FrancophonIA/ELRC3.0 huggingface dataset:
English: Since this is below the 49 days limit applied for the ivermectin component, a withdrawal period of 49 days is recommended for the combination products containing ivermectin and closantel.
Danish: Da dette er lavere end grænsen på 49 dage, der gælder for ivermectinkomponenten, anbefales en tilbageholdelsestid på 49 dage for kombinationsprodukter indeholdende ivermectin og closantel.
English: Therefore, the Committee concluded that a harmonised withdrawal period of 49 days could be established for the ivermectin component of all injectable products containing ivermectin, for use in cattle.
Danish: Udvalget konkluderede derfor, at en harmoniseret tilbageholdelsestid på 49 dage kunne fastlægges for ivermectinkomponenten af alle injicerbare produkter indeholdende ivermectin til kvæg.
English: If, on the other hand, the withdrawal period determined on the basis of residue depletion data for the second active substance is greater than 49 days, then the recommended withdrawal period for the product should be based on depletion of residues of the second active substance.
Danish: Hvis tilbageholdelsestiden bestemt på grundlag af restkoncentrationsdata for det andet aktive stof derimod er længere end 49 dage, bør den anbefalede tilbageholdelsestid for produktet baseres på restkoncentrationen af det andet aktive stof.
English: DIVASA FARMAVIC, S.A. Ctra.
Danish: Spanien DIVASA FARMAVIC, S.A. Ctra.
English: 3 Othellou Street, 2540 Dhali Industrial Estate Nicosia
Danish: Cypern Vetagrica Ltd 3 Othellou Street 2540 Dhali Industrial Estate Nicosia
English: 2.2 Derivation of the withdrawal period for injectable veterinary medicinal products contains ivermectin as well as a second active substance (combination products)
Danish: 2.2 Udledning af tilbageholdelsestiden for injicerbare veterinærlægemidler indeholdende ivermectin i kombination med et andet aktivt stof (kombinationsprodukter)
English: Gerbičeva 50, 1000 Ljubljana Slovenia
Danish: 1000 Ljubljana Slovenia
English: VET4VET d.o.o.
Danish: Slovenien VET4VET d.o.o.
English: For injectable veterinary medicinal products containing ivermectin in combination with another active substance residue depletion of the second active substance must also be considered, and a withdrawal period for the second active substance derived.
Danish: For injicerbare veterinærlægemidler indeholdende ivermectin i kombination med et andet aktivt stof skal restkoncentrationen af det andet aktive stof også tages i betragtning, ligesom der skal udledes en tilbageholdelsestid for det andet aktive stof.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
Danish: ÆNDRINGER I DE RELEVANTE DELE AF ETIKETTERINGEN
English: 1991 JL Velserbroek The Netherlands
Danish: Kleermakerstraat 10 1991 JL Velserbroek The Netherlands
English: S.C. ROMVAC COMPANY S.A. Şos.
Danish: ROMVAC COMPANY S.A.
English: ANNEX III AMENDMENT TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III ÆNDRING I PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: B. For products listed in Annex I containing ivermectin as sole active ingredient or in combination with closantel:
Danish: B. For produkter anført i bilag I indeholdende ivermectin som det eneste aktive stof eller i kombination med closantel:
English: • the CVMP considered that sources of variation linked to the subcutaneous use of ivermectin in cattle are present that lead to different depletion profiles in residue studies, and this variation is of much more importance than any variation that may be caused by formulation differences.
Danish: • Udvalget fandt, at der forekommer kilder til variation i forbindelse med subkutan injektion af ivermectin i som medfører forskellige koncentrationsprofiler i restkoncentrationsundersøgelser, og at denne er af meget større betydning end en variation, der kan være forårsaget af forskelle i formuleringerne.
English: Wherever possible the CVMP used the statistical method for calculating the individual withdrawal periods based on single studies, but in line with the CVMP Note for Guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1, where the necessary parameters were not shown to be valid for the statistical analysis, the alternative approach was used for calculating withdrawal periods.
Danish: Så vidt muligt anvendte CVMP den statistiske metode til beregning af de individuelle tilbageholdelsestider baseret på enkelte undersøgelser, men i overensstemmelse med CVMP's "Note for Guidance: Approach towards harmonisation of withdrawal periods" (EMEA/CVMP/036/95)1.
English: Alfasan International B.V., P.O.
Danish: Bulgarien Alfasan International B.V.
English: Vetagrica Ltd
Danish: Alstoe Ltd
English: Invesa International S.A. Esmeralda 19
Danish: Litauen Invesa International S.A. Esmeralda 19
English: 288 02 Nymburk,
Danish: 288 02 Nymburk Czech Republic
English: AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas
Danish: AV Maria Lamas, Lote 19 - BLA Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro Portugal
English: All mammalian food producing species
Danish: Alle pattedyrarter bestemt til levnedsmiddelproduktion
English: Panchris Feeds Ltd. P.O.Box 40261, 6302 Larnaca Cyprus
Danish: Cypern Panchris Feeds Ltd. P.O.Box 40261
English: Gran Vía Carlos III, 98 - 7ºth floor.
Danish: Spanien Chemo Iberica Gran Vía Carlos III, 98 - 7ºth floor
English: Czech Republic Bremer Pharma GmbH Cherbourger Str. 25
Danish: Estland Bremer Pharma GmbH Cherbourger Str. 25
English: 3440 AB Woerden, The Netherlands
Danish: 3440 AB Woerden
English: United Kingdom VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1,
Danish: VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1
English: Spyros Stavrinides Chemicals Ltd 28 Stasinou Avenue, 1060 Nicosia,
Danish: Cypern Spyros Stavrinides Chemicals Ltd 28 Stasinou Avenue
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 4.11 Withdrawal period(s)
Danish: A. For produkter anført i bilag I indeholdende ivermectin og clorsulon som aktive stoffer: 4.11 Tilbageholdelsestid
English: Av.Los Cerrilos 602 Santiago,
Danish: Bulgarien Centrovet Ltd. Av.Los Cerrilos 602 Santiago
English: • the CVMP considered that, taking into account the high variation observed, a single harmonised withdrawal period based on all available residue intake data should be established for all products concerned that contain ivermectin as the only active substance;
Danish: • Udvalget fandt, at der bør fastlægges en fælles harmoniseret tilbageholdelsestid for alle de berørte produkter, der indeholder ivermectin som det eneste aktive stof, baseret på alle tilgængelige data for indtagelse af restkoncentrationer under hensyntagen til den observerede høje variation.
English: Box 78,
Danish: P.O. Box 78
English: While the precise sources of variation remain unidentified, it is quite likely that the sampling procedure is one important factor; it is difficult to be sure that the area with the highest residue concentration is accurately sampled, in particular for subcutaneous injections.
Danish: Mens de præcise kilder til variation er uidentificerede, er det ret sandsynligt, at prøvetagningsproceduren er en vigtig faktor.
English: Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),
Danish: Letland Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited)
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients:
Danish: A. For produkter anført i bilag I indeholdende ivermectin og clorsulon som aktive stoffer:
English: Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2,
Danish: Rua Dionísio Saraiva, Lote 1
English: Closiver Injection Ivermectin 5 mg/ml, Closantel 125 mg/ml
Danish: Closamectin Injection Ivermectin 5 mg/ml Closantel 125 mg/ml
English: Vetoquinol Biowet Sp. z o.o., ul.
Danish: Vetoquinol Biowet Sp. z o.o.
English: Sant Hipolit, km 71 08503 - Gurb-Vic Barcelona
Danish: 08503 - Gurb-Vic
English: 1 CVMP Note for guidance:
Danish: 1 CVMP Note for guidance: Approach towards harmonisation of withdrawal periods.
English: Cattle: Meat and offal - 66 days.
Danish: Kvæg: Kød og indvolde - 66 dage
English: Cattle, Sheep, Goats, Pigs
Danish: Kvæg, får, geder, svin
English: Cattle, Sheep, Reindeer, Pigs
Danish: Kvæg, får, rensdyr, svin
English: Cattle, Reindeer, Pigs
Danish: Kvæg, rensdyr, svin
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Danish: ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN
English: 4.11 Withdrawal period(s) Cattle: Meat and offal - 49 days.
Danish: 4.11 Tilbageholdelsestid Kvæg: Kød og indvolde - 49 dage
English: Mogilska 80, 31546 Krakow Poland
Danish: 31546 Krakow
English: Approach towards harmonisation of withdrawal periods http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf 2 CVMP Guideline on Injection Site Residues.
Danish: Publikation på EMEA's hjemmeside, http://www.emea.europa.eu/pdfs/vet/swp/054203en.pdf.
English: Subcutaneous 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw
Danish: Subkutan 200 μg ivermectin/kg kropsvægt, 2 mg clorsulon/kg kropsvægt
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMÉET
English: MERIAL GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Germany
Danish: D-85399 Hallbergmoos Germany
English: Slovak Republic Vétoquinol s.r.o., Zámečnícka 411,
Danish: Slovakiet Vétoquinol s.r.o.
English: • the CVMP considered that for combination products containing ivermectin as well as a second active substance, residue depletion of the second active substance must also be considered when setting the withdrawal period and the withdrawal period for the product shall be the longest established for the individual components.
Danish: • Udvalget fandt, at restkoncentrationen af det andet aktive stof i forbindelse med kombinationsprodukter indeholdende ivermectin og et andet aktivt stof også skal tages i betragtning ved fastsættelsen af tilbageholdelsestiden, og tilbageholdelsestiden for produktet skal være den længste tilbageholdelsestid, der fastsættes for de enkelte komponenter anbefaler Udvalget for Veterinærlægemidler, at markedsføringstilladelserne for alle injicerbare veterinærlægemidler indeholdende ivermectin til kvæg, som nævnt i bilag I, ændres.
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 66 days.
Danish: TILBAGEHOLDELSESTID Kvæg: Kød og indvolde: 66 dage
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days
Danish: TILBAGEHOLDELSESTID Kvæg: Kød og indvolde: 49 dage
English: Belgium Laboratorios Calier SA Barcelones
Danish: Belgien Laboratorios Calier SA Barcelones
English: Subcutaneous 200 μg ivermectin/kg bw, 5 mg closantel/kg bw
Danish: Subkutan 200 μg ivermectin/kg kropsvægt, 5 mg closantel/kg kropsvægt
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 10.
Danish: A. For produkter anført i bilag I indeholdende ivermectin og clorsulon som aktive stoffer: 10. TILBAGEHOLDELSESTID
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
Danish: Cross Vetpharm Group Ltd, Broomhill RoadTallaght Dublin 24
English: Belgium VIRBAC DE PORTUGAL Laboratorios Lda
Danish: Belgien VIRBAC DE PORTUGAL Laboratorios Lda
English: Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Danish: Slovakiet MERIAL 29 avenue Tony Garnier 69007 LYON France
English: Belgium Norbrook Laboratories Limited Station Works
Danish: Belgien Norbrook Laboratories Limited Station Works
English: Subcutaneous Cattle, Sheep, Goats: 200 μg ivermectin/kg bw
Danish: Subkutan Kvæg, får, geder: 200 μg ivermectin/kg kropsvægt
English: Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Danish: Frankrig MERIAL 29 avenue Tony Garnier 69007 LYON France
English: Luxembourg
Danish: Barcelona
English: United Kingdom Chanelle Animal Health Ltd 7 Rodney Street
Danish: Spanien Chanelle Animal Health Ltd 7 Rodney Street
English: Belgium Cross Vetpharm Group Ltd, Broomhill Road
Danish: Belgien Cross Vetpharm Group Ltd, Broomhill Road
English: The Netherlands Dopharma Research B.V. Zalmweg 24
Danish: Dopharma Research B.V.
English: Closamectin Injection
Danish: Closiver Injection
English: Subcutaneous Cattle, Sheep, Reindeer: 200 μg ivermectin/kg bw
Danish: Subkutan Kvæg, får, rensdyr: 200 μg ivermectin/kg kropsvægt
English: The Netherlands Chanelle Animal Health Ltd 7 Rodney Street
Danish: Frankrig Chanelle Animal Health Ltd 7 Rodney Street
English: VIRBAMEC Ivermectin 10 mg/ml
Danish: VIRBAMEC VET Ivermectin 10 mg/ml
English: Belgium ECO Animal Health Ltd 78 Coombe Road
Danish: Belgien ECO Animal Health Ltd 78 Coombe Road
English: Subcutaneous Cattle, Reindeer: 200 μg ivermectin/kg bw
Danish: Subkutan Kvæg, rensdyr: 200 μg ivermectin/kg kropsvægt
English: United Kingdom Norbrook Laboratories Limited Station Works
Danish: Frankrig Norbrook Laboratories Limited Station Works
English: Slovak Republic Norbrook Laboratories Limited Station Works
Danish: Slovakiet Norbrook Laboratories Limited Station Works
English: Slovak Republic ECO Animal Health Ltd 78 Coombe Road
Danish: Slovakiet ECO Animal Health Ltd 78 Coombe Road
English: Enovex Injection 1% w/v
Danish: Enovex Injection 1% w/v Ivermectin 10 mg/ml
English: Topimec Injection Ivermectin 10 mg/ml
Danish: Paramectin Inyectable Ivermectin 10 mg/ml
English: United Kingdom Laboratorios Calier SA Barcelones
Danish: Frankrig Laboratorios Calier SA Barcelones
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill Road
Danish: Frankrig Cross Vetpharm Group Ltd, Broomhill Road
English: IVERTIN Ivermectin 10 mg/ml
Danish: IVERTIN BOVIN Ivermectin 10 mg/ml
English: The Netherlands VIRBAC DE PORTUGAL Laboratorios Lda
Danish: Danmark VIRBAC DE PORTUGAL Laboratorios Lda
English: Animec Injection Ivermectin 10 mg/ml
Danish: Noromectin Injection Ivermectin 10 mg/ml
English: United Kingdom VIRBAC DE PORTUGAL Laboratorios Lda
Danish: Norge VIRBAC DE PORTUGAL Laboratorios Lda
English: Czech Republic ECO Animal Health Ltd 78 Coombe Road
Danish: Litauen ECO Animal Health Ltd 78 Coombe Road
English: Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017.
Danish: Jylamvo fik en markedsføringstilladelse med gyldighed i hele EU den 29. marts 2017.
English: This especially affects fast-growing cells such as cancer cells.
Danish: Dette påvirker især hurtigt voksende celler såsom kræftceller.
English: For inflammatory conditions it is taken once a week, on the same day each week.
Danish: Ved betændelsessygdomme skal det tages én gang om ugen på den samme ugedag.
English: It must not be used if the patient is breastfeeding or is receiving live vaccines.
Danish: Det må ikke anvendes, hvis patienten ammer eller får levende vacciner.
English: Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo.
Danish: Yderligere information om Jylamvo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/jylamvo.
English: The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week.
Danish: Lægen vil måske tjekke med patienten eller patientens omsorgsperson, at lægemidlet med sikkerhed kan tages én gang om ugen.
English: The company will also send out follow-up questionnaires for dosing errors that result in overdose.
Danish: Virksomheden vil også udsende opfølgende spørgeskemaer vedrørende doseringsfejl, der medfører overdosis.
English: In most cases, methotrexate medicines are used for long-term treatment.
Danish: I de fleste tilfælde bruges methotrexat-lægemidler til langtidsbehandling.
English: How often methotrexate is given depends on the other medicines it is used with.
Danish: Hvor ofte methotrexat skal tages, afhænger af de andre lægemidler, som det gives sammen med.
English: The dose that the patient takes each week depends on which inflammatory condition it is being used for, how well the treatment is working and, in the case of children, on the child's height and weight.
Danish: Den dosis, som patienten tager hver uge, afhænger af, hvilken betændelsessygdom den anvendes til, hvor godt behandlingen virker, og, for så vidt angår børn, barnets højde og vægt.
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Danish: Det bør kun ordineres af læger med ekspertise i brugen af methotrexat og et grundigt kendskab til risiciene ved methotrexat-behandling.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Jylamvo is given in a different way.
Danish: Det betyder, at det er identisk med et "referencelægemiddel", som indeholder det samme aktive stof, men Jylamvo indgives på en anden måde.
English: Jylamvo (methotrexate)
Danish: Jylamvo (methotrexat)
English: Other information about Jylamvo
Danish: Andre oplysninger om Jylamvo
English: What measures are being taken to ensure the safe and effective use of Jylamvo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jylamvo?
English: The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.
Danish: Virksomheden fremlagde data fra den offentliggjorte litteratur om fordelene og risiciene ved methotrexat i de godkendte behandlinger.
English: For acute lymphoblastic leukaemia, the dose of Jylamvo depends on the patient's height and weight.
Danish: Ved akut lymfatisk leukæmi afhænger dosen af Jylamvo af patientens højde og vægt.
English: Jylamvo is a ‘hybrid medicine'.
Danish: Jylamvo er et "hybridlægemiddel".
English: Why is Jylamvo authorised in the EU?
Danish: Hvorfor er Jylamvo godkendt i EU?
English: The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Jylamvo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: As for all medicines, data on the use of Jylamvo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Jylamvo løbende overvåget.
English: Side effects reported with Jylamvo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Jylamvo vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The company that markets Jylamvo will supply a guide for healthcare professionals and a patient alert card, on how to use the medicine correctly and how to avoid medication errors.
Danish: Virksomheden, der markedsfører Jylamvo, vil udlevere en vejledning til sundhedspersoner og et patientinformationskort om, hvordan lægemidlet anvendes korrekt, og hvordan man undgår medicineringsfejl.
English: What is Jylamvo and what is it used for?
Danish: Hvad er Jylamvo, og hvad anvendes det til?
English: An overview of Jylamvo and why it is authorised in the EU
Danish: En oversigt over Jylamvo, og hvorfor det er godkendt i EU
English: The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Danish: Det vides ikke med sikkerhed, hvordan methotrexat virker hos patienter med leddegigt og psoriasis, men fordelene ved methotrexat menes at skyldes stoffets evne til at reducere betændelse og undertrykke et overaktivt immunforsvar.
English: For more information about using Jylamvo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Jylamvo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: As for every medicine, the company provided studies on the quality of Jylamvo.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Jylamvo.
English: What are the risks associated with Jylamvo?
Danish: Hvilke risici er der forbundet med Jylamvo?
English: Jylamvo contains the active substance methotrexate.
Danish: Jylamvo indeholder det aktive stof methotrexat.
English: The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Danish: De hyppigste bivirkninger ved Jylamvo (som kan forekomme hos mere end 1 ud af 10 personer) er virkninger i fordøjelsessystemet (f.eks. betændelse i munden, fordøjelse, mavesmerter, kvalme og appetitløshed) og blodprøver, der viser leverændringer.
English: The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Jylamvo var af sammenlignelig kvalitet og var bioækvivalent med de methotrexat-holdige lægemidler Methotrexat Lederle og Ebetrexat.
English: The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA.
Danish: Det aktive stof i Jylamvo, methotrexat, forhindrer celler i at vokse ved at forstyrre deres dnafremstilling.
English: Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions:
Danish: Jylamvo er både et antiinflammatorisk lægemiddel og et kræftlægemiddel, der anvendes til behandling af følgende sygdomme:
English: The company also carried out studies that showed that it is bioequivalent to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets).
Danish: Virksomheden gennemførte også studier, der viste, at stoffet er "bioækvivalent" med andre methotrexat-lægemidler, der anvendes til behandling af betændelsessygdomme og akut lymfatisk leukæmi (Methotrexat Lederle og Ebetrexat-tabletter).
English: The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.
Danish: De alvorligste bivirkninger omfatter nedsat produktion af blodceller, beskadigelse af lungerne, leveren, nyrerne og nerverne, tromboemboli (problemer forårsaget af blodpropper i blodårerne) og alvorlige allergiske reaktioner og hudreaktioner.
English: Jylamvo is available as a liquid to be taken by mouth and it can only be obtained with a prescription.
Danish: Jylamvo fås som en væske, der tages gennem munden, og det fås kun på recept.
English: Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Danish: Jylamvo må ikke anvendes til patienter med alkoholmisbrug, leverproblemer, svære nyreproblemer, blodsygdomme, svækket immunsystemet (kroppens forsvar), alvorlige eller langvarige infektioner såsom tuberkulose og hiv-infektion, sår i munden, betændelse i munden og sår i fordøjelsessystemet.
English: • acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.
Danish: • akut lymfatisk leukæmi (kræft i de hvide blodlegemer) hos voksne og børn fra 3 år og opefter.
English: For the full list of side effects and restrictions of Jylamvo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Jylamvo fremgår af indlægssedlen.
English: The reference medicine for Jylamvo is Methotrexat Lederle injection.
Danish: Referencelægemidlet for Jylamvo er Methotrexat Lederle som injektionsvæske.