FrancophonIA/ELRC3.0 huggingface dataset:
English: Opportunistic infections: Patients receiving Combivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection.
Danish: Opportunistiske infektioner: Patienter kan fortsat udvikle opportunistiske infektioner eller andre komplikationer af hiv-infektionen, selv om de får Combivir eller anden antiretroviral behandling.
English: Rare side effects
Danish: Meget sjældne bivirkninger
English: Children weighing between 21 kg and 30 kg: the recommended oral dose of Combivir is one-half tablet taken in the morning and one whole tablet taken in the evening.
Danish: Børn, der vejer mellem 21 kg og 30 kg: Den anbefalede dosis Combivir er én halv tablet om morgenen og én hel tablet om aftenen.
English: Dose reduction is required for patients with creatinine clearance ≤50 ml/min (see section 4.2).
Danish: Til patienter med kreatininclearance ≤ 50 ml/minut er dosisreduktion påkrævet (se pkt.
English: The usual starting dose of Combivir is one half tablet (½) taken in the morning and one whole tablet taken in the evening.
Danish: Den sædvanlige startdosis er en halv (½) tablet om morgenen og en hel tablet om aftenen.
English: Uncommon: Transient rises in liver enzymes (AST, ALT) Rare: Hepatitis
Danish: Ikke almindelig: Midlertidige stigninger af leverenzymer (ASAT, ALAT) Sjælden: Hepatitis
English: • clarithromycin, an antibiotic if you are taking clarithromycin, take your dose at least 2 hours before or after you take your Combivir.
Danish: Hvis du tager clarithromycin, skal der gå mindst to timer, fra du har taget Combivir, til du tager clarithromycin.
English: What you need to know before you take Combivir
Danish: Det skal du vide, før du begynder at tage Combivir Tag ikke Combivir
English: Metabolism and nutrition disorders Rare : Lactic acidosis in the absence of hypoxaemia, anorexia
Danish: Metabolisme og ernæring Sjælden: Laktacidose uden samtidig hypoxæmi, anoreksi
English: A bioequivalence study compared Combivir with lamivudine 150 mg and zidovudine 300 mg tablets taken together.
Danish: Et bioækvivalensstudie sammenlignede Combivir med lamivudin 150 mg og zidovudin 300 mg tabletter givet sammen.
English: As well as the side effects listed below for Combivir, other conditions can develop during combination therapy for HIV.
Danish: Ud over bivirkninger ved Combivir nævnt nedenfor, kan du få andre sygdomme, når du får kombinationsbehandling mod hiv.
English: Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTIs are available
Danish: Ved fremkomst af M184V-mutationer bør man kun overveje at fortsætte med lamivudin i de tilfælde, hvor der ikke længere er andre virksomme NRTI'er.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/058/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/98/058/001
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of zidovudine (see section 4.4).
Danish: Der er rapporteret tilfælde af laktacidose, undertiden fatal, sædvanligvis i forbindelse med svær hepatomegali med fedtinfiltration ved brug af ziduvodin (se pkt.
English: • stavudine, to treat HIV infection
Danish: • Stavudin, mod hiv-infektion
English: Your doctor may need to monitor you while you are taking Combivir.
Danish: Lægen vil eventuelt holde ekstra øje med dig under behandlingen med Combivir.
English: General disorders and administration site conditions Common: Fatigue, malaise, fever
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelige: Træthed, utilpashed, feber.
English: Rare : Insomnia, paraesthesiae, somnolence, loss of mental acuity, convulsions
Danish: Sjælden: Søvnløshed, paræstesi, somnolens, mental sløring, krampeanfald
English: Common : Dizziness
Danish: Almindelig: Svimmelhed
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/058/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/98/058/002
English: Adults and adolescents 30 kg or more
Danish: Voksne og unge, der vejer mindst 30 kg
English: • sodium valproate, to treat epilepsy
Danish: • natriumvalproat mod epilepsi
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Ranitidine/Lamivudine
Danish: Zidovudin: AUC ↑ 80 % (Hæmning af UGT) ANTIHISTAMINER (HISTAMIN H1-RECEPTORANTAGONISTER) Ranitidin / lamivudin
English: General disorders and administration site conditions Common : Malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: Utilpashed
English: Swallow Combivir tablets, with some water.
Danish: Tabletterne skal synkes med vand.
English: Zidovudine showed clastogenic effects in an oral repeated dose micronucleus test in mice.
Danish: Zidovudin viste clastogen effekt i en mikronukleustest hos mus efter gentagen oral dosering.
English: As dosage adjustment of Combivir is not possible, separate preparations of zidovudine and lamivudine should be used.
Danish: Da dosisjustering af Combivir ikke er mulig, bør der anvendes særskilte præparater med lamivudin og zidovudin.
English: The clinical relevance of such findings remains, however, not well defined.
Danish: Den kliniske relevans af disse fund er dog ikke veldefineret.
English: When such development is found, treatment with Combivir should not be continued (see section 4.4).
Danish: Hvis der ses udvikling af lipoatrofi, bør behandlingen med Combivir/Trizivir ikke fortsættes (se pkt.
English: Very common side effects These may affect more than than 1 in 10 people:
Danish: Meget almindelige bivirkninger Disse kan forekomme hos flere end 1 ud af 10 personer:
English: • interferon, to treat viral infections
Danish: • interferon mod virusinfektioner
English: • numbness or weakness in the limbs
Danish: • følelsesløshed eller svækkelse i arme og ben
English: • stomach pain.
Danish: • mavesmerter.
English: Following single dose Combivir administration in healthy volunteers, mean (CV) lamivudine and zidovudine Cmax values were 1.6 µg/ml (32%) and 2.0 µg/ml (40%), respectively and the corresponding values for AUC were 6.1 µg h/ml (20%) and 2.4 µg h/ml (29%) respectively.
Danish: Efter administration af en enkelt dosis Combivir til raske frivillige var de gennemsnitlige (CV) Cmaxværdier for lamivudin og zidovudin henholdsvis 1,6 µg/ml (32 %) og 2,0 µg/ml (40 %).
English: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia Very rare: Pure red cell aplasia
Danish: Ikke almindelig: Neutropeni og anæmi (begge af og til alvorlige), trombocytopeni Meget sjælden: Ren erytrocyt aplasi
English: Do not store above 30°C
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Children weighing from 14 kg to 21 kg: the recommended oral dose of Combivir is one-half tablet taken twice daily.
Danish: Børn, der vejer mellem 14 kg og 21 kg: Den anbefalede dosis Combivir er én halv tablet 2 gange daglig.
English: • amphotericin or co-trimoxazole, to treat fungal and bacterial infections
Danish: • amphotericin eller sulfamethoxazol/trimethoprim mod svampe- og bakterieinfektioner
English: • emtricitabine, to treat HIV infection
Danish: • Emtricitabin, mod hiv-infektion
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains lamivudine 150 mg zidovudine 300 mg
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder lamivudin 150 mg zidovudin 300 mg
English: Uncommon : Fever, generalised pain and asthenia Rare :Chills, chest pain and influenza-like syndrome
Danish: Ikke almindelig: Feber, generaliserede smerter og asteni Sjælden: Kulderystelser, brystsmerter og influenzalignende symptomer.
English: Cardiac disorders Rare :Cardiomyopathy
Danish: Hjerte Sjælden: Kardiomyopati
English: Skin and subcutaneous tissue disorders Uncommon : Rash and pruritus Rare : Nail and skin pigmentation, urticaria and sweating
Danish: Ikke almindelig: Udslæt og pruritus Sjælden: Pigmentering af hud og negle, urtikaria og svedtendens
English: Do not store above 30oC.
Danish: Må ikke opbevares ved temperaturer over 30 ºC.
English: Common : Raised blood levels of liver enzymes and bilirubin Rare : Liver disorders such as severe hepatomegaly with steatosis
Danish: Almindelig: Midlertidige stigninger af leverenzymer og bilirubin Sjælden: Leverændringer som f.eks. svær hepatomegali med fedtinfiltration
English: These findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown etiology particularly neurologic findings.
Danish: Mitokondriel dysfunktion bør overvejes hos alle børn med svære kliniske symptomer af ukendt ætiologi, især neurologiske symptomer, der har været eksponeret for nukleosid-/nukleotid-analoger in utero.
English: How to take Combivir
Danish: Sådan skal du tage Combivir
English: In vitro data tend to suggest that the continuation of lamivudine in antiretroviral regimen despite the development of M184V might provide residual antiretroviral activity (likely through impaired viral fitness).
Danish: Ved fremkomst af M184V tyder in vitro-data på, at lamivudin stadig har antiretroviral aktivitet (formentlig på grund af svækkede vira).
English: NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Combivir 150 mg/300 mg filmovertrukne tabletter
English: Combination therapy for HIV can also cause: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
Danish: • øget mængde af mælkesyre i blodet, der i sjældne tilfælde kan medføre laktacidose
English: Read the information ‘Other possible side effects of combination therapy for HIV' in
Danish: Læs oplysningerne 'Andre mulige bivirkninger ved kombinationsbehandling af hiv' under punkt 4 i denne indlægsseddel.
English: Lactic acidosis: Lactic acidosis usually associated with hepatomegaly and hepatic steatosis has been reported with the use of zidovudine.
Danish: Laktacidose: Der er rapporteret tilfælde af laktacidose, sædvanligvis i forbindelse med hepatomegali, med fedtinfiltration ved brug af zidovudin.
English: Renal and urinary disorders Rare: Urinary frequency
Danish: Nyrer og urinveje Sjælden: Hyppig vandladning
English: Common : Vomiting, abdominal pain and diarrhoea Uncommon : Flatulence
Danish: Almindelig: Opkastning, mavesmerter og diarré Ikke almindelig: Flatulens
English: What Combivir contains
Danish: Combivir indeholder:
English: Lamivudine and zidovudine are well absorbed from the gastrointestinal tract.
Danish: Absorption: Lamivudin og zidovudin absorberes godt fra mave-tarmkanalen.
English: The M184V RT mutant shows a <4-fold decrease in susceptibility to didanosine; the clinical significance of these findings is unknown.
Danish: M184V RT-mutanten udviser et mindre end 4 gange fald i følsomheden over for didanosin.
English: Respiratory, thoracic and mediastinal disorders Common: Cough, nasal symptoms
Danish: Luftveje, thorax og mediastinum Almindelig: Hoste, symptomer fra næsen
English: Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea
Danish: Luftveje, thorax og mediastinum Ikke almindelig: Dyspnø Sjælden: Hoste
English: ViiV Healthcare S.r.l Tel: + 39 (0)45 9212611
Danish: Tel: + 39 (0)45 9212611
English: Blood and lymphatic system disorders Common : Anaemia, neutropenia and leucopenia Uncommon: Thrombocyopenia and pancytopenia (with marrow hypoplasia) Rare : Pure red cell aplasia
Danish: Almindelig: Anæmi, neutropeni og leukopeni Ikke almindelig: Trombocytopeni og pancytopeni (med knoglemarvshypoplasi) Sjælden: Ren erytrocyt aplasi
English: Very rare : Aplastic anaemia
Danish: Meget sjælden: Aplasi af røde blodlegemer
English: Rare : Oral mucosa pigmentation, taste perversion and dyspepsia.
Danish: Sjælden: Pigmentering af mundslimhinden, smagsforstyrrelser og dyspepsi, pancreatitis
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Combivir.
Danish: Hæmatologiske parametre bør derfor monitoreres omhyggeligt (se pkt.
English: Reproductive system and breast disorders Rare : Gynaecomastia
Danish: Det reproduktive system og mammae Sjælden: Gynækomasti
English: • high doses of co-trimoxazole, an antibiotic
Danish: • Høje doser af sulfamethoxazol/trimethoprim, mod bakterieinfektioner
English: Skin and subcutaneous tissue disorders Common: Rash, alopecia Rare: Angioedema
Danish: Hud og subkutane væv Almindelig: Udslæt, hårtab Sjælden: Angioødem
English: NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg tablets Lamivudine/zidovudine
Danish: LÆGEMIDLETS NAVN Combivir 150 mg/300 mg tabletter lamivudin/zidovudin
English: Rare side effects that may show up in blood tests are:
Danish: Sjældne bivirkninger, der kan ses i dine blodprøver:
English: Scored tablets
Danish: Tabletter med delekærv
English: Musculoskeletal and connective tissue disorders Common : Arthralgia, muscle disorders Rare: Rhabdomyolysis
Danish: Knogler, led, muskler og bindevæv Almindelige: Artralgi, muskelforstyrrelser Sjælden: Rabdomyolyse
English: Therefore the concomitant use of lamivudine with cladribine is not recommended
Danish: Derfor frarådes samtidig brug af lamivudin og cladribin (se pkt.
English: (see section 4.4)
Danish: 4.3 og 4.4).
English: Combivir 150 mg/300 mg film-coated tablets lamivudine/zidovudine
Danish: Combivir® 150 mg/300 mg filmovertrukne tabletter Lamivudin/zidovudin
English: Common side effects that might show up in blood tests are:
Danish: Almindelige bivirkninger, der kan ses i dine blodprøver:
English: ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine/Lamivudine
Danish: ANTIRETROVIRALE LÆGEMIDLER Didanosin / lamivudin Interaktion ikke undersøgt.
English: NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg film-coated tablets Lamivudine/zidovudine
Danish: LÆGEMIDLETS NAVN Combivir 150 mg/300 mg filmovertrukne tabletter lamivudin/zidovudin
English: If you take more Combivir than you should
Danish: Hvis du har taget for mange Combivir
English: ANTI-INFECTIVE PRODUCTS Atovaquone/Lamivudine
Danish: LÆGEMIDLER MOD INFEKTIONER Atovaquon / lamivudin Interaktion ikke undersøgt.
English: Combivir can make you dizzy and have other side effects that make you less alert.
Danish: Combivir kan medføre svimmelhed og andre bivirkninger, der kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Danish: Brug af anden medicin sammen med Combivir Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: What Combivir is and what it is used for What you need to know before you take Combivir How to take Combivir
Danish: Det skal du vide, før du begynder at tage Combivir Sådan skal du tage Combivir Bivirkninger
English: • muscle weakness.
Danish: • muskelsvækkelse.
English: The active substances are lamivudine and zidovudine.The other ingredients are
Danish: Aktive stoffer: Lamivudin og zidovudin.
English: VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
Danish: Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
English: When concomitant administration with cotrimoxazole is warranted, patients should be monitored
Danish: Når samtidig behandling med sulfa/trim er påkrævet, bør
English: Musculoskeletal and connective tissue disorders Common : Myalgia
Danish: Knogler, led, muskler og bindevæv Almindelig: Myalgi Ikke almindelig: Myopati
English: Absorption
Danish: • opkastning
English: What Combivir looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Pancreatitis
Danish: Amning
English: Pharmacotherapeutic group: Antivirals for treatment of HIV infections, combinations, ATC Code: J05AR01
Danish: Farmakoterapeutisk klassifikation: Antiviralt kemoterapeutikum.
English: An uncommon side effect that may show up in blood test is:
Danish: Meget sjælden bivirkning, der kan ses i blodprøver:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER PACK OUTER CARTON
Danish: BLISTERPAKNINGENS YDRE KARTON
English: Some medicines interact with Combivir
Danish: 4.3) hos patienter i behandling med Combivir.
English: DATE OF REVISION OF THE TEXT MM/YYYY
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: • numbness
Danish: • udslæt
English: • itching
Danish: • kramper
English: ANTICONVULSANTS Phenobarbital/Lamivudine
Danish: ANTIKONVULSIVA Phenobarbital / lamivudin Interaktion ikke undersøgt.
English: The standard dose is one tablet once a day.
Danish: Standarddosen er én tablet én gang dagligt.
English: Dopamine is important for controlling movement and coordination.
Danish: Dopamin er vigtigt for styringen af bevægelser og koordinering.
English: The full EPAR for Rasagiline 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 Rasagilin Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Rasagiline Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rasagilin Mylan.
English: A risk management plan has been developed to ensure that Rasagiline Mylan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Rasagilin Mylan anvendes så sikkert som muligt.
English: The Committee recommended that Rasagiline Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Rasagilin Mylan godkendes til anvendelse i EU.
English: This means that Rasagiline Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Azilect.
Danish: Det betyder, at Rasagilin Mylan svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Azilect.
English: Rasagiline Mylan EMA/281859/2016
Danish: Rasagilin Mylan EMA/75811/2016
English: It blocks the enzyme monoamine oxidase type B, which breaks down a substance called dopamine in the brain.
Danish: Det blokerer enzymet monoaminoxidase type B, som nedbryder stoffet dopamin i hjernen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Rasagilin Mylan er af sammenlignelig kvalitet og er bioækvivalent med Azilect.
English: Therefore, the CHMP's view was that, as for Azilect, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Azilect.
English: By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline Mylan reduces the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Danish: Ved at øge dopaminindholdet i de dele af hjernen, der styrer bevægelser og koordinering, mindsker Rasagilin Mylan symptomerne på Parkinsons sygdom såsom stivhed og langsomme bevægelser.
English: Rasagiline Mylan is available as tablets (1 mg).
Danish: Rasagilin Mylan fås som tabletter (1 mg).
English: Rasagiline Mylan is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Danish: Rasagilin Mylan er et lægemiddel, der anvendes til behandling af voksne patienter med Parkinsons sygdom (en fremadskridende hjernesygdom, som medfører rysten, langsomme bevægelser og muskelstivhed).
English: Rasagiline Mylan can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Danish: Rasagilin Mylan kan anvendes enten alene eller som en tillægsbehandling til levodopa (et andet lægemiddel, der anvendes ved Parkinsons sygdom) hos patienter, der har såkaldte "fluktuationer" (svingninger) i deres sygdomskontrol.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rasagilin Mylan, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What measures are being taken to ensure the safe and effective use of Rasagiline Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rasagilin Mylan?
English: For more information about treatment with Rasagiline 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 Rasagilin Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Rasagiline Mylan, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Danish: Det aktive stof i Rasagilin Mylan, rasagilin, er en "monoaminoxidase B-hæmmer".
English: Other information about Rasagiline Mylan
Danish: Andre oplysninger om Rasagilin Mylan
English: Rasagiline Mylan is a ‘generic medicine'.
Danish: Rasagilin Mylan er et "generisk lægemiddel".
English: Rasagiline Mylan contains the active substance rasagiline.
Danish: Rasagilin Mylan indeholder det aktive stof rasagilin.
English: What is Rasagiline Mylan and what is it used for?
Danish: Hvad er Rasagilin Mylan, og hvad anvendes det til?
English: Because Rasagiline 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.
Danish: Da Rasagilin Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What are the benefits and risks of Rasagiline Mylan?
Danish: Hvilken fordel og risiko er der forbundet med Rasagilin Mylan?
English: Rasagiline Mylan rasagiline
Danish: Rasagilin Mylan rasagilin
English: Because Rasagiline Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Azilect.
Danish: Da Rasagilin Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Azilect.
English: It is not intended to provide practical advice on how to use Rasagiline Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Rasagilin Mylan bør anvendes.
English: For practical information about using Rasagiline Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Rasagilin Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Rasagiline Mylan approved?
Danish: Hvorfor blev Rasagilin Mylan godkendt?
English: How has Rasagiline Mylan been studied?
Danish: Hvordan blev Rasagilin Mylan undersøgt?
English: How is Rasagiline Mylan used?
Danish: Hvordan anvendes Rasagilin Mylan?
English: How does Rasagiline Mylan work?
Danish: Hvordan virker Rasagilin Mylan?
English: 100 U
Danish: 100 E
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Sær)navn Styrke