FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders Common: dyspnoea, snoring, nasal congestion Not known: respiratory depression, sleep apnoea
Danish: Luftveje, thorax og mediastinum Almindelig: dyspnø, snorken, nasal kongestion Ikke kendt: respirationsdepression, søvnapnø
English: The combined use of alcohol with sodium oxybate may result in potentiation of the central nervous system-depressant effects of sodium oxybate.
Danish: Kombineret brug af alkohol og natriumoxybat kan resultere i forstærkning af natriumoxybats CNSdepressive virkning.
English: Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Danish: Knogler, led, muskler og bindevæv Almindelig: artralgi, muskelspasmer, rygsmerter
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid Xyrem nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Therefore, patients should be warned against the use of topiramate in conjunction with sodium oxybate (section 4.5).
Danish: Derfor bør patienter advares mod at bruge topiramat sammen med natriumoxybat (se pkt.
English: To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
Danish: Som en hjælp indeholder Xyrem-æsken 1 flaske lægemiddel, en målesprøjte og to doseringsbægre med børnesikkert låg.
English: Apnoea and respiratory depression have been observed in a fasting healthy subject after a single intake of 4.5 g (twice the recommended starting dose).
Danish: Apnø og respirationsdepression har været observeret hos fastende raske personer efter et enkelt indtag på 4,5 g (det dobbelte af den anbefalede startdosis) Patienter bør udspørges angående tegn på depression af centralnervesystemet (CNS) eller respirationsdepression.
English: Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, events such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Danish: Selv om erfaring fra kliniske studier med natrium oxybat til narkolepsi-/katapleksipatienter i terapeutiske doser ikke udviser klar evidens for abstinenssymptomer, er der i sjældne tilfælde observeret episoder med insomnia, hovedpine, angst, svimmelhed, søvnforstyrrelser, somnolens, hallucinationer og psykotiske lidelser efter ophør med GHB.
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: Discontinuation of Xyrem
Danish: Ophør med Xyrem-behandlingen
English: Xyrem 500 mg/mL oral solution Sodium oxybate
Danish: Xyrem 500 mg/ml oral opløsning Natriumoxybat
English: Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left).
Danish: Flaskelåget fjernes ved at trykke det ned, mens det drejes mod uret (mod venstre).
English: Sleepwalking has been reported in patients treated in clinical trials with sodium oxybate.
Danish: Der er rapporteret søvngængeri hos patienter, som i kliniske studier er behandlet med natriumoxybat.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 2.25 g) and the antidepressants protriptyline hydrochloride (single dose of 10 mg) and duloxetine (60 mg at steady state).
Danish: Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat (enkelt dosis på 2,25 g) og de 2 antidepressiva protriptylinhydrochlorid (enkelt dosis på 10 mg) og duloxetin (60 mg ved steady state).
English: A drug interaction study in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 4.5 g) and modafinil (single dose of 200 mg).
Danish: Et interaktionsstudie hos raske voksne viste ingen farmakokinetisk interaktion mellem natriumoxybat (enkelt dosis på 4,5 g) og modafinil (enkelt dosis på 200 mg).
English: Convulsion, decreased breathing depth or rate, hives, suicidal thoughts, short cessation of breathing during sleep, euphoric mood, dry mouth, swelling face (angioedema), dehydration, panic attack, mania / bipolar disorder, delusion, bruxism (teeth grinding and jaw clenching), pollakiuria / micturition urgency (increase need to urinate), nocturia (excessive urination at night), tinnitus (noise in the ears such as ringing or buzzing) sleep-related eating disorder, loss of consciousness, increased appetite, irritability, aggression, dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) and thoughts of committing violent acts (including harming others), dandruff and increased sexual desire
Danish: Kramper, nedsat vejrtrækningsdybde eller -hastighed, nældefeber, selvmordstanker, kortvarige vejrtrækningspauser under søvn, eufori, mundtørhed, hævet ansigt (angioødem), dehydrering, panikanfald, mani/bipolar lidelse, vrangforestilling, bruksisme (tænderskæren og knytten kæbe), pollakisuri/imperiøs vandladning (hyppig vandladning), nykturi (overdreven vandladning om natten), tinnitus (ringen og susen for ørerne), søvnrelateret spiseforstyrrelse, tab af bevidsthed, øget appetit, irritabilitet, aggression, dyskinesi (f.eks. unormale, ufrivillige bevægelser af lemmerne) og tanker om at begå voldelige handlinger (herunder at skade andre), skæl og øget seksualadfærd.
English: The effectiveness of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials (Trial 1, 2, 3 and 4) in patients with narcolepsy with cataplexy except for trial 2 where cataplexy was not required for enrolment Concomitant stimulant use was permitted in all trials (except for the active-treatment phase of Trial 2); antidepressants were withdrawn prior to active treatment in all trials with the exception of Trial 2.
Danish: Natriumoxybats effektivitet til behandling af narkolepsisymptomer, blev dokumenteret i fire randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier med parallelle grupper (studie 1, 2, 3 og 4) med patienter, der havde narkolepsi med katapleksi, en undtagelse var studie 2, hvor katapleksi ikke var et inklusionskrav.
English: EDS - Excessive daytime sleepiness; ESS - Epworth Sleepiness Scale; MWT - Maintenance of Wakefulness Test; Naps - Number of inadvertent daytime naps; CGIc - Clinical Global Impression of Change; FOSQ - Functional Outcomes of Sleep Questionnaire
Danish: CGIc - Clinical Global Impression of Change (klinisk global vurdering af ændring); FOSQ - Functional Outcomes of Sleep Questionnaire (funktionelle resultater fra spørgeskema om søvn)
English: Seizures have been observed in patients treated with sodium oxybate.
Danish: Krampeanfald er set hos patienter behandlet med natriumoxybat.
English: • Topiramate
Danish: • Topiramat
English: A drug interaction study in healthy adults with sodium oxybate (single dose of 2.25 g) and tramadol (single dose of 100 mg) demonstrated no pharmacokinetic/pharmacodynamic interaction.
Danish: Et interaktionsstudie hos raske voksne med natriumoxybat (enkelt dosis på 2,25 g) og tramadol (enkelt dosis på 100 mg) viste ingen farmakokinetisk/farmakodynamisk interaktion.
English: Each mL contains 500 mg of sodium oxybate.
Danish: Hver ml indeholder 500 mg natriumoxybat.
English: Drug interaction studies in healthy adults with sodium oxybate (single dose of 2.25 g) and lorazepam (single dose of 2 mg) and zolpidem tartrate (single dose of 5 mg) demonstrated no pharmacokinetic interactions.
Danish: Lægemiddelinteraktionsstudier hos raske voksne med natriumoxybat (enkelt dosis på 2,25 g) og lorazepam (enkelt dosis på 2 mg) og zolpidemtartrat (enkelt dosis på 5 mg) viste ingen farmakokinetiske interaktioner.
English: The dose should be titrated to effect based on efficacy and tolerability (see section 4.4) up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose).
Danish: 4.4) til en maksimal dosis på 9 g/dag fordelt på to lige store doser á 4,5 g ved op-eller nedjustering i intervaller på 1,5 g/dag (dvs. 0,75 g/dosis).
English: After dilution in the dosing cups, the preparation should be used within 24 hours.
Danish: Efter fortynding i doseringsbægeret, skal opløsningen indtages inden for 24 timer.
English: After dilution in the dosing cups the preparation should be used within 24 hours.
Danish: Efter fortynding i doseringsbægrene skal opløsningen indtages inden for 24 timer.
English: Psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behaviour), paranoia, abnormal thinking, hallucination, agitation, suicide attempt, difficulty in falling asleep, restless legs, forgetfulness, myoclonus (involuntary contractions of muscles), involuntary passage of faeces, hypersensitivity
Danish: Psykose (en mental lidelse, som kan medføre hallucinationer, usammenhængende tale eller desorienteret og ophidset opførsel), paranoia, unormal tankevirksomhed, hallucinationer, ophidselse,
English: The combined use of alcohol, or any CNS -depressant medicinal product, with sodium oxybate may result in potentiation of the CNS-depressant effects of sodium oxybate as well as increased risk of respiratory depression.
Danish: • Alkohol og CNS-supprimerende lægemidler Kombineret brug af alkohol eller ethvert CNS-supprimerende lægemiddel og natriumoxybat kan resultere i potensering af natriumoxybats CNS-supprimerende virkning.
English: Each mL of solution contains 500 mg of sodium oxybate.
Danish: Hver ml opløsning indeholder 500 mg natriumoxybat.
English: Each mL of solution contains 500 mg sodium oxybate
Danish: Hver ml opløsning indeholder 500 mg natriumoxybat
English: Treatment Group Number of Subjects
Danish: Behandlingsgruppe
English: For storage conditions after first opening of the medicinal product, see section 6.3 For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: Possible side effects
Danish: Sekundær effekt
English: Major depression is contraindicated for use with Xyrem (section 4.3).
Danish: Brug af Xyrem er kontraindiceret til patienter med major depression (pkt.
English: Possible pharmacodynamic and pharmacokinetic interactions when sodium oxybate is used concomitantly with topiramate cannot be excluded as clinical observation(s) of coma, and increased plasma GHB concentration were reported in a patient(s) under concomitant use of sodium oxybate and topiramate (section 4.4).
Danish: Da der har været klinisk(e) observation(er) af koma og forhøjet GBH-plasmakoncentration hos patienter efter samtidig administration af natriumoxybat og topiramat, kan mulige farmakodynamiske og farmakokinetiske interaktioner ikke udelukkes ved samtidig administration af natriumoxybat og topiramat (se pkt.
English: Gastric lavage may be considered if co-ingestants are suspected.
Danish: Ventrikelskylning bør overvejes ved mistanke om samtidig indtagelse af andre stoffer.
English: Not known: pollakiuria / micturition urgency, nocturia
Danish: Ikke kendt: urticaria, angioødem, seborrhea
English: Common: sleep paralysis, somnolence, tremor, balance disorder, disturbance in attention, hypoesthesia, paraesthesia, sedation, dysgeusia Uncommon: myoclonus, amnesia, restless legs syndrome Not known: convulsion, loss of consciousness, dyskinesia
Danish: Almindelig: søvn paralyse, somnolens, tremor, balanceproblemer, opmærksomhedsforstyrrelser, hypæstesi, paræstesi, sedation, dysgeusi
English: When the bottle is delivered, there is a plastic covered foil seal which is on the top of the bottle, underneath the cap. Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.
Danish: Hver pakning indeholder en flaske, en flaskeadapter (BIPA), en doseringssprøjte i plast og to doseringsbægre med børnesikre låg.
English: TRIAL 2
Danish: STUDIE 2
English: Studies in male and female rats at doses up to 1,000 mg/kg/day GHB have shown no evidence of an adverse effect on fertility.
Danish: GBH har ikke forårsaget negative virkninger relateret til fertilitet i studier med han- og hunrotter ved doser på op til 1.000 mg/kg/dag.
English: What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem
Danish: Det skal De vide, før De begynder at tage Xyrem Sådan skal De tage Xyrem Bivirkninger
English: Doses should be taken within 24 hours after preparation, or else discarded.
Danish: Efter fortynding skal opløsningen indtages inden for 24 timer; hvis opløsningen ikke anvendes inden for 24 timer, skal den kasseres.
English: If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended.
Danish: 4.5) bør dosis af natriumoxybat reduceres med 20 %.
English: If you take more Xyrem than you should
Danish: Hvis De har taget for meget Xyrem
English: Cataplexy Attacks
Danish: Mave-tarm-kanalen
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Xyrem til Dem personligt.
English: Number of Subjects
Danish: Antal patienter
English: Renal and urinary disorders Common: enuresis nocturna, urinary incontinence
Danish: Almindelig: natlig enurese, urininkontinens Ikke kendt: pollakisuri/imperiøs vandladning, nykturi
English: It is given once every three weeks as an infusion lasting 10 minutes.
Danish: Det gives hver tredje uge ved en infusion over 10 minutter.
English: Further information on Pemetrexed Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Pemetrexed Krka findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Danish: Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi.
English: The recommended dose of Permetrexed Krka is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis Pemetrexed Krka er 500 mg pr. kvadratmeter kropsoverflade (beregnet ud fra patientens højde og vægt).
English: As for every medicine, the company provided studies on the quality of Pemetrexed Krka.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Pemetrexed Krka.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Krka?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Krka?
English: For more information about using Pemetrexed Krka, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brugen af Pemetrexed Krka, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Pemetrexed Krka has been shown to be comparable to Alimta.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Krka kan sammenlignes med Alimta.
English: Side effects reported with Pemetrexed Krka are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Pemetrexed Krka vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Because Pemetrexed Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pemetrexed Krka er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Krka.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Alimta, og de behøver ikke at blive gentaget for Pemetrexed Krka.
English: What are the benefits and risks of Pemetrexed Krka?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed Krka?
English: There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Krka is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Pemetrexed Krka optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: Pemetrexed Krka is a cancer medicine used to treat two types of lung cancer:
Danish: Pemetrexed Krka er et kræftlægemiddel til behandling af to typer af lungekræft:
English: This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Alimta.
Danish: Det betyder, at Pemetrexed Krka indeholder det samme aktive stof og virket på samme måde som et "referencelægemidlet", som allerede er godkendt i EU, og som hedder Alimta.
English: Other information about Pemetrexed Krka
Danish: Andre oplysninger om Pemetrexed Krka
English: An overview of Pemetrexed Krka and why it is authorised in the EU
Danish: Oversigt over Pemetrexed Krka, og hvorfor det er godkendt i EU
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Danish: • fremskreden ikkesmåcellet lungekræft af typen ikke-pladecellekarcinom, hvor det anvendes enten i kombination med cisplatin hos tidligere ubehandlede patienter eller som enkeltstofbehandling hos patienter, der tidligere har fået kræftbehandling.
English: What is Pemetrexed Krka and what is it used for?
Danish: Hvad er Pemetrexed Krka, og hvad anvendes det til?
English: Why is Pemetrexed Krka authorised in the EU?
Danish: Hvorfor er Pemetrexed Krka godkendt i EU?
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes involved in producing nucleotides (the building blocks of DNA and RNA, the genetic material of cells).
Danish: I kroppen omdannes pemetrexed til en aktiv form, der blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i DNA og RNA, cellernes genetiske materiale).
English: Therefore, the Agency's view was that, as for Alimta, the benefit of Pemetrexed Krka outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene af Pemetrexed Krka opvejer de identificerede risici, som for Alimta, og at det kan godkendes til anvendelse i EU.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Danish: • malignt pleuramesoteliom (kræft i lungehinderne, der sædvanligvis skyldes udsættelse for asbest), hvor det anvendes sammen med cisplatin hos patienter, der ikke tidligere har fået kemoterapi, og hos hvem kræften ikke kan fjernes ved operation
English: As for all medicines, data on the use of Pemetrexed Krka are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Pemetrexed Krka løbende overvåget.
English: Pemetrexed Krka contains the active substance pemetrexed.
Danish: Pemetrexed Krka indeholder det aktive stof pemetrexed.
English: This slows down the division of cancer cells, while normal cells are only slightly affected.
Danish: Det får kræftcellerne til at dele sig langsommere, men har kun ringe virkning på normale celler.
English: This is because Pemetrexed Krka is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Pemetrexed Krka gives som infusion i en vene, så det aktive stof leveres direkte ind i blodbanen.
English: The active substance in Pemetrexed Krka, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Danish: Det aktive stof i Pemetrexed Krka, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
English: When Pemetrexed Krka is given with cisplatin, an antiemetic medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Pemetrexed Krka gives sammen med cisplatin, bør der desuden før og efter cisplatindosen gives medicin mod kvalme (for at forhindre opkastning) samt væsketilskud (for at forhindre dehydrering).
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Krka.
Danish: For at mindske bivirkningerne ved bør patienten under behandlingen med Pemetrexed Krka få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med B12vitamin.
English: How has Pemetrexed Krka been studied?
Danish: Hvordan er Pemetrexed Krka blevet undersøgt?
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood cell counts are low or who have certain other side effects.
Danish: Hvis patienten får lave blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller standses, eller dosis nedsættes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Krka have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pemetrexed Krka.
English: Pemetrexed Krka is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed Krka fås som et pulver, der efter opløsning indgives ved infusion (drop) i en blodåre.
English: Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Danish: I kræftceller omdannes pemetrexed hurtigere til den aktive form end i normale celler.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing.
Danish: Dannelsen af DNA og RNA bremses derved af den aktive form af pemetrexed.
English: How does Pemetrexed Krka work?
Danish: Hvordan virker Pemetrexed Krka?
English: How is Permetrexed Krka used?
Danish: Hvordan anvendes Pemetrexed Krka?
English: The procedure started on 17 October 2002.
Danish: Proceduren indledtes den 17. oktober 2002.
English: The CPMP adopted a positive opinion on 20 February 2003.
Danish: CPMP vedtog derfor en positiv udtalelse den 20. februar 2003.
English: The final opinion was converted into a decision by the European Commission on 25 June 2003.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 25. juni
English: London, 20 August 2003 EMEA/CPMP/4260/03/en
Danish: London, 20 August 2003 EMEA/CPMP/4260/03/da