FrancophonIA/ELRC3.0 huggingface dataset:
English: AVONEX should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Danish: AVONEX bør administreres med forsigtighed til patienter med tidligere eller nuværende depressive lidelser.
English: • Place the pen cover on a flat, hard surface.
Danish: • Læg penhætten på en flad, hård bordplade Tip: Hold ikke på penhætten.
English: Renal and urinary disorders rare nephrotic syndrome, glomerulosclerosis (see section 4.4 ‘special warnings and precautions')
Danish: Nyre- og urinvejssygdomme sjælden nefrotisk syndrom, glomerulosklerose (se pkt.
English: AVONEX 30 micrograms/0.5ml solution for injection in pre-filled pen.
Danish: AVONEX 30 mikrogram/0,5 ml injektionsvæske, opløsning, i fyldt pen.
English: Blood and lymphatic system disorders not known rare pancytopenia, thrombocytopenia thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome*
Danish: Blod og lymfesystem ikke kendt sjælden pancytopeni, trombocytopeni
English: Changes to your mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to your doctor immediately.
Danish: Du bør omgående fortælle det til din læge, hvis du får humørændringer, selvmordstanker eller en følelse af ualmindelig tristhed, angst eller ringe selvagtelse.
English: Solution for injection, in pre-filled pen.
Danish: injektionsvæske, opløsning, i fyldt pen
English: 4 Check the injector shield is extended correctly
Danish: 4 Kontrollér, at injektorafskærmningen dækker helt.
English: EU/1/97/033/005 4 pack EU/1/97/033/006 12 pack
Danish: EU/1/97/033/005 pakning med 4 EU/1/97/033/006 pakning med 12
English: Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Danish: AVONEX bremser handikapudviklingen og reducerer antallet af attakker.
English: Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
Danish: Hændelser er indrapporteret på forskellige tidspunkter under behandlingen fra flere uger til flere år efter start af behandling med interferon-beta.
English: They are more common when you first start using Avonex.
Danish: Symptomerne er mest almindelige i starten af Avonex-behandlingen.
English: Store in the original package in order to protect from light.
Danish: Opbevar pennen i den originale emballage for at beskytte den mod lys.
English: IM
Danish: Vend
English: How to use AVONEX PEN
Danish: Sådan skal du bruge AVONEX PEN
English: EU/1/97/033/003 4 pack EU/1/97/033/004 12 pack
Danish: EU/1/97/033/003 pakning med 4 EU/1/97/033/004 pakning med 12
English: Keep the pen upright.
Danish: Skub ikke på stemplet.
English: How to inject AVONEX PEN
Danish: Sådan injicerer du vha. AVONEX PEN
English: How AVONEX works
Danish: Sådan virker AVONEX
English: Three simple ways to help reduce the impact of flu-like symptoms: 1.
Danish: Tre enkle måder, hvorpå man kan reducere virkningen af influenzalignende symptomer: Tag din Avonex Pen lige inden sengetid.
English: Each 0.5 ml pre-filled syringe contains 30 micrograms (6 million IU) of interferon beta-1a.
Danish: Hver 0,5 ml fyldte sprøjte indeholder 30 mikrogram (6 millioner IE) interferon beta-1a.
English: What AVONEX looks like and contents of the pack Avonex Solution for Injection comes as a ready to use injection.
Danish: Udseende og pakningsstørrelser Avonex injektionsvæske, opløsning, leveres klar til brug.
English: Each single-use pre-filled pen contains 30 micrograms (6 million IU) of interferon beta-1a in 0.5ml of solution.
Danish: Hver fyldt engangspen indeholder 30 mikrogram (6 millioner IE) interferon beta-1a i 0,5 ml opløsning.
English: - Keep this leaflet.
Danish: - Riv papirlåget helt af.
English: Cardiac disorders not known cardiomyopathy, congestive heart failure (see section 4.4), palpitations, arrhythmia, tachycardia
Danish: Hjerte ikke kendt kardiomyopati, kongestivt hjertesvigt (se pkt.
English: For single-use only: The solution for injection in a pre-filled syringe is contained within the AVONEX PEN.
Danish: Kun til éngangsbrug: AVONEX PEN indeholder injektionsvæske i en fyldt sprøjte.
English: AVONEX should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Danish: Dette gælder især, hvis deres epilepsi er utilstrækkeligt kontrolleret med antiepileptika (se pkt.
English: Posology
Danish: Kanylehætte
English: In a box of Avonex there are four or twelve ready to use (pre-filled) syringes, each with 0.5 ml of a clear, colourless liquid inside.
Danish: I en pakke med Avonex er der fire eller tolv (fyldte) sprøjter klar til brug.
English: The injection needle is provided.
Danish: Der er vedlagt en injektionskanyle.
English: As you keep using your injections, the flu-like symptoms gradually decrease.
Danish: De influenzalignende symptomer forsvinder gradvis i takt med, at du får dine injektioner.
English: Denmark
Danish: Danmark.
English: - An underactive or overactive thyroid - Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that are not real), confusion or suicide - Numbness, dizziness, seizures or fits and migraines - An awareness of your heartbeat (palpitations), a rapid or irregular heartbeat, or heart problems which would have the following symptoms: a reduced ability to exercise, inability to lie flat in bed, shortness of breath or swollen ankles - Liver problems as described above - Nettle rash or blister-like rash, itching, worsening of psoriasis if you have it - Swelling or bleeding at the site of injection, or chest pain after an injection - Gaining or losing weight - Changes to test results, including changes to liver function tests.
Danish: man kan ikke ligge fladt ned i sengen, kortåndethed eller hævede ankler - leverproblemer som beskrevet ovenfor - nældefeber- eller vablelignende udslæt, kløe eller forværring af eventuel psoriasis - hævelse eller blødning ved injektionsstedet eller brystsmerte efter en injektion - vægtøgning eller -tab - ændringer i prøveresultater, herunder ændringer i leverfunktionsprøver - Pulmonal arteriel hypertension: en sygdom med svær forsnævring af blodkarrene i lungerne,
English: Your doctor will advise you for how long you can use Avonex or when to stop.
Danish: Avonex kan hjælpe med til at reducere antallet af dine attakker, og det kan forsinke de invaliderende virkninger af MS. Din læge vil rådgive dig om, hvor længe du kan bruge Avonex, eller hvornår du bør ophøre med at bruge Avonex.
English: Symptoms you might notice are tiredness, repeated infection,
Danish: du kan opleve symptomer som træthed, tilbagevendende infektion, uforklarlig dannelse af blå mærker eller blødning.
English: (Notes information) If there's anything you're not sure about, ask your doctor or pharmacist.
Danish: (Bemærk) Spørg din læge eller på apoteket, hvis der er noget du er i tvivl om.
English: Each pre-filled syringe of 0.5 ml contains 30 micrograms (6 million IU) of interferon beta-1a.
Danish: Hver fyldt sprøjte med 0,5 ml indeholder 30 mikrogram (6 millioner IE) interferon beta-1a
English: Pre-filled syringe
Danish: Fyldt sprøjte
English: • Avonex is injected into a muscle, the best area is the upper, outer thigh muscle as shown in the diagram opposite.
Danish: Det bedste område er den store, forreste lårmuskel som vist på billedet her.
English: Discard the unused portion of any pre-filled syringe.
Danish: En eventuel ubrugt rest i sprøjten kasseres.
English: Avonex pen, injection needle and pen cover.
Danish: Injektionsvæske, opløsning, i fyldt pen Avonex pen, injektionskanyle og penhætte.
English: Do not make changes unless your doctor tells you.
Danish: Det er vigtigt at fortsætte med at bruge Avonex regelmæssigt og ikke at foretage ændringer, medmindre din læge siger, at du skal.
English: Avonex can also be stored at room temperature (between 15°C and 30°C) for up to one week.
Danish: Avonex kan også opbevares ved stuetemperatur (mellem 15°C og 30°C) i op til én uge.
English: Avonex Pen can be stored at room temperature (between 15°C and 30°C) for up to one week.
Danish: Avonex pen kan opbevares ved stuetemperatur (mellem 15°C og 30°C) i op til én uge.
English: Excipient(s) with known effect For the full list of excipients, see section 6.1.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Alle hjælpestoffer er anført under pkt.
English: Fatigue
Danish: Amning
English: AVONEX can be stored at room temperature (between 15°C and 30°C) for up to one week.
Danish: Avonex kan opbevares ved stuetemperatur (mellem 15 °C og 30 °C) i op til én uge.
English: For administration of AVONEX via the AVONEX PEN, the instructions in the package leaflet should be followed.
Danish: Følg vejledningen i indlægssedlen til administration af AVONEX vha. AVONEX PEN.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Intramuscular use.
Danish: Se indlægsseddel.
English: If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex Pen again.
Danish: Lad der gå én uge, før du bruger Avonex Pen igen.
English: In addition, an updated RMP should be submitted:
Danish: Desuden skal en opdateret RMP fremsendes:
English: Date of first authorisation: 21-March-2012 Date of latest renewal: 05 December 2016
Danish: Dato for første markedsføringstilladelse: 21 Marts 2012 Dato for seneste fornyelse: 5 december 2016
English: Your doctor will tell you the dose to take.
Danish: Deres læge vil fortælle Dem, hvilken dosis De skal tage.
English: • if you have or have ever had bladder cancer.
Danish: hvis De har eller nogensinde har haft blærekræft.
English: • If you have a problem with your liver or heart.
Danish: • hvis De har problemer med Deres lever eller hjerte.
English: The Prescriber Guide highlights the following:
Danish: Ordinationsvejledningen bør sætte fokus på følgende:
English: • if you have blood in your urine that your doctor has not checked.
Danish: hvis De har blod i urinen, og Deres læge ikke har undersøgt årsagen.
English: See the package leaflet for further information.
Danish: Se indlægsseddel for yderligere information.
English: • if you retain water (fluid retention) or have heart failure problems, in particular if you are over 75 years old.
Danish: • hvis De har vand i kroppen (ødemer) eller har problemer med hjertesvigt, specielt hvis De er over 75 år.
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Pioglitazone Accord helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Danish: Pioglitazone Accord hjælper med at kontrollere sukkerniveauet i Deres blod, hvis De har type 2diabetes, ved at hjælpe Deres krop til bedre at udnytte den insulin, kroppen producerer.
English: • if you have cysts on your ovaries (polycystic ovary syndrome).
Danish: • hvis De har cyster på æggestokkene (polycystisk ovariesyndrom).
English: Pioglitazone Accord has no or negligible influence on the ability to drive and use machines.
Danish: Pioglitazone Accord påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Prior to distribution of the prescriber guide in each Member State, the MAH agreed the content and format of the educational material, together with a communication plan, with the national competent authority.
Danish: Forud for udlevering af ordinationsvejledningen i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen og den nationale kompetente myndighed blive enige om indholdet og formatet af informationsmaterialet samt en kommunikationsplan.
English: • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).
Danish: hvis De har haft diabetisk ketoacidose (en komplikation ved diabetes, der giver hurtigt vægttab, kvalme eller opkastning).
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Accord.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi De kan få ægløsning igen, når De tager Pioglitazone Accord.
English: Take Pioglitazone Accord daily as prescribed.
Danish: Tag Pioglitazone Accord dagligt som foreskrevet.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer, før og mens produktet markedsføres.
English: Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Danish: Epidemiologiske studier har også antydet en let øget risiko for blærecancer hos diabetespatienter behandlet med pioglitazon, selv om der ikke blev fundet en statistisk signifikant øget risiko i alle studier.
English: • Risk Management Plan
Danish: Risikostyringsprogram (RMP)
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product
Danish: Betingelser eller restriktioner med hensyn til sikker og effektiv brug af lægemidlet
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Danish: Interaktion med præparater, der metaboliseres af disse enzymer, f.eks. orale kontraceptiva, ciclosporin, calciumblokkere og HMGCoAreduktasehæmmere, kan ikke forventes.
English: If you take Pioglitazone Accord with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Hvis De tager Pioglitazone Accord sammen med anden diabetesmedicin, er der en større risiko for, at Deres blodsukker falder til under det normale niveau (hypoglykæmi).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER BLISTERSTRIPS BLISTER
English: When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually.
Danish: Ved behandling af patienter, der har mindst én risikofaktor for udvikling af hjerteinsufficiens (f.eks. tidligere hjerteinfarkt, symptomgivende koronar arteriel sygdom eller alder), bør lægen starte med den lavest tilgængelige dosis, som derefter øges gradvist.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Pioglitazone Accord (also see Section 4)
Danish: Kontakt lægen eller apotekspersonalet, før De tager Pioglitazone Accord (se også punkt 4)
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Accord.
Danish: Deres læge vil bede Dem om at få taget blodprøver periodevis, mens De er i behandling med Pioglitazone Accord.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The MAH shall submit within 1 month of the Commission decision an updated Risk Management Plan which shall include a risk minimisation plan which includes additional risk minimisation measures to address the identified risks of bladder cancer and heart failure, as detailed below.
Danish: Inden for 1 måned efter Kommissionens beslutning skal indehaveren af markedsføringstilladelsen indsende et opdateret risikostyringsprogram (RMP) med et risikominimeringsprogram, som omfatter yderligere risikominimerende foranstaltninger, som beskrevet nedenfor, for at imødegå de identificerede risici for blærecancer og hjerteinsufficiens.
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Danish: Den gennemsnitlige plasmahalveringstid for uomdannet pioglitazon er hos mennesket 5-6 timer og for dets samlede, aktive metabolitter 1623 timer.
English: The safety and efficacy of Pioglitazone Accord in children and adolescents under 18 years of age have not been established.
Danish: Pioglitazone Accords sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Pioglitazone hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Before you start taking Pioglitazone Accord you will have a blood sample taken to check your liver function.
Danish: Før De begynder at tage Pioglitazone Accord, vil De få taget en blodprøve til kontrol af leverfunktionen.
English: If you stop using Pioglitazone Accord, your blood sugar may go up.
Danish: Hvis De holder op med at tage Pioglitazone Accord, kan Deres blodsukker stige.
English: Do not take Pioglitazone Accord: • if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in Section
Danish: Tag ikke Pioglitazone Accord: hvis De er overfølsom (allergisk) over for pioglitazon, eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6).
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at udføre de pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen ifølge aftalen i risikostyringsprogrammets (RMP), Modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP, som vedtages af Udvalget for Humanmedicinske Lægemidler (CHMP).
English: If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Accord.
Danish: Hvis De følger en særlig diæt på grund af Deres diabetes, skal De fortsætte med denne diæt, mens De tager Pioglitazone Accord.
English: • if you have heart failure or have had heart failure in the past.
Danish: hvis De lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: • if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
Danish: • hvis De lider af en særlig diabetisk øjenlidelse, som hedder makulaødem (væskeansamling i det bagerste af øjet).
English: Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4).
Danish: Efter markedsføringen er der rapporteret knoglefrakturer hos både mandlige og kvindelige patienter (se pkt.
English: Tablet 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Danish: Tablet 14 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter 112 tabletter 196 tabletter
English: Your doctor may increase the dose to a maximum of 45 mg once a day.
Danish: Deres læge øger måske Deres dosis til maksimalt 45 mg en gang daglig.
English: • if you have liver disease.
Danish: hvis De har leversygdom.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Danish: Lignende ændringer blev observeret for metformin (hæmoglobin 3-4% og hæmatokrit 3,6-4,1% relative reduktioner) og i mindre grad for sulfonylurinstof og insulin (hæmoglobin 1-2% og hæmatokrit 1-3,2% relative reduktioner) hos patienter i kontrollerede sammenlignende studier med pioglitazon.
English: In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
Danish: I et placebo-kontrolleret forsøg blev patienter med utilstrækkelig glykæmisk regulering på trods af en tre måneders insulinoptimeringsperiode, randomiseret til pioglitazon eller placebo i 12 måneder.
English: Pioglitazone Accord may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulfonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Danish: Pioglitazone Accord kan anvendes alene til patienter, som ikke er i stand til at tage metformin, og hos hvem diæt og motion ikke har været i stand til at kontrollere blodsukkeret, eller det kan anvendes som supplement til andre lægemidler (såsom metformin, sulfonylurinstof eller insulin), hvis disse ikke har været i stand til at kontrollere blodsukkeret tilstrækkeligt.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Accord.
Danish: De kan normalt blive ved med at tage anden medicin, mens De får Pioglitazone Accord.
English: Pioglitazone Accord with food and drink You may take your tablets with or without food.
Danish: Brug af Pioglitazone Accord sammen med mad og drikke De kan tage Deres tabletter i forbindelse med et måltid, men det er ikke nødvendigt.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Danish: Der er været sjældne rapporter vedrørende hepatocellulær funktionssvigt under post-marketing-studier (se pkt.
English: Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Pioglitazone Accord.
Danish: Der er rapporteret om allergiske reaktioner (hyppigheden kan ikke vurderes ud fra de tilgængelige data) hos patienter, der tager Pioglitazone Accord.
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Danish: Et klinisk forsøg, hvor pioglitazon blev sammenlignet med gliclazid begge som monoterapi, blev forlænget til en varighed af to år for at undersøge hvornår behandlingen svigter (defineret som forekomst af HbA1c  8,0% efter de første seks måneders behandling).
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Danish: Da både insulin og pioglitazon er associeret med væskeretention, kan samtidig indgift måske øge risikoen for ødemer.