FrancophonIA/ELRC3.0 huggingface dataset:
English: In the future if the animals are exposed to the virus the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for virusset, vil immunsystemet reagere hurtigere.
English: The period of protection is 8 weeks.
Danish: Vaccinen beskytter i 8 uger.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på etiketten/den ydre emballage.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in chickens.
Danish: Effektiviteten af vaccinen blev først undersøgt hos kyllinger i en række laboratorieundersøgelser.
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 or eggs or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelse af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeføde, eller æg eller mælk kan anvendes til menneskeføde.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at “lære” organismens naturlige forsvar, immunsystemet, hvordan det skal forsvare organismen mod en sygdom.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Afvejningen af fordele og risici (benefit/risk-forholdet) fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis IB Primo QX on 4 September 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis IB Primo QX den 4. september 2014.
English: The laboratory studies showed that the vaccine had its full effect by three weeks and that protection lasted for eight weeks; protection was not affected by antibodies transmitted from the mother.
Danish: Laboratorieundersøgelserne viste, at vaccinen havde fuld virkning i løbet af tre uger, og at beskyttelsen holdt sig i otte uger; beskyttelsen var ikke afhængig af antistoffer overført fra moderdyret.
English: The vaccine is given to chickens from 1 day of age or older by spraying onto the chickens or by applying drops into the eyes or nostrils.
Danish: Vaccinen gives til kyllinger fra de er 1 dag gamle ved spraypåføring på kyllingerne eller ved dråbepåføring i øjne eller næsebor.
English: If vaccinating by spray masks with eye protection should be worn when handling the product.
Danish: Ved sprayvaccinering skal der anvendes maske med øjenværn under håndtering af produktet.
English: Live avian infectious bronchitis virus strain D388
Danish: Levende svækket aviær infektiøs bronkitisvirus stamme D388
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis IB Primo QX exceed the risks for the approved indication and recommended that Nobilis IB Primo QX be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Nobilis IB Primo QX overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Nobilis IB Primo QX.
English: Control groups of birds were unvaccinated to show the effectiveness of the challenge.
Danish: Der blev anvendt kontrolgrupper af uvaccinerede fugle for at vise, at belastningen var effektiv.
English: This will help protect them against infectious bronchitis.
Danish: Derved opnås bedre beskyttelse mod smitsom bronkitis.
English: When Nobilis IB Primo QX is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når Nobilis IB Primo QX gives til kyllinger, registrerer dyrenes immunsystem virus som “fremmede” og reagerer ved at danne antistoffer mod dem.
English: After vaccination a mild short lived reaction in the airways, including a nasal discharge, may occur for at least 10 days.
Danish: Efter vaccination kan der i mindst 10 dage forekomme en kortvarig mild luftvejsreaktion med udflåd fra næsen.
English: The purpose of the studies was to establish how long it took for chickens to be fully protected, the length of time protection lasts against infectious bronchitis due to QX-like variants, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Danish: Formålet var at finde ud af, hvor lang tid det tog for kyllinger at opnå fuld beskyttelse, hvor længe vaccinen beskytter mod smitsom bronkitis forårsaget af QX-lignende varianter, og i hvor høj grad vaccinens virkning afhænger af antistoffer, der overføres fra moderdyret.
English: Nobilis IB Primo QX must not be given to birds which are laying eggs or within 4 weeks before the start of the laying period.
Danish: Nobilis IB Primo QX må ikke gives til æglæggende fugle senere end fire uger før æglægningsperioden begynder.
English: The avian infection bronchitis virus in Nobilis IB Primo QX has been attenuated (weakened) so that it does not cause disease.
Danish: Det smitsomme bronkitisvirus i Nobilis IB Primo QX er blevet svækket, så det ikke kan forårsage sygdom.
English: In a second study 42 broiler chickens were spray vaccinated at 1 day old and challenged 3 weeks after vaccination with a QX strain of the virus.
Danish: I endnu en undersøgelse blev 42 slagtekyllinger sprayvaccineret, da de var 1 dag gamle, og blev tre uger efter vaccinationen belastet med en QX-stamme af virusset.
English: Two groups of 28 birds were challenged with the virus 3 weeks after vaccination, one group with a QX strain and the second group with another strain called M41.
Danish: To grupper på 28 fugle blev belastet med virusset 3 uger efter at være blevet vaccineret, den ene med en QX-stamme, den anden med en anden stamme, M41.
English: Nobilis IB Primo QX is available as a lyophilisate (freeze-dried powder) which may be supplied with a solvent.
Danish: Nobilis IB Primo QX fås som et frysetørret pulver (et lyofilisat), der kan leveres med opløsningsvæske (solvens).
English: The withdrawal period for Nobilis IB Primo QX for chickens is zero days.
Danish: Tilbageholdelsestiden for Nobilis IB Primo QX for kyllinger er 0 døgn.
English: In the first field study 100% of the birds vaccinated with Nobilis IB Primo QX mixed with Nobilis IB Ma5 were protected from the QX strain and 90% were protected from M41, compared with none of the unvaccinated birds.
Danish: I den første feltundersøgelse var 100 % af de fugle, der var vaccineret med Nobilis IB Primo QX blandet med Nobilis IB Ma5, beskyttet mod QX-stammen, og 90 % var beskyttet mod M41, sammenholdt med ingen af de uvaccinerede fugle.
English: The effectiveness of Nobilis IB Primo QX was investigated in two field studies.
Danish: Effektiviteten af Nobilis IB Primo QX blev undersøgt i to feltundersøgelser.
English: The second field study showed 93% of the Nobilis IB Primo QX vaccinated birds and none of the unvaccinated birds to be protected from the challenge.
Danish: Den anden feltundersøgelse viste, at 93 % af de fugle, der var vaccineret med Nobilis IB Primo QX, og ingen af de uvaccinerede fugle var beskyttet mod belastningen.
English: In the first study broiler chickens (chickens bred for meat) were spray vaccinated with both Nobilis IB Primo QX and Nobilis IB Ma5, a vaccine against a Massachusetts strain of infectious bronchitis virus.
Danish: I den første undersøgelse blev slagtekyllinger sprayvaccineret med både Nobilis IB Primo QX og Nobilis IB Ma5, en vaccine mod en Massachusetts-stamme af smitsomt bronkitisvirus.
English: Nobilis IB Primo QX is used to protect chickens against viral infectious bronchitis caused by strains of infectious bronchitis virus known as QX-like variants, such as strain D388.
Danish: Nobilis IB Primo QX anvendes til at beskytte kyllinger mod smitsom virusbronkitis forårsaget af stammer af smitsomt bronkitisvirus med betegnelsen QX-varianter såsom stamme D388.
English: Nobilis IB Primo QX is a vaccine.
Danish: Nobilis IB Primo QX er en vaccine.
English: The vaccine is to be made up into a suspension for use.
Danish: Vaccinen skal opslæmmes før brug.
English: Nobilis IB Primo QX is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus strain D388.
Danish: Nobilis IB Primo QX er en veterinær vaccine, der indeholder levende, svækket smitsom fuglebronkitis virus stamme D388.
English: Other information about Nobilis IB Primo QX:
Danish: Andre oplysninger om Nobilis IB Primo QX:
English: What is the risk associated with Nobilis IB Primo QX?
Danish: Hvilken risiko er der forbundet med Nobilis IB Primo QX?
English: Why has Nobilis IB Primo QX been approved?
Danish: Hvorfor blev Nobilis IB Primo QX godkendt?
English: What is Nobilis IB Primo QX?
Danish: Hvad er Nobilis IB Primo QX?
English: How has Nobilis IB Primo QX been studied?
Danish: Hvordan blev Nobilis IB Primo QX undersøgt?
English: How does Nobilis IB Primo QX work?
Danish: Hvordan virker Nobilis IB Primo QX?
English: What is Nobilis IB Primo QX used for?
Danish: Hvad anvendes Nobilis IB Primo QX til?
English: What benefit has Nobilis IB Primo QX shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobilis IB Primo QX?
English: Inadequate response
Danish: Utilstrækkelig respons
English: Not relevant.
Danish: Ikke relevant.
English: They were considered so inert that testing was not required.
Danish: De betragtes som så inerte, at ingen testning var påkrævet.
English: In order to avoid all incidents, the following instructions should be absolutely respected.
Danish: For at undgå enhver uønsket hændelse skal følgende instrukser nøje overholdes.
English: - If you have been told that you (as the patient) or your child (as the patient) have an abnormal circulation within the heart.
Danish: - Hvis De har fået at vide, at De (som patient) eller Deres barn (som patient) har unormalt kredsløb i hjertet.
English: The potential risk for humans is unknown.
Danish: Den potientelle risiko for mennesker er ukendt.
English: Storage is supervised by the specialists at the hospital.
Danish: Opbevaringen overvåges af specialister på hospitalet.
English: The prospectively defined primary endpoint was the receipt of ECMO.
Danish: Det prospektivt definerede primære slutpunkt var modtagelsen af ECMO.
English: At the request of the European Medicines Agency;
Danish: • på anmodning af det Europæiske Lægemiddelagentur
English: The duration of therapy is variable, but typically less than four days.
Danish: Behandlingens varighed er variabel, men typisk mindre end 4 dage.
English: Clinical data supporting the suggested dose in the age range 12-17 years is limited.
Danish: Kliniske data, der understøtter den foreslåede dosis i aldersgruppen 12-17 år, er begrænsede.
English: Currently available data are described in section 5.1 but no recommendation or posology can be made.
Danish: De tilgængelige data er beskrevet i afsnit 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Summary of safety profile
Danish: Resumé af sikkerhedsprofil
English: Follow-up exams at 18-24 months of age were similar between the two groups with respect to mental, motor, audiologic, and neurologic evaluations.
Danish: Opfølgende undersøgelser ved en alder på 18-24 måneder var ens for de to grupper med hensyn til mental, motorisk, audiologisk og neurologisk vurdering.
English: Among metallic construction materials, only stainless steel can be recommended.
Danish: Til metalkonstruktioner kan kun rustfrit stål anbefales.
English: Bradycardiab (following abrupt discontinuation of therapy)
Danish: Bradykardib (efter pludselig seponering af behandlingen)
English: Higher exposures have not been investigated.
Danish: Højere eksponeringer er ikke undersøgt.
English: The lowest effective dose will be sought.
Danish: Det forsøges at finde den mindste dosis, der er effektiv.
English: Immediately prior to each patient initiation, proper procedure must be applied to purge the system of NO2.
Danish: Umiddelbart forud for initieringen af den enkelte patient skal der foretages en korrekt procedure for at rense systemet for NO2.
English: The displayed frequency categories use the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: De viste hyppighedskategorier benytter følgende konvention: meget almindelige (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1,000), meget sjældne (<1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: The rebound may be seen early as well as late during therapy.
Danish: Rebound kan forekomme både tidligt og sent i behandlingen.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: If it is judged that clinical response is inadequate at 4-6 hours after starting INOmax, the following should be considered.
Danish: Hvis det vurderes, at den kliniske respons er utilstrækkelig 4-6 timer efter påbegyndelse af INOmax, skal følgende overvejes.
English: The power supply for the monitoring equipment should be independent of the delivery device function.
Danish: Energiforsyningen til monitoreringsudstyret skal være uafhængig af tilførselsanordningens funktion.
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: The nitrogen dioxide (NO2) concentration and FiO2 must also be measured at the same site using calibrated and approved (CE-marked) monitoring equipment.
Danish: Nitrogenoxid (NO2)-koncentrationen og FiO2 skal ligeledes måles samme sted ved hjælp af kalibreret og godkendt (CE-mærket) monitoreringsudstyr.
English: The NO2 concentration should be maintained as low as possible and always < 0.5 ppm.
Danish: Koncentrationen af NO2 skal holdes så lav som muligt og altid < 0,5 ppm.
English: The adverse events collected occurred at similar incidence rates in both groups.
Danish: De indsamlede bivirkninger havde samme incidensrate i begge grupper.
English: In case of insufficient response the dose may be titrated after a minimum of 10 minutes.
Danish: Ved utilstrækkelig respons kan dosis titreres efter mindst 10 minutter.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Effekter i ikke-kliniske undersøgelser blev kun observeret ved eksponeringer, der blev betragtet som værende væsentligt over den maksimale humane eksponering, hvilket tyder på begrænset relevans for den kliniske anvendelse.
English: However, therapy with INOmax may last longer.
Danish: Behandlingen med INOmax kan dog vare længere.
English: See section 4.2 for information on monitoring for NO2.
Danish: 4.2 for information om monitorering af NO2.
English: A clinically significant interaction with other medicinal products used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data.
Danish: Klinisk signifikant interaktion med andre lægemidler anvendt i behandlingen af hypoxisk respirationssvigt kan ikke udelukkes på baggrund af de tilgængelige data.
English: This may increase the right ventricular ejection fraction.
Danish: Dette kan øge den højre ventrikels ejektionsfraktion.
English: Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
Danish: Det skal overvejes at seponere behandlingen, hvis der ikke ses nogen gunstige fysiologiske effekter efter behandlingsforsøg i 30 minutter.
English: Rescue, such as Extra Corporeal Membrane Oxygenation (ECMO) where available, should be considered based on continued deterioration or failure to improve, defined by criteria based on local circumstances.
Danish: Livredning, f.eks. ekstrakorporal membranoxygenering (ECMO) hvor dette er tilgængeligt, bør baseres på kontinuert forværring eller slet ingen forbedring, defineret efter kriterier baseret på lokale forhold.
English: Infants who cannot be weaned off INOmax by 4 days should undergo careful diagnostic work-up for other diseases.
Danish: Spædbørn, der ikke kan vænnes fra INOmax inden for 4 dage, skal underkastes nøje diagnostisk gennemgang for andre sygdomme.
English: All gas cylinders should be returned to the supplier for disposal.
Danish: Alle gasflasker skal returneres til leverandøren til bortskaffelse.
English: Care must be taken when INOmax is given at the same time as medicinal products containing prilocaine.
Danish: Der skal udvises forsigtighed, hvis INOmax gives samtidig med andre lægemidler, der indeholder prilocain.
English: Butyl rubber, polyamide, and polyurethane should not be used.
Danish: Butylgummi, polyamid og polyurethan bør ikke anvendes.
English: There are no adequate data from the use of nitric oxide in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af nitrogenoxid til gravide kvinder.
English: Treatment with INOmax should not be stopped suddenly.
Danish: Behandlingen med INOmax må ikke ophøre pludseligt.
English: Your doctor will take care to check that the blood can carry enough oxygen when you are taking these medicines.
Danish: Deres læge vil sørge for at kontrollere, at blodet kan transportere tilstrækkelig ilt, hvis De får disse lægemidler.
English: Inhaled nitric oxide may not always be effective and thus other therapies may be considered necessary for you or your child.
Danish: Inhaleret nitrogenoxid er muligvis ikke altid effektivt og derfor kan det være nødvendigt at iværksætte anden behandling af Dem eller Deres barn.
English: The overall number of death at week 36 was slightly higher in the iNO group; 53/395 (13.4 %) as compared to control 42/397 (10.6 %).
Danish: Det samlede antal dødsfald ved uge 36 var en anelse højere i iNO-gruppen; 53/395 (13,4 %) sammenlignet med kontrolgruppens 42/397 (10,6 %).
English: Training in administration The key elements that need to be covered in training hospital personnel are as follows.
Danish: De vigtigste elementer, der skal dækkes ved træning af hospitalspersonale er følgende:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret MM/YYYY.
English: Nitric oxide is a compound produced by many cells of the body.
Danish: Nitrogenoxid er en forbindelse, der produceres af mange celler i kroppen.
English: The monitoring of NO2 formation
Danish: Monitorering af NO2-dannelse
English: It is unknown whether nitric oxide is excreted in human milk.
Danish: Det er ukendt, om nitrogenoxid udskilles i human mælk.
English: Pharmacotherapeutic group: Other respiratory system products, ATC code R07AX01.
Danish: Farmakoterapeutisk klassifikation: Øvrige respirationssystemprodukter ATC-kode: R07AX01.
English: Persistent Pulmonary Hypertension in the Newborn (PPHN) The maximum recommended dose of INOmax is 20 ppm and this dose should not be exceeded.
Danish: Persisterende pulmonal hypertension hos nyfødte (PPHN) Den maksimale anbefalede dosis af INOmax er 20 ppm, og denne dosis må ikke overskrides.
English: Monitoring formation of nitrogen dioxide (NO2)
Danish: Kontrol af dannelse af nitrogendioxid (NO2)
English: Tested polymers which can be used in nitric oxide administration systems include polyethylene (PE) and polypropylene (PP).
Danish: Testede polymerer, der kan anvendes i nitrogenoxid-administrationssystemer, inkluderer polyethylen (PE) og polypropylen (PP).
English: The doctor will examine you or your child closely for all side effects.
Danish: Lægen vil undersøge Dem eller Deres barn omhyggeligt for alle bivirkninger.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen, via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Although it is unusual for the methaemoglobin level to increase significantly if the first level is low, it is prudent to repeat methaemoglobin measurements every one to two days.
Danish: Selv om det er usædvanligt, at koncentrationen af methæmoglobin stiger væsentligt, hvis den første koncentration er lav, er det klogt at gentage målingerne af methæmoglobin hver eller hver anden dag.
English: No signs of any increase adverse effects were noted in this study.
Danish: Der blev ikke bemærket nogen tegn på øget antal bivirkninger i dette forsøg.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The frequency and number of adverse events were similar in the two study groups.
Danish: Frekvensen og antallet af bivirkninger var ens i de to grupper.
English: The objective of this double-blind, randomised, placebo controlled trial was to determine whether inhaled nitric oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO).
Danish: Formålet med dette dobbeltblinde, randomiserede, placebokontrollerede forsøg var at fastslå, om inhaleret nitrogenoxid ville reducere forekomsten af dødstilfælde og/eller initiering af extrakorporel membranoxygenering (EMCO).
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 der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Of the 97 patients treated with INOmax, 2(2 %) were withdrawn from study drug due to methaemoglobin levels >4 %.
Danish: Af de 97 patienter, der blev behandlet med INOmax blev 2 (2 %) trukket ud af undersøgelsen på grund af methæmoglobinniveauer >4 %.
English: INOmax therapy should only be used and handled by hospital personnel.
Danish: INOmax-behandling må kun bringes i anvendelse og håndteres af hospitalspersonale.
English: Methaemoglobin levels > 7 % were attained only in patients receiving 80 ppm, where they comprised 35 % of the group.
Danish: Methæmoglobinkoncentrationer > 7 % blev kun nået hos patienter, der fik 80 ppm, hvor de udgjorde 35 % af gruppen.
English: Elevated NO2 may cause acute lung injury.
Danish: Forhøjet NO2 kan forårsage akut lungebeskadigelse.