FrancophonIA/ELRC3.0 huggingface dataset:
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT Kontakt din dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly.
Danish: Fra 14 dage til 6 uger gamle: 0,25 ml eller 0,5 ml subkutant eller intramuskulært.
English: PHARMACEUTICAL FORM Emulsion for injection.
Danish: Injektionsvæske, emulsion til kyllinger.
English: 6 weeks and older: 0.5ml subcutaneously or intramuscularly.
Danish: 6 uger og ældre: 0,5 ml subkutant eller intramuskulært.
English: Nobilis Influenza H5N2 emulsion for injection for chickens
Danish: Nobilis Influenza H5N2 Injektionsvæske, emulsion til kyllinger
English: From 14 days to 6 weeks old: administer 0.25 or 0.5 ml subcutaneously or intramuscularly.
Danish: Fra 14 dage til 6 uger gamle: indgiv 0,25 ml eller 0,5 ml subkutant eller intramuskulært.
English: From 8 - 14 days old: administer 0.25 ml subcutaneously.
Danish: Fra 8 - 14 dage gamle: indgiv 0,25 ml subkutant.
English: WITHDRAWAL PERIOD Zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 døgn.
English: 250ml; 500ml
Danish: 250 ml; 500 ml flaske
English: Shelf-life of the veterinary medicinal product as packaged for sale: PET vials: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning:
English: Disposal: read package leaflet.
Danish: Hjælpestoffer: Alle hjælpestoffer er anført under pkt.
English: WITHDRAWAL PERIOD Withdrawal period: zero days.
Danish: Tilbageholdelsestid: 0 døgn
English: Adjuvant:
Danish: A.
English: 6 weeks and older: administer 0.5 ml subcutaneously or intramuscularly.
Danish: 6 uger og ældre: indgiv 0,5 ml subkutant eller intramuskulært.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N2 emulsion for injection for chickens.
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobilis Influenza H5N2, injektionsvæske, emulsion, til kyllinger.
English: 250ml/500ml
Danish: FLASKE ETIKER 250 ml/500 ml
English: ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous use.
Danish: Til intramuskulær eller subkutan anvendelse.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N2 emulsion for injection
Danish: INDLÆGSSEDDEL Nobilis Influenza H5N2 Injektionsvæske, emulsion
English: at least 17 weeks.
Danish: Mindst 17 uger.
English: 2 weeks post vaccination
Danish: 2 uger efter vaccination
English: SPECIAL WARNINGS, IF NECESSARY
Danish: SÆRLIGE ADVARSLER, OM NØDVENDIGT
English: Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.
Danish: Sterile overførselskanyler (CE-certificeret) er almindeligt tilgængelige via leverandører af medicinsk udstyr.
English: Adjuvant:
Danish: Adjuvans:
English: Each dose (1 ml) contains:
Danish: En dosis (1 ml) indeholder:
English: Duration of immunity:
Danish: Varighed af immunitet:
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Vaccinate healthy animals only.
Danish: Vacciner kun raske dyr.
English: Store and transport refrigerated (2 °C-8 °C).
Danish: Opbevares og transporteres nedkølet (2 °C - 8 °C).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på ydre emballage og flasken efter EXP.
English: On very rare occasions anaphylactic reactions may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner forekomme og disse bør behandles symptomatisk.
English: The excipients (including adjuvants) 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Use the entire vaccine mixture immediately after mixing.
Danish: Brug hele indholdet af vaccineblandingen umiddelbart efter blanding.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/.
English: A mild and transient hyperthermia very commonly occurs on the day of vaccination.
Danish: En let og forbigående hypertermi indtræder almindeligvis på vaccinationsdagen.
English: Withdrawal period: Zero days.
Danish: Tilbageholdelsestid: 0 dage.
English: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Danish: RP* 1,0-3,75 *Relativ Potency (ELISA test) ved sammenligning med referencevaccine
English: Shake well before use.
Danish: Omrystes godt før brug.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ
English: Any unused mixture or waste material should be disposed according to the instructions given in section 6.6.
Danish: Ubrugt blanding eller affald skal bortskaffes i henhold til anvisningerne i afsnit 6.6.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Danish: En beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: Each bottle is closed with a chlorobutyl stopper and lacquered aluminium seal.
Danish: Hver flaske er lukket med chlorobutyl-gummiprop og forseglet med aluminiumhætte.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
English: Avoid introduction of contamination during use.
Danish: Undgå kontaminering under anvendelse.
English: When mixed with Ingelvac MycoFLEX the following equipment should be used:
Danish: Når lægemidlet blandes med Ingelvac MycoFLEX bør følgende udstyr anvendes:
English: If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.
Danish: Hvis nødvendigt, tryk forsigtigt på vaccineflasken med Ingelvac CircoFLEX for at lette overførslen.
English: Porcine circovirus type 2 ORF2 protein
Danish: Porcint circovirus type 2 ORF2-protein
English: This vaccine is designed to stimulate the development of an active immune response to porcine circovirus type 2.
Danish: Denne vaccine stimulerer udviklingen af et aktivt immunrespons overfor porcint circovirus type 2.
English: Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift) Efter administration af fire gange så store doser som anbefalet er der ikke rapporteret bivirkninger ud over de, der er nævnt under ”Bivirkninger”.
English: PACKAGE SIZES
Danish: PAKNINGSSTØRRELSER
English: Carbomer Sodium chloride Water for injections
Danish: Natriumchlorid Vand til injektionsvæsker
English: Ingelvac MycoFLEX may be not authorised in certain Member States.
Danish: Ingelvac MycoFLEX er ikke nødvendigvis tilladt i visse medlemsstater.
English: To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour.
Danish: For at opnå en passende blanding af de to vacciner rystes vaccineflasken med Ingelvac MycoFLEX forsigtigt, indtil blandingen har en ensartet orange til rødlig farve.
English: Ingelvac MycoFLEX may be not authorised to use in certain Member States.
Danish: Ingelvac MycoFLEX er ikke nødvendigvis tilladt at anvende i visse medlemsstater.
English: Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section 4.6 have been observed.
Danish: Efter administration af fire gange så store doser som anbefalet er der ikke rapporteret bivirkninger ud over de i punkt 4.6 nævnte.
English: • Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
Danish: • Brug samme mængde af Ingelvac CircoFLEX og Ingelvac MycoFLEX.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Danish: Der foreligger ingen oplysninger om vaccinens sikkerhed og effekt ved samtidig brug med andre lægemidler til dyr end dem, der er nævnt ovenfor.
English: INDICATIONS
Danish: INDIKATIONER
English: 10 ml (10 doses) 50 ml (50 doses) 100 ml (100 doses) 250 ml (250 doses) 12 x 10 ml (12 x 10 doses) 12 x 50 ml (12 x 50 doses) 12 x 100 ml (12 x 100 doses) 12 x 250 ml (12 x 250 doses)
Danish: 10 ml (10 doser) 50 ml (50 doser) 100 ml (100 doser) 250 ml (250 doser) 12 x 10 ml (12 x 10 doser) 12 x 50 ml (12 x 50 doser) 12 x 100 ml (12 x 100 doser) 12 x 250 ml (12 x 250 doser)
English: QUANTITY OF THE ACTIVE SUBSTANCE
Danish: MÆNGDEN AF AKTIVT STOF
English: Any unused mixture or waste material should be disposed according with local requirements.
Danish: Ubrugt blanding eller affald skal bortskaffes i overensstemmelse med de lokale krav.
English: Pregnancy and lactation Can be used during pregnancy and lactation.
Danish: Drægtighed og laktation Kan anvendes under drægtighed og diegivning.
English: Suspension for injection.
Danish: Injektionsvæske, suspension.
English: One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer
Danish: En dosis (1 ml) indeholder: Porcint circovirus type 2 ORF2-protein Carbomer
English: Boehringer Ingelheim Vetmedica GmbH GERMANY
Danish: Boehringer Ingelheim Vetmedica GmbH TYSKLAND
English: Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac MycoFLEX (not for use in pregnant or lactating pigs).
Danish: Må ikke blandes med andre lægemidler til dyr, undtagen med Boehringer Ingelheims Ingelvac MycoFLEX (må ikke anvendes til drægtige eller diegivende grise).
English: Interactions with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Danish: Interaktion med andre lægemidler og andre former for interaktion Tilgængelige data for sikkerhed og virkning viser, at vaccinen kan blandes med Boehringer Ingelheims Ingelvac MycoFLEX og administreres på ét injektionssted.
English: Can be used during pregnancy and lactation.
Danish: Kan anvendes under drægtighed og laktation.
English: 10 ml (10 doses) 50 ml (50 doses)
Danish: 10 ml (10 doser) 50 ml (50 doser)
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Danish: Tilgængelige data for sikkerhed og virkning viser, at vaccinen kan blandes med Boehringer Ingelheims Ingelvac MycoFLEX og administreres på ét injektionssted.
English: Avoid multiple broaching.
Danish: Undgå anbrud gentagne gange.
English: Single IM injection of 1 ml.
Danish: injektion af 1 ml som engangsdosis.
English: To ensure correct mixing follow the steps as described below: Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
Danish: Trinene beskrevet nedenfor skal følges for at sikre en korrekt blanding: Tilslut den ene ende af overførselsskanylen til vaccineflasken med Ingelvac MycoFLEX.
English: - After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.
Danish: - Når alt indholdet af Ingelvac CircoFLEX er overført, fjernes og kasseres kanylen og den tomme vaccineflaske med Ingelvac CircoFLEX.
English: Vaccination devices should be used in accordance with the device instructions provided by the manufacturer.
Danish: Vaccinationsudstyret bør anvendes i overensstemmelse med producentens vejledning.
English: Shelf life after first opening the bottle: use immediately.
Danish: Opbevaringstid efter første åbning af flasken: Anvendes straks.
English: Ingelvac CircoFLEX suspension for injection for pigs
Danish: Ingelvac CircoFLEX injektionsvæske, suspension til grise
English: For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Danish: For aktiv immunisering af grise fra 2 ugers alderen mod porcint circovirus type 2 (PCV2) for at reducere dødelighed, kliniske symptomer - inklusive vægttab - og læsioner i lymfevæv som følge af PCV2 relaterede sygdomme (PCVD).
English: • Cannot be administered in pregnant or lactating pigs.
Danish: - Må ikke anvendes til drægtige eller diegivende grise.
English: In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Danish: Tillige er det vist, at vaccination reducerer PCV2-virusudskillelse via luftvejene, virusmængde i blod og lymfevæv og varighed af viræmi.
English: 100 ml (100 doses) 250 ml (250 doses)
Danish: 100 ml (100 doser) 250 ml (250 doser)
English: METHOD AND ROUTE OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ
English: - Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
Danish: - Overfør Ingelvac CircoFLEX vaccinen til vaccineflasken med Ingelvac MycoFLEX.
English: Administer one single injection dose (2 ml) of the mixture intramuscularly per pig, irrespective of body weight.
Danish: Giv en enkelt injektionsdosis (2 ml) af blandingen intramuskulært pr. gris, uafhængigt af legemsvægt.
English: Clear to slightly opalescent, colourless to yellowish suspension for injection.
Danish: Klar til let opaliserende, farveløs til gullig injektionsvæske, suspension.
English: • Use a pre-sterilised transfer needle.
Danish: • Brug en steril overførselskanyle.
English: Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).
Danish: Pakningsstørrelser med 1 eller 12 flasker à 10 ml (10 doser), 50 ml (50 doser), 100 ml (100 doser) eller 250 ml (250 doser).
English: During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.
Danish: Under vaccinationen bør det ved jævnlig omrystning sikres, at blandingen til stadighed har en ensartet farve.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines for pigs ATCvet code: QI09AA07
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til svin (Suidae), inaktiverede virale vacciner til svin
English: Single intramuscular injection of one dose (1 ml), irrespective of body weight.
Danish: Intramuskulær injektion af 1 dosis (1 ml) uafhængig af legemsvægt.
English: For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.
Danish: Ved vaccination skal vaccineudstyr anvendes i overensstemmelse med producentens vejledning.
English: Date of first authorisation: Date of last renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse af markedsføringstilladelse: 14.01.2013
English: EXP {month/year} Once broached use immediately.
Danish: EXP {måneder/år} Efter åbning: Anvendes straks.
English: Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml.
Danish: Pakningsstørrelser med 1 eller 12 højdensitet polyethylen hætteglas à 10 ml, 50 ml, 100 ml eller 250 ml.
English: Onset of immunity:
Danish: Immunitet indtræder:
English: U.S.A.
Danish: USA
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway,
English: Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: - Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
Danish: - Tilslut den modsatte ende af overførselskanylen til vaccineflasken med Ingelvac CircoFLEX.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 10 ml; 50 ml, 100 ml, 250 ml cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 10 ml, 50 ml, 100 ml, 250 ml karton
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 ml, 50 ml bottle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER 10 ml, 50 ml flasker
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: PACKAGE LEAFLET: Ingelvac CircoFLEX suspension for injection for pigs
Danish: INDLÆGSSEDDEL Ingelvac CircoFLEX injektionsvæske, suspension til grise
English: Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
Danish: injektion af 1 dosis (1 ml) til grise, uafhængig af legemsvægt.
English: Porcine circovirus type 2 ORF2 protein: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine.
Danish: RP* 1,0-3,75 * Relativ Potency (ELISA test) ved sammenligning med referencevaccine.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Danish: TEKSTEN ”OPBEVARES UTILGÆNGELIGT FOR BØRN”
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml, 250 ml bottle
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 100 ml, 250 ml flasker
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ikke relevant.
English: WITHDRAWAL PERIOD
Danish: 10. TILBAGEHOLDELSESTID
English: Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for af batchfrigivelse Boehringer Ingelheim Vetmedica GmbH
English: IM
Danish: i.m.
English: • Vaccinate only pigs as from 3 weeks of age.
Danish: Når lægemidlet blandes med Ingelvac MycoFLEX - Vaccinér kun grise fra 3 ugers alderen.
English: This summary was last updated in 07-2017
Danish: Dette sammendrag blev sidst ajourført i 07-2017.
English: (An 8-point improvement is considered clinically significant in this scale, which ranges from 0 to 100).
Danish: (En forbedring på 8 point anses for klinisk signifikant på denne skala, som går fra 0 til 100).
English: Fampyra fampridine
Danish: Fampyra fampridin
English: This was switched to a full marketing authorisation on 22 May 2017.
Danish: Den blev ændret til en fuldgyldig markedsføringstilladelse den 22. maj 2017.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Fampyra on 20 July 2011.
Danish: Europa-Kommissionen udstedte en betinget markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fampyra den 20. juli 2011.
English: The full EPAR for Fampyra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Fampyra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Fampyra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fampyra.
English: Other information about Fampyra
Danish: Andre oplysninger om Fampyra
English: With regard to the medicine's safety, serious side effects with Fampyra are rare.
Danish: Hvad angår lægemidlets sikkerhed, er alvorlige bivirkninger ved Fampyra sjældne.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Danish: Da virksomheden har indsendt de fornødne supplerende oplysninger, er godkendelsen ændret fra en betinget godkendelse til en fuldgyldig godkendelse.
English: After two to four weeks, patients are evaluated and those who have not shown an improvement should stop treatment.
Danish: Efter to til fire uger evalueres patienterne, og de patienter, som ikke viser tegn på bedring, skal stoppe behandlingen.
English: Why is Fampyra approved?
Danish: Hvorfor blev Fampyra godkendt?
English: Fampyra is available as 10 mg tablets taken without food twice a day, 12 hours apart.
Danish: Fampyra fås som 10-mg-tabletter, der tages uden mad to gange om dagen med 12 timers mellemrum.
English: What measures are being taken to ensure the safe and effective use of Fampyra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fampyra?
English: The patients were treated for 9 or 14 weeks, with their waking speed measured along a 25 feet (7.5 metres) footpath.
Danish: Patienterne blev behandlet i ni eller 14 uger, og deres ganghastighed blev målt langs en sti på 7,5 m (25 fod).
English: Treatment should also be stopped if a patient's walking ability worsens or if the patient does not report any benefit.
Danish: Behandlingen skal også stoppes, hvis en patients gangevne forværres, eller hvis patienten ikke rapporterer nogen fordel.
English: What is Fampyra and what is it used for?
Danish: Hvad er Fampyra, og hvad anvendes det til?
English: The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection.
Danish: De hyppigste bivirkninger, der er indberettet i kliniske undersøgelser, og som optræder hos ca. 12 % af patienterne, er urinvejsinfektioner.