natgillin/translations-raw huggingface dataset:
Pradaxa må ikke anvendes hos patienter, der får anden blodfortyndende medicin, bortset fra ved skift til anden blodfortyndende medicin, eller hvor heparin (et andet blodfortyndende lægemiddel) anvendes ved specifikke medicinske procedurer.
It must not be used in patients taking any other anticoagulant medicine, except when the anticoagulant medicine is being switched or when heparin (another anticoagulant medicine) is being used in specific medical procedures.
• forebyggelse af slagtilfælde og blodpropdannelse hos voksne, der har såkaldt ikke-valvulær atrieflimren (unormalt hjerteslag), og som vurderes at have risiko for slagtilfælde
• preventing stroke and the formation of clots in adults who have an abnormal heartbeat called ‘nonvalvular atrial fibrillation' and are considered to be at risk of stroke;
• forebyggelse af blodpropdannelse i venerne hos voksne, der har fået udskiftet en hofte eller et knæ
• preventing the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee;
Derudover er de overordnede fordele ved Pradaxa til behandling og forebyggelse af dyb venetrombose og lungeemboli sammenlignelige med warfarins overordnede fordele.
In addition, the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin.
Den fuldstændige liste over alle indberettede bivirkninger ved Pradaxa fremgår af indlægssedlen.
For the full list of all side effects reported with Pradaxa, see the package leaflet.
Pradaxa var lige så effektivt som warfarin til at reducere dannelsen af blodpropper i venerne (dyb venetrombose) eller lungerne (lungeemboli) samt forekomsten af blodproprelaterede dødsfald under behandling.
Pradaxa was as effective as warfarin in reducing formation of blood clots in the veins (DVT) or lungs (PE), or blood-clot-related death during treatment.
Pradaxa må ikke gives til patienter, der har svært nedsat nyrefunktion, der har aktuel kraftig blødning, eller som har en sygdom, der betyder, at de har betydelig risiko for større blødningshændelser.
Pradaxa must not be used in patients who have severely reduced kidney function, who are currently bleeding significantly or who have a condition putting them at significant risk of major bleeding.
I to hovedstudier var Pradaxa (220 eller 150 mg pr. dag) lige så effektivt som enoxaparin (et blodfortyndende lægemiddel, der indgives ved injektion) til at forebygge dannelsen af blodpropper eller dødsfald hos patienter, der havde fået udskiftet en hofte eller et knæ.
Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies.
Hvilke fordele viser studierne, at der er ved Pradaxa?
What benefits of Pradaxa have been shown in studies?
• behandling af dyb venetrombose (blodprop i en dyb vene, typisk i benet) og lungeemboli (blodprop i en lunge-arterie) hos voksne samt forebyggelse af ny dyb venetrombose og lungeemboli.
• treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.
Hvordan virker Pradaxa?
How does Pradaxa work?
Andelen af patienter pr. år, der fik et slagtilfælde eller andre problemer forårsaget af blodpropper, var ca. 1,5 % for de patienter, der fik 110 mg Pradaxa (183 ud af 6.015), og 1,1 % for de patienter, der fik 150 mg Pradaxa (135 ud af 6.076), sammenholdt med 1,7 % for de patienter, der fik warfarin (203 ud af 6.022).
The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1.5% for patients taking 110 mg Pradaxa (183 patients out of 6,015) and 1.1% for patients taking 150 mg Pradaxa (135 out of 6,076), compared with 1.7% for patients taking warfarin (203 out of 6,022).
Patienter, der får udskiftet en hofte eller et knæ, har høj risiko for at få blodpropper i venerne i benet.
Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in their leg veins.
Desuden bør nyrefunktionen vurderes hos alle patienter inden påbegyndelse af behandling for at udelukke patienter med svært nedsat nyrefunktion.
In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pradaxa.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pradaxa have also been included in the summary of product characteristics and the package leaflet.
4.200 voksne med symptomer på tilbagefald af blodpropper, og som var i langtidsbehandling med blodtyndende medicin.
Another two studies looked at the prevention of VTE or PE in around 4,200 adults with symptoms of recurring blood clots and who were on long-term treatment with anticoagulants.
I behandlingsperioden sås blodpropper hos 36 % af de patienter, der fik 220 mg Pradaxa (183 ud af 503), sammenholdt med 38 % af de patienter, der fik enoxaparin (193 ud af 512).
During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512).
I det andet studie sås blodpropper eller blodproprelaterede dødsfald hos 0,4 % af de patienter, der fik Pradaxa (3 ud af 681), sammenholdt med 5,6 % af de patienter, der fik placebo (37 ud af 662).
In the second study, blood clots or blood-clot-related death occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.
I behandlingsperioden sås blodpropper hos 6 % af de patienter, der fik 220 mg Pradaxa (53 ud af 880), sammenholdt med 7 % af de patienter, der fik enoxaparin (60 ud af 897).
During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897).
I det første studie sås blodpropper eller blodproprelaterede dødsfald hos 1,8 % af de patienter, der fik Pradaxa (26 ud af 1.430), sammenholdt med 1,3 % af de patienter, der fik warfarin (18 ud af 1.426).
In the first study, blood clots or blood-clot-related death occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin.
Blodpropper eller blodproprelaterede dødsfald sås hos 2,7 % af de patienter, der fik Pradaxa (68 ud af 2.553), sammenholdt med 2,4 % af de patienter, der fik warfarin (62 ud af 2.554).
Blood clots or blood-clot-related death occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.
I et studie hos patienter med ikke-valvulær atrieflimren, der vurderedes at have risiko for slagtilfælde, var Pradaxa (110 mg eller 150 mg to gange dagligt) lige så effektivt som warfarin (et andet blodfortyndende lægemiddel, der indgives gennem munden) til at forebygge slagtilfælde eller blodpropper i blodårerne i andre dele af kroppen.
Pradaxa (110 mg or 150 mg twice a day) was as effective as warfarin (another anticoagulant given by mouth) in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
• maksimal livstidsdosis
• life-time maximum dose
Indehaverne af markedsføringstilladelse for Novantrone og relaterede navne forelægger en risikostyringsplan for referencemedlemsstaten med de hovedelementer, der er beskrevet i CHMP's vurderingsrapport.
The Marketing Authorisation Holders of Novantrone and associated names shall submit for assessment to the Reference Member State a Risk Management Plan containing key elements as described in the CHMP assessment report.
Indehaveren (indehaverne) af markedsføringstilladelse sikrer, at i hver medlemsstat, hvor Novantrone og relaterede navne markedsføres, har alle sundhedspersoner og patienter/omsorgsgivere, der forventes at ordinere og dispensere eller anvende Novantrone til behandling af multipel sklerose, adgang til/får udleveret følgende informationspakke:
The Marketing Authorisation Holder(s) shall ensure that in each Member State where Novantrone and associated names are marketed, all healthcare professional (HCP) and patients/carers who are expected to prescribe and dispense or use Novantrone in treatment of multiple sclerosis have access to/are provided with the following educational package:
• Novantrone kan medføre kardiotoksicitet o nødvendigheden af et ekkokardiogram eller bestemmelse ved multiple-gated acquisition (MUGA) af venstre ventrikels uddrivningsfraktion før administration af hver dosis og årligt i indtil 5 år efter afslutningen af behandlingen.
• Novantrone could cause cardiotoxicity o need for echocardiogram or multiple-gated acquisition (MUGA) evaluation of the left-ventricular ejection fraction (LVEF) prior to administration of each dose and yearly for up to 5 years after the end of therapy.
• tegn og symptomer på kardiotoksicitet og hæmatotoksicitet
• signs and symptoms of cardiotoxicity and haematotoxicity
• bestemmelse af venstre ventrikels uddrivningsfraktion
• evaluation of the left-ventricular ejection fraction (LVEF)
• Novantrone kan medføre hæmotoksicitet, herunder sekundær akut myeloid leukæmi og myelodysplastisk syndrom o nødvendigheden af overvågning ved behandlingens påbegyndelse og før hver administration af behandlingen checkliste til sundhedspersoner med følgende hovedelementer:
• Novantrone could cause haematotoxicity, including secondary acute myeloid leukaemia and myelodysplastic syndrome o the need for monitoring at the start and prior to each treatment administration
• vigtigste tegn og symptomer på kardiotoksicitet og hæmatotoksicitet
• key signs and symptoms regarding cardiotoxicity and haematotoxicity
• information om nødvendigheden af regelmæssig overvågning for kardiotoksicitet og hæmatotoksicitet, og hvornår den bør foretages patientkort med følgende hovedelementer:
• Information on the need of regular monitoring, and when it should be carried out, for cardiotoxicity and haematotoxicity
• fuldstændig blodtælling, herunder trombocytter skriftlig information til patienterne med følgende hovedelementer:
• full blood count including platelets
brochure til sundhedspersoner, der indeholder følgende hovedelementer:
HCP brochure including the following key-elements:
Forventet rekrutteringsperiode er 18 måneder.
The expected recruitment period is 18 months.
Vis dem pakningen.
Show them the package.
Den endelige study report vil være tilgængelig 6 måneder efter sidste patientbesøg i undersøgelsen.
The final study report will be available 6 months after the last patient visit in the study.
Tag ikke flere tabletter end lægen har anbefalet.
Do not take more tablets than your doctor has recommended.
Husk at tage medicinen.
Remember to take your medicine.
Tag Adartrel en gang daglig, hver dag og omtrent på samme tidspunkt hver dag.
Take ADARTREL once a day by mouth, every day at about the same time each day.
Lægen vil afgøre hvilken dosis du skal tage hver dag, og du bør altid følge lægens anvisninger.
Your doctor will decide on the dose you need to take each day and you should follow the doctor's instructions.
Der blev udstedt en markedsføringstilladelse for Ropirinol af Frankrig den 30. juni 2004.
Ropirinol has been granted a marketing authorisation by France on 30 June 2004.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ADARTREL (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ADARTREL (see Annex I)
Modul 5 - Clinical
Module 5 - Clinical
Adartrel er ikke anbefalet til brug hos børn under 18 år p.g.a. mangel på data vedrørende sikkerhed og effekt.
ADARTREL is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Adartrel kan tages sammen med eller uden mad.
You can take ADARTREL with or without food.
Biotilgængeligheden af ropinirol varierer betydeligt mellem individer.
The bioavailability of ropinirole varies greatly between individuals.
Behandlingsinitiering (uge 1)
Treatment initiation (week 1)
Bivirkninger skal følges nøje.
Undesirable effects should be closely monitored.
Anden erfaring med ropinirol
Other experience with ropinirole
• hvis du stopper eller begynder på at ryge mens du tager Adartrel.
- you give up or start smoking while taking ADARTREL.
Det ændrede produktresumé vedtages af CHMP.
The amended SPC is endorsed by the CHMP.
Du bør fortsætte med at tage din medicin selvom du ikke får det bedre, da det kan tage et antal uger inden den virker.
You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work for you.
Ropinirol kan tages sammen med mad for at forbedre gastrointestinal tolerance.
Ropinirole may be taken with food, to improve gastrointestinal tolerance.
Der blev ingen klinisk signifikant effekt observeret på QT-intervallet.
No clinically significant effect on the QT interval was observed.
Patientens respons på ropinirol bør evalueres efter 3 måneders behandling (se afsnit 5.1).
The patient's response to ropinirole should be evaluated after 3 months treatment (see section 5.1).
Dosisforøgelse bør være gradvis og titreres mod det symptomatiske respons.
The increase in dosage should be gradual and titrated against the symptomatic response.
De bivirkninger, der er specifikke for RLS-patienter, såsom augmentation og reboundeffekter, er blevet drøftet.
The adverse events that are specific to RLS patients, such as augmentation and rebound effects have been discussed.
På grund af risiko for hypotension, bør patienter med alvorlig kardiovaskulær sygdom (specielt hjerteinsufficiens) behandles med forsigtighed.
Due to the risk of hypotension, patients with severe cardiovascular disease (in particular coronary insufficiency) should be treated with caution.
Meget sjældent er der set ændret leverfunktion (unormale blodprøver).
Very rarely, cases of altered liver function (abnormal blood tests) have been reported.
Hos patienter over 65 år er reduktion af den systemiske clearance af ropinirol med omkring 30% mulig.
In patients over 65 years of age, a reduction in the systemic clearance of ropinirole by about 30% is possible.
Efter behandlingsinitiering øges daglig dosis indtil optimal terapeutisk respons opnås.
Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved.
Eliminationshalveringstiden for ropinirol er gennemsnitlig 6 timer.
The elimination half-life of ropinirole is 6 hours on average.
Fortæl lægen hvis du oplever bivirkninger som bekymrer dig.
Tell your doctor if you notice any side effects and they worry you.
Anvend ikke efter udløbsdatoen, som er angivet på æsken flasken.
Do not use ADARTREL after the expiry date which is stated on the carton.
Størstedelen af patienterne i de kliniske forsøg var af kaukasisk oprindelse.
In clinical studies most patients were of Caucasian origin.
Hvis behandlingen afbrydes i mere end et par dage bør re-initiering ske med dosistitrering som beskrevet ovenfor.
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Patienter der er intolerante over for laktose, skal lægge mærke til, at hver Adartrel tablet indeholder en lille mængde lactose.
Patients who are intolerant to lactose should note that each ADARTREL tablet contains a small amount of lactose.
Brug af Adartrel til børn med Restless Legs Syndrome er ikke undersøgt og derfor ordineres Adartrel normalt ikke til børn under 18 år.
The use of ADARTREL in children with Restless Legs Syndrome has not been studied and therefore ADARTREL is not usually prescribed in patients under 18 years of age.
Vigtige oplysninger om visse af indholdsstofferne i Adartrel
Important information about some of the ingredients of ADARTREL
• du får Adartrel, og lægen vil ordinere dig anden medicin.
- you are taking ADARTREL and the doctor is going to prescribe you any other medicine.
Inden afslutningen af den gensidige anerkendelses-procedure indbragte Spanien og Nederlandene en sag for EMEA ud fra den betragtning, at dette lægemiddel muligvis udgør en risiko for folkesundheden, eftersom sikkerhed og virkning for ropinirol til langtidsbehandling af Restless Legs Syndrome (RLS) efter deres opfattelse ikke er påvist.
Before the end of a mutual recognition procedure, Spain and the Netherlands, presented to the EMEA a referral considering that this medicinal product might present a risk to public health since they were of the opinion that safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
Disse påvirkninger anses for at være et species relateret fænomen og giver ikke anledning til risiko ved klinisk anvendelse af ropinirol.
These lesions are considered to be a species specific phenomenon and do not constitute a hazard with regard to the clinical use of ropinirole.
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Sammen med mad bliver Cmax forsinket omkring 2,6 time og peak plasma niveau reduceres med 25% uden effekt på den mængde der er biotilgængelig.
In the presence of food, Cmax is delayed by about 2.6 hours and the peak plasma level is reduced by 25%, with no effect on the bioavailable quantity.
Når du starter med at tage Adartrel, vil dosis blive øget gradvist.
When you first start taking ADARTREL, the dose you take will be increased gradually.
Ropinirols plasma proteinbinding er ikke høj (<40%) og uden effekt på distributionen som er meget udtalt (distributionsvolumen er af størrelsesordenen 7 l/kg).
The binding of ropinirole to plasma proteins is not high (<40%), with no effect on the distribution, which is very extensive (volume of distribution in the order of 7 l/kg).
Ikke almindelige bivirkninger er forvirring og oplevelse af hallucinationer.
Uncommon side effects are feeling confused and experiencing hallucinations.
De spørgsmål, der blev drøftet, vedrørte oplysninger om virkning i de kliniske undersøgelser, navnlig hos andelen af patienter med en funktionel påvirkning samt langtidsvirkningen, sikkerheden og benefit/risk-forholdet.
The issues discussed included the efficacy data provided in the clinical trials, particularly in the subset of patients having a functional impact and the long-term efficacy and safety as well as the benefit-risk ratio.
På dette tidspunkt bør dosis og behovet for fortsat behandling overvejes.
At this time the dose prescribed and the need for continued treatment should be considered.
Du bør konsultere din læge eller apotek, hvis du er usikker.
You should check with your doctor or pharmacist if you are not sure.
Hver pakke indeholder 2 eller 12 tabletter.
Each pack contains 2 or 12 tablets.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Ikke relevant
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Patienter med svære psykotiske lidelser bør kun behandles med dopaminagonister, såfremt potentielle fordele opvejer risici.
Patients with major psychotic disorders should not be treated with dopamine agonists unless the potential benefits outweigh the risks.
Ropinirolclearance er nedsat hos patienter over 65 år.
The clearance of ropinirole is decreased in patients over 65 years of age.
Forøgede plasmakoncentrationer af ropinirol er blevet observeret hos patienter behandlet med HRT (Hormone Replacement Therapy).
Increased plasma concentrations of ropinirole have been observed in patients treated with hormone replacement therapy.
Dette forekommer når man hviler sig eller er inaktiv, for eksempel når man sidder eller ligger ned, og er værst om aftenen eller om natten.
These feelings occur during periods of rest or inactivity such as sitting or lying down, especially in bed, and are worse in the evening or at night.
Tolerabilitetsprofilen for ropinirol skal i denne patientpopulation ifølge dokumentationen analyseres på baggrund af den fysiske tilstand, som i væsentlig grad påvirker patienternes livskvalitet, hvilket navnlig skyldes, at RLS-patienter lider af kronisk søvnløshed.
According to the literature, the tolerability profile of ropinirole in this population of patients must be analysed in the context of a physical condition that significantly affects the quality of life of patients mainly due to the fact that RLS patients suffer with chronic insomnia.
Meget sjældne (<1/10.000) tilfælde af leverreaktioner, primært øgning af leverenzymer, er rapporteret.
Very rare cases of hepatic reactions (<1/10,000), mainly increase of liver enzymes, have been reported.
Hvis du har en fornemmelse af, at virkningen af Adartrel er for kraftig eller for svag, så tal med lægen eller apoteket om det.
If you have the impression that the effect of ADARTREL is too strong or too weak, talk to your doctor or pharmacist.
Tel +33 1 39 178000 <[Se bilag I - Udfyldes nationalt]>
France tel +33 1 39 178000 [See Annex I- to be completed nationally] 8 MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Det kan være nødvendigt at justere dosis
Your doctor may need to adjust your dose.
Der er blevet fremlagt en indgående vurdering af de mest almindelige bivirkninger i målgruppen (scoringsresultat ved baseline på 24-40 point).
A detailed assessment of the most common adverse events in the target population (IRLS baseline score 24-40 points) has been provided.
Det antages, at symptomerne på overdosering med ropinirol er relateret til dets dopaminerge aktivitet.
It is anticipated that the symptoms of ropinirole overdose will be related to its dopaminergic activity.
Under behandling med Adartrel skal du være særlig opmærksom, hvis du skal køre eller håndtere maskiner.
During treatment with ADARTREL take special care when you drive or operate machinery.
Patienterne skal imidlertid informeres om dette fænomen, og de bør rådes til at være forsigtige, hvis de fører motorkøretøj eller betjener maskiner, mens de er i behandling med Ropinirol.
Nevertheless, patients must be informed of this phenomenon and advised to exercise caution while driving or operating machines during treatment with ropinirole.
Behandlingsregime (uge 2 og fremefter)
Therapeutic regimen (week 2 onwards)
Disse symptomer kan lindres ved relevant behandling med dopamin antagonister såsom neuroleptika eller metoklopramid.
These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.
Individuel dosistitrering anbefales i henhold til effekt og tolerans.
Individual dose titration against efficacy and tolerability is recommended.
Toksikologi: Den toksikologiske profil er pricipielt bestemt af lægemidlets farmakologiske profil: adfærdsændringer, hypoprolactæmi, fald i blodtryk og hjertefrekvens, ptose og spytafsondring.
Toxicology: The toxicology profile is principally determined by the pharmacological activity of the drug: behavioural changes, hypoprolactinaemia, decrease in blood pressure and heart rate, ptosis and salivation.
Doser over 4 mg en gang daglig er ikke undersøgt i Restless Legs Syndrome patienter.
Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
I den moderate til svære RLS-population ses fordelene ved behandling med ropinirol i alle resultatermålt på en ensartet måde.
In the moderate to severe RLS population the benefit of treating with ropinirole is seen in all outcomes measured in a consistent way.