FrancophonIA/ELRC3.0 huggingface dataset:
English: 1, nephrolithiasis
Danish: 1, nefrolitiasis
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan påvirke op til 1 ud af 10 patienter)
English: The recommended initial daily dose of Deferasirox Mylan film-coated tablets is 14 mg/kg body weight.
Danish: Startdosis Anbefalet startdosis for Deferasirox Mylan filmovertrukne tabletter er 14 mg/kg kropsvægt.
English: Caution should be taken during chelation therapy to minimise the risk of over-chelation in all patients (see section 4.4).
Danish: Der skal udvises forsigtighed hos alle patienter under kelationsbehandling for at minimere risikoen for overkelering (se pkt.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: Deferasirox Mylan is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older.
Danish: Indikationen gælder for de følgende patientgrupper: - pædiatriske patienter med beta-talassæmi major med jernophobning forårsaget af regelmæssige blodtransfusioner (≥ 7 ml/kg/måned af pakkede røde blodceller) i alderen 2 til 5 år, - voksne og pædiatriske patienter med beta-talassæmi major med jernophobning forårsaget af sjældne blodtransfusioner (< 7 ml/kg/måned pakkede røde blodceller) i alderen 2 år og derover, - voksne og pædiatriske patienter med andre anæmier i alderen 2 år og derover.
English: However, in patients with liver iron concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Danish: Hos patienter med lever-jernkoncentration < 7 mg Fe/g biopsi-tørvægt, der blev behandlet med deferasirox dispergible tabletter (5 og 10 mg/kg) eller deferoxamin (20 eller 35 mg/kg), blev non-inferioritet imidlertid ikke opnået.
English: Generics [UK] Limited Station Close Potters Bar
Danish: Generics [UK] Limited
English: Dizziness
Danish: Leversvigt
English: Increase 3.5 - 7 mg/kg/day
Danish: Øget dosis 3,5 - 7 mg/kg/dag
English: • If you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems),
Danish: • Hvis du oplever en kombination af døsighed, smerter i den øvre højre del af maven, gulfarvning af din hud eller øjne og mørk urin (tegn på leverproblemer),
English: - if you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems).
Danish: - hvis du oplever en kombination af døsighed, smerter i den øvre højre del af maven, gulfarvning af din hud eller øjne og mørk urin (tegn på leverproblemer).
English: Agents that may decrease Deferasirox Mylan systemic exposure
Danish: Lægemidler, der kan øge den systemiske eksponering af Deferasirox Mylan
English: What Deferasirox Mylan looks like and contents of the pack Deferasirox Mylan is supplied as film-coated tablets.
Danish: Udseende og pakningsstørrelser for Deferasirox Mylan Deferasirox Mylan udleveres som filmovertrukne tabletter.
English: Syndrome).
Danish: Fanconis syndrom).
English: What you need to know before you take Deferasirox Mylan
Danish: Det skal du vide, før du begynder at tage Deferasirox Mylan
English: Although deferasirox has a lower affinity for aluminium than for iron, it is not recommended to take deferasirox tablets with aluminium-containing antacid preparations.
Danish: Det kan ikke anbefales at tage deferasirox-tabletter sammen med aluminiumholdige antacidapræparater, selvom deferasirox har en lavere affinitet for aluminium end for jern.
English: In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor (repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 73% to 95%).
Danish: I et studie med raske frivillige blev det påvist, at samtidig administration af deferasirox som CYP1A2hæmmer (gentagen dosis på 30 mg/kg daglig, dispergibel tablet-formulering) og CYP1A2-substratet theofyllin (enkeltdosis på 120 mg) øgede theofyllins-AUC med 84 % (90 % CI: 73 % til 95 %).
English: ≥5 mg Fe/g dw or >800 µg/l
Danish: ≥ 5 mg Fe/g tørvægt eller > 800 µg/l
English: Transfusional iron overload:
Danish: Transfusionsbetinget jernophobning:
English: > age appropriate ULN
Danish: Aldersrelateret ULN
English: 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)
Danish: 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
English: 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).
Danish: 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.
English: If you forget to take Deferasirox Mylan
Danish: Hvis du har glemt at tage Deferasirox Mylan
English: Before initiating treatment
Danish: Inden behandlingsstart.
English: - 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
Danish: - 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.
English: Decrease 3.5 - 7 mg/kg/day
Danish: Nedsat dosis 3,5 - 7 mg/kg/dag
English: 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.
Danish: Ved dødelige doser hos rotter uden jernophobning forårsagede deferasirox dannelse af mikronuclei in vivo i knoglemarven, men ikke i leveren.
English: Serum creatinine at Day - X
Danish: Før påbegyndelse af behandling Serum-kreatinin ved Dag X
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations (see section 5.2).
Danish: Deferasirox filmovertrukne tabletter udviser højere biotilgængelighed sammenlignet med deferasirox dispergible tabletter (se pkt.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 patienter)
English: <3 mg Fe/g dw or <300 µg/l
Danish: < 3 mg Fe/g tørvægt eller < 300 µg/l
English: Film-coated tablets
Danish: Filmovertrukne tabletter Transfusioner
English: 21 mg/kg/day
Danish: 21 mg/kg/dag
English: What Deferasirox Mylan is
Danish: Hvad Deferasirox Mylan er
English: Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.
Danish: Lægemidler kaldet jernkelatorer anvendes til at fjerne det overskydende jern.
English: 14 mg/kg/day
Danish: 14 mg/kg/dag
English: • Each film-coated tablet of Deferasirox Mylan 360 mg contains 360 mg deferasirox.
Danish: • Hver filmovertrukket tablet af Deferasirox Mylan 360 mg indeholder 360 mg deferasirox.
English: What Deferasirox Mylan contains
Danish: Deferasirox Mylan indeholder
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: What Deferasirox Mylan is and what it is used for
Danish: Virkning og anvendelse, hvad er Deferasirox Mylan og hvad bruges det til
English: • Low urine output
Danish: • Nedsat vandladning
English: After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN
Danish: Forbliver > 33 % over gennemsnittet fra før behandling og/eller Faldende < LLN
English: 7 mg/kg/day
Danish: 7 mg/kg/dag
English: How long to take Deferasirox Mylan
Danish: Hvor længe skal du tage Deferasirox Mylan
English: Transfusional iron overload
Danish: Transfusionsbetinget jernophobning
English: 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.
Danish: Deferasirox dispergible tabletter blev vurderet i et 1-årigt randomiseret, dobbeltblindet, placebokontrolleret studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromer og jernophobning.
English: ≥7 mg Fe/g dw or >2,000 µg/l
Danish: ≥ 7 mg Fe/g tørvægt eller > 2.000 µg/l
English: • Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria (monitor as needed).
Danish: magnesium eller urat, fosfaturi, aminoaciduri (monitoreres efter behov).
English: • Each film-coated tablet of Deferasirox Mylan 180 mg contains 180 mg deferasirox.
Danish: • Hver filmovertrukket tablet af Deferasirox Mylan 180 mg indeholder 180 mg deferasirox.
English: • Each film-coated tablet of Deferasirox Mylan 90 mg contains 90 mg deferasirox.
Danish: • Hver filmovertrukket tablet af Deferasirox Mylan 90 mg indeholder 90 mg deferasirox.
English: You will have regular blood and urine tests during treatment.
Danish: Kontrol af din behandling med Deferasirox Mylan Du vil få taget regelmæssige blod- og urinprøver under behandlingen.
English: ◦ 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)
Danish: Voksne og børn: holder sig > 33 % over baseline eller kreatinin-clearance < LLN (90 ml/min)
English: Breast-feeding is not recommended during treatment with Deferasirox Mylan.
Danish: Amning frarådes under behandling med Deferasirox Mylan.
English: Starting dose
Danish: Startdosis
English: 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.
Danish: 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.
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets deferasirox
Danish: Deferasirox Mylan 90 mg filmovertrukne tabletter Deferasirox Mylan 180 mg filmovertrukne tabletter Deferasirox Mylan 360 mg filmovertrukne tabletter deferasirox
English: 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.
Danish: Deferasirox Mylan anvendes til at behandle kronisk jernophobning hos patienter i alderen 6 år og derover med beta-talassæmi major forårsaget af hyppige blodtransfusioner.
English: 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.
Danish: I de tilfælde, hvor afbrydelse af behandling kan være nødvendig, kan behandlingen påbegyndes igen efter at udslættet er væk.
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Lidelser i øre Ikke almindelig: Døvhed Respiratoriske lidelser, lidelser i thorax og mediastinum Ikke almindelig: Smerter i strubehoved Gastrointestinale lidelser Almindelig:
English: Hepatobiliary disorders Common:
Danish: Dermatologiske lidelser Almindelig:
English: Each film-coated tablet contains 90 mg deferasirox.
Danish: Hver filmovertrukket tablet indeholder 90 mg deferasirox.
English: Oesophagitis
Danish: Øsofagitis
English: Pigmentation disorder
Danish: Hæmatologiske forstyrrelser
English: In duplicate prior to therapy.
Danish: Dobbeltbestemmelse inden behandling.
English: Each film-coated tablet contains 360 mg deferasirox.
Danish: Hver filmovertrukket tablet indeholder 360 mg deferasirox.
English: Interruption of treatment should be considered in patients who develop unexplained cytopenia.
Danish: Hos patienter, der udvikler uforklarlig cytopeni, bør det vurderes, om behandlingen skal afbrydes.
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets
Danish: Deferasirox Mylan 90 mg filmovertrukne tabletter Deferasirox Mylan 180 mg filmovertrukne tabletter Deferasirox Mylan 360 mg filmovertrukne tabletter
English: 30 film-coated tablets 90 film-coated tablets
Danish: 30 filmovertrukne tabletter 90 filmovertrukne tabletter
English: 90 film-coated tablets 300 film-coated tablets
Danish: 90 filmovertrukne tabletter 300 filmovertrukne tabletter
English: Each film-coated tablet contains 180 mg deferasirox.
Danish: Hver filmovertrukket tablet indeholder 180 mg deferasirox.
English: • Deferasirox Mylan 180 mg film-coated tablets are peach, film-coated, modified capsule shaped,
Danish: • Deferasirox Mylan 180 mg filmovertrukne tabletter er ferskenfarvede, filmovertrukne,
English: If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should be considered (see section 4.4).
Danish: Afbrydelse af behandlingen bør overvejes, hvis serumferritin falder konsekvent under 500 µg/l (se pkt.
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
Danish: En ferskenfarvet, filmovertrukket, modificeret kapselformet, bikonveks tablet præget med ” ” på den ene side af tabletten og ”DF 1” på den anden side.
English: • Deferasirox Mylan 360 mg film-coated tablets are peach, film-coated, modified capsule shaped,
Danish: • Deferasirox Mylan 360 mg filmovertrukne tabletter er ferskenfarvede, filmovertrukne,
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Danish: En ferskenfarvet, filmovertrukket, modificeret kapselformet, bikonveks tablet præget med ” ” på den ene side af tabletten og ”DF 2” på den anden side.
English: Deferasirox Mylan 360 mg film-coated tablets deferasirox
Danish: Deferasirox Mylan 360 mg filmovertrukne tabletter deferasirox
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF' on the other side.
Danish: En ferskenfarvet, filmovertrukket, modificeret kapselformet, bikonveks tablet præget med ” ” på den ene side af tabletten og ”DF” på den anden side.
English: How to store Deferasirox Mylan
Danish: Opbevaring af Deferasirox Mylan
English: 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.
Danish: Patienter med ikke-transfusionsafhængige talassæmi-syndromer kan på sigt også udvikle jernophobning.
English: Deferasirox Mylan 360 mg film-coated tablets
Danish: Deferasirox Mylan 360 mg filmovertrukne tabletter
English: Deferasirox Mylan 180 mg film-coated tablets
Danish: Deferasirox Mylan 180 mg filmovertrukne tabletter
English: Treatment cessation
Danish: Behandlingsophør
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg.
Danish: Dosis må ikke overstige 7 mg/kg hos patienter, hvor LIC ikke blev bestemt, og serumferritin er ≤ 2000 µg/l.
English: • Deferasirox Mylan 90 mg film-coated tablets are peach, film-coated, modified capsule shaped,
Danish: • Deferasirox Mylan 90 mg filmovertrukne tabletter er ferskenfarvede, filmovertrukne,
English: 30 film-coated tablets 90 film -coated tablets 300 film-coated tablets
Danish: 30 filmovertrukne tabletter 90 filmovertrukne tabletter 300 filmovertrukne tabletter
English: 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.
Danish: Deferasirox Mylan er yderligere indiceret til behandling af kronisk jernophobning, forårsaget af blodtransfusioner, i de tilfælde hvor deferoxamin-behandling er kontraindiceret eller utilstrækkelig.
English: Deferasirox Mylan 180 mg film-coated tablets deferasirox
Danish: Deferasirox Mylan 180 mg filmovertrukne tabletter deferasirox
English: Deferasirox Mylan 90 mg film-coated tablets
Danish: Deferasirox Mylan 90 mg filmovertrukne tabletter
English: Deferasirox Mylan 90 mg film-coated tablets deferasirox
Danish: Deferasirox Mylan 90 mg filmovertrukne tabletter deferasirox
English: When to take Deferasirox Mylan
Danish: Hvornår skal du tage Deferasirox Mylan
English: 1, renal tubular necrosis General disorders and administration site conditions Uncommon:
Danish: 1, renal tubulær nekrose
English: Posology
Danish: Målinterval
English: BOTTLE LABEL
Danish: Potters Bar
English: Monitoring your Deferasirox Mylan treatment
Danish: 2: ”Kontrol af din behandling med Deferasirox Mylan”).
English: If you stop taking Deferasirox Mylan
Danish: Hvis du har taget for meget Deferasirox Mylan
English: Liver function test elevations have been observed in patients treated with deferasirox.
Danish: Hos patienter i behandling med deferasirox, har der været observeret stigninger i leverfunktionstest.
English: Target range
Danish: Station Close
English: 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).
Danish: Der er indberettet sjældne tilfælde af alvorlige overfølsomhedsreaktioner (som anafylaksi og angioødem) hos patienter, som får deferasirox.
English: Renal tubular disorder
Danish: Proteinuri Ikke almindelig: Renale tubulære forstyrrelser
English: 1, urticaria erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 Renal and urinary disorders Very common:
Danish: 1, toksisk epidermal nekrolyse (TEN)
English: How to take Deferasirox Mylan
Danish: Sådan skal du tage Deferasirox Mylan
English: biconvex tablets debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
Danish: modificeret kapselformede, bikonvekse tabletter præget med ” ” på den ene side af tabletten og ”DF 1” på den anden side.
English: Hepatic function
Danish: Leverfunktion
English: Taking Deferasirox Mylan at the same time each day will also help you remember when to take your tablets.
Danish: Det vil også gøre det lettere for dig at huske, hvornår du skal tage dine tabletter.
English: Up to 28 mg/kg/day Decrease
Danish: Op til 28 mg/kg/dag Nedsat dosis 3,5 - 7 mg/kg/dag
English: biconvex tablets debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Danish: modificeret kapselformede, bikonvekse tabletter præget med ” ” på den ene side af tabletten og ”DF 2” på den anden side.
English: Do not store it for future use.
Danish: Maden skal indtages med det samme og skal spises op. Gem den ikke til senere brug.
English: Optic neuritis Ear and labyrinth disorders Uncommon:
Danish: Lidelser i nyrer og urinveje Meget almindelig:
English: Gastrointestinal disorders Common:
Danish: Lever- og galdevejslidelser Almindelig:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Deferasirox Mylan Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: This summary was last updated in August 2012.
Danish: Dette sammendrag blev sidst ajourført i august-2012.
English: 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.
Danish: Den fuldstændige EPAR for Zoledronsyre Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronsyre Mylan den 23. august 2012.
English: 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.
Danish: 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.
English: For more information about treatment with Zoledronic acid Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: This means that Zoledronic acid Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Danish: Det betyder, at Zoledronsyre Mylan er identisk med et “referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Zometa.