natgillin/translations-raw huggingface dataset:
Det er vist, at naldemedin ikke har nogen klinisk relevante bivirkninger på fertiliteten eller reproduktionsevnen hos han- og hunrotter (se pkt.
Naldemedine was found to have no clinically relevant adverse effects on fertility or reproductive performance in male and female rats (see section 5.3).
Kliniske studier med patienter med cancer og OIC Naldemedins sikkerhed og virkning blev evalueret i 2 randomiserede, dobbeltblindede og placebokontrollerede studier (V9222 og V9236) med patienter med cancer og OIC.
The safety and efficacy of naldemedine was also evaluated in 2 randomised, double-blind and placebocontrolled studies (V9222 and V9236) in patients with cancer and OIC.
Hvis naldemedin anvendes sammen med potente P-gp-hæmmere, skal der overvåges for bivirkninger.
If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions.
Rizmoic 200 mikrogram filmovertrukne tabletter
Rizmoic 200 micrograms film-coated tablets
Overfølsomheda
Hypersensitivitya
Hovedparten af disse gastrointestinale bivirkninger var af let eller moderat sværhedsgrad og gik væk med behandling.
The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved with treatment.
Anvendelse sammen med potente CYP3A-hæmmere og -induktorer Anvendelse af naldemedin sammen med potente CYP3A-hæmmere (f.eks. grapefrugtjuice, itraconazol, ketoconazol, ritonavir, indinavir, saquinavir, telithromycin og clarithromycin) fører til en øget eksponering for naldemedin og kan øge risikoen for bivirkninger.
Concomitant use with strong CYP3A inhibitors and inducers Concomitant use of naldemedine with strong CYP3A inhibitors (e.g. grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin) leads to an increase in naldemedine exposure and may increase the risk of adverse reactions.
Plasmakoncentrationerne af naldemedin hos forsøgspersoner med ESRD med behov for dialyse var ens, hvad enten naldemedin blev administreret før eller efter hæmodialyse.
Plasma concentrations of naldemedine in subjects with ESRD requiring dialysis were similar when naldemedine was administered either pre- or post-haemodialysis, indicating that naldemedine was not removed from the blood by haemodialysis.
Hvis det anvendes sammen med moderate CYP3A-hæmmere, skal der overvåges for bivirkninger.
If used with moderate CYP3A inhibitors, monitor for adverse reactions.
I studie V9235 var de tre mest almindelige former for smerter rygsmerter (58,0 %), osteoartritis (9,5 %) og nakkesmerter (8,1 %).
In Study V9235, the three most common types of pain were back pain (58.0%); osteoarthritis (9.5%) and neck pain (8.1%).
Ændring i hyppighed af SBM'er uden der kræves anstrengelse pr. uge (LS gennemsnit)
Change in frequency of SBMs without straining per week (LS Mean)
Naldemedin (N=97)
Naldemedine (N=97)
** p<0,0001 *** p=0,0003 for studie V9231 og p=0,0011 for studie V9232
CI=Confidence Interval *Statistically significant: p-values based on the Cochran-Mantel-Haenszel test. ** p<0.0001 *** p=0.0003 for study V9231 and p=0.0011 for study V9232
Naldemedin (N=58)
Naldemedine (N=58)
I studie V9231 var de tre mest almindelige former for smerter rygsmerter (62,0 %), nakkesmerter (8,3 %) og osteoartritis (5,3 %).
In Study V9231, the three most common types of pain were back pain (62.0%); neck pain (8.3%) and osteoarthritis (5.3%).
Anvendelse af naldemedin sammen med potente CYP3A-induktorer (f.eks. prikbladet perikon (Hypericum perforatum), rifampin, carbamazepin, phenobarbital og phenytoin) fører til en reduktion i eksponeringen for naldemedin og kan reducere naldemedins virkning.
Concomitant use of naldemedine with strong CYP3A inducers (e.g. St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin) leads to a decrease in naldemedine exposure and may reduce the efficacy of naldemedine.
• øjne, der løber i vand, eller næseflåd
• watery eyes or runny nose
Naldemedin må ikke anvendes til patienter med kendt eller mistænkt mave-tarmobstruktion eller til patienter med en øget risiko for tilbagevendende obstruktion på grund af muligheden for en mave-tarm-perforation.
Naldemedine must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Patienter med kendt eller formodet mave-tarm-obstruktion eller -perforation eller patienter med en øget risiko for tilbagevendende obstruktion på grund af risikoen for mave-tarm-perforation (se pkt.
Patients with known or suspected gastrointestinal obstruction or perforation or patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Naldemedin må ikke anvendes under amning.
Naldemedine should not be used during breast-feeding.
Mave-tarm-perforation
Gastrointestinal perforation
Farmakokinetikken for naldemedin efter administration af en enkelt 200 mikrogram dosis af naldemedin blev undersøgt hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion eller med nyresygdom i slutstadiet (end-stage renal disease, ESRD) med behov for hæmodialyse, og den blev sammenlignet med kinetikken hos raske forsøgspersoner med normal nyrefunktion.
The pharmacokinetics of naldemedine after administration of a single 200 microgram dose of naldemedine was studied in subjects with mild, moderate or severe renal impairment, or with endstage renal disease (ESRD) requiring haemodialysis, and compared with healthy subjects with normal renal function.
Naldemedin bør ikke anvendes hos disse patienter (se pkt.
The use of naldemedine is not recommended in these patients (see section 4.2).
Den maksimale plasmakoncentration og arealet under kurven over plasmakoncentration som funktion af tiden steg næsten dosisproportionalt inden for dosisintervallet fra 0,1 til 100 mg. Der blev observeret en let akkumulation (1 til 1,3-gange) for den maksimale plasmakoncentration og arealet under kurven over plasmakoncentration som funktion af tiden efter flere administrationer af én daglig dosis i fastende tilstand i 10 dage.
The peak plasma concentration and area under the plasma concentration-time curve increased in an almost dose-proportional manner within the dose range of 0.1 to 100 mg. A slight accumulation
• kvalme eller opkastning
• nausea (feeling sick) or vomiting
Skema over bivirkninger
Possible side effects
≤5 SBM'er i løbet af 14 på hinanden følgende dage før randomisering og ≥1 af de følgende tarmsymptomer ved ≥25 % af alle BM'er uanset brugen af behovsafføringsmidler: anstrengelse ved afføring, følelse af ufuldstændig udtømning, passage af hård afføring eller små knolde.
In studies V9222 and V9236, OIC was confirmed through a 2-week run-in period and was defined as ≤5 SBMs during the 14 consecutive days prior to the randomisation and ≥1 of the following bowel symptoms in ≥25% of all BMs regardless of the use of rescue laxatives: presence of straining during bowel movement, feeling of incomplete evacuation, passage of hard stools or small pellets.
• depression
• feeling depressed
Hver filmovertrukket tablet indeholder 200 mikrogram naldemedin (som tosylat).
Each film-coated tablet contains 200 micrograms naldemedine (as tosylate).
Farmakokinetikken for naldemedin hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion eller forsøgspersoner med ESRD med behov for hæmodialyse svarede til den hos raske forsøgspersoner med normal nyrefunktion.
The pharmacokinetics of naldemedine between subjects with mild, moderate or severe renal impairment, or subjects with ESRD requiring hemodialysis and healthy subjects with normal renal function were similar.
Tabletkerne Mannitol (E421) Croscarmellosenatrium Magnesiumstearat
Croscarmellose sodium Magnesium stearate
Naldemedin fjernes ikke fra kroppen ved hæmodialyse.
Naldemedine is not removed from the body by haemodialysis.
- Hver tablet indeholder 200 mikrogram naldemedin (som tosylat).
- Each tablet contains 200 micrograms of naldemedine (as tosylate).
Naldemedin må ikke anvendes til patienter med kendt eller mistænkt mave-tarm-obstruktion eller til patienter med en øget risiko for tilbagevendende obstruktion på grund af muligheden for en mavetarm-perforation (se pkt.
Naldemedine must not be used in patients with known or suspected GI obstruction or in patients at increased risk of recurrent obstruction, due to the potential for GI perforation (see section 4.3).
• udvidede pupiller
• pupils dilating
Sådan skal du tage Rizmoic
How to take Rizmoic
Hver tablet indeholder 200 mikrogram naldemedin (som tosylat).
Each tablet contains 200 micrograms naldemedine (as tosylate).
Abdominalsmertera
Abdominal paina
• smertende muskler
• achy muscles
Naldemedin (N=621)
Naldemedine (N=621)
Alvorlige allergiske reaktioner omfatter: hævelse af hænder, fødder, ankler, ansigt, læber eller halsen, som kan forårsage synkebesvær eller vejrtrækningsproblemer, hudkløe og nældefeber.
• If you experience a serious allergic reaction, stop taking Rizmoic and see a doctor or go to a hospital straight away.. Serious allergic reactions include: swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash.
• søvnløshed
• inability to sleep
Naldemedin (N=276)
Naldemedine (N=276)
Ændring i hyppighed af SBM'er pr. uge (Mindste kvadraters (LS) gennemsnit)
Change in frequency of CSBMs per week (LS Mean)
Hvis det ikke kan undgås at anvende naldemedin sammen med potente CYP3A-hæmmere, skal der overvåges for bivirkninger (se pkt.
If use with strong CYP3A inhibitors is unavoidable, monitor for adverse reactions (see section 4.4).
Kontakt lægen eller apotekspersonalet, før du tager Rizmoic, hvis du er i tvivl.
If you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Farmakokinetikken for naldemedin hos forsøgspersoner med let eller moderat nedsat leverfunktion svarede til farmakokinetikken hos raske forsøgspersoner med normal leverfunktion.
The pharmacokinetics of naldemedine between subjects with mild or moderate hepatic impairment and healthy subjects with normal hepatic function were similar.
• mavesår,
• a stomach ulcer;
Uge 12* Uge 24* Uge 36* Uge 52*
Mean frequency of BMs at baseline Change in the Frequency of BMs per week Week 12* Week 24* Week 36* Week 52* *nominal p≤0.0001
Det skal du vide, før du begynder at tage Rizmoic Sådan skal du tage Rizmoic Bivirkninger
What Rizmoic is and what it is used for What you need to know before you take Rizmoic How to take Rizmoic
Bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Rizmoic 200 mikrogram filmovertrukne tabletter naldemedin
Rizmoic 200 micrograms film-coated tablets naldemedine
Rizmoic 200 mikrogram tabletter naldemedin
Rizmoic 200 micrograms tablets naldemedine
14,8 % var 65 år eller ældre, 62,0 % var kvinder, og 80,2 % var af hvid herkomst.
In Studies V9231, V9232 and V9235, the mean age of the subjects in these three studies was 53.2 years; 14.8% were 65 years of age or older; 62.0% were women; 80.2% were white.
Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
Name and address of the manufacturers responsible for batch release Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
Naldemedin (N=273)
Naldemedine (N=273)
Hvis du har taget for meget Rizmoic
If you take more Rizmoic than you should
Kvalme Opkastning
Hepatic impairment
• svedtendens
Breast-feeding
Imidlertid var der ingen signifikant forskel i vedligeholdelsesfasen.
However, there was no significant difference during the maintenance phase.
* hvis det er nødvendigt
* if needed
Dette mindsker risikoen for, at symptomerne forværres.
This reduces the risk of worsening symptoms.
Dato for seneste fornyelse: 26. august 2013
Date of latest renewal: 26 August 2013
Hyppigheden kan ikke estimeres ud fra forhåndenværende data
Frequency cannot be estimated from the available data
Dato for første markedsføringstilladelse: 18. december 2008
Date of first authorisation: 18 December 2008
Relevansen for mennesker er ukendt.
The relevance for humans is unknown.
I det tilfælde skal du kun tage tabletterne én eller to gange dagligt.
In this case, you will have to take the tablets only once or twice a day.
Laveste vedligeholdelsesdosis Højeste vedligeholdelsesdosis
Lowest maintenance dose Highest maintenance dose
Fortæl det til din læge, hvis dette sker.
You should tell your doctor if this occurs.
Spørg din læge om råd.
Ask your doctor for advice.
I fortsatte, åbne undersøgelser over mere end 3 år var der ikke tegn på aftagende virkning.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Hyppighedskategorien er formentlig ikke større end "ikke almindelig".
The frequency category is probably not greater than “uncommon”.
Mani og delirium
Mania and delirium
Kropssystem Meget almindelig
Body System Very common
Den absolutte biotilgængelighed er større end 90 %, og maksimal plasmakoncentration opnås efter 1-3 timer.
The absolute bioavailability is greater than 90 % and the maximum plasma concentrations occur between 1 and 3 hours.
Dette fund er ikke klinisk relevant for mennesket.
This finding is not clinically relevant to man.
Patienterne bør informeres om, at hallucinationer (hyppigst visuelle) kan forekomme.
Patients should be informed that (mostly visual) hallucinations can occur.
Der kan opstå hallucinationer eller somnolens.
Hallucinations or somnolence can occur.
1 Denne bivirkning er observeret efter markedsføring.
1 This side effect has been observed in post-marketing experience.
Pramipexol absorberes hurtigt og fuldstændigt efter oral administration.
Pramipexole is rapidly and completely absorbed following oral administration.
305 747 70 Opava-Komarov Tjekkiet
747 70 Opava-Komarov Czech Republic
Derefter kan din dosis sættes gradvis op igen på samme måde, som du gjorde første gang.
You can then build up the dose again, as you did the first time.
Yderligere kan en reduktion af dosis eller ophør med behandling overvejes.
Furthermore a reduction of the dose or termination of therapy may be considered.
Inddelingen af disse bivirkninger er baseret på følgende hyppigheder: Meget almindelig:
Evaluation of these side effects is based on the following frequencies:
Pludseligt opstået søvn midt under daglige aktiviteter, i nogle tilfælde uden nogen form for advarsel, har sjældent været rapporteret.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Interaktioner med andre lægemidler, der påvirker plasmaproteinbindingen eller elimineres ved biotransformation er derfor usandsynlig.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Der er ingen klinisk erfaring med massiv overdosering.
There is no clinical experience with massive overdose.
Der er ikke gennemført studier over påvirkningen af human fertilitet.
No studies on the effect on human fertility have been conducted.
Eliminationens halveringstid (t½) varierer mellem 8 timer hos yngre og 12 timer hos ældre.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Indehaveren af markedsføringstilladelsen skal imidlertid fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel, såfremt lægemidlet bliver inkluderet på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Med 95 % sikkerhed er frekvenskategorien ikke højere end "ikke almindelig" og kan være lavere.
With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Der er ikke set en tilsvarende virkning i patientstudier.
Such effect was not observed in patient studies.
Tabletterne bør synkes med vand.
Swallow the tablets with water.
Patienter, som lider af psykotiske lidelser, bør kun behandles med dopaminagonister, hvis de potentielle fordele opvejer risikoen.
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
TEVA UK Ltd. Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG UK
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Plasmaproteinbinding
Plasma protein binding
Hvis du holder op med at tage tabletterne i mere end et par dage og ønsker at begynde igen, skal du igen begynde med den laveste dosis.
If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose.
Patienter skal informeres herom inden nedtrapning af dopaminagonisten og monitoreres regelmæssigt derefter.
Patients should be informed about this before tapering the dopamine agonist, and monitored regularly thereafter.
Neuroleptisk malignt syndrom
Neuroleptic malignant syndrome
Lægen vil rådgive dig om doseringen.
The doctor will advise you on the right dosing.
Hvis problemet varer længere end et par uger, skal din læge muligvis justere din behandling.
If the problems persist more than a few weeks, your doctor may need to adjust your treatment.
Da antikolinergika hovedsageligt elimineres via biotransformation, er den potentielle risiko for interaktion begrænset, selvom interaktion med antikolinergika ikke er blevet undersøgt.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Hos rotter var koncentrationen af radioaktivitet forbundet med det aktive stof højere i modermælk end i plasma.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
• Manglende evne til at modstå trangen eller fristelsen til at udføre en handling, der kan være skadelig for dig selv eller andre, og som kan omfatte:
• Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Opstår der sådanne, så bør dosis af levodopa reduceres.
If they occur, the dose of levodopa should be decreased.
Sidstnævnte fund blev hverken observeret hos pigmenterede rotter eller i albinomus i et karcinogenstudie over 2 år eller hos nogen anden undersøgt dyreart.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Kaplan-Meier-analyse af tid til augmentation viste ingen signifikant forskel mellem pramipexol- og placebogruppen.
Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Den potentielle virkning af pramipexol på den reproduktive funktion er blevet undersøgt hos rotter og kaniner.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Hvis dette sker, kan det være, at lægen vil justere eller ændre din medicin.
If this happens, your doctor may want to adjust or change your medication.
Pramipexol var ikke genotoksisk.
Pramipexole was not genotoxic.
Dosisreduktion/gradvis seponering bør overvejes, hvis sådanne symptomer opstår.
Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Det anbefales at monitorere blodtrykket, særligt i starten af behandlingen, hvilket skyldes den generelle risiko for postural hypotension i forbindelse med dopaminbehandling.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Yderligere dosisjusteringer bør foretages på basis af klinisk respons og forekomst af bivirkninger.
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Det kan tages alene eller sammen med levodopa (medicin til behandling af Parkinsons sygdom).
It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
• Stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser.
• Strong impulse to gamble excessively despite serious personal or family consequences.
Farmakoterapeutisk klassifikation: Anti-Parkinson-lægemiddel, dopaminagonister, ATC-kode: N04BC05
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05
Fortæl din læge, hvis du oplever et sådant adfærdsmønster; han vil diskutere måder til at håndtere eller mindske symptomerne.
Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.
Kombination med levodopa
Combination with levodopa
Ud af disse var ca. 1.000 på mere avancerede stadier, de fik ledsagende levodopaterapi og led af motoriske komplikationer.
Out of these, approximately 1,000 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Meget almindelig: • Kvalme
Very common: • Nausea (sickness)
• Unormale drømme
• Abnormal dreams
Derfor bør du ikke tage Pramipexol Teva, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
Therefore, do not take Pramipexole Teva if you are pregnant unless your doctor tells you to do so.
Stimulation af dopaminreceptorerne påvirker nerveimpulser i hjernen, som kontrollerer kroppens bevægelser.
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
GALIEN LPS 98 rue Bellocier 89100 Sens Frankrig
GALIEN LPS 98 rue Bellocier 89100 Sens France
Patienter som har oplevet somnolens og/eller en episode med pludseligt opstået søvnanfald, må ikke køre bil eller betjene maskiner.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Langtidsvirkningen blev evalueret i et placebokontrolleret klinisk forsøg.
Longer term efficacy was evaluated in a placebo-controlled clinical trial.
Virkningen på graviditet og amning er ikke blevet undersøgt hos mennesker.
The effect on pregnancy and lactation has not been investigated in humans.
Rapporter fra litteraturen indikerer, at behandling af restless legs syndrom med dopaminerge lægemidler kan resultere i augmentation.
Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Restless legs syndrom (RLS) Den sædvanlige dosis tages almindeligvis én gang dagligt, 2-3 timer før sengetid.
Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
Pramipexol Teva bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, f.eks. hvis den potentielle gavn retfærdiggør den potentielle risiko for fostret.
Pramipexole Teva should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Augmentation vil sige, at symptomerne optræder tidligere om aftenen (eller tilmed om eftermiddagen) og at symptomerne forværres og involverer andre ekstremiteter.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Følgende doseringsregime foreslås som begyndelsesterapi:
The following dose schedule is suggested for initiation of therapy:
Hos mennesket er proteinbindingen af pramipexol meget lav (<20 %) og fordelingsvoluminet stort (400 l).
In humans, the protein binding of pramipexole is very low (< 20 %) and the volume of distribution is large (400 l).
• Forandring af søvnmønster, såsom søvnløshed (insomni) og søvnighed
• Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
Det aktive stof er pramipexol.
The active substance is pramipexole.