FrancophonIA/ELRC3.0 huggingface dataset:
English: Halocur should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Danish: Halocur må ikke hældes ud i vandløb, da det kan være farligt for fisk og andre vandlevende organismer.
English: Halocur can be used:
Danish: Halocur kan anvendes:
English: The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B.V. on 29 October 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Halocur til Intervet International B.V.
English: Halocur should be given after feeding.
Danish: Halocur skal gives, efter at dyret har indtaget føde.
English: Protective gloves should be worn while handling the product and hands should be washed after use.
Danish: Ved håndtering af produktet skal der anvendes beskyttelseshandsker, og hænderne skal vaskes bagefter.
English: The exact way halofuginone works is unknown.
Danish: Den nøjagtige måde, halofuginon virker på, er ukendt.
English: If eye irritation persists, medical advice should be sought.
Danish: Ved vedvarende øjenirritation skal der søges lægehjælp.
English: What is the risk associated with Halocur?
Danish: Hvilken risiko er der forbundet med Halocur?
English: Such symptoms can include diarrhoea, visible blood in the faeces, a decline in milk consumption, dehydration, apathy (lack of responsiveness), weakness and collapse.
Danish: Sådanne symptomer kan bestå i diarré, synligt blod i afføringen, nedsat dielyst, dehydrering, sløvhed, svaghed og kollaps.
English: A number of field trials were performed involving calves from different farms.
Danish: Der blev udført en række feltundersøgelser hos kalve fra forskellige landbrugsbesætninger.
English: In one trial, calves were included from 40 farms.
Danish: Den ene undersøgelse omfattede kalve fra 40 besætninger.
English: They recommended that Halocur be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Halocur.
English: People who handle Halocur repeatedly may develop skin allergies.
Danish: Personer, der håndterer Halocur gentagne gange, kan få hudallergi.
English: Why has Halocur been approved?
Danish: Hvorfor blev Halocur godkendt?
English: In all cases, Halocur is given to the calf by mouth after a feed, not on an empty stomach, once a day for seven consecutive days.
Danish: Halocur skal altid gives til kalven oralt efter fødeindtagelse, ikke på tom mave, én gang dagligt i syv på hinanden følgende dage.
English: Halocur should not be administered to calves in cases where diarrhoea has been established for more than 24 hours, or to weak animals.
Danish: Halocur bør ikke gives til kalve, som har fået konstateret diarré for over 24 timer siden, eller til svækkede dyr.
English: Halocur is presented as a clear, yellow solution for administration by mouth.
Danish: Halocur leveres som en klar, gul opløsning til oral indgift.
English: Early treatment in the first 24 to 48 hours after birth was shown to be most beneficial.
Danish: Størst gavnlig virkning opnåedes ved tidlig behandling de første 24 til 48 timer efter kælvning.
English: • to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with
Danish: • til forebyggelse af diarré på landbrugsbesætninger, hvor der tidligere har været cryptosporidiose (infektion med Cryptosporidium).
English: These studies compared treatment with Halocur to placebo.
Danish: I disse undersøgelser blev Halocur sammenlignet med placebo.
English: It was also shown to prevent diarrhoea following 11 days of treatment.
Danish: Det blev også påvist, at 11 dages behandling forebygger diarré.
English: • to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.
Danish: • til reduktion af diarré ved indgift senest 24 timer efter diarréens indsætten.
English: What is Halocur?
Danish: Hvad er Halocur?
English: Halocur contains the active substance halofuginone lactate, which is used against parasitic diseases caused by protozoa.
Danish: Halocur indeholder det aktive stof halofuginonlaktat, der anvendes mod parasitære sygdomme forårsaget af protozoer.
English: This contributes to the spread of the disease to other animals.
Danish: Gennem de udskilte oocyster spredes sygdommen til andre dyr.
English: Clinical signs of Cryptosporidium parvum infection are seen mainly as diarrhoea.
Danish: De kliniske tegn på infektion med Cryptosporidium parvum er hovedsagelig diarré.
English: How has Halocur been studied?
Danish: Hvordan blev Halocur undersøgt?
English: Treatment with the recommended dose of Halocur orally during 7 consecutive days, in calves aged from 4 to 10 days was shown to reduce diarrhoea compared to placebo.
Danish: Undersøgelsen viste, at oral indgift af Halocur i den anbefalede dosis hos fire til ti dage gamle kalve i syv på hinanden følgende dage mindsker forekomsten af diarré i forhold til placebo.
English: The active substance in Halocur, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Danish: Det aktive stof i Halocur, halofuginonlaktat, hæmmer væksten af Cryptosporidium parvum.
English: It also prevents it from forming oocysts, which are formed at a certain stage in the lifecycle of the parasite and are excreted (shed) in the faeces.
Danish: Det forhindrer også parasitten i at danne oocyster, dvs. befrugtede ægceller, der dannes på et bestemt stadium i parasittens livscyklus og udskilles i afføringen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Halocur outweigh the risks in the prevention and reduction of diarrhoea due to Cryptosporidium parvum in newborn calves.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Halocur opvejer risiciene ved behandling og forebyggelse af diarré forårsaget af Cryptosporidium parvum hos nyfødte kalve.
English: What is Halocur used for?
Danish: Hvad anvendes Halocur til?
English: Another trial of calves aged from 24 to 48 hours demonstrated that Halocur can prevent diarrhoea due to Cryptosporidium parvum compared with placebo.
Danish: En anden undersøgelse, der omfattede 24 til 48 timer gamle kalve, viste, at Halocur er bedre end placebo til at forebygge diarré forårsaget af Cryptosporidium parvum.
English: Halocur treatment was shown to reduce the level of excretion of Cryptosporidium parvum by the calves and to reduce diarrhoea.
Danish: Det blev påvist, at Halocur mindsker udskillelsen af Cryptosporidium parvum fra kalvene og reducerer diarré.
English: Halocur is used in newborn calves to prevent or reduce diarrhoea due to an organism called Cryptosporidium parvum.
Danish: Halocur anvendes hos nyfødte kalve til forebyggelse af diarré forårsaget af organismen Cryptosporidium parvum.
English: What benefit has Halocur shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Halocur?
English: How does Halocur work?
Danish: Hvordan virker Halocur?
English: Users should avoid skin and eye contact with the product and if such contact happens, they should wash the exposed area thoroughly with clean water.
Danish: Sker det alligevel, skal det pågældende sted vaskes grundigt med rent vand.
English: Symptoms of toxicity may occur if Halocur is administered at twice the recommended dose.
Danish: Hvis Halocur gives i en dosis på det dobbelte af den anbefalede, kan der opstå forgiftningssymptomer.
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system causing diarrhoea.
Danish: Den invaderer fordøjelsessystemet og fremkalder diarré.
English: Cryptosporidium), when it is given to newborn calves in the first 24 to 48 hours of life,
Danish: Det anvendes hos nyfødte kalve i de første
English: 1 pre-filled pen (single-dose)
Danish: 1 fyldt pen (enkeltdosis)
English: 1 pre-filled syringe (singledose)
Danish: 1 fyldt injektionssprøjte (enkeltdosis)
English: • Wash your hands.
Danish: • Vask dine hænder.
English: • Tilt your head back.
Danish: • Læn hovedet tilbage.
English: Ask your doctor for advice.
Danish: Spørg din læge til råds.
English: Uncommon abnormal dreams
Danish: Ikke almindelig abnorme drømme
English: Contact with soft contact lenses is to be avoided.
Danish: Kontakt med bløde kontaktlinser bør undgås.
English: • Make sure you have a mirror handy and wash your hands.
Danish: • Sørg for at du har et spejl tilgængeligt og vask dine hænder.
English: 6 OTHER
Danish: 6 ANDET
English: • Do not use EMADINE in children under the age of 3 years.
Danish: • Brug ikke Emadine til børn under 3 år.
English: • Get the EMADINE bottle and a mirror.
Danish: • Hent flasken med Emadine og et spejl.
English: It works by reducing the intensity of the allergic reaction.
Danish: Det virker ved at nedsætte den allergiske reaktions styrke.
English: After first opening a foil pouch: 7 days.
Danish: Efter første åbning af folieposen: 7 dage.
English: There are no adequate data from the use of emedastine in pregnant women.
Danish: Der er ikke tilstrækkelige data vedrørende brugen af emedastin hos gravide kvinder.
English: Date of first authorisation: 27 January 1999 Date of latest renewal: 13 January 2009
Danish: Dato for første markedsføringstilladelse: 27. januar 1999 Dato for seneste fornyelse:13. januar 2009
English: Do not drive or use machines until your vision is clear.
Danish: Du må ikke køre bil eller betjene maskiner, før dit syn er klart igen.
English: In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days.
Danish: I 13 kliniske undersøgelser med 696 patienter blev EMADINE administreret 1-4 gange dagligt i begge øjne i op til 42 dage.
English: If a drop misses your eye, try again.
Danish: Hvis dråben ikke rammer øjet må du prøve igen.
English: Do not use EMADINE after the expiry date which is stated on the bottle and box after “EXP”.
Danish: Brug ikke Emadine efter den udløbsdato, der står på flasken og kartonen efter ”EXP”.
English: They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Danish: De er sorteret efter systemorganklasser og klassificeret i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til, <1/10), ikke almindelig (≥1/1000 til, <1/100), sjælden (≥1/10.000 til, <1/1000), meget sjælden (<1/10.000) eller ukendt (kan ikke vurderes ud fra de tilgængelige data).
English: Not known tachycardia
Danish: Ukendt takykardi
English: (picture 2).
Danish: (se figur 3).
English: Since EMADINE contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Danish: Da EMADINE indeholder benzalkoniumchlorid, er tæt overvågning påkrævet ved hyppig eller langvarig brug.
English: The recommended dose < see side 1
Danish: Den anbefalede dosis < se side 1
English: Two primary metabolites, 5-and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms.
Danish: To primære metabolitter 5-og 6-hydroxyemedastin udskilles i urinen som både frie og konjugerede former.
English: Always use this medicine exactly as described in this leaflet or as your doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens anvisning.
English: It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Danish: Det er uvist om lokaladministration hos mennesket kan medføre en tilstrækkelig systemisk absorption til at producere målbare mængder i modermælk.
English: EMADINE should not be used for longer than 4 weeks after first opening.
Danish: EMADINE bør ikke anvendes længere end 4 uger efter første åbning af flasken.
English: For single use only; one container is sufficient to treat both eyes.
Danish: Kun til engangsbrug; en beholder rækker til behandling af begge øjnene.
English: It could infect the drops left in the bottle.
Danish: Det kan forurene øjendråberne, der er tilbage i flasken.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 brugere)
English: • If you wear contact lenses please see section ‘EMADINE contains benzalkonium chloride below'.
Danish: • Hvis du bruger kontaktlinser, skal du læse afsnittet 'Emadine indeholder benzalkoniumchlorid' nedenfor.
English: You must talk to a doctor if you do not feel better or if you feel worse.
Danish: Kontakt lægen, hvis du ikke får det bedre, eller hvis du får det værre.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Caution should be exercised if EMADINE is administered during breast-feeding.
Danish: Forsigtighed bør udvises, hvis EMADINE administreres under amning.
English: Do not use a container you've already opened.
Danish: Brug ikke en enkeltdosisbeholder du allerede har åbnet.
English: Belgium.
Danish: Belgien.
English: EMADINE contains benzalkonium chloride
Danish: Emadine indeholder benzalkoniumchlorid
English: Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of administration.
Danish: Emedastin difumarat har vist et meget lavt niveau af akut toksicitet i en række arter, indgivet ved forskellige administrationsveje.
English: Eye ointments should be administered last.
Danish: Øjensalve skal administreres til sidst.
English: Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.
Danish: Inden for de forskellige grupper af hyppighed er bivirkningerne anført i faldende orden efter alvorlighed.
English: Patients must be instructed to remove contact lenses prior to the application of EMADINE and wait 15 minutes after instillation of the dose before reinsertion.
Danish: Patienter skal instrueres i at fjerne kontaktlinserne før applikation af EMADINE og vente 15 minutter efter instillation af dosis, før linserne sættes på igen.
English: The drop will go in here (picture 1).
Danish: Dråben skal placeres her (figur 1).
English: Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics, ATC code: S01G X
Danish: Farmakoterapeutisk klassifikation: dekongestiantia og antiallergika; andre antiallergika ATC kode: S01G X 06
English: Do not use a double dose to make up for the one missed.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The 5-oxo analogues of 5-and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites.
Danish: 5'-oxo analoger af 5-og 6-hydroxyemedastin og N-oxid udgør en mindre del af metabolitterne.
English: Approximately 44% of an oral dose is recovered in the urine over 24 hours, with only 3.6% of the dose excreted as parent drug substance.
Danish: Ca. 44% af den perorale dosis udskilles i urinen over 24 timer, med kun 3.6% af dosen udskilt som uomdannet stof.
English: If you accidentally swallow EMADINE or inject it contact a doctor immediately.
Danish: Hvis du ved et uheld sluger eller indsprøjter Emadine skal du omgående kontakte din læge.
English: System Organ Classification
Danish: Systemorganklasser
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
English: Emedastine has been identified in the milk of rats following oral administration.
Danish: Emedastin er blevet påvist i mælken hos rotter efter peroral administration.
English: Emedastine is absorbed systemically, as are other topically administered drug substances.
Danish: Emedastin absorberes systemisk, som andre topikalt administrerede lægemiddelstoffer.
English: The following adverse reactions listed below were observed in clinical studies or with post marketing experience.
Danish: De bivirkninger, der er opført nedenfor, blev observeret i kliniske undersøgelser og/eller i tiden efter markedsføring.
English: The human oral bioavailability of emedastine is approximately 50% and maximum plasma concentrations were achieved within one-two hours after dosing.
Danish: Den perorale biotilgængelighed hos mennesket af emedastin er ca. 50%, og den maksimale plasmakoncentration opnås inden for en til to timer efter dosering.
English: Talk to your doctor or pharmacist before using EMADINE.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Emadine.
English: Symptomatic treatment of seasonal allergic conjunctivitis.
Danish: Symptomatisk behandling af sæsonbetinget allergisk konjunktivitis.
English: You may find that your vision is blurred for a time just after you use EMADINE.
Danish: Dit syn kan blive kortvarigt sløret efter at du har brugt Emadine.
English: Do not use EMADINE
Danish: Brug ikke Emadine
English: Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).
Danish: Benzalkoniumchlorid kan også give øjenirritation, især hvis du har tørre øjne eller hornhinde problemer (det klare lag forrest i øjet).
English: EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis of the eye (allergic conditions of the eye).
Danish: Emadine er et lægemiddel til behandling af sæsonbetinget øjenallergi (allergisk konjunktivitis).
English: The recommended dose is in adults and children over 3 years: One drop in the eye, twice a day.
Danish: Den anbefalede dosis til voksne og børn over 3 år er: en dråbe i øjet to gange om dagen.
English: The drop will go in here.
Danish: Dråben skal placeres her.
English: The preservative in EMADINE, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: Konserveringsmidlet i EMADINE, benzalkoniumchlorid, kan absorberes af bløde kontaktlinser og kan ændre farven af kontaktlinserne.
English: Ocular corneal infiltrates
Danish: Okulære korneale infiltrater
English: If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Danish: Hvis du har unormale fornemmelser i øjet såsom svie eller smerte, når du bruger dette lægemiddel, skal du tale med din læge.
English: Eye ointments should be used last.
Danish: Øjensalve skal bruges til sidst.
English: The elimination half-life of topical emedastine is ten hours.
Danish: Halveringstiden efter topikal emedastin i plasma er ti timer.
English: Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
Danish: Visse partikler (allergener) som pollen, husstøv eller dyrehår kan være årsag til allergiske reaktioner, som medfører kløe, rødme og hævelse af øjenomgivelserne.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Studier i dyr har vist reproduktionstoksiske effekter (se afsnit 5.3).
English: • If your doctor has told you to use drops in both eyes, repeat the steps for your other eye-using the same container.
Danish: • Hvis din læge har bedt dig bruge dråberne i begge øjne, gentages proceduren for det andet øje med den samme enkeltdosisbeholder.
English: No specific reactions are to be expected with an ocular overdose of the product.
Danish: Ingen konkrete reaktioner kan forventes ved okulær overdosering af præparatet.
English: It may affect your heart rhythm.
Danish: Der kan være risiko for forstyrret hjerterytme.
English: If you get too much in your eyes, rinse it all out preferably with sterile saline or, if not available, with warm water.
Danish: Hvis du får dryppet for meget i dine øjne, skyl det da ud, helst med sterilt saltvand eller, hvis dette ikke er tilgængeligt, med varmt vand.
English: Always use EMADINE exactly as your doctor has told you.
Danish: Brug altid Emadine nøjagtigt efter lægens anvisning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: You must throw away the bottle four weeks after you first opened it, to prevent infections.
Danish: Flasken skal smides ud 4 uger efter åbning for at forhindre, at indholdet bliver forurenet.
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Danish: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanien.
English: This medicine contains 0.5 mg or 1 mg benzalkonium chloride in each 5 or 10 ml, which are equivalent to 0.1 mg/ml.
Danish: Dette lægemiddel indeholder 0,5 mg eller 1 mg benzalkoniumchlorid pr. 5 ml eller 10 ml, svarende til 0,1 mg/ml.
English: • if you are allergic to emedastine or any of the other ingredients of this medicine listed in section 6.
Danish: • hvis du er allergisk over for emedastin eller et af de øvrige indholdsstoffer angivet i afsnit 6.
English: Emedastine difumarate was not genotoxic in a standard battery of in vitro and in vivo genotoxicity assays.
Danish: Emadastin difumarat er ikke fundet genotoksisk i et standardbatteri af in vitro og in vivo genotoksiske undersøgelser.
English: • EMADINE is not recommended for use in patients with kidney or liver problems.
Danish: • Emadine anbefales ikke til patienter med nyre- eller leverproblemer.
English: Studies with emedastine have not shown effects on adrenergic, dopaminergic, and serotonin receptors.
Danish: Studier med emedastin har ikke påvist nogen virkning på adrenerge-, dopaminerge- og serotonerge receptorer.
English: Five single-dose containers are provided in a pouch.
Danish: 5 enkeltdosisbeholdere leveres i en foliepose.
English: Emedastine is principally metabolised by the liver.
Danish: Emedastin metaboliseres hovedsagelig i leveren.
English: • Hold the long flat end of the container between your thumb and forefinger and open it by twisting off the other end (picture 2).
Danish: • Hold beholderens lange, flade ende mellem din tommel- og pegefinger og åbn den ved at dreje den anden ende af (figur 2).
English: Don't put in any more drops until it's time for your next regular dose.
Danish: Dryp ikke flere dråber i øjet før næste planlagte dosis.
English: Emedastine is a potent selective and topically effective histamine H1 antagonist (Ki = 1.3 nM).
Danish: Emedastin er en potent, selektiv og effektiv topikal histamin H1-antagonist (Ki = 1,3 nM).
English: • Do not use if the solution is cloudy or has bits in it.
Danish: • Brug ikke opløsningen hvis den er grumset eller uklar.
English: Do not use any sealed containers from a foil wrapper that was opened more than a week ago.
Danish: Brug heller ikke nogen af de ubrugte enkeltdosisbeholdere fra en foliepose, som blev åbnet for mere end en uge siden.
English: No reproductive toxicity was observed in a study in rabbits.
Danish: Der blev ikke observeret reproduktiv toksicitet i et forsøg med kaniner.
English: Manufacturer Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Spain
Danish: Fremstiller Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Spanien
English: • If you use drops in both eyes, repeat the steps for your other eye.
Danish: • Hvis begge øjne skal behandles, gentages alle trin for det andet øje.
English: Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Danish: Det er blevet rapporteret, at benzalkoniumchlorid, der normalt bruges som konserveringsmiddel i oftalmiske produkter, kan medføre punktformet keratopati og/eller toksisk ulcerøs keratopati.
English: How to use EMADINE (continued)
Danish: Sådan skal du bruge Emadine (fortsat)
English: • Throw away any unused containers one week after opening the foil wrapper-even if the containers are still sealed.
Danish: • Smid ubrugte enkeltdosisbeholdere væk én uge efter at folieposen er åbnet selv om enkeltdosisbeholderne stadigvæk er forseglede.