natgillin/translations-raw huggingface dataset:
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.
Uddannelsesmaterialet skal være klar til distribution for begge terapeutiske indikationer før lancering af den nye indikation (forebyggelse af apopleksi og systemisk emboli hos voksne patienter med nonvalvulær atrieflimren med en eller flere risikofaktorer) i medlemslandet. 
- The educational pack must be available for distribution for both therapeutic indications prior to the launch of the new indication (prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors) in the Member State.
Patientoplysningskortet skal indeholde følgende hovedpunkter om sikkerhed: Tegn og symptomer på blødning, og hvornår man skal kontakte sundhedspersonale 
The Patient alert card should contain the following key safety messages: o Signs or symptoms of bleeding and when to seek attention from a health care provider.
Nødvendigheden af at oplyse sundhedspersonale om, at man tager Pradaxa, hvis man skal opereres eller have foretaget andre former for indgreb. 
o Importance of treatment compliance o The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Indehaveren af markedsføringstilladelsen og den nationale ansvarlige myndighed skal blive enige om indhold og udformning af uddannelsesmaterialet og om en kommunikationsplan forud for udlevering af uddannelsesmaterialet. 
- The content and format of the educational material, together with a communication plan, is agreed with the MAH prior to distribution of the educational pack.
Anbefalinger til dosisnedsættelse i risikopopulationer Håndtering af overdosering Brug af koagulationstests og tolkning af samme At alle patienter skal have udleveret et patientoplysningskort og informeres om: Tegn og symptomer på blødning, og hvornår man skal kontakte sundhedspersonale Vigtigheden af compliance Nødvendigheden af altid at have patientoplysningskortet på sig Nødvendigheden af at oplyse sundhedspersonale om, at man tager Pradaxa, hvis man skal opereres eller have foretaget andre former for indgreb. 
The Prescriber Guide should contain the following key safety messages: - Details of populations potentially at higher risk of bleeding - Recommendation not to use Pradaxa in patients with prosthetic heart valves - Recommendation for kidney function measurement - Recommendations for dose reduction in at risk populations - Management of overdose situations - The use of coagulation tests and their interpretation - That all patients should be provided with a Patient alert card and be counselled about:
Medlemslandene skal sikre, at følgende betingelser eller begrænsninger i forhold til sikker og korrekt anvendelse af lægemidlet beskrevet herunder er implementeret: 
The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: - The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Vigtigheden af compliance Nødvendigheden af altid at have patientoplysningskortet på sig 
The physician educational pack should contain: - The Summary of Product Characteristics - Prescriber Guide - Patient Alert Cards
Medlemsstat EU/EAA 
Member State EU/EEA
15 ANDRE OPLYSNINGER 
15 OTHER INFORMATION
4 INDIKATIONER 
4 INDICATIONS
Samlet resumé af den videnskabelige vurdering af Seresto og det relaterede navn Foresto (se bilag I) 
Overall summary of the scientific evaluation of Seresto and its associated name Foresto (see Annex I)
Vurdering af de fremlagte data 
Assessment of the data submitted
Alle risici, der er relateret til måldyrearten, brugeren og miljøet, er tilstrækkeligt beskrevet i produktlitteraturen. 
All risks relating to the target animal, the user and the environment are adequately addressed in the product literature.
Følgende tekst skal tilføjes i de relevante afsnit af produktinformationen. 
Add the following text in the relevant sections of the product information:
Alle tre feltundersøgelser blev gennemført på dyreinternater inden for et begrænset geografisk område. 
All three field studies were performed in animal shelter situations within a limited geographical area.
Benefit/risk-forholdet for den godkendte indikation vurderes at være gunstigt. 
The benefit-risk balance for the agreed indication is considered favourable.
Seresto indeholder de aktive stoffer imidacloprid 10% og flumethrin 4,5%. 
Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Hundene blev hver især påført 80 hunsandfluer på 13 forskellige tidspunkter (dag 7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215 og 222). 
The dogs were each infested with 80 female sand flies on 13 occasions (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, and 222).
I denne laboratorieundersøgelse blev 14 hunde randomiseret til enten behandling med Serestohalsbånd (n = 7) eller ingen behandling (n = 7). 
In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
Undersøgelsen varede 300 dage ± 10 dage, og de behandlede dyr havde halsbåndet på i de første 210 ± 10 dage. 
The study duration was 300 days ± 10 days, and the treated animals wore the collar for the first 210 ± 10 days of this period.
Fortegnelse over lægemidlets navn, lægemiddelform, styrk for det veterinærmedicinske produkt, dyreart, indgivelsesvej, indehaver af markedsføringstilladelse i medlemsstaterne 
List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Vurdering af fordele og risici er foretaget på denne baggrund. 
The benefit-risk assessment is made on this basis.
Både vejledning 7AE17a og vejledning EMEA/CVMP/EWP/005/2000-Rev.2 anfører, at feltundersøgelser bør gennemføres i mindst to geografiske regioner, og at den undersøgte dyrepopulation bør være repræsentativ for målpopulationen. 
Both Guideline 7AE17a and Guideline EMEA/CVMP/EWP/005/2000-Rev.2 state that field studies should be performed in at least two geographical regions and the animal population studied should be representative of the target population.
Ifølge vejledning 7AE17a bør effekttærsklen for Diptera være 80-100% (helst over 90%). 
According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
Gældende produktresume, etikettering og indlægsseddel er de endelige versioner, der er udarbejdet af koordineringsgruppen under proceduren med følgende ændringer: 
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Undersøgelsen blev gennemført mellem april/maj og december 2013 (ca. otte måneder), og efterbehandlingsfasen løb frem til april/maj 2014. 
The study ran between April/May and December 2013 (approximately eight months), and there was a post-treatment phase which ran until April/May 2014.