FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness of Oxybee against varroa mites was investigated in two field studies in European countries with different climates.
Danish: Virkningen af Oxybee mod varroamider er undersøgt i to feltundersøgelser i europæiske lande med forskellige klimaer.
English: Used measuring devices and empty containers should be disposed of immediately in a safe way.
Danish: Det anvendte doseringsudstyr og tom emballage skal straks bortskaffes på en sikker måde.
English: It is not intended to provide practical advice on how to use Oxybee.
Danish: Det er ikke en praktisk vejledning i, hvordan Oxybee bør anvendes.
English: Other information about Oxybee
Danish: Andre oplysninger om Oxybee
English: Oxybee is a medicine used to treat varroosis in honey bee colonies.
Danish: Oxybee er et lægemiddel til behandling af varroasyge i honningbikolonier.
English: If the product is accidentally swallowed by a person, their mouth should be cleaned with water and water or milk should be drunk, but vomiting should not be induced.
Danish: Ved utilsigtet indtagelse vaskes munden med vand, og der drikkes vand eller mælk, men opkastning bør ikke fremprovokeres.
English: Oxybee can only be used on colonies without brood.
Danish: Oxybee må kun anvendes i kolonier uden yngel.
English: Why is Oxybee approved?
Danish: Hvorfor blev Oxybee godkendt?
English: Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor).
Danish: Varroasyge er en sygdom hos honningbier, som er angrebet af en parasit, der kaldes varroamide (Varroa destructor).
English: What is Oxybee and what is it used for?
Danish: Hvad er Oxybee, og hvad anvendes det til?
English: Oxybee is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose).
Danish: Oxybee er meget surt og kan virke irriterende og ætsende på hud, øjne og slimhinder (den indvendige side af kroppens hulrum, som f.eks. munden og næsen).
English: What are the risks associated with Oxybee?
Danish: Hvilke risici er der forbundet med Oxybee?
English: How oxalic acid works on mites is not well understood but is thought to be due to the acidity of the medicine, which kills the mites on contact.
Danish: Det er ikke helt klarlagt, hvordan oxalsyre virker på miderne, men det menes, at det er stoffets surhed,
English: Oxybee oxalic acid
Danish: Oxybee oxalsyre
English: The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees; the mite can also help spread viruses and bacteria.
Danish: Varroamidens ernæring består af hæmolymfe (blod) fra voksne bier samt larver og pupper (honningbiens udviklingsstadier), hvilket resulterer i, at honningbierne skades og/eller dør.
English: Oxybee is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Danish: Oxybee fås som et pulver og opløsning til bistadedispersion (en væske, der bruges inde i bistadet) og udleveres uden recept.
English: For more information about treatment with Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Oxybee, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Oxybee work?
Danish: Hvordan virker Oxybee?
English: What benefits of Oxybee have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Oxybee?
English: How is Oxybee used?
Danish: Hvordan anvendes Oxybee?
English: For practical information about using Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Oxybee, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The European Commission granted a marketing authorisation valid throughout the EU for Oxybee on 1 February 2018.
Danish: Union for Oxybee den 01/02/2018.
English: MedDRA Preferred term
Danish: MedDRA foretrukken term
English: These studies however, are of limited relevance.
Danish: Disse forsøg er imidlertid af begrænset relevans.
English: It is not known whether elderly patients respond differently from younger patients.
Danish: Det vides ikke, om ældre patienter reagerer anderledes end yngre patienter.
English: It is important to initiate treatment as early as possible.
Danish: Det er vigtigt at starte behandlingen så tidligt som muligt.
English: Date of first authorisation: 28 April 2014 Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 28. april 2014 Dato for seneste fornyelse:
English: Elderly patients (≥ 65 years old)
Danish: Særlige populationer Ældre patienter (≥ 65 år)
English: As a result, these substances do not get broken down and processed by the body as they should.
Danish: Som et resultat heraf, bliver disse stoffer ikke nedbrudt og behandlet af kroppen, som de skal.
English: These problems can be a part of the disease and may be caused by pressure on your spinal cord.
Danish: Disse problemer kan være en del af sygdommen og kan være forårsaget af tryk på din rygmarv.
English: The current medical standards for emergency treatment are to be followed.
Danish: De nuværende medicinske standarder for akutbehandling skal følges.
English: Aseptic technique is to be used.
Danish: Aseptisk teknik skal anvendes.
English: No differences in the safety profile were observed.
Danish: Der blev ikke observeret nogen forskelle i sikkerhedsprofilen.
English: This medicine may improve the symptoms of MPS IVA.
Danish: Dette lægemiddel kan forbedre symptomerne på MPS IVA.
English: • Educational material for Healthcare Professionals
Danish: • Undervisningsmateriale for sundhedsprofessionelle
English: ATC code: A16AB12.
Danish: ATCkode: A16AB12.
English: The primary and secondary endpoints were evaluated at Week 24 (see Table 3).
Danish: De primære og sekundære endepunkter blev evalueret i uge 24 (se tabel 3).
English: The treatment benefit to the child compared to the associated risks must be fully evaluated prior to treatment.
Danish: Fordelen ved behandlingen for barnet sammenholdt med de forbundne risici skal vurderes fuldt ud inden behandlingen.
English: The evaluation of the peri- and postnatal development study in rats is hampered due to subsequent administration of DPH, and therefore of limited relevance.
Danish: Evaluering af den peri- og postnatale udvikling hos rotter er hæmmet på grund af efterfølgende administration af DPH, og er derfor af begrænset relevans.
English: The safety and efficacy of Vimizim in patients older than 65 years has not been established, and no alternative treatment regimen can be recommended in these patients.
Danish: Sikkerhed og virkning af Vimizim hos patienter, der er ældre end 65 år, er ikke klarlagt, og intet alternativt behandlingsregime kan anbefales til disse patienter.
English: Treatment with Vimizim may be started at as young as an age possible and is intended for long term use.
Danish: Behandling med Vimizim kan startes ved så ung en alder som muligt og er beregnet til langvarig brug.
English: The total volume of the infusion should be delivered over approximately 4 hours (see Table 1).
Danish: Den samlede infusionsvolumen skal leveres over ca. 4 timer (se tabel 1).
English: Model-based mean‡ (95%CI) p-value
Danish: Model-baseret middel‡ (95 % CI) p-værdi
English: The difference was greatest between the placebo group and the weekly treatment group for all endpoints.
Danish: Forskellen var størst mellem placebogruppen og den ugentlige behandlingsgruppe for alle endepunkter.
English: Patients continued a long-term follow-up observational study for at least another 52 weeks, for a total of 104 weeks.
Danish: Patienterne fortsatte et langtids observationsstudie i mindst endnu 52 uger i op til i alt 104 uger.
English: If you experience such a reaction, you should immediately contact your doctor.
Danish: Hvis du oplever en sådan reaktion, skal du straks kontakte din læge.
English: Patients who could walk more than 30 meters (m) but less than 325 m in a 6 Minute Walk Test (MWT) at baseline were enrolled in the study.
Danish: Patienter, der kunne gå mere end 30 meter (m) men mindre end 325 m i en 6-minutters gangtest (MWT) ved baseline, blev indskrevet i studiet.
English: Frequencies are defined as: 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) and not known (cannot be estimated from available data).
Danish: Hyppigheden er defineret som: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The educational material for Healthcare Professionals should be a step by step dosing and administration guide that includes information on the following key elements:
Danish: Undervisningsmaterialet for sundhedsprofessionelle skal være en trinvis doserings- og administrationsvejledning, som omfatter oplysninger om følgende nøgleelementer:
English: Warnings and precautions - If you are treated with Vimizim, you may develop infusion reactions.
Danish: Advarsler og forsigtighedsregler - Hvis du behandles med Vimizim, kan du udvikle infusionsreaktioner.
English: Set up a MPS IVA disease Registry to assess the long term safety and efficacy of elosulfase alfa.
Danish: Oprette et MPS IVA sygdomsregister for at vurdere den langsigtede sikkerhed og effekt af elosulfase alfa.
English: Your doctor or nurse will give Vimizim to you by an infusion into a vein.
Danish: Din læge eller sygeplejerske vil give dig Vimizim via en infusion i en vene.
English: Safety and pharmacodynamic results in these patients are consistent with results observed in the first 52 weeks (see section 4.8).
Danish: Sikkerheden og de farmakodynamiske resultater hos disse patienter stemmer overens med de resultater, der er observeret i de første 52 uger (se pkt.
English: This is equivalent to 0.4 % of the recommended daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,4 % af det anbefalede daglige indtag af natrium for en voksen.
English: There are no data on the use of Vimizim in pregnant women.
Danish: Der er ingen data fra anvendelse af Vimizim til gravide kvinder.
English: IRs were generally mild or moderate, and the frequency was higher during the first 12 weeks of treatment and tended to occur less frequently with time.
Danish: Infusionsreaktionerne var generelt milde eller moderate, og hyppigheden var højere i de første 12 uger af behandlingen, og der var en tendens til, at de forekom mindre hyppigt med tiden.
English: ▼This medicine is subject to additional monitoring.
Danish: ▼Dette lægemiddel er underlagt supplerende overvågning.
English: Renal elimination of elosulfase alfa is considered a minor pathway for clearance.
Danish: Renal elimination af elosulfase alfa betragtes som en mindre transportvej for clearance.
English: Vimizim must be diluted prior to administration.
Danish: Vimizim skal fortyndes før administration.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vimizim in one or more subsets of the paediatric population in MPS IVA.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Vimizim i en eller flere undergrupper af den pædiatriske population med MPS IVA.
English: Re-administration after a severe reaction should be carried out with caution and close monitoring by the treating physician.
Danish: Re-administration efter en svær reaktion bør foretages med forsigtighed og under nøje overvågning af den behandlende læge.
English: For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.
Danish: For patienter, der har oplevet allergiske reaktioner under infusion, skal der udvises forsigtighed ved re-administration.
English: Table 1: Recommended infusion volumes and rates*
Danish: Tabel 1: Anbefalede infusionsvolumener og hastigheder*
English: Patient weight (kg)
Danish: Patient ens vægt (kg)
English: The medicine has to be diluted before being given.
Danish: Lægemidlet skal fortyndes, før det gives.
English: From a microbiological safety point of view, the diluted solution should be used immediately.
Danish: Ud fra et mikrobiologisk sikkerhedssynspunkt skal den fortyndede opløsning anvendes straks.
English: - If you have an allergic reaction during your infusion your doctor may slow down, or stop your infusion.
Danish: - Hvis du har en allergisk reaktion i løbet af infusionen, kan din læge gøre infusionen langsommere eller standse din infusion.
English: The dose you receive is based on your body weight.
Danish: Den dosis, du får, er baseret på din kropsvægt.
English: Therefore, appropriate medical support must be readily available when elosulfase alfa is administered.
Danish: Derfor skal passende lægehjælp være let tilgængelig, når elosulfase alfa administreres.
English: Due to lack of human data, Vimizim should only be administered to breast-feeding woman if the potential benefit is considered to outweigh the potential risk to the infant.
Danish: På grund af manglende humane data bør Vimizim kun gives til ammende kvinder, hvis den potentielle fordel anses for at opveje den mulige risiko for spædbarnet.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Vimizim are provided with an Educational pack.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal ved lanceringen sikre, at alt sundhedspersonale, som forventes at anvende og/eller ordinere Vimizim, forsynes med undervisningsmateriale.
English: Elosulfase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Danish: Elosulfase alfa er et protein og forventes at blive metabolisk nedbrudt via peptidhydrolyse.
English: Table 3: Results from placebo-controlled clinical study at 2 mg per kg per week
Danish: Tabel 3: Resultater fra placebo-kontrolleret klinisk studiemed 2 mg/kg pr. uge
English: Discuss with your doctor if the benefits of taking Vimizim are greater than the potential risk to your newborn while breast-feeding.
Danish: Drøft med din læge, om fordelene ved at tage Vimizim er større end den potentielle risiko for dit nyfødte barn, mens du ammer.
English: All patients were treated with antihistamines prior to each infusion.
Danish: Alle patienter blev behandlet med antihistaminer før hver infusion.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepål (lægemiddelovervågning eller risikominimering) er nået.
English: However, patients with positive neutralizing antibodies responses had decreased total clearance (CL) values and prolonged t1/2.
Danish: Men patienter med positive, neutraliserende antistofreaktioner havde reducerede, samlet clearance (CL)-værdier og forlænget t1/2.
English: A total of 235 patients with MPS IVA were enrolled and exposed to Vimizim in six clinical studies.
Danish: I alt 235 patienter med MPS IVA blev rekrutteret og eksponeret for Vimizim i seks kliniske studier.
English: The recommended dose is 2 mg per kg.
Danish: Den anbefalede dosis er 2 mg/kg.
English: It is not known whether elosulfase alfa is excreted in human breast milk, but systemic exposure via breast milk is not expected.
Danish: Det vides ikke, hvorvidt elosulfase alfa udskilles i human mælk, men systemisk eksponering via modermælk forventes ikke.
English: Your doctor or nurse will give you some medicines before your treatment to reduce allergic reactions and you may also be given medicines to help control any fever.
Danish: Din læge eller sygeplejerske vil give dig noget medicin før din behandling for at mindske allergiske reaktioner, og du kan også få medicin til at hjælpe med at kontrollere eventuel feber.
English: Mean half-life (t1/2) increased from 7.52 minutes at Week 0 to 35.9 minutes at Week 22.
Danish: Den gennemsnitlige halveringstid (t1/2) steg fra 7,52 minutter i uge 0 til 35,9 minutter i uge 22.
English: Vimizim should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Danish: Vimizim bør ikke blandes med andre lægemidler i samme infusion end dem, der er nævnt nedenfor.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Danish: Før lancering i hvert medlemsland skal undervisningsprogrammets indhold og format godkendes af den relevante nationale myndighed.
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion reactions”).
Danish: Bivirkninger sås hovedsageligt, mens patienterne fik medicinen eller kort tid efter (”infusionsreaktioner”).
English: Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with elosulfase alfa.
Danish: Langsigtede dyrestudier for at vurdere kræftfremkaldende potentiale eller studier for at evaluere mutagent potentiale er ikke blevet udført med elosulfase alfa.
English: If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine unless discussed with your doctor.
Danish: Hvis du (eller dit barn) har arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, må du (eller dit barn) ikke få dette lægemiddel, medmindre I har talt med lægen om det.
English: The appropriate number of vials is removed from the refrigerator.
Danish: Det nødvendige antal hætteglas tages ud af køleskabet.
English: The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator in advance in order to allow them to reach 23C - 27C.
Danish: Antal hætteglas, der skal fortyndes baseret på den enkelte patients vægt, skal bestemmes og tages ud af køleskabet i forvejen for at gøre det muligt for dem at nå 23 C til 27 C.
English: Once the product has been diluted it should be used immediately.
Danish: Når produktet er fortyndet, skal det anvendes straks.
English: An infusion reaction is any side effect, including an allergic reaction, occurring during the infusion or within a day following infusion (see section 4).
Danish: En infusionsreaktion er enhver bivirkning, inklusive en allergisk reaktion, som opstår under infusionen eller inden for en dag efter infusionen (se punkt 4).
English: Each infusion will take approximately 4 hours.
Danish: Hver infusion tager ca. 4 timer.
English: Because this is a protein solution, slight flocculation (thin translucent fibres) may occur.
Danish: Da dette er en proteinopløsning, kan der forekomme en let flokkulering (tynde gennemsigtige fibre).
English: Treatment should be supervised by a physician experienced in the management of patients with MPS IVA or other inherited metabolic diseases.
Danish: Behandling skal superviseres af en læge med erfaring i behandling af patienter med MPS IVA eller andre arvelige stofskiftesygdomme.
English: Home administration under the supervision of an appropriately trained healthcare professional may be considered for patients who are tolerating their infusions well.
Danish: Administration i hjemmet under tilsyn af en behørigt uddannet sundhedsfaglig person kan overvejes for patienter, der tolererer infusionerne godt.
English: In clinical studies, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo.
Danish: I kliniske studier blev SCC (spinal/cervical cord compression) observeret både hos patienter, der fik Vimizim og hos patienter, der fik placebo.
English: The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Danish: De fleste patienter havde kort statur, nedsat udholdenhed og muskuloskeletale symptomer.
English: Treatment has been shown to improve walking and to reduce the levels of keratan sulphate in the body.
Danish: Behandlingen har vist sig at forbedre evnen til at gå og nedbringe keratansulfatniveauerne i kroppen.
English: At Week 22, the mean AUC0-t and Cmax increased by 181% and 192%, respectively, when compared to Week 0
Danish: I uge 22 steg middel-AUC0-t og -Cmax med henholdsvis 181 % og 192 % i forhold til uge 0.
English: A detailed history with regard to HFI symptoms has to be taken for each patient prior to being given this medicinal product.
Danish: Detaljeret anamnese med henblik på symptomer på HFI skal foretages for hver patient, før lægemidlet administreres.
English: The results from the every other week regimen in the distance walked in 6 minutes or in stairs climbed per minute were comparable to placebo.
Danish: Resultaterne fra regimet med hver anden uge med tilbagelagt afstand på 6 minutter eller med trappetrin besteget pr. minut var sammenlignelig med placebo.
English: Polysorbate 20;
Danish: Polysorbat 20;
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Danish: Inden du får dette lægemiddel, skal du fortælle din læge, hvis du (eller dit barn) har HFI, eller hvis dit barn ikke længere må få sød mad eller drikke, fordi det føler sig sygt, kaster op eller får ubehagelige bivirkninger som oppustethed, mavekramper eller diarré.
English: It is not known if Vimizim impacts human fertility.
Danish: Det vides ikke, om Vimizim påvirker menneskers frugtbarhed.
English: Vimizim contains an enzyme called elosulfase alfa, which belongs to a group of medicines known as enzyme replacement therapies.
Danish: Vimizim indeholder et enzym kaldet elosulfase alfa, som tilhører en gruppe lægemidler kendt som enzymerstatningsbehandlinger.
English: No effect on fertility was observed in animals.
Danish: Der blev ikke observeret nogen påvirkning af frugtbarheden hos dyr.
English: Male and female patients had comparable elosulfase alfa clearance, and clearance did not trend with age or weight at week 22.
Danish: Mandlige og kvindelige patienter havde sammenlignelig elosulfase alfa clearance, og clearance bevægede sig ikke i forhold til alder eller vægt i uge 22.
English: The safety and efficacy of Vimizim was assessed in a randomised, double-blind, placebo-controlled, Phase 3 clinical study of 176 patients with MPS IVA, ranging in age from 5 to 57 years.
Danish: Sikkerheden og effekten af Vimizim blev vurderet i et randomiseret, dobbelt-blindet, placebokontrolleret, klinisk studie i fase 3 med 176 patienter med MPS IVA i alderen fra 5 til 57 år.
English: You must not receive Vimizim - if you have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Vimizim - hvis du har oplevet livstruende allergiske reaktioner på elosulfase alfa eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The majority of adverse reactions in clinical studies were IRs, which are defined as reactions occurring after initiation of infusion until the end of the day following the infusion.
Danish: Størstedelen af bivirkningerne ved kliniske studier var infusionsreaktioner, som er defineret som reaktioner, der opstår mellem begyndelsen af infusion og slutningen af dagen efter infusionen.