natgillin/translations-raw huggingface dataset:
- blødning i et led
- Bleeding into a joint
- fald i antallet af blodplader
- A fall in the number of platelets in the blood
- næseblod
- Nose bleed
- blødning i mave eller tarm
- Bleeding into the stomach or bowel
- blødning fra hæmorroider
- Bleeding from piles
- blødning fra endetarmen
- Bleeding into the rectum
- blod i urinen, som farver urinen lyserød eller rød
- Blood in the urine that stains the urine pink or red
- blodudtrædninger
- Bleeding under the skin
- blodigt udflåd fra det sted, hvor et kateter går ind i venen
- Blood-stained discharge from the site of entry of a catheter into a vein
- blødning fra det sted, hvor et kateter går ind i venen
- Bleeding from the site of entry of a catheter into a vein
- blod i afføringen, fundet ved laboratorieanalyse
- Blood detected in the stools by a laboratory test
- fald i andelen af røde blodlegemer i blodet
- A decrease in the proportion of red cells in the blood
- blødning fra operationssåret
- Bleeding from a surgical incision
- unormale leverresultater ud fra de leverprøver, laboratoriet har analyseret
- Unusual laboratory test results on liver function
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller hvis De får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
SÅDAN OPBEVARER DE PRADAXA
HOW TO STORE PRADAXA
Brug ikke Pradaxa efter den udløbsdato, der står på pakningen.
Do not use Pradaxa after the expiry date which is stated on the carton, blister or bottle.
Udløbsdatoen er den sidste dag i den nævnte måned og kan være angivet med EXP.
The expiry date refers to the last day of that month.
Når beholderen er åbnet, skal produktet anvendes i løbet af højst 30 dage.
Once opened, the product must be used within 30 days.
Det aktive stof hedder dabigatran og bliver givet i form af 75 mg eller 150 mg dabigatran- etexilat (som mesilat).
The active substance is dabigatran, which is administered in the form of 75 mg or 110 mg dabigatran etexilate given as mesilate.
Øvrige indholdsstoffer er vinsyre, akaciegummi, hypromellose, dimeticon 350, talkum og hydroxypropylcellulose.
The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose
Selve kapslen består af carrageenan, kaliumklorid, titandioxid (E171), indigocarmin (E132), sunset yellow FCF (E110), hypromellose og renset vand.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, sunset yellow, hypromellose and purified water
Den sorte tryksværte består af shellac, N- butylalkohol, isopropylalkohol, denatureret sprit til industrielt brug, sort jernoxid (E172), renset vand og propylenglycol.
The black printing ink contains shellac, N-butyl alcohol, isopropyl alcohol, industrial methylated spirit, iron oxide black, purified water and propylene glycol
Pradaxas udseende og pakningsstørrelse
What Pradaxa looks like and contents of the pack
Pradaxa fremstilles som hårde kapsler.
Pradaxa is a hard capsule.
Pradaxa 75 mg hårde kapsler har en uigennemsigtig, lyseblå top og en uigennemsigtig flødefarvet bund.
Pradaxa 75 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body.
Boehringer Ingelheims logo er trykt på toppen og ” R75 ” på bunden af kapslen.
The Boehringer Ingelheim logo is printed on the cap and “ R75 ” on the body of the capsule.
Pradaxa 110 mg hårde kapsler har en uigennemsigtig, lyseblå hætte og en uigennemsigtig, flødefarvet bund.
Pradaxa 110 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body.
Boehringer Ingelheims logo er trykt på hætten, og ” R110 ” på bunden af kapslen.
The Boehringer Ingelheim logo is printed on the cap and “ R110 ” on the body of the capsule.
Pradaxa 75 mg og 110 mg, hårde kapsler, fås i pakninger med 10 x 1, 30 x 1, 60 x 1 kapsel i perforerede aluminium- blisterkort.
Pradaxa 75 mg and 110 mg hard capsules are available in packs containing 10 x 1, 30 x 1, 60 x 1 capsules in aluminium perforated unit dose blisters.
Pradaxa 75 mg og 110 mg, hårde kapsler, fås også i polypropylen - (plastik -) beholdere med 60 hårde kapsler.
Pradaxa 75 mg and 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
51 Indehaveren af markedsføringstilladelsen
49 Marketing Authorisation Holder
Fremstiller Boehringer Ingelheim Pharma GmbH & Co.
Boehringer Ingelheim Pharma GmbH & Co.
52 Hvis De vil have yderligere oplysninger om Pradaxa, skal De henvende Dem til den lokale repræsentant:
50 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
53 Italia Boehringer Ingelheim Italia S. p. A.
51 Italia Boehringer Ingelheim Italia S. p. A.
De kan finde yderligere information om Pradaxa på det europæiske lægemiddelagenturs (EMEAs) hjemmeside: http: // www. emea. europa. eu /
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
PRAMIPEXOL TEVA
PRAMIPEXOLE TEVA
Det fås som hvide, runde tabletter (0, 088, 0, 18, 0, 35 og 0, 7 mg).
It is available as white, round tablets (0.088, 0.18, 0.35 and 0.7 mg).
Pramipexol Teva er et ” generisk lægemiddel ”.
Pramipexole Teva is a ‘ generic medicine’.
Det betyder, at Pramipexol Teva er identisk med et ” referencelægemiddel ”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Sifrol.
This means that Pramipexole Teva is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Sifrol.
Pramipexol Teva anvendes til behandling af symptomerne på Parkinsons sygdom, der er en fremadskridende hjernesygdom, som forårsager rysten, langsomme bevægelser og muskelstivhed.
Pramipexole Teva is used to treat the symptoms of Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Pramipexol Teva kan enten anvendes alene eller i kombination med levodopa (et andet lægemiddel til behandling af Parkinsons sygdom) på ethvert stadium af sygdommen, herunder de senere stadier, når levodopa begynder at blive mindre effektivt.
Pramipexole Teva can be used either on its own or in combination with levodopa (another medicine for Parkinson’ s disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Pramipexol Teva- tabletter sluges med vand med eller uden et måltid.
Pramipexole Teva tablets should be swallowed with water, with or without food.
Pramipexol stimulerer hjernen på samme måde som dopamin, så patienten kan styre sine bevægelser
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’ s disease, such as shaking, stiffness and slowness of movement.
Reproduction is authorised provided the source is acknowledged. og har færre tegn og symptomer på Parkinsons sygdom som f. eks. rysten, stive og langsomme bevægelser.
Reproduction is authorised provided the source is acknowledged.
Da Pramipexol Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de to lægemidler producerer samme mængde af det aktive stof i kroppen).
Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Da Pramipexol Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/ risk- forholdet for at være det samme som for referencelægemidlet.
Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Pramipexol Teva i overensstemmelse med EU’ s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Sifrol.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pramipexol Teva til Teva Pharma B. V. den 18. december 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B. V. on 18 December 2008.
Tablet Tablet
Package size
Tablet Tablet Tablet Tablet
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
blister (alu/ alu) tabletbeholder (HDPE) blister (alu/ alu) blister (alu/ alu) - enhedsdosis
blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE) blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE) blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE) blister (alu/ alu) blister (alu/ alu) - unit dose blister (alu/ alu) tablet container (HDPE)
100 tabletter 90 tabletter 30 tabletter 50 x 1 tabletter
30 tablets 50 x 1 tablets 100 tablets 90 tablets 30 tablets 50 x 1 tablets 100 tablets 90 tablets 30 tablets 50 x 1 tablets 100 tablets 90 tablets 30 tablets 50 x 1 tablets 100 tablets 90 tablets
Pramipexol Teva 0, 088 mg tabletter
Pramipexole Teva 0.088 mg tablets
Hver tablet indeholder 0, 088 mg pramipexolbase (som 0, 125 mg pramipexoldihydrochloridmonohydrat).
Each tablet contains 0.088 mg pramipexole base (as 0.125 mg pramipexole dihydrochloride monohydrate).
Hvid, rund, flad tablet med skrå kant, 5, 55 mm diameter, præget med “ 93 ” på den ene side og “ P1 ” på den anden side.
White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “ 93 ” on one side and “ P1” on the other side.
Pramipexol Teva er indiceret til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom, alene (uden levodopa) eller i kombination med levodopa dvs. i hele sygdomsforløbet, ved sene stadier når effekten af levodopa klinger af eller bliver ustadig og svingninger i den terapeutiske effekt opstår ("end of dose" eller "on off" svingninger).
Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “ on off ” fluctuations).
Tabletterne skal indtages peroralt og synkes med vand sammen med eller uden føde.
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Døgndosis bør indtages ligeligt fordelt på 3 gange i døgnet.
The daily dosage is administered in equally divided doses 3 times a day.
Initial dosis:
Initial treatment:
Dosis øges gradvist hver 5 - 7. dag fra en startdosis på 0, 264 mg base (0, 375 mg salt) / døgn.
Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Dosis bør titreres til maksimal terapeutisk effekt, forudsat at patienterne ikke får uacceptable bivirkninger.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Skema for øgning af dosis for Pramipexol Teva
Ascending – Dose schedule of Pramipexole Teva Week
Hvis en yderligere øgning af den daglige dosis er nødvendig, bør den øges med 0, 54 mg base (0, 75 mg salt) ugentligt op til en maksimal døgndosis på 3, 3 mg base (4, 5 mg salt).
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
4. 8)
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Vedligeholdelsesdosis:
2 Maintenance treatment:
2 Den individuelle dosis bør være inden for 0, 264 mg base (0, 375 mg salt) - højst 3, 3 mg base (4, 5 mg salt) / døgn.
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Ved øgning af dosis blev der i 3 kliniske studier observeret effekt allerede ved en døgndosis på 1, 1 mg base (1, 5 mg salt).
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Pramipexol Teva, afhængigt af den enkelte patients reaktioner.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Teva, depending on reactions in individual patients.
Behandlingsophør:
Treatment discontinuation:
Pludseligt ophør af dopaminbehandling kan føre til udvikling af neuroleptisk malignt syndrom.
Abrupt discontinuation of dopaminergic therapy can lead to the development of aneuroleptic malignant syndrome.
Derfor bør pramipexol aftrappes med 0, 54 mg base (0, 75 mg salt) pr. dag, indtil den daglige dosis er blevet reduceret til 0, 54 mg base (0, 75 mg salt).
Therefore, pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Dosering for patienter med nedsat nyrefunktion:
Dosing in patients with renal impairment:
Hos patienter med en kreatininclearance mellem 20 og 50 ml/ min. bør startdosis af Pramipexol Teva fordeles på 2 daglige doser begyndende ved 0, 088 mg base (0, 125 mg salt) 2 gange dagligt (0, 176 mg base/ 0, 25 mg salt) / døgn.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of Pramipexole Teva should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
Hos patienter med kreatininclearance mindre end 20 ml/ min. bør startdosis af Pramipexol Teva gives som en enkeltdosis begyndende med 0, 088 mg base (0, 125 mg salt) / døgn.
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Pramipexole Teva should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Hvis nyrefunktionen skulle blive nedsat under vedligeholdelsesbehandling med Pramipexol Teva bør dosis reduceres med samme procent som nedgangen i kreatininclearance, dvs. hvis f. eks. kreatininclearance går ned med 30%, så reduceres den daglige dosis Pramipexol Teva med 30%.
If renal function declines during maintenance therapy, reduce Pramipexole Teva daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the Pramipexole Teva daily dose by 30%.
Den daglige dosis kan fordeles på 2 daglige doser, hvis kreatininclearance er mellem 20 og 50 ml/ min. og som en enkeltdosis, hvis kreatininclearance er under 20 ml/ min.
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Den potentielle indflydelse af nedsat leverfunktion er imidlertid ikke undersøgt på pramipexols farmakokinetik.
However, the potential influence of hepatic insufficiency on pramipexole pharmacokinetics has not been investigated.
Dosering for børn og unge Pramipexol bør ikke anvendes til børn og unge under 18 år pga. manglende dokumentation for sikkerhed og virkning.
Dosing in children and adolescents Pramipexole is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
4. 2.
When prescribing Pramipexole Teva in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Hallucinationer er kendt som bivirkning ved behandling med dopaminagonister og levodopa.
Hallucinations are known as an adverse event of treatment with dopamine agonists and levodopa.
3 Ved fremskreden Parkinsons sygdom, i kombinationsbehandling med levodopa, kan dyskinesi forekomme i optrapningsfasen med Pramipexol Teva.
3 In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
Patienterne bør informeres om dette og tilrådes forsigtig brug ved bilkørsel eller betjening af maskiner under behandling med pramipexol.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with pramipexole.
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.
Yderligere kan en reduktion af dosis eller ophør med behandling overvejes.
Furthermore a reduction of dosage or termination of therapy may be considered.
Ludomani, forøget libido og hyperseksualitet er blevet rapporteret hos patienter, der var under behandling med dopaminagonister for Parkinsons sygdom, herunder pramipexol.
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Derudover bør patienter og pårørende være opmærksomme på, at adfærdsmønstret kan ændre sig.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Dosisreduktion/ gradvis nedtrapning eller seponering bør overvejes.
Dose reduction/ taper or discontinuation should be considered.
Der anbefales oftalmologisk monitorering med regelmæssige mellemrum eller hvis der fremkommer synsabnormaliteter.
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Hyppigheden af augmentation efter længerevarende brug af pramipexol og korrekt håndtering af disse tilfælde er ikke evalueret i kontrollerede kliniske forsøg.
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
34%, antagelig ved hæmning af det kationiske sekretionstransportsystem i de renale tubuli.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Lægemidler, som således hæmmer den aktive, renale eliminationsvej eller elimineres via denne vej, såsom cimetidin og amantadin, kan være årsag til interaktioner med pramipexol, resulterende i reduceret clearance af et eller begge lægemidler.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
4 Når Pramipexol Teva gives i kombination med levodopa, anbefales det at reducere doseringen af levodopa og at holde doseringen af andre antiparkinson- lægemidler konstant, mens doseringen af Pramipexol Teva øges.
4 When Pramipexole Teva is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Pramipexole Teva.
Pga. mulig additiv effekt, bør påpasselighed udvises, når patienter tager anden sedativ medicin eller alkohol i kombination med pramipexol.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
4. 4), f. eks. hvis antagonistiske virkninger kan forventes.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Effekten på graviditet og amning er ikke blevet undersøgt hos mennesker.
The effect on pregnancy and lactation has not been investigated in humans.
Pramipexol Teva bør ikke bruges under graviditet, 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.
Da man ingen erfaring har med Pramipexol Tevas udskillelse i modermælk, bør det ikke anvendes af ammende kvinder.
In the absence of human data, Pramipexole Teva should not be used during breast-feeding.
Pramipexol Teva kan have stor indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
Pramipexole Teva can have a major influence on the ability to drive an use machines.
4. 4, 4. 5 og 4. 8).
Patients being treated with Pramipexole Teva and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
Abnorme drømme, konfusion, forstoppelse, vrangforestillinger, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hypotension, overspisning (bulimi- lignende tilstand, uhæmmet madindtagelse), søvnløshed, libidoforstyrrelser, kvalme, perifert ødem, paranoia, ludomani, hyperseksualitet og anden abnorm adfærd, somnolens, vægtøgning, pludseligt opståede søvnepisoder, kløe og udslæt og anden overfølsomhed.
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behaviour, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Baseret på analysen af poolede placebo- kontrollerede kliniske forsøg, der i alt omfattede 1. 923 patienter i behandling med pramipexol og 1. 354 patienter i placebobehandling, blev bivirkninger hyppigt rapporteret for begge grupper.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
63% af patienterne i pramipexolbehandling og 52% af patienterne i placebobehandling rapporterede mindst en bivirkning.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse reaction.
Tabel 1 og 2 viser hyppigheden af bivirkninger i placebo- kontrollerede kliniske forsøg ved Parkinsons sygdom og en anden indikation.
Table 1 and 2 displays the frequency of adverse reactions from placebo-controlled clinical trials in Parkinson’ s disease and another indication.
Desuden er klinisk relevante bivirkninger også anført.
The adverse reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Størstedelen af bivirkningerne var milde til moderate, de startede som regel tidligt i behandlingen og forsvandt for det meste ved fortsat behandling.
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.