FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose.
Danish: På grund af evidensen for øget risiko for maligne sygdomme ved langvarig brug af calcitonin (se punkt 4.4) bør behandlingen ved alle indikationer begrænses til kortest mulig tid og laveste effektive dosis.
English: - Treatment of high calcium levels in the blood (hypercalcaemia) due to cancer.
Danish: - Behandling af for højt calciumindhold i blodet (hyperkalcæmi) på grund af kræft.
English: Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations.
Danish: I disse studier blev patienterne behandlet med orale eller intranasale formuleringer, men det er sandsynligt, at der også er en øget risiko, når calcitonin administreres subkutant, intramuskulært eller intravenøst, specielt ved langtidsbehandling, da den systemiske eksponering for calcitonin hos disse patienter forventes at være højere end for andre formuleringer.
English: Annex III Amendments to the relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til de relevante sektioner i produktresumé og indlægsseddel (formuleringer til injektion)
English: For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.
Danish: Behandling af Pagets sygdom, men kun hos patienter, der ikke reagerer på alternative behandlinger, eller hvor sådanne behandlinger ikke er hensigtsmæssige, f.eks. patienter med svært nedsat nyrefunktion
English: A.
Danish: A. Produktresumé
English: What <invented name> is and what it is used for: [the currently approved wording should be deleted and replaced by the following] <invented name> can be given for the following conditions: - Prevention of bone loss in patients who have suddenly become immobile.
Danish: Virkning og anvendelse [den nuværende godkendte ordlyd skal slettes og erstattes af følgende ordlyd] <særnavn> kan bruges ved følgende sygdomme: - Forebyggelse af knogletab hos patienter, der pludseligt er blevet immobile, fx patienter, som er sengeliggende pga. knoglebrud.
English: Under exceptional circumstances, e.g. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months.
Danish: I særlige tilfælde, f.eks. hos patienter med truende patologisk fraktur, kan behandlingsvarigheden øges til maksimalt 6 måneder.
English: Analyses of randomised controlled trials conducted in patients with osteoarthritis and osteoporosis have shown that calcitonin is associated with a statistically significant increase in the risk of cancer compared to patients treated with placebo.
Danish: Analyser af randomiserede kontrollerede studier udført hos patienter med osteoarthritis og osteoporose har vist, at calcitonin er forbundet med statistisk signifikant øget risiko for cancer sammenlignet med placebobehandlede patienter.
English: Treatment should be discontinued once the patient has responded and symptoms have resolved.
Danish: Når patienten har reageret på behandlingen, og symptomerne er ophørt, bør behandlingen stoppes.
English: For Paget's disease: 100 IU daily injected into a muscle or into the tissue just under the skin, normally for up to 3 months.
Danish: - Til Pagets sygdom: 100 IE daglig som indsprøjtning i musklen eller i vævet lige under huden, normalt i op til 3 måneder.
English: The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use.
Danish: Den anbefalede behandlingsvarighed er to uger og bør ikke under nogen omstændigheder overstige fire uger på grund af øget risiko for malign sygdom ved langtidsbehandling med calcitonin.
English: 4.4 Special warnings and precautions for use [the wording below should be inserted]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [ordlyden nedenfor skal indsættes]
English: Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use.
Danish: Behandlingsvarigheden bør normalt ikke være over tre måneder på grund af evidensen for øget risiko for maligne sygdomme ved langvarig anvendelse af calcitonin.
English: These trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo which varied between 0.7% and 2.
Danish: Disse studier viste en stigning på mellem 0,7 % og 2,4 % i den absolutte risiko for cancer hos patienter i langvarig behandling med calcitonin sammenlignet med placebo.
English: Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section
Danish: Hos sådanne patienter kan periodisk genbehandling overvejes, idet der herunder tages hensyn til de potentielle fordele og evidensen for øget risiko for maligne sygdomme ved langvarig anvendelse af calcitonin (se punkt 4.4).
English: In clinical trials, patients treated with calcitonin for osteoporosis and osteoarthritis have shown an increase in the risk of cancer following long term treatment.
Danish: I kliniske studier har patienter behandlet med calcitonin for osteoporose og slidgigt haft en øget risiko for kræft efter langtidsbehandling.
English: - Paget's disease of bone in patients who cannot take other treatments for this condition, for example patients with serious kidney problems.
Danish: - Pagets knoglesygdom hos patienter, der ikke kan tage anden behandling for denne sygdom, fx patienter med alvorlige nyreproblemer.
English: 4.2 Posology and method of administration [the wording below should be inserted]
Danish: 4.2 Dosering og indgivelsesmåde [ordlyden nedenfor skal indsættes]
English: daily at the start of remobilisation.
Danish: Dosis kan reduceres til 50 IE daglig efter påbegyndt remobilisering.
English: For the treatment of high calcium levels: 100 IU every 6 to 8 hours, given into a muscle or into the tissue just under the skin.
Danish: - Til behandling af for højt calciumindhold i blodet: 100 IE hver 6. til 8. time som indsprøjtning i musklen eller i vævet lige under huden.
English: Treatment of hypercalcaemia of malignancy.
Danish: Behandling af hyperkalcæmi på grund af malign sygdom
English: Your doctor will decide the correct dose and how long you should receive calcitonin treatment depending on your condition.
Danish: Afhængigt af din tilstand vil din læge fastsætte den korrekte dosis og hvor længe, du skal have calcitonin.
English: How to take <invented name> [the wording below should be inserted]
Danish: Sådan skal du tage <særnavn> [ordlyden nedenfor skal indsættes]
English: Patient Information Leaflet
Danish: B. Indlægsseddel: Information til brugeren
English: per day administered subcutaneously or intramuscularly, however a minimum dosage regimen of 50 I.U.
Danish: Den anbefalede dosis er 100 IE pr. dag subkutant eller intramuskulært; der er dog opnået klinisk og biokemisk effekt ved en minimumsdosering på 50 IE 3 gange ugentlig.
English: Before you take <invented name> [the wording below should be inserted]
Danish: Det skal du vide, før du begynder at tage<særnavn> [ordlyden nedenfor skal indsættes]
English: For prevention of bone loss: 100 IU per day or 50 IU twice daily for 2 to 4 weeks, given into the muscle or the tissue just under the skin.
Danish: Den sædvanlige dosis er: - Til forebyggelse af knogletab: 100 IE daglig eller 50 IE to gange daglig i 2-4 uger.
English: Malignancy (with long term use), frequency: common
Danish: Almindelig: Malign sygdom (ved langtidsbehandling).
English: 4.1 Therapeutic indication [the currently approved indications should be deleted and replaced by the following]
Danish: 4.1 Terapeutiske indikationer [de nuværende godkendte indikationer skal slettes og erstattes med følgende] Forebyggelse af akut knogletab på grund af pludselig immobilisering f.eks. hos patienter med nylige osteoporotiske frakturer
English: twice daily administered subcutaneously or intramuscularly.
Danish: Den anbefalede dosis er 100 IE daglig eller 50 IE to gange daglig subkutant eller intramuskulært.
English: The usual doses are:
Danish: Forebyggelse af akut knogletab:
English: This summary was last updated in 05-2017.
Danish: Dette sammendrag blev sidst ajourført i 05-2017.
English: Doses can be increased further until the most effective dose is reached.
Danish: Dosis kan øges yderligere, indtil den mest effektive dosis er nået.
English: Pregabalin Mylan is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Danish: Pregabalin Mylan fås som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg) og udleveres kun efter recept.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: • generaliseret angstsygdom (langvarig angst eller nervøsitet over hverdagsanliggender).
English: Patients who have kidney problems may need to take lower doses.
Danish: Patienter med nyreproblemer skal muligvis have lavere dosis.
English: The maximum dose is 600 mg per day.
Danish: Den maksimale dosis er 600 mg dagligt.
English: After three to seven days, the dose can be increased to 300 mg per day.
Danish: Efter tre til syv dage kan dosis øges til 300 mg dagligt.
English: To stop treatment with Pregabalin Mylan the dose should be reduced gradually, over at least a week.
Danish: For at indstille behandlingen med Pregabalin Mylan bør dosis reduceres gradvist i løbet af mindst en uge.
English: • epilepsy, where it is used as an ‘add-on' to other epilepsy treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain);
Danish: • epilepsi, hvor det anvendes som tillægsbehandling til anden epilepsibehandling hos patienter med partielle anfald (epileptiske anfald, som begynder i en bestemt del af hjernen)
English: The full EPAR for Pregabalin 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 Pregabalin 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 Pregabalin Mylan on 25 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Mylan den 25. juni 2015.
English: The recommended starting dose is 150 mg per day, divided into two or three doses.
Danish: Den anbefalede startdosis er 150 mg dagligt fordelt på to eller tre doser.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også undersøgelser, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Danish: Neurotransmittere er kemiske signalstoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Mylan.
English: This means that Pregabalin Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: Det betyder, at Pregabalin Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Lyrica.
English: The Committee recommended that Pregabalin Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Pregabalin Mylan godkendes til anvendelse i EU.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Lyrica, og det er ikke nødvendigt at gentage disse med Pregabalin Mylan.
English: As for every medicine, the company provided studies on the quality of Pregabalin Mylan.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Pregabalin Mylan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pregabalin Mylan er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Danish: Det vides endnu ikke nøjagtigt, hvordan pregabalin virker, men det menes at påvirke indstrømningen af calcium i nervecellerne.
English: Pregabalin Mylan is a medicine used to treat adults with the following conditions:
Danish: Pregabalin Mylan er et lægemiddel til behandling af voksne med følgende tilstande:
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Danish: • smerter, der skyldes beskadigelse af nerver uden for centralnervesystemet (perifere neuropatiske smerter), såsom ved sukkersyge eller helvedesild (herpes zoster), og smerter fra centralnervesystemet (centrale neuropatiske smerter), såsom smerter efter rygmarvsskader
English: The active substance in Pregabalin Mylan, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Mylan, pregabalin, minder i struktur om kroppens egen neurotransmitter GABA (gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Mylan?
English: What are the benefits and risks of Pregabalin Mylan?
Danish: Hvilke fordele og risici er der forbundet med Pregabalin Mylan?
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Lyrica.
English: Because Pregabalin 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 Pregabalin Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Pregabalin Mylan is a ‘generic medicine'.
Danish: Pregabalin Mylan er et "generisk lægemiddel".
English: For more information about treatment with Pregabalin 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 Pregabalin Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Pregabalin Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Mylan bør anvendes.
English: What is Pregabalin Mylan and what is it used for?
Danish: Hvad er Pregabalin Mylan, og hvad anvendes det til?
English: Pregabalin Mylan contains the active substance pregabalin.
Danish: Pregabalin Mylan indeholder det aktive stof pregabalin.
English: For practical information about using Pregabalin Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Mylan, bør du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Danish: Derved mindskes frigivelsen af andre neurotransmittere, der er en medvirkende årsag til epilepsi og angst.
English: Other information about Pregabalin Mylan
Danish: Andre oplysninger om Pregabalin Mylan
English: Why is Pregabalin Mylan approved?
Danish: Hvorfor blev Pregabalin Mylan godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Mylan have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pregabalin Mylan.
English: How is Pregabalin Mylan used?
Danish: Hvordan anvendes Pregabalin Mylan?
English: How has Pregabalin Mylan been studied?
Danish: Hvordan blev Pregabalin Mylan undersøgt?
English: How does Pregabalin Mylan work?
Danish: Hvordan virker Pregabalin Mylan?
English: --1 Live myxoma vectored rabbit haemorrhagic disease (RHD) virus: Strain 009: ≥103.0 and ≤105.8 FFU* Strain MK1899: ≥103.0 and ≤105.8 FFU* *Focus Forming Units
Danish: --1 Levende myxoma vector Rabbit Haemorrhagic Disease (RHD) virus: Stamme 009: ≥ 103,0 og ≤ 105,8 FFU* Stamme MK1899: ≥ 103,0 og ≤ 105,8 FFU* * Focus Forming Units
English: Annex A
Danish: Anneks A
English: Lyophilisate: 50 doses, solvent: 10 ml
Danish: Lyofilisat: 50 doser, Solvens: 10 ml
English: In cardboard box:
Danish: I papæske:
English: Solvent: 10 vials
Danish: Solvens:
English: Lyophilisate: 10 vials, In cardboard box:
Danish: 10 hætteglas, I papæske:
English: Immediate packaging
Danish: Emballage Indhold Pakningsstør- EUnummer
English: The European Commission granted a marketing authorisation valid throughout the EU for Aclasta on 15 April 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aclasta den 15. april 2005.
English: The full EPAR for Aclasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Aclasta findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Aclasta:
Danish: Andre oplysninger om Aclasta:
English: This document is a summary of the European Public Assessment Report (EPAR) for Aclasta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aclasta.
English: A risk management plan has been developed to ensure that Aclasta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Aclasta anvendes så sikkert som muligt.
English: Aclasta zoledronic acid
Danish: Aclasta zoledronsyre
English: Aclasta is given as an infusion lasting at least 15 minutes.
Danish: Aclasta gives som en infusion, der varer mindst 15 minutter.
English: This is a disease where the normal process of bone growth is changed.
Danish: Det er en sygdom, hvor den normale knoglevækst ændres.
English: The effect of each infusion lasts for a year or more.
Danish: Effekten af infusionen varer et år eller mere.
English: What measures are being taken to ensure the safe and effective use of Aclasta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aclasta?
English: This can be repeated once a year in patients being treated for osteoporosis.
Danish: Dette kan gentages en gang årligt hos patienter, der er i behandling for osteoporose.
English: After six months, around 96% of patients had responded to treatment in the two studies, compared with around 74% of the patients who received risedronate.
Danish: Efter seks måneder havde ca. 96 % af patienterne reageret på behandlingen i de to undersøgelser sammenlignet med ca. 74 % af de patienter, der fik risedronat.
English: The patients received one infusion of Aclasta or they took risedronate once a day for two months.
Danish: Patienterne fik en infusion af Aclasta, eller de fik risedronat en gang dagligt i to måneder.
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported rarely (seen in between 1 and 10 patients in 10,000).
Danish: Osteonekrose i kæben (skade på knoglerne i kæben, hvilket kan medføre smerter, sår i munden eller løsning af tænder) er sjældent blevet rapporteret (ses hos mellem 1 og 10 patienter ud af 10 000).
English: In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Danish: Ved Pagets sygdom nedbrydes knoglen hurtigere, og når den vokser frem igen, er den svagere end normalt.
English: Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium.
Danish: Patienterne skal have tilstrækkelige væskemængder før og efter behandlingen og bør have tilstrækkelige tilskud af vitamin D og calcium.
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 Aclasta.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Aclasta.
English: Because zoledronic acid has been authorised in the EU as Zometa for a number of years, the company presented the results of some studies carried out with Zometa, which were taken into account when assessing Aclasta.
Danish: Da zoledronsyre har været godkendt i EU under navnet Zometa i nogle år, fremlagde virksomheden resultaterne af en række undersøgelser med Zometa, som blev taget i betragtning ved vurderingen af Aclasta.
English: The CHMP decided that Aclasta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Aclasta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: For osteoporosis, Aclasta has been studied in three main studies.
Danish: Til osteoporose blev Aclasta undersøgt i tre hovedundersøgelser.
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Danish: Dette fører til mindre knogletab ved osteoporose og mindre sygdomsaktivitet ved Pagets sygdom.
English: For Paget's disease, only one infusion of Aclasta is usually given, but additional infusions can be considered if the patient's disease comes back.
Danish: Ved Pagets sygdom gives der almindeligvis kun en infusion af Aclasta, men yderligere infusioner kan overvejes, hvis patientens sygdom kommer tilbage.
English: Aclasta should not be used in patients with severe kidney problems.
Danish: Aclasta bør ikke anvendes til patienter, som har svære nyreproblemer.
English: The active substance in Aclasta, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Aclasta, zoledronsyre, er et bisphosphonat.