FrancophonIA/ELRC3.0 huggingface dataset:
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne 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: Type I glass vials with butyl elastomer closure.
Danish: Type I glass hætteglas med butyl elastomer lukning.
English: Then remove the trocar from both containers.
Danish: Fjern trokaret fra begge containere.
English: - Second vaccination: at 17 days of age.
Danish: - Anden vaccination: Ved 17 dages alderen.
English: No adverse reactions were observed after the administration of an overdose (10 x the dose).
Danish: Ingen bivirkninger blev observeret efter administration af en overdosis (10 x dosis)
English: Concentrate:
Danish: Koncentrat:
English: The entire flock should be vaccinated to lower the risk of any circulation of the vaccine strain and virus recombination.
Danish: Hele besætningen bør vaccineres for at sænke risikoen for cirkulation af vaccine stammen og rekombinering af virus
English: - First vaccination: at 1 day of age.
Danish: - Første vaccination: Ved 1 dags alderen.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question
Danish: b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: In ducklings free of maternally derived antibodies a single vaccination at day 1 will lead to an onset of immunity after 14 days.
Danish: Hos ællinger der er frie for maternelle antistoffer, vil en enkelt vaccination om dagen lede til immunitet efter 14 dage.
English: STATEMENT OF ACTIVE SUBSTANCES Saline buffer
Danish: ANGIVELSE AF AKTIVE STOFFER Salinsk buffer
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed after the administration of an overdose (10x the dose).
Danish: Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt: Ingen uønskede reaktioner blev observeret efter administration af en overdosis (10 x dosis)
English: SPECIAL STORAGE CONDITIONS Store below 25° C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares under 25° C.
English: After mixing, connect the bag to a high-speed, automated or semi-automated injection system.
Danish: Efter blanding, forbind da posen til et højhastigheds injektionssystem, der er hel eller semiautomatisk.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinære lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Goose Parvovirus
Danish: Gåse Parvovirus
English: PACKAGE SIZE 10 x 500 doses 1x 2,500 doses
Danish: PAKNINGSSTØRRELSE 10 x 500 doser 1 x 2.500 doser
English: Special precaution for use in animals:
Danish: Særlige forsigtighedsregler til brug hos dyr:
English: Onset of immunity: 11 days after the primary vaccination course Duration of immunity: 26 days after the primary vaccination course The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Danish: Indtrædelse af immunitet: 11 dage efter det primære vaccinations program Varighed af immunitet: 26 dage efter det primære vaccinations program Den viste varighed af immunitet, beskytter fuglene i den periode hvor de er mest modtagelige overfor parvovirus fra moskusand og Derzsys sygdom
English: Antigen Concentrate:
Danish: Antigenkoncentrat:
English: Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme:
Danish: Administrer en dosis på 0,2 ml ved subkutan injektion efter det følgende vaccinationsprogram.
English: Duration of immunity: 26 days after the primary vaccination course
Danish: Varighed af immunitet: 26 dage efter det primære vaccinationsprogram.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each reconstituted dose of 0.2 ml contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver rekonstitueret dosis på 0,2 ml indeholder:
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicine.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre lægemidler til dyr.
English: Store and transport refrigerated (2° C - 8° C).
Danish: Opbevares og transporteres nedkølet(2° C - 8° C) Må ikke nedfryses.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på kartonen efter EXP. Opbevaringstid efter fortynding ifølge anvisning: 4 timer.
English: 2,500 doses
Danish: 2.500 doser
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each reconstituted dose of 0.2 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver rekonstitueret dosis på 0,2 ml indeholder:
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Danish: Kaliumdihydrogenphosphat Natriumdihydrogenphosphathydrat Vand til injektionsvæsker.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 500 doses
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: CONTRAINDICATIONS Do not use in birds in lay.
Danish: KONTRAINDIKATIONER Må ikke anvendes til æglæggende fugle.
English: Shelf life of the veterinary medicinal product as packaged for sale : 2 years Shelf life after dilution according to directions: 4 hours.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter fortynding ifølge vejledning: 4 timer
English: Eleven genetic markers (nucleotides) in the VP1 gene allow differentiation of the Parvoduk vaccine strain from the field strains of duck and goose parvovirus, as shown below:
Danish: 11 genetiske markører (nukleotider) i VP1 genet tillader differentiering af Parvoduk vaccine stammen fra de naturligt forefindende stammer i and- og gåse parvovirus, som vist herunder:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For subcutaneous use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: EXP Once diluted, use within 4 hours.
Danish: EXP Anvendes inden for 4 timer efter fortynding.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: live viral vaccines, duck parvovirus.
Danish: Farmakoterapeutisk gruppe: Levende virale vacciner, parvovirus vaccine til ænder.
English: Onset of immunity: 11 days after the primary vaccination course
Danish: Indtrædelse af immunitet: 11 dage efter det primære vaccinationsprogram.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren (fremstillerne) der er ansvarlig for batchfrigivelse
English: The vaccine contains a live attenuated Muscovy duck parvovirus.
Danish: Vaccinen indeholder levende attenueret parvovirus fra moskusand.
English: WITHDRAWAL PERIOD(S) Withdrawal period: zero days.
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid: 0 dage
English: Gently shake the bag to mix the antigen concentrate with the solvent.
Danish: Omryst forsigtigt posen for at blande antigenkoncentratet i solvensen.
English: PACKAGE SIZE 500 doses.
Danish: PAKNINGSSTØRRELSE 500 doser
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Muscovy duck parvovirus.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Levende attenueret parvovirus fra moskusand
English: The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Danish: Den viste varighed af immunitet, beskytter fuglene i den periode hvor de er mest modtagelige overfor parvovirus fra moskusand og Derzsys sygdom
English: One reconstituted dose of 0.2 ml contains:
Danish: Hver rekonstitueret dosis på 0,2 ml indeholder:
English: 29 avenue Tony Garnier 69007 Lyon,
Danish: 29 avenue Tony Garnier 69007 Lyon, France
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Parvoduk concentrate
Danish: VETERINÆRLÆGEMIDLETS NAVN Solvens til Parvoduk koncentrat
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/162/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/162/001
English: It induces an active and specific immunity against Muscovy duck parvovirosis and Derzsy's disease in the vaccinated birds.
Danish: Vaccinen inducerer en aktiv og specifik immunitet mod parvovirus fra moskusænder og Derzsys sygdom i de vaccinerede fugle.
English: MARKETING AUTHORISATION NUMBERS EU/2/14/162/001-002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/162/001-002
English: Transfer the content of the glass vial into the bag of solvent.
Danish: Overfør indholdet af hætteglasset til solvensposen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials of concentrate
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med koncentrat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of concentrate
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med koncentrat
English: INDICATION(S) Read the package leaflet before use.
Danish: INDIKATION(ER) Læs indlægssedlen før brug
English: Live attenuated Muscovy duck parvovirus strain GM 199 ...................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Danish: Levende attenueret parvovirus fra moskusand stamme GM 199 ........................ 2.6 - 4.8 log10 CCID*50 *Cellekultur infektiøs dosis 50%
English: 4.2 Indications for use, specifying the target species Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til aktiv immunisering af moskusænder for at reducere vægttab og læsioner som følge af parvovirus fra moskusand, Derzsys sygdom, i fraværet af maternelt afledte antistoffer, og at forhindre død.
English: Live attenuated Muscovy duck parvovirus strain GM 199 ............................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Danish: Levende attenueret parvovirus fra moskusand stamme GM 199 ........................ 2.6 - 4.8 log10 CCID*50 * Cellekultur infektiøs dosis 50%
English: PHARMACEUTICAL FORM Concentrate for suspension for injection.
Danish: LÆGEMIDDELFORM Koncentrat til injektionsvæske, suspension
English: Once reconstituted, use within 4 hours.
Danish: Anvendes senest 4 timer efter rekonstitution.
English: Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Danish: Til aktiv immunisering af moskusænder for at reducere vægttab og læsioner som følge af parvovirus fra moskusand, Derzsys sygdom, i fraværet af maternelt afledte antistoffer, og at forhindre død.
English: A small occasional impact on growth cannot be excluded upon vaccination of day-old ducklings free of maternally derived antibodies.
Danish: Ved vaccination af dag-gamle ællinger, der er frie for maternelle antistoffer, kan en mindre påvirkning af vækst ikke udelukkes.
English: Once diluted use within 4 hours.
Danish: Anvendes indenfor 4 timer efter fortynding.
English: Insert the trocar provided with the bag of solvent through the closures of both the glass vial and the solvent bag to connect them.
Danish: Isæt det trokar der følger med solvensposen igennem lukningerne på begge containere, for at forbinde hætteglasset indeholdende suspensionen, med solvensposen.
English: Shake the vial of antigen concentrate.
Danish: Omryst hætteglasset med antigenkoncentrat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med solvens
English: Live attenuated Muscovy duck parvovirus strain GM 199 .................................... 2.6-4.8 log10 CCID50.
Danish: Levende attenueret parvovirus fra moskusand stamme GM 199 ........................ 2.6 - 4.8 log10 CCID*50
English: Concentrate and solvent for suspension for injection.
Danish: Koncentrat og solvens til injektionvæske, suspension.
English: Insert the trocar provided with the bag of diluent through the closures of both the glass vial and the diluent bag to connect them.
Danish: Isæt det trokar der følger med solvensposen igennem lukningerne på begge containere, for at forbinde hætteglasset med koncentratet, med solvensposen.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bags of solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Poser med solvens
English: PACKAGE LEAFLET: Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Danish: INDLÆGSSEDDEL: Parvoduk koncentrat og solvens til injektionsvæske, suspension til moskusænder
English: WITHDRAWAL PERIOD(S) Zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 dage
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate for suspension for injection for Muscovy ducks
Danish: VETERINÆRLÆGEMIDLETS NAVN Parvoduk koncentrat til injektionsvæske, suspension til moskusænder
English: Lay: Do not use in birds in lay.
Danish: Anvendelse under æglægning: Må ikke anvendes til æglæggende fugle.
English: Store below 25 °C.
Danish: Solvens: Opbevares under 25°C
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk solvent for suspension for injection for Muscovy ducks
Danish: VETERINÆRLÆGEMIDLETS NAVN Parvoduk solvens til injektionsvæske, suspension til moskusænder.
English: Cardboard box of 10 bags of 500 doses.
Danish: Polypropylen poser med butyl elastomer lukning og trokar Papæske med 10 poser á 500 doser Papæske med 1 pose á 2500 doser
English: TARGET SPECIES Muscovy ducks.
Danish: DYREARTER Moskusænder
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Danish: VETERINÆRLÆGEMIDLETS NAVN Parvoduk koncentrat og solvens til injektionsvæske, suspension til moskusænder.
English: Cardboard box of 1 bag of 2,500 doses.
Danish: Papæske med 10 hætteglas á 500 doser Papæske med 1 hætteglas á 2.500 doser Solvens:
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Danish: --1 Lyofilisat (levende svækket) Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15 103,1 -105,1 TCID50*
English: * Tissue culture infectious dose 50%
Danish: *Vævskulturinficerende dosis - 50 % (tissue culture infectious dose 50 %)
English: Package size
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: Date of first authorisation: 23 June 2017
Danish: Dato for første tilladelse: 23 juni 2017
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Tag ikke en dobbelt dosis for at udligne for den glemte individuelle dosis.
English: Diffusion into erythrocytes is non-existent.
Danish: Diffusion ind i erythrocytter forekommer ikke.
English: 75011 Paris France
Danish: 75011 Paris Frankrig
English: Ucedane with food and drink
Danish: Brug af Ucedane sammen med mad og drikke
English: Consult your doctor for advice if you are pregnant or planning to become pregnant.
Danish: Få rådgivning af Deres læge, hvis De er gravid eller planlægger at blive gravid.
English: Blister (ALU/ALU) packed in cartons.
Danish: Blister (alu/alu) pakket i æsker.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Danish: De indberettede bivirkninger er anført nedenfor efter systemorganklasse og hyppighed.
English: The effects of Ucedane on pregnancy and the unborn child are not known.
Danish: Ucedanes effekt på graviditet og det ufødte barn er ukendt.
English: Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four intakes to be given before meals or feedings.
Danish: Baseret på farmakokinetiske data og klinisk erfaring anbefales det at opdele den totale daglige dosis i to til fire dele, der gives inden måltider eller madning.
English: The breaking of the tablets in halves allows most of the required posology adjustments.
Danish: Delingen af tabletterne i halve muliggør de fleste af de påkrævede doseringsjusteringer.
English: The tablet can be divided into four equal doses.
Danish: Tabletten kan deles i fire lige store doser.
English: The tablets must be dispersed in a minimum of 5 to 10 mL of water and taken immediately.
Danish: Tabletterne skal opløses i mindst 5 til 10 ml vand og tages med det samme.
English: Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/mL.
Danish: Uanset den daglige dosis gik de langsomt ned i løbet af 15 timer til niveauer omkring 100 ng/ml.
English: Talk to your doctor or pharmacist before taking Ucedane.
Danish: Tal med Deres læge eller apotekspersonalet, før De begynder at tage Ucedane.
English: Do not stop Ucedane without informing your doctor.
Danish: De må ikke holde op med at tage Ucedane uden at informere lægen.
English: Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05.
Danish: Farmakoterapeutisk klassifikation: Aminosyrer og derivater; ATC Kode: A16A A05.
English: Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
Danish: Ernæringsstyring Proteinrestriktion og tilskud af arginin kan være indiceret i tilfælde af lav proteintolerance.
English: Ucedane must be taken orally before meals or feedings.
Danish: Ucedane skal tages gennem munden inden måltider eller fødeindtagelse.
English: Not known side effects (frequency cannot be estimated from the available data) rash
Danish: Bivirkninger med ikke kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data): - udslæt.
English: The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary.
Danish: Den indledende daglige dosis bør være 100 mg/kg, op til 250 mg/kg, om nødvendigt.
English: It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4).
Danish: Den bør derefter justeres individuelt med henblik på at opretholde normale ammoniak plasmaniveauer (se afsnit 4.4).
English: The tablets must be dispersed in a minimum of 5-10 mL of water and ingested immediately or administered by fast push through a syringe via a nasogastric tube.
Danish: Tabletterne skal dispergeres i et minimum af 5-10 ml vand og straks indtages eller gives ved et hurtigt tryk gennem en sprøjte via en nasogastrisk tube.
English: Ucedane treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Danish: Behandling med Ucedane skal indledes under overvågning af en læge, der har erfaring i behandlingen af metaboliske sygdomme.
English: Safety pharmacology studies have shown that carglumic acid administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular system.
Danish: Sikkerhedsmæssige farmakologiske undersøgelser har vist, at cargluminsyre administreret oralt i doser på 250, 500, 1000 mg/kg ikke havde nogen statistisk signifikant virkning på respiration, centralnervesystem og kardiovaskulære system.
English: The tablets are presented in Aluminium/aluminium blister packed in cartons.
Danish: Tabletterne fås i blistre af aluminium/aluminium, der er pakket i æsker.
English: If you stop taking Ucedane
Danish: Hvis De holder op med at tage Ucedane
English: Uncommon increased transaminases
Danish: Ikke almindelig forhøjede transaminaser
English: Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants to adolescents, treated with various daily doses (7-122 mg/kg/day).
Danish: Plasmaniveauer af cargluminsyre blev målt hos patienter i alle aldersgrupper, fra nyfødte spædbørn til halvvoksne, behandlet med forskellige daglige doser (7 - 122 mg/kg/dag).
English: The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half-life up to 28 hours).
Danish: Plasmaeliminationskurven for cargluminsyre er bifasisk med en hurtig fase over de første 12 timer efter administrering efterfulgt af en langsom fase (terminal halveringstid op til 28 timer).
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100) 100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: til <1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: What you need to know before you take Ucedane Do not take Ucedane:
Danish: Det skal De vide, før De begynder at tage Ucedane Tag ikke Ucedane:
English: Carglumic acid showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat).
Danish: Cargluminsyre viste ingen signifikant mutagen aktivitet i et batteri af genotoksiske tests udført in vitro (Ames test, human lymfocyt metafase analyse) og in vivo (mikronucleustest på rotter).
English: If you forget to take Ucedane
Danish: Hvis De har glemt at tage Ucedane
English: Absorption After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Danish: Efter en enkelt oral dosis på 100 mg/kg kropsvægt estimeres det, at omtrent 30% af cargluminsyren absorberes.
English: sodium stearyl fumarate, mannitol, copovidone K28, crospovidone type B.
Danish: natriumstearylfumarat, mannitol, copovidon K 28, crospovidon type B.
English: Ucedane should ONLY be administered by mouth or via a feeding tube into the stomach (using a syringe, if necessary).
Danish: Ucedane må KUN indtages gnnem munden eller via en ernæringssonde ned i maven (ved brug af en sprøjte, hvis det er nødvendigt).
English: Do not use this medicine after the expiry date which is stated on the blister and carton.
Danish: Brug ikke Ucedane efter den udløbsdato, der står på pakningen.
English: Pack size of 12 or 60 tablets.
Danish: Pakningsstørrelse på 12 eller 60 tabletter.
English: Not known rash
Danish: Ikke kendt udslæt
English: The initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10 kg, you should take 1 g per day, or 5 tablets of 200 mg).
Danish: Den indledende daglige dosis er sædvanligvis 100 mg pr. kilo legemsvægt, op til maksimalt 250 mg pr. kilo legemsvægt (f.eks. hvis De vejer 10 kg, skal De tage 1 g om dagen svarende til 5 tabletter a 200 mg).