natgillin/translations-raw huggingface dataset:
• Der er rapporteret om tilfælde af leverskade hos patienter, der blev behandlet med Esmya (ulipristalacetat), herunder fire tilfælde af alvorlig leverskade, som medførte levertransplantation. 
• Four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury have been reported in patients treated with Esmya (ulipristal acetate).
ATCvet kode: QI05AD02. 
ATCvet code: QI05AD02.
Dato for første markedsføringstilladelse: 06/03/2003 Dato for seneste fornyelse af markedsføringstilladelse: 06/03/2013 
Date of first authorisation: 06/03/2003 Date of last renewal: 06/03/2013
Opbevares og transporteres nedkølet ( 2 °C - 8 °C ). 
Store and transport refrigerated (2 °C - 8 °C).
De aktive stoffer er principielt af biologisk oprindelse med henblik på at give aktiv immunitet i henhold til Forordning (EU) 470/2009. 
The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
En let temperaturforøgelse (max. 1,5 oC) kan forekomme i 1 dag, undtagelsesvis i 2 dage. 
A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
adjuvans, der er nævnt i produktresuméets afsnit 6.1, er enten tilladte stoffer, for hvilke det er angivet i tabel 1 i bilaget til Kommissionens forordning (EU) No 37/2010, at der ikke kræves nogen MRL-værdier eller opfattes som at høre ind under Forordning (EU) No 470/2009, når de anvendes som angivet i dette lægemiddel. 
The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Efter administration af en overdosis af vaccinen, er der ikke observeret andre bivirkninger end de under punkt 4.6. beskrevet. 
Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Forbigående hævelse , der sædvanligvis forsvinder i løbet af 4 dage, kan forekomme på injektionsstedet. 
A transient swelling which usually regresses within 4 days may appear at the injection site.
Aktiv immunisering af heste, der er 4 måneder eller ældre, mod influenza for at nedsætte kliniske symptomer og virusudskillelse efter infektion. 
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 10 doser : 10 hætteglas à 1 dosis 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
Undtagelsesvis kan der iagttages apati og nedsat ædelyst dagen efter vaccination. 
In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
Undtagelsesvis kan der ses hypersensitivitetsreaktion, der kan kræve korrekt symptomatisk behandling. 
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Vaccinen stimulerer aktiv immunitet mod influenza. 
The vaccine stimulates active immunity against equine influenza.
Varighed af immunitet opnået efter vaccinationsprogrammet: 5 måneder efter basisvaccination og 1 år efter tredje vaccination. 
Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.
Fremstiller af batchfrigivelse: MERIAL, 
Manufacturer responsible for the batch release: MERIAL
I meget sjældne tilfælde kan der ses abscesdannelse. 
In very rare occasions, abscessation may be observed.
Carbomer……………………………………………………………………… ............................... .4 mg Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer. 
Carbomer ........................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
2. program - vaccination mod influenza og tetanus: 
2nd scheme - vaccination against equine influenza and tetanus:
DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ 1. program - vaccination mod hesteinfluenza: 
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1st scheme - vaccination against equine influenza:
Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som , men ikke blandet med Merials dræbte vaccine mod rabies; dog på et andet administrationssted 
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
I sjældne tilfælde kan der forekomme smerte, lokal hyperthermi og muskelstivhed. 
Pain, local hyperthermia and muscle stiffness can occur in rare cases.
- Revaccination: 5 måneder efter basisvaccination og derefter årlig revaccination. 
- Revaccination: 5 months after primary vaccination course followed by annual booster injections.
I tilfælde af forøget infektionsrisiko eller utilstrækkelig colostrumoptagelse, kan der gives yderligere en injektion ved 4 måneders alderen efterfulgt af det fulde vaccinationsprogram (basisvaccination 5-6 måneder gamle og 4-6 uger senere fulgt af revaccination). 
In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE 
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
I meget sjældne tilfælde kan der ses bylddannelse. 
In very rare occasions, abcessation may be observed.
Administrer en dosis (1 ml) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: - Basisvaccination med ProteqFlu-Te: første injektion fra 5-6 måneders alderen, anden injektion 4-6 uger senere. 
Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Administrer en dosis (1 ml ProteqFlu) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: - Basisvaccination: første injektion fra 5-6 måneders alderen, anden injektion 4-6 uger senere. 
Administer one dose (1 ml of ProteqFlu), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later.
Hævelse på op til 15-20 cm i diameter (der kan vare i op til 2-3 uger) observeres sjældent. 
In rare occasions swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
1. program - vaccination mod hesteinfluenza: 
1st scheme - vaccination against equine influenza:
Vaccinestammerne vCP2242 og vCP3011 er rekombinant canarypox virus der afgiver hæmagglutinin HA genet fra hhv. influenza virusstammerne A/eq/Ohio/03 (amerikansk stamme, Florida undergruppe clade 1) og A/eq/Richmond/1/07 (Amerikansk stamme, Florida undergruppe clade 2) hos hest. 
The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
BETINGELSER, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG 
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
ProteqFlu Suspension til injektion til hest. 
ProteqFlu suspension for injection for horses
Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt: Efter administration af en overdosis af vaccinen, er der ikke observeret andre bivirkninger end de der er beskrevet under ”Bivirkninger”. 
Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Influenza A/eq/Ohio/03 [H3N8] rekombinant canarypox virus (vCP2242) ..............≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinant canarypox virus (vCP3011) ...................................................................................................................................≥ 5,3 log10 FAID50* * vCP indhold kontrolleret ved global FAID50 (fluorescent assay" infektiøs dosis 50 %) og qPCR rate mellem vCP. 
Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............. ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .. ≥ 5.3 log10 FAID50*
INDLÆGSSEDDEL ProteqFlu Injektionsvæske, suspension, til heste. 
PACKAGE LEAFLET FOR: ProteqFlu suspension for injection for horses
Biotilgængeligheden er 65 til 70 %. 
Bioavailability is 65 to 70 %.
Dette punkt kræver nærmere redegørelse. 
This needs point further discussion.
ATC-kode: C09A A04 
ATC code: C09A A04
Der er begrænsede data til rådighed om overdosering hos mennesker. 
Limited data are available for overdosage in humans.
Samlet konklusion vedrørende benefit/risk-forhold 
Overall conclusion on benefit/risk
Såfremt der er planlagt eller konstateret graviditet, skal der skiftes til en alternativ behandling så hurtigt som muligt. 
When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.
Dette kan forekomme på ethvert tidspunkt under behandlingen. 
This may occur at any time during therapy.
Mekanismen bag dette syndrom er ikke afklaret. 
The mechanism of this syndrome is not understood.
Følgende liste med spørgsmål (LoQ) blev vedtaget af CHMP i april 2005: 
The following LoQ was adopted by the CHMP in April 2005:
Meget almindelig (>1/10); almindelig (>1/100, <1/10); ualmindelig (>1/1000, <1/100); sjælden (>1/10000, <1/1000); meget sjælden (<1/10000), inklusive isolerede tilfælde. 
Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.
Der er ikke observeret nogen carcinogenicitet i langtidsstudier af rotter og mus. 
No carcinogenicity has been observed in long term studies in rats and mice.
Nederlandene indbragte officielt en sag med henblik på voldgift for CHMP den 17.3.2005. 
An official referral for arbitration was notified by the Netherlands to the CHMP on 17.03.2005.
Nedsættelsen af blodtrykket sker hurtigt. 
The decrease in blood pressure occurs rapidly.
Behandlingen skal seponeres én dag før operationen. 
The treatment should be discontinued one day prior to the surgery.
Denne virkning er forudset og er normalt ikke grund til at seponere behandlingen. 
This effect is anticipated and is usually not a reason to discontinue treatment.
Hvis det er påkrævet, kan den diuretiske behandling genoptages. 
If required, diuretic therapy may be resumed.
LÆGEMIDDELFORM Tabletter. 
PHARMACEUTICAL FORM Tablets.
Anvendelse til børn Effekt og sikkerhed for anvendelse til børn er ikke fastlagt. 
Efficacy and safety of use in children has not been established.
Resultaterne i denne patientgruppe er mindre overbevisende, og yderligere risikodifferentiering kan være nødvendig, før denne patientgruppe kan indgå i ordlyden af indikationen. 
Results in this population are less convincing and further differentiation of risk may be needed before this patient group can be included in the wording of the indication.
Resultaterne viste, at behandling med perindopril én gang dagligt resulterede i en væsentlig absolut risikoreduktion for det primære endepunkt. 
The results showed that treatment with perindopril once daily resulted in a significant absolute reduction in the primary endpoint.
Studier af patienter med hjerteinsufficiens har påvist: 
Studies in patients with heart failure have demonstrated:
Nogle af disse patienter har udviklet alvorlige infektioner, som i nogle få tilfælde ikke har responderet på intensiv antibiotikabehandling. 
Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy.
Det anbefales derfor at udvise forsigtighed, da disse patienter kan blive volumen- og/eller saltdepleterede. 
Caution is therefore recommended since these patients may be volume and/or salt depleted.
Perindopril er kontraindiceret under andet og tredje trimester af graviditeten. 
Perindopril is contraindicated during the second and third trimesters of pregnancy.
øget kardialt output og forbedret kardialt indeks. 
increased cardiac output and improved cardiac index.
Ca. 20 % af den totale mængde absorberet perindopril omdannes til perindoprilat, den aktive metabolit. 
About 20 % of the total quantity of perindopril absorbed is converted into perindoprilat, the active metabolite.
Meget sjældne: erythema multiforme 
Very rare: erythema multiforme
Hvis der anvendes perindopril til sådanne patienter, anbefales periodisk kontrol af antallet af hvide blodceller, og patienterne skal instrueres om at rapportere ethvert tegn på infektion. 
If perindopril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
• Der er indsat en advarsel i afsnit 4.4: 
• A warning has been introduced in Section 4.4:
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMÉET FREMLAGT AF EMEA 
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
anbefalet dosis 
recommended dose
Ved føring af motorkøretøj eller betjening af maskiner bør man tage højde for, at der kan forekomme lejlighedsvis svimmelhed eller træthed. 
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Efter gentagne doser er der ikke observeret nogen akkumulering af perindopril. 
After repeated administration, no accumulation of perindopril is observed.
Efterfølgende indsendte ansøgeren den 23.2.2005 til alle medlemsstater en erklæring om, at den af referencemedlemsstaten foreslåede indikation ikke var acceptabel, og at der burde godkendes en bredere indikation, som afspejlede hele populationen i undersøgelsen, nemlig: 
The applicant subsequently sent on 23.02.2005 a Position Paper to all MS stating that the indication proposed by the RMS was not acceptable, and that a broader indication reflecting the study population should be approved, namely:
Derfor frarådes anvendelse til børn. 
Therefore, use in children is not recommended.
Denne ordlyd vil være på linje med CHMP's generelle politik for produkter, hvis virkning evalueres ved hjælp af sammensatte endepunkter. 
This wording would be in line with the general CHMP policy regarding products using composite endpoints for evaluation of efficacy.
Det anbefales, at <COVERSYL og øvrige navne> tages én gang dagligt om morgenen før et måltid. 
It is recommended that <COVERSYL and associated names> is taken once daily in the morning before a meal.
Patienter med tidligere revaskularisering ville være omfattet af disse patientgrupper. 
Patients with a history of revascularisation would be included in these groups of patients.
• CHMP har behandlet indbringelsen i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003 vedrørende Coversyl og tilknyttede navne (jf. bilag I). 
• the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for Coversyl and associated names (see Annex I),
SAMLET RESUME AF DEN FAGLIGE VURDERING AF COVERSYL OG TILKNYTTEDE NAVNE (se bilag I) 
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COVERSYL AND ASSOCIATED NAMES (see Annex I)
Som regel øges den renale blodgennemstrømning, mens den glomerulære filtrationsrate (GFR) sædvanligvis er uændret. 
Renal blood flow increases as a rule, while the glomerular filtration rate (GFR) is usually unchanged.
Hæmodialysepatienter * ClKR < 15 
Haemodialysed patients * ClCR < 15
CHMP finder ikke, at den manglende signifikante forskel for to af de tre komponenter af det sammensatte endepunkt i EUROPA-undersøgelsen giver grund til at begrænse indikationen til en enkelt komponent, eftersom der ses en positiv og fuldstændig konsistent tendens for disse to komponenter. 
The CHMP believes that the lack of a statistically significant difference for two of the three components of the composite endpoint in the EUROPA study is not a reason to restrict the indication to a single component, given that a positive and fully consistent trend for these two components is observed.
• Hereditært eller idiopatisk angioødem; 
• Hereditary or idiopathic angioedema;
Efter oral indgift absorberes perindopril hurtigt, og den maksimale koncentration nås inden for 1 time. 
After oral administration, the absorption of perindopril is rapid and the peak concentration complete within 1 hour.
Dette er sædvanligvis reversibelt. 
These effects are usually reversible.
Hos patienter, der reagerer på behandlingen, opnås normalisering inden for en måned og er vedvarende uden forekomst af tachyphylaxis. 
In responding patients, normalisation is achieved within a month and persists without the occurrence of tachyphylaxis.
Denne indikation blev godkendt af flere af de berørte medlemsstater. 
This indication was endorsed by several CMS.
Den antihypertensive aktivitet er maksimal mellem 4 og 6 timer efter en enkelt dosis og varer i mindst 24 timer: Den gennemsnitlige effekt er ca. 87-100 % af den maksimale effekt. 
The antihypertensive activity is maximal between 4 and 6 hours after a single dose and is sustained for at least 24 hours: trough effects are about 87-100 % of peak effects.
Meget sjældne: pancreatitis 
Very rare: pancreatitis
Den maksimale plasmakoncentration af perindoprilat opnås i løbet af 3 til 4 timer. 
The peak plasma concentration of perindoprilat is achieved within 3 to 4 hours.
I sådanne tilfælde skal <COVERSYL og øvrige navne> seponeres omgående, og passende observation skal initieres og fortsættes, indtil symptomerne er svundet fuldstændig. 
In such cases, <COVERSYL and associated names> should promptly be discontinued and appropriate monitoring should be initiated and continued until complete resolution of symptoms has occurred.
Doseringen bør kun øges, hvis den forudgående lavere dosis tolereres godt. 
The dose should be increased only if the previous lower dose is well tolerated.
• anså CHMP benefit/risk-forholdet for ovenstående udvidelse af indikationen for gunstigt. 
• the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
Dissociering af perindoprilat bundet til det angiotensinkonverterende enzym bevirker en ”effektiv” halveringstid for eliminering på 25 timer, der resulterer i steady-state inden for 4 dage. 
Dissociation of perindoprilat bound to angiotensin converting enzyme leads to an “effective” elimination half-life of 25 hours, resulting in steady-state within 4 days.
Den anbefalede startdosis er 4 mg, der indgives én gang dagligt om morgenen. 
The recommended starting dose is 4 mg given once daily in the morning.
Denne gavnlige virkning var statistisk signifikant for ikke-dødeligt MI, den ene komponent i det kombinerede endepunkt. 
This benefit was statistically significant for non-fatal MI, one of the components of the combined endpoint.
Proteinbindingen er lille (perindoprilats binding til det angiotensinkonverterende enzym er mindre end 30 %), men er koncentrationsafhængig. 
Protein binding is slight (binding of perindoprilat to angiotensin converting enzyme is less than 30 %), but is concentration-dependent.
En forbigående hypotensiv respons er ikke kontraindikation for fortsat dosis, der som regel kan gives uden problemer, når blodtrykket er øget efter volumenekspansion. 
A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
Hos patienter med normal nyrefunktion og ingen yderligere komplicerende faktorer forekommer neutropeni sjældent. 
In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.
De andre metabolitter viser ingen hæmning af ACE-aktivitet in vitro. 
The other metabolites show no inhibition of ACE activity in vitro.
CHMP anbefalede godkendelse af type II-ændringen med den udvidede indikation. 
The CHMP recommended the granting of the type II variation to extend the indication.
Det vides ikke, om perindopril udskilles i modermælken. 
It is not known whether perindopril is excreted into human breast milk.
Graviditet <COVERSYL og øvrige navne> må ikke bruges under første trimester af graviditeten. 
Pregnancy: <COVERSYL and associated names> should not be used during the first trimester of pregnancy.
Distributionsmængden er ca. 0,2 l/kg for ubundet perindoprilat. 
The volume of distribution is approximately 0.2 l/kg for unbound perindoprilat.
Resultaterne af HOPE- og PEACE-undersøgelserne synes at underbygge den gavnlige virkning af perindopril, der er iagttaget i EUROPA-undersøgelsen for patienter med middelhøj til høj risiko for kardiale hændelser. 
The results of the HOPE and PEACE trials seem to support the beneficial effect of perindopril observed in the EUROPA study for patients with medium to high risk of cardiac events.
Efterfølgende dosering af <COVERSYL og øvrige navne> skal justeres efter blodtryksreaktion. 
The subsequent dosage of <COVERSYL and associated names> should be adjusted according to blood pressure response.
reduceret samlet perifer karmodstand, 
reduced total peripheral vascular resistance,
Dosisjustering ved nyreinsufficiens er ønskelig, afhængigt af graden af insufficiens (kreatininclearance). 
Dosage adjustment in renal insufficiency is desirable depending on the degree of impairment (creatinine clearance).
Pacemaker-behandling er indiceret ved behandlingsresistent bradycardia. 
Pacemaker therapy is indicated for therapy-resistant bradycardia.
LÆGEMIDLETS NAVN <COVERSYL og øvrige navne (se bilag I)>, <styrke>, tabletter <[Se bilag I - Udfyldes nationalt]> 
NAME OF THE MEDICINAL PRODUCT <COVERSYL and associated names (see Annex I)>, <strength>, tablets <[See Annex I - to be completed nationally]>
I den randomiserede periode af EUROPA-undersøgelsen er kun oplysninger om alvorlige bivirkninger blevet indsamlet. 
During the randomised period of the EUROPA study, only serious adverse events were collected.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE 
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Perindoprilat elimineres i urinen, og halveringstiden for den ubundne fraktion er ca. 3 til 5 timer. 
Perindoprilat is eliminated in the urine and the half-life of the unbound fraction is approximately 3 to 5 hours.
Det forbedrer de store arteriers elasticitet og reducerer de små arteriers media:lumen relation. 
It improves large artery elasticity and decreases the media: lumen ratio of small arteries.
Coversyl og tilknyttede navne indeholder perindopril, en velkendt hæmmer af Angiotensin Converting Enzyme (ACE-hæmmer), der markedsføres i hele EU, bl.a. siden 1988 i Frankrig under navnet Coversyl 2 og 4 mg, foruden i flere end 10 andre lande verden over, herunder USA og Japan. 
Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), marketed in France as Coversyl 2 and 4 mg since 1988, the entire European Union, and world-wide in more than 10 countries including USA and Japan.
Ud over det aktive perindoprilat, danner perindopril fem metabolitter, der alle er inaktive. 
In addition to active perindoprilat, perindopril yields five metabolites, all inactive.