæggelsesdage.
English: This reduces the risk of blood vessels becoming blocked.
Danish: Derved mindskes risikoen for blodpropper.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Siklos.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Siklos.
English: For more information about treatment with Siklos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Siklos, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The full EPAR for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Siklos finds på agenturets websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is the risk associated with Siklos?
Danish: Hvilken risiko er der forbundet med Siklos?
English: Because the number of patients with sickle cell syndrome is low, the disease is considered ‘rare', and Siklos was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2003.
Danish: Da antallet af patienter med seglcellesygdom er lavt, betragtes sygdommen som sjælden, og Siklos blev udpeget som "lægemiddel til sjældne sygdomme" den 9. juli 2003.
English: In particular, it presented evidence on the effectiveness of Siklos from 11 published studies involving 378 children and from three national registries of information on 155 children with sickle cell syndrome who were treated with Siklos for up to seven years.
Danish: Navnlig fremlagde virksomheden dokumentation for virkningen af Siklos fra 11 offentliggjorte undersøgelser foretaget hos 378 børn og fra tre nationale registre med oplysninger om 155 børn med seglcellesygdom, der blev behandlet med Siklos i indtil syv år.
English: Blood cell counts normally return to normal within two weeks of stopping Siklos treatment.
Danish: Blodtællingen bliver sædvanligvis normal igen i løbet af to uger efter ophør af behandlingen med Siklos.
English: In the study comparing Siklos with placebo in adults, there were fewer vaso-occlusive crises in the patients taking Siklos (2.5 crises per year) than in those taking placebo (4.5 crises per year).
Danish: I undersøgelsen, hvor Siklos blev sammenlignet med placebo hos voksne, sås der færre vaso-okklusive kriser hos de patienter, der fik Siklos (2,5 kriser pr. år) end hos dem, der fik placebo (4,5 kriser pr. år).
English: Patients had fewer vaso-occlusive crises when treated with Siklos than before treatment, with the frequency falling by between 66% and 80% in children and adults.
Danish: Efter behandling med Siklos havde patienterne færre vaso-okklusive kriser end før behandlingen, idet hyppigheden faldt med mellem 66 og 80 % hos børn og voksne.
English: Siklos is a medicine that contains the active substance hydroxycarbamide.
Danish: Siklos er et lægemiddel, der indeholder det aktive stof hydroxycarbamid.
English: Because hydroxycarbamide is a well-known substance that is already used in other medicines, the company used data from the scientific literature to support the use of Siklos in adults and children with sickle cell syndrome.
Danish: Da hydroxycarbamid er et velkendt stof, som allerede anvendes i andre lægemidler, fremlagde virksomheden oplysninger fra den videnskabelige litteratur til at underbygge brugen af Siklos hos voksne og børn med seglcellesygdom.
English: Doses of up to 35 mg per kilogram body weight per day can be used in exceptional cases, as long as the patient's blood is monitored for side effects.
Danish: I undtagelsestilfælde kan der anvendes en daglig dosis på op til 35 mg/kg kropsvægt, forudsat at patientens blod overvåges for bivirkninger.
English: What is Siklos?
Danish: Hvad er Siklos?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Siklos findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It also presented evidence from one study in 299 adults, in which the effects of Siklos were compared with those of placebo (a dummy treatment), as well as the results of other studies involving 430 adults and one national registry of information on 123 adults treated with Siklos.
Danish: Virksomheden fremlagde desuden resultaterne af en undersøgelse med 299 voksne, hvor virkningen af Siklos blev sammenlignet med virkningen af placebo (virkningsløs behandling), samt resultaterne af andre undersøgelser med 430 voksne og et nationalt register med oplysninger om 123 voksne, som blev behandlet med Siklos.
English: The active substance in Siklos, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells.
Danish: Det aktive stof i Siklos, hydroxycarbamid, blokerer væksten og formeringen af visse celler som f.eks. blodcellerne.
English: Treatment with Siklos should be started by a doctor who has experience in the management of sickle cell syndrome.
Danish: Behandlingen med Siklos bør indledes af en læge med erfaring i behandling af seglcellesygdom.
English: Hydroxycarbamide, which used to be known as hydroxyurea, has been available in the European Union (EU) for several decades for use in other illnesses, including some types of cancer.
Danish: Hydroxycarbamid, som tidligere var kendt under navnet hydroxyurea, har været på markedet i EU i flere årtier til behandling af andre sygdomme, bl.a. visse former for kræft.
English: The studies compared the number of vaso-occlusive crises before and after treatment with Siklos, as defined by any painful episode involving the arms, legs, abdomen, back or chest.
Danish: I undersøgelserne sammenlignedes antallet af vaso-okklusive kriser før og efter behandlingen med Siklos, bestemt som antallet af smerteanfald i arme, ben, mave, ryg eller bryst.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Siklos, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Siklos, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: It is used to prevent recurrent, painful vaso-occlusive crises that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ.
Danish: Det anvendes til forebyggelse af tilbagevendende, smertefulde vaso-okklusive kriser, som optræder, når blodkarrene tilstoppes af de abnorme røde blodlegemer, og blodtilstrømningen til et organ derved bliver hæmmet.
English: Patients taking Siklos should have blood tests before and regularly during treatment, to check their blood cell counts and also to monitor their kidneys and liver.
Danish: Patienter, der er i behandling med Siklos, skal have taget blodprøver før behandlingen og med jævne mellemrum under behandlingen for at få foretaget blodtælling og for, at nyrer og lever kan overvåges.
English: Why has Siklos been approved?
Danish: Hvorfor blev Siklos godkendt?
English: The company that makes Siklos will also provide information packs for doctors and for patients describing the safety information on the medicine.
Danish: Virksomheden, der fremstiller Siklos, skal også sørge for, at læger og patienter får udleveret sikkerhedsinformation om lægemidlet.
English: They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X ray.
Danish: Kriserne kan være ledsaget af akut thoraxsyndrom, en livstruende tilstand, hvor patienten har pludselige brystsmerter, feber og åndenød eller tegn på væske i lungerne ved røntgenundersøgelse.
English: Siklos, reversible oligospermia or azoospermia (reduced or absent production of healthy sperm) is also very commonly seen.
Danish: Hos mænd, som behandles med Siklos, ses også ofte reversibel oligospermi eller azoospermi (nedsat eller udebleven produktiion af sund sæd).
English: Siklos must not be used in people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts.
Danish: Siklos må ikke anvendes til patienter med alvorlig nyre- eller leversygdom eller med et faretruende lavt antal blodlegemer.
English: For the full list of all side effects reported with Siklos, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Siklos fremgår af indlægssedlen.
English: Although the precise way that it works in this disease is not understood, hydroxycarbamide can reduce the numbers of cells that are circulating in the blood, as well as prevent red blood cells changing shape in patients with sickle cell syndrome.
Danish: Det vides ikke nøjagtigt, hvordan hydroxycarbamid virker ved denne sygdom, men man ved, at det er i stand til at reducere antallet af cirkulerende celler i blodet og forhindre, at de røde blodlegemer ændrer form hos patienter med seglcellesygdom.
English: What benefit has Siklos shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Siklos?
English: The starting dose is usually 15 mg per kilogram body weight, using the most appropriate tablet strengths (100 or 1,000 mg) to make up the dose, breaking up the 1,000-mg tablet in quarters (250 mg) if needed.
Danish: Med de forskellige tabletstyrker (100 eller 1 000 mg) sammensættes den rette dosis, og 1 000 mg-tabletten kan deles i kvarte (250 mg) efter behov.
English: The most common side effect with Siklos (seen in more than one patient in 10) is bone marrow suppression, causing neutropenia (low levels of neutrophils, a type of white blood cell), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and macrocytosis (enlargement of red blood cells).
Danish: Dette medfører neutropeni (for få neutrofile, der er en type hvide blodlegemer), retikulocytopeni (for få retikulocytter, der er en type umodne røde blodlegemer) og makrocytose (for store røde blodlegemer).
English: The dose is adjusted according to the response to treatment, with the usual dose being between 15 and 30 mg per kilogram body weight per day.
Danish: Den sædvanlige dosis er mellem 15 og 30 mg pr. kg legemsvægt dagligt.
English: Breast-feeding must be stopped while taking Siklos.
Danish: Amning skal afbrydes under behandlingen med Siklos.
English: How has Siklos been studied?
Danish: Hvordan blev Siklos undersøgt?
English: How is Siklos used?
Danish: Hvordan anvendes Siklos?
English: What is Siklos used for?
Danish: Hvad anvendes Siklos til?
English: Patients who do not respond to this dose or who have side effects may need to stop or suspend treatment.
Danish: Hvis denne dosis ikke virker eller patienten får bivirkninger, kan det være nødvendigt holde pause i brugen af medicinen eller helt ophøre med den. Ved moderat eller svær nyresygdom bør der gives en lavere dosis af Siklos.
English: For more information, see the package leaflet.
Danish: De yderligere oplysninger fremgår af indlægssedlen.
English: Siklos is used in adults, adolescents and children over two years of age who have sickle cell syndrome, a genetic disease where the red blood cells become rigid and sticky, and change from being discshaped to being crescent-shaped (like a sickle).
Danish: Det er en arvelig sygdom, hvor de røde blodlegemer bliver stive og klæbrige og ændrer form fra skiveformede til halvmåneformede (som en seglcelle).
English: How does Siklos work?
Danish: Hvordan virker Siklos?
English: Symptoms were reversible.
Danish: Symptomerne var reversible.
English: The recommended dose should not be exceeded.
Danish: Den anbefalede dosis bør ikke overskrides.
English: ΑΘηνών - Λαμίαζ, 14452, Μεταμόρυωση, Αττική Τηλ.
Danish: ΑΘηνών - Λαμίαζ, 14452, Μεταμόρφωση, Αττική Τηλ.
English: See also section 4.7.
Danish: Se også afsnit 4.7.
English: In order to minimise risk of intolerance, the product should be mixed into muesli feed.
Danish: For at minimere risikoen for intolerance, skal produktet blandes i müsli foder.
English: To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing or overdosing.
Danish: For at sikre korrekt dosering, bør kropsvægten bestemmes så præcist som muligt for at undgå underdosering eller overdosering.
English: A one ml syringe is provided with the product.
Danish: En 1 ml sprøjte leveres med produktet.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EC) nr. 470/2009, når de anvendes i dette veterinærlægemiddel.
English: Reduction of post-operative pain (over a period of 24 hours):
Danish: Reduktion af postoperative smerter (over en periode på 24 timer):
English: Dosage for each species
Danish: Dosering for hver dyreart
English: The metabolism in horses was not investigated.
Danish: Metabolismen hos hest er ikke undersøgt.
English: Inflacam alone will not provide adequate pain relief during the dehorning procedure.
Danish: Inflacam alene vil ikke give tilstrækkelig smertelindring under afhorning.
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Inflacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Danish: Inflacam tyggetabletter kan administreres med eller uden foder, er tilsat aroma og indtages frivilligt af de fleste hunde.
English: The active substance in Inflacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) 37/2010:
Danish: Følgende indholdsstoffer Inflacam i og er inkluderet i Tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010:
English: This product is only for use in horses weighing between 500 and 600 kg.
Danish: Dette produkt er kun til brug hos heste, der vejer mellem 500 og 600 kg.
English: Handelsweg 25, 5531 AE Bladel, The Netherlands
Danish: Handelsweg 25, 5531 AE Bladel, Nederlandene
English: The product should be added to 250 g of muesli feed, prior to feeding.
Danish: Produktet skal tilsættes til 250 g müsli foder, inden fodring.
English: PVC/PVDC blister packs with a 20 micron foil.
Danish: PVC / PVDC blisterpakninger med 20 micron foil.
English: It reduces leukocyte infiltration into the inflamed tissue.
Danish: Det reducerer leukocyt infiltrationen i det betændte væv.
English: When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%.
Danish: Når præparatet anvendes i overensstemmelse med den anbefalede dosering, er biotilgængeligheden cirka 98 %.
English: After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Danish: Efter indgivelse af veterinærlægemidlet, skal flasken lukkes ved at sætte låget på, vask doseringssprøjten med varmt vand og lad den tørre.
English: If required, a second administration can be given after 24 hours.
Danish: Om nødvendigt kan en yderligere dosis gives efter 24 timer.
English: If the animal is fed at the time of dosing, the absorption may be slightly delayed.
Danish: Hvis dyret er fodret når dosis gives, kan absorptionen blive lettere forsinket.
English: Body weight (kg)
Danish: Legemsvægt (kg)
English: Please carefully follow the instructions of the veterinarian.
Danish: Dyrlægens anvisninger bør følges nøje.
English: ATCvet code: QM01AC06.
Danish: ATCvet-kode: QM01AC06.
English: Dogs and cats
Danish: Hunde og katte
English: In horses, a transient swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan der forekomme en forbigående hævelse på injektionsstedet, som forsvinder uden indgriben.
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Danish: Meloxicam metaboliseres til en alkohol, et syrederivat og til adskillige polære metabolitter.
English: The highest meloxicam concentrations are to be found in liver and kidney.
Danish: De højeste meloxicam koncentrationer ses i lever og nyrer.
English: In-feed use.
Danish: Anvendelse i foderet.
English: This is equivalent to 1 ml of Inflacam per 25 kg body weight of horse.
Danish: Dette svarer til 1 ml Inflacam for hver 25 kg kropsvægt af hest.
English: During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
Danish: Under anæstesi bør overvågning og væsketerapi være standardpraksis.
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i to halvdele.
English: Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
Danish: Meloxicam har en snæver terapeutisk sikkerhedsmargen hos katte, og kliniske tegn på overdosering kan ses ved relativt små overdoser.
English: 15 μg/kg Milk
Danish: 15 μg/kg Mælk
English: Dose scheme for the maintenance dose: Body weight (kg)
Danish: Doseringsskema for vedligeholdelsesdosis: Legemsvægt (kg)
English: The syringe has a scale which corresponds to the volume required.
Danish: Sprøjten er forsynet med en skala, som viser det nødvendige volumen.
English: Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Danish: Laboratorieundersøgelser i kvæg har ikke afsløret potentielle teratogene, føtotoksiske eller maternotoksikse effekter.
English: Apple flavour (containing butylated hydroxyanisole (E320)) Crospovidone
Danish: Apple smag (indeholdende butylhydroxyanisol (E320)) Crospovidone
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt (se afsnit 4.3).
English: Dose scheme for the maintenance dose:
Danish: Doseringsskema for vedligeholdelsesdosis:
English: Meloxicam is predominantly found in plasma.
Danish: Meloxicam findes overvejende i plasma.
English: In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent.
Danish: I tilfælde af overdosering kan bivirkninger, som angivet i afsnit 4.6, optræde alvorligere og hyppigere.
English: Cattle, pigs and horses
Danish: Kvæg, svin og heste
English: Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.
Danish: Enhver oral opfølgningsbehandling med meloxicam eller et andet NSAID-præparat må ikke anvendes til katte, da passende dosering for en sådan behandling ikke er fastlagt.
English: Post-operative pain and inflammation following surgical procedures: In case additional pain relief is required, multimodal pain therapy should be considered.
Danish: Postoperative smerter og inflammation efter kirurgiske indgreb: I tilfælde hvor supplerende smertelindring er nødvendig, bør multimodal smertebehandling overvejes.
English: Maximal plasma concentrations are obtained after approximately 2-3 hours.
Danish: Maksimal plasmakoncentration opnås efter cirka 2-3 timer.
English: One ml contains:
Danish: En ml indeholder:
English: For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Danish: Ved behandling af diarré hos kvæg bør præparatet ikke gives til dyr, som er mindre end en uge gamle.
English: Treatment of calves with Inflacam 20 minutes before dehorning reduces post-operative pain.
Danish: Behandling af kalve med Inflacam 20 minutter før afhorning reducerer postoperativ smerte.
English: The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.
Danish: Distributionsvolumen er 0,3 l/kg hos hunde og 0,09 l/kg hos katte.
English: Purified water
Danish: Renset vand
English: Treatment of piglets with Inflacam before castration reduces post-operative pain.
Danish: Behandling af smågrise med Inflacam inden kastration reducerer posteropative smerter.
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Danish: I mindre udstrækning hæmmes også collagen-induceret trombocyt-aggregation.
English: The metabolism is qualitatively similar in rats, humans, cattle and pigs (including mini-pigs), although quantitatively there are differences.
Danish: Kvalitativt er metabolismen ens hos rotter, smågrise, mennesker, kvæg og svin (herunder mini svin), men kvantitativt er der forskelle.
English: The major metabolites found in all species were the 5-hydroxyand 5-carboxy- metabolites and the oxalyl- metabolite.
Danish: Hovedmetabolitterne, som blev fundet i alle species var 5-hydroxyog 5- carboxymetabolitter samt oxalyl-metabolitten.
English: This product for dogs should not be used in cats as it is not suitable for use in this species.
Danish: Dette lægemiddel er til hunde og må ikke bruges til katte da det ikke er egnet til brug hos denne dyreart.
English: In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
Danish: Hvis lægemidlet opblandes i foderet, bør det tilsættes en lille mængde foder, som gives lige inden fodring.
English: Chronic musculoskeletal disorders: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Danish: Kroniske lidelser i bevægeapparatet: Reaktion ved langtidsbehandling bør overvåges regelmæssigt af dyrlægen.
English: A clinical response is normally seen within 7 days.
Danish: En klinisk reaktion ses normalt inden for 7 dage.
English: To obtain the best possible relieving effect post-surgery Inflacam should be administered 30 minutes before surgical intervention.
Danish: For at opnå den bedst mulige posteropative smertelindrende effekt, bør Inflacam administreres 30 minutter før et kirurgisk indgreb.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Veterinærlægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt.
English: Particular care should be taken with regard to the accuracy of dosing.
Danish: Der bør udvises særlig omhyggelighed i forbindelse med doseringsnøjagtigheden.
English: The syringe fits onto the bottle and has a 2 ml scale.
Danish: Sprøjten passer til flasken og er forsynet med en 2 ml skala.
English: Comparatively low concentrations are detectable in skeletal muscle and fat.
Danish: Der ses relativt lave koncentrationer i muskler og fedt.