FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Posaconazole AHCL, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Posaconazole AHCL, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: • fusariosis (fungal infection caused by Fusarium),
Danish: • fusariose (svampeinfektion forårsaget af Fusarium)
English: As for every medicine, the company provided studies on the quality of Posaconazole AHCL.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Posaconazole AHCL.
English: Posaconazole AHCL contains the active substance posaconazole and is a ‘generic medicine'.
Danish: Posaconazole AHCL indeholder det aktive stof posaconazol og er et "generisk lægemiddel".
English: As for all medicines, data on the use of Posaconazole AHCL are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Posaconazole AHCL løbende overvåget.
English: The active substance in Posaconazole AHCL, posaconazole, is an antifungal medicine that belongs to the triazole group.
Danish: Det aktive stof i Posaconazole AHCL, posaconazol, er et svampemiddel, der tilhører triazolgruppen.
English: Posaconazole AHCL is also used as a first-line treatment for ‘thrush', a fungal infection of the mouth and throat due to Candida.
Danish: Posaconazole AHCL anvendes som førstevalgsbehandling til "trøske", en svampeinfektion i mund og svælg forårsaget af Candida.
English: • invasive aspergillosis (fungal infection caused by Aspergillus),
Danish: • invasiv aspergillose (svampeinfektion forårsaget af Aspergillus)
English: Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole AHCL outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Posaconazole AHCL opvejer de identificerede risici som for Noxafil, og at det kan godkendes til anvendelse i EU.
English: An overview of Posaconazole AHCL and why it is authorised in the EU
Danish: En oversigt over Posaconazole AHCL, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Posaconazole AHCL?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Posaconazole AHCL?
English: For the prevention of invasive fungal infections, Posaconazole AHCL is taken at a dose of 200 mg (5 ml) three times a day.
Danish: Til forebyggelse af invasive svampeinfektioner tages Posaconazole AHCL i en dosis på 200 mg (5 ml) tre gange dagligt.
English: Posaconazole AHCL (posaconazole)
Danish: Posaconazole AHCL (posaconazol)
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Danish: • coccidioidomykose (infektion i lungerne på grund af indånding af sporer).
English: For the treatment of fungal infections, with the exception of thrush, Posaconazole AHCL is taken at a dose of 400 mg (10 ml) twice a day, or 200 mg (5 ml) four times a day in patients who are not eating.
Danish: Til behandling af svampeinfektioner, med undtagelse af trøske, tages Posaconazole AHCL i en dosis på 400 mg (10 ml) to gange dagligt eller 200 mg (5 ml) fire gange dagligt hos patienter, der ikke spiser.
English: For thrush, Posaconazole AHCL is taken as 200 mg (5 ml) on the first day followed by 100 mg (2.5 ml) once a day for the following 13 days.
Danish: Til trøske tages Posaconazole AHCL i en dosis på 200 mg (5 ml) den første dag efterfulgt af 100 mg (2,5 ml) én gang dagligt i de efterfølgende 13 dage.
English: Other information about Posaconazole AHCL
Danish: Andre oplysninger om Posaconazole AHCL
English: What are the benefits and risks of Posaconazole AHCL?
Danish: Hvilke fordele og risici er der forbundet med Posaconazole AHCL?
English: Why is Posaconazole AHCL authorised in the EU?
Danish: Hvorfor er Posaconazole AHCL godkendt i EU?
English: What is Posaconazole AHCL and what is it used for?
Danish: Hvad er Posaconazole AHCL, og hvad anvendes det til?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Posaconazole AHCL have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Posaconazole AHCL.
English: How has Posaconazole AHCL been studied?
Danish: Hvordan er Posaconazole AHCL blevet undersøgt?
English: The list of fungi posaconazole is active against can be found in the summary of product characteristics.
Danish: Listen over svampe, som posaconazol virker mod, findes i produktresuméet.
English: How does Posaconazole AHCL work?
Danish: Hvordan virker Posaconazole AHCL?
English: How is Posaconazole AHCL used?
Danish: Hvordan anvendes Posaconazole AHCL?
English: In case of doubt, it is advisable to test the urine.
Danish: I tvivlstilfælde tilrådes det at teste urinen.
English: Overdosing may lead to death of treated animals.
Danish: Overdosering kan medføre døden for behandlede dyr.
English: Treatment can be continued for a maximum of 14 consecutive days.
Danish: Behandlingen kan fortsættes i maksimalt 14 sammenhængende dage.
English: Horse.
Danish: Hest.
English: The most abundant metabolite is a monohydroxylated derivative.
Danish: Den mest almindelige metabolit er et monohydroxyleret derivat.
English: The terminal half-life following oral administration is 350-500 minutes and no accumulation occurs following repeated oral dosing.
Danish: Den terminale halveringstid efter oral indgift er 350-500 minutter og akkumulering forekommer ikke efter vedvarende dosering.
English: Symptoms are reversible.
Danish: Symptomerne er reversible.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 4 December 1997
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 4 December 1997
English: The product is presented as a single syringe in a carton box or as a multipack of 3 syringes in a carton box.
Danish: Produktet leveres som en enkelt sprøjte i karton eller som en flerstykspakning med 3 sprøjter i karton.
English: Bioavailability after oral administration is 80-90%, but is reduced significantly if medication is administered with food.
Danish: Biotilgængeligheden efter oral administration er 8090%, men reduceres signifikant, hvis medicinen gives samtidigt med foderet.
English: In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.
Danish: Ved profylaktisk behandling er en maksimal behandlingsperiode på 7 sammenhængende dage tilstrækkelig.
English: Kidney Liver Muscle Fat
Danish: Nyre Lever Muskel Fedt
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: 6.1 i produktresuméet, er enten tilladte stoffer, hvor tabel 1 i bilaget til Forordning (EU) nr. 37/2010 tilkendegiver, at ingen MRL-værdier er påkrævet eller betragtes som værende ikke omfattet af Forordning (EC) nr. 470/2009, når de anvendes i dette veterinære lægemiddel.
English: Vedaprofen is rapidly absorbed following oral administration.
Danish: Vedaprofen absorberes hurtigt efter oral indgift.
English: It is advisable to administer the product before feeding.
Danish: Det anbefales at administrere præparatet før fodring.
English: Both enantiomers contribute to therapeutic actions of the compound.
Danish: Begge enantiomerer bidrager til stoffets terapeutiske virkning.
English: Date of last renewal: 13 November 2007
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 13 November 2007
English: Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects.
Danish: Andre NSAID-præparater, diuretika og stoffer med høj proteinbinding kan konkurrere om binding og medføre toksiske effekter.
English: Otto Hahnweg 24 3542 AX Utrecht NETHERLANDS
Danish: 3542 AX Utrecht NEDERLANDENE
English: Twice daily administration.
Danish: Gives to gange dagligt.
English: Do not use in foals under the age of 6 months.
Danish: Bør ikke anvendes til føl under 6 måneder.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Quadrisol oral gel contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml Quadrisol oral gel indeholder:
English: The active substance in Quadrisol is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: C. ANGIVELSE AF MRL-VÆRDIER Den aktive substans i Quadrisol er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Both enantiomers are equipotent PGF2α antagonists.
Danish: Enantiomerer er equipotente PGF2α - antagonister.
English: Appropriate precautions must be taken for such horses to ensure compliance with competition regulations.
Danish: Fornøden forsigtighed skal udvises for at sikre, at konkurrenceregulativer overholdes.
English: Vedaprofen contains an asymmetric carbon atom and, therefore, is a racemic mixture of a (+) enantiomer and a (-) enantiomer.
Danish: Vedaprofen indeholder et asymmetrisk kulstofatom og er derfor en racemisk blanding af (+)-enantiomerer og (-)-enantiomerer.
English: Steady state is reached quickly following onset of treatment.
Danish: Steady state nås kort efter behandlingens start.
English: Vedaprofen is highly bound to plasma proteins and extensively metabolised.
Danish: Vedaprofen er stærkt bundet til plasma-proteiner og bliver metaboliseret i udstrakt grad.
English: Quadrisol must not be given with other NSAIDs or glucocorticosteroids.
Danish: Quadrisol må ikke gives sammen med andre NSAID-præparater eller glukokortikosteroider.
English: Side effects are reversible.
Danish: Bivirkningerne er reversible.
English: Studies in the horse have demonstrated potent inhibition of prostaglandin E2 (PG E2) synthesis in exudate and thromboxane B2 synthesis in serum and exudate.
Danish: Studier på heste har demonstreret potent inhibering af prostaglandin E2 (PGE2) syntesen i ekssudat og af tromboxan B2 syntesen i serum og ekssudat.
English: INDICATION(S) Reduction of inflammation and relief of pain.
Danish: INDIKATION(ER) Til reduktion af inflammatoriske tilstande og smertestillende behandling.
English: A 30 ml adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white and natural).
Danish: En 30 ml justerbar flerdosis-sprøjte af højmolekylær polyethylen (hvid) og lavmolekylær polyethylen (hvid og natur).
English: Bodyweight and dosage must be accurately determined to avoid overdosing.
Danish: Legemsvægt og dosering skal nøje fastlægges for at undgå overdosering.
English: Meat and offal: 12 days.
Danish: Slagtning: 12 dage.
English: OTHER INFORMATION For animal treatment only.
Danish: ANDRE OPLYSNINGER Kun til dyr.
English: EXPIRY DATE EXP: {Month/year}
Danish: 10. UDLØBSDATO EXP {måned/år}
English: Quadrisol 100 mg/ml can be used during pregnancy.
Danish: Quadrisol 100 mg/ml kan anvendes under drægtighed.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/)
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/)
English: Do not use in the case of hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Horses with oral lesions should be assessed clinically and the attending veterinarian should take a decision as to whether treatment should be continued.
Danish: Heste med læsioner i mundhulen bør undersøges klinisk, og den tilsynsførende dyrlæge må beslutte, hvorvidt behandlingen bør fortsættes.
English: Vedaprofen inhibits the prostaglandin synthesis enzyme system (cyclo-oxygenase enzyme) and thus possesses anti-inflammatory, antipyretic and analgesic properties.
Danish: Vedaprofen hæmmer prostaglandinsyntesens enzymsystem (cyclo-oxygenase) og har derfor anti-inflammatorisk, antipyretisk og analgesisk virkning.
English: Avoid the use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Danish: Undgå brug af præparatet i dehydrerede, hypovolæmiske eller hypotensive dyr, da der er risiko for forøget renal toksicitet.
English: For full contra-indications, see package leaflet.
Danish: For fuld information om kontraindikationer, se indlægssedlen.
English: Adjustable dose syringe, containing 30 ml gel 3 adjustable dose syringes, each containing 30 ml gel
Danish: PAKNINGSSTØRRELSE Justerbar dosissprøjte, indeholdende 30 ml gel 3 justerbare dosissprøjter, hver indeholdende 30 ml gel
English: Vedaprofen is a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivate group.
Danish: Vedaprofen er et non-steroidt anti-inflammatorisk lægemiddel (NSAID), tilhørende propionsyregruppen.
English: The (+) enantiomer is more potent in inhibiting prostaglandin synthesis.
Danish: (+)-enantiomeren er en mere potent inhibitor af prostaglandinsyntesen.
English: SPECIAL WARNINGS, IF NECESSARY If side effects occur, treatment should be discontinued.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER OM NØDVENDIGT Hvis bivirkninger forekommer, bør behandlingen afbrydes.
English: SPECIAL STORAGE CONDITIONS No special precautions for storage.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Ingen særlige forholdsregler vedrørende opbevaringen.
English: An initial dose of 2 mg/kg (2.0 ml/100 kg) is followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Danish: En initialdosis på 2 mg/kg (2,0 ml/100 kg) efterfulgt af en vedligeholdelsesdosis på 1 mg/kg (1,0 ml/100 kg) hver 12. time.
English: Purna Pharmaceuticals N.V. Rijksweg 17
Danish: Purna Pharmaceuticals N.V.
English: The advised dosage is an initial dose of 2 mg/kg (2.0 ml/100 kg) followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Danish: Den anbefalede dosis er en initialdosis på 2 mg/kg (2,0 ml/100 kg) efterfulgt af en vedligeholdelsesdosis på 1 mg/kg (1,0 ml/100 kg) hver 12. time.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/005/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/97/005/001
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/005/001 (1 x 30 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/97/005/001 (1 x 30 ml)
English: Before administration, the syringe should be adjusted to the calculated dosage by setting the ring on the plunger.
Danish: Inden administrering indstilles sprøjten til beregnet dosis ved at justere ringens plads på stemplet.
English: The syringe is fitted with variable dose capability, adjustable in steps of 0.5 ml and graduated to 1 ml.
Danish: Sprøjten kan justeres, således at dosis kan indstilles i trin af 0,5 ml og med graduering pr. ml.
English: Horses intended for racing and competition should be treated according to local requirements.
Danish: Løbs- og konkurrenceheste bør behandles ifølge de lokale dopingregler.
English: Shelf-life after first opening of the product: 2 months.
Danish: Opbevaringstid efter første åbning af beholderen: 2 måneder.
English: Do not use in animals suffering from alimentary tract disorders, impaired heart, liver and kidney function.
Danish: Bør ikke anvendes til dyr med lidelser i fordøjelseskanalen, nedsat hjerte-, lever-og nyrefunktion.
English: Shelf-life after first opening the immediate packaging: 2 months.
Danish: Opbevaringstid efter første åbning af den indre emballage: 2 måneder.
English: Horses should be monitored for oral lesions during treatment.
Danish: Heste bør under behandlingen kontrolleres for læsioner i mundhulen.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Quadrisol is intended for twice daily administration.
Danish: Quadrisol er beregnet til administration 2 gange dagligt.
English: ROUTE(S) OF ADMINISTRATION For oral use.
Danish: INDGIVELSESVEJ(E) Til oral anvendelse.
English: Reduction of inflammation and relief of pain associated with musculo-skeletal disorders and soft tissue lesions (traumatic injuries and surgical trauma).
Danish: Reduktion af inflammatoriske tilstande og smertestillende behandling af lidelser i muskler, led og knogler samt bløddelsskader (traumatiske læsioner og kirurgiske trauma).
English: In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery.
Danish: Ved kirurgiske indgreb, der kan forventes at medføre trauma, kan Quadrisol gives profylaktisk mindst 3 timer før indgrebet.
English: If oral lesions persist, treatment should be discontinued.
Danish: Hvis orale læsioner vedvarer, bør behandlingen afbrydes.
English: All metabolites of vedaprofen were shown to be less active than the parent compound as determined by a thromboxane B2 formation inhibition assay.
Danish: Alle vedaprofens metabolitter er mindre aktive end udgangsstoffet bestemt ved en tromboxan B2 inhibitions test. Omkring 70% af en oral dosis udskilles i urinen.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Vedaprofen:
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Vedaprofen
English: Typical non-steroidal anti-inflammatory drugs (NSAIDs) side effects such as lesions and bleedings in the alimentary tract, diarrhoea, urticaria, lethargy, inappetence.
Danish: De for non-steroide anti-inflammatoriske midler (NSAID) typiske bivirkninger såsom læsioner og blødninger i fordøjelseskanalen, diarré, nældefeber, sløvhed og manglende ædelyst.
English: Do not use in lactating mares.
Danish: Bør ikke anvendes til lakterende hopper.
English: The gel is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of gel on the back of the tongue.
Danish: Gelen administreres oralt ved at indsætte sprøjtens spids mellem for- og kindtænder, og dosis indsprøjtes bagest på tungen.
English: Lesions and bleedings in the alimentary tract, diarrhoea, urticaria, lethargy, inappetence.
Danish: Læsioner og blødninger i fordøjelseskanalen, diarré, nældefeber, sløvhed og manglende ædelyst.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: non-steroidal anti-inflammatory drug ATCvet code: QM01AE90
Danish: Farmakoterapeutisk gruppe: Non-steroidt anti-inflammatorisk lægemiddel (NSAID).
English: If side effects occur, treatment should be discontinued.
Danish: Hvis bivirkninger forekommer, bør behandlingen afbrydes.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Quadrisol 100 mg/ml oral gel for horses
Danish: VETERINÆRLÆGEMIDLETS NAVN Quadrisol 100 mg/ml oral gel til heste
English: PACKAGE LEAFLET: Quadrisol 100 mg/ml oral gel for horses
Danish: INDLÆGSSEDDEL: Quadrisol 100 mg/ml oral gel til heste
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Vedaprofen:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Vedaprofen 100 mg/ml
English: WITHDRAWAL PERIOD(S) Withdrawal period(s):
Danish: TILBAGEHOLDELSESTID(er) Tilbageholdelsestid(er):
English: Typical undesirable effects associated with NSAID use, such as lesions in the alimentary tract, soft faeces, urticaria and lethargy.
Danish: Typiske bivirkninger ved brug af NSAID inkluderer læsioner i fordøjelseskanalen, blød afføring, nældefeber og apati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 mg/ml oral gel for horses
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 100 mg/ml oral gel til heste
English: Water (minimum purified grade), Propylene glycol, Hydroxyethylcellulose, Potassium hydroxide (E525), Hydrochloric acid, Chocolate flavour.
Danish: Kaliumhydroxid (E525).
English: Propylene glycol:
Danish: Propylenglycol
English: If symptoms occur, treatment should be discontinued.
Danish: Opstår der symptomer, stoppes behandlingen.
English: 130 mg For the full list of excipients, see section 6.1.
Danish: 130 mg Alle hjælpestoffer er anført under pkt.
English: Excipients: Propylene glycol:
Danish: Hjælpestoffer: Propylenglycol
English: Target tissues Other provisions vedaprofen vedaprofen Equidae 1000 µg/kg 100 µg/kg
Danish: ANGIVELSE AF AKTIVE STOFFER Vedaprofen 100 mg/ml
English: TARGET SPECIES Horse.
Danish: Vedaprofen Heste
English: 20 µg/kg
Danish: 1000 µg/kg 100 µg/kg 50 µg/kg 20 µg/kg
English: Meat and offal: 12 days Not authorised for use in animals producing milk for human consumption.
Danish: Må ikke anvendes til dyr, hvis mælk er bestemt til menneskeføde.
English: Pharmacologically active substance
Danish: De(t) farmakologisk aktive stof(fer)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rapilysin on 9 November 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rapilysin den 9. november 1996.
English: The full EPAR for Rapilysin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Rapilysin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance reteplase.
Danish: Det indeholder det aktive stof reteplase.
English: This is a summary of the European public assessment report (EPAR) for Rapilysin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rapilysin.
English: The studies looked at the number of patients who had died 30 to 35 days after treatment, and at the number of patients who had heart failure (an inability of the heart to pump enough blood around the body) or a stroke.
Danish: Undersøgelserne fokuserede på det antal patienter, som døde 30-35 dage efter behandlingen samt det antal patienter, som fik hjertestop (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen) eller et slagtilfælde.
English: Each injection is given into a vein slowly, but in less than two minutes.
Danish: Hver injektion gives intravenøst (i en vene), langsomt, men inden for to minutter.
English: For more information about treatment with Rapilysin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rapilysin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Rapilysin has been studied in more than 21,000 patients in four studies.
Danish: Virkningen af Rapilysin blev undersøgt hos over 21 000 patienter i 4 undersøgelser.
English: Treatment with Rapilysin should be started as soon as possible after the start of heart attack symptoms.
Danish: Behandlingen med Rapilysin skal indledes hurtigst muligt, efter at symptomerne på hjerteanfaldet er indtrådt.
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 Rapilysin.
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 Rapilysin skal anvendes.
English: The active substance in Rapilysin, reteplase, is a copy of a natural enzyme called t-PA that has been modified so that it starts working faster and for longer.
Danish: Det aktive stof i Rapilysin, reteplase, er en kopi af et naturligt enzym ved navn t-PA, der er blevet ændret på en måde, så det begynder at virke hurtigere og i længere tid.
English: However, Rapilysin and heparin or aspirin must not be given in the same syringe.
Danish: Rapilysin og heparin og aspirin må dog ikke gives med den samme sprøjte.