FrancophonIA/ELRC3.0 huggingface dataset:
English: In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg-/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Danish: I et studie af fertilitet og reproduktion udført på hunrotter forårsagede orale doser på 4,5/mg/kg/dag misdannelser (inkl.
English: Hypomagnesemia
Danish: Hypomagnesæmi
English: Inspect the infusion solution for particulate matter or discoloration.
Danish: b) Inspicer opløsningen for partikler og misfarvning.
English: The daily dose is 10 mL suspension (2 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 10 ml suspension (2 g af medicinen) indtaget som 2 separate doser.
English: Elderly patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared with younger individuals (see section 4.8).
Danish: Ældre patienter kan have større risiko for bivirkninger såsom visse infektioner (inklusiv vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre patienter (se pkt.
English: The recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose).
Danish: Den anbefalede dosis CellCept til infusion til levertransplanterede patienter er 1 g to gange daglig (en døgndosis på 2 g).
English: In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Danish: I et studie af fertilitet og reproduktion udført på hunrotter forårsagede orale doser på 4,5 mg/kg/dag misdannelser (inkl.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. den er i det væsentlige natriumfri.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 500 mg mycophenolatmofetil som hydrochlorid.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. kapsel, dvs. den er i det væsentlige natriumfri.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept tablets should not be crushed.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist fosterbeskadigende virkning hos rotter og kaniner, må CellCept tabletter ikke knuses.
English: The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 4 tabletter (2 g af medicinen) indtaget som 2 separate doser.
English: CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6).
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal rekonstitueres og yderligere fortyndes med 5 % glucose intravenøs infusionsvæske før indgift til patienten.
English: No data are available for hepatic transplant patients with severe chronic renal impairment.
Danish: Der findes ingen data for levertransplanterede patienter med svær, kronisk nedsat nyrefunktion.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005 CellCept (4 vials)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/005 CellCept (4 hætteglas)
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Danish: Den anbefalede dosis til nyretransplanterede patienter er 1 g administreret to gange daglig (en døgndosis på 2 g).
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Danish: cyster og polypper) Benignt neoplasme af huden
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: There is no information for the use of CellCept in children with a liver transplant.
Danish: Børn • Der er ingen information om brug af CellCept til levertransplanterede børn.
English: What in this leaflet:
Danish: Gør dette ved at:
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Musculoskeletal and connective tissue disorders Arthralgia
Danish: Knogler, led, muskler og bindevæv Arthralgi
English: MPA AUC values obtained following administration of 1 g BID intravenous CellCept to renal transplant patients in the early post-transplant phase are comparable to those observed following 1 g BID oral CellCept.
Danish: Efter intravenøs indgift af CellCept (1 g to gange daglig) til nyretransplanterede patienter i den tidlige posttransplantationsperiode var værdierne for MPA-AUC sammenlignelige med værdierne efter oral indgift af CellCept (1 g to gange daglig).
English: Lymphocele
Danish: Lymfocele
English: Powder for concentrate for solution for infusion: do not store above 30°C.
Danish: • Pulver til koncentrat til infusionsvæske, opløsning: Må ikke opbevares ved temperaturer over
English: In hepatic transplant patients, administration of 1 g BID intravenous CellCept followed by 1.5 g BID oral CellCept resulted in MPA AUC values similar to those found in renal transplant patients administered 1 g CellCept BID.
Danish: administration af CellCept (1 g to gange daglig) efterfulgt af 1,5 g to gange daglig oralt sammenlignelige med værdierne hos nyretransplanterede patienter, der fik oral CellCept (1 g CellCept to gange daglig).
English: Hepatobiliary disorders Blood alkaline phosphatase increased
Danish: Lever og galdeveje Forhøjede basiske phosphataser
English: The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 6 tabletter (3 g af medicinen) indtaget som 2 separate doser.
English: Elderly patients receiving CellCept as part of a combination immunosuppressive regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Danish: Ældre patienter, som får CellCept som led i et immunsuppressivt kombinationsregime, kan have større risiko for visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre individer.Indberetning af formodede bivirkninger
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg tablets mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN CellCept 500 mg tabletter mycophenolatmofetil
English: The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Danish: Den anbefalede dosis til hjertetransplanterede patienter er 1,5 g administreret to gange daglig (døgndosis, 3 g).
English: Sodium less than 1 mmol (23 mg) per dose
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Natrium, mindre end 1 mmol (23 mg) pr. dosis.
English: Pulmonary fibrosis
Danish: Lungefibrose
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Danish: Kontakt lægen før du tager denne medicin, hvis din læge har fortalt dig, at du ikke tåler eller kan fordøje visse sukkerarter.
English: The recommended dose of oral CellCept in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Danish: Den anbefalede orale CellCept dosis til levertransplanterede patienter er 1,5 g to gange daglig (en døgndosis på 3 g).
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning mycophenolatmofetil
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg film-coated tablets mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN CellCept 500 mg filmovertrukne tabletter mycophenolatmofetil
English: Equivalence with oral dosage forms
Danish: Ækvivalens med oral administration
English: Blood creatinine increased
Danish: Forhøjet serumcarbamid
English: Gastro-intestinal
Danish: Knoglemarvssvigt
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg mycophenolate mofetil. Excipient(s) with known effect
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 250 mg mycophenolatmofetil.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules.
Danish: Undgå inhalation og undgå at hud og slimhinder kommer i direkte kontakt med pulveret i CellCept kapslerne.
English: Take off the child safety bottle cap.
Danish: Fjern det børnesikrede låg.
English: No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Danish: Der findes ingen tilgængelige data for hjertetransplanterede patienter med svær leverparenkymlidelse.
English: • The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.
Danish: • Du får tidligst den første dosis CellCept til indtagelse gennem munden 4 dage efter transplantationen.
English: Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy.
Danish: CellCept er kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling, og for at udelukke en uønsket anvendelse under graviditet må behandling ikke initieres, uden at en negativ graviditetstest foreligger.
English: The active substance is mycophenolate mofetil.
Danish: Mycophenolsyre (MPA) er den aktive metabolit af mycophenolatmofetil.
English: The made-up medicine can be used for 2 months.
Danish: • Den rekonstituerede opløsning er holdbar i to måneder.
English: Constipation
Danish: Neoplasme
English: Uncommon Uncommon Uncommon
Danish: Ikke almindelig Ikke almindelig
English: What CellCept is and what it is used for What you need to know before you take CellCept How to take CellCept
Danish: Det skal du vide, før du begynder at bruge CellCept Sådan skal du bruge CellCept Bivirkninger
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg mycophenolate mofetil. Excipient(s) with known effect
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 500 mg mycophenolatmofetil.
English: • Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172),
Danish: • Øvrige indholdsstoffer: CellCept kapsler: Pregelatineret majsstivelse, croscarmellosenatrium, polyvidon (K-90), magnesiumstearat Kapselskallen: Gelatine, indigocarmin (E132), gul jernoxid (E172), rød jernoxid (E172), titandioxid (E171), sort jernoxid (E172), kaliumhydroxid, shellac
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001 CellCept
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/96/005/001 CellCept (100 kapsler)
English: CellCept 500 mg film-coated tablets
Danish: CellCept 500 mg filmovertrukne tabletter mycophenolatmofetil
English: Nervous system problems such as: feeling drowsy or numb, tremor, muscle spasms convulsions, feeling anxious or depressed changes in your mood or thoughts.
Danish: • følelse af angst eller depression, ændringer i dit humør eller dine tanker.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/002
English: Hernia
Danish: Gulsort
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/006
English: Making up the medicine
Danish: Opblanding af medicinen
English: Heart and blood vessel problems such as: change in blood pressure, blood clots accelerated heartbeat pain, redness and swelling of the blood vessels where you had the infusion.
Danish: • smerte, rødmen og hævelse af blodåren hvor du fik infusionen
English: By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Danish: Galdesyrekompleksdannere såsom colestyramin, reducerer MPAs AUC ved at interferere med det enterohepatiske kredsløb af lægemidlet (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/003
English: If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in Section 6) If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
Danish: • hvis du er kvinde og kan blive gravid, og der ikke foreligger en negativ graviditetstest, før du har fået den første recept, eftersom mycophenolat forårsager medfødte misdannelser og abort
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/005
English: No pharmacokinetic data are available for paediatric patients following hepatic transplants.
Danish: Der er ingen farmakokinetiske data for nyretransplanterede børn.
English: If you have more CellCept than you should
Danish: Hvis du har fået for meget CellCept
English: (E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), red iron oxide (E172).
Danish: • Tabletovertræk: Hydroxypropylmethylcellulose, hydroxypropylcellulose, titandioxid (E171), polyethylenglycol 400, indigocarminaluminiumlak (E132), rød jernoxid (E172).
English: Muscular weakness
Danish: Muskelsvækkelse
English: Nervous system problems such as: feeling dizzy, drowsy or numb, tremor, muscle spasms convulsions, feeling anxious or depressed changes in your mood or thoughts.
Danish: • følelse af angst og depression, ændringer i dit humør eller dine tanker.
English: CellCept 500 mg powder for concentrate for solution for infusion polysorbate 80 citric acid hydrochloric acid sodium chloride
Danish: Polysorbat 80 citronsyre saltsyre natriumchlorid
English: Uncommon Very Common
Danish: Ikke almindelig Meget almindelig
English: Hands should be washed after handling the product.
Danish: Der skal vaskes hænder efter håndtering af produktet.
English: The European Commission granted a marketing authorisation valid throughout the EU for Velactis on 9 December 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Velactis den 9. december 2015.
English: • reduce discomfort.
Danish: • at mindske ubehag
English: This is a summary of the European public assessment report (EPAR) for Velactis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Velactis.
English: The full EPAR for Velactis can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Velactis findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It contains the active substance cabergoline.
Danish: Det indeholder det aktive stof cabergolin.
English: A third field study involved 228 dairy cows.
Danish: I en tredje feltundersøgelse indgik 228 malkekøer.
English: Cabergoline has a long-lasting action on receptors in these cells (called D2 receptors) that block release of the hormone.
Danish: Cabergolin har langvarig virkning på disse cellers receptorer (såkaldte D2-receptorer), der blokerer frigivelsen af hormonet.
English: Velactis is used to:
Danish: Velactis anvendes til:
English: • reduce the risk of new infections of the udder during the dry period,
Danish: • at mindske risikoen for nye infektioner af yveret i goldperioden
English: By blocking prolactin release in this way, milk production is reduced.
Danish: Ved at blokere prolaktinfrigivelsen på denne måde nedsættes mælkeproduktionen.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Velactis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Velactis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The withdrawal period for meat from dairy cows treated with Velactis is 23 days.
Danish: Tilbageholdelsestiden for kød fra malkekøer, der er behandlet med Velactis, er 23 dage.
English: As Velactis reduces milk production, breastfeeding women should also avoid contact with the product.
Danish: Da Velactis nedsætter mælkeproduktionen, bør også ammende kvinder undgå kontakt med produktet.
English: It is not intended to provide practical advice on how to use Velactis.
Danish: Det er ikke en praktisk vejledning i, hvordan Velactis bør anvendes.
English: It is 4 days (8 milkings) after calving when the dry period length is less than 32 days.
Danish: Tilbageholdelsestiden er 4 dage (8 malkninger) efter kælvning, hvis goldperioden varer under 32 dage.
English: Velactis reduced the incidence of milk leakage to 2% compared to 10.7% in the cows treated with placebo.
Danish: Velactis nedsatte forekomsten af udsivende mælk til 2 %, sammenholdt med 10,7 % hos de køer, der blev behandlet med placebo.
English: People who are hypersensitive (allergic) to cabergoline should avoid contact with Velactis.
Danish: Personer, som er overfølsomme (allergiske) over for cabergolin, bør undgå kontakt med Velactis.
English: • reduce milk leakage at drying off (the point at which the cow is no longer milked),
Danish: • at mindske udsivning af mælk ved goldning (det tidspunkt, hvor man holder op med at malke)
English: What is Velactis and what is it used for?
Danish: Hvad er Velactis, og hvad anvendes det til?
English: The withdrawal period for milk from dairy cows treated with Velactis is ‘zero' days, which means there is no mandatory waiting time after calving, if the dry period length is 32 days or more.
Danish: Tilbageholdelsestiden for mælk fra køer, der behandles med Velactis, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid efter kælvning, hvis goldperioden varer mindst 32 dage.
English: Why is Velactis approved?
Danish: Hvorfor er Velactis blevet godkendt?
English: Velactis is a medicine used in the herd management programme of dairy cows as an aid to reduce milk production in dairy cows at the start of the dry period (the period when the cow is not milked before calving and start of the next lactation).
Danish: Velactis er et lægemiddel, der anvendes i besætninger af malkekøer som et hjælpemiddel til at reducere mælkeproduktionen i begyndelsen af goldperioden (fra den periode, hvor koen ikke malkes før kælvning, til næste periode, hvor mælkeydelse begynder).
English: The most common side effects with Velactis (which may affect up to 1 in 10 cows) are slight injection site reactions (mostly swellings) after injection of the product which may persist for at least 7 days.
Danish: De hyppigste bivirkninger ved Velactis (som kan optræde hos op til 1 ud af 10 køer) er lette reaktioner på injektionsstedet (hovedsagelig hævelse) efter indsprøjtning af produktet.
English: What are the risks associated with Velactis?
Danish: Hvilke risici er der forbundet med Velactis?
English: Pregnant women and women attempting to conceive should avoid contact with Velactis.
Danish: Kvinder, der er gravide eller planlægger at blive gravide, bør undgå kontakt med Velactis.
English: In a second field study involving 263 dairy cows the percentage of Velactis-treated cows with milk leakages during a 14-day period after drying-off was 3.9% compared with 17.6% for the cows treated with placebo.
Danish: I en anden feltundersøgelse med 263 malkekøer var der 3,9 % af de køer, der blev behandlet med Velactis, som havde udsivning af mælk i en 14-dages periode efter goldning, sammenholdt med 17,6 % af dem, der blev behandlet med placebo.
English: Velactis cabergoline
Danish: Velactis cabergolin
English: Safety information has been included in the summary of product characteristics and the package leaflet for Velactis, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Velactis, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Other information about Velactis?
Danish: Andre oplysninger om Velactis
English: Velactis is given as a single injection into the muscle within four hours of the last milking on the day of drying off. Velactis is available as a solution for injection in multidose vials of 5 ml, 25 ml or 50 ml.
Danish: Velactis fås som en injektionsvæske, opløsning, i flerdosishætteglas på 5 ml, 25 ml eller 50 ml.
English: Milk production is stimulated by a hormone, prolactin, released from specialised cells in the pituitary gland (a small gland attached to the brain).
Danish: Mælkeproduktionen stimuleres af hormonet prolaktin, der afgives af specialiserede celler i hypofysen
English: How is Velactis used?
Danish: Hvordan anvendes Velactis?
English: Velactis treated cows showed reduced discomfort on the first day of drying-off as indicated by increased daily lying time.
Danish: De køer, der blev behandlet med Velactis, viste mindsket ubehag på den første dag i goldperioden.
English: What benefits of Velactis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Velactis?
English: How does Velactis work?
Danish: Hvordan virker Velactis?
English: For more information about treatment with Velactis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Velactis, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Velactis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Velactis, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: In an initial field study with 917 cows, Velactis was given to cows free of subclinical mastitis (inflammation of the udder without visible clinical signs) and in the absence of antimicrobial treatment, showed a 5.5% reduction of new udder infections during the dry period compared to cows treated with placebo (the dummy treatment).
Danish: I en indledende feltundersøgelse med 917 køer blev Velactis givet til køer, der ikke havde yverbetændelse uden kliniske tegn (subklinisk mastitis).
English: [95% CI] Best response
Danish: [95 % CI] Bedste respons
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Danish: Da dette lægemiddel gives af din læge eller sygeplejerske, er det ikke sandsynligt at du vil blive givet for meget.