FrancophonIA/ELRC3.0 huggingface dataset:
English: The review was triggered by concerns in France over increased reports of rare but potentially serious or fatal side effects, particularly cardiovascular side effects (such as heart attack and stroke), neurological side effects such as seizures (fits) and psychiatric side effects (such as hallucinations and manic episodes).
Danish: Gennemgangen var foranlediget af betænkeligheder i Frankrig over et øget antal indberetninger af sjældne, men potentielt alvorlige eller dødbringende, bivirkninger, navnlig hjerte-kar-bivirkninger (såsom hjerteanfald og slagtilfælde), neurologiske bivirkninger såsom krampeanfald, og psykiske bivirkninger (såsom hallucinationer og maniske episoder).
English: Since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available, the French medicines agency (ANSM) asked the EMA to review the medicines and see if the benefits of such use still outweighed the risks.
Danish: Da mælkeproduktionen til sidst standser af sig selv, hvis barnet ikke ammes, og da der findes andre behandlingsmuligheder, anmodede den franske lægemiddelstyrelse (ANSM) EMA om at gennemgå lægemidlerne og vurdere, om fordelene ved denne anvendelse af dem fortsat opvejer risiciene.
English: Bromocriptine should not be used routinely for preventing or stopping milk production, and must not be used in women at increased risk of serious side effects, including women with various disorders that increase blood pressure or who have or have had heart disease or severe psychiatric disorders.
Danish: Bromocriptin bør ikke rutinemæssigt anvendes til at forhindre eller standse mælkeproduktionen og må ikke anvendes hos kvinder med øget risiko for alvorlige bivirkninger, herunder kvinder med forskellige lidelser, der medfører forhøjet blodtryk, og hos kvinder, som lider af eller tidligere har lidt af hjertesygdom eller svære psykiske sygdomme.
English: • Blood pressure should be monitored in those who take the medicine (especially on the first day of taking it) so that early signs of problems can be detected, and the medicine stopped.
Danish: • Blodtrykket bør overvåges under behandlingen (navnlig den første dag), således at tidlige tegn på problemer kan opdages, og behandlingen standses.
English: It mimics some of the actions of dopamine, a hormone that regulates the release of another hormone, prolactin, which in turn controls lactation.
Danish: Det efterligner nogle af virkningerne af hormonet dopamin, som regulerer frigivelsen af et andet hormon, prolaktin, der igen kontrollerer mælkeproduktionen.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.
Danish: Eftersom CMD(h) vedtog sit standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som vedtog en retligt bindende afgørelse for hele EU den 30. oktober 2014.
English: On 20 August 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth.
Danish: Den 20. august 2014 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h))1 ved en flertalsafgørelse anbefalinger for oral brug af bromocriptinholdige lægemidler til at forebygge eller standse produktionen af brystmælk efter en fødsel.
English: • They should only be used for this purpose if there are medical reasons for doing so, for example to avoid further distress in women who lose a baby during or just after birth, or in women who have HIV infection (to avoid any risk of passing the virus on in breast milk).
Danish: • De må kun anvendes til dette formål, hvis der er lægelig begrundelse for det, f.eks. for at undgå yderligere gener hos kvinder, der mister et spædbarn under eller lige efter fødslen, og hos kvinder, der er hivsmittet (for at undgå risiko for overførsel af virusset gennem mælken).
English: Bromocriptine is also used to treat other conditions, such as hyperprolactinaemia (high levels of prolactin in the body) and Parkinson's disease; however these uses are not covered by this review.
Danish: Bromocriptin anvendes også til behandling af andre lidelser såsom for højt indhold af prolaktin i kroppen (hyperprolaktinæmi) og Parkinsons sygdom; disse anvendelser er dog ikke omfattet af denne gennemgang.
English: Blood pressure should be monitored so that early signs of an increase can be detected and treatment stopped immediately.
Danish: Blodtrykket bør overvåges, så behandlingen omgående kan standses ved tegn på stigning.
English: The medicine should not be used routinely for preventing or stopping milk production after childbirth
Danish: Lægemidlet bør ikke rutinemæssigt anvendes til at forhindre eller standse mælkeproduktionen efter en fødsel
English: The above recommendations are based on a review of the available evidence of safety and efficacy of oral bromocriptine for prevention and suppression of lactation.
Danish: Ovenstående anbefalinger er baseret på en gennemgang af den foreliggende evidens for sikkerheden og virkningen af oralt bromocriptin til forebyggelse og suppression af laktation.
English: However, the data available were such that conclusions on the efficacy of bromocriptine in mastitis, breast engorgement and painful breast engorgement could not be made.
Danish: Af de foreliggende data kunne der imidlertid ikke drages konklusioner om virkningen af bromocriptin ved mastitis, brystforstørrelse eller smertefuld brystforstørrelse.
English: • Patients who develop chest pain or an unusually severe headache should consult their doctor urgently.
Danish: • Ved smerter i brystkassen eller usædvanligt svær hovedpine skal patienten øjeblikkelig kontakte lægen.
English: • Medicines containing bromocriptine are licensed in many EU countries for use by mouth to prevent or stop milk production after childbirth in women who are not breastfeeding.
Danish: • Lægemidler med bromocriptin er i mange EU-lande godkendt til indtagelse gennem munden for at forhindre eller standse mælkeproduktionen efter fødsel hos kvinder, der ikke ammer.
English: • On the basis of available safety data, a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events could not be excluded.
Danish: • Som konklusion udelukker de foreliggende sikkerhedsdata ikke en kausal sammenhæng mellem anvendelse af bromocriptin og alvorlige kardiovaskulære, neurologiske eller psykiatriske hændelser.
English: If hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbance) or evidence of central nervous system toxicity develops, treatment should be discontinued and the patient evaluated promptly.
Danish: Hvis der opstår hypertension, suspekte smerter i thorax, svær, progredierende eller ikkeremitterende hovedpine (med eller uden synsforstyrrelser) eller tegn på CNS-toksicitet, skal behandlingen seponeres, og patienten straks vurderes.
English: As the CMDh position on bromocriptine was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.
Danish: Eftersom CMD(h) vedtog sit standpunkt vedrørende bromocriptin ved en flertalsafgørelse, blev det overgivet til Europa-Kommissionen, som godkendte det og vedtog en retligt bindende afgørelse for hele EU den 30. oktober 2014.
English: The CMDh position followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth, which led to these recommendations.
Danish: CMD(h)'s udtalelse fulgte efter, at Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) havde gennemgået de foreliggende data om sikkerheden om virkningen af bromocriptin ved anvendelse til ammestop efter fødslen, hvilket førte til disse anbefalinger.
English: • Use is contraindicated for patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium, a history of coronary artery disease or other severe cardiovascular conditions, or a history of severe psychiatric disorders.
Danish: • Anvendelsen er kontraindiceret ved ukontrolleret hypertension, hypertensive graviditetsrelaterede tilstande (herunder eklampsi, præeklampsi og graviditetsbetinget hypertension) hypertension post partum og i puerperiet, anamnese med koronararteriesygdom eller med anden svær kardiovaskulær sygdom samt ved tidligere svær psykisk lidelse.
English: • Evidence from the clinical trials originally used to license the product as well as those in the published literature suggests that bromocriptine is efficacious in the prevention and inhibition of lactation.
Danish: • Evidens fra de kliniske undersøgelser fra den oprindelige godkendelse af lægemidlet og fra den publicerede litteratur viser, at bromocriptin er effektivt til forebyggelse og suppression af laktation.
English: • Bromocriptine should only be used orally in strengths up to 2.5 mg to inhibit lactation when medically indicated, such as in case of intrapartum loss, neonatal death or HIV infection of the mother.
Danish: • Bromocriptin bør kun anvendes i styrker op til 2,5 mg oralt til laktationssuppression på medicinsk indikation, såsom intrapartal død, neonatal død eller hivsmitte hos moderen.
English: • Bromocriptine should not be used to relieve symptoms of pain or swelling of the breasts after childbirth when such symptoms can be managed by measures such as breast support or applying ice, and the use of painkillers if needed.
Danish: • Bromocriptin bør ikke anvendes til at lindre symptomer såsom smerter i brysterne eller brystforstørrelse efter fødslen, når sådanne symptomer kan behandles med tiltag som bryststøtte eller isomslag eller om nødvendigt smertestillende midler.
English: Restrictions in use of bromocriptine for stopping breast milk production
Danish: Begrænsninger i anvendelsen af bromocriptin til ammestop
English: The CMDh agreed that the medicines should only be used for this purpose (in strengths up to 2.5 mg) when there are compelling medical reasons for stopping lactation, such as the need to avoid further distress after loss of the baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed.
Danish: CMD(h) vedtog, at lægemidlerne kun bør anvendes til dette formål (i styrke op til 2,5 mg), når der er tvingende lægelige grunde til at standse mælkeproduktionen, såsom for at undgå yderligere gener ved tabet af et barn under eller lige efter fødslen, eller hvis moderen er hivsmittet og derfor ikke bør amme.
English: As a result, bromocriptine prevents the secretion of prolactin, thereby preventing or suppressing milk production.
Danish: Bromocriptin forhindrer udskillelsen af prolaktin og forebygger eller undertrykker derved mælkeproduktionen
English: Women may not always breastfeed after childbirth for a variety of reasons ranging from stillbirth and HIVinfection of the mother to personal choice.
Danish: Dette kan skyldes forskellige årsager, herunder dødfødsel, hivsmitte af moderen og personligt valg.
English: • Bromocriptine should not be used for the routine suppression of lactation, nor for the relief of symptoms of post-partum pain and engorgement, which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and simple analgesics.
Danish: Det må heller ikke anvendes til lindring af post partum-smerter og brystforstørrelse, som kan behandles tilfredsstillende ved ikkemedikamentel intervention (såsom fast bryststøtte og isomslag) og simple analgetika.
English: Bromocriptine is used to prevent or suppress milk production in women who have given birth.
Danish: Bromocriptin anvendes til ammestop (forebyggelse eller hæmning af mælkeproduktionen hos kvinder, der har født).
English: • Women who are at greater risk of side effects, such as those who have a condition that increases blood pressure, or who have a history of serious mental illness, should not take bromocriptine.
Danish: • Kvinder med forhøjet risiko for bivirkninger bør ikke tage bromocriptin.
English: The following recommendations (some of which are already included in the product information) should be borne in mind when prescribing bromocriptine for the prevention or suppression of lactation.
Danish: Information til sundhedspersoner For ordination af bromocriptin til forebyggelse eller suppression af laktation gælder følgende anbefalinger (hvoraf nogle allerede indgår i produktinformationen):
English: This summary was last updated in January 2014.
Danish: Dette sammendrag blev sidst ajourført i januar 2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equisolon on 12/03/2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Equisolon den 12/03/2014.
English: What is the withdrawal period?
Danish: Hvad er tilbageholdelsestiden?
English: The dose may be repeated for ten consecutive days.
Danish: Doseringen kan gentages i ti på hinanden følgende dage
English: This document cannot replace a face-to-face discussion with your veterinarian.
Danish: Dette dokument kan ikke erstatte den personlige drøftelse med din dyrlæge.
English: This document is a summary of the European Public Assessment Report.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
English: Other information about Equisolon:
Danish: Andre oplysninger om Equisolon:
English: A field study was conducted in which the same 8 horses with RAO after exposure to hay participated in 4 treatment periods receiving either no treatment or Equisolon at three different doses, each for ten days.
Danish: Der blev udført en feltundersøgelse, hvor de samme otte heste med tilbagevendende vejrtrækningshindring efter udsættelse for hø indgik i fire behandlingsperioder, hvor de enten ikke modtog nogen behandling eller blev behandlet med Equisolon i tre forskellige doser, hver i 10 dage.
English: Prednisolone
Danish: Equisolon prednisolon
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på etiketten/den ydre emballage.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equisolon exceed the risks for the approved indication and recommended that Equisolon be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) besluttede, at fordelene ved Equisolon opvejer risiciene til den godkendte anvendelse, og anbefalede udstedelse af en markedsføringstilladelse for Equisolon.
English: It is available as a powder to be given by mouth.
Danish: Det leveres som et pulver til indgift gennem munden.
English: The withdrawal period for Equisolon for meat is ten days.
Danish: Tilbageholdelsestiden for Equisolon er 10 døgn for kød.
English: What is the risk associated with Equisolon?
Danish: Hvilken risiko er der forbundet med Equisolon?
English: The medicine should not be given to horses by pregnant women as there is a risk of malformation to the unborn baby.
Danish: Lægemidlet bør ikke indgives af gravide kvinder, da der er risiko for misdannelser hos fosteret.
English: Equisolon should not be used in mares producing milk for human consumption.
Danish: Equisolon må ikke anvendes hos hopper, der producerer mælk til menneskeligt konsum.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: Equisolon is a veterinary medicine that contains the active substance prednisolone.
Danish: Equisolon er et lægemiddel til dyr indeholdende det aktive stof prednisolon.
English: Equisolon should be mixed with a small amount of food and given by mouth at a dose of 1 mg prednisolone per kg bodyweight once a day.
Danish: Equisolon bør blandes i en mindre portion foder og gives gennem munden i en dosis af 1 mg prednisolon/kg kropsvægt én gang dagligt.
English: This decreases inflammation, thereby helping to keep the airways clear and allowing the horse to breathe more easily.
Danish: Dette nedsætter inflammation, så luftvejene holdes åbne, og hesten får lettere ved at trække vejret.
English: It is also the time allowed after administration of the medicine before milk can be used for human consumption.
Danish: Det er også den tid, der skal gå efter indgivelsen af lægemidlet, før mælken kan anvendes til menneskeligt konsum.
English: The active substance in Equisolon, prednisolone, is a corticosteroid, a medicine that acts to reduce the activity of the immune system.
Danish: Det aktive stof i Equisolon, prednisolon, er et binyrebarkhormon, som er et lægemiddel, der nedsætter immunsystemets aktivitet.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: The use of prednisolone in horses with RAO has been well described in the scientific literature.
Danish: Anvendelsen af prednisolon hos heste med tilbagevendende vejrtrækningshindring er velbeskrevet i den videnskabelige litteratur.
English: In addition to treatment with prednisolone, the exposure to organic dust was reduced by substituting hay with silage and by improving the ventilation in the stable.
Danish: Foruden behandling med prednisolon blev udsættelsen for organisk støv mindsket ved at erstatte hø med ensilage og forbedre udluftningen i stalden.
English: This results in inflammation and blockage of the airways inside the lungs, leading to difficulty in breathing.
Danish: Dette medfører inflammation og blokering af luftvejene i lungerne, så vejrtrækningen bliver besværlig.
English: The environmental measures include keeping horses outside as much as possible or improving the ventilation in the stable, soaking hay or feeding silage (fermented grass) and using bedding with a minimum of dust in the stable.
Danish: Kontrollen af omgivelserne består i at holde hesten udendørs så meget som muligt eller forbedre udluftningen i stalden, fugte høet eller fodre med ensilage (gæret græs) samt bruge strøelse med mindst muligt støv.
English: In horses with RAO, the immune system (the body's natural defences) over-reacts to triggering substances (antigens) that are present in dust that the horse breathes in.
Danish: Hos heste med tilbagevendende vejrtrækningshindring overreagerer immunsystemet (kroppens naturlige forsvar) på udløsende stoffer (antigener), der findes i det støv, hesten indånder.
English: The most common side effects (seen in more than 1 in 10 horses) with Equisolon are suppression of production of cortisol (a natural corticosteroid important in the body's response to stress), and an increase in the level of triglycerides (a type of fat) in the blood.
Danish: De hyppigste bivirkninger med Equisolon (som optræder hos mere end 1 ud af 10 heste) er undertrykkelse af produktionen af det naturlige binyrebarkhormon kortisol, der er vigtigt for kroppens reaktion på stress, og stigning i blodets indhold af fedtstoffer af typen triglycerider.
English: Equisolon must not be used in horses with viral or fungal infections, gastrointestinal or corneal ulcers or in pregnant mares.
Danish: Equisolon må ikke anvendes hos heste med virus- eller svampeinfektioner, sår i mave-tarm-systemet eller hornhinden eller hos drægtige hopper.
English: Treatment with prednisolone at the recommended dose of 1 mg per kg bodyweight over ten days in combination with environmental control resulted in significant improvements in fluid in the airways and clinical signs associated with RAO.
Danish: Behandling med prednisolon i den anbefalede dosis på 1 mg/kg kropsvægt i 10 dage kombineret med kontrol af omgivelserne resulterede i væsentlig bedring i væskemængden i luftvejene og i de kliniske tegn, der forbundet med tilbagevendende vejrtrækningshindring.
English: For a full list of all side effects reported with Equisolon, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Equisolon fremgår af indlægssedlen.
English: RAO is a chronic (long-term) allergic condition in which horses wheeze, cough and have difficulty in breathing.
Danish: Tilbagevendende vejrtrækningshindring er en langvarig (kronisk) allergisk sygdom, hvor hesten har hvæsende vejrtrækning, hoste og vejrtrækningsbesvær.
English: Why has Equisolon been approved?
Danish: Hvorfor blev Equisolon godkendt?
English: The main measures of effectiveness were clinical signs of RAO disease as well as the amount of fluid and immune cells in the airways and the air pressure in the lungs.
Danish: Virkningen blev hovedsagelig bedømt på kliniske tegn på tilbagevendende vejrtrækningshindring og på mængderne af væske og immunceller i luftvejene og lufttrykket i lungerne.
English: The product should not be shaken to prevent dust formation.
Danish: For at undgå støvdannelse bør lægemidlet ikke omrystes.
English: What is Equisolon used for?
Danish: Hvad anvendes Equisolon til?
English: How has Equisolon been studied?
Danish: Hvordan blev Equisolon undersøgt?
English: What is Equisolon?
Danish: Hvad er Equisolon?
English: What benefit has Equisolon shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Equisolon?
English: How does Equisolon work?
Danish: Hvordan virker Equisolon?
English: Equisolon is used to treat recurrent airway obstruction (RAO or heaves) in horses in combination with environmental measures.
Danish: Equisolon anvendes i kombination med kontrol af omgivelserne til behandling af tilbagevendende vejrtrækningshindring hos heste.
English: These measures should help to protect the environment.
Danish: Disse foranstaltninger skal bidrage til at beskytte miljøet.
English: Protect from light.
Danish: Beskyttes mod lys.
English: If such reactions occur appropriate treatment is recommended.
Danish: Hvis sådanne reaktioner opstår anbefales passende behandling.
English: However, these reactions may be more severe and/or last longer.
Danish: Imidlertid kan reaktionerne være værre og/eller vare længere.
English: Active substances:
Danish: Aktive stoffer:
English: Duration of immunity: 1 year.
Danish: Varighed af immunitet: 1 år.
English: Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.
Danish: Sådanne hævelser vil enten være forsvundet eller være tydelig formindskede 14 dage efter vaccination.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten.
English: None.
Danish: Ingen.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant.
English: ATCvet code: QI07AB01.
Danish: ATCvet-kode:QI07AB01
English: In very rare cases a transient acute hypersensitivity reaction may occur.
Danish: I meget sjældne tilfælde kan en forbigående akut overfølsomhedsreaktion forekomme.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: Onset of immunity: 3 weeks.
Danish: Indtræden af immunitet: 3 uger.
English: Dogs.
Danish: Hunde.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16/07/2012.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16/07/2012.