FrancophonIA/ELRC3.0 huggingface dataset:
English: Mycamine is not recommended for use in patients who have severe problems with their liver, who have long-term liver disease or who are taking other medicines that could harm the liver or the DNA.
Danish: Mycamine anbefales ikke til brug hos patienter, som har svære leverproblemer, som har en langvarig leversygdom, eller som tager andre lægemidler, som kan skade leveren eller DNA.
English: What is the risk associated with Mycamine?
Danish: Hvilken risiko er der forbundet med Mycamine?
English: The CHMP decided that Mycamine's benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days.
Danish: CHMP vurderede, at Mycamines gavnlige virkninger er større end de risici, der er forbundet med stoffet til behandling af invasiv candidiasis og candidiasis i spiserøret og til profylakse af infektion med Candida hos patienter, som gennemgår allogen hæmatopoietisk stamcelletransplantation, eller som forventes at få neutropeni i 10 dage eller mere.
English: However due to a possible risk of liver tumour, based on results seen in rats, the Committee recommended that Mycamine should only be used if other antifungal medicines are not appropriate.
Danish: På grund af en mulig risiko for levertumor, baseret på resultater hos rotter, anbefalede udvalget dog, at Mycamine kun anvendes, hvis andre lægemidler mod svamp ikke er egnede.
English: Why has Mycamine been approved?
Danish: Hvorfor blev Mycamine godkendt?
English: Mycamine is a powder that is dissolved to make a solution for infusion (drip into a vein).
Danish: Mycamine er et pulver, som anvendes til at fremstille en infusionsopløsning (intravenøst drop).
English: Patients being treated for invasive candidiasis should receive Mycamine for at least two weeks, and for a week after symptoms have resolved and there are no signs of fungus in the blood.
Danish: Patienter, som behandles for invasiv candidiasis, skal have Mycamine i mindst to uger og i en uge efter, at symptomerne er svundet, og der ikke er tegn på svamp i blodet.
English: When Mycamine is used to prevent Candida infection, treatment should continue for one week after white blood cell counts have recovered.
Danish: Når Mycamine anvendes til at forhindre en Candida-infektion, skal behandlingen fortsætte i en uge efter, at niveauet af de hvide blodlegemer er steget til normalt niveau.
English: Additional common side effects in children (seen in between 1 and 10 children in 100) are thrombocytopenia (low blood platelet counts), tachycardia (rapid heart rate), hypertension (high blood pressure), hypotension (low blood pressure), hepatomegaly (enlarged liver), acute renal failure (sudden kidney failure) and increased blood urea levels.
Danish: Andre almindelige bivirkninger hos børn (der ses hos imellem 1 og 10 børn ud af 100) er trombocytopeni (lavt antal blodplader), takykardi (hurtig hjerterytme), hypertension (højt blodtryk), hypotension (lavt blodtryk), leverforstørrelse, akut nyresvigt og stigning i urinkvælstofniveau i blodet.
English: Because of a possible risk of liver tumours, Mycamine is only to be used if other antifungal medicines are not appropriate.
Danish: På grund af øget risiko for at udvikle levertumorer, må Mycamine kun anvendes, hvis andre midler mod svampeinfektioner ikke er egnede.
English: In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
Danish: I de to undersøgelser af candidiasis i spiserøret var behandlingen vellykket hos cirka 90% af de patienter, som fik Mycamine, fluconazole eller caspofungin.
English: For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in a study involving 531 adults and 106 children, including newborns and premature babies.
Danish: Til behandling af invasiv candidiasis blev Mycamine sammenlignet med amphotericin B i en undersøgelse med 531 voksne og 106 børn, herunder nyfødte og for tidligt fødte spædbørn.
English: Patients being treated for oesophageal candidiasis should continue to receive Mycamine for at least one week after symptoms have resolved.
Danish: Patienter, som behandles for candidiasis i spiserøret, skal fortsætte med at få Mycamine i mindst en uge efter, at symptomerne er forsvundet.
English: For the full list of all side effects reported with Mycamine, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Mycamine fremgår af indlægssedlen.
English: The list of fungi against which Mycamine is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: Listen over svampe, som Mycamine er aktiv over for, fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: Mycamine is also used to treat candidiasis in the oesophagus (gullet) in patients over 16 years of age for whom intravenous treatment is suitable.
Danish: Mycamine anvendes også til behandling af candidiasis i spiserøret hos patienter, som er fyldt 16 år, og som er egnede til intravenøs behandling.
English: For the prevention of candidiasis, Mycamine was compared with fluconazole in 889 adults and children undergoing a bone marrow transplant.
Danish: Til forebyggelse af candidiasis blev Mycamine sammenlignet med fluconazole hos 889 voksne og børn, som gennemgik knoglemarvstransplantation.
English: In the study of invasive candidiasis, around 90% of the adults receiving either Mycamine or amphotericin B were successfully treated.
Danish: I undersøgelsen af invasiv candidiasis var behandlingen vellykket hos cirka 90 % af de voksne, som fik enten Mycamine eller amphotericin B. Der blev observeret lignende resultater hos børn.
English: For the treatment of oesophageal candidiasis, Mycamine was compared with fluconazole in a study involving 518 adults, and with caspofungin in another study involving 452 adults.
Danish: Til behandling af candidiasis i spiserøret blev Mycamine sammenlignet med fluconazol i en undersøgelse med 518 voksne og med caspofungin i en anden undersøgelse med 452 voksne.
English: What is Mycamine?
Danish: Hvad er Mycamine?
English: Mycamine was more effective than fluconazole in preventing fungal infection in patients undergoing a bone marrow transplant: 80% of the patients (340 out of 425) receiving Mycamine did not develop a fungal infection, compared with 74% of the patients (336 out of 457) receiving fluconazole.
Danish: udviklede ikke svampeinfektion sammenlignet med 74 % af patienterne (336 af 457), som fik fluconazole.
English: How has Mycamine been studied?
Danish: Hvordan blev Mycamine undersøgt?
English: What is Mycamine used for?
Danish: Hvad anvendes Mycamine til?
English: What benefit has Mycamine shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Mycamine?
English: How is Mycamine used?
Danish: Hvordan anvendes Mycamine?
English: How does Mycamine work?
Danish: Hvordan virker Mycamine?
English: Blister (aluminium/PVC/PVDC)
Danish: Blister (alu/PVC/PVDC)
English: 500 mg Film-coated tablet
Danish: 500 mg Filmovertrukket tablet Oral anvendelse
English: EU/1/18/1310/001
Danish: EU/1/18/1310/001 Deferiprone Lipomed
English: Immediate packaging
Danish: Emballage
English: Oral use
Danish: Styrke
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31/07/2014
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 31/07/2014
English: Avoid accidental contact to the dog's eyes.
Danish: Undgå utilsigtet kontakt med hundens øjne.
English: These findings are considered reversible.
Danish: Disse fund anses for at være reversible.
English: ATC-vet code: QS02CA90.
Danish: ATCvet-kode: QS02CA90.
English: EU/2/14/170/0001 (2 tubes) EU/2/14/170/0002 (12 tubes) EU/2/14/170/0003 (20 tubes) EU/2/14/170/0004 (40 tubes)
Danish: EU/2/14/170/0001 (2 tuber) EU/2/14/170/0002 (12 tuber) EU/2/14/170/0003 (20 tuber) EU/2/14/170/0004 (40 tuber)
English: Date of last renewal:
Danish: Dato for sidste fornyelse:
English: Administer one tube per infected ear.
Danish: Anvend én tube pr. inficeret øre.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.2 g) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 dosis (1,2 g) indeholder:
English: Instructions for proper use:
Danish: Instruktioner til korrekt anvendelse:
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 oC - 8 oC).
English: Inflammation can increase the percutaneous absorption of veterinary medicinal products.
Danish: Inflammation kan øge den perkutane absorption af veterinærlægemidler.
English: Additional corticosteroid treatments should be avoided.
Danish: Yderligere behandlinger med kortikosteroider skal undgås.
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN <{MM/ÅÅÅÅ}> <{DD/MM/ÅÅÅÅ}> <{DD måned ÅÅÅÅ}>
English: Repeat the administration after 7 days.
Danish: Gentag behandlingen efter 7 dage.
English: Propylene carbonate Glycerol formal
Danish: Propylencarbonat Glycerolformal
English: Absorption occurred primarily during the first two to four days after administration, with low plasma concentrations (1 to 42 ng/ml) of active substances.
Danish: Absorption forekom hovedsageligt i løbet af de første to til fire dage efter administrering, med lave plasmakoncentrationer (1 til 42 ng/ml) af de aktive stoffer.
English: 2 tubes 12 tubes 20 tubes 40 tubes
Danish: 2 tuber 12 tuber 20 tuber 40 tuber
English: This observation is attributed to presence of product and is not of clinical concern.
Danish: Denne observation tilskrives tilstedeværelsen af produktet og har ingen klinisk betydning.
English: The safety of the product has not been established in dogs less than 2 months of age or weighing less than 1.4 kg.
Danish: Produktets sikkerhed er ikke fastlagt i hunde, der er under 2 måneder gamle eller vejer under 1,4 kg.
English: Open the tube by twisting the soft tip.
Danish: Åbn tuben ved at dreje den bløde spids.
English: Accidental eye exposure may occur when the dog shakes its head during or just after administration.
Danish: Utilsigtet kontakt med øjnene kan forekomme, når hunden ryster på hovedet under eller lige efter administrering.
English: In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Danish: I tilfælde af parasitær otitis, skal passende acaricidal behandling implementeres.
English: The veterinary medicinal product may be irritating to eyes.
Danish: Veterinærlægemidlet kan være irriterende for øjnene.
English: Additionally, dogs showed slightly elevated red blood cell count, hematocrit, total protein, albumin and alanine aminotransferase.
Danish: Desuden udviste hundene let forhøjet antal røde blodlegemer, hæmatokrit, total protein, albumin og alaninaminotransferase.
English: Cardboard box containing 2, 12, 20 or 40 tubes (each tube containing 2.05 g of product of which a single dose of 1.2 g can be extracted).
Danish: Karton med 2, 12, 20 eller 40 tuber (hver tube indeholder 2,05 g produkt, hvoraf en enkelt dosis på 1,2 g kan udtages).
English: The formulation dissolves in ear wax and is slowly eliminated from the ear mechanically.
Danish: Formuleringen opløses i ørevoks og elimineres langsomt og mekanisk fra øret.
English: These findings were not associated with clinical signs.
Danish: Disse fund var ikke forbundet med kliniske tegn.
English: Terbinafine is an allylamine with a pronounced fungicidal activity.
Danish: Terbinafin er et allylamin med udtalt fungicid aktivitet.
English: Whenever possible the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.
Danish: Anvendelsen af veterinærlægemidlet bør så vidt muligt baseres på identifikation af infektionsorganismer og følsomhedstest.
English: Do not use in dogs with generalised demodicosis.
Danish: Skal ikke anvendes til hunde med generaliseret demodicose.
English: To avoid this risk for the owners, it is recommended that this veterinary product is administered only by veterinarians or under their close supervision.
Danish: For at undgå denne risiko for ejerne, anbefales det, at veterinærlægemidlet kun administreres af dyrlæger eller under deres nøje tilsyn.
English: Systemic absorption of all active substances was determined in multiple-dose studies after placing the veterinary medicinal product into both ear canals of healthy mixed breed dogs.
Danish: Den systemiske absorption af alle aktive stoffer blev fastlagt i multidosisstudier efter påføring af lægemidlet i begge øregange på raske hunde af blandet race.
English: Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo- or hyper-thyroid disease, etc.).
Danish: Anvendes med forsigtighed til hunde med formodet eller bekræftet endokrin lidelse (f.eks. diabetes mellitus, hypo- eller hyperthyroidisme osv.).
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 lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: In very rare cases, eye disorders such as keratoconjunctivitis sicca and corneal ulcers have been reported in treated dogs, in absence of eye contact with the product.
Danish: I meget sjældne tilfælde er øjensygdomme som keratokonjunctivitis sicca og hornhindesår blevet rapporteret hos behandlede hunde, uden at der har været øjenkontakt med produktet.
English: Apply the product into the ear canal by pressing it between two fingers.
Danish: Påfør produktet i øregangen ved at trykke på tuben med to fingre.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelse af den pågældende batch.
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis.
Danish: Florfenicol er et bakteriostatisk antibiotikum, der virker ved at hæmme proteinsyntesen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Tube
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Tube
English: Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners, other than saline, has not been demonstrated.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Der er ikke påvist forligelighed med andre ørerensemidler end saltvand.
English: The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Danish: Omfanget af perkutan absorption af topikale lægemidler bestemmes af mange faktorer, herunder tilstanden af den epidermale barriere.
English: These findings don't affect hearing and are reversible.
Danish: Disse tegn påvirker ikke hørelsen og er reversible.
English: The finding was not correlated with pathological or clinical signs and was reversible.
Danish: Denne observation hang ikke sammen med patologiske eller kliniske tegn og var reversibel.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: Transient wetness of the inner and outer pinna can be observed.
Danish: Forbigående fugtighed på indre og ydre pinna kan ses.
English: In case of accidental skin contact, wash exposed skin thoroughly with water.
Danish: I tilfælde af utilsigtet hudkontakt, vask udsat hud grundigt med vand.
English: The maximum clinical response may not be seen until 21 days after the second administration.
Danish: Det maksimale kliniske respons ses måske først 21 dage efter den anden behandling.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Fertility: Do not use in breeding animals.
Danish: Fertilitet: Skal ikke bruges til avlsdyr.
English: Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Danish: Egnede foranstaltninger (f.eks. brug af sikkerhedsbriller under administrering, grundig massering af ørekanalen efter administrering for at sikre jævn fordeling af produktet, fastholdelse af hunden efter administrering) er nødvendige for at undgå kontakt med øjnene.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Due to the high antimicrobial concentrations achieved in the ear canal and the multifactorial nature of otitis externa, in vitro susceptibility may not be directly correlated with clinical success.
Danish: På grund af de høje antimikrobielle koncentrationer, der opnås i øregangen, og den multifaktorielle karakter af otitis externa er følsomheden in vitro ikke nødvendigvis forbundet med den kliniske virkning.
English: Pharmacotherapeutic group: Otologicals - Corticosteroids and anti-infectives in combination.
Danish: Farmakoterapeutisk gruppe: Otologika - kortikosteroider og antiinfektiva i kombination.
English: Butylhydroxytoluene (E 321) Hypromellose
Danish: Butylhydroxytoluen (E 321) Hypromellose Lecithin
English: Auricular administration of five times the recommended dose, one week apart, for 5 consecutive weeks (a total six administrations of 5 tubes per ear or 10 tubes per dog) to mixed breed dogs weighing 10 to 14 kg resulted in clinical signs of wetness of the inner and outer pinna (attributed to presence of the product).
Danish: Anvendelse i øret med fem gange den anbefalede dosis med 1 uges mellemrum i 5 uger i træk (i alt seks indgivelser á 5 tuber pr. øre eller 10 tuber pr. hund) til hunde af blandet race, der vejede 10 til 14 kg, medførte kliniske tegn på fugtighed på indre og ydre pinna (tilskrives tilstedeværelsen af produktet).
English: Bacterial and fungal otitis is often secondary to other conditions.
Danish: Bakteriel otitis og otomykose opstår ofte sekundært til andre tilstande.
English: If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.
Danish: Hvis der opstår overfølsomhed over for nogen af indholdsstofferne, bør ørerne vaskes grundigt.
English: Appropriate diagnosis should be used and therapy of causative conditions should be investigated before antimicrobial treatment is considered.
Danish: En diagnose bør stilles, og årsagsbehandling bør undersøges, inden antimikrobiel behandling overvejes.
English: Introduce this flexible soft tip into the ear canal.
Danish: Før den fleksible, bløde spids ind i øregangen.
English: In clinical trials, saline only was used for ear cleaning.
Danish: I kliniske forsøg blev der kun brugt saltvand til rensing af ørerne.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 8 µg/ml).
Danish: Dets aktivitetsspektrum omfatter Gram-positive og Gram-negative bakterier inklusiv Staphylococcus pseudintermedius (MIC90 på 8 µg/ml).
English: It is recommended to clean and dry the external ear canal before the first administration of the product.
Danish: Det anbefales at rense og tørre den ydre øregang inden første anvendelse af produktet.
English: There were no clinical signs associated with unilateral vesicle formation within the epithelium of the tympanic membrane (also observed after six administrations, one week apart, of 1 tube per ear or 2 tubes per dog), unilateral mucosal ulceration in the lining of the middle ear cavity, or decrease in serum cortisol response below normal reference range in ACTH stimulation testing.
Danish: Der var ingen kliniske tegn forbundet med ensidig vesikeldannelse i trommehindens epitel (også observeret efter seks indgivelser med 1 uges mellemrum á 1 tube pr. øre eller 2 tuber pr. hund), ensidig slimhindeulceration i mellemørekavitetens hinde eller fald i serumkortisol-responset til under det normale referenceområde inden for ACTH-stimuleringstesten.
English: Terbinafine has a different mode of action than azole antifungals, therefore there is no cross resistance with azole antifungals.
Danish: Terbinafin har en anden virkningsmekanisme end azolantimykotika, og der er derfor ingen krydsresistens med azolantimykotika.
English: This product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Danish: Dette produkt er en fast kombination af tre aktive stoffer: antibiotikum, antimykotikum og kortikosteroid.
English: Florfenicol:
Danish: Florfenicol (Florfenicolum):
English: Betamethasone acetate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which relieves both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Danish: Betamethasonacetat tilhører diester-klassen af glukokortikosteroider med en potent intrinsisk glukokortikoid aktivitet, der lindrer både inflammation og pruritus og fører til en bedring af de kliniske tegn, der observeres i forbindelse med otitis externa.
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that betamethasone is absorbed and enters the systemic circulation.
Danish: I tolerance studier (før og efter ACTH stimulation) blev der observeret formindskede niveauer af cortisol efter inddrypning af produkt, hvilket indikerer, at betamethason bliver absorberet og går ind i den systemiske cirkulation.
English: Betamethasone is known to be teratogenic in laboratory species.
Danish: Det er kendt, at betamethason er teratogent i laboratoriedyr.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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)
English: Do not use in pregnant or breeding animals (see section 4.7).
Danish: Skal ikke anvendes til drægtige dyr eller avlsdyr (se pkt 4.7).
English: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, France
Danish: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, Frankrig
English: In animals with a history of chronic or recurrent otitis externa, efficacy of the product may be affected if the underlying causes of the condition such as allergy or anatomical conformation of the ear are not addressed.
Danish: Hos dyr med tidligere kronisk eller tilbagevendende otitis externa, kan effekten af produktet blive påvirket, hvis der ikke er taget højde for de underliggende årsager til tilstanden, såsom allergi eller ørets anatomi.