FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex related to the Art. 127a
Danish: Annex relateret til artikel 127a
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Danish: Detaljerne i dette PPP, herunder implementeringen af nationale foranstaltninger for at vurdere effektiviteten og overholdelsen af PPP, skal aftales med den relevante nationale myndighed i hvert enkelt medlemsland og være på plads, inden præparatet markedsføres.
English: The Member State shall ensure that the MAH shall implement a pregnancy prevention programme (PPP) within their territory.
Danish: Medlemslandet skal sikre, at indehaveren af markedsføringstilladelsen implementerer et program til svangerskabsforebyggelse (PPP, Pregnancy Prevention Programme) inden for landets område.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally to ensure that: - Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Danish: Medlemslandet skal aftale detaljerne omkring et kontrolleret distributionssystem med indehaveren af markedsføringstilladelsen og implementere et sådant program nationalt for at sikre at: - Alle læger, som har til hensigt at ordinere pomalidomid, og alle farmaceuter, der eventuelt udleverer pomalidomid, modtager den nedenfor beskrevne information, der stiles direkte til sundhedspersonalet, inden præparatet markedsføres.
English: - Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following: - Educational Health Care Professional's kit - Educational brochures for Patients - Patient cards - Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Danish: Informationspakken indeholder følgende: - Sæt med oplysningsmateriale til sundhedspersonale - Informationsbrochurer til patienter - Patientkort - Produktresumé (SmPC), indlægsseddel og etikettering.
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/09/605/001 Temomedac
Danish: Lægemiddelform Indgivelsesvej
English: 5 x 1012 vg/ml Concentrate and solvent for solution for injection
Danish: 5 x 1012 vg/ml Koncentrat og solvens til injektionsvæske, opløsning
English: 1 concentrate vial + 2 solvent vials
Danish: 1 hætteglas koncentrat + 2 hætteglas solvens
English: Solvent: vial (COC)
Danish: Solvens: hætteglas (COC)
English: Solvent: 1.7 ml
Danish: Koncentrat: 0,5 ml; Solvens: 1,7 ml
English: Strength Pharmaceutical form
Danish: Lægemiddelform Administration Embalage
English: Concentrate: vial (COC);
Danish: Subretinal brug Koncentrat: hætteglas (COC);
English: This summary was last updated in 06-2009.
Danish: Dette sammendrag blev sidst ajourført i 06-2009.
English: It is available as white, round tablets (75 mg).
Danish: Det fås som hvide, runde tabletter (75 mg).
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Hexal to Acino Pharma GmbH on 28 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Hexal til Acino Pharma GmbH den 28. juli 2009.
English: Clopidogrel Hexal can be given to the following groups of patients:
Danish: Clopidogrel Hexal kan gives til følgende patientgrupper:
English: In acute coronary syndrome, Clopidogrel Hexal is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Danish: Ved akut koronarsyndrom anvendes Clopidogrel Hexal sammen med aspirin, og behandlingen indledes almindeligvis med en startdosis på fire 75 mg-tabletter.
English: This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Danish: Dette efterfølges af en standarddosis på 75 mg en gang dagligt i mindst 4 uger (ved myokardieinfarkt med forhøjelse af ST-segmentet) eller i op til 12 måneder (ved syndrom uden ST-segmentforhøjelse).
English: Clopidogrel Hexal clopidogrel EPAR summary for the public
Danish: Clopidogrel Hexal clopidogrel EPAR - sammendrag for offentligheden
English: The standard dose of Clopidogrel Hexal is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel Hexal er 75 mg en gang dagligt med eller uden et måltid.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Danish: • patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne),
English: Clopidogrel Hexal is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Hexal anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: This means that Clopidogrel Hexal is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Hexal er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, kaldet Plavix.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Hexal has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Hexal i overensstemmelse med EU-kravene har vist sig at være af sammenlignelig kvalitet og at være bioækvivalent med Plavix.
English: The Committee recommended that Clopidogrel Hexal be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Hexal.
English: Other information about Clopidogrel Hexal:
Danish: Andre oplysninger om Clopidogrel Hexal:
English: The full EPAR for Clopidogrel Hexal can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel Hexal findes her.
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, der ikke har denne unormale visning på EKG'et, hvis de har ustabil angina (en alvorlig form for brystsmerter) eller myokardieinfarkt uden forekomst af Q-takker.
English: Clopidogrel Hexal can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel Hexal kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Clopidogrel Hexal can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Danish: Clopidogrel Hexal kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af ST-segmentet” (STelevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: What are the benefit and risk of Clopidogrel Hexal?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Hexal?
English: Clopidogrel Hexal can be started between seven days and six months after the stroke;
Danish: Behandlingen med Clopidogrel Hexal kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter,
English: • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • patienter, der for nyligt har haft et iskæmisk slagtilfælde (et slagtilfælde forårsaget af manglende blodforsyning til en del af hjernen).
English: Clopidogrel Hexal is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Hexal er et lægemiddel, der indeholder det aktive stof clopidogrel.
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 ligesom for Plavix.
English: Because Clopidogrel Hexal is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Hexal er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel Hexal is a ‘generic medicine'.
Danish: Clopidogrel 1A er et ‘generisk lægemiddel'.
English: Because Clopidogrel Hexal is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Hexal er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The active substance in Clopidogrel Hexal, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Hexal, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: Why has Clopidogrel Hexal been approved?
Danish: Hvorfor blev Clopidogrel Hexal godkendt?
English: What is Clopidogrel Hexal?
Danish: Hvad er Clopidogrel Hexal?
English: How has Clopidogrel Hexal been studied?
Danish: Hvordan blev Clopidogrel Hexal undersøgt?
English: How is Clopidogrel Hexal used?
Danish: Hvordan anvendes Clopidogrel Hexal?
English: What is Clopidogrel Hexal used for?
Danish: Hvad anvendes Clopidogrel Hexal til?
English: How does Clopidogrel Hexal work?
Danish: Hvordan virker Clopidogrel Hexal?
English: *All these reactions are class effect.
Danish: *Alle disse reaktioner er klassevirkninger.
English: The frequency of this type of event is not known.
Danish: Hyppigheden af denne type hændelse er ikke kendt.
English: The application can be repeated, if necessary.
Danish: Applikationen kan gentages, hvis det er nødvendigt.
English: For other procedures, larger volumes may be required.
Danish: For andre indgreb kan det være nødvendigt med større voluminer.
English: The device is now ready to use.
Danish: Anordningen er nu klar til brug.
English: The temperature of the water bath must not exceed 37 ºC.
Danish: Temperaturen i vandbadet må ikke overstige 37 ºC.
English: Frozen solutions.
Danish: Frosne opløsninger.
English: MedDRA System Organ Class (SOC)
Danish: MedDRA Systemorganklasse (SOC)
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal standard medicinsk behandling for shock implementeres.
English: Intravascular administration is contraindicated.
Danish: Intravaskulær administration er kontraindiceret.
English: Discard if the package is damaged.
Danish: Bortskaffes, hvis pakningen er beskadiget.
English: Tip will retain its shape.
Danish: Spidsen vil bibeholde sin form.
English: See scheme below.
Danish: Se anordningen nedenfor.
English: AT/BE/BG/CY/EE/EL/ES/HR/HU/IE/LV/ LT/LU/MT/NL/RO/SI/SK Instituto Grifols, S.A.
Danish: AT/BE/BG/CY/EE/EL/ES/HR/HU/IE/LV/ LT/LU/MT/NL/RO/SI/SK
English: Allergic reactions are possible.
Danish: Allergiske reaktioner er mulige.
English: If it does not seem to be enough, a second layer can be applied.
Danish: Hvis det ikke ser ud til at være nok, kan der påføres et lag til.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being treated with this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bliver behandlet med dette lægemiddel.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and acute toxicity.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og akut toksicitet.
English: Such substances should be removed to the greatest possible extent before applying the product.
Danish: Sådanne stoffer skal fjernes i størst muligt omfang, før præparatet appliceres.
English: Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Danish: Fibrin-vævsklæbere kan i sjældne tilfælde (op til 1 ud af 1.000 personer) forårsage en allergisk reaktion.
English: Increase distance accordingly to achieve desired coverage of the target area.
Danish: Øg afstanden i passende grad for at opnå den ønskede dækning af målområdet.
English: This medicine must not be used after the expiry date which is stated on the label and carton after EXP.
Danish: Lægemidlet må ikke bruges efter den udløbsdato, der står på etiketten og kartonen efter EXP.
English: None were reported in clinical trials; thus it is not possible to establish frequencies.
Danish: Da ingen blev rapporteret i kliniske studier, er det derfor ikke muligt at fastlægge hyppigheder.
English: In clinical trials, the individual dosages have typically ranged from 0.3 to 12 ml.
Danish: I kliniske studier har de individuelle doseringer typisk været mellem 0,3 og 12 ml.
English: Thaw completely before use.
Danish: Optøs fuldstændigt før brug.
English: Your doctor will decide whether you should be treated with VeraSeal.
Danish: Lægen vil beslutte, om du skal behandles med VeraSeal.
English: Please see pictograms at the end of this leaflet.
Danish: Se venligt piktogrammerne sidst i denne indlægsseddel.
English: Eleven paediatric subjects aged 16 years or younger were treated with VeraSeal in the described clinical studies.
Danish: 11 pædiatriske personer i alderen 16 år eller yngre blev behandlet med VeraSeal i de beskrevne kliniske studier.
English: Before administration of VeraSeal, care must be taken that the parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Danish: Før administration af VeraSeal skal man være omhyggelig med, at de dele af kroppen, som er uden for det ønskede applikationsområde, er tilstrækkeligt beskyttet (dækket) for at forhindre vævsadhæsion på uønskede steder.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: De forholdsregler, der tages, kan være af begrænset værdi mod uindkapslede vira, såsom parvovirus B19.
English: The spray device should not be used closer than the recommended distance.
Danish: Sprøjteanordningen må ikke bruges tættere på end den anbefalede afstand.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
Danish: Dato for første markedsføringstilladelse: 10. november 2017
English: The safety and efficacy of VeraSeal in children aged 0 to 18 years has not yet been established.
Danish: VeraSeals sikkerhed og virkning hos børn i alderen 0 til 18 år er endnu ikke klarlagt.
English: Summary of the safety profile
Danish: Oversigt af sikkerhedsprofilen
English: The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Danish: Fibrin-adhæsionssystemet påbegynder den sidste fase af fysiologisk blodkoagulation.
English: No formal interaction studies have been performed.
Danish: Der er ikke udført formelle interaktionsstudier.
English: It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.
Danish: Det påføres på overfladen af det blødende væv for at reducere blødning under og efter operationen, når standard kirurgiske teknikker ikke er tilstrækkelige.
English: Therefore, the product should be administered to pregnant and breast-feeding women only if clearly needed.
Danish: Derfor må præparatet kun administreres til gravide eller ammende kvinder, hvis det er klart nødvendigt.
English: Use sterile technique to avoid the possibility of contamination due to improper handling, and follow the steps below accurately.
Danish: Brug steril teknik for at undgå mulig kontaminering som følge af forkert håndtering, og følg de nedenstående trin nøje.
English: The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
Danish: Det indledende volumen af præparatet, der skal appliceres på et udvalgt anatomisk sted eller en måloverflade, bør være tilstrækkeligt til helt at dække det tilsigtede applikationsområde.
English: In the event of overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment and supportive measures instituted.
Danish: I tilfælde af overdosering skal patienterne overvåges nøje for tegn eller symptomer på bivirkninger, og der skal iværksættes passende symptomatisk behandling og støttende tiltag.
English: 08150 Parets del Vallès SPAIN
Danish: 08150 Parets del Vallès SPANIEN
English: Remove carton from freezer, open it and take out the two blisters.
Danish: Tag kartonen ud af dybfryseren, åbn den, og tag de 2 blistere ud.
English: The outside of the blister should not come in contact with the sterile field.
Danish: Ydersiden af blisteren må ikke komme i kontakt med det sterile område.
English: There is also a theoretical possibility that your immune system will produce proteins to attack VeraSeal and, that these may interfere with your blood clotting.
Danish: Der er også en teoretisk mulighed for, at dit immunsystem vil danne proteiner, som kan angribe VeraSeal, og at disse proteiner kan påvirke din blodstørkning.
English: This device allows equal amounts of the two components of VeraSeal to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to work at its best.
Danish: Dette udstyr gør det muligt at påføre lige store mængder af VeraSeals to komponenter på samme tid, og sikrer, at de blandes godt, hvilket er vigtigt for at vævsklæberen virker bedst muligt.
English: NOTE: Red indicator will not be visible if Airless Spray Tip is properly connected.
Danish: BEMÆRK: Den røde indikator vil ikke være synlig, hvis den luftfrie sprøjtespids er korrekt tilsluttet.
English: There is also a risk of a severe allergic reaction.
Danish: Der er også en risiko for en svær allergisk reaktion.
English: The cold storage chain must not be interrupted until use.
Danish: Den kolde opbevaringskæde må ikke brydes før brug.
English: The volume of VeraSeal to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
Danish: Det volumen af VeraSeal, der skal appliceres, og applikationshyppigheden bør altid orienteres mod patientens underliggende kliniske behov.
English: Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin.
Danish: Faktor XIIIa, som aktiveres fra faktor XIII af trombin, krydsbinder fibrin.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabellen, som vises nedenfor, er opdelt i henhold til MedDRA systemorganklassifikation (SOC og foretrukket terminologi niveau).
English: After thawing, it is not necessary to warm the product for its use.
Danish: Efter optøning er det ikke nødvendigt at varme præparatet til brug.
English: If these symptoms occur, the administration must be discontinued immediately.
Danish: Hvis disse symptomer opstår, skal administrationen straks seponeres.
English: VeraSeal contains human fibrinogen and human thrombin, two proteins extracted from the blood that form a clot when they are mixed together.
Danish: VeraSeal indeholder humant fibrinogen og humant trombin, to proteiner, der er udvundet fra blodet, som danner en prop, når de blandes sammen.
English: - if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for humant fibrinogen eller humant trombin eller et af de øvrige indholdsstoffer i VeraSeal (angivet i punkt 6).
English: At 37 ºC, the time needed is approximately 5 minutes for the 2 ml, 4 ml, 6 ml, and 10 ml package sizes, but must not be left at this temperature for longer than 10 minutes.
Danish: Ved 37 ºC er den nødvendige tid ca. 5 minutter for pakningsstørrelser med 2 ml, 4 ml, 6 ml og 10 ml, men de må ikke efterlades ved denne temperatur i mere end 10 minutter.
English: The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Danish: Den applicerede dosis vejledes af flere variable, herunder, men ikke begrænset til, typen af kirurgisk intervention, størrelsen af området og den tilsigtede applikationsmåde samt antallet af applikationer.
English: Other CE-marked applicator tips (including open surgery and laparoscopic use devices) intended for specific use with VeraSeal may also be used.
Danish: Andre CE-mærkede applikatorspidser (inklusive udstyr til åben kirurgi og laparoskopisk anvendelse), der er specifikt beregnet til at blive anvendt sammen med VeraSeal, kan også anvendes.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om forberedelse af lægemidlet før administration, se pkt.
English: VeraSeal is not recommended for use in children and adolescents under 18 years of age.
Danish: VeraSeal bør ikke anvendes til børn og unge under 18 år.
English: Anxiety, insomnia
Danish: Angst, insomni
English: Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and post-natal development.
Danish: Eksperimentelle data fra dyreforsøg er utilstrækkelige til at vurdere sikkerheden, hvad angår reproduktion, udvikling af embryo eller foster, gestationsforløbet og peri- og postnatal udvikling.
English: Fertility studies have not been conducted.
Danish: Der er ikke blevet udført fertilitetsstudier.
English: As with any protein product, allergic type hypersensitivity reactions are possible.
Danish: Som for alle proteinpræparater er overfølsomhedsreaktioner mulige.
English: The surgeon will decide how much is appropriate, and will apply just enough to form a thin, even layer.
Danish: Kirurgen vil beslutte, hvor meget der er hensigtsmæssigt, og han/hun vil påføre lige akkurat nok til at danne et tyndt, jævnt lag.
English: - as suture support: in vascular surgery.
Danish: - som suturstøtte: ved karkirurgi.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Danish: Disse forholdsregler anses for at være effektive for indkapslede vira, såsom human immundefekt virus (hiv), hepatitis B-virus og hepatitis C-virus, og for den uindkapslede hepatitis A-virus.
English: Read this leaflet before you open the package.
Danish: Læs denne indlægsseddel, før du åbner pakningen.
English: Conjunctival irritation
Danish: Konjunktival irritation
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for eventuelle ukendte eller nye opdukkende vira eller andre infektionstyper.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også for ukendte eller nye vira og andre patogener.