natgillin/translations-raw huggingface dataset:
Vejledning til patienten skal indeholde følgende nøgleelementer: ◦ Information om nødvendigheden af regelmæssig monitorering af serum-kreatinin, kreatinin-clearance, proteinuri, leverenzymer, ferritin, og hvornår denne skal udføres ◦ Information om, at man vil overveje at udføre nyrebiopsi, hvis der opstår signifikante nyreabnormaliteter
Patient guide should contain the following key elements: ◦ Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin ◦ Information that renal biopsy may be considered if significant renal abnormalities occur ◦ Availability of several oral formulations (e.g. dispersible tablets, film-coated tablets and granules) and the main differences associated with these formulations (i.e., different posology regimen, different conditions of administration notably with food)
Eksempelvis kan en patient, der modtager 40 mg/kg/dag af deferoxamin fem dage om ugen (eller tilsvarende), overføres til en daglig startdosis på 14 mg/kg/dag af Deferasirox Mylan filmovertrukne tabletter.
For patients, already well managed on treatment with deferoxamine, a starting dose of Deferasirox Mylan film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of Deferasirox Mylan film-coated tablets).
Hvis du har glemt at tage Deferasirox Mylan
If you forget to take Deferasirox Mylan
Inden behandlingsstart.
Before initiating treatment
- hvis du oplever en kombination af ethvert af de følgende symptomer: udslæt, rød hud, blærer på læberne, øjne eller mund, hudafskalninger, høj feber, influenzalignende symptomer, forstørrede lymfekirtler (tegn på alvorlig hudreaktion, se også pkt.
- if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes
Nedsat dosis 3,5 - 7 mg/kg/dag
Decrease 3.5 - 7 mg/kg/day
Ved dødelige doser hos rotter uden jernophobning forårsagede deferasirox dannelse af mikronuclei in vivo i knoglemarven, men ikke i leveren.
Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of non-ironloaded rats at lethal doses.
Før påbegyndelse af behandling Serum-kreatinin ved Dag X
Serum creatinine at Day - X
Deferasirox filmovertrukne tabletter udviser højere biotilgængelighed sammenlignet med deferasirox dispergible tabletter (se pkt.
Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations (see section 5.2).
Ikke almindelige (kan påvirke op til 1 ud af 100 patienter)
Uncommon (may affect up to 1 in 100 people)
< 3 mg Fe/g tørvægt eller < 300 µg/l
<3 mg Fe/g dw or <300 µg/l
Filmovertrukne tabletter Transfusioner
Film-coated tablets
21 mg/kg/dag
21 mg/kg/day
Hvad Deferasirox Mylan er
What Deferasirox Mylan is
Lægemidler kaldet jernkelatorer anvendes til at fjerne det overskydende jern.
Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.
14 mg/kg/dag
14 mg/kg/day
• Hver filmovertrukket tablet af Deferasirox Mylan 360 mg indeholder 360 mg deferasirox.
• Each film-coated tablet of Deferasirox Mylan 360 mg contains 360 mg deferasirox.
Deferasirox Mylan indeholder
What Deferasirox Mylan contains
I tillæg producerede deferasirox dispergible tabletter i dosis op til 20 og 30 mg/kg et fald i leverjernkoncentration og serumferritin sammenligneligt med det opnåde hos patienter med beta-talassæmi.
In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia.
173 voksne og pædiatriske patienter med transfusionsafhængig talassæmi eller myelodysplastisk syndrom blev behandlet i 24 uger i et studie, der undersøgte sikkerheden af deferasirox filmovertrukne tabletter og dispergible tabletter.
In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated for 24 weeks.
Virkning og anvendelse, hvad er Deferasirox Mylan og hvad bruges det til
What Deferasirox Mylan is and what it is used for
• Nedsat vandladning
• Low urine output
Forbliver > 33 % over gennemsnittet fra før behandling og/eller Faldende < LLN
After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN
7 mg/kg/dag
7 mg/kg/day
Hvor længe skal du tage Deferasirox Mylan
How long to take Deferasirox Mylan
Transfusionsbetinget jernophobning
Transfusional iron overload
Deferasirox dispergible tabletter blev vurderet i et 1-årigt randomiseret, dobbeltblindet, placebokontrolleret studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromer og jernophobning.
In patients with non-transfusion-dependent thalassaemia syndromes and iron overload, treatment with deferasirox dispersible tablets was assessed in a 1-year, randomised, double-blind, placebo-controlled study.
≥ 7 mg Fe/g tørvægt eller > 2.000 µg/l
≥7 mg Fe/g dw or >2,000 µg/l
magnesium eller urat, fosfaturi, aminoaciduri (monitoreres efter behov).
• Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria (monitor as needed).
• Hver filmovertrukket tablet af Deferasirox Mylan 180 mg indeholder 180 mg deferasirox.
• Each film-coated tablet of Deferasirox Mylan 180 mg contains 180 mg deferasirox.
• Hver filmovertrukket tablet af Deferasirox Mylan 90 mg indeholder 90 mg deferasirox.
• Each film-coated tablet of Deferasirox Mylan 90 mg contains 90 mg deferasirox.
Kontrol af din behandling med Deferasirox Mylan Du vil få taget regelmæssige blod- og urinprøver under behandlingen.
You will have regular blood and urine tests during treatment.
Voksne og børn: holder sig > 33 % over baseline eller kreatinin-clearance < LLN (90 ml/min)
◦ The need to interrupt treatment after a dose reduction if serum creatinine rises: Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min)
Amning frarådes under behandling med Deferasirox Mylan.
Breast-feeding is not recommended during treatment with Deferasirox Mylan.
Deferasirox Mylan anvendes også til ikke-transfusionsafhængige patienter i alderen 10 år eller derover, der har fået jernophobning i forbindelse med deres talassæmi-syndromer, når deferoxaminbehandling er kontraindiceret eller utilstrækkelig.
Deferasirox Mylan is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent.
Deferasirox Mylan 90 mg filmovertrukne tabletter Deferasirox Mylan 180 mg filmovertrukne tabletter Deferasirox Mylan 360 mg filmovertrukne tabletter deferasirox
Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets deferasirox
Deferasirox Mylan anvendes til at behandle kronisk jernophobning hos patienter i alderen 6 år og derover med beta-talassæmi major forårsaget af hyppige blodtransfusioner.
Deferasirox Mylan is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
I de tilfælde, hvor afbrydelse af behandling kan være nødvendig, kan behandlingen påbegyndes igen efter at udslættet er væk.
When interruption of treatment may be necessary, treatment may be reintroduced after resolution of the rash, at a lower dose followed by gradual dose escalation.
Lidelser i øre Ikke almindelig: Døvhed Respiratoriske lidelser, lidelser i thorax og mediastinum Ikke almindelig: Smerter i strubehoved Gastrointestinale lidelser Almindelig:
Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Dermatologiske lidelser Almindelig:
Hepatobiliary disorders Common:
Hver filmovertrukket tablet indeholder 90 mg deferasirox.
Each film-coated tablet contains 90 mg deferasirox.
Øsofagitis
Oesophagitis
Hæmatologiske forstyrrelser
Pigmentation disorder
Dobbeltbestemmelse inden behandling.
In duplicate prior to therapy.
Hver filmovertrukket tablet indeholder 360 mg deferasirox.
Each film-coated tablet contains 360 mg deferasirox.
Hos patienter, der udvikler uforklarlig cytopeni, bør det vurderes, om behandlingen skal afbrydes.
Interruption of treatment should be considered in patients who develop unexplained cytopenia.
Deferasirox Mylan 90 mg filmovertrukne tabletter Deferasirox Mylan 180 mg filmovertrukne tabletter Deferasirox Mylan 360 mg filmovertrukne tabletter
Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets
30 filmovertrukne tabletter 90 filmovertrukne tabletter
30 film-coated tablets 90 film-coated tablets
90 filmovertrukne tabletter 300 filmovertrukne tabletter
90 film-coated tablets 300 film-coated tablets
Hver filmovertrukket tablet indeholder 180 mg deferasirox.
Each film-coated tablet contains 180 mg deferasirox.
• Deferasirox Mylan 180 mg filmovertrukne tabletter er ferskenfarvede, filmovertrukne,
• Deferasirox Mylan 180 mg film-coated tablets are peach, film-coated, modified capsule shaped,
Afbrydelse af behandlingen bør overvejes, hvis serumferritin falder konsekvent under 500 µg/l (se pkt.
If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should be considered (see section 4.4).
En ferskenfarvet, filmovertrukket, modificeret kapselformet, bikonveks tablet præget med ” ” på den ene side af tabletten og ”DF 1” på den anden side.
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
• Deferasirox Mylan 360 mg filmovertrukne tabletter er ferskenfarvede, filmovertrukne,
• Deferasirox Mylan 360 mg film-coated tablets are peach, film-coated, modified capsule shaped,
En ferskenfarvet, filmovertrukket, modificeret kapselformet, bikonveks tablet præget med ” ” på den ene side af tabletten og ”DF 2” på den anden side.
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Deferasirox Mylan 360 mg filmovertrukne tabletter deferasirox
Deferasirox Mylan 360 mg film-coated tablets deferasirox
En ferskenfarvet, filmovertrukket, modificeret kapselformet, bikonveks tablet præget med ” ” på den ene side af tabletten og ”DF” på den anden side.
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF' on the other side.
Opbevaring af Deferasirox Mylan
How to store Deferasirox Mylan
Patienter med ikke-transfusionsafhængige talassæmi-syndromer kan på sigt også udvikle jernophobning.
In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts.
Deferasirox Mylan 360 mg filmovertrukne tabletter
Deferasirox Mylan 360 mg film-coated tablets
Deferasirox Mylan 180 mg filmovertrukne tabletter
Deferasirox Mylan 180 mg film-coated tablets
Behandlingsophør
Treatment cessation
Dosis må ikke overstige 7 mg/kg hos patienter, hvor LIC ikke blev bestemt, og serumferritin er ≤ 2000 µg/l.
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg.
• Deferasirox Mylan 90 mg filmovertrukne tabletter er ferskenfarvede, filmovertrukne,
• Deferasirox Mylan 90 mg film-coated tablets are peach, film-coated, modified capsule shaped,
30 filmovertrukne tabletter 90 filmovertrukne tabletter 300 filmovertrukne tabletter
30 film-coated tablets 90 film -coated tablets 300 film-coated tablets
Deferasirox Mylan er yderligere indiceret til behandling af kronisk jernophobning, forårsaget af blodtransfusioner, i de tilfælde hvor deferoxamin-behandling er kontraindiceret eller utilstrækkelig.
Deferasirox Mylan is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusiondependent thalassaemia syndromes aged 10 years and older.
Deferasirox Mylan 180 mg filmovertrukne tabletter deferasirox
Deferasirox Mylan 180 mg film-coated tablets deferasirox
Deferasirox Mylan 90 mg filmovertrukne tabletter
Deferasirox Mylan 90 mg film-coated tablets
Deferasirox Mylan 90 mg filmovertrukne tabletter deferasirox
Deferasirox Mylan 90 mg film-coated tablets deferasirox
Hvornår skal du tage Deferasirox Mylan
When to take Deferasirox Mylan
1, renal tubulær nekrose
1, renal tubular necrosis General disorders and administration site conditions Uncommon:
Målinterval
Posology
Potters Bar
BOTTLE LABEL
2: ”Kontrol af din behandling med Deferasirox Mylan”).
Monitoring your Deferasirox Mylan treatment
Hvis du har taget for meget Deferasirox Mylan
If you stop taking Deferasirox Mylan
Hos patienter i behandling med deferasirox, har der været observeret stigninger i leverfunktionstest.
Liver function test elevations have been observed in patients treated with deferasirox.
Station Close
Target range
Der er indberettet sjældne tilfælde af alvorlige overfølsomhedsreaktioner (som anafylaksi og angioødem) hos patienter, som får deferasirox.
Cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving deferasirox, with the onset of the reaction occurring in the majority of cases within the first month of treatment (see section 4.8).
Proteinuri Ikke almindelig: Renale tubulære forstyrrelser
Renal tubular disorder
1, toksisk epidermal nekrolyse (TEN)
1, urticaria erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 Renal and urinary disorders Very common:
Sådan skal du tage Deferasirox Mylan
How to take Deferasirox Mylan
modificeret kapselformede, bikonvekse tabletter præget med ” ” på den ene side af tabletten og ”DF 1” på den anden side.
biconvex tablets debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
Leverfunktion
Hepatic function
Det vil også gøre det lettere for dig at huske, hvornår du skal tage dine tabletter.
Taking Deferasirox Mylan at the same time each day will also help you remember when to take your tablets.
Op til 28 mg/kg/dag Nedsat dosis 3,5 - 7 mg/kg/dag
Up to 28 mg/kg/day Decrease
modificeret kapselformede, bikonvekse tabletter præget med ” ” på den ene side af tabletten og ”DF 2” på den anden side.
biconvex tablets debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Maden skal indtages med det samme og skal spises op. Gem den ikke til senere brug.
Do not store it for future use.
Lidelser i nyrer og urinveje Meget almindelig:
Optic neuritis Ear and labyrinth disorders Uncommon:
Lever- og galdevejslidelser Almindelig:
Gastrointestinal disorders Common:
Brug af anden medicin sammen med Deferasirox Mylan Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Dette sammendrag blev sidst ajourført i august-2012.
This summary was last updated in August 2012.
Den fuldstændige EPAR for Zoledronsyre Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Zoledronic acid Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronsyre Mylan den 23. august 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Zoledronsyre Mylan.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Mylan.
Hvis du ønsker yderligere oplysninger om behandling med Zoledronsyre Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Zoledronic acid Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det betyder, at Zoledronsyre Mylan er identisk med et “referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Zometa.
This means that Zoledronic acid Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Nærmere oplysninger om generiske lægemidler kan du finde i dokumentet med spørgsmål og svar her.
For more information on generic medicines, see the question-and-answer document here.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronsyre Mylan.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan.
Når infusionen gives til forebyggelse af knoglekomplikationer, kan den gentages hver tredje til fjerde uge, og patienterne bør desuden have tilskud af kalcium og vitamin D. Der tilrådes lavere dosis til patienter med knoglemetastaser (dvs. kræft, der har bredt sig til knoglerne), hvis de har lette til moderate nyreproblemer.
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Den normale dosis af Zoledronsyre Mylan er én infusion af 4 mg, der gives i løbet af mindst 15 minutter.
The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes.
Virksomheden fremlagde oplysninger fra den offentliggjorte litteratur om zoledronsyre.
The company provided data from the published literature on zoledronic acid.
Ved at forhindre nedbrydningen af knoglerne mindsker Zoledronsyre Mylan også mængden af kalcium, der frigives til blodet.
By preventing the breakdown of bones, Zoledronic acid Mylan also helps to reduce the amount of calcium released into the blood.
Hertil hører knoglebrud, spinal kompression (sammenpresning af rygmarven pga. knoglerne), knoglesygdomme, der kræver behandling med stråling eller operation, samt hyperkalcæmi (for højt kalciumindhold i blodet).
This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Der var ikke brug for flere undersøgelser hos patienter, da Zoledronsyre Mylan er et generisk lægemiddel, der gives ved infusion og indeholder samme aktive stof som referencelægemidlet Zometa.
No additional studies in patients were needed as Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Da Zoledronsyre Mylan er et generisk lægemiddel og bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
Because Zoledronic acid Mylan 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.
Zoledronsyre Mylan må kun gives af en læge med erfaring i brug af denne type medicin ved indgift i en vene.
Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Det hæmmer virkningen af osteoklasterne, dvs. de celler i kroppen, der medvirker ved nedbrydning af knoglevæv.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Zometa.
Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Zoledronsyre Mylan kan anvendes til at forebygge knoglekomplikationer hos voksne med fremskreden kræft i knoglerne.
Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Hvilke fordele og risici er der forbundet med Zoledronsyre Mylan?
What are the benefits and risks of Zoledronic acid Mylan?
Hos patienter med svulster kan blodet have for højt indhold af kalcium, der frigives fra knoglerne.
Patients with tumours can have high levels of calcium in their blood, released from the bones.
Andre oplysninger om Zoledronsyre Mylan
Other information about Zoledronic acid Mylan
Det aktive stof i Zoledronsyre Mylan, zoledronsyre, er et bifosfonat.
The active substance in Zoledronic acid Mylan, zoledronic acid, is a bisphosphonate.
Zoledronsyre Mylan er et lægemiddel, der indeholder det aktive stof zoledronsyre.
Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid.
Zoledronsyre Mylan kan desuden anvendes til behandling af hyperkalcæmi forårsaget af svulster.
Zoledronic acid Mylan can also be used to treat the hypercalcaemia caused by tumours.
Zoledronsyre Mylan er et “generisk lægemiddel”.
Zoledronic acid Mylan is a ‘generic medicine'.
CHMP konkluderede, at Zoledronsyre Mylan er påvist at være af samme kvalitet som Zometa og er bioækvivalent med dette i overensstemmelse med EU-kravene.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronsyre Mylan.
The Committee recommended that Zoledronic acid Mylan be given marketing authorisation.
EPAR - sammendrag for offentligheden zoledronsyre
EPAR summary for the public zoledronic acid
Til patienter med svære nyreproblemer frarådes det at anvende lægemidlet.
It is not recommended for patients with severe kidney problems.
Det leveres som et koncentrat til infusionsvæske, opløsning, 4 mg/5 ml.
It is available as a 4mg/5ml concentrate for a solution for infusion.
Hvorfor blev Zoledronsyre Mylan godkendt?
Why has Zoledronic acid Mylan been approved?
Hvad er Zoledronsyre Mylan?
What is Zoledronic acid Mylan?
Hvordan blev Zoledronsyre Mylan undersøgt?
How has Zoledronic acid Mylan been studied?
Hvordan virker Zoledronsyre Mylan?
How does Zoledronic acid Mylan work?
Hvad anvendes Zoledronsyre Mylan til?
What is Zoledronic acid Mylan used for?
Hvordan anvendes Zoledronsyre Mylan?
How is Zoledronic acid Mylan used?
Instruktion i, hvordan man tager Pradaxa
- An instruction how to take Pradaxa
Dette uddannelsesmateriale skal øge opmærksomheden om den potentielle risiko for blødning ved behandling med Pradaxa og give vejledning i, hvorledes denne risiko håndteres.
This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk.