FrancophonIA/ELRC3.0 huggingface dataset:
English: What EMEND is and what it is used for What you need to know before you take or give EMEND How to take EMEND
Danish: Det skal du vide, før du begynder at tage eller give EMEND Sådan skal du tage EMEND
English: †, vomiting gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare
Danish: Perforeret duodenalulcus, stomatitis, oppustethed, hård afføring, neutropen colitis
English: 5 Aluminium blisters each containing one 80 mg capsule.
Danish: 5 stk. aluminiumblistre med 1 stk. 80 mg kapsel i hver.
English: The aprepitant regimen consisted of aprepitant 125 mg on Day 1 and 80 mg/day on Days 2 and 3 in combination with intravenous ondansetron 32 mg on Day 1 and dexamethasone 12 mg on Day 1 and 8 mg daily on Days 2 through 4.
Danish: Aprepitantregimet bestod af aprepitant 125 mg på dag 1 og 80 mg/dag på dag 2 og 3 i kombination med ondansetron 32 mg i.v.
English: Gastrointestinal disorders constipation, dyspepsia common eructation, nausea
Danish: †, opkastning gastroesophageal refluxlidelse, mavesmerter, mundtørhed, flatulens
English: EMEND should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, ergot alkaloid derivatives, fentanyl, and quinidine (see section 4.5).
Danish: EMEND bør anvendes med forsigtighed til patienter, som er i samtidig oral behandling med aktive substanser, der primært metaboliseres gennem CYP3A4 og som har et smalt terapeutisk virkningsområde såsom ciclosporin, tacrolimus, sirolimus, everolimus, alfentanil, sekalealkaloidderivater, fentanyl og quinidin (se pkt.
English: Common side effects (may affect up to 1 in 10 people) are: - constipation, indigestion, - headache, - tiredness, - loss of appetite, - hiccups,
Danish: Almindelige bivirkninger (kan berøre op til 1 ud af 10 personer): - Forstoppelse, fordøjelsesbesvær - Hovedpine - Træthed - Appetitløshed - Hikke - Forhøjet indhold af leverenzymer i blodet.
English: METHOD AND ROUTES OF ADMINISTRATION
Danish: Almene symptomer og reaktioner på administrationsstedet
English: What EMEND looks like and contents of the pack The 40 mg hard capsule is opaque with a white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.
Danish: 40 mg kapslen er ugennemsigtig med hvid kerne og sennepsgul kappe med "464" og "40 mg" præget med sort blæk på kapslen.
English: If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.
Danish: Kontakt lægen, før du eller barnet tager denne medicin, hvis lægen har fortalt dig eller barnet, at du eller barnet ikke tåler visse sukkerarter.
English: In a clinical study, single doses of an oral contraceptive containing ethinyl estradiol and norethindrone were administered on Days 1 through 21 with EMEND, given as a regimen of 125 mg on Day 8 and 80 mg/day on Days 9 and 10 with ondansetron 32 mg intravenously on Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/day on Days 9, 10, and 11.
Danish: EMEND blev samtidigt givet som 125 mg på dag 8 og som 80 mg /dag på dag 9 og 10 sammen med ondansetron 32 mg intravenøst på dag 8 og oral dexamethason givet som 12 mg på dag 8 og som 8 mg/dag på dag 9, 10 og 11.
English: The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving Moderately Emetogenic Chemotherapy (MEC) was fatigue (1.4 % versus 0.9 %).
Danish: Moderat emetogen kemoterapibehandling (MEC): Den almindeligste bivirkning, som blev rapporteret med højere incidens hos de patienter, der var i aprepitantbehandling end i standardbehandling, var træthed (1,4 % versus 0,9 %).
English: Table 4 Percent of adult patients receiving Highly Emetogenic Chemotherapy responding by treatment group and phase - Cycle 1
Danish: Tabel 4 Procent voksne patienter, der responderer pr. behandlingsgruppe og -fase - cyklus 1 Højemetogen kemoterapi
English: During continuous treatment with methylprednisolone, the AUC of methylprednisolone may decrease at later time points within 2 weeks following initiation of the EMEND dose, due to the inducing effect of aprepitant on CYP3A4.
Danish: På grund af aprepitants inducerende virkning på CYP3A4 kan AUC for methylprednisolon, ved kontinuerlig administration af methylprednisolon, mindskes i op til 2 uger efter behandlingsstart med EMEND.
English: When to take
Danish: Hvornår lægemidlet skal gives
English: terfenadine, astemizole, or cisapride (see section 4.3).
Danish: Samtidig administration af pimozid, terfenadin, astemizol eller cisaprid (se pkt.
English: Days 2 and 3: - one 80 mg capsule each day - If no chemotherapy is given, take EMEND in the morning.
Danish: Dag 2 og 3: - En 80 mg kapsel hver dag.
English: Printing ink
Danish: Foliepose med
English: bloating - urinating more often or passing more urine than normal, sugar or blood in urine - chest discomfort, swelling, change in the manner of walking - cough, mucus in the back of the throat, throat irritation, sneezing, sore throat - eye discharge and itching - ringing in the ears - muscle spasms, muscle weakness - feeling very thirsty - slow heartbeat, heart and blood vessel disease - low number of white blood cells, low sodium levels in the blood, weight loss.
Danish: Sjælden: kan forekomme hos op til 1 ud af 1.000 personer - Koncentrationsbesvær, manglende energi, smagsforstyrrelse - Øget hudfølsomhed over for solen, kraftigt øget svedtendens, fedtet hud, sår på huden, kløende udslæt, Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse (sjælden alvorlig hudreaktion) - Eufori (ekstrem lykkefølelse), desorientering - Bakterieinfektion, svampeinfektion - Svær forstoppelse, mavesår, betændelse i tyndtarmen og tyktarmen, sår i munden, oppustethed - Hyppig vandladning, større urinmængde end normalt, sukker eller blod i urinen - Ubehag i brystet, hævelser, ændringer i måden at gå på - Hoste, slim bagest i svælget, irritation i svælget, nysen, ondt i halsen - Tåreflåd, øjenkløe - Ringen for ørerne - Muskelspasmer, muskelsvækkelse - Udtalt tørst - Langsom hjerterytme (puls), sygdom i hjerte- eller blodkar - Lavt antal hvide blodlegemer, lavt indhold natrium i blodet, vægttab.
English: In clinical interaction studies, aprepitant, when given as a regimen of 125 mg on Day 1 and 80 mg on Days 2 and 3, did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Danish: I kliniske interaktionsstudier havde aprepitant ingen klinisk betydningsfuld virkning på farmakokinetikken for ondansetron, granisetron eller hydrodolasetron (dolasetrons aktive metabolit), når det blev givet som et regime på 125 mg på dag 1 og 80 mg på dag 2 og 3.
English: The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with intravenous ondansetron 32 mg on Day 1 and dexamethasone 12 mg on Day 1, 8 mg on Day 2, and 8 mg twice daily on Days 3 and 4.
Danish: på dag 1 og dexamethason 12 mg på dag 1, 8 mg på dag 2 og 8 mg to gange dagligt på dag 3 og 4.
English: Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND, - pimozide (used to treat psychiatric illnesses), - terfenadine; astemizole (used for hay fever and other allergic conditions), - cisapride (used for treating digestive problems), - medicines containing ergot alkaloid derivatives (used for treating migraines), - rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections), - phenytoin (a medicine used to treat seizures), - carbamazepine (used to treat depression and epilepsy), - midazolam, phenobarbital (medicines used to produce calmness or help you sleep), - St. John's Wort (an herbal preparation used to treat depression), - protease inhibitors (used to treat HIV infections), - nefazodone (used to treat depression), - ketoconazole except shampoo (used to treat Cushing's syndrome - when the body produces an excess of cortisol), - itraconazole, voriconazole, posaconazole (antifungals), - corticosteroids (such as dexamethasone)
Danish: - Pimozid (mod psykisk sygdom) - Terfenadin, astemizol (mod høfeber og andre allergiske lidelser) - Cisaprid (til behandling af problemer med fordøjelsen) - Lægemidler der indeholder sekalealkaloider (til behandling af migræne) - Rifampicin, clarithromycin, telithromycin (antibiotika til behandling af infektioner) - Phenytoin (til behandling af krampeanfald) - Carbamazepin (til behandling af depression og epilepsi) - Midazolam, phenobarbital (beroligende midler eller sovemidler) - Perikon (et naturlægemiddel til behandling af depression) - Proteasehæmmere (til behandling af hiv-infektioner) - Nefazodon (til behandling af depression) - Ketoconazol undtagen shampoo (til behandling af Cushings syndrom - når kroppen producerer for meget kortisol) - Itraconazol, vorconazol, posaconazol (til behandling af svampeinfektioner) - Kortikosteroider (såsom dexamethason).
English: Table 1 Percent of adult patients receiving Highly Emetogenic Chemotherapy responding by treatment group and phase - Cycle 1
Danish: Tabel 1 Procent voksne patienter, som responderer pr. behandlingsgruppe og fase - cyklus 1 Højemetogen kemoterapibehandling
English: 8 mg orally 8 mg orally 8 mg orally
Danish: 8 mg oralt
English: Vascular disorders hot flush uncommon
Danish: Dyspnø, hvæsende vejrtrækning
English: Batch
Danish: Hikke
English: Merck Sharp & Dohme B.V. Tel: 0800 9999000
Danish: Tel: 0800 9999000
English: ALT increased common
Danish: Stigning i ALAT
English: The European Commission issued a decision on 5 October 2010.
Danish: Europa-Kommissionen traf en afgørelse den 15. marts 2010.
English: Why was Fortipan Combi D reviewed?
Danish: Hvorfor blev Lescol vurderet igen?
English: Daniela Melchiorri (Italy)
Danish: Catherine Moraiti (Grækenland)
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Fortipan Combi D outweigh its risks, and therefore that the marketing authorisation for Fortipan Combi D should be granted in the concerned Member State.
Danish: På grundlag af de fremlagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméet, etiketteringen og indlægssedlen skulle harmoniseres inden for EU.
English: Kristina Dunder (Sweden)
Danish: Alar Irs (Estland)
English: 24 June 2010
Danish: 19. februar 2009
English: 5 October 2010
Danish: 19. november 2009
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på baggrund af divergerende nationale beslutninger i medlemsstaterne.
English: What is Fortipan Combi D?
Danish: Hvad er Lescol?
English: 20 May 2010
Danish: 29. maj 2009, 16. oktober 2009
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Danish: Den 9. februar 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Lescol i EU.
English: It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol).
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Lescol og relaterede navne Kapsler indeholdende 20 mg eller 40 mg fluvastatin Depottabletter indeholdende 80 mg fluvastatin
English: Co-rapporteur:
Danish: De harmoniserede områder omfatter:
English: The active substance in the tablets, risedronate sodium, is a bisphosphonate.
Danish: Lescol indeholder det aktive stof fluvastatin.
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Danish: Det virker ved at blokere aktiviteten af et enzym kaldet HMG-CoA-reduktase.
English: The grounds for the referral were concerns over the evidence provided on the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).
Danish: CHMP godkendte to harmoniserede indikationer (de sygdomme, som lægemidlet kan anvendes til): "Dyslipidæmi Behandling af primær hyperkolesterolæmi eller blandet dyslipidæmi som et supplement til diæt, når responsen på diætbehandling og andre ikkefarmakologiske behandlinger (f.eks. motion og vægttab) er utilstrækkelig.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Fortipan Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fortipan Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in Italy.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var behov for at harmonisere ordinationsoplysningerne for Lescol og relaterede navne i Den Europæiske Union (EU) samt Norge og Island.
English: Fortipan Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol (vitamin D3).
Danish: Patienter med blandet dyslipidæmi har høje koncentrationer af det "dårlige" LDL-kolesterol og triglycerider (en type fedtstof) i blodet og lave koncentrationer af det "gode" HDLkolesterol.
English: Fortipan Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Lescol anvendes endvidere til at forebygge yderligere alvorlige hjertehændelser (såsom hjerteanfald) hos patienter, der har gennemgået perkutan koronarintervention (et kirurgisk indgreb, der udføres for at fjerne blokeringer i forsnævrede koronararterier).
English: Blocking the action of these cells leads to less bone loss.
Danish: Når dette enzym blokeres, falder mængden af kolesterol i blodet.
English: It is used to reduce the risk of fractures in the hip and the spine.
Danish: Lescol anvendes til at behandle dyslipidæmi (abnormt høje koncentrationer af fedtstoffer i blodet), særlig "primær hyperkolesterolæmi" og "blandet dyslipidæmi".
English: The company wanted the authorisation to be recognised in Italy (the ‘concerned Member State').
Danish: Lescol er godkendt i EU efter nationale procedurer.
English: Date of first authorisation: 03 October 2011 Date of latest renewal: 29 June 2016
Danish: Dato for første markedsføringstilladelse: 3. oktober 2011 Dato for seneste fornyelse: 29 juni 2016
English: You may take Matever with or without food.
Danish: De kan tage Matever med eller uden mad.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: UNIQUE IDENTIFIER - LÆSELIG DATA
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms;
Danish: • encefalopati (se underafsnittet ”Kontakt omgående lægen” for en detaljeret beskrivelse af symptomer);
English: Contact your doctor if you took more tablets than you should.
Danish: Kontakt lægen, hvis De har taget flere tabletter, end De skal.
English: There was no effect on embryomortality and no increased incidence of malformations.
Danish: Der var ingen effekt på embryo -mortaliteten og ingen øget forekomst af malformationer.
English: A doctor or a nurse will administer you Matever as an intravenous infusion.
Danish: En læge eller en sygeplejerske vil give Dem Matever som intravenøs infusion.
English: The use of Matever in accordance with the product information is not likely to result in an unacceptable environmental impact (see section 6.6).
Danish: Anvendelse af Matever i overensstemmelse med produktinformationen forventes ikke at medføre en uacceptabel påvirkning af miljøet (se pkt.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two medicinal products.
Danish: Niveauet af methotrexat og levetiracetam i blodet bør omhyggeligt monitoreres hos patienter, som behandles samtidigt med de to lægemidler.
English: 2D barcode carrying the unique identifier included.
Danish: 2D stregkode bærer den entydige identifikator inkluderet.
English: After dilution the infusion is stable for 24 hours at 2 °C - 8 °C (in a refrigerator).
Danish: Efter fortynding er infusionsopløsningen stabil i 24 timer ved 2 °C - 8 °C (i køleskab).
English: If you forget to take Matever Contact your doctor if you have missed one or more doses.
Danish: Hvis De har glemt at tage Matever Kontakt lægen, hvis De har glemt en eller flere doser.
English: • Matever is used as a chronic treatment.
Danish: • Matever anvendes til kronisk behandling.
English: This is equivalent to 2.86 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 2.86 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: You should continue Matever treatment for as long as your doctor has told you.
Danish: De skal fortsætte behandlingen med Matever så lang tid, som Deres læge har fortalt Dem.
English: Matever therapy can be initiated with either intravenous or oral administration.
Danish: Behandling med Matever kan indledes med enten intravenøs eller oral administration.
English: The pharmacokinetic profile has been characterized following oral administration.
Danish: Den farmakokinetiske profil har været karakteriseret efter oral administration.
English: • If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
Danish: • Hvis De bemærker en stagnation i væksten eller uventet pubertetsudvikling hos Deres barn, så kontakt Deres læge.
English: Clear, colourless concentrate.
Danish: Klart, farveløst koncentrat.
English: Preparation and administration of Matever concentrate
Danish: Fremstilling og administration af Matever-koncentrat
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Danish: Effektiviteten ved dialyse -ekstraktion er 60 % for levetiracetam og 74 % for den primære metabolit.
English: • A small number of people being treated with anti-epileptics such as Matever have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin, som for eksempel Matever, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: • Risk management plan (RMP) Not applicable.
Danish: • Risikostyringsplan (RMP)
English: The efficacy analysis consisted of 109 patients who had at least 24 hours of video EEG in both baseline and evaluation periods.
Danish: Effektanalyserne omfattede 109 patienter, som havde mindst 24 timers video -EEG i både baseline samt i evalueringsperioderne.
English: The plasma half-life in adults was 71 hours and did not vary either with dose, route of administration or repeated administration.
Danish: Halveringstiden for levetiracetam hos voksne var 71 timer og påvirkedes hverken af dosis, administrationsvej eller gentagen dosering.
English: Matever must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Matever skal tages to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight.
Danish: På grund af fuldstændig og lineær absorption kan plasmaniveauerne forudsiges ud fra oral levetiracetam-dosis udtrykt som mg/kg legemsvægt.
English: When you will first start taking Matever, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Danish: Når De begynder at tage Matever, vil Deres læge ordinere en lavere dosis i 2 uger, før De får den laveste vedligeholdelsesdosis.
English: The following information is intended for healthcare professionals only: Directions for the proper use of Matever is provided in section 3.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Retningslinjer for korrekt anvendelse af Matever er beskrevet i punkt 3.
English: Your doctor will prescribe the most appropriate pharmaceutical form of Matever according to the age, weight and dose.
Danish: Deres læge vil ordinere den mest hensigtsmæssige lægemiddelform af Matever afhængigt af alder, vægt og dosis.
English: Should your doctor decide to stop your Matever treatment, he/she will instruct you about the gradual withdrawal of Matever.
Danish: Hvis lægen beslutter at stoppe Deres behandling med Matever, vil han/hun instruere Dem i, hvordan De gradvist skal ophøre med at tage Matever.
English: The major route of excretion was via urine, accounting for a mean 95 % of the dose (approximately 93 % of the dose was excreted within 48 hours).
Danish: Hovedparten blev udskilt via urinen, gennemsnitligt 95 % af dosis (ca. 93 % af dosis var udskilt inden for 48 timer).
English: Do not use this medicine after the expiry date which is stated on the carton box and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterkortet efter ”Exp”.
English: Matever tablets are packaged in blister packs supplied in cardboard boxes containing:
Danish: Matever tabletter er pakket i blisterpakninger og udleveres i papæsker indeholdende:
English: For doctors and nurses, more detailed direction for the proper use of Matever is provided in section
Danish: For læger og sygeplejersker er der angivet mere detaljerede retningslinjer for korrekt anvendelse af Matever i punkt 6.
English: Matever concentrate is an alternative for patients when oral administration is temporarily not feasible.
Danish: Matever-koncentrat er et alternativ til patienter, når oral administration midlertidigt ikke er mulig.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Danish: Epilepsi er en tilstand, hvor patienter har gentagne anfald (kramper).
English: This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
Danish: Dette fald er mere udtalt i 3. trimester (op til 60 % af baseline-koncentrationen før graviditet).
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m
Danish: Derfor anbefales en reduktion på 50 % af den daglige vedligeholdelsesdosis, når kreatininclearance er <60 ml/min/1,73 m
English: You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Danish: De kan skifte direkte fra filmovertrukne tabletter eller fra oral opløsning til intravenøs formulering eller omvendt uden dosisjustering.
English: Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Danish: Da den individuelle følsomhed er forskellig, kan nogle patienter opleve døsighed eller andre CNSrelaterede symptomer især i begyndelsen af behandlingen eller ved dosisøgning.
English: Matever must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Matever skal indgives to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: Therefore, the interaction of Matever with other substances, or vice versa, is unlikely
Danish: Derfor er interaktion mellem Matever og andre lægemidler eller vice versa ikke sandsynlig.