natgillin/translations-raw huggingface dataset:
PhotoBarr anvendes til fotodynamisk terapi (behandling med lys) til at fjerne dysplasi af høj grad (abnorme celler med høj risiko for at udvikle sig til kræft) hos patienter med Barretts øsofagus. 
PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett's oesophagus.
Hvorfor blev PhotoBarr godkendt? 
Why has PhotoBarr been approved?
PhotoBarr er et pulver, der anvendes til fremstilling af en injektionsvæske, opløsning. 
PhotoBarr is a powder that is made up into a solution for injection.
PhotoBarr må ikke bruges hos patienter med porfyri (manglende evne til at nedbryde porfyriner), alvorlige problemer med lever eller nyrer, åreknuder i spiserør eller mave, store sår i spiserøret, fistler (abnorme passager) mellem spiserøret og luftrøret eller bronkierne eller formodet beskadigelse af større blodkar. 
PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Det er en sygdom, hvor mavesyren har ændret slimhinden i nederste del af spiserøret på grund af beskadigelse som følge af mavesyre. 
This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
De hyppigste bivirkninger ved PhotoBarr (som optræder hos flere end 1 ud af 10 patienter) er udtørring, spiserørsforsnævning, opkastning, synkebesvær, forstoppelse, kvalme, lysoverfølsomhed (reaktioner svarende til solskoldning) og feber. 
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
Ved at begrænse belysningen til dysplasiområdet opnår man, at kun disse celler beskadiges. 
By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.
Der kan gives indtil to supplerende behandlingsforløb (hver bestående af én indsprøjtning og en eller to laserbehandlinger) med mindst tre måneders mellemrum. 
Up to two additional treatment courses (one injection and one or two laser treatments) can be given, separated by at least three months, as long as the risk of narrowing of the gullet is taken into account.
Virkningerne af fotodynamisk terapi med PhotoBarr anvendt i kombination med omeprazol (et antacidum) blev sammenholdt med virkningerne af omeprazol alene. 
The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Af de patienter, der fik PhotoBarr i kombination med omeprazol, var 72 % efter seks måneder helt uden dysplasi af høj grad sammenlignet med 31 % af dem, der kun fik omeprazol. 
After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Den fuldstændige liste over indberettede bivirkninger ved PhotoBarr fremgår af indlægssedlen. 
For a more complete list of the side effects reported with PhotoBarr, see the package leaflet.
Hvilken fordel viser undersøgelserne, at der er ved PhotoBarr? 
What benefit has PhotoBarr shown during the studies?
Når fotodynamisk terapi med PhotoBarr blev anvendt som tillægsbehandling til omeprazol, forsvandt dysplasien hos et øget antal patienter. 
Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
PhotoBarr gives ved forsigtig, langsom indsprøjtning i en vene i en dosis a 2 mg pr. kg legemsvægt i løbet af tre til fem minutter. 
Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser. PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Hvad er PhotoBarr? 
What is PhotoBarr?
Derfor skal de undgå at udsætte hud og øjne for stærkt lys i indtil tre måneder efter injektionen. 
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection.
Hvordan blev PhotoBarr undersøgt? 
How has PhotoBarr been studied?
Hvad anvendes PhotoBarr til? 
What is PhotoBarr used for?
Det anvendte apparatur og belysningens varighed afhænger af, hvor stort det syge område er. Om nødvendigt kan der gives endnu en kortvarig laserbehandling to-tre dage senere. 
If necessary, patients may receive a second, shorter laser treatment two to three days later.
Hvordan anvendes PhotoBarr? 
How is PhotoBarr used?
Hvordan virker PhotoBarr? 
How does PhotoBarr work?
Hertil anvendes følgende formel: 
Use the following formula:
Udvalget blev desuden anmodet om at anbefale, om markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages. 
The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Hvis den eksisterende beskrivelse ikke anses for fyldestgørende, skal der forelægges en revideret tekst. 
If the existing advice is not considered sufficient a proposal for revised text should be submitted.
I: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006 
In: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
Forebyggelse og behandling af luftvejssygdom 
Prevention and treatment of respiratory disease
Betingelsen for markedsføringstilladelserne fremgår af bilag IV. 
The condition of the Marketing Authorisations is described in Annex IV.
Medlemssta t EU/EØS 
Member State EU/EEA
A-4600 Wels ØSTRIG 
A-4600 Wels AUSTRIA
Tilberedningen og pelleteringen blev beskrevet. 
The conditioning and pelleting were described.
Under den foregående henvisningsprocedure i henhold til artikel 34 i direktiv 2001/82/EF (EMEA/V/A/037) 
During the previous referral procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/037)
Resultaterne af undersøgelserne forelægges for de relevante myndigheder senest 12 måneder efter Kommissionens afgørelse vedrørende denne henvisningsprocedure. 
The results of those studies should be provided to the relevant authorities for assessment not later than 12 months after the Commission Decision on this referral procedure.
Data til støtte for den anbefalede dosis 
Supporting data for the recommended dose
20041 Agrate Brianza (MB) ITALIEN 
20041 Agrate Brianza (MB) ITALY
De nationale kompetente myndigheder sikrer, med referencemedlemsstaten som koordinerende instans, hvor dette er relevant, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser: 
National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure that following conditions are fulfilled by the marketing authorisation holders:
Disse højere værdier kræver nærmere gennemgang, da de medfører højere dosis end den tilsigtede. 
These higher values require further consideration as they would lead to higher than target dose.
Indehaveren af markedsføringstilladelsen blev anmodet om at indsende følgende: 
The marketing authorisation holders were requested to provide the following:
Stabilitetsundersøgelserne viste, at der efter 3 måneder ikke var væsentlige ændringer i udseende eller tørringstab. 
According to stability results, after 3 months no significant change was observed for appearance and loss on drying.
Det skal godtgøres, at dette krav opfyldes af alle pakningsstørrelser for alle styrker. 
Confirmation should be provided that this requirement will be fulfilled by all of the pack sizes for all the different strengths.
En kanin på 1,5 kg kan således gennemsnitligt indtage 180 g foder dagligt. 
Thus, one rabbit of 1.5 kg can consume in average 180 g of feed per day.
Liste over veterinærlægemidlernes navne, lægemiddelformer, aktive indholdsstof, styrker, måldyrearter og indehavere af markedsføringstilladelse i medlemsstaterne 
List of the names, pharmaceutical forms, active substance, strengths of the veterinary medicinal products, animal species, marketing authorisation holders in the Member States
For at opnå korrekt dosering skal koncentrationen af tilmicosin justeres i henhold dertil. 
In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
De farmakokinetiske parametre bekræfter den effektive dosis af tilmicosin. 
The pharmacokinetic parameters confirm the effective dose of tilmicosin.
Syge dyr indtager mindre, 100 g dagligt er acceptabelt. 
Sick animals hereby consume less, being acceptable at 100 g per day.
Der blev påvist homogenitet, idet variationskoefficienten var under 5 % i alle 
Homogeneity was demonstrated as the coefficient of variation was less than 5 % in all the cases tested.
Tyskland Lilly Deutschland GmbHAbt. 
Germany Lilly Deutschland GmbHAbt.
Spanien ELANCO VALQUÍMICA, S.A. Avda. 
ELANCO VALQUÍMICA, S.A. Avda.
Betingelser for markedsføringstilladelserne 
Conditions of the marketing authorisation
Den indtagne mængde medicineret foder afhænger af dyrets kliniske tilstand. 
The uptake of medicated feed depends on the clinical condition of the animals.
Der er ifølge det oplyste ikke tilsat overskud i formuleringen, og ingen begrundelse er fundet for disse resultater, som falder uden for det iagttagne normalområde i andre undersøgelser af foderet. 
Even though it was confirmed that no overage was used in the formulation, no justification was found for those results and it was considered that the results do not fall into the normal range observed in other feed studies.
Indehaverne af markedsføringstilladelserne oplyste, at der anvendes fuldfoder til fødevareproducerende kaniner. 
The marketing authorisation holders reported that the administration of feed to the food producing rabbits is via complete feedingstuff.
3991 RA Houten NEDERLANDENE 
3991 RA Houten
Diskussionen skal underbygges med passende data, der viser, at betingelserne under pelletering er hensigtsmæssige og ikke forringer den godkendte opbevaringstid af det medicinerede foder (1 måned). 
This discussion should be supported with the appropriate data, i.e. data confirming the pelleting conditions suitability and demonstrating that these conditions do not affect the shelf-life granted for the medicated feedingstuff (1 month).
Frankrig SOGEVAL 200 Route de Mayenne Zi des Touches 53000 Laval 
200 Route de Mayenne Zi des Touches 53000 Laval FRANCE
Som anført i CVMP's vejledning (EMEA/CVMP/080/95) skal der gives en beskrivelse af, hvordan premixen skal tilsættes foderet. 
As outlined in the CVMP's Note for guidance (EMEA/CVMP/080/95) a description should be provided of how the pre-mix is to be incorporated into the feedingstuff.
Dette støttedes af yderligere forelagte data, som ikke viste tilsvarende problemer for batcher i pilotskala. 
This was further supported considering further data provided in which no such problems were presented thus far with pilot scale batches.
D-61352 Bad Homburg TYSKLAND 
D-61352 Bad Homburg GERMANY
Det blev anset for velbegrundet kun at teste én styrke, da koncentrationen af tilmicosin i det endelige medicinerede foder i alle tilfælde ville være 200 ppm, eftersom homogeniteten af de andre medicinerede premixer var tilfredsstillende godtgjort. 
The testing of only one strength was considered valid because the concentration of tilmicosin in the final medicated feeding stuffs would be 200 ppm in all cases, as the homogenicity of the other medicated premixes was sufficiently justified.
kg premix/ton foder = Dosis (mg/kg kropsvægt) x kropsvægt (kg) Dagligt indtag af foder (kg) x styrke af premix (g/kg) 
kg pre-mix/ton feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x pre-mix strength (g/kg)
Dette anses for acceptabelt, da der opnås homogenitet af medicineret foder med lave koncentrationer af medicineret premix. 
This was considered acceptable, as homogeneity of medicated feedingstuffs is reached with low concentrations of medicated pre-mixes.
CVMP's udtalelse efter en artikel 34-indbringelse vedrørende Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix og relaterede navne (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf 
CVMP opinion following an Article 34 referral on Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
Danmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110 
Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Denne beskrivelse, der gives i produktinformationen, skal være ledsaget af en diskussion af, om dette er i overensstemmelse med CVMP's vejledning (EMEA/CVMP/080/95). 
The relevant advice given in the product literature should be provided along with a discussion of whether this is in line with CVMP's Note for guidance (EMEA/CVMP/080/95).
Opbevaringstid efter iblanding i foder eller pelleteret foder: 3 måneder 
Shelf life after incorporation into meal or pelleted feed: 3 months
Der blev ikke forelagt data om tilsætning for tilmicosin 40 g premix. 
No data on incorporation were provided for Tilmicosin 40 g pre-mix.
1, at den daglige dosis af den medicinerede premix skal være fordelt i mindst halvdelen af det behandlede dyrs daglige foderration. 
states that the daily dose of the medicated pre-mix must be contained in at least half the daily ration of the animals under treatment.
Om måldyreartens ædeadfærd vides, at kaniner æder hyppigt (2-8 g foder i løbet af 4-6 minutter op til 30 gange dagligt) 
Regarding the target species feeding behaviour, it is known that rabbits feed frequently (up to 30 times per day of 2-8 g of feed over 4-6 minute periods
Bemærkning: I nedenstående gælder tekst med grå skygge ikke for MICLOZAN 200 premix (se bilag I til udtalelsen) 
Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion)
Denne dosis bør opretholdes ved korrekt iblanding af medicineret premix med forskellig koncentration i foderet. 
This dose should be maintained by a proper mixing of medicated pre-mixes of different concentrations into feedingstuffs.
Tyskland Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4 
Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Der blev kun anvendt medicineret kaninfoder tilberedt med tilmicosin 100 g premix. 
Only medicated rabbit feed prepared with tilmicosin 100 g pre-mix was used.
For at sikre grundig opblanding af produktet skal dette først opblandes i en passende mængde foder (20-50 kg), før det iblandes i det færdige foder. 
“To ensure through dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients (20 - 50 kg) before incorporation into the finished feed.
4.9 Dosering og indgivelsesvej: 
4.9 Amounts to be administered and administration route:
Holdbarheden af pellets blev vurderet ved undersøgelse af ændringen i koncentrationen af tilmicosin gennem 12 uger ved 25 °C og 60 % relativ fugtighed (RH) samt ved 40 °C og 70 % RH. 
Pellet storage stability was evaluated by examining the difference in the level of tilmicosin assay over a 12 week period at 25 °C/60% relative humidity (RH) and 40 °C/70% RH.
Bemærkning: I nedenstående gælder tekst med grå skygge ikke for MICLOZAN 200 premix (se bilag I): 
Note: The text in grey shading below is not applicable for MICLOZAN 200 pre-mix (see Annex I):
De høje koncentrationer af tilmicosin i det medicinerede foder inden pelletering kræver nærmere afklaring. 
The high values of tilmicosin in the medicated feed prior to the pelleting process need further explanation.
Videnskabelige konklusioner og begrundelse for ændringen af produktresuméet og etiketteringen 
Scientific conclusions and grounds for amendment of the Summary of Product Characteristics and labelling
Det fremgår af CVMP's “Note for guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (medicated pre-mixes) (EMEA/CVMP/080/95)” 
The CVMP's Note for guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (medicated pre-mixes) (EMEA/CVMP/080/95)
Opbevaringstid efter iblanding i pelleteret foder indeholdende mere end 30 % hvede: 1 måned 
Shelf life after incorporation into pelleted feed containing more than 30% wheat: 1 month
CVMP anmoder derfor om, at der udføres stabilitetsundersøgelser vedrørende forbehandling og pelletering på 3 batcher medicineret kaninfoder for at fastslå, om de høje koncentrationer af tilmicosin er typiske (se bilag IV). 
The CVMP therefore requests that conditioning/pelleting stability studies with three batches of medicated rabbit feeds are carried out in order to confirm whether or not the high tilmiscosin valuies are typical results (see Annex IV).
Den 8. april 2011 indledte Europa-Kommissionen en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF, som ændret, for alle premixer, der anvendes til fremstilling af medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix. 
On 8 April 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
For tilmicosin 40 g premix ville iblandingsforholdet for foderet være 5 kg pr. ton (jf. kravet i Ph.Eur.monografien om premix til medicineret foder til veterinær anvendelse). 
The incorporation rate of Tilmicosin 40 g pre-mix in the feed would be 5 kg per ton (the requirement of the European Pharmacopoeia monograph on pre-mixes for medicated feedingstuffs for veterinary use).
I en undersøgelse af homogeniteten af en 200 g premix blev der anvendt to forskellige batcher af 200 g premix til fremstilling af fire prøvebatcher medicineret foder (2 batcher fodergranulat og 2 batcher pelleteret foder). 
In a study provided on the homogeneity of a 200 g pre-mix two different batches of 200 g premix were used to prepare 4 pilot batches of medicated feedingstuff (2 batches of crumble feed and 2 batches of pelleted feed).
Da produktinformationen er fælles for svin og kaniner, ansås det for acceptabelt med en opbevaringstid på en måned efter iblanding i pelleteret foder indeholdende mere end 30 % hvede. 
As the product information is common for pigs and rabbits, the one month shelf life after incorporation into pelleted feed containing more than 30% wheat was considered acceptable.
Ved sammenligning af indholdet af tilmicosin i foderet fra undersøgelsen af blandingshomogenitet (dvs. før pelletering) med indholdet af tilmicosin i det pelleterede foder sås et betydeligt fald i indholdet af tilmicosin, der dog var inden for det fastsatte acceptområde på ± 15 %. 
When comparing tilmicosin content in the meal feeds during the mixing uniformity test (i.e. prior to pelleting) versus tilmicosin content of the pelleted feeds, a significant decrease in tilmicosin content was observed, although that decrease was within the ± 15% preset acceptance range.
Ved iblanding i foderet er koncentrationerne 10-13 % højere end den forventede nominelle koncentration på 200 mg/kg. 
Regarding meal feeds, concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
På baggrund af beskaffenheden af det kaninfoder, der anvendes til fremstilling af pelleteret medicineret foder, konkluderedes det, at indholdet af korn i kommercielt foder til opfedning af kaniner maksimalt må være 30 % (tilsætning af 30 % hvedemel er ikke hensigtsmæssig på grund af risiko for svære tarmproblemer). 
Taking into account the characteristics of a rabbit feed used to prepare pelleted medicated feedingstuffs, it was concluded that the maximum limit of cereal meals that can be used in commercial feedingstuffs for fattening rabbits should be less than 30% (the inclusion of 30% of wheat meal is not appropriate due to the risk of triggering severe enteric problems).
Dosis af tilmicosin Behandlingsvarighed Mængde, der skal tilsættes foderet 
Dose of tilmicosin Duration of treatment Inclusion rate in feed
Ændringer i de relevante afsnit af etiketteringen 
Amendments in the relevant sections of the labelling
Det bemærkedes, at der var et fald i indholdet af tilmicosin for medicineret pelleteret svinefoder med et indhold af hvede på over 30 %. 
Decrease on tilmicosin content for swine medicated pelleted feeds containing more than 30% wheat was noted.
Koncentrationerne er således 10-13 % over den nominelle koncentration på 200 mg/kg. 
Concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Uanset den uforklarede høje koncentration i foderet fandt udvalget, at hvis kaninfoder formuleres korrekt med en koncentration på 200 ppm (i stedet for de beskrevne høje værdier), må indholdet af tilmicosin i det pelleteret foder forventes at være inden for det specificerede område på ±15 % af den nominelle værdi. 
Regardless of the unexplained high meal assay results, it has been considered that if rabbit feed meal was correctly formulated with a concentration of 200 ppm (instead of the high values reported) it would be expected that the tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value.
Oral anvendelse af tilmicosin hos kaniner i en dosering på 12,5 mg/kg legemsvægt/dag i 7 dage viste, at koncentrationen i lungevævet og i makrofagerne i lungealveolerne fra den anden behandlingsdag var henholdsvis 7 og 400 gange højere end i plasma, og at der vedvarende var høje koncentrationer i hele behandlingsperioden. 
The use of tilmicosin in rabbits orally at 12.5 mg/kg bw/day for 7 days showed that from the second day of treatment, tilmicosin concentrations attained in lung tissue and pulmonary alveolar macrophages exceeded those in plasma by 7 and 400 fold, respectively, and high levels were maintained in lung tissues during the entire treatment duration.
Mens homogeniteten fandtes tilfredsstillende godtgjort, kræves der en forklaring på disse resultater, da koncentrationen i det foder, der gives til dyrene, vil være over målværdien på 200 ppm. 
Whilst the demonstration of homogeneity was considered acceptable, the higher than expected values need explanation, taking into account that if those meal feeds were administered to animals, the concentration in those feeds would be higher than the target dose of 200 ppm.
Da det er uhensigtsmæssigt at tilsætte 30 % hvedemel til medicinerede pelleteret kaninfoder, fandtes iblanding i foderet ved en arbejdsdelingsprocedure ikke ville medføre problemer i form af begrænset opbevaringstid, da dette tilfælde ikke forventes at opstå for kaniner. 
Consequently, since the inclusion of 30% of wheat meal in medicated pelleted feed in rabbits would not be appropriate, it was considered that there would be no problem with the restriction on the shelf life after incorporation into meal adopted through a worksharing procedure because that case was not expected to be presented in rabbit.
Ved vurderingen er der fundet en risiko i form af højt indhold af tilmicosin i foderet før tilberedning/pelletering, uden at der er givet en forklaring på dette forhold. 
A risk has been identified on the assessment due to the high values of tilmicosin content in the meal feed prior to the conditioning/pelleting process and no explanation has been provided