FrancophonIA/ELRC3.0 huggingface dataset:
English: Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of  4 per 30 minutes a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of  50% a gestational age from 24 until 33 completed weeks a normal foetal heart rate
Danish: 30 minutter - en cervikal dilatation på 1 til 3 cm (0-3 hos nullipara) og en udslettelse på  50% - en gestationsalder fra 24 til 33 fuldbårne uger - en normal foetal hjertefrekvens.
English: Österreich Ferring Arzneimittel Ges.m.b.H
Danish: Deutschland Ferring Arzneimittel GmbH
English: Tractocile is given intravenously in three successive stages: - The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
Danish: Tractocile gives intravenøst i tre successive stadier: - Den indledende intravenøs injektion på 6,75 mg i 0,9 ml injiceres langsomt i en vene over 1
English: Tractocile will be given into a vein (intravenously) in three stages: - The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
Danish: Tractocile indsprøjtes i en vene (intravenøst) i tre trin: - en indledende intravenøs injektion på 6,75 mg i 0,9 ml injiceres langsomt i en vene over 1 minut.
English: Tractocile 6.75 mg/0.9 ml injection atosiban
Danish: Tractocile 6,75 mg/0,9 ml injektionsvæske atosiban i.v.
English: Hydrochloric acid 1M Water for injections
Danish: Saltsyre 1M
English: Tel: +36 1 236 3800 ferring@ferring.hu
Danish: Magyarország Ferring Magyarország Gyógyszerkereskedelmi Kft. Tel: +36 1 236 3800 ferring@ferring.hu
English: VIAL
Danish: Opkast
English: Tractocile 37.5 mg/5 ml sterile concentrate atosiban
Danish: Tractocile 37,5 mg/5 ml koncentrat, sterilt atosiban i.v.
English: - Each vial of Tractocile 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Danish: - Hvert hætteglas med Tractocile 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning indeholder atosibanacetate svarende til 37,5 mg atosiban i 5 ml - De øvrige indholdsstoffer er mannitol, saltsyre og vand til injektionsvæsker
English: Instructions for use Before using Tractocile, the solution should be examined to ensure it is clear and free from particles.
Danish: Inden Tractocile anvendes, skal injektionsvæsken undersøges visuelt.
English: What you need to know before you are given Tractocile 3.
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Tractocile Sådan får du Tractocile Bivirkninger
English: Tractocile 37.5 mg/5 ml concentrate for solution for infusion Atosiban
Danish: Tractocile 37,5 mg/5 ml koncentrat til infusionsvæske, opløsning atosiban
English: Nausea Vomiting
Danish: Mave-tarm-kanalen Kvalme
English: In atosiban clinical trials no effects were observed on breast-feeding.
Danish: Der blev ikke observeret nogen indvirkninger på amning under kliniske afprøvninger med atosiban.
English: Pruritis, Rash
Danish: Pruritus, udslæt
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Danish: Indehaver af markedsføringstilladelsen og fremstiller
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ
English: Justification for not including Braille accepted
Danish: Fritaget fra krav om blindskrift
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Danish: Som følge heraf sænkes blodsukkeret, og dette medvirker til at kontrollere type 2-diabetes.
English: The recommended starting dose of Pioglitazone Krka is 15 or 30 mg once a day.
Danish: Den anbefalede startdosis af Pioglitazone Krka er 15 eller 30 mg én gang dagligt.
English: The full EPAR for Pioglitazone Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pioglitazone Krka 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 Pioglitazone Krka on 21 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pioglitazone Krka den 21. marts 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 Pioglitazone Krka.
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 Pioglitazone Krka.
English: Treatment with Pioglitazone Krka should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Pioglitazone Krka skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke har tilstrækkelig gavn af behandlingen.
English: The active substance in Pioglitazone Krka, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone Krka, pioglitazon, virker ved at gøre cellerne (fedt, muskler og lever) mere følsomme over for insulin, hvilket betyder, at kroppen gør bedre brug af det insulin, den danner.
English: For more information about treatment with Pioglitazone Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pioglitazone Krka, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Pioglitazone Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone Krka er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Krka.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pioglitazone Krka.
English: Pioglitazone Krka is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Pioglitazone Krka anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), specielt overvægtige personer.
English: At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Danish: Ved efterfølgende kontroller skal den ordinerende læge kontrollere, at patienten fortsat har gavn af behandlingen.
English: Pioglitazone Krka is a medicine that contains the active substance pioglitazone.
Danish: Pioglitazone Krka er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Because Pioglitazone Krka 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: Eftersom Pioglitazone Krka er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som referencelægemidlets.
English: Pioglitazone Krka can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Pioglitazone Krka kan også anvendes i kombination med insulin til patienter, der ikke er tilstrækkeligt kontrolleret med insulin alene, og som ikke kan tage metformin.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Krka has been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Pioglitazone Krkas kvalitet svarer til Actos', og at Pioglitazone Krka er bioækvivalent med Actos.
English: Because Pioglitazone Krka is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone Krka er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet Actos.
English: Pioglitazone Krka should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Danish: Pioglitazone Krka bør ikke anvendes til patienter i dialyse (en blodrensningsteknik, der anvendes på personer med nyrelidelse).
English: Pioglitazone Krka is a ‘generic medicine'.
Danish: Pioglitazone Krka er et ‘generisk lægemiddel'.
English: Other information about Pioglitazone Krka
Danish: Andre oplysninger om Pioglitazone Krka
English: What are the benefits and risks of Pioglitazone Krka?
Danish: Hvilken fordel og risiko er der ved Pioglitazone Krka?
English: Pioglitazone Krka can also be used with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Danish: Pioglitazone Krka kan også anvendes i kombination med et sulfonylurinstof, (et andet lægemiddel mod diabetes) når metformin ikke er hensigtsmæssigt (”tostofbehandling”).
English: The Committee recommended that Pioglitazone Krka be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Pioglitazone Krka.
English: Pioglitazone Krka is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Pioglitazone Krka anvendes alene til patienter, når metformin (et andet lægemiddel mod diabetes) ikke er hensigtsmæssigt.
English: Why has Pioglitazone Krka been approved?
Danish: Hvorfor blev Pioglitazone Krka godkendt?
English: What is Pioglitazone Krka?
Danish: Hvad er Pioglitazone Krka?
English: How has Pioglitazone Krka been studied?
Danish: Hvordan blev Pioglitazone Krka undersøgt?
English: How is Pioglitazone Krka used?
Danish: Hvordan anvendes Pioglitazone Krka?
English: What is Pioglitazone Krka used for?
Danish: Hvad anvendes Pioglitazone Krka til?
English: How does Pioglitazone Krka work?
Danish: Hvordan virker Pioglitazone Krka?
English: In the MRP United Kingdom is the Reference Member State (RMS) and Austria, Belgium, Finland, France, Germany, Italy, Ireland, Luxembourg, Portugal, Spain and Sweden are Concerned Member States (CMS).
Danish: I proceduren for gensidig anerkendelse er Det Forenede Kongerige referencemedlemsstaten, og Østrig, Belgien, Finland, Frankrig, Tyskland, Italien, Irland, Luxembourg, Portugal, Spanien og Sverige er de berørte medlemsstater.
English: VIANI EVOHALER and associated names (See Annex I)
Danish: VIANI EVOHALER og tilknyttede navne (se bilag I)
English: 4 July 2006 EMEA/306455/2006
Danish: 4. juli 2006 EMEA/306455/2006
English: Viani Evohaler and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Danish: Viani Evohaler og tilknyttede navne (se bilag I) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, og er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta-2-agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta-2-agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta-2-agonist.
English: In several EU Member States Viani Evohaler and associated names are approved through the Mutual Recognition Procedure (MRP).
Danish: Viani Evohaler og tilknyttede navne er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: The full EPAR for Palonosetron Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Palonosetron Hospira findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Danish: Når 5HT binder sig til disse receptorer, medfører det normalt kvalme og opkastning.
English: In adults, the recommended dose is 250 micrograms, injected into a vein over 30 seconds.
Danish: Den anbefalede dosis til voksne er 250 mikrogram, som injiceres i en vene over 30 sekunder.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Danish: Det betyder, at det forhindrer et kemisk stof i kroppen kaldet 5-hydroxytryptamin (5HT, også kaldet serotonin) i at binde sig til 5HT3-receptorerne i maven.
English: The Committee recommended that Palonosetron Hospira be approved for use in the EU.
Danish: Udvalget anbefalede, at Palonosetron Hospira godkendes til anvendelse i EU.
English: This is a summary of the European public assessment report (EPAR) for Palonosetron Hospira.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Palonosetron Hospira.
English: A risk management plan has been developed to ensure that Palonosetron Hospira is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Palonosetron Hospira anvendes så sikkert som muligt.
English: It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Danish: Det anvendes til voksne og børn på en måned og derover til kemoterapi med lægemidler, som enten i kraftig grad udløser kvalme og opkastninger (såsom cisplatin), eller som i moderat grad udløser kvalme og opkastninger (såsom cyclophosphamid, doxorubicin eller carboplatin).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Hospira has been shown to be comparable to Aloxi.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Palonosetron Hospira er sammenligneligt med Aloxi.
English: the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Danish: Hos børn gives opløsningen ved infusion (drop) i en vene over 15 minutter i en dosis på 20 mikrogram pr. kilo kropsvægt.
English: This means that Palonosetron Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi.
Danish: Det betyder, at Palonosetron Hospira svarer til et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Aloxi.
English: It is available as a solution for injection which should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Danish: Det fås som en injektionsvæske, opløsning, som skal indgives af en sundhedsperson ca. 30 minutter før kemoterapien starter.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Palonosetron Hospira, 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 Palonosetron Hospira, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: No additional studies were needed as Palonosetron Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
Danish: Der var ikke brug for yderligere undersøgelser, da Palonosetron Hospira er et generisk lægemiddel, som gives ved injektion og indeholder samme aktive stof som referencelægemidlet Aloxi.
English: By blocking these receptors, Palonosetron Hospira prevents the nausea and vomiting that often happen after chemotherapy.
Danish: Ved at blokere disse receptorer forebygger Palonosetron Hospira den kvalme og de opkastninger, som ofte indtræder efter kemoterapi.
English: The active substance in Palonosetron Hospira, palonosetron, is a ‘5HT3 antagonist'.
Danish: Det aktive stof i Palonosetron Hospira, palonosetron, er en "5HT3-antagonist".
English: Palonosetron Hospira should only be given before chemotherapy and can only be obtained with a prescription.
Danish: Palonosetron Hospira bør kun gives inden kemoterapi og udleveres kun efter recept.
English: Therefore, the CHMP's view was that, as for Aloxi, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Aloxi.
English: For more information about treatment with Palonosetron Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Palonosetron Hospira, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Palonosetron Hospira?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Palonosetron Hospira?
English: What are the benefits and risks of Palonosetron Hospira?
Danish: Hvilke fordele og risici er der forbundet med Palonosetron Hospira?
English: Because Palonosetron Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Palonosetron Hospira er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Palonosetron Hospira
Danish: Andre oplysninger om Palonosetron Hospira
English: It is not intended to provide practical advice on how to use Palonosetron Hospira.
Danish: Det er ikke en praktisk vejledning i, hvordan Palonosetron Hospira bør anvendes.
English: Palonosetron Hospira is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Danish: Palonosetron Hospira anvendes til forebyggelse af kvalme og opkastninger forårsaget af kemoterapi (lægemidler til behandling af kræft).
English: Palonosetron Hospira contains the active substance palonosetron.
Danish: Palonosetron Hospira indeholder det aktive stof palonosetron.
English: What is Palonosetron Hospira and what is it used for?
Danish: Hvad er Palonosetron Hospira, og hvad anvendes det til?
English: Palonosetron Hospira is a ‘generic medicine'.
Danish: Palonosetron Hospira er et "generisk lægemiddel".
English: For practical information about using Palonosetron Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Palonosetron Hospira, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect.
Danish: Det kan gives sammen med et corticosteroid (en anden type lægemiddel, der kan anvendes til
English: Why is Palonosetron Hospira approved?
Danish: Hvorfor blev Palonosetron Hospira godkendt?
English: The company provided data from the published literature on palonosetron.
Danish: Virksomheden fremlagde data fra faglitteraturen om palonosetron.
English: How has Palonosetron Hospira been studied?
Danish: Hvordan er Palonosetron Hospira blevet undersøgt?
English: How is Palonosetron Hospira used?
Danish: Hvordan anvendes Palonosetron Hospira?
English: How does Palonosetron Hospira work?
Danish: Hvordan virker Palonosetron Hospira?
English: Date of first authorisation: 10 January 2008 Date of latest renewal: 20 September 2012
Danish: Dato for første markedsføringstilladelse: 10. januar 2008 Dato for seneste fornyelse: 20. september 2012
English: It is important to stay on the diet and exercise recommended by your doctor while taking TESAVEL.
Danish: Det er vigtigt at forblive på den diæt og motion, som lægen anbefaler, mens De tager TESAVEL.
English: Due to lack of human data, TESAVEL should not be used during pregnancy.
Danish: På grund af mangel på humane data bør TESAVEL ikke anvendes under graviditet.
English: Your doctor may ask you to stop TESAVEL.
Danish: Lægen vil måske bede Dem om at stoppe med at tage TESAVEL.
English: - an allergic reaction to TESAVEL (see section 4).
Danish: - Allergisk reaktion over for TESAVEL (se punkt 4).
English: TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: TESAVEL bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of TESAVEL and periodically thereafter.
Danish: Da der er dosisjustering på baggrund af nyrefunktionen, anbefales det at vurdere nyrefunktionen før initiering af TESAVEL og med mellemrum derefter.
English: The level of digoxin in your blood may need to be checked if taking with TESAVEL.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager TESAVEL.
English: Method of administration TESAVEL can be taken with or without food.
Danish: Administration TESAVEL kan tages med eller uden mad.
English: If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis TESAVEL glemmes, bør den tages, så snart patienten kommer i tanke om det.
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, TESAVEL may be administered with or without food.
Danish: Eftersom samtidig administration af et fedtrigt måltid sammen med sitagliptin ikke havde nogen effekt på farmakokinetikken, kan TESAVEL administreres med eller uden mad.
English: What TESAVEL contains
Danish: TESAVEL indeholder:
English: If pancreatitis is suspected, TESAVEL and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, TESAVEL should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør TESAVEL og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med TESAVEL ikke genoptages.
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and TESAVEL administered concomitantly.
Danish: Ved anvendelse sammen med metformin og/eller en PPAR-agonist bør dosis af metformin og/eller PPAR-agonisten opretholdes, og TESAVEL administreres samtidigt.
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Danish: Aktiviteten af GLP-1 og GIP begrænses af DPP4-enzymet, som hurtigt hydrolyserer inkretinhormonerne til inaktive produkter.
English: Plasma AUC of sitagliptin increased in a dose-proportional manner.
Danish: Plasma AUC for sitagliptin øgedes proportionalt med dosis.
English: If you stop taking TESAVEL
Danish: Hvis De holder op med at tage TESAVEL
English: If you forget to take TESAVEL
Danish: Hvis De har glemt at tage TESAVEL