FrancophonIA/ELRC3.0 huggingface dataset:
English: The information in the paragraph below is a summary of the known interactions between itraconazole and other medicinal products in humans, and in animals other than birds.
Danish: Nedenstående afsnit sammenfatter de kendte interaktioner mellem itraconazol og andre lægemidler hos mennesker og hos andre dyr end fugle.
English: One metabolite, hydroxyitraconazole, has the same antifungal activity as the parent drug.
Danish: Én metabolit, hydroxyitraconazol, har samme antimykotiske aktivitet som moderstoffet.
English: 7255 LX Hengelo (Gld) THE NETHERLANDS.
Danish: 7255 LXHengelo (Gld) NEDERLANDENE.
English: Mascotasana s.a. Poima 26
Danish: Mascotasana s.a.
English: The concomitant use of erythromycin can result in an increased plasma concentration of itraconazole.
Danish: Sideløbende brug af erythromycin kan medføre øget plasmakoncentration af itraconazol.
English: Hydroxypropylbetadex Caramel flavour
Danish: Hydroxypropylbetadex Karamelaroma
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Purified water.
Danish: Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) Vand, renset.
English: It also affects membrane-bound enzyme function and membrane permeability, and as this effect is irreversible it results in structural degeneration of the fungus.
Danish: Det griber desuden ind i funktionen af membranbundet enzym og membranpermeabiliteten, og da denne virkning er irreversibel, medfører den, at svampen nedbrydes.
English: Laboratory studies in rats have shown evidence of dose-related teratogenic, foetotoxic and maternotoxic effects at high dosages (40 and 160 mg/kg bodyweight administered daily for 10 days during their gestational period).
Danish: I laboratorieundersøgelser hos rotter er der set dosisrelateret teratogen, føtotoksisk og maternotoksisk effekt ved høje doser (40 og 160 milligram pr. kg kropsvægt administreret dagligt i 10 dage i drægtighedsperioden).
English: Strigiformes (owls)
Danish: Strigiformes (ugler)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE EMBALLAGER
English: However, if direct oral administration is not feasible (for example, for raptors) the medicinal product can be administered with the bird's food.
Danish: Hvis det ikke er praktisk muligt at indgive lægemidlet direkte (f.eks. til rovfugle), kan lægemidlet dog indgives sammen med fuglens foder.
English: 7255 LX Hengelo (Gld) THE NETHERLANDS
Danish: 7255 LXHengelo (Gld) NEDERLANDENE
English: In cases where, 8 weeks after the start of treatment, clinical signs are still present, or endoscopy indicates a fungal presence remains, the whole 8 weeks course of treatment should be repeated (using the same dose regimen).
Danish: Hvis der 8 uger efter påbegyndelse af behandlingen stadig er kliniske tegn, eller endoskopi viser fortsat tilstedeværelse af svampe, bør hele det 8 ugers behandlingsforløb gentages (med samme dosisregime).
English: The information below is indicative of the known interactions in humans, and in animals other than birds.
Danish: Nedenfor er angivet kendte interaktioner hos mennesker og dyr, bortset fra fugle.
English: EXP {month/year} Once opened, use within 28 days.
Danish: EXP {måned/år} Skal anvendes senest 28 dage efter åbning.
English: Lay: Do not use in birds in lay and within 4 weeks before the startof the laying period.
Danish: Æglægning: Må ikke anvendes til æglæggende fugle eller inden for fire uger før æglægningsperiodens start.
English: The prevalence of such acquired resistance may vary geographically and over time for specific species, and therefore local information on antifungal/azole resistance is desirable, particularly when treating severe infections.
Danish: Forekomsten af sådan erhvervet resistens kan variere geografisk og tidsmæssigt for de enkelte arter, og der bør fremskaffes lokale oplysninger om resistens over for svampemidler/azoler, navnlig ved behandling af svære infektioner.
English: In humans it is known that itraconazole can inhibit the metabolism of medicinal products that are substrates for cytochrome 3A isoenzymes, for example, chloramphenicol, ivermectin or methylprednisolone.
Danish: Hos mennesker vides itraconazol at hæmme metaboliseringen af lægemidler, der er substrater for cytokrom 3A-isoenzymer, f.eks. chloramphenicol, ivermectin og methylprednisolon.
English: Psittaciformes (specifically cockatoos and true parrots: parakeets; budgerigars) Falconiformes (falcons)
Danish: Psittaciformes (specielt nymfeparakitter og egentlige papegøjer: parakitter; undulater) Falconiformes (falke)
English: THE NETHERLANDS
Danish: NEDERLANDENE
English: Description: Yellow to slightly amber, clear solution.
Danish: Beskrivelse: Gul til let ravgul, klar opløsning.
English: Cardboard box containing an amber glass (type III) bottle with a tamper-evident polypropylene screw cap and LDPE insert.
Danish: Kartonen indeholder en flaske af gult glas (type III) med forseglet skruelåg af polypropylen og LDPEindsats.
English: Administration route:
Danish: Indgivelsesvej:
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke-anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: In case of accidental contact with the eyes, rinse thoroughly with water.
Danish: Ved uforvarende kontakt med øjnene skal de vaskes grundigt med vand.
English: Itraconazole 10 mg/ml
Danish: Itraconazol 10 mg/ml
English: If vomiting, loss of appetite or loss of weight occurs, then in the first instance it is advisable to lower the dose (see section “Special warnings”) or treatment with the veterinary medicine should be discontinued.
Danish: Ved opkastning, appetitløshed eller vægttab tilrådes det i første instans at nedsætte dosis (se afsnittet “Særlige advarsler”) eller at ophøre med behandlingen med veterinærlægemidlet.
English: Because of the risk of transmission of aspergillosis to people, personal protective equipment consisting of latex gloves and a mask should therefore be worn when handling infected birds or when cleaning the syringe.
Danish: På grund af risikoen for overførsel af aspergillose til personer bør der derfor anvendes personlige værnemidler bestående af latexhandsker og maske ved håndtering af inficerede fugle og ved rengøring af sprøjten.
English: The minimum inhibitory concentrations of itraconazole for different Aspergillus isolates in birds in Europe varies between 0.25 and >16 g/ml.
Danish: De mindste hæmmende koncentrationer af itraconazol er mellem 0,25 og >16 g/ml for forskellige isolater af Aspergillus hos fugle i Europa.
English: Resistance to azole antifungals is most commonly exhibited by modification of the cyp51A gene which encodes for the target enzyme 14-alpha-sterol demethylase.
Danish: Oftest udløses resistens over for azol-antimykotika ved modifikation af cyp51A-genet, der koder for målenzymet 14-alfa-sterol demethylase.
English: Laboratory animal studies have shown that itraconazole used concomitantly with amphotericin B may be antagonistic against Aspergillus spp.
Danish: Forsøg med laboratoriedyr har vist, at itraconazol ved anvendelse sammen med amphotericin B kan være antagonistisk over for Aspergillus spp.
English: Unit 2, 2 Cavendish Rd Bury Saint Edmunds IP33 3TE Tel.: 0044-1284761131
Danish: Enhed 2, 2 Cavendish Rd Bury Saint Edmunds IP33 3TE Tlf .
English: Cross-resistance amongst members of the azole class of drugs has been observed within Candida species, although resistance to one member of the class does not necessarily confer resistance to other azoles.
Danish: Der er iagttaget krydsresistens over for lægemidler i klassen af azoler hos arter af Candida-slægten, men resistens over for ét medlem af klassen medfører ikke nødvendigvis resistens over for andre azoler.
English: No information is available on the safety and efficacy of this veterinary medicinal product when used in the target species with any other veterinary medicinal product.
Danish: Der er ingen tilgængelig information om sikkerheden og virkningen af dette veterinærlægemiddel, når det anvendes hos dyrearterne, som veterinærlægemidlet er beregnet til, sammen med andre veterinærlægemidler.
English: Accipitriformes (hawks)
Danish: Accipitriformes (høge)
English: An appropriate rate of air renewal in the environment of the treated birds is also important.
Danish: Tilstrækkeligt luftskifte i omgivelserne for alle behandlede fugle er ligeledes vigtigt.
English: Although the relevance of this information for the target species is unknown, it would be prudent to avoid the concurrent use of such substances with this product because an increase and/or a prolongation of their pharmacological effects, including side effects, may occur.
Danish: Skønt relevansen heraf for dyrearterne, som veterinærlægemidlet er beregnet til, er ukendt, tilrådes det at undgå anvendelse af sådanne stoffer sammen med produktet, da dette kan øge og/eller forlænge deres farmakologiske virkninger, herunder bivirkninger.
English: Box containing 1 bottle of 10 ml with one 1 ml oral syringe.
Danish: Karton indeholdende 1 flaske på 10 ml med én 1 ml oral sprøjte.
English: Package sizes
Danish: Paknings-størrelse
English: Vomiting, loss of appetite and loss of weight have commonly been observed in treated birds, however, these adverse reactions are usually mild and dose related.
Danish: Opkastning, appetitløshed og vægttab er almindeligt forekommende hos behandlede fugle, men disse bivirkninger er sædvanligvis milde og dosisafhængige.
English: Box containing 1 bottle of 50 ml with one 5 ml oral syringe.
Danish: Karton indeholdende 1 flaske på 50 ml med én 5 ml oral sprøjte.
English: Itraconazole is generally not well tolerated by African Grey Parrots and therefore the product should only be used with care in this species and if no alternative treatment is available and with the lowest recommended dose for the whole of the recommended treatment period.
Danish: Hos denne art bør produktet derfor anvendes med forsigtighed, og kun når der ikke er en alternativ behandlingsmulighed og i den laveste anbefalede dosis i hele den anbefalede behandlingsperiode.
English: Co-administration of this product with other veterinary medicinal products should therefore be avoided.
Danish: Samtidig administration med andre veterinærlægemidler bør derfor undgås.
English: Emesis, anorexia and weight loss have commonly been observed in treated birds, however, these adverse reactions are usually mild and dose related.
Danish: Emesis, anoreksi og vægttab forekommer almindeligt hos behandlede fugle, men disse bivirkninger er sædvanligvis milde og dosisrelaterede.
English: Using the oral syringe provided, place the syringe nozzle into the opening of the bottle and withdraw the necessary volume.
Danish: Sæt spidsen af den medfølgende orale sprøjte i flaskens åbning, og træk det nødvendige volumen op. Påsæt skruelåget efter brug.
English: In case of accidental ingestion, rinse the mouth with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Ved indgift ved hændeligt uheld skylles munden med vand, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: The different target species consume different types of food and exhibit differing metabolism.
Danish: De forskellige dyrearter, som veterinærlægemidlet er beregnet til, indtager foder af forskellig type og har forskellig metabolisering.
English: The concomitant use of the antibiotic erythromycin can result in an increased plasma concentration of itraconazole in the blood of the bird, which may result in increased adverse effects.
Danish: Samtidig brug af det antibiotiske lægemiddel erythromycin kan medføre forhøjet koncentration af itraconazol i fuglens blod og derved forstærke bivirkningerne.
English: Slowly and gently administer the oral solution into the mouth of the bird, allowing the bird to swallow it.
Danish: Indgiv den orale opløsning langsomt og forsigtigt i munden på fuglen, så den får mulighed for at synke den.
English: Psittaciformes (only):
Danish: Kun Psittaciformes:
English: 10 mg (1 ml) itraconazole per kg bodyweight per day for 14 days.
Danish: 10 mg (1 ml) itraconazol pr. kg kropsvægt pr. dag i 14 dage.
English: Lubichowska 126 83-200 Starogard Gdański Tel.: 0048-583523849
Danish: Lubichowska 126 83-200 Starogard Gdański Tlf .
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
English: (For example, for raptors a ‘spiked' chick is generally used.)
Danish: (Til rovfugle tilsættes lægemidlet f.eks. sædvanligvis til en kylling.)
English: In accordance with good animal husbandry, the cleaning and disinfection of the infected birds' environment with an appropriate antifungal product should be recommended.
Danish: I overensstemmelse med god avlspraksis bør de inficerede fugles omgivelser desuden rengøres og desinficeres med et egnet antimykotisk produkt.
English: The 5 ml oral syringe has graduations for 0.2 ml solution (= 2 mg itraconazole).
Danish: Den orale sprøjte på 5 ml har inddelinger på 0,2 ml opløsning (= 2 mg itraconazol).
English: The 1 ml oral syringe has graduations for 0.05 ml solution (= 0.5 mg itraconazole).
Danish: Den orale sprøjte på 1 ml har inddelinger på 0,05 ml opløsning (= 0,5 mg itraconazol).
English: Remove the screw cap on the bottle.
Danish: Skru låget af flasken.
English: The mode of action of itraconazole is based on its highly selective binding ability for fungal cytochrome P-450 isoenzymes.
Danish: Itraconazols virkning er baseret på dets stærkt selektive binding til svampecellernes cytokrom P-450isoenzymer.
English: Therefore if suspected adverse reactions such as emesis, anorexia or weight loss occur, the dose should be lowered, or treatment with the medicinal product should be discontinued.
Danish: Derfor, hvis formodede bivirkninger, såsom emesis, anoreksi eller vægttab opstår, bør dosis derfor nedsættes, eller lægemidlet seponeres.
English: 5 to 10 mg (0.5 ml to 1 ml) itraconazole per kg bodyweight per day for 8 weeks.
Danish: 5-10 mg (0,5 ml til 1 ml) itraconazol pr. kg kropsvægt pr. dag i 8 uger.
English: If suspected lesions (such as the occurrence of cutaneous nodules or erythematous papules, respiratory symptoms such as coughing and wheezing) occur in humans, consult a physician.
Danish: Ved suspekte forandringer (såsom kutane noduli eller erytematøse papler eller luftvejssymptomer såsom hoste eller hvæsende vejrtrækning) bør der søges læge.
English: A graduated polypropylene oral syringe is also included.
Danish: Der medfølger en polypropylen oral sprøjte med målestreger.
English: Therefore if suspected adverse reactions related to this medicine, such as vomiting, loss of appetite or weight loss occur, the dose should be lowered, or treatment with the medicinal product should be discontinued.
Danish: Ved mistanke om lægemiddelrelaterede bivirkninger, såsom opkastning, appetitløshed eller vægttab, bør dosis derfor nedsættes eller behandlingen ophøre.
English: No information on overdose is currently available in the target species.
Danish: Der foreligger på nuværende tidspunkt ingen oplysninger om overdosering hos dyrearterne, som veterinærlægemidlet er beregnet til.
English: Av Herrmann Debrouxlaan 17 B 1160 Oudergem- Brussels Tel.: 0032-27344899
Danish: Av Herrmann Debrouxlaan 17 B 1160 Oudergem- Bruxelles Tlf .
English: Although the relevance of this information for the target species (ornamental birds) is unknown, it is wise to avoid the use of such substances together with this product because an increase and/or a prolongation of their pharmacological effects, including side effects, may occur.
Danish: Det vides ikke, hvilken betydning dette har for dyrearterne (prydfugle), som veterinærlægemidlet er beregnet til, men det tilrådes at undgå at anvende sådanne stoffer sammen med produktet, da dette kan medføre, at virkningerne af disse lægemidler, herunder bivirkningerne, bliver forstærket eller mere langvarige.
English: No information on overdose is currently available in the target species (see section 4.6.
Danish: Der foreligger på nuværende tidspunkt ingen oplysninger om overdosering hos dyrearterne, som veterinærlægemidlet er beregnet til (se pkt.
English: In birds, itraconazole plasma concentrations vary with the type of bird.
Danish: Hos fugle afhænger plasmakoncentrationen af itraconazol af fuglearten.
English: Av. Herrmann-Debrouxlaan 17 B 1160 Oudergem- Brussels Tel.: 0032-27344899
Danish: Av. Herrmann-Debrouxlaan 17 B 1160 Oudergem- Bruxelles Tlf .
English: Aspergillosis:
Danish: Aspergillose:
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Væsentlige uforligeligheder: Dette lægemiddel må ikke blandes med andre lægemidler, da der ikke er udført forligelighedsundersøgelser.
English: Itraconazole elimination may be a saturable process.
Danish: Udskillelsen af itraconazol kan udvise mætningskinetik.
English: 10 ml including oral syringe 50 ml including oral syringe
Danish: 50 ml herunder oral sprøjte.
English: For the treatment of African Grey Parrots (see section “Special warnings”) use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day.
Danish: Til afrikanske grå papegøjer (se afsnittet “Særlige advarsler”) må der højst anvendes 5 mg (0,5 ml) itraconazol pr. kg kropsvægt pr. dag.
English: For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section “Special warnings”).
Danish: Til behandling af afrikanske grå papegøjer må der ikke anvendes over 5 mg (0,5 ml) itraconazol pr. kg kropsvægt pr. dag i 14 dage (se afsnittet ”Særlige advarsler”).
English: Outer carton
Danish: Karton
English: Laboratory animal studies have shown that when itraconazole is used together with amphotericin B it may be antagonistic against Aspergillus spp.
Danish: Dyreforsøg i laboratoriet har vist, at når itraconazol anvendes sammen med amphotericin B, kan det have modsat virkning på svampe af slægterne Aspergillus og Candida; den kliniske betydning heraf er uklar.
English: Fungitraxx 10 mg/ml oral solution itraconazole
Danish: Fungitraxx, oral opløsning, 10 mg/ml Itraconazol
English: Laboratory studies in pregnant rats administered high dosages (40 and 160 mg/kg bodyweight daily for 10 days) have shown evidence of dose-related harmful effects to the pregnant rat and to the embryo/foetus.
Danish: Laboratorieforsøg med drægtige rotter har vist tegn på dosisafhængig skadelig virkning på drægtige rotter og deres fostre ved høje doser (40 og 160 milligram pr. kg kropsvægt indgivet dagligt i 10 dage).
English: Therefore co-administration of this product with other veterinary medicinal products should be avoided.
Danish: Derfor bør det ikke anvendes sammen med andre veterinærlægemidler.
English: Floris Veterinaire Produkten B.V. Kempenlandstraat 33
Danish: Floris Veterinaire Produkten B.V.
English: For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section 4.5).
Danish: Til afrikanske grå papegøjer må der ikke anvendes over 5 mg (0,5 ml) itraconazol pr. kg kropsvægt pr. dag i 14 dage (se pkt.
English: Lot {number}
Danish: Batch{nummer}
English: Yellow to slightly amber, clear solution.
Danish: Oral opløsning Gul til let ravgul, klar opløsning.
English: 6-8 88326 Aulendorf Tel.: 0049-7525205-71
Danish: 6-8 88326 Aulendorf Tlf .
English: Oral solution.
Danish: Oral opløsning
English: PACKAGE LEAFLET FOR: Fungitraxx 10 mg/ml oral solution for ornamental birds
Danish: INDLÆGSSEDDEL TIL: Fungitraxx, oral opløsning, 10 mg/ml, til prydfugle
English: If emesis, anorexia or weight loss occurs, then in the first instance it is advisable to lower the dose (see section 4.5) or treatment with the veterinary medicinal product should be discontinued.
Danish: Ved emesis, anoreksi eller vægttab tilrådes i første instans dosisreduktion (se pkt.
English: Fungitraxx 10 mg/ml oral solution for ornamental birds itraconazole
Danish: Fungitraxx, oral opløsning, 10 mg/ml, til prydfugle itraconazol
English: Fungitraxx 10 mg/ml oral solution for ornamental birds
Danish: Fungitraxx, oral opløsning, 10 mg/ml, til prydfugle
English: Ornamental birds
Danish: Prydfugle
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) navn Styrke
English: No other details were provided.
Danish: Der blev ikke angivet yderligere detaljer.
English: Excessive pressure
Danish: For højt tryk
English: Benefit Risk balance
Danish: Benefit/risk-forhold
English: Inappropriate distance from the tissue surface
Danish: Uhensigtsmæssig afstand til vævsoverfladen
English: As a result, gas embolism may occur even with a reduced pressure.
Danish: Der kan derfor opstå gasemboli selv ved reduceret tryk.
English: Tisseel and Tissucol differ in terms of Factor XIII content.
Danish: Tisseel og Tissucol har forskelligt indhold af faktor XIII.
English: The CHMP agreed that the DHPC should be circulated to all users of those products in Europe, no later than 15 January 2013.
Danish: CHMP bestemte, at denne direkte meddelelse udsendes til alle brugere af disse produkter i Europa senest den 15. januar 2013.
English: Tisseel/Tissucol and Artiss
Danish: Tisseel/Tissucol og Artiss
English: The experts unanimously agreed that the risk of air embolism is not related to the medicinal product itself but to the device design and its misuse in practice.
Danish: Eksperterne tilsluttede sig enstemmigt, at risikoen for luftemboli ikke hænger sammen med selve lægemidlet, man med anordningens udformning og fejlanvendelse i praksis.
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Danish: BILAG II VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRINGEN AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSERNE
English: This report only reflects the assessment of Tisseel/Tissucol, Artiss and Beriplast P.
Danish: Denne rapport omhandler kun vurderingen af Tisseel/Tissucol, Artiss og Beriplast P.
English: Artiss is only indicated for subcutaneous use.
Danish: Artiss er kun indiceret til subkutan anvendelse.
English: The CHMP therefore considered that correct administration of sprayable fibrin sealants is essential to reduce this risk and focused its assessment on the identification of measures that would be necessary and adequate to minimise this risk.
Danish: CHMP fandt derfor, at korrekt spraypåføring af fibrinklæbere er afgørende nødvendig for at nedsætte denne risiko, og fokuserede sin vurdering på foranstaltninger, der er nødvendige og tilstrækkelige til at minimere risikoen.
English: The CHMP also noted that there appears to be evidence for the need to use the combination spray sealants in situations where there is significant blood loss from a wide surface area and the survival of the patient is threatened.
Danish: CHMP bemærkede endvidere, at der synes at være evidens for behovet for anvendelse af kombinerede sprayklæbere i situationer, hvor der er betydeligt blodtab fra et større areal, og patientens overlevelse er truet.
English: In minimally invasive/laparoscopic procedures (Tisseel/Tissucol), only carbon dioxide gas should be used.
Danish: Ved minimalt invasive/laparoskopiske procedurer (Tisseel/Tissucol) bør der udelukkende anvendes kuldioxid.
English: It is not recommended for use in laparoscopic surgery.
Danish: Det anbefales ikke til brug ved laparoskopiske procedurer.
English: The CHMP also concluded the Article 20 review on Evicel.
Danish: CHMP foretog desuden en artikel 20-gennemgang af Evicel.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC fibrinogencontaining solutions for sealant authorised for administration by spray application;
Danish: • udvalget fulgte proceduren i henhold til artikel 31 i direktiv 2001/83/EF for fibrinogenholdige opløsninger, der er godkendt til anvendelse som vævsklæber ved spraypåføring,