FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position.
Danish: PRAC's anbefalinger blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - lægemidler til mennesker (CMDh), som vedtog et standpunkt.
English: • Companies have been asked to take steps by 2019 to replace current formulations containing lactose with lactose-free formulations.
Danish: • Virksomhederne er blevet anmodet om seneste i 2019 at træffe foranstaltninger til at erstatte de nuværende laktoseholdige formuleringer med laktosefri formuleringer.
English: The review of injectable medicines for acute allergic reaction that contain lactose from cows' milk was initiated on 1 December 2016 at the request of Croatia, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler til injektion, der anvendes mod akutte allergiske reaktioner og indeholder laktose fra komælk, blev indledt den 1. december 2016 på anmodning af Kroatien i henhold til artikel 31 i direktiv 2001/83/EF.
English: 1 The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) is a medicines regulatory body representing the European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.
Danish: 1 Koordineringsgruppen for gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) er et lægemiddelregulerende organ, der repræsenterer EU's medlemsstater samt Island, Liechtenstein og Norge.
English: This is of particular concern in patients already being treated for an allergic reaction as they are more prone to developing new allergic reactions.
Danish: Dette er særligt bekymrende hos patienter, der allerede er i behandling for en allergisk reaktion, da de har øget tilbøjelighed til at få nye allergiske reaktioner.
English: Considering that methylprednisolone is used for the treatment of severe allergic reactions in an emergency setting where details of the patients' allergies may not always be known, the CMDh confirmed that the most effective way of minimising any risks is to remove cow's milk proteins from the preparation.
Danish: I betragtning af, at methylprednisolon anvendes til behandling af alvorlige allergiske reaktioner i akutte situationer, hvor detaljer om patientens allergier måske ikke altid er kendt, fastslog CMDh, at den mest effektive måde at minimere alle risici på er at fjerne mælkeproteinerne fra præparatet.
English: In some of the reported cases the adverse reaction was misinterpreted as a lack of therapeutic effect, leading to re-administration of methylprednisolone and subsequent worsening of the patient's clinical condition.
Danish: I nogle af de beskrevne tilfælde blev bivirkningen fejlfortolket som manglende terapeutisk virkning, hvad der førte til endnu en administration af methylprednisolon og efterfølgende forværring af patientens kliniske tilstand.
English: Methylprednisolone-containing medicines have been authorised by national procedures for use by injection into a vein or muscle and have been available for many years in the EU under a variety of brand names including Solu-Medrol.
Danish: Lægemidler indeholdende methylprednisolon er ved nationale procedurer godkendt til anvendelse ved injektion i en vene eller muskel og har i mange år været på markedet i EU under forskellige handelsnavne, bl.a. Solu-Medrol.
English: CMDh further confirmed that patients being treated with methylprednisolone for an allergic reaction should have their treatment stopped if their symptoms worsen or they develop new symptoms.
Danish: CMDh har desuden fastslået, at patienter, der er i behandling med methylprednisolon for en allergisk reaktion, skal tages ud af behandlingen, hvis deres symptomer forværres eller de får nye symptomer.
English: • Patients being treated for an allergic reaction with these products should have their treatment stopped if their symptoms worsen or they develop new symptoms as these could be signs of an allergic reaction to cow's milk proteins.
Danish: • Hos patienter, der behandles for en allergisk reaktion med disse produkter, bør behandlingen afbrydes i tilfælde af forværring af symptomerne eller ved nye symptomer, da dette kan være tegn på en allergisk reaktion på mælkeproteiner.
English: In this case it may be difficult to determine whether the patient's symptoms are due to a new allergic reaction caused by methylprednisolone products containing lactose or due to a worsening of the original condition.
Danish: I sådanne tilfælde kan det være svært at afgøre, om patientens symptomer skyldes en ny allergisk reaktion forårsaget af methylprednisolon-præparater indeholdende laktose, eller om de skyldes forværring af den oprindelige lidelse.
English: CMDh agreed with the PRAC's conclusion that there is no level of cow's milk proteins that can be considered safe for these medicines when used to treat severe allergic reactions.
Danish: CMDh tilsluttede sig PRAC's konklusion om, at der ikke er nogen koncentration af proteiner fra komælk, der kan betragtes som sikker i disse lægemidler, når de anvendes til behandling af alvorlige allergiske reaktioner.
English: It is considered that allergic conditions, such as asthma exacerbation, may increase susceptibility to allergic reactions to cow's milk proteins in methylprednisolone products containing lactose of bovine origin.
Danish: Det antages, at allergiske tilstande såsom eksacerbation af astma kan øge tilbøjeligheden til allergiske reaktioner på mælkeproteiner i methylprednisolonpræparater indeholdende laktose af bovin oprindelse.
English: Current formulations containing lactose will be replaced with lactose-free formulations
Danish: De nuværende laktoseholdige præparater skal erstattes med laktosefri præparater
English: The review of these medicines was triggered following reports of serious allergic reactions such as bronchospasm (excessive contraction of the airway muscles causing breathing difficulty) and anaphylaxis (sudden severe allergic reaction) with these medicines in patients allergic to cow's milk proteins.
Danish: Gennemgangen af disse lægemidler var foranlediget af rapporter om alvorlige allergiske reaktioner såsom krampe i luftvejsmuskulaturen med vejrtrækningsbesvær (bronkospasme) og pludselig alvorlig allergisk reaktion (anafylaksi) med disse lægemidler hos patienter med allergi over for mælkeproteiner.
English: Methylprednisolone injections are used to treat the symptoms of severe allergic reactions and other inflammatory conditions.
Danish: Methylprednisolon-injektionspræparater anvendes til behandling af symptomer på svære allergiske reaktioner og andre betændelsestilstande (inflammatoriske tilstande).
English: In addition, the vial and packaging of these medicines will be clearly marked with a warning against use in patients with cow's milk allergy.
Danish: Derudover skal hætteglasset og emballagen til disse lægemidler være tydeligt forsynet med en advarsel om, at det ikke må anvendes hos patienter, der er allergiske over for komælk.
English: The review covered certain injectable medicines which contain the corticosteroid methylprednisolone and are used to treat the symptoms of severe allergic reactions and other inflammatory conditions.
Danish: Gennemgangen omfattede visse injektionslægemidler, der indeholder binyrebarkhormonet methylprednisolon og anvendes til behandling af symptomerne på svære allergiske reaktioner og andre betændelsestilstande.
English: • Methylprednisolone injections containing lactose of bovine origin are now contraindicated in patients known or suspected to be allergic to cow's milk proteins.
Danish: • Methylprednisolon-injektionspræparater indeholdende laktose af bovin oprindelse er nu kontraindiceret hos patienter med kendt eller formodet allergi over for mælkeproteiner.
English: • Lactose of bovine origin is used as an excipient in some injectable methylprednisolone-containing products.
Danish: • laktose af bovin oprindelse anvendes som hjælpestof i visse injektionspræparater med methylprednisolon.
English: • If you are being treated for an allergic reaction with these products and your symptoms worsen,
Danish: • Hvis du er i behandling for en allergisk reaktion med sådanne lægemidler, og dine symptomer bliver værre, vil lægen stoppe behandlingen.
English: • Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions with these medicines.
Danish: • Der er beskrevet alvorlige allergiske reaktioner, herunder bronkospasme og anafylaksi, hos patienter, der er allergiske over for mælkeproteiner og behandles med sådanne lægemidler for akutte allergiske tilstande.
English: Specifically, the review covered the strengths of injections that contain lactose (milk sugar) derived from cows' milk and hence can contain traces of cows' milk proteins.
Danish: Gennemgangen omfattede specielt de styrker af lægemidler til injektion, der indeholder laktose (mælkesukker) fra komælk og derfor kan indeholde spor af mælkeproteiner.
English: Corticosteroids are anti-inflammatory medicines used to control the immune system (the body's natural defences) when it is overactive, as in allergic conditions.
Danish: Binyrebarkhormoner er betændelsesdæmpende (antiinflammatoriske) lægemidler, der anvendes til at kontrollere immunsystemet, når det er overaktivt som ved allergiske tilstande.
English: The review found that methylprednisolone injections containing lactose derived from cow's milk may also contain traces of cow's milk proteins which can trigger allergic reactions.
Danish: Ved gennemgangen fandtes, at methylprednisolon-injektionspræparater, der indeholder laktose fra komælk, kan indeholde spor af mælkeproteiner, som kan udløse allergiske reaktioner.
English: This is because these products could contain traces of cow's milk proteins, which can cause serious allergic reactions in patients allergic to cow's milk.
Danish: Det skyldes, at sådanne lægemidler kan indeholde spor af mælkeproteiner, som kan medføre alvorlige allergiske reaktioner hos patienter med allergi over for komælk.
English: These products may also contain trace amounts of milk proteins, which can trigger an allergic reaction in patients allergic to cow's milk proteins.
Danish: Sådanne produkter kan indeholde spor af mælkeproteiner, der kan udløse en allergisk reaktion hos patienter med allergi over for mælkeproteiner.
English: The CMDh1 has endorsed the recommendation of EMA's Pharmacovigilance Risk Assessment Committee (PRAC) that methylprednisolone injections containing lactose (milk sugar), which potentially contain traces of cow's milk proteins, must not be used in patients with a known or suspected allergy to the proteins in cow's milk.
Danish: CMDh1 har tilsluttet sig anbefalingen fra EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC) om, at methylprednisolon-injektionspræparater, der indeholder laktose (mælkesukker), ikke må anvendes til patienter med kendt eller formodet allergi over for proteiner i komælk, da præparaterne kan indeholde spor af mælkeproteiner.
English: In the meantime, the product information will be revised to reflect that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins.
Danish: I mellemtiden vil produktoplysningerne blive revideret, så de afspejler, at patienter med allergi over for proteiner fra komælk ikke må få laktoseholdige methylprednisolon-injektionspræparater.
English: On 31 July 2017 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: De foranstaltninger, som PRAC anbefaler, skal derfor nu gennemføres direkte af de medlemsstater, hvor lægemidlerne er godkendt.
English: • Tell your doctor if you have or suspect you have an allergy to cow's milk proteins.
Danish: • Sig det til lægen, hvis du er allergisk over for mælkeproteiner eller formoder at være det.
English: • If you are allergic to cow's milk proteins and you require methylprednisolone, your doctor will use a methylprednisolone medicine that does not contain lactose or use an alternative medicine.
Danish: • Hvis du er allergisk over for mælkeproteiner og behøver methylprednisolon, vil lægen anvende et laktosefrit methylprednisolon-lægemiddel eller et andet lægemiddel.
English: • For patients allergic to cow's milk protein who require methylprednisolone, consider preparations that do not contain lactose or use alternative treatments.
Danish: • For patienter, der er allergiske over for mælkeproteiner og behøver methylprednisolon, bør det overvejes at anvende laktosefri præparater eller andre behandlinger.
English: • If you have any questions or concerns, speak with your doctor or pharmacist.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du vil vide mere om eller er betænkelig ved.
English: • If you are allergic or suspected to be allergic to the proteins in cow's milk, you must not receive methylprednisolone injections containing lactose.
Danish: • Hvis du er allergisk over for proteinerne i komælk eller formoder at være det, må du ikke få methylprednisolon i form af laktoseholdige injektionslægemidler.
English: CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins
Danish: CMDh fastslår, at patienter, der er allergiske over for proteiner i komælk, ikke må få methylprednisoloninjektionspræparater, der indeholder laktose
English: Companies have been asked to provide data allowing the replacement of formulations containing lactose from cow's milk; this data should be provided by the middle of 2019.
Danish: Disse data skal forelægges senest i midten af 2019.
English: Tube (Alu) 60 g (0.1%)
Danish: 60 g (0,1%)
English: EU number Invented name Strength Pharmaceutical formRoute of administration Packaging Content (concentration) Package size EU/1/00/149/001 Panretin
Danish: EU/1/00/149/001 Panretin
English: Cutaneous use
Danish: Pakningsstørrelse
English: This summary was last updated in January 2012.
Danish: Dette sammendrag blev sidst ajourført i januar 2012.
English: In cattle, seven main studies were carried out.
Danish: Hos kvæg er der foretaget syv hovedundersøgelser.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dicural on 16 January 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dicural den 16. januar 1998.
English: These tend to disappear within one or two days and do not require additional treatment.
Danish: Disse bivirkninger forsvinder som regel inden for én eller to dage og kræver ikke yderligere behandling.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Danish: Hvor lang tid skal der gå, før dyret kan slagtes, og kødet anvendes til menneskeføde (tilbageholdelsestid)?
English: Other information about Dicural:
Danish: Andre oplysninger om Dicural:
English: It is only used in calves and young cattle.
Danish: Det anvendes kun til kalve og ungkvæg.
English: The itching tends to disappear within a few minutes and the swelling within a few days.
Danish: Kløen forsvinder som regel inden for nogle få minutter, og hævelsen inden for nogle få dage.
English: It is available as an oral solution for chickens and turkeys (100 mg/ml), as tablets for dogs (15 mg, 50 mg, 100 mg and 150 mg), and as a solution for injection for cattle and dogs (50 mg/ml).
Danish: Det fås som oral opløsning til kyllinger og kalkuner (100 mg/ml), som tabletter til hunde (15 mg, 50 mg, 100 mg og 150 mg) og som opløsning til injektion til kvæg og hunde (50 mg/ml).
English: This includes small- and medium-sized breeds up to and including eight months of age, large breeds up to one year of age and giant breeds up to 18 months of age.
Danish: Dette omfatter små- og mellemstore racer til og med 8 måneder, større racer op til 1 år og meget store racer op til 18 måneder.
English: Dicural must not be used in birds producing eggs for human consumption or within four weeks before the onset of the laying period.
Danish: Dicural må ikke anvendes til fugle, der producerer æg til konsum, eller inden for fire uger inden starten af læggeperioden.
English: Dicural is used to treat infections caused by bacteria:
Danish: Dicural anvendes til behandling af infektioner forårsaget af bakterier:
English: In all species, Dicural was effective in reducing the number of infected animals or reducing the severity of infection.
Danish: I alle dyrearterne var Dicural effektivt med hensyn til at reducere antallet af smittede dyr eller reducere graden af infektion.
English: After the last administration of Dicural, chickens and turkeys should not be slaughtered for 24 hours and cattle should not be slaughtered for 46 days.
Danish: Efter den sidste indgift af Dicural må kyllinger og kalkuner ikke slagtes i 24 timer, og kvæg må ikke slagtes i 46 dage.
English: Dicural must not be used in epileptic dogs.
Danish: Dicural må ikke anvendes til hunde med epilepsi.
English: It is given as tablets by mouth once a day for at least five days until the infection has been cured.
Danish: Det indgives via munden som tablet én gang daglig i mindst fem dage, indtil infektionen er forsvundet.
English: Dicural was as effective as or slightly more effective than the comparator antibiotics.
Danish: Dicural var lige så effektivt som eller en smule mere effektivt end de antibiotika, som det blev sammenlignet med.
English: Dicural is given once a day for up to five days as an injection under the skin.
Danish: Dicural gives én gang daglig i op til fem dage som en injektion under huden.
English: People who are hypersensitive (allergic) to quinolones (a group of antibiotics that includes the fluoroquinolones) should avoid any contact with Dicural.
Danish: Personer, som er overfølsomme (allergiske) over for quinoloner (en gruppe af antibiotika, som omfatter fluoroquinolonerne), skal undgå enhver kontakt med Dicural.
English: In chickens and turkeys, no side effects from Dicural are known.
Danish: Hos kyllinger og kalkuner er der ingen kendte bivirkninger ved Dicural.
English: In chickens and turkeys, nine main trials have been carried out in birds with respiratory system infections.
Danish: Hos høns og kalkuner er der foretaget ni hovedundersøgelser med fugle, der havde luftvejsinfektioner.
English: When handling Dicural oral solution for chickens and turkeys, use gloves and a face-protecting device to avoid irritation of the skin or eyes.
Danish: Ved håndtering af Dicural oral opløsning til kyllinger og kalkuner skal der anvendes handsker og ansigtsbeskyttelse for at undgå irritation af huden eller øjnene.
English: As for other fluoroquinolones, difloxacin should not be used in dogs that are growing quickly because it can affect the cartilage of some joints.
Danish: I lighed med andre fluoroquinoloner må difloxacin ikke anvendes til hunde, som vokser hurtigt, da det kan påvirke brusken i nogle af hundens led.
English: What is the risk associated with Dicural?
Danish: Hvilken risiko er der forbundet med Dicural?
English: Difloxacin works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Danish: Difloxacin virker ved at blokere et enzym kaldet "DNA-gyrase", som spiller en vigtig rolle for, at bakterier kan lave kopier af deres eget DNA.
English: In dogs, side effects from Dicural are rare, but include loss of appetite, vomiting, diarrhoea and anal irritation.
Danish: Hos hunde er bivirkninger ved Dicural sjældne, men omfatter appetitløshed, opkastning, diarré og irritation ved endetarmen.
English: The active substance in Dicural, difloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Danish: Det aktive stof i Dicural, difloxacin, tilhører en gruppe af antibiotika kaldet "fluoroquinoloner".
English: On the first day of treatment, it can be given by injection under the skin before switching to the tablets;
Danish: På den første dag af behandlingen kan det indgives som injektion under huden, hvorefter man går over til tabletformen
English: Why has Dicural been approved?
Danish: Hvorfor blev Dicural godkendt?
English: Dicural contains the active substance difloxacin, which is an antibiotic.
Danish: Dicural indeholder det aktive stof difloxacin, som er et antibiotikum.
English: By blocking the production of DNA, difloxacin stops the bacteria that are causing an infection from growing and multiplying.
Danish: Ved at blokere produktionen af DNA forhindrer difloxacin de bakterier, som forårsager en infektion, i at vokse og formere sig.
English: Injection of Dicural solution for injection under the skin may result in some itching, local swelling and slight pain.
Danish: Injektion af Dicural opløsning til injektion under huden kan medføre kløe, lokal hævelse og milde smerter.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for dette produkt findes på emballagen.
English: In cattle, injection of Dicural solution for injection under the skin may result in some temporary swelling at the site of the injection.
Danish: Hos kvæg kan injektion af Dicural opløsning til injektion under huden medføre forbigående hævelse på injektionsstedet.
English: The full list of bacteria against which Dicural is active can be found in the SPC.
Danish: Den fuldstændige liste med bakterier, som Dicural har en aktiv virkning mod, findes i produktresuméet.
English: What is Dicural?
Danish: Hvad er Dicural?
English: In dogs, four main trials looked at the effects of Dicural in treating bladder infections.
Danish: Fire af hovedundersøgelserne havde til formål at undersøge virkningerne af Dicural til behandling af blæreinfektioner hos hunde.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Dicural are greater than the risks for the treatment and recommended that Dicural be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede at fordelene ved Dicural er større end risiciene.
English: However, since no studies have been performed in lame birds, Dicural must not be used in birds with existing leg weakness or osteoporosis (brittle bones).
Danish: Men da der ikke er foretaget undersøgelser med halte fugle, må Dicural ikke anvendes til fugle med bensvækkelse eller knogleskørhed.
English: One of these trials compared Dicural-treated birds with untreated birds, and another compared Dicural with enrofloxacin (another veterinary fluoroquinolone).
Danish: I en af disse undersøgelser blev Dicural-behandlede fugle sammenlignet med ubehandlede fugle, og i en anden af undersøgelserne blev Dicural sammenlignet med enrofloxacin (et andet veterinærlægemiddel indeholdende fluoroquinolon).
English: What is Dicural used for?
Danish: Hvad anvendes Dicural til?
English: How has Dicural been studied?
Danish: Hvordan blev Dicural undersøgt?
English: Two of these studies compared Dicural with enrofloxacin and one compared it with the combination of amoxicillin and clavulanic acid (used together as an antibiotic).
Danish: I to af disse undersøgelser blev Dicural sammenlignet med enrofloxacin, og i en af undersøgelserne blev det sammenlignet med kombinationsbehandling med amoxicillin og clavulansyre (bruges sammen som et antibiotikum).
English: For full details, see the Summary of Product Characteristics (SPC, also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (der ligeledes er en del af denne EPAR).
English: All seven studies compared Dicural with enrofloxacin in calves.
Danish: Alle syv undersøgelser havde til formål at sammenligne Dicural med enrofloxacin til behandling af kalve.