natgillin/translations-raw huggingface dataset:
4.2) bør den ordinerende læge være opmærksom på, at søvnapnø forekommer hos op til 50 % af patienter med narkolepsi.
Before increasing the sodium oxybate dose (see section 4.2), prescribers should be aware that sleep apnoea occurs in up to 50% of patients with narcolepsy.
Når Xyrem tages sammen med valproat, er den sædvanlige begyndelsesdosis af Xyrem 3,6 g/dag givet som to lige store doser på hver 1,8 g. Tag den første dosis ved sengetid og den anden dosis 2½ til 4 timer senere.
The recommended starting dose for Xyrem, when used together with valproate, is 3.6 g/day, given as two equally divided doses of 1.8 g. Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Den initiale dosis bør halveres til alle patienter med nedsat leverfunktion, og respons på dosisøgninger skal monitoreres nøje (se pkt.
The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.2).
Søvnproblemer herunder søvnløshed, sløret syn, hjertebanken, opkastning, mavesmerter, diarré, anoreksi, nedsat appetit, vægttab, mathed, unormale drømme, træthed, følelse af beruselse, søvnlammelse, søvnighed, rystelser, forvirring/desorientering, mareridt, søvngængeri, sengevædning, svedeture, depression, muskelkramper, hævelse, faldtendens, ledsmerter, rygsmerter, overdreven søvnighed i dagtimerne, balanceforstyrrelser, opmærksomhedsforstyrrelser, nedsat følsomhed over for berøring, unormal følsomhed ved berøring, følelse af "prikken og stikken" (en del af kroppen (typisk en fod eller en hånd) begynder at snurre og bliver følelsesløs eller "falder i søvn"), sløvhed, smagsforstyrrelser, angst, problemer med at falde i søvn midt om natten, nervøsitet, følelse af at ”snurre rundt” (svimmelhed), ufrivillig vandladning, åndenød, snorken, tilstoppet næse, udslæt, bihulebetændelse, betændelse i næse og svælg, forhøjet blodtryk.
Sleeping problems including insomnia, blurred vision, feeling the heartbeat, vomiting, stomach pains, diarrhoea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, tiredness, feeling drunk, sleep paralysis, sleepiness, trembling, confusion/ disorientation, nightmares, sleep walking, bed wetting, sweating, depression, muscle cramps, swelling, fall, joint pain, back pain, excessive daytime sleepiness, balance disorder, disturbance in attention, decreased sensitivity particularly to touch, abnormal touch sensation, feeling of “pins and needles” (part of the body (typically a foot or hand) begins to tingle and becomes numb, or"falls asleep" sedation, abnormal taste, anxiety, difficulty in falling asleep in the middle of the night, nervousness, feeling of “spinning” (vertigo), urinary incontinence, shortness of breath, snoring, congestion of the nose, rash, inflammation of the sinuses, inflammation of nose and throat, increased blood pressure
Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat og ibuprofen.
Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Ældre patienter skal monitoreres nøje for hæmning af motoriske og/eller kognitive funktioner under behandling med natriumoxybat (se pkt.
Elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate (see section 4.4).
Spørg på apoteket, hvordan De skal aflevere medicinrester.
Ask your pharmacist how to dispose of medicines you no longer use.
Når højere doser på op til 9 g natriumoxybat/dag kombineres med højere doser hypnotikum (inden for det anbefalede dosisinterval) kan farmakodynamiske interaktioner med symptomer på CNS-depression og/eller respirationsdepression ikke udelukkes (se pkt.
When higher doses up to 9 g/d of sodium oxybate are combined with higher doses of hypnotics (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see section 4.3).
Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat og diclofenac.
Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Fjern låget fra det første doseringsbæger ved at trykke den børnesikre låsetap ned og drej låget mod uret (mod venstre).
Remove the cap from the first dosing cup by pressing down on the childresistant locking tab and turning the cap anticlockwise (to the left).
Luftveje, thorax og mediastinum Almindelig: dyspnø, snorken, nasal kongestion Ikke kendt: respirationsdepression, søvnapnø
Respiratory, thoracic and mediastinal disorders Common: dyspnoea, snoring, nasal congestion Not known: respiratory depression, sleep apnoea
Kombineret brug af alkohol og natriumoxybat kan resultere i forstærkning af natriumoxybats CNSdepressive virkning.
The combined use of alcohol with sodium oxybate may result in potentiation of the central nervous system-depressant effects of sodium oxybate.
Knogler, led, muskler og bindevæv Almindelig: artralgi, muskelspasmer, rygsmerter
Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Tag altid Xyrem nøjagtigt efter lægens eller apotekspersonalets anvisning.
Always take this medicine exactly as your doctor or pharmacist has told you.
Derfor bør patienter advares mod at bruge topiramat sammen med natriumoxybat (se pkt.
Therefore, patients should be warned against the use of topiramate in conjunction with sodium oxybate (section 4.5).
Som en hjælp indeholder Xyrem-æsken 1 flaske lægemiddel, en målesprøjte og to doseringsbægre med børnesikkert låg.
To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
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.
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).
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.
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.
Er De i tvivl, så spørg lægen eller på apoteket.
- If you have any further questions, ask your doctor or your pharmacist.
Ophør med Xyrem-behandlingen
Discontinuation of Xyrem
Xyrem 500 mg/ml oral opløsning Natriumoxybat
Xyrem 500 mg/mL oral solution Sodium oxybate
Flaskelåget fjernes ved at trykke det ned, mens det drejes mod uret (mod venstre).
Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left).
Der er rapporteret søvngængeri hos patienter, som i kliniske studier er behandlet med natriumoxybat.
Sleepwalking has been reported in patients treated in clinical trials with sodium oxybate.
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).
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).
Et interaktionsstudie hos raske voksne viste ingen farmakokinetisk interaktion mellem natriumoxybat (enkelt dosis på 4,5 g) og modafinil (enkelt dosis på 200 mg).
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).
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.
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
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.
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.
CGIc - Clinical Global Impression of Change (klinisk global vurdering af ændring); FOSQ - Functional Outcomes of Sleep Questionnaire (funktionelle resultater fra spørgeskema om søvn)
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
Krampeanfald er set hos patienter behandlet med natriumoxybat.
Seizures have been observed in patients treated with sodium oxybate.
• Topiramat
• Topiramate
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.
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.
Hver ml indeholder 500 mg natriumoxybat.
Each mL contains 500 mg of sodium oxybate.
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.
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.
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).
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).
Efter fortynding i doseringsbægeret, skal opløsningen indtages inden for 24 timer.
After dilution in the dosing cups, the preparation should be used within 24 hours.
Efter fortynding i doseringsbægrene skal opløsningen indtages inden for 24 timer.
After dilution in the dosing cups the preparation should be used within 24 hours.
Psykose (en mental lidelse, som kan medføre hallucinationer, usammenhængende tale eller desorienteret og ophidset opførsel), paranoia, unormal tankevirksomhed, hallucinationer, ophidselse,
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
• 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.
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.
Hver ml opløsning indeholder 500 mg natriumoxybat.
Each mL of solution contains 500 mg of sodium oxybate.
Hver ml opløsning indeholder 500 mg natriumoxybat
Each mL of solution contains 500 mg sodium oxybate
Behandlingsgruppe
Treatment Group Number of Subjects
Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
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.
Sekundær effekt
Possible side effects
Brug af Xyrem er kontraindiceret til patienter med major depression (pkt.
Major depression is contraindicated for use with Xyrem (section 4.3).
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.
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).
Ventrikelskylning bør overvejes ved mistanke om samtidig indtagelse af andre stoffer.
Gastric lavage may be considered if co-ingestants are suspected.
Ikke kendt: urticaria, angioødem, seborrhea
Not known: pollakiuria / micturition urgency, nocturia
Almindelig: søvn paralyse, somnolens, tremor, balanceproblemer, opmærksomhedsforstyrrelser, hypæstesi, paræstesi, sedation, dysgeusi
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
Hver pakning indeholder en flaske, en flaskeadapter (BIPA), en doseringssprøjte i plast og to doseringsbægre med børnesikre låg.
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.
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.
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.
Det skal De vide, før De begynder at tage Xyrem Sådan skal De tage Xyrem Bivirkninger
What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem
Efter fortynding skal opløsningen indtages inden for 24 timer; hvis opløsningen ikke anvendes inden for 24 timer, skal den kasseres.
Doses should be taken within 24 hours after preparation, or else discarded.
4.5) bør dosis af natriumoxybat reduceres med 20 %.
If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended.
Hvis De har taget for meget Xyrem
If you take more Xyrem than you should
Mave-tarm-kanalen
Cataplexy Attacks
- Lægen har ordineret Xyrem til Dem personligt.
- This medicine has been prescribed for you only.
Antal patienter
Number of Subjects
Almindelig: natlig enurese, urininkontinens Ikke kendt: pollakisuri/imperiøs vandladning, nykturi
Renal and urinary disorders Common: enuresis nocturna, urinary incontinence
Det gives hver tredje uge ved en infusion over 10 minutter.
It is given once every three weeks as an infusion lasting 10 minutes.
Yderligere information vedrørende Pemetrexed Krka findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Pemetrexed Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi.
It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Den anbefalede dosis Pemetrexed Krka er 500 mg pr. kvadratmeter kropsoverflade (beregnet ud fra patientens højde og vægt).
The recommended dose of Permetrexed Krka is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Pemetrexed Krka.
As for every medicine, the company provided studies on the quality of Pemetrexed Krka.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Krka?
What measures are being taken to ensure the safe and effective use of Pemetrexed Krka?
For mere information om brugen af Pemetrexed Krka, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
For more information about using Pemetrexed Krka, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Krka kan sammenlignes med Alimta.
The European Medicines Agency concluded that, in accordance with EU requirements, Pemetrexed Krka has been shown to be comparable to Alimta.
Bivirkninger rapporteret for Pemetrexed Krka vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Pemetrexed Krka are carefully evaluated and any necessary action taken to protect patients.
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.
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.
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.
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.
Hvilke fordele og risici er der forbundet med Pemetrexed Krka?
What are the benefits and risks of Pemetrexed Krka?
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.
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.
Pemetrexed Krka er et kræftlægemiddel til behandling af to typer af lungekræft:
Pemetrexed Krka is a cancer medicine used to treat two types of lung cancer:
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.
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.
Andre oplysninger om Pemetrexed Krka
Other information about Pemetrexed Krka
Oversigt over Pemetrexed Krka, og hvorfor det er godkendt i EU
An overview of Pemetrexed Krka and why it is authorised in the EU
• 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.
• 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.
Hvad er Pemetrexed Krka, og hvad anvendes det til?
What is Pemetrexed Krka and what is it used for?
Hvorfor er Pemetrexed Krka godkendt i EU?
Why is Pemetrexed Krka authorised in the EU?
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).
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).
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.
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.
• 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
• 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;
Som for alle lægemidler bliver data vedrørende brugen af Pemetrexed Krka løbende overvåget.
As for all medicines, data on the use of Pemetrexed Krka are continuously monitored.
Pemetrexed Krka indeholder det aktive stof pemetrexed.
Pemetrexed Krka contains the active substance pemetrexed.
Det får kræftcellerne til at dele sig langsommere, men har kun ringe virkning på normale celler.
This slows down the division of cancer cells, while normal cells are only slightly affected.
Dette skyldes, at Pemetrexed Krka gives som infusion i en vene, så det aktive stof leveres direkte ind i blodbanen.
This is because Pemetrexed Krka is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Det aktive stof i Pemetrexed Krka, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
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'.