FrancophonIA/ELRC3.0 huggingface dataset:
English: Allow the vaccine to reach a temperature of 15°C - 25°C and shake well before use.
Danish: Lad vaccinen opnå stuetemperatur (15 - 250C) og omryst grundigt før brug.
English: Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Danish: Kommende æglæggere og avlsdyr bør gives en anden vaccination 4 - 6 uger efter første vaccination.
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap. Not all pack sizes may be marketed.
Danish: Flaskerne er lukket med nitryl-gummiprop og forseglet med en kodet aluminiumshætte.
English: Chickens and ducks
Danish: Kyllinger og ænder.
English: Batch potency test:
Danish: Batchstyrketest:
English: -In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.
Danish: - Hos ænder; reduktion i udskillelse og overførsel af virus efter belastningsforsøg blev vist 2 uger efter en enkelt vaccination.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Chickens
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
English: No information is available on the safety of this vaccine for birds in lay.
Danish: Der foreligger ingen information om sikkerheden af denne vaccine hos æglæggere.
English: A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Danish: Hos 50% af kyllingerne kan der opstå en udbredt men forbigående hævelse, som varer i ca. 14 dage.
English: 6.5 Nature and composition of immediate packaging 250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Danish: 250 ml og 500 ml flasker af hydrolytisk glas type II eller af polyethylen terephthalat (PET).
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Danish: Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om fingerbløddele eller sener.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter, hidrørende fra behandlede dyr, ikke er kontamineret, b) at den sygdom, som lægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: Sorbitane mono-oleate
Danish: Sorbitan mono-oleat Glycin
English: TARGET SPECIES Chickens and ducks
Danish: DYREARTER Kyllinger og ænder.
English: The distinction between what might be protective titres of antibodies and the level of antibodies generated under the conditions of the batch potency test should be taken into account and the minimum potency at the time of batch release should be sufficient to provide the claimed duration of immunity.
Danish: Skelnen mellem hvad der er beskyttende antistoftitre og niveauet af antistoffer, der er genereret under forholdene for batch styrketest, skal tages med i bedømmelsen.
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Lad vaccinen opnå stuetemperatur (15 - 250C) og omryst grundigt før brug.
English: Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Danish: Inaktiveret helt fugleinfluenza-virusantigen, subtype H7N1, (stamme, A/CK/Italy/473/99), inducerer en HI titer på > 6.0 log2, der er testet svarende til styrketest.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C to +8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet (2 - 80C).
English: From 8 to 14 days old: 0.25 ml subcutaneously
Danish: Fra 8 til 14 dage gamle: 0,25 ml subkutant
English: The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H7N1.
Danish: Vaccinen stimulerer aktiv immunitet mod fugleinfluenza-virus type A, subtype H7N1.
English: Polysorbate 80
Danish: Paraffinolie, tynd Polysorbat 80
English: The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Danish: Det opnåede virkningsniveau kan variere mellem vaccinestammer og cirkulerende stammer afhængig af graden af ensartethed i antigenerne.
English: For a list of excipients see section 6.1
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
Danish: Der er ikke observeret andre symptomer efter administration af dobbelt dosis end dem, der er beskrevet i afsnit 4.6.
English: or S.C. injection of 0.25, 0.5 ml or 1 ml, depending on the age and species.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær eller subkutan injektion af 0,25; 0,5 ml eller 1 ml, afhængigt af alder og art.
English: Liquid light paraffin 234.8 mg/0,5 ml
Danish: Flydende lys paraffinolie 234,8 mg/0,5 ml
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne veterinærlægemidler skal destrueres i overensstemmelse med de lokale krav.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 0.5 ml contains:
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 1 dosis (0,5 ml) indeholder:
English: INDICATION(S) Active immunisation against avian influenza type A, subtype H7N1.
Danish: INDIKATION(ER) Aktiv immunisering mod fugleinfluenza type A, subtype H7N1.
English: Chickens
Danish: Kyllinger:
English: For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.
Danish: Aktiv immunisering af kyllinger og ænder mod fugleinfluenza type A, subtype H7N1.
English: One dose of 0.5 ml contains:
Danish: 1 dosis (0,5 ml) indeholder:
English: 6 weeks and older: 0.5 ml subcutaneously or intramuscularly
Danish: 6 uger og ældre: 0,5 ml subkutant eller intramuskulært
English: The report of the overdose safety studies in ducks with Nobilis Influenza H7N1 administered by both s.c. and i.m.
Danish: Der skal foreligge rapporter om sikkerhedsstudier af enkel- og overdosis hos ænder med Nobilis Influenza H7N1, som er indgivet både subkutant og intramuskulært, så snart de er tilgængelige.
English: From 2 to 6 weeks: 0.5 ml subcutaneously or intramuscularly.
Danish: Fra 2 til 6 uger: 0,5 ml subkutant eller intramuskulært.
English: From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly
Danish: Fra 14 dage til 6 uger gamle: 0,25 ml eller 0,5 ml subkutant eller intramuskulært
English: Batch release data for all batches of H7N1 vaccine used in the efficacy trials presented in the dossier and justification for the potency release criteria should be provided.
Danish: Så vidt muligt skal batchprotokoller og specielt resultater af styrketest fremsendes for alle batch af H7N1-vaccine som er anvendt i det kliniske studie, som er præsenteret i dossieret.
English: Store and transport at 2°C to 8°C.
Danish: Opbevares og transporteres nedkølet (2°C - 8°C).
English: Adjuvant: Liquid paraffin
Danish: Adjuvans: Flydende paraffinolie.
English: SAFETY ASPECTS 6.
Danish: ASPEKTER VEDR.
English: Ducks
Danish: Holland
English: EFFICACY ASPECTS
Danish: BIVIRKNINGER
English: ROUTE(S) OF ADMINISTRATION I.M.
Danish: INDGIVELSESVEJ(E)
English: • Marketing authorisation under exceptional circumstances The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Danish: • Markedsføringstilladelsen under særlige omstændigheder Efter at have vurderet ansøgningen er CHMP af den opfattelse, at risk/benefit-forholdet er positivt for anbefaling af udstedelse af markedsføringstilladelse under særlige omstændigheder.
English: Annex IV Conclusions on the granting of the marketing authorisation under exceptional circumstances presented by the European Medicines Agency
Danish: Bilag IV Konklusioner vedrørende udstedelse af markedsføringstilladelse under særlige omstændigheder fremlagt af Det Europæiske Lægemiddelagentur
English: 25 June 2013
Danish: Den 25. juni 2013
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Danish: Fremsendelse af oversættelserne af bilagene til aftalen til de nationale kompetente myndigheder:
English: May 2013 CMDh meeting
Danish: CMDh's møde i maj 2013
English: Implementation of the agreement by the Member States:
Danish: Tidsplan for gennemførelse af aftalen
English: Annex III
Danish: Bilag III Tidsplan for gennemførelse af aftalen
English: 25 July 2013
Danish: Gennemførelse af aftalen af medlemsstaterne Den 25. juli 2013
English: If more than one eye medicine is being used, they should be given at least five minutes apart.
Danish: Hvis der anvendes mere end en type øjenlægemiddel, skal de gives med mindst fem minutters mellemrum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yellox on 18 May 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Yellox den 18. maj 2011.
English: Treatment begins the day after the cataract operation and continues for two weeks.
Danish: Behandlingen begynder dagen efter kataraktoperationen og fortsætter i to uger.
English: The full EPAR for Yellox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Yellox findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Yellox.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Yellox.
English: In both studies, the main measure of effectiveness was the number of patients with no sign of inflammation after two weeks.
Danish: I begge undersøgelser blev effektiviteten hovedsagelig bedømt på antallet af patienter uden tegn på betændelse efter to uger.
English: Other information about Yellox
Danish: Andre oplysninger om Yellox
English: The European Medicines Agency decided that Yellox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Yellox opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Yellox.
English: What measures are being taken to ensure the safe and effective use of Yellox?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Yellox?
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Danish: Det virker ved at blokere et enzym, der hedder cyklooxygenase, som producerer prostaglandiner, som er stoffer, der medvirker i betændelsesprocessen.
English: The most common or most important side effects seen with Yellox are abnormal sensation in eye (0.5%), mild or moderate erosion of the cornea (the transparent layer in front of the eye) (0.4%), eye pruritus (itching) (0.4%), eye pain (0.3%) and eye redness (0.3%).
Danish: De hyppigste eller væsentligste bivirkninger ved Yellox er en unormal følelse i øjet (0,5 %), mild eller moderat erosion af hornhinden (det gennemsigtige lag foran øjet) (0,4 %), kløe i øjet (0,4 %), øjensmerter (0,3 %) og røde øjne (0,3 %).
English: By reducing the production of prostaglandins in the eye, Yellox can reduce the inflammation caused by eye surgery.
Danish: Ved at reducere dannelsen af prostaglandiner i øjet kan Yellox reducere den betændelse, som øjenoperationen forårsager.
English: In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.
Danish: I den anden undersøgelse var tallene 63 % (124 ud af 198) for patienter behandlet med Yellox og 40 % (39 ud af 98) for de patienter, der fik placebo.
English: Why is Yellox approved?
Danish: Hvorfor blev Yellox godkendt?
English: It is not intended to provide practical advice on how to use Yellox.
Danish: Det er ikke en praktisk vejledning i, hvordan Yellox bør anvendes.
English: In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73).
Danish: I den ene undersøgelse havde 66 % af de patienter, der blev behandlet med Yellox (104 ud af 158), ingen tegn på betændelse efter to uger sammenlignet med 48 % af de patienter, der fik placebo (35 ud af 73).
English: The active substance in Yellox, bromfenac, is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Det aktive stof i Yellox, bromfenac, er et nonsteroidt antiinflammatorisk lægemiddel (NSAID).
English: What is Yellox and what is it used for?
Danish: Hvad er Yellox, og hvad anvendes det til?
English: Yellox contains the active substance bromfenac.
Danish: Yellox indeholder det aktive stof bromfenac.
English: It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.
Danish: Det må ikke anvendes hos patienter, der får astmaanfald, urticaria (kløende udslæt) eller akut rhinitis (tilstoppet og løbende næse) af at tage acetylsalicylsyre (aspirin) eller andre NSAID'er.
English: Yellox is available as an eye drop solution and the recommended dose is one drop into the affected eye(s) twice a day.
Danish: Yellox er tilgængeligt som en øjendråbeopløsning, og den anbefalede dosis er én dråbe i det angrebne øje to gange daglig.
English: What are the risks associated with Yellox?
Danish: Hvilke risici er der forbundet med Yellox?
English: For more information about treatment with Yellox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Yellox, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Yellox must not be used in people who are hypersensitive (allergic) to bromfenac, to any of the other ingredients or to other NSAIDs.
Danish: Yellox må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for bromfenac, nogen af de øvrige indholdsstoffer eller andre NSAID'er.
English: For practical information about using Yellox, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Yellox, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Yellox is a medicine used in adults to treat inflammation in the eye that can occur after an operation to remove a cataract (clouding of the lens).
Danish: Yellox er et lægemiddel, der anvendes til behandling af øjenbetændelse, som kan opstå efter kataraktoperation (grå stær) hos voksne.
English: For the full list of all side effects reported with Yellox, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Yellox fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yellox have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Yellox.
English: For more information see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: How does Yellox work?
Danish: Hvordan virker Yellox?
English: How is Yellox used?
Danish: Hvordan anvendes Yellox?
English: What benefits of Yellox have been shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Yellox?
English: Yellox was found to be more effective than placebo (a dummy treatment) at relieving inflammation in the eye following cataract surgery in two main studies involving a total of 527 patients undergoing cataract surgery.
Danish: Af to hovedundersøgelser med i alt 527 patienter, der gennemgik en kataraktoperation, fremgik det, at Yellox var mere effektivt end placebo (en uvirksom behandling) til at lindre symptomerne på øjenbetændelse efter kataraktoperation.
English: • If you are under 18 years of age.
Danish: hvis De er under 18 år.
English: (see section 4.4).
Danish: (se afsnit 4.4).
English: Do NOT pass it on to others.
Danish: De bør IKKE give det videre til andre.
English: Elderly: Same dosage as for adults.
Danish: Ældre: Samme dosering som for voksne.
English: Take your next dose at the normal time.
Danish: Tag den næste dosis til sædvanlig tid.
English: Macrogol 1300-1600
Danish: Makrogol 1300-1600
English: This should be considered when interpreting laboratory data.
Danish: Dette skal der tages hensyn til ved fortolkning af laboratoriedata.
English: Remember to take the pack and any remaining tablets with you.
Danish: Husk at tage pakningen og eventuelle resterende tabletter med Dem.
English: The food-interaction study was not performed according to the CHMP guidelines.
Danish: Undersøgelsen for interaktion med fødevarer blev ikke gennemført i overensstemmelse med CHMP's retningslinjer.
English: Common (affecting less than one person in 10 but more than one person in 100):
Danish: Almindelig (rammer under en person ud af 10, men flere end en person ud af 100):
English: Close control of blood pressure.
Danish: Tæt overvågning af blodtryk.
English: Trough levels at 24 hours are, however, similar.
Danish: De laveste niveauer ved 24 timer er dog ensartede.
English: This helps to lower blood pressure.
Danish: Dette medvirker til at sænke blodtrykket.
English: The tablets can be taken at any time of the day and before, during or after meals.
Danish: Tabletterne kan tages når som helst på dagen og før, under eller efter et måltid.
English: If you become pregnant whilst taking this medicine you should contact your doctor as soon as possible.
Danish: Hvis De bliver gravid, mens De tager denne medicin, bør De hurtigst muligt kontakte Deres læge.
English: Hertfordshire, SG1 4SZ United Kingdom Tel 00 44 207 612 7612 Fax 00 44 207 612 7620
Danish: Hertfordshire, SG1 4SZ Det Forenede Kongerige Tlf. 00 44 207 612 7612 Fax 00 44 207 612 7620
English: PVC/PVDC/aluminium blister.
Danish: PVC/PVDC/aluminium blisterpak.
English: Tel 00 351 21 896 51 05 Fax 00 351 21896 51 06
Danish: Tlf. 00 351 21 896 51 05 Fax 00 351 21896 51 06
English: Possibly hypoglycaemia, hypokalaemia.
Danish: Muligvis hypoglykæmi, hypokalæmi.
English: The occurrence of adverse reactions are mainly due to the pharmacological properties of the medicinal product.
Danish: Forekomsten af bivirkninger skyldes hovedsageligt lægemidlets farmakologiske egenskaber.
English: 6 FURTHER INFORMATION
Danish: 6 YDERLIGERE OPLYSNINGER
English: You should contact your doctor immediately or go to the nearest casualty department.
Danish: Kontakt omgående lægen eller nærmeste skadestue.
English: Some patients may experience impaired ability to react.
Danish: Visse patienter kan få nedsat reaktionsevne.
English: In hypertensive patients both conditions are treated concomitantly.
Danish: Hos hypertensive patienter behandles begge lidelser samtidigt.
English: Particular caution:
Danish: Særlig forsigtighed:
English: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1, 000, <1/100); rare (>1/10, 000, <1/1, 000); very rare (<1/10, 000), including isolated reports
Danish: Meget almindelig (>1/10), almindelig (>1/100, <1/10), usædvanlig (>1/1.000 <1/100), sjælden (>1/10.000, <1/1.000), meget sjælden (<1/10.000), herunder isolerede indberetninger.
English: When you start taking your tablets, make sure that your senses are not affected before you drive or operate machinery.
Danish: Når De begynder at tage tabletterne, skal De sikre Dem, at Deres sanser ikke er blevet påvirket, før De kører bil eller betjener maskiner.
English: Doxazosin is extensively metabolised with <5% excreted as unchanged product.
Danish: Doxazosin metaboliseres i omfattende grad med <5% udskilt som uændret produkt.
English: Doxazosin is one of a group of medicines called alpha-blockers.
Danish: Doxazosin tilhører en gruppe lægemidler, der kaldes alfa-blokkere.
English: A dosage regime of 82 mg/kg/day (8 times the human exposure) was associated with reduced foetal survival.
Danish: En dosisplan på 82 mg/kg/dag (8 gange den humane eksponering) var forbundet med reduceret fosteroverlevelse.
English: Symptomatic treatment.
Danish: Symptombehandling.
English: Children and adolescents: Doxazosin is not recommended for use in children and adolescents due to a lack of clinical experience.
Danish: Børn og unge: Doxazosin kan ikke anbefales til brug hos børn og unge på grund af manglende klinisk erfaring.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEA medlemslandene under følgende navne [Udfyldes nationalt]
English: The following side effects have been reported:
Danish: Følgende bivirkninger er indberettet:
English: Choose a time that is convenient for you and take your tablet at this time each day.
Danish: Vælg et tidspunkt på dagen, hvor det passer Dem bedst at tage Deres daglige tablet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: OPLYSNINGER, DER SKAL STÅ PÅ DEN YDRE EMBALLAGE ÆSKE
English: If these symptoms persist or become a problem please contact your doctor.
Danish: Hvis disse symptomer varer ved eller bliver et problem, skal De kontakte Deres læge.
English: Your doctor may wish to increase your dose to 8 mg per day.
Danish: Deres læge kan ønske at øge Deres dosis til 8 mg dagligt.
English: The majority of patients are controlled on the initial dose of 4 mg doxazosin.
Danish: De fleste patienter kontrolleres ved den indledende dosis på 4 mg doxazosin.
English: They should be informed about the potential risk for injuries and measures of precaution to minimise orthostatic symptoms.
Danish: Patienterne bør informeres om den potentielle risiko for skader og forebyggende metoder til minimering af ortostatiske symptomer.
English: Alternatively, breast-feeding must be stopped, if treatment with doxazosin is unavoidable.
Danish: Alternativt må amningen ophøre, dersom behandling med doxazosin er uundgåelig.
English: This effect is thought to result from selective blockade of the alpha-1-adrenoceptors located in the vasculature.
Danish: Denne effekt menes at være en følge af selektiv blokade af alfa-1-adrenoceptorerne, der sidder i karrene.
English: Postural hypotension and in rare cases syncope may occur at the beginning of therapy, especially at very high doses but also when treatment is recommenced after a break.
Danish: Postural hypotension og i sjældne tilfælde synkope kan forekomme i behandlingens begyndelse , specielt ved meget høje doser, men også når behandling genoptages efter en pause.