FrancophonIA/ELRC3.0 huggingface dataset:
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 Capecitabine Accord.
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 Capecitabine Accord.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Accord.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Capecitabine Accord.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Danish: Det tages som tabletter, hvorimod 5-FU sædvanligvis må gives ved indsprøjtning.
English: The dose depends on the type of cancer being treated.
Danish: Dosis afhænger af den pågældende kræfttype.
English: It is available as tablets (150, 300 and 500 mg).
Danish: Det leveres som tabletter (150, 300 og 500 mg).
English: As a result, it inhibits the growth of tumour cells and eventually kills them.
Danish: Derved hæmmes kræftcellernes vækst, så de til sidst dør.
English: For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Capecitabine Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Capecitabine Accord is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis af Capecitabine Accord er 625 til 1 250 mg pr. kvadratmeter legemsoverflade to gange dagligt (beregnet efter patientens højde og vægt).
English: The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take.
Danish: Lægen beregner det antal tabletter på 150, 300 mg og 500 mg, som patienten skal tage.
English: 5-FU is an analogue of pyrimidine.
Danish: 5-FU et stof, der ligner pyrimidin.
English: Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Capecitabine Accord er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
English: Other information about Capecitabine Accord
Danish: Andre oplysninger om Capecitabine Accord
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Danish: • fremskreden eller metastatisk brystkræft (brystkræft, der er begyndt at brede sig til andre dele af kroppen).
English: Treatment is continued for six months after colon surgery.
Danish: Ved tyktarmskræft fortsættes behandlingen i seks måneder efter operationen.
English: While the reference medicine, Xeloda, is available as 150 and 500 mg tables, Capecitabine Accord is also available as 300 mg tablets.
Danish: Referencelægemidlet, Xeloda, leveres kun som tabletter på 150 og 500 mg, hvorimod Capecitabine Accord desuden leveres som 300 mg tabletter.
English: Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.
Danish: Dosis skal tilpasses, hvis patienten har lever- eller nyresygdom, eller hvis patienten får visse bivirkninger.
English: What are the benefits and risks of Capecitabine Accord?
Danish: Hvilke fordele og risici er der forbundet med Capecitabine Accord?
English: The Committee recommended that Capecitabine Accord be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Capecitabine Accord.
English: Capecitabine Accord is a ‘hybrid generic medicine'.
Danish: Capecitabine Accord er et “hybridt generisk lægemiddel”.
English: The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda.
Danish: Virksomheden fremlagde data fra undersøgelser, der skal fastlægge, om Capecitabine Accord er bioækvivalent med referencelægemidlet, Xeloda.
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Danish: Det kan desuden bruges alene, når antracycliner og taxaner (en anden type kræftmidler) ikke virker, eller når det ikke er hensigtsmæssigt at gentage behandlingen med antracycliner.
English: Capecitabine Accord is used with or without other anticancer medicines;
Danish: Capecitabine Accord anvendes her sammen med eller uden andre kræftmidler,
English: EPAR summary for the public capecitabine
Danish: EPAR - sammendrag for offentligheden capecitabin
English: The active substance in Capecitabine Accord, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Danish: Det aktive stof i Capecitabine Accord, capecitabin, er et vævsgiftigt stof (dvs. det dræber celler, der deler sig, såsom kræftceller) og tilhører gruppen af “antimetabolitter” (stofskiftehæmmere).
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues.
Danish: Capecitabin er et “prodrug” (et forstadium), der i kroppen omdannes til 5-fluoruracil (5-FU).
English: Full details are available in the summary of product characteristics (also part of the EPAR).
Danish: Fuldstændige oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Xeloda.
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Accord has been shown to have comparable quality and to be bioequivalent to Xeloda.
Danish: CHMP konkluderede, at Capecitabine Accord er påvist at være af samme kvalitet som Xeloda og er bioækvivalent med dette i overensstemmelse med EU-reglerne.
English: Capecitabine Accord is an anticancer medicine.
Danish: Capecitabine Accord er et lægemiddel mod kræft.
English: Capecitabine Accord is a medicine that contains the active substance capecitabine.
Danish: Capecitabine Accord er et lægemiddel, der indeholder det aktive stof capecitabin.
English: Capecitabine Accord is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Danish: Capecitabine Accord anvendes her sammen med docetaxel (et andet kræftmiddel), når antracycliner (en anden type kræftmidler) ikke virker.
English: Capecitabine Accord is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Danish: Capecitabine Accord kan her anvendes alene eller sammen med andre kræftmidler til patienter, der er opereret for tyktarmskræft i “trin III” eller ”Dukes trin C”,
English: Capecitabine Accord is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Danish: Capecitabine Accord anvendes her sammen med andre kræftmidler, bl.a. platinholdige midler som cisplatin,
English: Capecitabine Accord should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Danish: Behandlingen med Capecitabine Accord bør udelukkende ordineres af en læge med særligt kendskab til kemoterapi.
English: • colon (large bowel) cancer.
Danish: • tyktarmskræft (coloncancer).
English: How has Capecitabine Accord been studied?
Danish: Hvordan blev Capecitabine Accord undersøgt?
English: Why has Capecitabine Accord been approved?
Danish: Hvorfor blev Capecitabine Accord godkendt?
English: What is Capecitabine Accord?
Danish: Hvad er Capecitabine Accord?
English: How is Capecitabine Accord used?
Danish: Hvordan anvendes Capecitabine Accord?
English: What is Capecitabine Accord used for?
Danish: Hvad anvendes Capecitabine Accord til?
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: United Kingdom
Danish: UKStorbritannien
English: Norway
Danish: NO - Norge
English: Portugal
Danish: PT - Portugal
English: Netherlands
Danish: NL - Holland
English: Finland
Danish: FI - Finland
English: Poland
Danish: PL - Polen
English: Cyprus
Danish: CY - Cypern
English: Slovak Republic
Danish: SK - Slovakiet
English: Luxembourg
Danish: LULuxembourg
English: Bulgaria
Danish: BG - Bulgarien
English: Denmark
Danish: DK - Danmark
English: Czech Republic
Danish: CZ - Tjekkiet
English: Sweden
Danish: SE - Sverige
English: Ireland
Danish: IE - Irland
English: Belgium
Danish: BE - Belgien
English: Iceland
Danish: IS - Island
English: Austria
Danish: AT - Østrig
English: Flutiform® 250/10 µg 250mcg/10mcg
Danish: 250mcg/10mcg
English: France
Danish: FR - Frankrig
English: Germany
Danish: DE - Tyskland
English: Italy
Danish: IT - Italien
English: 140 (2 x 70) tablets (multipack)
Danish: 250 mg Filmovertrukne tabletter Oral anvendelse Blister (PA/Alu/PVC/Alu) 140 (2x70) tabletter (multipakning)
English: Strength
Danish: Pakningsstørrelse
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: Wash hands after use.
Danish: Vask hænder efter brug.
English: Protect from direct sunlight.
Danish: Beskyttes mod direkte sollys.
English: Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
Danish: Allergiske reaktioner over for disse stoffer kan undertiden være alvorlige, og direkte kontakt skal derfor undgås.
English: 4.8 Interaction with other medicinal products and other forms of interaction None known.
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion Ingen kendte.
English: The referral relates to the divergent national decisions taken by Member States, raised by Germany.
Danish: Indbringelsesproceduren vedrører divergerende nationale beslutninger truffet af medlemsstaterne og er indledt af Tyskland.
English: For oral use only.
Danish: Kun til oral anvendelse.
English: 4600 Wels Austria
Danish: 4600 Wels Østrig
English: The other marketing authorisations were approved via national procedures.
Danish: De øvrige markedsføringstilladelser blev godkendt via nationale procedurer.
English: 1030 Vienna
Danish: 1030 Wien
English: In very rare cases, a decrease in water intake has been observed.
Danish: Der er i meget få tilfælde blevet observeret et reduceret vandforbrug.
English: Based on the data presented, the following self-life periods are considered acceptable:
Danish: På grundlag af de fremlagte data betragtes følgende opbevaringstider for at være acceptable:
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Danish: Der skal tages højde for officielle, nationale og regionale politikker vedrørende antimikrobielle stoffer ved anvendelse af lægemidlet.
English: Personal protective equipment should be worn.
Danish: Der bør bæres personligt beskyttelsesudstyr.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30°C.
English: - Tilmicosin may induce irritation.
Danish: - Tilmicosin kan forårsage irritation.
English: Manure from treated animals should not be deposited on the same field in successive years.
Danish: Gødning fra behandlede dyr må ikke anvendes på den samme mark i efterfølgende år.
English: Pigs, chickens and turkeys: Water consumption should be monitored in order to guarantee adequate dosing.
Danish: Svin, høns og kalkuner: Vandforbruget skal overvåges for at garantere korrekt dosering.
English: 35396 Gießen Germany
Danish: 35396 Gießen Tyskland
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: 1000 Brussel
Danish: 1000 Bruxelles
English: Do not eat, drink or smoke when handling this product.
Danish: Der må ikke spises, drikkes eller ryges under håndtering af lægemidlet.
English: MANUFACTURER'S BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: The use of the product should be based on susceptibility tests.
Danish: Anvendelsen af lægemidlet skal baseres på følsomhedstest.
English: ATC vet code: QJ01FA91
Danish: ATCvet-kode: QJ01FA91
English: Eight marketing Authorisations were approved via the Mutual Recognition Procedure using Italy as the Reference Member State.
Danish: Otte markedsføringstilladelser blev godkendt via proceduren for gensidig anerkendelse med Italien som referencemedlemsstat.
English: Medicated drinking water or milk replacer should be prepared fresh every 24 hours.
Danish: Medicineret drikkevand eller mælkeerstatning skal tilberedes frisk hver 24 timer.
English: - Do not handle the product if you are allergic to ingredients in the product.
Danish: - Undgå at håndtere lægemidlet, hvis du er allergisk over for lægemidlets indholdsstoffer.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Important: Must be diluted before administration to animals.
Danish: Vigtigt: Skal fortyndes før indgivelse til dyr.
English: The main section of disharmony of the existing SPCs (non exhaustive) are:
Danish: Det område, der især er uenighed om i de eksisterende produktresuméer, er (ikke udtømmende):
English: Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelse af ansigtet, læberne og øjnene eller vejrtrækningsbesvær er mere alvorlige symptomer, som kræver øjeblikkelig lægehjælp.
English: Therapeutically effective concentrations of tilmicosin were measured up to 60 hours after treatment.
Danish: Effektive behandlingskoncentrationer af tilmicosin blev målt op til 60 timer efter behandling.
English: LABELLING
Danish: ETIKETTERING
English: The uptake of medicated drinking water/milk replacer depends on the clinical condition of the animals.
Danish: Indtagelsen af medicineret drikkevand/mælkeerstatning afhænger af dyrenes kliniske tilstand.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally
Danish: VETERINÆRLÆGEMIDLETS NAVN Udfyldes nationalt
English: 13 Rue Pagès 92158 Suresnes Cedex France
Danish: 13 Rue Pagès 92158 Suresnes Cedex Frankrig
English: It has bacteriostatic action but at high concentrations it may be bactericidal.
Danish: Det har bakteriostatisk virkning, men kan ved høje koncentrationer være baktericid.
English: In particular, its activity has been demonstrated against the following microorganism:
Danish: Veterinærlægemidlets aktivitet er blevet påvist at være særligt effektiv over for følgende mikroorganismer:
English: INDICATION(S)
Danish: INDIKATION(ER)
English: Discussion
Danish: Drøftelse
English: Severely ill individuals tend to drink less and may need simultaneous treatment, preferably by parenteral medication.
Danish: Meget syge dyr har tendens til at drikke mindre, og det kan være nødvendigt at give anden samtidig behandling, fortrinsvis ved parenteral medicinering.
English: Do not inject
Danish: Må ikke injiceres.
English: Cross-resistance between tilmicosin and other macrolides and lincomycin has been observed.
Danish: Krydsresistens mellem tilmicosin og andre makrolider samt lincomycin er blevet observeret.
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin-related substances.
Danish: Ukorrekt brug af lægemidlet kan øge forekomsten af bakterier, der er resistente over for tilmicosin, og kan nedsætte effektiviteten af behandlingen med tilmicosin-lignende stoffer.
English: Pulmotil AC 250 mg/ml concentrate for oral solution is currently registered in 18 European Member States.
Danish: Pulmotil AC 250 mg/ml koncentrat til oral opløsning er i øjeblikket registreret i 18 europæiske medlemsstater.
English: The CVMP can accept the indication and posology in all species as these are in accordance with those used in the experimental and field studies.
Danish: CVMP kan acceptere indikationen og doseringsanvisningen hos alle arter, da disse er i overensstemmelse med dem, der er anvendt i forsøgs- og feltundersøgelser.
English: Scientific evidence suggests that macrolides act synergistically with the host immune system.
Danish: Videnskabelig dokumentation angiver, at makrolider virker synergistisk med værtens immunsystem.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, DYREART, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATEN
English: PACKAGE SIZE 240 ml
Danish: PAKNINGSSTØRRELSE 240 ml
English: People with known hypersensitivity to tilmicosin should avoid contact with the product.
Danish: Personer med kendt overfølsomhed over for tilmicosin bør undgå kontakt med lægemidlet.
English: To be supplied only on veterinary prescription.
Danish: Må kun udleveres efter veterinærrecept.
English: Tilmicosin is a semi-synthetic antibiotic of the macrolide group and is believed to affect protein synthesis.
Danish: Tilmicosin er et semisyntetisk antibiotikum tilhørende gruppen af makrolider og menes at påvirke proteinsyntesen.
English: Pharmacotherapeutic Group: antibacterials for systemic use, macrolides.
Danish: Farmakoterapeutisk gruppe: Antibakterielt stof til systemisk brug, makrolider.
English: Veterinary medicinal product must not be disposed of via waste water or the drainage systems.
Danish: Veterinærlægemidlet må ikke udledes med spildevand eller via kloaksystemet.
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning
English: The CVMP accepts the Marketing Authorisation Holders' proposal to harmonise the withdrawal period for all species on the basis of the pivotal residue studies presented.
Danish: CVMP accepterer forslaget fra indehaverne af markedsføringstilladelsen om harmonisering af tilbageholdelsestiden for alle arter på grundlag af de fremlagte pivotale restkoncentrationsundersøgelser.
English: Pigs - 14 days
Danish: Svin - 14 dage.
English: Phosphoric acid (for pH adjustment) Purified water
Danish: Fosforsyre (til justering af pH)
English: 6.5 Nature and composition of immediate packaging
Danish: 6.5 Den indre emballages art og indhold
English: The Marketing Authorisation Holders submitted at the request of CVMP: - an exhaustive list of differences between the SPCs of the product authorized in the member states; - a proposal for a harmonised product information (SPC, labelling and package leaflet), taking into account the latest guidance; - the available relevant data substantiating such proposed harmonised product information.
Danish: Indehaverne af markedsføringstilladelsen fremsendte på CVMP's anmodning følgende: - en udtømmende liste over forskelle mellem produktresuméerne for produktet tilladt i medlemsstaterne - et forslag til en harmoniseret produktinformation (produktresumé, etikettering og indlægsseddel), hvori der tages hensyn til den seneste vejledning - de tilgængelige relevante data, der underbygger denne foreslåede harmoniserede produktinformation.
English: Macrolides appear to enhance phagocyte killing of bacteria.
Danish: Makrolider lader til at fremme fagocytternes destruering af bakterier.
English: Eli Lilly Italia Elanco Animal Health Via A. Gramsci, 731-733 50019 Sesto Fiorentino Florence
Danish: Eli Lilly Italia Elanco Animal Health Via A. Gramsci, 731-733 50019 Sesto Fiorentino Firenze
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND LABELLING
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG ETIKETTERINGEN
English: This can be corrected by the removal of the medicated drinking water and replacement with fresh unmedicated water.
Danish: Dette kan korrigeres ved udskiftning med umedicineret frisk vand efter behov.
English: For a full list of excipients, see section 6.1.
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: When mixing the veterinary medicinal product direct contact with eyes, skin and mucous membranes should be avoided.
Danish: Ved iblanding af veterinærlægemidlet skal direkte kontakt med øjnene, huden og slimhinderne undgås.
English: Do not allow horses and other equines access to drinking water containing tilmicosin.
Danish: Heste eller andre dyr af hestefamilien må ikke drikke vand, som indeholder tilmicosin.
English: Introduction
Danish: Indledning
English: Whilst blood concentrations of tilmicosin are low, there is pH-dependent macrophage accumulation of tilmicosin in inflamed tissues.
Danish: Mens koncentrationer af tilmicosin i blodet er lave, forekommer der en pH-afhængig makrofag akkumulation af tilmicosin i betændt væv.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {For national implementation}
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN {Til national implementering}
English: 4.1 Target species/ 4.2 Indications for Use, Specifying the Target Species: In some Member States the product is indicated for turkeys and in others not.
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til/4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til: I visse medlemsstater er produktet indiceret til kalkuner i andre ikke.
English: Cattle
Danish: Kvæg
English: Once opened, use within 3 months Once reconstituted, use within 24 hours
Danish: Efter åbning anvendes inden 3 måneder Efter rekonstituering anvendes inden 24 timer
English: As no Maximum Residue Limit has been set for tilmicosin in eggs, the following statement should be included in the SPC: Not authorised for use in laying birds producing eggs for human consumption.
Danish: Da der ikke er fastsat nogen maksimumsgrænse for restkoncentrationer af tilmicosin i æg, bør følgende erklæring fremgå af produktresuméet: Må ikke bruges til æglæggende fugle, der producerer æg, som anvendes til menneskeføde.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND LABELLING
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG ETIKETTERINGEN
English: Although this has a self-limiting effect on tilmicosin intake, it could, in extreme circumstances, result in dehydration.
Danish: Selv om dette i sig selv begrænser tilmicosin-indtagelsen, kan det i ekstreme situationer også føre til dehydrering af dyrene.
English: - If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning.
Danish: - Ved udvikling af symptomer efter eksponering, såsom hududslæt, søg straks læge, og vis lægen denne advarsel.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet on reverse of the label before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen på bagsiden af etiketten inden brug.