FrancophonIA/ELRC3.0 huggingface dataset:
English: Acticam is presented as an oral suspension 1.5 mg/ml for dogs (to be given mixed with food) and a solution for injection 5mg/ml.
Danish: Acticam leveres som en oral suspension 1,5 mg/ml til hunde (som gives opblandet i foder) og som en opløsning til injektionsvæske 5mg/ml.
English: Occasional side effects of Acticam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Danish: De bivirkninger, der undertiden ses ved Acticam, er dem, der normalt ses ved NSAID'er, såsom appetitløshed, opkastning, diarré, blod i afføringen og apati (mangel på vitalitet).
English: A study looked at how Acticam was absorbed and its effects in the body, in comparison with Metacam oral suspension 1.5mg/ml.
Danish: Der blev gennemført en undersøgelse af, hvordan Acticam blev optaget i kroppen, og hvilke virkninger det havde i kroppen, sammenlignet med Metacam 1,5 mg/ml oral suspension.
English: Acticam is a ‘generic': this means that Acticam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Danish: Acticam er et ‘generisk lægemiddel': Det betyder, at Acticam ligner et 'referenceveterinærlægemiddel', som allerede er godkendt i EU (Metacam 1,5 mg/ml oral suspension).
English: What is Acticam?
Danish: Hvad er Acticam?
English: Studies have been carried out to prove that Acticam is ‘bioequivalent' to the reference veterinary medicine: this means that Acticam is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
Danish: Der er blevet udført undersøgelser for at dokumentere, at Acticam er 'bioækvivalent' med referenceveterinærlægemidlet: det betyder, at Acticam svarer til Metacam 1,5 mg/ml suspension med hensyn til den måde, hvorpå det optages og anvendes i kroppen.
English: What benefit has Acticam shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Acticam?
English: Acticam contains meloxicam which belongs to a class of medicines having anti-inflammatory action.
Danish: Acticam indeholder meloxicam, som tilhører gruppen af lægemidler med antiinflammatorisk virkning.
English: How has Acticam been studied?
Danish: Hvordan blev Acticam undersøgt?
English: What is Acticam used for?
Danish: Hvad anvendes Acticam til?
English: Cats: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Danish: Katte: Begrænsning af postoperative smerter efter ovariehysterektomi og mindre bløddelskirurgi.
English: Meloxicam acts by inhibition of prostaglandin synthesis.
Danish: Meloxicam virker ved at hæmme prostaglandinsyntesen.
English: How does Acticam work?
Danish: Hvordan virker Acticam?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Acticam has been shown to be bioequivalent to Metacam
Danish: Udvalget for Veterinærlægemidler (CVMP) vurderede, at det i overensstemmelse med EU's krav er blevet påvist, at Acticam er bioækvivalent med Metacam 1,5 mg/ml oral suspension.
English: The CVMP concluded that the benefits of Acticam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Acticam be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Acticam opvejede risiciene ved lindring af inflammation og smerter ved både akutte og kroniske lidelser i bevægeapparatet og ved begrænsning af postoperative smerter og inflammation efter ortopædiske operationer og bløddelskirurgi hos hunde og ved begrænsning af postoperative smerter efter ovariehysterektomi og mindre bløddelskirurgi hos katte.
English: Acticam should also not be used in animals suffering from gastrointestinal or hemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than 6 weeks of age or in cats of less than 2 kg.
Danish: Acticam må ikke gives til dyr, som lider af gastrointestinale eller blødningsmæssige forstyrrelser, eller som har nedsat nyre- eller leverfunktion, dyr med kendt overfølsomhed over for NSAID'er eller dyr, som er under 6 uger gamle, eller katte på under 2 kg. Der må ikke anvendes en oral opfølgningsbehandling med meloxicam eller andre NSAID'er til katte, da der ikke er fastsat nogen dosis, som er sikker til brug ved gentagen indgivelse.
English: Acticam is efficacious in alleviating the inflammation and pain in both acute and chronic musculoskeletal disorders and reducing the post operative pain following orthopaedic and soft tissue surgery in dogs and in reducing the post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats.
Danish: Acticam er effektivt til lindring af inflammation og smerter ved både akutte og kroniske lidelser i bevægeapparatet og til begrænsning af postoperative smerter efter ortopædiske operationer og bløddelskirurgi hos hunde og til begrænsning af postoperative smerter efter ovariehysterektomi og mindre bløddelskirurgi hos katte.
English: Dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Danish: Hunde: Lindring af inflammation og smerter ved både akutte og kroniske lidelser i bevægeapparatet og begrænsning af postoperative smerter og inflammation efter ortopædiske operationer og bløddelskirurgi.
English: This summary was last updated in 11-2015.
Danish: Dette sammendrag blev senest ajourført i 11-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for CellCept on 14 February 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for CellCept den 14. februar 1996.
English: This is a summary of the European public assessment report (EPAR) for CellCept.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for CellCept.
English: The full EPAR for CellCept can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for CellCept findes under ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Danish: Det gør dem mindre effektive til at genkende og angribe det transplanterede organ, og risikoen for, at organet afstødes, bliver derfor mindre.
English: The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer.
Danish: Den alvorligste risiko ved CellCept er den mulige udvikling af kræft, især lymfe- og hudkræft.
English: Other information about CellCept
Danish: Andre oplysninger om CellCept
English: Therefore, CellCept must not be used during pregnancy unless there is no suitable alternative to prevent rejection of the transplant.
Danish: CellCept må derfor ikke anvendes under graviditeten, medmindre der ingen passende alternativer findes til at forebygge afstødning af transplantatet.
English: Further studies showed that the solution for infusion and the oral suspension produced similar levels of the active substance in the blood as the capsules.
Danish: Yderligere undersøgelser viste, at opløsningen til infusion og den orale suspension frembragte samme niveauer af det aktive stof i blodet som kapslerne.
English: What measures are being taken to ensure the safe and effective use of CellCept?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af CellCept?
English: CellCept treatment should be initiated and maintained by a qualified transplant specialist.
Danish: Behandling med CellCept bør påbegyndes og fortsættes af en specialist i transplantationer.
English: The way that CellCept should be given and the dose depend on the type of organ transplant and the patient's age and size.
Danish: Den måde, som CellCept skal gives på, og dosis afhænger af den type organ, som transplanteres, og af patientens alder og fysiske størrelse.
English: Women must not breastfeed while using CellCept and patients should not donate blood or sperm during treatment or for a period afterwards.
Danish: Kvinder må ikke amme, mens de tager CellCept, og patienter bør ikke donere blod eller sperm under behandlingen eller i et stykke tid efter behandlingen.
English: Women able to have children should be tested before starting treatment to ensure that they are not pregnant.
Danish: Kvinder i den fødedygtige alder, skal testes inden behandlingen påbegyndes for at sikre, de ikke er gravide.
English: The dose may need to be adjusted in patients with liver or kidney disease.
Danish: Det kan være nødvendigt at tilpasse dosis hos patienter med lever- eller nyresygdomme.
English: The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick).
Danish: De almindeligste bivirkninger ved CellCept givet i kombination med ciclosporin og kortikosteroider (som optræder hos flere end 1 ud af 10 patienter) er sepsis (blodforgiftning), candidiasis i mave/tarmkanalen (en svampeinfektion), urinvejsinfektion, herpes simplex (en virusinfektion, der giver forkølelsessår), herpes zoster (en virusinfektion, der giver skoldkopper og helvedesild), leucopeni (nedsat antal hvide blodlegemer), trombocytopeni (nedsat antal blodplader), anæmi (blodmangel), opkast, mavesmerter, diarré og kvalme.
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Danish: Dette enzym er vigtigt for dannelsen af dna i cellerne, især i lymfocytterne (en slags hvide blodceller, der medvirker til afstødningen af transplanterede organer).
English: CellCept was as effective as azathioprine and more effective than placebo in preventing the rejection of transplanted kidneys after six months.
Danish: CellCept var lige så effektivt som azathioprin og mere effektivt end placebo til at forhindre afstødningen af transplanterede nyrer efter seks måneder.
English: Both men and women must use highly effective contraception before, during and for a suitable period after CellCept treatment.
Danish: Både mænd og kvinder skal anvende effektiv kontraception før, under og i en passede periode efter behandlingen.
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 CellCept.
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, hvordan CellCept skal anvendes.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Danish: Det anvendes sammen med ciclosporin og kortikosteroider (andre lægemidler, der bruges til at forhindre kroppen i at afstøde organer).
English: CellCept capsules and tablets have been studied in three studies involving a total of 1,493 adults following kidney transplant, in one study involving 650 adults following heart transplant and in one study involving 565 adults following liver transplant.
Danish: CellCept-kapsler og -tabletter er blevet undersøgt i tre undersøgelser med 1 493 voksne patienter, der havde fået foretaget en nyretransplantation, i én undersøgelse med 650 voksne patienter, der havde fået foretaget en hjertetransplantation, og i én undersøgelse med 565 voksne patienter, der havde fået foretaget en levertransplantation.
English: For more information about treatment with CellCept, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med CellCept, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is available as capsules (250 mg), tablets (500 mg), a powder to be made up into an oral suspension (1 g/5 ml) and a powder to be made up into a solution for infusion (drip) into a vein (500 mg).
Danish: Det fås som kapsler (250 mg), tabletter (500 mg), et pulver til oral suspension (1 g/5 ml) og et pulver, der opløses og indgives ved infusion (500 mg).
English: In all of the studies, all of the patients also received ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ had been rejected after six months.
Danish: I samtlige undersøgelser fik alle patienter også ciclisporin og kortikosteroider, og det primære mål for virkning var andelen af patienter, hvis nye organ var afstødt efter seks måneder.
English: Safety information has also been included in the summary of product characteristics and the package leaflet for CellCept, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er også anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for CellCept, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: There will also be very close monitoring of the outcomes of any accidentally exposed pregnancies.
Danish: Der vil også blive fortaget en tæt overvågning af resultaterne af graviditeter hos kvinder, der ved et uheld bliver eksponeret under graviditeten.
English: CellCept is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Danish: CellCept anvendes til at forhindre kroppen i at afstøde et transplanteret organ, f.eks. en nyre, hjertet eller leveren.
English: The CHMP decided that CellCept's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved CellCept opvejer risiciene og anbefalede udstedelse af en markedsføringstilladelse for CellCept.
English: CellCept mycophenolate mofetil
Danish: CellCept mycophenolatmofetil
English: It can also be given as an infusion lasting two hours starting within 24 hours after the transplant, for up to 14 days.
Danish: Det kan også gives som en infusion over to timer med start 24 timer efter
English: CellCept was compared with azathioprine (another anti-rejection medicine) in all studies except for one of the kidney transplant studies, in which it was compared with placebo (a dummy treatment).
Danish: CellCept blev sammenlignet med azathioprin (et andet lægemiddel mod organafstødning) i alle undersøgelserne, undtagen i en af nyretransplantationsundersøgelserne, hvor det blev sammenlignet med placebo (inaktiv behandling).
English: It has been shown that there is a significant risk of harm to a developing baby and of miscarriage if CellCept is used in pregnancy.
Danish: Det er påvist, at der er en betydelig risiko for fosterskader og aborter, hvis CellCept anvendes under graviditeten.
English: The company that markets CellCept will provide educational materials for patients and healthcare professionals explaining the risk of harm to a developing baby and the precautions and measures to be taken to avoid pregnancy during treatment.
Danish: Den virksomhed, der markedsfører CellCept, skal udlevere oplysningsmateriale til patienter og sundhedspersoner om risikoen for fosterskader og de foranstaltninger og forholdsregler der skal træffes for at undgå graviditet under behandlingen.
English: What is the risk associated with CellCept?
Danish: Hvilken risiko er der forbundet med CellCept?
English: Following liver transplant, 38% of the adult patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Danish: Af de voksne patienter, der fik en levertransplantation, og som blev behandlet med CellCept, oplevede 38 % afstødning af deres nye lever efter seks måneder sammenlignet med 48 % af dem, der blev behandlet med azathioprin, men andelen af patienter, som oplevede afstødning af deres nye lever efter et år, var den samme i begge grupper, nemlig cirka 4 %.
English: By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Danish: CellCept virker ved at forhindre produktionen af nyt dna og reducerer derigennem hastigheden, hvormed lymfocytterne formerer sig.
English: For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Danish: Ved transplantation af nyrer er den anbefalede dosis for voksne 1 g to gange dagligt gennem munden (kapsler, tabletter eller oral suspension), og behandlingen skal starte inden for 72 timer efter transplantationen.
English: In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Danish: Hos børn, der havde fået foretaget en nyretransplantation, svarede afstødningshyppigheden til den, der sås hos voksne patienter, der blev behandlet med CellCept, og den var lavere end den hyppighed, der sås i undersøgelser med børn, som ikke blev behandlet med CellCept.
English: CellCept is a medicine containing the active substance mycophenolate mofetil.
Danish: CellCept er et lægemiddel, der indeholder det aktive stof mycophenolatmofetil.
English: A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant.
Danish: Derudover er virkningen af CellCept som oral suspension blevet undersøgt hos 100 børn, der havde fået foretaget en nyretransplantation.
English: In the heart transplant study, around 38% of adult patients taking CellCept and those taking azathioprine experienced rejection after six months.
Danish: I undersøgelsen med hjertetransplanterede patienter oplevede cirka 38 % af de voksne patienter, der blev behandlet med CellCept, og dem, der blev behandlet med azathioprin, organafstødning efter seks måneder.
English: The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Danish: Det aktive stof i CellCept, mycophenolatmofetil, er et immunsupprimerende lægemiddel.
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Danish: Det omdannes i kroppen til mycophenolsyre, der blokerer enzymet inosinmonofosfat-dehydrogenase.
English: For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Danish: Ved transplantation af lever hos voksne bør CellCept gives som en 1 g-infusion to gange dagligt i de første fire dage efter transplantationen, hvorefter patienten skiftes over til 1,5 g to gange dagligt gennem munden, så snart patienten kan tåle det.
English: For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Danish: Ved transplantation af hjerter er den anbefalede dosis til voksne 1,5 g to gange dagligt gennem munden med start fem dage efter transplantationen.
English: Why has CellCept been approved?
Danish: Hvorfor blev CellCept godkendt?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom between two and 18 years, the dose of CellCept is calculated depending on height and weight and should be given by mouth.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: For the full list of side effects reported with CellCept, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved CellCept fremgår af indlægssedlen.
English: What is CellCept?
Danish: Hvad er CellCept?
English: What is CellCept used for?
Danish: Hvad anvendes CellCept til?
English: For full details of the restrictions with CellCept, see the package leaflet.
Danish: Oplysninger om begrænsninger i forbindelse med CellCept fremgår af indlægssedlen.
English: What benefit has CellCept shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved CellCept?
English: How has CellCept been studied?
Danish: Hvordan blev CellCept undersøgt?
English: How is CellCept used?
Danish: Hvordan anvendes CellCept?
English: How does CellCept work?
Danish: Hvordan virker CellCept?
English: EU (MA) Number
Danish: EU (MF)-nummer
English: Strength Pharmaceutical form
Danish: Lægemiddelform Indgivelsesvej
English: Route of administration
Danish: EU's procedurenr.
English: EU/1/10/629/001
Danish: EU/1/10/629/001 HUMENZA -1
English: l t o r
Danish: r l g
English: 3.8 µg HA
Danish: 3,8 μg HA
English: 3.8 micrograms HA**
Danish: 3,8 mikrogram**
English: AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Danish: AF03-adjuvans bestående af squalen (12,4 mg), sorbitanoleat (1,9 mg), polyoxyethylencetostearylether (2,4 mg) og mannitol (2,3 mg)
English: 10 vials (suspension)
Danish: 10 hætteglas (suspension)
English: Suspension and emulsion for emulsion for injection
Danish: Suspension og emulsion til injektionsvæske, emulsion.
English: Split Influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)
Danish: Efter rekonstitution indeholder 1 dosis (0,5 ml): Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: A/California/7/2009 (H1N1)-lignende stamme (X-179A)
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: 10 vials (emulsion)
Danish: 10 hætteglas (emulsion)
English: Emulsion (adjuvant): vial (glass)
Danish: emulsion (adjuvans): hætteglas (glas)
English: Suspension (H1N1): vial (glass);
Danish: Intramuskulær anvendelse suspension (H1N1): hætteglas (glas)
English: * propagated in eggs ** haemagglutinin
Danish: * opformeret i æg
English: This summary was last updated in 04-2014.
Danish: Dette sammendrag blev sidst ajourført i 04-2014.
English: If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Danish: Hvis patienterne har behov for mere end 8 inhalationer dagligt, anbefales det, at de taler med lægen om at få deres astmabehandling revurderet.
English: The full EPAR and risk management plan summary for BiResp Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for BiResp Spiromax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also be used for the treatment of COPD.
Danish: Det kan desuden anvendes til behandling af KOL.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BiResp Spiromax den 28. april 2014.