FrancophonIA/ELRC3.0 huggingface dataset:
English: − Review all patients who are currently taking Zinbryta to assess whether the medicine is still appropriate for them.
Danish: − Gennemgå alle patienter, der er i behandling med Zinbryta, for at vurdere, om lægemidlet stadig er hensigtsmæssigt for dem.
English: Several cases of serious liver injury including immune-mediated hepatitis and fulminant liver injury have been reported.
Danish: Der er rapporteret om adskillige tilfælde af alvorlig leverskade, herunder immunmedieret hepatitis og fulminant leverskade.
English: − Monitor patients' serum transaminase and bilirubin levels at least monthly and as close as possible before each administration, and for up to 6 months after stopping treatment.
Danish: − Overvåge patienternes serumtransaminase og bilirubin mindst en gang måneden og så tæt som muligt forud for hver administration samt i op til 6 måneder efter behandlingens afslutning.
English: • If you are currently on Zinbryta, your doctor will check whether you should continue your treatment or switch to an alternative.
Danish: • Hvis du allerede er i behandling med Zinbryta, vil din læge undersøge, om du skal fortsætte eller skifte til en anden behandling.
English: The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment.
Danish: Under gennemgangen blev det vurderet, at der kan opstå uforudsigelig og potentielt dødelig immunmedieret leverskade under behandling med Zinbryta og i op til 6 måneder efter behandlingens afslutning.
English: • Zinbryta can cause unpredictable and potentially fatal immune-mediated liver injury.
Danish: • Zinbryta kan give uforudsigelig og potentielt dødelig immunmedieret leverskade.
English: The Committee for Medicinal Products for Human Use (CHMP) then adopted EMA's final opinion, which was sent to the European Commission for adoption of a legally binding decision.
Danish: Derefter vedtog Udvalget for Lægemidler til Mennesker (CHMP) EMA's endelige udtalelse, som blev fremsendt til Europa-Kommissionen, der traf en juridisk bindende beslutning.
English: Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Danish: Multipel sklerose er en sygdom, hvor den beskyttende skede omkring nervecellerne i hjernen og rygmarven beskadiges af inflammation.
English: Relapsing means that the patient has flare-ups of neurological symptoms.
Danish: Recidiverende (tilbagevendende) vil sige, at patienten oplever en opblussen af de neurologiske symptomer.
English: − Screen patients for hepatitis B or C infection before starting treatment in new patients and refer those who test positive to a liver specialist.
Danish: − Screene nye patienter for hepatitis B eller C før behandlingsstart og henvise patienter med positive test til en leverspecialist.
English: The review of the liver effects of Zinbryta was conducted by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which issued recommendations in October 2017.
Danish: Gennemgangen af Zinbrytas leverpåvirkning blev foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), der fremsatte sine anbefalinger i oktober 2017.
English: • Tell your doctor of any medicines you are taking, including non-prescription products and herbal supplements, as these may affect the liver.
Danish: • Du skal fortælle lægen om alle de lægemidler, du tager, herunder håndkøbsmedicin og kosttilskud, da disse også kan have indvirkning på leveren.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), der har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte en række anbefalinger.
English: − It is recommended that you do not start treatment in new patients with ALT or AST levels equal to or more than 2 times the upper limit of normal (ULN) or in patients with autoimmune conditions other than multiple sclerosis.
Danish: − Det anbefales ikke at påbegynde behandling hos nye patienter, der har ALAT- eller ASATniveauer på 2 gange den øvre normalgrænse (ULN) eller derover, eller hos patienter med andre autoimmune tilstande end multipel sklerose.
English: − Exercise caution in patients taking other medicinal products with known hepatotoxic potential, including non-prescription products and herbal supplements.
Danish: − Udvise forsigtighed hos patienter, der tager andre lægemidler med kendt levertoksisk potentiale, herunder håndkøbsmedicin og kosttilskud.
English: In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
Danish: I de kliniske undersøgelser sås en alvorlig leverreaktion hos 1,7 % af de patienter, der fik Zinbryta.
English: • In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction such as autoimmune hepatitis, hepatitis and jaundice.
Danish: • I de kliniske undersøgelser sås en alvorlig leverreaktion hos 1,7 % af de patienter, der fik Zinbryta, herunder autoimmun hepatitis, hepatitis og gulsot.
English: − Inform patients about the risk of hepatic injury, how to recognise it and the need for regular monitoring.
Danish: − Informere patienterne om risikoen for leverskade, om symptomerne på leverskade og om nødvendigheden af regelmæssig kontrol.
English: Zinbryta is a medicine used to treat certain patients with relapsing forms of multiple sclerosis.
Danish: Zinbryta er et lægemiddel til behandling af visse patienter med recidiverende (tilbagevendende) multipel sklerose.
English: Zinbryta to be used in restricted patient group, with strict liver monitoring
Danish: Zinbryta kan anvendes hos en begrænset patientgruppe under nøje overvågning af leverfunktionen
English: Zinbryta is available as a solution for injection in pre-filled pens and syringes.
Danish: Zinbryta fås som injektionsvæske i fyldte penne og sprøjter.
English: − Promptly refer patients with signs and symptoms of liver damage to a specialist.
Danish: − Henvise patienter med tegn og symptomer på leverskade til en leverspecialist med det samme.
English: − Do not prescribe Zinbryta for patients with pre-existing hepatic disease or hepatic impairment as it is contraindicated in these patients.
Danish: − Lade være med at ordinere Zinbryta til patienter med eksisterende leversygdom eller nedsat leverfunktion, da lægemidlet er kontraindiceret hos disse patienter.
English: • In view of the risk, the indication for Zinbryta is restricted to adult patients with relapsing forms of multiple sclerosis who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable.
Danish: • På baggrund af denne risiko begrænses indikationen for Zinbryta til voksne patienter med recidiverende multipel sklerose, der har udvist utilstrækkeligt respons på mindst 2 sygdomsmodificerende midler, og hos hvem behandling med andre sygdomsmodificerende midler er kontraindiceret eller på anden måde uhensigtsmæssigt.
English: − It is recommended that you stop treatment in patients with ALT or AST levels more than 3 times the ULN regardless of bilirubin levels.
Danish: − Det anbefales, at behandlingen seponeres hos patienter med ALAT- eller ASAT-niveauear på over 3 gange den øvre normalgrænse (ULN), uanset bilirubin-niveau.
English: − Consider stopping Zinbryta if an adequate response to treatment has not been achieved or the patient fails to follow the requirement for scheduled liver function tests.
Danish: − Overveje at seponere Zinbryta, hvis patienten ikke udviser tilstrækkeligt respons på behandlingen eller ikke kommer til de planlagte leverfunktionstest.
English: Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs.
Danish: Zinbryta må nu kun anvendes hos patienter, der har udvist utilstrækkelig respons på mindst 2 sygdomsmodificerende midler, og som ikke kan behandles med andre sygdomsmodificerende midler.
English: • Your doctor will check your liver regularly (via a blood test), during treatment with Zinbryta and for up to 6 months after stopping treatment.
Danish: • Din læge vil undersøge din lever regelmæssigt (via en blodprøve), mens du er i behandling med
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: PRAC's anbefalinger blev fremsendt til Udvalget for Lægemidler til Mennesker (CHMP), som vedtog agenturets udtalelse.
English: • Because of this risk, Zinbryta will now only be given to patients who have tried at least two other disease modifying treatments and cannot be treated with any other such treatments.
Danish: • Som følge af denne risiko vil Zinbryta fremover kun blive givet til patienter, der har prøvet mindst
English: This is normal and will generally resolve within a couple of days.
Danish: Dette er normalt og forsvinder almindeligvis inden for et par dage.
English: This overview was last updated in March 2018.
Danish: Dette sammendrag blev sidst ajourført i 03-2018.
English: People should not eat, drink or smoke while handling the medicine.
Danish: Der bør ikke spises, drikkes eller ryges, mens lægemidlet håndteres.
English: These effects usually resolve without treatment.
Danish: Disse bivirkninger svinder sædvanligvis uden behandling.
English: Fleas, ticks and sand flies might still be able to transmit any diseases which they may be carrying.
Danish: Lopper, flåter og sandfluer kan muligvis stadig overføre eventuelle sygdomme, de bærer.
English: Activyl Tick Plus received a marketing authorisation valid throughout the EU on 9 January 2012.
Danish: Activyl Tick Plus modtog en markedsføringstilladelse med gyldighed i hele EU den 9. januar 2012.
English: Further information on Activyl Tick Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Activyl Tick Plus findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Both treatments reduced flea and tick numbers to almost zero by the end of the study period.
Danish: Begge behandlinger havde mindsket antallet af lopper og flåter til næsten nul ved slutningen af studieperioden.
English: On the day of treatment, children must not handle treated dogs and the dogs should not be allowed to sleep with their owners, especially children.
Danish: På behandlingsdagen må hunden ikke berøres af børn, og hunden må ikke sove sammen med ejeren, især ikke børn.
English: For larger dogs, the content can be applied in two (medium dogs), three (large dogs), or four (very large dogs) different spots along the back from the shoulders to the base of the tail.
Danish: Hos større hunde kan pipettens indhold påføres på to (mellemstore hunde), tre (store hunde) eller fire (meget store hunde) forskellige steder langs ryggen fra skuldrene til haleroden.
English: The medicine should be applied in a well-ventilated area and treated dogs should not be handled until the application site is dry.
Danish: Lægemidlet bør påføres på et sted med god udluftning, og behandlede hunde bør ikke håndteres, før påføringsstedet er tørt.
English: The medicine is highly flammable and should be kept away from possible sources of ignition.
Danish: Lægemidlet er meget brandfarligt og skal holdes på afstand af eventuelle antændelseskilder.
English: The European Medicines Agency decided that Activyl Tick Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Activyl Tick Plus opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: If adverse reactions occur, medical advice should be sought and the package leaflet shown to the doctor.
Danish: Hvis der opstår bivirkninger, bør der søges lægehjælp, og indlægssedlen vises til lægen.
English: If Activyl Tick Plus is accidentally spilled into eyes, it should be rinsed off with water.
Danish: Hvis en person utilsigtet får Activyl Tick Plus i øjnene, skal det skylles ud med vand.
English: Activyl Tick Plus can also be used as a repellent (a substance that deters insects from approaching and settling) against sand flies (Phlebotomus perniciosus) that is active for up to 3 weeks.
Danish: Activyl Tick Plus kan også anvendes som et insektmiddel (et stof, der afskrækker insekter fra at nærme og sætte sig) mod sandfluer (Phlebotomus perniciosus), som er aktivt i op til tre uger.
English: For very small and small dogs, the full content of a pipette appropriate for the dog's weight is applied to the skin between the shoulder blades, after parting the fur.
Danish: Hos små og meget små hunde påføres alt indholdet i den rette pipette til hundens størrelse på huden mellem skulderbladene, efter at pelsen er delt til siderne.
English: Permethrin also acts as a repellent and so helps prevent sand flies from settling and taking a blood meal.
Danish: Permethrin virker også som insektmiddel og hjælper således med at afholde sandfluer fra at sætte sig og suge blod.
English: In one study, Activyl Tick Plus showed repellant activity of above 95% at 1 day after treatment, falling to 92% at 3 weeks after treatment.
Danish: I et studie udviste Activyl Tick Plus en fordrivende aktivitet på over 95 % én dag efter behandling, som faldt til 92 % tre uger efter behandling.
English: The medicine, available as a spot-on solution, is given as a single application to the dog's skin.
Danish: Lægemidlet fås som spot-on, opløsning, og gives som en enkelt påføring på hundens hud.
English: In the other study, Activyl Tick Plus showed repellant activity of 98% at 2 days after treatment falling to 86% at 3 weeks.
Danish: I det andet studie udviste Activyl Tick Plus en fordrivende aktivitet på 98 % to dage efter behandling, som faldt til 86 % tre uger efter behandling.
English: People who are known to be hypersensitive to indoxacarb or permethrin should avoid contact with the product.
Danish: Personer, som vides at være overfølsomme over for indoxacarb eller permethrin, bør undgå kontakt med lægemidlet.
English: For more information about using Activyl Tick Plus, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Activyl Tick Plus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The effectiveness of Activyl Tick Plus against sand flies was shown in two laboratory studies.
Danish: Virkningen af Activyl Tick Plus mod sandfluer blev påvist i to laboratoriestudier.
English: It must not be used in dogs which are known to be hypersensitive (allergic) to indoxacarb, permethrin or to any of the other ingredients.
Danish: Det må ikke anvendes til hunde, som vides at være overfølsomme (allergiske) over for indoxacarb, permethrin eller andre af indholdsstofferne.
English: The effectiveness of Activyl Tick Plus against fleas and ticks was investigated in laboratory studies and in three field studies.
Danish: Virkningen af Activyl Tick Plus mod lopper og flåter blev undersøgt i laboratoriestudier og i tre feltstudier.
English: Protective gloves should be worn when handling or applying Activyl Tick Plus to dogs.
Danish: Der bør bæres beskyttelseshandsker, mens Activyl Tick Plus håndteres eller påføres hunde.
English: What is Activyl Tick Plus and what is it used for?
Danish: Hvad er Activyl Tick Plus, og hvad anvendes det til?
English: The solution is supplied in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of various weights.
Danish: Opløsningen leveres i pipetter, der er påfyldt den rette mængde indoxacarb og permethrin til hunde af forskellig vægt.
English: Other information about Activyl Tick Plus:
Danish: Andre oplysninger om Activyl Tick Plus
English: An overview of Activyl Tick Plus and why it is authorised in the EU
Danish: En oversigt over Activyl Tick Plus, og hvorfor det er godkendt i EU
English: Together, the active form of indoxacarb and permethrin interfere with the parasites' nervous system, causing paralysis and death.
Danish: Tilsammen angriber den aktive form af indoxacarb og permethrin parasitternes nervesystem og fremkalder lammelse og død.
English: The most common side effects seen with Activyl Tick Plus (which may affect up to 1 in 10 animals) are transitory scratching, erythema (reddening of the skin) and hair loss at the application site.
Danish: De hyppigste bivirkninger ved Activyl Tick Plus (som kan optræde hos op til 1 ud af 10 dyr) er forbigående kløe, erytem (rødme af huden) og hårtab på påføringsstedet.
English: Activyl Tick Plus is a veterinary medicine used in dogs to treat flea and tick infestations.
Danish: Activyl Tick Plus er et lægemiddel til dyr, som anvendes hos hunde til behandling af loppe- og flåtangreb.
English: One field study involved 230 dogs where Activyl Tick Plus was compared with fipronil (another ectoparasiticide), where the medicines were given every four weeks for 12 weeks.
Danish: Det ene feltstudie omfattede 230 hunde, hvor Activyl Tick Plus blev sammenlignet med fipronil (et andet ektoparasiticid).
English: Activyl Tick Plus must not be used in cats as adverse reactions and even death can occur.
Danish: Activyl Tick Plus må ikke anvendes til katte, da det kan medføre bivirkninger eller have døden til følge.
English: To protect children, the medicine should be kept in its sachet until use, and the used pipette should be disposed of immediately.
Danish: Af hensyn til børn skal det opbevares i enkeltdosispakken, indtil det bruges, og den brugte pipette skal bortskaffes straks efter brug.
English: Hands should be washed immediately after use and any product in contact with the skin should be washed off immediately with soap and water.
Danish: Vask straks hænder efter brug, og vask straks hudområder, der har været i kontakt med lægemidlet, med sæbe og vand.
English: Why is Activyl Tick Plus authorised in the EU?
Danish: Hvorfor blev Activyl Tick Plus godkendt i EU?
English: After application, indoxacarb and permethrin are ingested by the fleas and ticks (indoxacarb is converted in their gut into an active form).
Danish: Når indoxacarb og permethrin er blevet påført, indtages de af lopperne og flåterne (indoxacarb omdannes i insekternes tarm til den aktive form).
English: Activyl Tick Plus contains the active substances indoxacarb and permethrin.
Danish: Activyl Tick Plus indeholder de aktive stoffer indoxacarb og permethrin.
English: The main measure of effectiveness was the repellent effect against sand flies as measured by the number of fed female sand flies.
Danish: Virkningen blev hovedsagelig målt på den fordrivende effekt på sandfluer målt på antallet af hunsandfluer, der havde indtaget næring.
English: What are the risks associated with Activyl Tick Plus?
Danish: Hvilke risici er der forbundet med Activyl Tick Plus?
English: The application of Activyl Tick Plus may produce a temporary oily appearance or hair clumping at the application site, or a dry white residue.
Danish: Efter påføring af Activyl Tick Plus kan der på påføringsstedet forekomme forbigående fedtede eller sammenfiltrede hår eller en indtørret hvid rest.
English: The effectiveness was measured by counting the number of fleas and ticks at fortnightly intervals.
Danish: Virkningen blev målt ved optælling af lopper og flåter hver anden uge.
English: How is Activyl Tick Plus used?
Danish: Hvordan anvendes Activyl Tick Plus?
English: What benefits of Activyl Tick Plus have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Activyl Tick Plus?
English: The active substances in Activyl Tick Plus, indoxacarb and permethrin, are ectoparasiticides, which kill parasites such as fleas and ticks that may be found on the skin or in the fur of animals.
Danish: Det betyder, at de dræber parasitter, såsom lopper og flåter, der kan findes på dyrets hud eller i pelsen.
English: For further information, see the package leaflet.
Danish: Du kan finde flere oplysninger i indlægssedlen.
English: The incidence is about 5-9 %.
Danish: Hyppigheden er ca. 5-9 %.
English: Page 2/2©EMEA 2008
Danish: Side 2/2©EMEA 2008
English: This summary was last updated in April 2008.
Danish: Dette sammendrag blev sidst ajourført i april 2008.
English: In rare cases vaginal bleeding occurred.
Danish: I sjældne tilfælde kan der forekomme vaginal blødning.
English: These effects are reversible after lowering the dose.
Danish: Bivirkningerne er reversible efter reduktion af dosis.
English: The majority of bitches involved in the studies responded positively: they became continent, and remained that way in the long term.
Danish: Hovedparten af tæverne, som deltog i undersøgelserne, reagerede positivt: de blev kontinente, og dette varede ved i lang tid.
English: In very rare cases development of alopecia (loss of hair) has also been observed.
Danish: I meget sjældne tilfælde har der også kunnet iagttages alopeci (hårtab).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) INCURIN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) INCURIN EPAR - sammendrag for offentligheden
English: Other information about Incurin:
Danish: Andre oplysninger om Incurin:
English: This condition is accompanied with a decrease of the endogenous oestrogen production.
Danish: Denne tilstand ledsages af en nedsættelse af den endogene østrogenproduktion.
English: The studies also established that there is no apparent relationship between the dosage and the body weight of the dog - therefore the dosing has to be decided on an individual basis.
Danish: Undersøgelserne gjorde det også muligt at fastslå, at der tilsyneladende ikke er nogen forbindelse mellem dosering og hundens kropsvægt - hvorfor doseringen skal besluttes på et individuelt grundlag.
English: Incurin has been studied in bitches in three large field trials.
Danish: Incurin blev undersøgt hos tæver i tre store feltundersøgelser.
English: Incurin is a tablet containing the natural hormone estriol as active substance.
Danish: Incurin er en tablet, som indeholder det naturlige hormon estriol som aktivt stof.
English: No special precautions are necessary when administering Incurin.
Danish: Der kræves ingen særlige forsigtighedsregler, når der indgives Incurin.
English: As the sensitivity of incontinent dogs to estriol is variable, the dose has to be determined on an individual basis.
Danish: Da modtageligheden for estriol hos inkontinente hunde varierer, skal dosis bestemmes på et individuelt grundlag.
English: Animals showing a polyuria-polydipsia (excessive water intake and consequent excretion of a large volume of urine) should also not be treated with this product.
Danish: Dyr, som lider af polyuri/sygelig tørst (uforholdsmæssigt stort vandindtag og følgelig udskillelse af store mængder urin), bør heller ikke behandles med dette lægemiddel.
English: Oestrogen receptors can be found in the urethral sphincter, where oestrogens induce a full response, this way improving urethral closure and bladder storage.
Danish: Der findes østrogenreceptorer i den uretrale sphincter, hvor østrogenerne inducerer fuld respons og derved forbedrer urinrørslukningen og opbevaringen i blæren.
English: During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.
Danish: I undersøgelserne havde gentagne indgivelser af op til 2 mg estriol pr. hund gavnlige virkninger på tæver, som udviste ufrivillig urinlækage.
English: Effects typical to oestrogens such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Danish: Østrogeneffekter såsom opsvulmede ydre kønsorganer, hævede mælkekirtler og/eller tiltrækkende virkning på hanhunde samt opkastning er set ved den højeste anbefalede dosis på 2 mg pr. hund.