FrancophonIA/ELRC3.0 huggingface dataset:
English: Becaplermin is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae.
Danish: Becaplermin dannes ved indsætning af genet for B-kæden af human Platelet Derived Growth Factor til gær Saccharomyces cerevisiae.
English: • Burning sensation at the application site
Danish: Ikke almindelig • Brændende følelse på administrationsstedet
English: The site(s) of application should then be covered by a moist saline gauze dressing that maintains a moist wound-healing environment.
Danish: Det behandlede hudområde skal derefter dækkes med en fugtig saltvandsvædet forbindingsgaze, som bevarer et fugtigt sårhelingsmiljø.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre motorkøretøj eller betjene
English: Do this before you apply REGRANEX
Danish: Gør dette før du påsmører REGRANEX
English: The biological activity of becaplermin includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair.
Danish: Becaplermins biologiske aktivitet omfatter fremskyndelsen af cellernes kemotaktiske tilgang og formering i forbindelse med sårheling.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: A. FREMSTILLER/FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER)
English: Following 14 consecutive daily topical applications of REGRANEX, there was no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations.
Danish: Efter 14 på hinanden daglige applikationer med REGRANEX forekom der ingen konsekvent stigning i plasmakoncentrationerne af trombocyt-afledt væksktfaktor-BB i forhold til
English: Do not apply any medicines to your ulcer while using REGRANEX, except for salt solution (saline) or water to clean the ulcer.
Danish: Du må ikke bruge anden medicin til dit sår, mens du bruger REGRANEX, bortset fra saltvand eller
English: Since there was no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations, following 14 consecutive daily topical applications to ulcers in man, carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX.
Danish: Da der ikke var konsekvent stigning i plasmakoncentrationerne af trombocyt-afledt væksktfaktor-BB i forhold til koncentrationerne før behandling ved at følge 14 på hinanden følgende daglige topikale administrationer på sår hos mennesker, er der ikke blevet udført karcinogenicitets- og reproduktionsstudier med REGRANEX.
English: • Cover the ulcer with a moist saline (salt) gauze dressing.
Danish: • Dæk såret med en fugtig saltvandsvædet forbindingsgaze.
English: Uncommon (≥1/1,000 to <1/100)
Danish: Ualmindelig (≥1/1.000 til <1/100)
English: ETHICON
Danish: France ETHICON
English: • If you are allergic (hypersensitive) to becaplermin or to any of the other ingredients of
Danish: - Hvis du er overfølsom (allergisk) over for det aktive stof eller et af de øvrige indholdsstoffer i REGRANEX.
English: Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF).
Danish: Becaplermin er en vækstfaktor (rekombinant af human Platelet Derived Growth Factor (rhPDGF)).
English: Pregnancy and breast-feeding • Do not use this medicine if you are pregnant, think you might be pregnant or planning to
Danish: • Brug ikke denne medicin, hvis du er gravid, tror at du måske er gravid eller planlægger Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: Since there was no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations, following 14 consecutive daily topical applications to ulcers, no untoward systemic events are expected.
Danish: Da der ikke var konsekvent stigning i plasmakoncentrationerne af trombocyt-afledt væksktfaktor-BB i forhold til koncentrationerne før behandling ved at følge 14 på hinanden følgende daglige topikale administrationer på sår, fornventes ingen systemiske bivirkninger.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 March 1999
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: It contains a substance called becaplermin.
Danish: Det indeholder stoffet becaplermin.
English: Adverse Drug Reactions Reported in Clinical Trials and Postmarketing Experience
Danish: Bivirkninger rapporteret fra kliniske forsøg og efter markedsføring Bivirkninger Frekvens
English: REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
Danish: REGRANEX indeholder E218 (methylparahydroxybenzoat) og E216 (propylparahydroxybenzoat).
English: • You have infections of the bone which may be seen as fever, severe pain around the bone that is affected, swelling and redness of the joints
Danish: • Du har infektion i knoglerne, hvilket kan vise sig ved feber, stærke smerter omkring
English: Malignancies distant from the site of application have occurred in becaplermin users in both clinical trial and in post-marketing use.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Der er forekommet maligne tilstande fjernt fra applikationsstedet hos personer, der anvendte becaplermin, såvel i kliniske forsøg som ved brug af præparatet efter markedsføring.
English: - Before each application, the ulcer should be gently rinsed with saline or water to remove residual gel.
Danish: - Såret skal vaskes omhyggeligt med saltvand eller vand før hver applikation for at fjerne tilbageværende gel.
English: Good wound care measures include: • Your doctor or healthcare professional removing dead skin/debris from the wound whenever
Danish: • At din læge eller sundhedsperson fjerner det døde hud fra såret, når det er nødvendigt.
English: Important information about possible allergies to some of the ingredients REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i REGRANEX REGRANEX indeholder E218 (methylparahydroxybenzoat) og E216 (propylparahydroxybenzoat).
English: REGRANEX is used to help the growth of normal tissue in order to heal skin ulcers.
Danish: Du får REGRANEX for at fremme væksten af normalt væv, der er nødvendigt for sårheling.
English: Store in a refrigerator (2°C - 8°C).
Danish: Gelen skal opbevares i køleskab (2 °C - 8 °C).
English: REGRANEX should not be used in conjunction with occlusive dressings.
Danish: REGRANEX bør ikke anvendes sammen med forbindinger, der indelukker såret fuldstændigt.
English: REGRANEX is a clear colourless to straw-coloured gel.
Danish: Regranex er en gel i flerdosistuber à 15 gram Regranex er en klar, farveløs til strågul gel.
English: please tell your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket,
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: If you are unsure, check with your doctor or pharmacist
Danish: Er du i tvivl, så spørg lægen eller på
English: Ulcers with a suspicious appearance should be biopsied to exclude malignancy.
Danish: For at udelukke maligne tilstande skal der tages biopsi af sår med mistænkeligt udseende.
English: Always try to follow the instructions for use exactly.
Danish: Brug altid REGRANEX nøjagtigt efter lægens anvisning.
English: Each gram contains E218 (methyl parahydroxybenzoate) 1.56 mg and E216 (propyl parahydroxybenzoate) 0.17 mg, see section 4.4.
Danish: Hvert gram indeholder 1,56 mg E218 (methylparahydroxybenzoat) og 0,17 mg E216
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu
Danish: Denne indlægsseddel blev senest godkendt MM/YYYY Du kan finde yderligere information om Regranex på Det europæiske Lægemiddelagenturs (EMEAs)
English: REGRANEX 0.01% gel becaplermin
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN REGRANEX 0,01% gel Becaplermin
English: JANSSEN-CILAG Ltd. United Kingdom Tel: +44 1 494 567567
Danish: JANSSEN-CILAG Ltd. Tel: +44 1 494 567 567
English: Contains carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride and water for injections.
Danish: Carmellosenatrium (E466), natriumklorid, natriumacetat, eddikesyre (E260), methylparahydroxybenzoat (methylparaben) (E218), propylparahydroxybenzoat (propylparaben) (E216), metacresol, lysinhydrochlorid og vand til injektionsvæsker.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Ikke anvendt lægemiddel samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: The active substance in REGRANEX is becaplermin.
Danish: - Aktivt stof: Becaplermin.
English: 6.1 List of excipients carmellose sodium (E466) sodium chloride sodium acetate glacial acetic acid (E260) methyl parahydroxybenzoate (methylparaben) (E218) propyl parahydroxybenzoate (propylparaben) (E216) metacresol lysine hydrochloride water for injections
Danish: 6.1 Hjælpestoffer carmellosenatrium (E466) natriumchlorid natriumacetat eddikesyre (E260) methylparahydroxibenzoat (metylparaben) (E218) propylparahydroxibenzoat (propylparaben) (E216)
English: The other ingredients are: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride and water for injections.
Danish: Hvert gram Regranex indeholder 100 mikrogram becaplermin - Øvrige indholdsstoffer: Carmellosenatrium (E466), natriumchlorid, natriumacetat, eddikesyre (E260), methylparahydroxybenzoat (methylparaben) (E218), propylparahydroxybenzoat (propylparaben) (E216), metacresol, lysinhydrochlorid og vand til injektionsvæsker.
English: Wound infection should be treated prior to the use of REGRANEX.
Danish: Før brug af REGRANEX skal eventuelle sårinfektioner behandles.
English: Adverse Drug Reactions Frequency Category Common (≥1/100 to <1/10)
Danish: Almindelig (≥1/100 til <1/10)
English: INSTRUCTIONS ON USE
Danish: Følg lægens anvisninger om
English: Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.
Danish: Det anbefales derfor, at REGRANEX ikke appliceres på såret
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: FARMACEUTISKE OPLYSNINGER
English: Česká republika JANSSEN-CILAG s.r.o.
Danish: Magyarország JANSSEN-CILAG Kft.
English: If you are unsure, talk to your doctor or pharmacist before using REGRANEX.
Danish: Tal med lægen eller apoteket, før
English: Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller du får
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om REGRANEX, skal du henvende dig til den lokale repræsentant:
English: Therefore, REGRANEX should not be used during breastfeeding.
Danish: Derfor bør REGRANEX ikke anvendes
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi on 4 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Versican Plus DHPPi den 4. juli 2014.
English: The effectiveness of Versican Plus DHPPi was initially investigated in a field study involving 129 dogs.
Danish: Effektiviteten af Versican Plus DHPPi blev oprindelig undersøgt i en feltundersøgelse med 129 hunde.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Danish: Den hyppigste bivirkning (som optræder hos mere end 1 ud af 100 hunde) ved Versican Plus DHPPi er kortvarig hævelse på op til 5 cm, der kan forekomme på injektionsstedet efter vaccinationen.
English: The vaccine is given to puppies from six weeks of age as an injection under the skin which is repeated three to four weeks later.
Danish: Vaccinen gives til hvalpe fra 6-ugers alderen ved en indsprøjtning under huden og gentages 3-4 uger senere.
English: Versican Plus DHPPi is used to protect dogs against:
Danish: Versican Plus DHPPi anvendes til at beskytte hunde mod:
English: When Versican Plus DHPPi is given to dogs, the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når Versican Plus DHPPi gives til hunde, registrerer dyrenes immunsystem virus som »fremmede« og reagerer ved at danne antistoffer mod dem.
English: The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100% and for parainfluenza virus 73 to 97%.
Danish: For parvovirus havde 73100 % af hundene beskyttende antistofniveau, og for parainfluenzavirus 73-97 %.
English: Versican Plus DHPPi is a vaccine.
Danish: Versican Plus DHPPi er en vaccine.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi exceed the risks for the approved indications and recommended that Versican Plus DHPPi be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Versican Plus DHPPi opvejer risiciene til de godkendte anvendelser, og anbefalede udstedelse af en markedsføringstilladelse for Versican Plus DHPPi.
English: Responses in puppies were lower than in adult dogs in some cases, because of antibodies inherited from their mothers since maternal antibodies may block the immune response to vaccination.
Danish: Hvalpe reagerede undertiden mindre kraftigt end voksne hunde, da antistoffer overført fra moderen kan blokere immunresponsen på vaccination.
English: Versican Plus DHPPi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.
Danish: Versican Plus DHPPi fås som en frysetørret pellet (et lyofilisat) med opløsningsvæske (solvens) og gives ved indsprøjtning.
English: • canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough.
Danish: • hundeparainfluenzavirus og hundeadenovirus type 2, der er årsag til kennelhoste
English: The field study showed that vaccination with Versican Plus DHPPi resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Danish: Feltundersøgelsen viste, at vaccination med Versican Plus DHPPi gav tilstrækkelig antistofkoncentration til at beskytte mod hundesygevirus og hundeadenovirus hos alle hundene.
English: Other information about Versican Plus DHPPi:
Danish: Andre oplysninger om Versican Plus DHPPi:
English: Versican Plus DHPPi is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2.
Danish: Versican Plus DHPPi er en dyrevaccine, der indeholder levende, svækkede hundesygevirus, hundeadenovirus type 2, hundeparvovirus type 2b og hundeparainfluenzavirus type 2.
English: This will help protect them against distemper, adenovirus liver infection, parvovirosis and kennel cough.
Danish: Derved er de beskyttet mod hundesyge, adenovirus-leverbetændelse, parvovirose og kennelhoste.
English: The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against distemper, adenovirus, parvovirosis and kennel cough in addition to other diseases to demonstrate effectiveness of Versican Plus DHPPi.
Danish: For at dokumentere effektiviteten af Versican Plus DHPPi omfattede feltundersøgelsen de bredere vaccinekombinationer Versican Plus DHPPi/L4 og Versican Plus DHPPi/L4R, som foruden andre sygdomme også er beregnet til at beskytte mod hundesyge, adenovirus, parvovirose og kennelhoste.
English: What is the risk associated with Versican Plus DHPPi?
Danish: Hvilken risiko er der forbundet med Versican Plus DHPPi?
English: For revaccination, a single dose of Versican Plus DHPPi is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus.
Danish: Revaccination er nødvendig en gang hvert tredje år med en enkelt dosis af Versican Plus DHPPi mod hundesyge, hundeadenovirus (type 1 og 2) og parvovirus.
English: Annual revaccination is required for protection against canine parainfluenza virus.
Danish: Der revaccineres en gang om året mod hundeparainfluenzavirus.
English: Why has Versican Plus DHPPi been approved?
Danish: Hvorfor blev Versican Plus DHPPi godkendt?
English: How has Versican Plus DHPPi been studied?
Danish: Hvordan blev Versican Plus DHPPi undersøgt?
English: What is Versican Plus DHPPi?
Danish: Hvad er Versican Plus DHPPi?
English: Canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated)
Danish: Vaccine mod hundesyge, hundeadenovirus, hundeparvovirose og hundeparainfluenzavirus (levende, svækket)
English: What benefit has Versican Plus DHPPi shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Versican Plus DHPPi?
English: What is Versican Plus DHPPi used for?
Danish: Hvad anvendes Versican Plus DHPPi til?
English: How does Versican Plus DHPPi work?
Danish: Hvordan virker Versican Plus DHPPi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zomarist on 1 December 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zomarist den 1. december 2008.
English: The full EPAR for Zomarist can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Zomarist findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Zomarist
Danish: Andre oplysninger om Zomarist
English: Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Danish: Vildagliptin alene blev godkendt af Den Europæiske Union (EU) i september 2007 under navnet Galvus, og metformin har været på markedet i EU siden 1959.
English: This is a summary of the European public assessment report (EPAR) for Zomarist.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zomarist.
English: The recommended dose of Zomarist is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Danish: Den anbefalede dosis Zomarist er en tablet to gange dagligt, hvor den ene tablet tages om morgenen og den anden om aftenen.
English: Vildagliptin / metformin hydrochloride
Danish: Zomarist vildagliptin/metforminhydrochlorid
English: For more information about treatment with Zomarist, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zomarist, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This medicine is the same as Eucreas, which is already authorised in the European Union (EU).
Danish: Dette lægemiddel er identisk med Eucreas, som allerede har markedsføringstilladelse i EU.
English: The applicant also presented the results of two studies showing that the active substances in the two strengths of Zomarist were absorbed in the body in the same way as when they were taken as separate tablets.
Danish: Ansøgeren fremlagde også resultaterne af to undersøgelser, der viser, at de aktive stoffer i de to styrker af Zomarist blev optaget i kroppen på samme måde, som når de blev taget hver for sig i to tabletter.
English: The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.
Danish: Firmaet, som fremstiller Eucreas, har givet tilladelse til, at dets videnskabelige oplysninger må anvendes for Zomarist.
English: Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘incretin' hormones in the body.
Danish: Vildagliptin, som er en dipeptidyl peptidase-4 (DPP-4)-hæmmer, virker ved at blokere nedbrydningen af ‘inkretin'-hormoner i kroppen.
English: Zomarist is used to treat type 2 diabetes.
Danish: Zomarist anvendes til behandling af type 2 diabetes.
English: Zomarist contains two active substances, which each have a different mode of action.
Danish: Zomarist indeholder to aktive stoffer, som hver især virker forskelligt.
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 Zomarist.
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 Zomarist.
English: Elderly patients taking Zomarist should have their kidney function monitored regularly.
Danish: Ældre patienter, som behandles med Zomarist, skal have deres nyrefunktion kontrolleret regelmæssigt.
English: It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Danish: Det må ikke anvendes til patienter, som har diabetisk ketoacidose (høje koncentrationer af ketoner og syrer i blodet), diabetisk prækoma, nyre- eller leverproblemer, sygdomme, som kan påvirke nyrerne, eller en sygdom, som forårsager reduceret iltforsyning til vævene såsom hjerte- eller lungeinsufficiens eller et nyligt hjerteanfald.
English: Therefore, the Committee decided that the benefits of Zomarist are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Zomarist opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The choice of tablet strength to start with depends on the patient's current treatment and the expected effects of Zomarist, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Danish: Valget af tabletstyrke i begyndelsen afhænger af patientens nuværende behandling og de forventede virkninger af Zomarist, men det anbefales, at den dosis metformin, der gives, svarer til den dosis, der allerede tages.
English: Patients already taking vildagliptin and metformin should switch to Zomarist containing the same amounts of each active substance.
Danish: Patienter, som allerede tager vildagliptin og metformin, bør skifte til Zomarist, der indeholder de samme mængder af hvert af de aktive stoffer.
English: • in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
Danish: • til patienter, som allerede tager kombinationen af vildagliptin og metformin som særskilte tabletter,
English: Taking Zomarist with or just after food may reduce any stomach problems caused by metformin.
Danish: Hvis Zomarist tages sammen med mad eller lige efter et måltid, kan dette reducere eventuelle maveproblemer forårsaget af metformin.