FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypoglycemic seizure
Danish: Hypoglykæmiske stoffer
English: - Information on how to detect and manage any sign of hypoglycaemia during treatment with HEMANGIOL
Danish: • Information om korrekt fremgangsmåde for forberedelse og administration inklusiv: - Anvisninger om, hvordan opløsningen med HEMANGIOL forberedes - Råd om, hvordan barnet skal gives mad i løbet af behandlingen - Information om, hvordan man opdager og behandler tegn på hypoglykæmi i løbet af behandlingen med HEMANGIOL - Anvisninger om, hvornår og hvordan administrationen af HEMANGIOL skal afbrydes
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: Hyperkaliemia
Danish: Hyperkaliæmi
English: • Nappy rash.
Danish: • Bleeksem.
English: Peripheral coldness
Danish: Perifer kulde
English: • Do not give this medicine to your child if you are taking medicines that must not be used with
Danish: • Giv ikke dette lægemiddel til dit barn, hvis du tager andre lægemidler, der ikke må bruges sammen med HEMANGIOL(se “Brug af anden medicin sammen med HEMANGIOL”).
English: How to give HEMANGIOL to your child
Danish: Sådan skal du give HEMANGIOL til dit barn
English: Very common
Danish: Meget almindelig Almindelig Ualmindelig Ikke kendt
English: • If you have any further questions, ask your doctor, or pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere du vil vide.
English: If you give to your child more HEMANGIOL than you should
Danish: Hvis du har givet dit barn for meget HEMANGIOL
English: - For bradycardia and hypotension: fatigue, coldness, pallor, bluish-coloured skin, and fainting.
Danish: • Nødvendigheden af at monitorere og kontakte lægen, apotekspersonalet eller sygeplejersken, hvis følgende tegn og symptomer opstår efter behandling: - For bradykardi og hypotension: Træthed, kulde, bleghed, blålig hud og besvimelse.
English: In the absence of data, administration of the medicinal product is not recommended to infants with hepatic or renal impairment (see section 4.4).
Danish: Lægemidlet er ikke undersøgt hos børn med lever- eller nyresygdom og bør derfor ikke anvendes til denne patientpopulation (se pkt.
English: 2- Pull the plunger in
Danish: 2- Træk stemplet tilbage
English: Breast-feeding:
Danish: Amning:
English: Lipid lowering medicinal products
Danish: Oversigt over indlægssedlen
English: Posology
Danish: Urticaria
English: 3 How to give HEMANGIOL to your child
Danish: SÅDAN SKAL DU GIVE HEMANGIOL TIL DIT BARN
English: This summary was last updated in 06-2015.
Danish: Dette sammendrag blev sidst ajourført i 06-2015.
English: It is available as tablets (75 mg).
Danish: Det leveres som tabletter (75 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel HCS on 28 October 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel HCS den 28. oktober 2010.
English: Clopidogrel HCS can be given to the following groups of patients:
Danish: Clopidogrel HCS kan gives til følgende patientgrupper:
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel HCS.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel HCS.
English: The full EPAR for Clopidogrel HCS can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Clopidogrel ratiopharm findes på agenturets websted: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
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 Clopidogrel HCS.
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, hvordan Clopidogrel HCS skal anvendes.
English: This is then followed by the standard 75mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in unstable angina or non-Q-wave myocardial infarction).
Danish: Dette efterfølges så af en standarddosis på 75 mg én gang dagligt i mindst fire uger (ved myokardieinfarkt med ST-segmentelevation) eller i op til 12 måneder (ved ustabil angina eller non-Q-tak-myokardieinfarkt).
English: The standard dose of Clopidogrel HCS is one 75-mg tablet once a day.
Danish: Standarddosis af Clopidogrel HCS er én tablet a 75 mg én gang dagligt.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Danish: Ved akut koronart syndrom indledes behandlingen normalt med en startdosis på fire tabletter.
English: For more information about treatment with Clopidogrel HCS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel HCS, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • patients who have recently had a myocardial infarction (heart attack).
Danish: • patienter, som for nylig har haft myokardieinfarkt (hjerteanfald).
English: This means that Clopidogrel HCS is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel HCS er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Danish: Dette forhindrer dem i at blive "klæbrige" og mindsker således risikoen for, at der dannes blodpropper, og hjælper til med at forhindre et hjerte- eller slagtilfælde.
English: Clopidogrel HCS can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel HCS kan påbegyndes mellem få dage og 35 dage efter anfaldet
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel HCS has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel HCS er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: It is used in patients who have at least one risk factor for events such as a heart attack or stroke, cannot take vitamin-K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Danish: Det anvendes til patienter, som har mindst én risikofaktor for hændelser såsom hjerteanfald eller slagtilfælde, som ikke kan tage vitamin K-antagonister (andre lægemidler, der forebygger blodpropper), og som har en lille blødningsrisiko.
English: • patients with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Danish: • patienter med atrieflimren (uregelmæssige hurtige sammentrækninger af de øverste hjertekamre), hvor det bør gives sammen med aspirin.
English: Clopidogrel HCS is used in adults to prevent problems caused by blood clots.
Danish: Clopidogrel HCS anvendes til forebyggelse af problemer forårsaget af blodpropper hos voksne.
English: This means that it helps to prevent blood clots from forming.
Danish: Det betyder, at det modvirker dannelse af blodpropper.
English: What are the benefits and risks of Clopidogrel HCS?
Danish: Hvilke fordele og risici er der forbundet med Clopidogrel HCS?
English: Clopidogrel HCS can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel HCS kan påbegyndes mellem syv dage og seks måneder efter slagtilfældet
English: • patients with acute coronary syndrome (a condition in which blood supply to the heart is reduced), when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Danish: • patienter, der lider af akut koronarsyndrom (nedsat blodforsyning til hjertet), hvor det bør gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper), herunder patienter, der har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
English: Clopidogrel HCS can be used in patients who are having a heart attack with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Danish: Clopidogrel HCS kan anvendes til patienter, som har hjertetilfælde med "forhøjelse af STsegmentet" (ST-elevation) (dvs. en unormal visning på elektrokardiogrammet (EKG)), når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: The Committee recommended that Clopidogrel HCS be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel HCS.
English: • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • patienter, som for nylig har haft et iskæmisk slagtilfælde (et slagtilfælde, som skyldes manglende blodforsyning til en del af hjernen).
English: Clopidogrel HCS is a ‘generic medicine'.
Danish: Clopidogrel HCS er et "generisk lægemiddel".
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Plavix.
English: Clopidogrel HCS is a blood-thinning medicine that contains the active substance clopidogrel.
Danish: Clopidogrel HCS er et blodfortyndende lægemiddel, der indeholder det aktive stof clopidogrel.
English: Because Clopidogrel HCS is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine's.
Danish: Da Clopidogrel HCS er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Clopidogrel HCS
Danish: Andre oplysninger om Clopidogrel HCS
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Danish: Det kan også anvendes til patienter uden en sådan unormal visning på elektrokardiogrammet, hvis de har ustabil angina (en alvorlig form for brystsmerter) eller har haft myokardieinfarkt uden forekomst af Q-takker
English: Because Clopidogrel HCS is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel HCS er et generisk lægemiddel, har personundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The active substance in Clopidogrel HCS, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel HCS, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel HCS is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Clopidogrel HCS sammen med aspirin.
English: Why has Clopidogrel HCS been approved?
Danish: Hvorfor blev Clopidogrel HCS godkendt?
English: What is Clopidogrel HCS?
Danish: Hvad er Clopidogrel HCS?
English: How has Clopidogrel HCS been studied?
Danish: Hvordan blev Clopidogrel HCS undersøgt?
English: What is Clopidogrel HCS used for?
Danish: Hvad anvendes Clopidogrel HCS til?
English: How is Clopidogrel HCS used?
Danish: Hvordan anvendes Clopidogrel HCS?
English: How does Clopidogrel HCS work?
Danish: Hvordan virker Clopidogrel HCS?
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for tetrazepam-containing medicinal product(s)
Danish: BILAG I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: 85101 Bratislava
Danish: 85101 Bratislava Slovak Republic
English: S.C. A.C. Helcor Pharma S.R.L.
Danish: Helcor Pharma S.R.L.
English: Coated tablet
Danish: Overtrukket tablet Oral anvendelse
English: Slovak Republic Sanofi-Aventis Slovakia s.r.o.
Danish: Sanofi-Aventis Slovakia s.r.o.
English: Praha 6 - Vokovice, 160 00
Danish: Evropská 846/176a Praha 6 - Vokovice, 160 00 Czech Republic
English: Chephasaar Chemisch- Pharmazeutische Fabrik GmbH
Danish: Chephasaar ChemischPharmazeutische Fabrik GmbH Mühlstrasse 50
English: Czech Republic Sanofi-Aventis, s.r.o.
Danish: Sanofi-Aventis, s.r.o.
English: Myolastan 50 mg film-coated tablets
Danish: Myolastan 50 mg filmcoated tablets
English: Belgium Eurogenerics NV Heizel Esplanade b22
Danish: Eurogenerics NV Heizel Esplanade b22 1020 Brussel Belgium
English: Tetra-saar 50mg 50 mg
Danish: Tetra-saar 50mg
English: ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Polen ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Belgium Sanofi Aventis Belgium N.V Culliganlaan 1C
Danish: Sanofi Aventis Belgium N.V Culliganlaan 1C 1831 Diegem
English: Belgium Will Pharma S.A. Monplaisirlaan 33
Danish: Will Pharma S.A. Monplaisirlaan 33 B-1030 Brussel Belgium
English: Tetrazepam KSK 50 mg
Danish: Tetrazepam KSK
English: Tetrazepam HEXAL 50 mg
Danish: Tetrazepam HEXAL
English: Tetrazepamratiopharm 50 mg Filmtabletten
Danish: Tetrazepam-ratiopharm 50 mg Filmtabletten
English: 22 October 2009
Danish: 20. april 2011
English: Why were these medicines reviewed?
Danish: Hvorfor blev disse lægemidler vurderet igen?
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Resultat af en procedure i henhold til artikel 31 i direktiv 2001/83/EF med senere ændringer
English: EMA/459105/2010 EMEA/H/A-31/1232
Danish: EMA/728909/2010 rev.1 EMEA/H/A-31/1232
English: See: http://www.who.int/cancer/palliative/painladder/en/.
Danish: 1 Se: http://www.who.int/cancer/palliative/painladder/en/.
English: They should take note of the restrictions and warnings for the medicines that they are using.
Danish: De skal være opmærksomme på de begrænsninger og advarsler, der gælder for de lægemidler, som de bruger.
English: Some information was also available from studies in human volunteers.
Danish: Der var ligeledes informationer til rådighed fra undersøgelser af frivillige forsøgspersoner.
English: This reduces the number of times a patient needs to take the medicine every day.
Danish: Dette mindsker det antal gange om dagen, som en patient skal tage lægemidlet.
English: The full changes made to the information to doctors and patients are detailed here.
Danish: De fuldstændige ændringer af informationen til læger og patienter findes her.
English: These are called ‘controlled-release systems'.
Danish: Det kaldes "systemer med kontrolleret udløsning".
English: What are the recommendations for patients and prescribers?
Danish: Hvilke anbefalinger gives der til patienter og ordinerende læger?
English: When these capsules were put into a 20% alcohol solution, 80% of the active substance was released within 15 minutes.
Danish: Når disse kapsler blev lagt i en 20 % alkoholopløsning, blev 80 % af det aktive stof frigivet i løbet af 15 minutter.
English: break down slowly in the body or limit the active substance's release, such as cellulose-based substances and polymers.
Danish: nedbrydes langsomt i kroppen eller begrænser det aktive stofs frigivelse, såsom cellulosebaserede stoffer og polymerer.
English: Modifiedrelease tablets and capsules are made by combining the active substance with other substances that
Danish: Tabletter og kapsler med modificeret udløsning fremstilles ved at kombinere det aktive stof med andre stoffer, der
English: They looked at seven different systems used with morphine, two used with hydromorphone and four used with oxycodone.
Danish: Man så på syv forskellige systemer anvendt sammen med morfin, to anvendt sammen med hydromorphon og fire anvendt sammen med oxycodon.
English: This means that almost a full day's dose of morphine would be released all at once if a patient were to take the capsule with large drink of neat strong liquor, such as whisky or vodka.
Danish: Det betyder, at næsten en hel dagsdosis morfin ville blive frigivet med det samme, hvis en patient tog kapslen sammen med et stort glas ren, stærk spiritus såsom whisky eller vodka.
English: For all other medicines in this class, the Committee concluded that their benefits continue to outweigh their risks, and therefore recommended that their marketing authorisations be maintained.
Danish: For alle andre lægemidler i denne klasse konkluderede udvalget, at deres fordele fortsat opvejer risiciene, og udvalget anbefalede derfor, at deres markedsføringstilladelser opretholdes.
English: • Prescribers are reminded that there are a large number of modified-release opioids available in each Member State.
Danish: • De ordinerende læger mindes om, at et stort antal opioider med modificeret udløsning er tilgængelige i de enkelte medlemsstater.
English: These suspensions will remain in force until the companies that make these medicines have reformulated them so that they are more stable in alcohol.
Danish: Disse suspenderinger vil være gældende, indtil de virksomheder, der fremstiller disse lægemidler, har reformuleret dem, så de er mere stabile i alkohol.
English: This is called ‘dose dumping' and could put patients at risk of exposure to large doses of the opioid, leading to side effects such as respiratory depression (an inhibition of breathing).
Danish: Dette kaldes "dosisdumping" og kan udsætte patienter for risikoen for at blive eksponeret for store doser af opioidet, hvilket medfører bivirkninger såsom respirationsdepression (vejrtrækningsproblemer).
English: There are over 500 different medicines belonging to the WHO level III scale group authorised in European Union (EU) Member States.
Danish: Over 500 forskellige lægemidler, som tilhører den gruppe lægemidler, der er omfattet af WHO's niveau III-skala, er godkendt i EU's medlemsstater.
English: They include morphine and the related medicines oxycodone and hydromorphone, all of which work by attaching to receptors in the brain and spinal cord to prevent pain.
Danish: De omfatter morfin og de relaterede lægemidler oxycodon og hydromorphon, der alle virker ved at binde sig til receptorer i hjernen og rygmarven for at hindre smerte.
English: This ladder gives recommendations on the order in which painkillers of increasing strength should be used to control a patient's pain1.
Danish: Denne stige giver anbefalinger om, i hvilken rækkefølge smertestillende midler af stigende styrke skal anvendes for at kontrollere en patients smerte1.
English: ‘Modified-release' forms of these medicines release the active substance slowly, often over many hours.
Danish: Lægemidler med "modificeret udløsning" frigiver det aktive stof langsomt, ofte over mange timer.
English: Therefore, the Committee recommended that the warnings on this interaction be made consistent in the information for doctors and patients across all oral opioid medicines of the WHO level III scale.
Danish: Derfor anbefalede udvalget, at advarslerne om denne interaktion blev medtaget i al information til læger og patienter for alle orale opioide lægemidler omfattet af WHO's niveau III-skala.
English: The CHMP noted that the use of this medicine in combination with alcohol is already contra-indicated.
Danish: CHMP bemærkede, at brugen af dette lægemiddel i kombination med alkohol allerede er kontraindiceret.
English: However, the CHMP noted that all medicines in this class have the potential to interact with alcohol, such as increasing the opioids' sedative effects.
Danish: CHMP bemærkede dog, at alle lægemidler i denne klasse potentielt kan interagere med alkohol, f.eks. ved at øge opioidets sedative virkninger.
English: • Prescribers of modified-release opioids and their patients should be aware of the potential interaction between these medicines and alcohol.
Danish: • Læger, som ordinerer opioider med modificeret udløsning, og deres patienter skal være klar over den potentielle interaktion mellem disse lægemidler og alkohol.
English: Consequently, the European Commission asked the CHMP to carry out an assessment of the benefitrisk balance of these medicines, concentrating on their interaction with alcohol, and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Danish: Derfor bad Europa-Kommissionen CHMP om at foretage en vurdering af disse lægemidlers risk/benefitforhold, med særligt fokus på deres interaktioner med alkohol, og om at afgive udtalelse om, hvorvidt deres markedsføringstilladelser bør opretholdes, ændres, suspenderes eller trækkes tilbage i hele EU.
English: However, studies looking at the drinking behaviour of patients with severe pain show that many patients drink alcohol while being treated with strong opioids.
Danish: Undersøgelser af drikkevanerne hos patienter med stærke smerter viste dog, at mange patienter drikker alkohol, når de bliver behandlet med stærke opioider.
English: The CHMP used the results of these studies to predict what would happen if these medicines were taken with alcohol.
Danish: CHMP brugte resultaterne af disse undersøgelser til at forudsige, hvad der ville ske, hvis disse lægemidler blev taget sammen med alkohol.
English: They are called ‘WHO level III scale' medicines as they are on the highest step of the World Health Organization's three-step pain relief ladder.
Danish: De kaldes lægemidler på "WHO's niveau III-skala", fordi de befinder sig på det højeste trin i Verdenssundhedsorganisationens tretrinsstige for smertebehandling.
English: The CHMP concluded that around half of the controlled-release systems tested showed a slight increase in the amount of active substance they released when placed in an alcohol solution, but that this effect was mild and would only have a minor effect on the release of the active substance.
Danish: CHMP konkluderede, at der hos ca. halvdelen af de undersøgte systemer med kontrolleret udløsning skete en let stigning i mængden af aktivt stof, når de blev placeret i en alkoholopløsning, men at denne virkning var mild og kun ville have en mindre effekt på frigivelsen af det aktive stof.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of most of these medicines continue to outweigh their risks, but that warnings on the use of these medicines together with alcohol should be made consistent across the class.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved de fleste af disse lægemidler fortsat opvejer risiciene, men at der for hele lægemiddelklassens vedkommende konsekvent bør advares mod at bruge disse lægemidler sammen med alkohol.
English: Oral opioid medicines of the WHO level III scale for the management of pain are strong painkillers that are taken by mouth and used to treat intense pain that has not been controlled sufficiently with other medicines.
Danish: Orale opioide lægemidler med modificeret udløsning omfattet af WHO's niveau III-skala for smertebehandling er stærke smertestillende midler, som tages gennem munden, og som anvendes til at behandle intense smerter, der ikke kan kontrolleres tilstrækkeligt med andre lægemidler.