FrancophonIA/ELRC3.0 huggingface dataset:
English: Afoxolaner Merial reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Danish: Afoxolaner Merial havde reduceret antallet af levende mider med 97 % 56 dage efter behandlingsstart og med 98 % 84 dage efter behandlingsstart.
English: Afoxolaner Merial is available as chewable tablets in four different strengths for use in dogs of different weights.
Danish: Afoxolaner Merial fås som tyggetabletter i fire forskellige styrker, så de kan anvendes til hunde med forskellig vægt.
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with Afoxolaner Merial.
Danish: Et tredje EU-feltstudie omfattede 38 hunde med sarcoptesskab, som blev behandlet månedligt i to måneder med Afoxolaner Merial.
English: Other information about Afoxolaner Merial
Danish: Andre oplysninger om Afoxolaner Merial
English: Afoxolaner Merial contains the active substance afoxolaner.
Danish: Afoxolaner Merial indeholder det aktive stof afoxolaner.
English: Why is Afoxolaner Merial authorised in the EU?
Danish: Hvorfor blev Afoxolaner Merial godkendt i EU?
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with Afoxolaner Merial.
Danish: Et andet EU-feltstudie omfattede 31 hunde med demodicoseskab, som blev behandlet tre gange med en måneds mellemrum med Afoxolaner Merial.
English: What are the risks associated with Afoxolaner Merial?
Danish: Hvilken risiko er der forbundet med Afoxolaner Merial?
English: The active substance in Afoxolaner Merial, afoxolaner, acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i Afoxolaner Merial, afoxolaner, er et ektoparasitdræbende middel.
English: How is Afoxolaner Merial used?
Danish: Hvordan anvendes Afoxolaner Merial?
English: What benefits of Afoxolaner Merial have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Afoxolaner Merial?
English: How does Afoxolaner Merial work?
Danish: Hvordan virker Afoxolaner Merial?
English: List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants / marketing authorisation holder in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i Medlemsstaterne
English: • Wash your hands
Danish: • Vask dine hænder
English: Use in adults, including elderly population
Danish: Anvendelse til voksne inklusive ældre personer
English: Unilateral treatment can result in permanent heterochromia.
Danish: Unilateral behandling kan resultere i permanent heterochromia.
English: Contact with the skin
Danish: Kontakt med huden
English: Date of first authorisation: 27 November 2001 Date of latest renewal: 06 October 2006
Danish: Dato for første markedsføringstilladelse: 27. november 2001 Dato for sidste fornyelse: 06. oktober 2006
English: This is especially important in women who are pregnant or are attempting to become pregnant.
Danish: Det gælder især kvinder, som er gravide eller forsøger at blive det.
English: ATC code: S01E E04
Danish: ATC-kode: S01E E04
English: • Tilt your head or your child's head gently back.
Danish: • Læn dit eller dit barns hoved tilbage.
English: It could infect the drops
Danish: Det kan forurene dråberne
English: No long-term safety data are available in the paediatric population.
Danish: Der foreligger ingen langtids-sikkerhedsdata for den pædiatriske population.
English: Mean Difference a
Danish: Gennemsnitlig forskel a
English: SE = Standard Error; CI = Confidence Interval;
Danish: SE = Standardafvigelse; CI = Konfidensinterval;
English: The drop will go in here (picture 2)
Danish: Dråben skal lægge sig der (figur 2)
English: The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to<1/1,000), very rare <1/10,000), or not known (frequency cannot be estimated from the available data).
Danish: Nedenstående bivirkninger er klassificeret i henhold til følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden <1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Mean difference is Travoprost - Timolol.
Danish: Gennensnitsforskellen er Travoprost - Timolol.
English: A change in the colour of the skin around the eye may also occur.
Danish: En ændring af hudfarven omkring øjet kan også forekomme.
English: However, this effect was not observed during the clinical trials and is considered to be species specific.
Danish: Denne effekt blev ikke observeret under de kliniske forsøg og anses for at være artsspecifik.
English: It works by reducing the pressure in the eye.
Danish: Det virker ved at sænke trykket i øjet.
English: EXP Discard 4 weeks after first opening
Danish: EXP Kasseres 4 uger efter åbning
English: Don't put in any more drops until it's time for the next regular dose.
Danish: Dryp ikke flere dråber i øjnene, før det er tid til næste dosis.
English: • TRAVATAN may change the colour of your iris (the coloured part of your eye).
Danish: • TRAVATAN kan ændre din irisfarve (den farvede del af dine øjne).
English: B-2870 Puurs Belgium or
Danish: B-2870, Puurs Belgien eller
English: If you think that you may be pregnant speak with your doctor right away.
Danish: Hvis du har mistanke om, at du er gravid, skal du straks tale med din læge.
English: 10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: 10 EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: The long term effects on the melanocytes and any consequences thereof are currently unknown.
Danish: Langtidseffekten på melanocyterne og konsekvenserne heraf er endnu ukendt.
English: The effect on IOP was seen after the second week of treatment and was consistently maintained throughout the 12 week period of study for all age groups.
Danish: Virkninger på IOP sås efter anden behandlingsuge, og den blev opretholdt gennem alle studiets 12 uger for samtlige aldersgrupper.
English: Do not use TRAVATAN after the expiry date which is stated on the bottle and the box after “EXP”.
Danish: Brug ikke TRAVATAN efter den udløbsdato, der står på pakningen efter ”EXP”.
English: No cases of overdose have been reported.
Danish: Der er ikke rapporteret om overdosering.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægssedlen grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger - Gem indlægssedlen.
English: The following side effects have been seen with TRAVATAN
Danish: Der er set følgende bivirkninger med TRAVATAN
English: There are no data on the effects of TRAVATAN on human fertility.
Danish: Der foreligger ingen data vedrørende TRAVATANs påvirkning af fertiliteten hos mennesker.
English: Patients received either travoprost 0.004% once daily or timolol 0.5% (or 0.25% for subjects younger than 3 years old) twice daily.
Danish: Patienterne fik enten travoprost 0,004 % en gang dagligt eller timolol 0,5 % (eller 0,25 % til forsøgspersoner under 3 år) to gange dagligt.
English: Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish.
Danish: Det typiske billede er, at den brune pigmentering rundt om pupillen spredes koncentrisk mod periferien af det berørte øje, men hele iris eller dele af den kan blive mere brunligt.
English: TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
Danish: TRAVATAN kan gradvis ændre øjenfarven ved at øge antallet af melanosomer (pigmentgranula) i melanocyterne.
English: While most of the plasma data across all studies was non-quantifiable, making statistical comparisons of systemic exposure across age groups unfeasible, the overall trend shows that plasma exposure to travoprost free acid following topical administration of TRAVATAN is extremely low across all age groups evaluated.
Danish: Mens de fleste plasmadata på tværs af alle studier ikke var kvantificerbare, hvilket gjorde statistiske sammenligninger af systemiske eksponeringer på tværs af aldersgrupper umulige, var den samlede tendens, at plasmaeksponeringerne for travoprost som fri syre efter topisk administration af TRAVATAN var ekstremt lave i alle de evaluerede aldersgrupper.
English: • Hold the bottle, pointing down, between your thumb and fingers
Danish: • Hold flasken i hånden med spidsen pegende nedad, mellem din tommelfinger og de andre fingre
English: Do not use TRAVATAN if you are pregnant.
Danish: Brug ikke TRAVATAN, hvis du er gravid.
English: You can usually carry on using the drops, unless the side effects are serious.
Danish: Du kan oftest fortsætte med at bruge dine øjendråber, hvis bivirkningerne ikke er alvorlige.
English: It is absorbed through the cornea where the isopropyl ester is hydrolysed to the active free acid.
Danish: Det absorberes gennem cornea, hvor isopropylesteren hydrolyseres til den aktive frie syre.
English: You may find that your vision is blurred for a time just after you use TRAVATAN.
Danish: Du kan opleve, at dit syn bliver midlertidigt sløret lige efter, at du har brugt TRAVATAN.
English: TRAVATAN getting into the rest of the body
Danish: Det forhindrer, at TRAVATAN kommer ud i resten af kroppen
English: Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Danish: Prostaglandiner og prostaglandin-analoger er biologisk aktive materialer, der kan absorberes via huden.
English: If you could become pregnant you must use adequate contraception whilst you use TRAVATAN.
Danish: Hvis du kan blive gravid, skal du bruge passende prævention, mens du bruger TRAVATAN.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel
English: Patients must be instructed to remove contact lenses prior to application of TRAVATAN and wait 15 minutes after instillation of the dose before reinsertion.
Danish: Patienterne skal instrueres i at fjerne kontaktlinser før applikation af TRAVATAN og vente 15 minutter efter drypning, før linserne sættes i igen.
English: The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1).
Danish: Korttids-sikkerhedsprofilerne hos forskellige pædiatriske undergrupper var også i overensstemmelse hermed (se pkt.
English: Specific in vitro interaction studies were performed with TRAVATAN and medicinal products containing thiomersal.
Danish: Specifikke in vitro-interaktionsstudier er gennemført med TRAVATAN og lægemidler indeholdende thiomersal.
English: The mechanism of eyelash changes and their long term consequences are currently unknown.
Danish: Mekanismen ved øjenvippeforandringer og deres konsekvenser på langt sigt er i dag ukendt.
English: Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.
Danish: Hudkontakt med TRAVATAN skal undgås, da transdermal absorption af travoprost er blevet observeret hos kaniner.
English: • Close the bottle cap firmly immediately after use
Danish: • Luk flasken omhyggeligt lige efter brug
English: Do not stop taking TRAVATAN without speaking to your doctor.
Danish: Du må ikke holde op med at bruge TRAVATAN, uden at du har talt med din læge.
English: • If you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for travoprost eller et af de øvrige indholdsstoffer angivet i punkt 6.
English: BOTTLE LABEL
Danish: FLASKE ETIKET
English: TRAVATAN should therefore be used with caution in patients with active intraocular inflammation.
Danish: TRAVATAN bør derfor anvendes med forsigtighed til patienter med aktiv, intraokulær inflammation.
English: If a drop misses the eye, try again.
Danish: Hvis en dråbe ikke rammer øjet, prøv da igen med en ny dråbe.
English: Topical ocular administration of travoprost to monkeys at concentrations of up to 0.012% to the right eye, twice daily for one year resulted in no systemic toxicity.
Danish: Topikal okulær administration af travoprost til aber i koncentrationer op til 0,012 % i højre øje 2 gange dagligt i et år resulterede ikke i nogen systemisk toksicitet.
English: If you or your child receive more TRAVATAN than you should Rinse all the medicine out with warm water.
Danish: Hvis du eller dit barn har brugt for meget TRAVATAN Skyl alt lægemidlet ud med lunkent vand.
English: It is unknown whether travoprost from the eye drops is excreted in human breast milk.
Danish: Det er ukendt, om travoprost i øjendråber udskilles i human mælk.
English: Not known prostatic specific antigen increased
Danish: Forhøjet prostata-specifikt antigen
English: IOP reductions for this group were based on only 6 patients in the timolol group and 9 patients in the travoprost group where 4 patients in the travoprost group versus 0 patients in the timolol group had no relevant mean IOP reduction at Week 12.
Danish: IOP-reduktionerne for denne gruppe var baseret på kun 6 patienter i timolol-gruppen og 9 patienter i travoprost-gruppen, hvor 4 patienter i travoprost-gruppen og 0 patienter i timolol-gruppen ikke havde nogen relevant gennemsnitlig IOP-reduktion ved Uge 12.
English: Travoprost free acid and its metabolites are mainly excreted by the kidneys.
Danish: Travoprost frie syre og dens metabolitter udskilles hovedsageligt via nyrerne.
English: The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%).
Danish: De hyppigste bivirkninger, der blev rapporteret hos den pædiatriske population, var okulær hyperæmi (16,9 %) og vækst af øjenvipper (6,5 %).
English: Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.
Danish: Dyrestudier har ikke vist nogen effekt af travopost på fertiliteten ved doser på mere end 250 gange den maksimalt anbefalede humane okulære dosis.
English: • After using TRAVATAN, keep the eyelid closed, apply gentle pressure by pressing a finger into the corner of the eye, by the nose (picture 4) for at least 1 minute.
Danish: • Når du har dryppet med TRAVATAN, skal du lukke øjet og forsigtigt trykke en finger mod øjenkrogen ind mod næsen (figur 4) i mindst 1 minut.
English: Mean IOP reductions in the travoprost and timolol groups were similar (see Table 1).
Danish: De gennemsnitlige reduktioner i IOP i travoprost- og timolol-grupperne svarede til hinanden (se Tabel 1).
English: In a similar 3 month study in adult patients, these events occurred at an incidence of 11.4% and 0.0%, respectively.
Danish: I et tilsvarende studie af 3 måneders varighed med voksne patienter forekom disse bivirkninger med en hyppighed på hhv. 11,4 % og 0,0 %
English: Table 1 Comparison of Mean IOP Change from Baseline (mmHg) at Week 12
Danish: Tabel 1 Sammenligning af gennemsnitlig ændring i IOP fra baseline (mmHg) ved uge 12
English: Both side effects were observed with a higher incidence in children and adolescents compared to adults.
Danish: Begge bivirkninger er set hyppigere hos børn og unge end hos voksne.
English: The primary efficacy endpoint was the intraocular pressure (IOP) change from baseline at Week 12 of the study.
Danish: Det primære effektendepunkt var ændringen i intraokulært tryk (IOP) fra baseline i studiets 12. uge.
English: If you are concerned about changes in your breathing pattern when using TRAVATAN advise your doctor as soon as possible.
Danish: Hvis du bliver bekymret over eventuelle ændringer ved din vejrtrækning, mens du er i behandling med TRAVATAN, skal du hurtigst muligt kontakte din læge.
English: No clinical data are available on adjunctive use with other ocular hypotensive medications.
Danish: Der findes ingen kliniske data for kombinationsbehandling med andre hypotensive okulære lægemidler.
English: It may be used on its own or with other drops e.g. beta-blockers, which also reduce pressure.
Danish: Det kan bruges alene eller sammen med andre øjendråber f.eks. betablokkere, som også sænker trykket i øjet.
English: TRAVATAN may get into your milk.
Danish: TRAVATAN kan udskilles i mælken.
English: The marketing authorisation holder Novartis Europharm Limited Vista Building
Danish: Indehaver af markedsføringstilladelsen Novartis Europharm Limited
English: Animal studies have shown excretion of travoprost and metabolites in breast milk.
Danish: Dyrestudier har vist udskillelse af travoprost og metabolitter i mælk.
English: Uncommon hypersensitivity, seasonal allergy
Danish: Ikke Almindelig Overfølsomhed, sæsonbetinget allergi
English: In children < 3 years old that mainly suffer from PCG (primary congenital glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Danish: Hos børn < 3 år, som fortrinsvis lider af PCG (primært medfødt glaukom), forbliver kirurgi (f.eks. trabekulotomi/goniotomi) førstevalgsbehandling.
English: • TRAVATAN may rarely cause breathlessness or wheezing or increase the symptoms of asthma.
Danish: • TRAVATAN kan i sjældne tilfælde give åndenød eller hvæsen eller forværre astmasymptomer.
English: After discontinuation of therapy, no further increase in brown iris pigment has been observed.
Danish: Efter at behandlingen er stoppet, er der ikke observeret en stigning i brun irispigmentering.
English: Continue with the next dose as planned.
Danish: Genoptag behandlingen med næste dosis i henhold til planen.
English: If you or your child are using other eye preparations such as eye drop or eye ointment, wait for at least 5 minutes between putting in TRAVATAN and the other eye preparations.
Danish: Hvis du eller dit barn bruger andre øjenpræparater, så vent mindst 5 minutter mellem TRAVATAN og de andre øjenpræparater.
English: Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed.
Danish: Forandringer af øjenlåg, herunder usædvanlig hårvækst eller hårvækst i huden omkring øjet er også set.
English: Ask your doctor for advice before taking any medicine
Danish: Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: Not known depression, anxiety, insomnia
Danish: Depression, angst, insomni
English: Pack sizes: 1 or 3 bottles.
Danish: Pakningsstørrelser: 1 eller 3 flasker
English: Not known asthma aggravated, epistaxis
Danish: Forværret astma, epistaxis
English: Low levels of radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered
Danish: Lave niveauer af radioaktivitet blev målt i amnionvæske og føtalt væv fra drægtige rotter, som havde fået indgivet
English: Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/ml and 30 pg/ml plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ml).
Danish: Reproduktionsog udviklingsstudier har vist en potent effekt på føtalt tab med en høj frekvens hos rotter og mus (henholdsvis 180 pg/ml og 30 pg/ml plasma) ved eksponering 1,2 til 6 gange den kliniske eksponering (op til 25 pg/ml).
English: TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min).
Danish: TRAVATAN er blevet undersøgt hos patienter med mild til svær nedsat leverfunktion og hos patienter med mild til svær nedsat nyrefunktion (kreatinin-clearance så lav som 14 ml/min).
English: Pull down the eyelid with a clean finger, until there is a ‘pocket' between the eyelid and the eye.
Danish: Træk forsigtigt ned i det nederste øjenlåg, indtil der dannes en “lomme” mellem øjenlåget og øjet.
English: Treatment of a suspected oral ingestion is symptomatic and supportive.
Danish: Ved mulig oral indtagelse skal behandlingen være symptomatisk og støttende.
English: No dosage adjustment is necessary in these patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for disse patienter (se pkt.
English: Rare blood pressure diastolic decreased, blood pressure systolic increased, hypotension, hypertension
Danish: Nedsat diastolisk blodtryk, forhøjet systolisk blodtryk, hypotension, hypertension
English: Mean IOP reduction at Week 12 in the 2 months to < 3 years of age group was 1.8 mmHg in the travoprost group and 7.3 mmHg in the timolol group.
Danish: Den gennemsnitlige reduktion i IOP ved Uge 12 i aldersgruppen 2 måneder til < 3 år var 1,8 mmHg i travoprost-gruppen og 7,3 mmHg i timolol-gruppen.
English: TRAVATAN is used to reduce high pressure in the eye in adults, adolescents and children from 2 months old onward.
Danish: TRAVATAN øjendråber bruges til at sænke forhøjet tryk i øjet hos voksne, unge og børn i alderen fra 2 måneder og opefter.
English: Women of child-bearing potential/contraception
Danish: Kvinder i den fertile alder/prævention
English: Due to the low plasma concentrations and rapid elimination following topical dosing, the elimination half-life of active free acid in man could not be determined.
Danish: På grund af den lave plasmakoncentration og den hurtige udskillelse efter topikal administration kan man ikke bestemme eliminationshalveringstid i mennesker på den aktive frie syre.
English: The systemic metabolic pathways parallel those of endogenous prostaglandin F2 which are characterised by reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and -oxidative cleavages of the upper side chain.
Danish: Den systemiske metabolisme er parallel med den for endogen prostaglandin-F2, som er karakteriseret ved reduktion af 13-14 dobbeltbindingen, oxidation af 15-hydroxyl og -oxidativ spaltning af den øverste sidekæde.
English: Effects in the eye: inflammation of the back of the eye, eyes appear more inset.
Danish: Reaktioner i øjet: Betændelseslignende tilstand (inflammation) på bagsiden af øjet, øjnene ser mere indsunkne ud.
English: Findings are related to FP receptor agonist activity in uterus with early embryolethality, post-implantation loss, foetotoxicity.
Danish: Fund er relateret til FP-receptor agonistaktivitet i uterus med tidlig embryonal letalitet (fosterdød), post-implantationstab, føtal-toksicitet (fostertoksicitet).
English: The active substance is travoprost 40 micrograms/ml.
Danish: Aktivt stof: Travoprost 40 mikrogram/ml.
English: Macular oedema has been reported during treatment with prostaglandin F2a analogues.
Danish: Der er rapporteret om maculaødem under behandling med prostaglandin-F2a-analoger.
English: Use of TRAVATAN is not recommended to those children under 2 months of age.
Danish: TRAVATAN anbefales ikke til børn under 2 måneder.
English: • If you have current or previous history of an eye inflammation (iritis and uveitis), talk to your doctor before you use TRAVATAN.
Danish: Hvis du tidligere har haft en betændelseslignende tilstand (inflammation) i øjnene (iritis eller uveitis), skal du tale med lægen, inden du bruger TRAVATAN.
English: One drop in the affected eye or eyes, once a day - in the evening.
Danish: Den anbefalede dosis er en dråbe i det/de pågældende øje/øjne, én gang dagligt - om aftenen.
English: • If you have had cataract surgery, talk to your doctor before you use TRAVATAN.
Danish: • Hvis du har gennemgået en operation for katarakt (grå stær), skal du tale med lægen, inden du bruger TRAVATAN.