FrancophonIA/ELRC3.0 huggingface dataset:
English: The Member States shall discuss and agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational material.
Danish: Medlemslandene skal drøfte og fastlægge indholdet og formatet af undervisningsmaterialet samt en kommunikationsplan med den kompetente nationale myndighed forud for distribution af undervisningmaterialet.
English: In addition, some previous infections may reappear.
Danish: Desuden skal der gøres opmærksom på at tidligere infektioner kan blusse op igen.
English: The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA and sJIA, targeting all physicians who are expected to prescribe/use RoActemra containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal udlevere en undervisningspakke, som dækker de terapeutiske indikationer RA og sJIA, til alle læger, som forventes at skulle udskrive/anvende RoActemra.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER, SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENE, MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • The product should not be given to patients with active or suspected infection
Danish: • Produktet bør ikke administreres til patienter med aktiv infektion eller mistanke om infektion
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger, som er beskrevet nedenfor med hensyn til sikker og effektiv anvendelse af lægemidlet, er implementeret:
English: • Patient Alert Card - to address the risk of getting infections which can become serious if not treated.
Danish: • Patientkort - til at gøre opmærksom på risikoen for at få infektioner, som kan blive alvorlige, hvis de ikke behandles.
English: - to address the risk that patients using RoActemra may develop complications of diverticulitis which can become serious if not treated.
Danish: - til at gøre opmærksom på risikoen for at patienter, som får RoActemra, kan udvikle komplikationer til diverticulitis og at disse komplikationer kan blive alvorlige, hvis de ikke behandles.
English: • Dose calculation (RA and sJIA patients), preparation of infusion and infusion rate
Danish: • Dosisberegning (RA- og sJIA-patienter), fremstilling af infusionen og infusionshastigheden
English: • Prevention of medical errors and infusion reactions
Danish: • Forebyggelse af medicinske fejl og infusionsreaktioner
English: • Recommendations for dose interruptions in sJIA patients
Danish: • Anbefalinger vedrørende afbrydelse af dosering hos sJIA-patienter
English: • Diagnosis of Macrophage Activation Syndrome in sJIA patients
Danish: • Diagnosticering af makrofag-aktiveringssyndrom hos sJIA-patienter
English: • Serious infusion reaction and their management
Danish: • Alvorlige infusionsreaktioner og deres håndtering
English: • Monitoring of the patient for infusion reactions
Danish: • Monitorering af infusionsreaktioner hos patienten
English: • Preparation of infusion
Danish: • Fremstilling af infusionen
English: The Physician Information Pack should contain the following key elements:
Danish: Informationsmaterialet til lægen skal indeholde følgende nøgleelementer:
English: • Patient Information Leaflet
Danish: • Informationsmateriale til patienten
English: This is a summary of the European public assessment report (EPAR) for Kinzalkomb.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kinzalkomb.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalkomb on 19 April 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kinzalkomb den 19. april 2002.
English: A risk management plan has been developed to ensure that Kinzalkomb is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Kinzalkomb anvendes så sikkert som muligt.
English: Kinzalkomb is taken by mouth once a day with liquid, with or without food.
Danish: Kinzalkomb indtages gennem munden en gang dagligt med væske enten med eller uden føde.
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 Kinzalkomb.
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, hvordan Kinzalkomb skal anvendes.
English: Kinzalkomb must not be used in women who are more than three months pregnant.
Danish: Kinzalkomb må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten.
English: What measures are being taken to ensure the safe and effective use of Kinzalkomb?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kinzalkomb?
English: Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Danish: Kinzalkomb blev undersøgt i fem hovedundersøgelser med deltagelse af i alt 2 985 patienter med mild til moderat hypertension.
English: The most common side effect with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness.
Danish: Den mest almindelige bivirkning ved Kinzalkomb (som ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kinzalkomb, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Kinzalkomb, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: What is the risk associated with Kinzalkomb?
Danish: Hvilken risiko er der forbundet med Kinzalkomb?
English: By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Danish: Ved at nedsætte blodtrykket mindskes de risici, som er forbundet med højt blodtryk, såsom slagtilfælde.
English: Kinzalkomb telmisartan / hydrochlorothiazide
Danish: Telmisartan/hydrochlorothiazid
English: It is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Danish: Det fås som tabletter (40 mg eller 80 mg telmisartan og 12,5 mg hydrochlorothiazid; 80 mg telmisartan og 25 mg hydrochlorothiazid).
English: The CHMP decided that Kinzalkomb's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Danish: CHMP vurderede, at fordelene ved Kinzalkomb er større end risiciene til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
English: In four of these studies, Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Danish: I fire af disse undersøgelser (2 272 patienter) blev Kinzalkomb sammenlignet med placebo (en uvirksom behandling) og med telmisartan taget alene.
English: The Committee recommended that Kinzalkomb be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Kinzalkomb.
English: Other information about Kinzalkomb
Danish: Andre oplysninger om Kinzalkomb
English: Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Danish: Kinzalkomb må heller ikke anvendes hos personer, der har alvorlige lever-, nyre- eller galdesygdomme, eller som har for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Kinzalkomb.
Danish: Tabletterne med 80/25 mg anvendes til patienter, hvis blodtryk ikke kan kontrolleres med 80/12,5 mg-tabletterne, eller som er blevet stabiliseret ved hjælp af de to aktive stoffer indtaget separat, inden de skiftede til Kinzalkomb.
English: Why has Kinzalkomb been approved?
Danish: Hvorfor blev Kinzalkomb godkendt?
English: Care must be taken when using Kinzalkomb with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når Kinzalkomb anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: Kinzalkomb contains two active substances, telmisartan and hydrochlorothiazide.
Danish: Kinzalkomb indeholder to aktive stoffer, telmisartan og hydrochlorothiazid.
English: Kinzalkomb is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Danish: Kinzalkomb anvendes til patienter med essentiel hypertension (højt blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af telmisartan alene.
English: Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Danish: Kinzalkomb er et lægemiddel, som indeholder de to aktive stoffer telmisartan og hydrochlorothiazid.
English: What is Kinzalkomb?
Danish: Hvad er Kinzalkomb?
English: Kinzalkomb was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Danish: Kinzalkomb var mere effektivt end placebo og telmisartan alene til at reducere det diastoliske blodtryk.
English: The full EPAR for Kinzalkomb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Kinzalkomb findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Hvis du ønsker yderligere oplysninger om behandling med Kinzalkomb, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalkomb must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Danish: Kinzalkomb i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), må heller ikke anvendes til patienter med type 2 diabetes eller til patienter med moderat eller alvorlig nyresygdom.
English: For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Kinzalkomb fremgår af indlægssedlen.
English: The dose of Kinzalkomb to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Danish: Patienter, som fik 40 mg telmisartan, skal tage 40/12,5 mg-tabletterne, og patienter, der fik 80 mg telmisartan, skal tage 80/12,5 mg-tabletterne.
English: How has Kinzalkomb been studied?
Danish: Hvordan blev Kinzalkomb undersøgt?
English: What is Kinzalkomb used for?
Danish: Hvad anvendes Kinzalkomb til?
English: How does Kinzalkomb work?
Danish: Hvordan virker Kinzalkomb?
English: How is Kinzalkomb used?
Danish: Hvordan anvendes Kinzalkomb?
English: What benefit has Kinzalkomb shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Kinzalkomb?
English: Avoid skin contact.
Danish: Undgå hudkontakt.
English: Most of the absorption occurred in the first few days after administration.
Danish: Hovedparten af absorptionen skete inden for de første dage efter behandlingen.
English: Interaction with other medicinal products and other forms of interaction: No data available.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Der er ingen tilgængelige data.
English: Date of last renewal: 23/06/2013
Danish: Dato for seneste fornyelse: 23/06/2013
English: Treatment should continue for 7 consecutive days.
Danish: Behandlingen skal fortsættes i 7 på hinanden følgende dage.
English: The underlying cause should be identified and treated.
Danish: Den tilgrundliggende årsag bør diagnosticeres og behandles.
English: Plasticised hydrocarbon gel (5% polyethylene in 95% mineral oil)
Danish: Plastificeret kulhydratgel (5% polyethylen i 95% mineralolie)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/06/2008
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 23/06/2008
English: Therefore do not use in animals less than 4 months of age.
Danish: Må derfor ikke anvendes til dyr under 4 måneder.
English: Mometasone furoate (as monohydrate)
Danish: Mometasonfuroat (som monohydrat)
English: Inflammation can increase the percutaneous absorption of veterinary medicinal products.
Danish: Inflammation kan øge den perkutane absorption af veterinærmedicinske lægemidler.
English: ATC vet code: QS02CA91
Danish: ATC-vet-kode: QS02CA91
English: Vet Pharma Friesoythe Sedelsberger Straße 2 26169 Friesoythe Germany
Danish: Vet Pharma Friesoythe Sedelsberger Strasse 2 26169 Friesoythe Tyskland
English: Such impairment disrupts replication of the bacterial cell, leading to rapid cell death.
Danish: Denne hæmning forstyrrer replikationen af bakteriecellen, hvilket fører til en hurtig celledød.
English: In case of accidental exposure, rinse the affected area with copious quantities of water.
Danish: I tilfælde af utilsigtet eksponering skylles det berørte område med rigelige mængder vand.
English: Mild erythematous lesions have been observed.
Danish: Der er set milde erytematøse læsioner.
English: Mometasone furoate is a corticosteroid with high topical potency but little systemic effect.
Danish: Mometasonfuroat er et kortikosteroid med høj topikal potens, men med lav systemisk effekt.
English: Wash hands carefully after applying the veterinary medicinal product.
Danish: Vask omhyggeligt hænderne efter håndtering af lægemidlet.
English: The rapidity and extent of killing are directly proportional to the drug concentration.
Danish: Hastigheden og omfanget af celledøden er direkte proportional med koncentrationen af lægemidlet.
English: The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Danish: Graden af perkutan absorption af topikale lægemidler bestemmes af mange faktorer, inklusive integriteten af den epidermale barriere.
English: See section 4.10..
Danish: Se pkt.4.10.
English: One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole.
Danish: En dråbe indeholder 267 µg orbifloxacin, 27 µg mometasonfuroat og 27 µg posaconazol.
English: Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Danish: Fluorokinoloner er kendt for at krydse placenta og blive distribueret til mælken.
English: Do not use after the expiry date, which is stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten.
English: The external ear canal should be meticulously cleaned and dried before treatment.
Danish: Den ydre øregang bør rengøres og tørres grundigt før behandling.
English: The in vitro activity of orbifloxacin against pathogens isolated from clinical cases of canine otitis externa in an EU field trial conducted in 2000 - 2001 was:
Danish: Orbifloxacins in vitro-aktivitet mod patogener, der er isolerede fra kliniske tilfælde af otitis externa hos hunde, der indgik i et feltforsøg i EU i 2000-2001, var:
English: Pharmacotherapeutic group: Otologic - Corticosteroids and anti-infectives in combination.
Danish: Farmakoterapeutisk gruppe: Otologisk- kortikosteroider og antiinfektive midler i kombination.
English: Mometasone furoate
Danish: Mometasonfuroat
English: Posaconazole is 40 - 100 times more potent in vitro against Malassezia pachydermatis than clotrimazole, miconazole and nystatin.
Danish: Posaconazol er 40-100 gange mere potent in vitro mod Malassezia pachydermatis sammenlignet med clotrimazol, miconazol og nystatin.
English: No data available..
Danish: Ingen tilgængelige oplysninger.
English: Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin.
Danish: Studier på hvalpe har vist arthropatier efter systemisk administration af orbifloxacin.
English: The use of auricular preparations may be associated with hearing impairment, usually temporary, and primarily in geriatric dogs.
Danish: Brugen af øredråber kan være associeret med nedsat hørelse, sædvanligvis forbigående og oftest hos geriatriske hunde.
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed eller laktation
English: White HDPE bottle with a white LDPE cap, a natural or white LDPE applicator and a sheath.
Danish: Hvid HDPE-flaske med en hvid LDPE-hætte, en ufarvet eller hvid applikator og en forsegling.
English: Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of treatment will result in a complete return to normal adrenal response.
Danish: Administration af den anbefalede dosis (4 dråber pr. øre) 5 gange dagligt i 21 på hinanden følgende dage til hunde, der vejede 7,6 til 11,4 kg, medførte let nedgang i serum-kortisol-responset efter indgift af adrenokortikotropt hormon (ACTH) i en ACTH-stimulationstest.
English: Use of the product should be based on susceptibility testing of isolated bacteria, and/or other appropriate diagnostic tests.
Danish: Anvendelsen af præparatet bør baseres på følsomhedsbestemmelse af isoleret bakterie og/eller andre hensigtsmæssige diagnostiske metoder.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Læs indlægssedlen inden brug
English: Do not use during the whole or part of the pregnancy.
Danish: Må ikke anvendes under hele eller en del af drægtigheden.
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Danish: Inden lægemidlet appliceres, skal den ydre øregang omhyggeligt inspiceres for at sikre, at trommehinden ikke er perforeret, for at undgå risikoen for overførsel af infektionen til mellemøret og forebygge skade på høre- og ligevægtsapparatet.
English: Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted.
Danish: Der er ikke udført studier til bestemmelse af orbifloxacins effekt på fertiliteten hos hunde.
English: packl sizes: 8.8 mL (7.5 g), 17.5 mL (15 g) and 35.1 mL (30 g)
Danish: Pakningsstørrelser: 8,8 ml (7,5 g); 17,5 ml (15 g) og 35,1 ml (30 g)
English: Posaconazole is a broad-spectrum triazole antifungal agent.
Danish: Posaconazol er et bredspektret triazol- antimykotiskt middel.
English: Systemic absorption of the active ingredients was determined in single-dose studies with [14C]orbifloxacin, [3H]-mometasone furoate and [14C]-posaconazole contained within the Posatex formulation and placed into the ear canals of normal Beagle dogs.
Danish: Systemisk absorption af de aktive stoffer blev bestemt ved enkeltdosis-studier med [14C]-orbifloxacin, [3H]-mometasonfuroat og [14C]-posaconazol i en Posatex-formulering og placeret i øregangen på normale beaglehunde.
English: Like other topical corticosteroids, it has anti-inflammatory and anti-pruritic properties.
Danish: Det har som andre topikale kortikosteroider antiinflammatoriske og kløestillende egenskaber.
English: Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Danish: Ensidig anvendelse af en enkelt klasse af antibiotika kan medføre udvikling af resistens hos en bakteriepopulation.
English: Pregnancy: Do not use during the whole or part of the pregnancy.
Danish: Drægtighed: Må ikke anvendes under hele eller en del af drægtigheden.
English: Malassezia pachydermatis resistance to azoles, including posaconazole, has not been reported.
Danish: Der er ikke rapporteret om resistens hos Malassezia pachydermatis mod azoler, herunder posaconazol.
English: Minimum Inhibitory Concentrations vs. Orbifloxacin - Summary Pathogen
Danish: Minimum Inhibitory Concentrations for Orbifloxacin - Oversigt Patogen
English: Orbifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative organisms.
Danish: Orbifloxacin har in vitroaktivitet mod et bredt spektrum af grampositive og gramnegative bakterier.
English: 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 ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: SPECIAL STORAGE CONDITIONS Store in the original carton.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning.
English: PHARMACEUTICAL FORM Ear drops suspension White to off-white viscous suspension
Danish: LÆGEMIDDELFORM Øredråber, suspension Hvid til offwhite viskøs suspension
English: In in vitro tests, posaconazole has shown fungicidal activity against most of the approximately 7,000 strains of yeast and filamentous fungi tested.
Danish: I in vitroforsøg har posaconazol vist fungicid virkning mod de fleste af de ca. 7000 stammer af gærsvampe og filamentøse fungi, som er testet.
English: Cross-resistance across the fluoroquinolone class of antibiotics is common.
Danish: Krydsresistens mellem de forskellige fluorokinoloner er almindelig.
English: It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics.
Danish: Brugen af fluorokinoloner bør reserveres til behandling af de kliniske tilfælde, der har responderet dårligt eller kan forventes at ville respondere dårligt på anden antibiotikabehandling.
English: The mechanism by which posaconazole exerts fungicidal action involves the selective inhibition of the enzyme lanosterol 14-demethylase (CYP51) involved in ergosterol biosynthesis in yeasts and filamentous fungi.
Danish: Mekanismen, gennem hvilken posaconazol udøver sin fungicide effekt, er en selektiv hæmning af enzymet lanosterol 14-demetylase (CYP51), der er involveret i ergosterolbiosyntesen hos gærsvampe og filamentøse fungi.
English: Bacterial and fungal otitis is often secondary in nature.
Danish: Otitis, der er forårsaget af bakterier eller svampe, er ofte af sekundær natur.
English: Orbifloxacin is a synthetic broad-spectrum bactericidal agent classified as a quinolone carboxylic acid derivative, or more specifically, a fluoroquinolone.
Danish: Orbifloxacin er et syntetisk bredspektret antibiotikum, der er klassificeret som et fluorokinolonkarboxylsyre-derivat, eller mere specifikt, en fluorokinolon.