FrancophonIA/ELRC3.0 huggingface dataset:
English: Following treatment with SYLVANT in clinical trials, transient or intermittent mild-to-moderate elevation of hepatic transaminase levels or other liver function tests such as bilirubin have been reported.
Danish: Der er rapporteret om forbigående eller periodisk let til moderat forhøjede levertransaminaser eller andre leverfunktionstal som f.eks. bilirubin efter behandling med SYLVANT i kliniske forsøg.
English: Renal and urinary disorders very common
Danish: Nyrer og urinveje Meget almindelige
English: No formal study of the effect of renal impairment on the pharmacokinetics of siltuximab has been conducted.
Danish: Der er ikke udført et formelt studie af, hvordan nedsat nyrefunktion påvirker siltuximabs farmakokinetik.
English: Similarly, in cultures of human Burkitt's B-lymphoma cells, the production of immunoglobulin M protein in response to IL-6 was dose-dependently inhibited by siltuximab.
Danish: Tilsvarende udvirkede siltuximab dosisafhængig hæmning af produktion af immunglobulin M-protein i dyrkede humane Burkitts B-lymfomceller som reaktion på IL-6.
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of siltuximab has been conducted.
Danish: Der er ikke udført et formelt studie af, hvordan nedsat leverfunktion påvirker siltuximabs farmakokinetik.
English: SYLVANT 100 mg powder for concentrate for solution for infusion 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab.
Danish: SYLVANT 100 mg pulver til koncentrat til infusionsvæske, opløsning 8 ml hætteglas af type 1-glas med elastomerlukke og aluminiumsforsegling med flip-off-låg der indeholder 100 mg siltuximab.
English: SYLVANT 400 mg powder for concentrate for solution for infusion 30 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of siltuximab.
Danish: SYLVANT 400 mg pulver til koncentrat til infusionsvæske, opløsning 30 ml hætteglas af type 1-glas med elastomerlukke og aluminiumsforsegling med flip-off-låg der indeholder 400 mg siltuximab.
English: For patients with baseline calculated creatinine clearance of 12 mL/min or greater, there was no meaningful effect on siltuximab PK. Four patients with severe renal impairment (creatinine clearance 12 to 30 mL/min) were included in the data set.
Danish: Fire patienter med svært nedsat nyrefunktion (kreatininclearance 12-30 ml/min) indgik i datasættet.
English: • abnormal kidney function test
Danish: • unormale nyrefunktionsværdier
English: Powder for concentrate for solution for infusion 1 vial
Danish: Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas
English: Durable tumour & symptomatic response (independent review)
Danish: Varig tumor- & symptomatisk respons (uvildig gennemgang)
English: SYLVANT 100 mg powder for concentrate SYLVANT 400 mg powder forconcentrate siltuximab
Danish: SYLVANT 100 mg pulver til koncentrat SYLVANT 400 mg pulver til koncentrat siltuximab i.v.
English: Vascular disorders very common
Danish: Vaskulære sygdomme Meget almindelige
English: Posology
Danish: Ringaskiddy
English: What SYLVANT is and what it is used for What you need to know before you are given SYLVANT How SYLVANT is given
Danish: Det skal du vide, før du begynder at bruge SYLVANT Sådan indgives SYLVANT Bivirkninger
English: Haemoglobina
Danish: Trombocyttal
English: * Best Supportive Care a Adjusted for corticosteroid use at randomisation b At the time of primary analysis data for 19 of 20 tumour and symptomatic responders were censored due to on-going response c N/A = “Not applicable”, there were no responders in the placebo arm, therefore, duration is not applicable d Complete symptomatic response is defined as a 100% reduction in the baseline MCD overall symptom score sustained for at least 18 weeks prior to treatment failure e Data from 11 of 13 complete symptomatic responders were censored due to on-going response
Danish: * BSC = bedste understøttende behandling (best supportive care) a Justeret for anvendelse af kortikosteroider ved randomisering b På tidspunktet for primær analyse blev data for 19 af 20 tumor- og symptomatiske responderere censureret på grund af igangværende respons c IR = “Ikke relevant”.
English: If you are given more SYLVANT than you should
Danish: Hvis du har fået for meget SYLVANT
English: What SYLVANT is used for
Danish: Sådan anvendes SYLVANT
English: How SYLVANT is given
Danish: Sådan indgives SYLVANT
English: Elevations in triglycerides and cholesterol (lipid parameters) were observed in patients treated with SYLVANT (see section 4.8).
Danish: Hos patienter i behandling med SYLVANT blev der set forhøjede triglycerider og kolesterol (lipidparametre) (se pkt.
English: SYLVANT passes into breast milk.
Danish: • Det vides ikke, om SYLVANT udskilles i modermælk.
English: Signs of such a tear developing include stomach pain getting worse, feeling sick (nausea), change in bowel habits and fever - if you get any of these, contact your doctor right away.
Danish: Symptomerne på en sådan rift kan omfatte tiltagende mavepine, kvalme, ændringer i afføringsmønsteret og feber.
English: Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population Durable complete symptomatic responsed
Danish: Hæmoglobinstigning > 15 g/l (0,9 mmol/l) i uge 13/hæmoglobinrespons i den evaluerbare population Varighed af tumor- & symptomatisk respons (dage) - uvildig gennemgang; median (min, max)
English: This leaflet was last revised in MM/YYYY Other sources of information
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Primary efficacy endpoint
Danish: Primært endepunkt for effekt
English: Each 400 mg vial should be reconstituted with 20 mL of single-use water for injections to yield a 20 mg/mL solution.
Danish: Hvert 400 mg hætteglas bør rekonstitueres med 20 ml vand til injektionsvæsker til engangsbrug, så der opnås en 20 mg/ml opløsning.
English: Each single-use vial contains 400 mg siltuximab.
Danish: Hvert hætteglas til engangsbrug indeholder 400 mg siltuximab.
English: • itching
Danish: • kløe
English: Each single-use vial contains 100 mg siltuximab.
Danish: Hvert hætteglas til engangsbrug indeholder 100 mg siltuximab.
English: Oropharyngeal pain
Danish: Orofaryngeale smerter
English: Each 100 mg vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Danish: Hvert 100 mg hætteglas bør rekonstitueres med 5,2 ml vand til injektionsvæsker til engangsbrug, så der opnås en 20 mg/ml opløsning.
English: SYLVANT 100 mg powder for concentrate for solution for infusion Each single-use vial contains 100 mg siltuximab powder for concentrate for solution for infusion.
Danish: SYLVANT 100 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas til engangsbrug indeholder 100 mg siltuximab pulver til koncentrat til infusionsvæske, opløsning.
English: SYLVANT 400 mg powder for concentrate for solution for infusion Each single-use vial contains 400 mg siltuximab powder for concentrate for solution for infusion.
Danish: SYLVANT 400 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas til engangsbrug indeholder 400 mg siltuximab pulver til koncentrat til infusionsvæske, opløsning.
English: N/Ac
Danish: Co. Cork
English: SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion siltuximab
Danish: SYLVANT 100 mg pulver til koncentrat til infusionsvæske, opløsning SYLVANT 400 mg pulver til koncentrat til infusionsvæske, opløsning siltuximab
English: SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion
Danish: SYLVANT 100 mg pulver til koncentrat til infusionsvæske, opløsning SYLVANT 400 mg pulver til koncentrat til infusionsvæske, opløsning
English: Each vial contains 400 mg of siltuximab.
Danish: Et hætteglas indeholder 400 mg siltuximab.
English: Each vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Danish: Hvert hætteglas bør rekonstitueres med 5,2 ml vand til injektionsvæsker til engangsbrug, så der opnås en 20 mg/ml opløsning.
English: • common cold
Danish: • forkølelse
English: Absolute neutrophil count
Danish: Neutrophilocyttal
English: Appropriate personnel and medicinal product should be available to treat anaphylaxis if it occurs (see section 4.8).
Danish: Akutberedskab til håndtering af anafylaksi omfattende uddannet personale og passende lægemidler bør være tilstede (se pkt.
English: negative.
Danish: Ikke relevantc
English: • rash, itchy skin rash (eczema)
Danish: • udslæt, kløende hududslæt (eksem)
English: Each vial contains 100 mg of siltuximab.
Danish: Et hætteglas indeholder 100 mg siltuximab.
English: Each vial should be reconstituted with 20.0 mL of single-use water for injections to yield a 20 mg/mL solution.
Danish: Hvert hætteglas bør rekonstitueres med 20 ml vand til injektionsvæsker til engangsbrug, så der opnås en 20 mg/ml opløsning.
English: Justification for not including Braille accepted.
Danish: Fritaget fra krav om brailleskrift
English: Malignancy
Danish: Amning
English: Janssen Biologics B.V. Einsteinweg 101
Danish: Einsteinweg 101
English: Gastointestinal disorders very common
Danish: Mave-tarm-kanalen Meget almindelige
English: In mice dosed subcutaneously with an anti-mouse IL-6 monoclonal antibody,
Danish: Hos mus doseret subkutant med et anti-muse-IL-6 monoklonalt antstof sås ingen påvirkning af fertiliteten hos han- eller hundyr.
English: This summary was last updated in April 2015.
Danish: Dette sammendrag blev sidst ajourført i april 2015.
English: Most of these dogs also received additional treatment.
Danish: De fleste af disse hunde modtog herudover yderligere behandling.
English: Cerenia was generally well tolerated.
Danish: Cerenia blev generelt tolereret godt
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cerenia on 29/09/2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cerenia den 29.9.2006.
English: Other information about Cerenia:
Danish: Andre oplysninger om Cerenia:
English: Cerenia is a medicine that contains the active substance maropitant.
Danish: Cerenia er et lægemiddel, der indeholder det aktive stof maropitant.
English: Other reported side effects were decreased activity levels and tiredness.
Danish: Andre indberettede bivirkninger var nedsat aktivitet samt træthed.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Danish: Hvilke forsigtighedsregler skal der træffes af den, der indgiver lægemidlet eller kommer i berøring med dyret?
English: Information on the prescription status of this product can be found on the label/outer package.
Danish: Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på etiketten/den ydre emballage.
English: The benefit-risk balance can be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet fremgår af modulet med den videnskabelige drøftelse i denne EPAR.
English: The CVMP concluded that the benefits of Cerenia exceed its risks and recommended that Cerenia be given a marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Cerenia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: A large number of studies with Cerenia were carried out either in laboratory dogs and cats or in animal patients at veterinary practices in several European countries and in the USA.
Danish: Der er gennemført et stort antal undersøgelser af Cerenia enten hos laboratoriehunde og katte eller syge dyr på dyrlægeklinikker i flere europæiske lande og i USA.
English: Since this was mainly observed in dogs with an empty stomach, it is recommended to feed a light meal or snack a while before the tablets are given.
Danish: Da dette for det meste blev observeret hos hunde med tom mave, anbefales det at give hunden et let måltid eller en godbid, et stykke tid inden tabletterne gives til hunden.
English: In case of accidental ingestion or self-injection medical advice should be sought immediately and the package leaflet or the label shown to the physician.
Danish: I tilfælde af utilsigtet indtagelse eller selvinjektion skal der omgående søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: Also, the treatment of vomiting should only be together with other supportive measures or other veterinary therapy while addressing the underlying causes of the vomiting.
Danish: Endvidere bør behandling af opkastning kun foretages sammen med anden støttebehandling eller anden dyrlægebehandling, mens den underliggende årsag til opkastningen undersøges.
English: Since maropitant could affect heart activity, Cerenia should be used with caution in animals with certain heart conditions.
Danish: Da maropitant kan påvirke hjertets aktivitet, bør Cerenia anvendes med forsigtighed hos dyr med visse hjertetilstande.
English: It is available as tablets (16, 24, 60 and 160 mg) for dogs, and as a solution for injection (10 mg/ml) under the skin or into a vein for dogs and cats.
Danish: Det fås som tabletter (16, 24, 60 og 160 mg) til hunde og som en injektionsvæske, opløsning (10 mg/ml), til indsprøjtning under huden på hunde og katte.
English: As injection under the skin causes pain in cats, the animal will need to be restrained when treated.
Danish: Da injektionen forårsager smerter hos katte, bør dyret fastholdes under behandling.
English: the animal owner can administer the tablets to the dog.
Danish: Til efterfølgende behandling kan hundens ejer give hunden tabletterne.
English: Why has Cerenia been approved?
Danish: Hvorfor blev Cerenia godkendt?
English: Since Cerenia has not been studied in very young dogs or cats, or in pregnant or lactating bitches or queens, use of Cerenia in these animals should be discussed with your veterinarian.
Danish: Da Cerenia ikke er blevet undersøgt hos meget unge hunde eller katte eller hos drægtige eller diegivende tæver eller hunkatte, bør brug af Cerenia hos disse dyr drøftes med den ansvarlige dyrlæge.
English: In the study looking at the effect of Cerenia before and after surgery, Cerenia was effective at preventing vomiting asociated with the use of morphine.
Danish: I den undersøgelse, der vedrørte virkningen af Cerenia før og efter operationer, var Cerenia effektivt til at forebygge opkastning i forbindelse med brug af morfin.
English: What is the risk associated with Cerenia?
Danish: Hvilken risiko er der forbundet med Cerenia?
English: A further study involving dogs looked at the prevention of nausea and vomiting before and after surgery.
Danish: Endnu en undersøgelse hos hunde vedrørte forebyggelse af kvalme og opkastning før og efter operationer.
English: The active substance in Cerenia, maropitant, is broken down in the liver and therefore it is recommended to be used with caution in animals with liver disease.
Danish: Det aktive stof i Cerenia, maropitant, nedbrydes i leveren, og det anbefales derfor at anvende Cerenia med forsigtighed hos dyr med leversygdom.
English: Only one out of 16 dogs given Cerenia vomited after receiving morphine, whilst 14 out of 15 dogs given placebo vomited, and in this group, nine of the dogs that vomited did so more than once.
Danish: Kun en ud af de 16 hunde, der fik Cerenia, kastede op efter at have fået morfin, mens 14 ud af de 15 hunde, der fik placebo, kastede op, og 9 af dem kastede op flere gange.
English: A common side effect of the tablets when used at a high dose of 8 mg/kg in dogs (for motion sickness) was vomiting before the car journey started.
Danish: En almindelig bivirkning ved tabletterne, når de blev anvendt i en høj dosis på 8 mg/kg (transportsyge) hos hunde, var opkastning, inden bilturen startede.
English: What is Cerenia?
Danish: Hvad er Cerenia?
English: In order to study the effect of Cerenia in motion sickness, dogs prone to vomiting when travelling were taken on car journeys lasting several hours for up to two consecutive days.
Danish: Med henblik på at undersøge virkningen af Cerenia i forbindelse med transportsyge blev hunde med tilbøjelighed til at kaste op under transport taget med på bilture af en varighed på flere timer i op til to på hinanden følgende dage.
English: The measures of effectiveness were evidence of retching, vomiting, intensity of nausea and improvements in the speed of recovery by for example measuring time to sit up and stand.
Danish: Virkningen blev bedømt på opkastningsbevægelser, opkastning, kvalmeintensitet og hvor meget hurtigere dyrene kom sig, f.eks. ved måling af tiden til de kunne sætte sig op og stå på benene.
English: What is Cerenia used for?
Danish: Hvad anvendes Cerenia til?
English: Dogs received either Cerenia soluton for injection or placebo 45 minutes before the administration of morphine for sedation and pain relief prior to anaesthesia .
Danish: Hundene fik enten Cerenia injektionsvæske eller placebo 45 minutter før de fik morfin som beroligende og smertelindrende middel inden bedøvelse.
English: Handling Cerenia does not represent a particular risk for people.However, maropitant can produce short lived eye irritation and in the case of accidental eye exposure, the eyes should be flushed with plenty of water and medical attention sought.
Danish: Imidlertid kan maropitant give kortvarig akut øjenirritation, og i tilfælde af, at stoffet utilsigtet kommer i kontakt med øjnene, skylles øjnene med rigeligt vand, og der søges lægehjælp.
English: The animals received either Cerenia tablets at a dose of 8 mg/kg bodyweight or a placebo for up to two consecutive days.
Danish: Dyrene modtog enten Cerenia- tabletter ved en dosis på 8 mg/kg legemsvægt eller placebo i op til to på hinanden følgende dage.
English: Cerenia solution for injection is used in dogs both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Danish: Cerenia, injektionsvæske, opløsning, anvendes til hunde til forebyggelse af kvalme og opkastning både før og efter operationer for at bedre genopvågningen fra helbedøvelse efter brug af morfin.
English: For the treatment of vomiting, the effect of Cerenia compared with placebo was examined in sick cats that were vomiting for various reasons.
Danish: Når det gælder behandling af opkastning blev virkningen af Cerenia, sammenlignet med placebo, undersøgt hos syge katte, som kastede op af forskellige årsager.
English: In cats, treatment of vomiting is with the injection only.
Danish: Til behandling af katte, der kaster op, anvendes kun injektion.
English: For the prevention of vomiting, Cerenia was studied in dogs which received either Cerenia or a placebo (a dummy tablet or injection) before another substance known to trigger vomiting (such as certain cancer medicines) was given to them.
Danish: I forbindelse med forebyggelse af opkastning blev Cerenia undersøgt hos hunde, som modtog enten Cerenia eller placebo (en uvirksom tablet eller injektion), inden de fik et andet stof, der er kendt for at fremkalde opkastning (som for eksempel visse lægemidler mod kræft).
English: For dogs, the treatment of vomiting should be started with the injection, since vomiting animals might throw the intact tablet up again.
Danish: Behandlingen af hunde, der kaster op, bør påbegyndes med injektionen, da dyr, der kaster op muligvis ikke vil være i stand til at holde en tablet nede (da de muligvis vil kaste den intakte tablet op igen).
English: For the prevention of vomiting, Cerenia was studied in cats which received either Cerenia or placebo before another substance known to trigger vomiting was given to them.
Danish: Når det gælder forebyggelse af opkastning, blev Cerenia undersøgt hos katte, som enten modtog Cerenia eller placebo inden de fik et andet stof, som er kendt for at fremkalde opkastning.
English: Dogs were treated with either 1 mg/kg (injection given under the skin) or 2 mg/kg (tablet) once daily up to five days.
Danish: Hundene blev behandlet med enten 1 mg/kg (injektion) eller 2 mg/kg (tablet) én gang daglig i op til fem dage.
English: Cerenia tablets are given to dogs at a dose of 2 mg maropitant per kg bodyweight once daily to prevent or treat vomiting for up to 14 days.
Danish: Cerenia tabletter gives til hunde i en dosis af 2 mg maropitant pr. kg kropsvægt én gang dagligt i indtil 14 dage for at forebygge eller behandle opkastning.
English: How does Cerenia work?
Danish: Hvordan virker Cerenia?
English: Cats were treated with 1 mg/kg (injection given under the skin) once daily up to five days.
Danish: Kattene blev behandlet med 1 mg/kg (injektion) en gang dagligt i op til fem dage.
English: How has Cerenia been studied?
Danish: Hvordan blev virkningen af Cerenia undersøgt?
English: What benefit has Cerenia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cerenia?
English: Cerenia solution for injection is given to dogs and cats once daily under the skin or into a vein (1 mg per kg bodyweight) for up to five days.
Danish: Cerenia, injektionsvæske, opløsning, gives til hunde og katte én gang dagligt ved indsprøjtning under huden (1 ml pr. 10 kg kropsvægt) i indtil fem dage.
English: For the treatment of vomiting, the effect of Cerenia (or a placebo) was examined in sick dogs that were vomiting for various reasons, for example because of a gastrointestinal infection.
Danish: Virkningen af Cerenia (eller placebo) til fbehandling af opkastning blev undersøgt hos syge hunde, der kastede op af forskellige årsager, for eksempel på grund af en mavetarminfektion.
English: Cerenia tablets are given to dogs at a dose of 8 mg maropitant per kg bodyweight once daily to prevent vomiting due to motion sickness for a maximum of two consecutive days.
Danish: Cerenia tabletter gives til hunde i en dosis af 8 mg maropitant pr. kg krops vægt én gang dagligt i højst to på hinanden følgende dage for at forebygge eller behandle transportsyge.
English: A very common side effect in cats was evidence of pain from injection under the skin and this may be reduced by injection of the product at refrigerated temperature.
Danish: En almindelig bivirkning hos katte var smerter ved injektionen.
English: Treatment is started as soon as possible and usually within 6 days after symptoms start.
Danish: Behandlingen indledes hurtigst muligt og normalt inden for 6 dage efter symptomernes start.
English: Lower doses are given to adults and children with reduced kidney function.
Danish: Der gives lavere doser til voksne og børn med nedsat nyrefunktion.
English: When the neuraminidases are blocked, the virus cannot spread.
Danish: Når neuraminidaserne blokeres, kan virusset ikke sprede sig.
English: The recommended dose for adults is 600 mg twice daily for 5 to 10 days while for children the dose is adjusted based on weight.
Danish: Den anbefalede dosis til voksne er 600 mg to gange dagligt i 5-10 dage, og dosis til børn justeres ud fra deres vægt.
English: Further information on Dectova can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dectova.
Danish: Yderligere information om Dectova findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/dectova.
English: Complicated influenza is a severe flu infection that requires hospitalisation of the patient.
Danish: Kompliceret influenza er en alvorlig influenzainfektion, der kræver, at patienten hospitalsindlægges.
English: The most serious side effect is liver injury.
Danish: Den mest alvorlige bivirkning er leverskader.
English: Its side effects, the most important one being liver injury, are similar to those seen with Tamiflu.
Danish: Dets bivirkninger, hvoraf den vigtigste er leverskader, svarer til dem, der ses med Tamiflu.
English: The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient.
Danish: Lægemidlet anvendes, når virusset er resistent over for andre influenzabehandlinger, eller når andre antivirale behandlinger, herunder inhaleret zanamivir, ikke er egnede til patienten.