natgillin/translations-raw huggingface dataset:
Den 25. april 2007 meddelte ISTA Pharma Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning om markedsføringstilladelse for Vitragan til behandling af glaslegemeblødning tilbage.
On 25 April 2007, ISTA Pharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vitragan, for the treatment of vitreous haemorrhage.
Hvad forventedes Vitragan anvendt til?
What was Vitragan expected to be used for?
EMEA/253854/2007
Ref. EMEA/195786/2007
Det skulle benyttes til at fremstille en opløsning til indsprøjtning i øjet.
It was to be made up into a solution for injection into the eye.
Hensigten var at forbedre synet og gøre det lettere for lægerne at diagnosticere den tilgrundliggende sygdom i nethinden (den lysfølsomme overflade bagest i øjet).
This was intended to improve vision and to help doctors in their diagnosis of underlying problems in the retina (the light-sensitive surface at the back of the eye).
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Vitragan eller i programmer for anvendelse med særlig udleveringstilladelse?
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vitragan?
Hvordan forventes Vitragan at virke?
How is Vitragan expected to work?
Det aktive stof i Vitragan, ovin hyaluronidase, er et enzym, der udvindes af får.
The active substance in Vitragan, hyaluronidase (ovine), is an enzyme extracted from sheep.
Efter gennemgang af den indledende dokumentation opstiller CHMP på dag 120 en række spørgsmål, der sendes til firmaet.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Vitragan er er et pulver, der indeholder det aktive stof hyaluronidase (fra får).
Vitragan is a powder containing the active substance hyaluronidase (ovine).
Virkningen blev hovedsagelig bedømt på bedringen i synet tre måneder efter injektionen, målt med en almindelig synstavle.
The main measure of effectiveness was the improvement in vision three months after the injection, assessed using a standard letter chart.
Firmaet har til CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Vitragan.
The company informed the CHMP that there are currently no clinical trials or compassionate use programmes with Vitragan.
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Vitragan ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vitragan had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af spørgsmålene fra CHMP var der i CHMP betænkelighed på tilbagetrækningstidspunktet, og udvalgets foreløbige standpunkt var, at Vitragan ikke kunne godkendes til behandling af glaslegemeblødning.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vitragan could not have been approved for the treatment of vitreous haemorrhage.
På denne måde forventedes det, at fagocytterne (immunsystemets specialiserede "ædeceller") ville kunne fjerne blodklumper i glaslegemet.
This was expected to allow phagocytes (specialised ‘scavenger' cells of the immune system) to clear away any blood clots from the vitreous humour.
Vitragan forventedes anvendt til behandling af blødning i glaslegemet (den geléagtige væske i øjets centrale del) hos voksne.
Vitragan was expected to be used to treat vitreous haemorrhage (bleeding into the vitreous humour, the jelly-like fluid in the central chamber of the eye) in adults.
I CHMP var der betænkelighed over, at hovedundersøgelserne ikke på overbevisende måde havde vist, at Vitragan var mere effektivt end andre alternativer til behandling af glaslegemeblødning.
The CHMP had concerns over the benefits of Vitragan, since the main studies had not shown convincingly that it was more effective than available options for managing vitreous haemorrhage.
Når hyaluronsyren nedbrydes, omdannes glaslegemets konsistens fra gelé til væske.
When the acid is broken down, the vitreous humour turns from a jelly into a liquid, allowing cells to move more freely through the vitreous humour.
Det forventes at virke ved at nedbryde hyaluronsyre, som er et stof, der fines i glaslegemet.
It is expected to work by breaking down a molecule in the vitreous humour called hyaluronic acid.
MF EU-nummer
MA (EU) number (Invented) name Strength Pharmaceutical
Dag 5, dag 14 og dag 28
Day 5, Day 14 and Day 28
Dato for seneste fornyelse: 18. februar 2016
Date of latest renewal: 18 February 2016
Der er ikke fundet noget mønster i årsagerne til dødsfaldene.
No pattern was identified in the causes of death.
Studie 2: extended criteria donorer
Study 2: extended criteria donors
Langtidsopfølgning af Studie 1 og Studie 2
Long-term extension in Study 1 and Study 2
Transplantationsdag, før implantation (Dag 1)
Day of transplantation, prior to implantation (Day 1)
Det er vigtigt, at du læser hele PIL'en for yderligere oplysninger.
It is important that you read the entire PL for more information.
Patienter med høj PRA har ofte brug for øget immunsuppression.
Patients with high PRA often require increased immunosuppression.
Fra 4. uge efter transplantationen vil du få behandling med NULOJIX hver 4. uge.
From week 4 after transplant, you will receive treatment with NULOJIX every 4 weeks.
PML medfører ofte svær invaliditet og død.
PML often leads to severe disability or death.
NULOJIX er ikke undersøgt hos børn og unge under 18 år, og derfor anbefales det ikke til denne aldersgruppe.
NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group.
Du får måske symptomer, som du ikke selv er klar over.
You might get symptoms that you might not be aware of yourself.
Generelt forekom disse hændelser tidligt og størstedelen medførte transplantattab.
In general, these events occurred early and the majority resulted in graft loss.
Belatacept bør ikke anvendes til gravide kvinder, medmindre dette anses for klart nødvendigt.
Belatacept should not be used in pregnant women unless clearly necessary.
Fortæl din familie eller plejere om din behandling.
Tell your family or caregiver about your treatment.
Dublin 15 - Irland
Dublin 15 - Ireland
Ca. 80% af AR opstod ved måned 3 og var sjældne efter måned 6.
Approximately 80% of AR episodes occurred by Month 3 and were infrequent after Month 6.
Almindelig depression
Common depression
* Se afsnittet ”Beskrivelse af udvalgte bivirkninger”.
* See section “Description of selected adverse reactions”.
Den kliniske relevans af disse antistoffer er ikke kendt.
The clinical relevance of such antibodies is unclear.
Der er administreret enkeltdoser på op til 20 mg/kg uden synlig toksisk effekt.
Single doses up to 20 mg/kg have been administered without apparent toxic effect.
Fortæl det til lægen, hvis du skal vaccineres.
Tell your doctor if you need to have vaccinations.
Tidlig diagnose og behandling kan nedsætte følgerne af PML.
Early diagnosis and treatment may mitigate the impact of PML.
Akkumuleringsindekset for belatacept ved steady state var 1,1.
The accumulation index for belatacept at steady state is 1.1.
** Omfatter alle hændelser rapporteret over gennemsnitligt 3,3 år i fase 3-studierne og over gennemsnitligt 7 år i fase 2-studiet.
** Includes all events reported over a median of 3.3 years in the Phase 3 studies, and a median of approximately 7 years in the Phase 2 study.
Op til år 3*,**
Up to Year 3*,**
Denne medicin vil blive opbevaret på det hospital, hvor det anvendes.
This medicine will be stored in the healthcare facility where it is administered.
Kortet indeholder din læges navn og telefonnummer og datoen for, hvornår du startede behandlingen, datoen for din sidste behandling og datoen for din næste behandling.
The card will have your doctor's name and phone number and the date when you started treatment, your last treatment visit, and your next visit for treatment.
Patienter bør informeres om, at hvis de oplever disse symptomer, skal de undgå potentielt farlige aktiviteter såsom bilkørsel og betjening af maskiner.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machines.
Dette bør tages i betragtning ved behandling af patienter på natriumkontrolleret diæt.
This should be taken into consideration when treating patients on a controlled sodium diet.
Op til år 1
Up to Year 1
To aminosyresubstitutioner (L104 til E; A29 til Y) er udført i den ligandbindende region af CTLA-4.
Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4.
I hver pakke med denne medicin er der et informationskort, som skal gives til patienten.
Each pack of the medicine contains an alert card that should be given to the patient.
Belatacept har vist sig at passere placenta hos rotter og kaniner.
Belatacept was shown to cross the placenta in rats and rabbits.
Belatacepts sikkerhed og virkning hos børn i alderen 0 til 18 år er endnu ikke klarlagt.
The safety and efficacy of belatacept in children and adolescents 0 to 18 years of age have not yet been established.
Dosis og behandlingshyppighed er anført nedenfor.
The dose and treatment frequency is given below.
Den anbefalede dosis er baseret på patientens kropsvægt (kg).
The recommended dose is based on patient body weight (kg).
Fortæl din familie eller plejere om din behandling, da du måske får symptomer, som du ikke selv er klar over.
Tell your family or caregiver about your treatment as you might get symptoms that you might not be aware of yourself.
Test kan vise:
Tests may show:
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til engangsbrug.
METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Det gives som infusion (som drop) i en af dine vener over en periode på ca. 30 minutter.
It will be given to you by infusion (as a "drip") into one of your veins over a period of about 30 minutes.
Belatacept er ikke blevet undersøgt hos patienter med Panel Reactive Antibody (PRA) > 30% (som ofte har behov for øget immunsuppression).
Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) > 30% (who often require increased immunosuppression).
Disse typer medicin mindsker aktiviteten af immunsystemet, som er kroppens naturlige forsvarssystem.
These are medicines that reduce the activity of the immune system, the body's natural defences.
Infusion af den første dosis bør gives umiddelbart i den præoperative periode eller under operationen, men inden afslutning af transplantatets vaskulære anastomose.
Infusion of the first dose should be given in the immediate preoperative period or during surgery, but before completion of the transplant vascular anastomoses.
Brugen af levende vacciner bør undgås sammen med NULOJIX.
The use of live vaccines should be avoided with the use of NULOJIX.
Der foreligger ikke tilstrækkelige data for brug af belatacept hos gravide kvinder.
There are no adequate data from use of belatacept in pregnant women.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
På grund af abatacepts lighed med belatacept hvad angår struktur og virkningsmekanisme og dets højere aktivitet i gnavere blev abatacept anvendt som en mere aktiv homolog for belatacept i gnavere.
Because of abatacept's similarity to belatacept in structure and mechanism of action and its higher activity in rodents, abatacept was used as a more active homolog for belatacept in rodents.
Dårlig appetit, mistet smagssans, nedsat hørelse
Poor appetite, loss of taste, decreased hearing
Ved det anbefalede dosisregime nåede serumkoncentrationer generelt steady state ved uge 8 i initialfasen efter transplantation og ved måned 6 i vedligeholdelsesfasen.
At the recommended dosing regimen, serum concentration generally reached steady-state by Week 8 in the initial phase following transplantation and by Month 6 during the maintenance phase.
Derfor kan vaccinationer under behandling med belatacept være mindre effektive, skønt dette ikke er blevet undersøgt i kliniske studier.
Therefore, during treatment with belatacept, vaccinations may be less effective although this has not been studied in clinical trials.
NULOJIX svækker kroppens evne til at bekæmpe infektioner.
NULOJIX weakens the body's ability to fight infections.
NULOJIX kan imidlertid forårsage alvorlige bivirkninger, som det kan være nødvendigt at behandle.
However, NULOJIX can cause serious side effects that may need treatment.
Det er sandsynligt, at den øgede følsomhed over for opportunistiske infektioner, der er observeret hos unge rotter, er associeret med eksponering for abatacept inden udvikling af hukommelsesrespons.
It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Den hyppigste CNS-infektion var kryptokokmeningitis.
The most common CNS infection was cryptococcal meningitis.
Forsøg med voksne mus og aber har ikke vist lignende fund.
Studies in adult mice and monkeys have not demonstrated similar findings.
Udlevering af kortet lægger også op til en dialog om nye eller ændrede symptomer siden sidste konsultation.
The distribution of the card will also prompt dialogue on any new or changes in symptoms since the prior visit.
Hyppigheden er defineret som følger: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelige (≥ 1/1.000 til  1/100).
The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
I alt 250 personer blev randomiseret til 1 af 5 behandlingsgrupper (3 belatacept- og 2 tacrolimus-grupper).
A total of 250 subjects were randomised to 1 of 5 treatment groups (3 belatacept and 2 tacrolimus groups).
Autoimmun proces
Autoimmune process
Tag præcis den steroiddosis, som din læge har angivet.
Please take the exact steroid dose as determined by your doctor.
Det anbefales også at behandle med en interleukin(IL)-2-receptorantagonist i den første uge efter transplantationen.
It is also recommended to administer an interleukin(IL)-2 receptor antagonist during the first week after transplantation.
Vævsdød pga. stoppet blodtilførsel
Dead tissue because of stopped blood supply
PML er en sjælden, ofte hurtigt progredierende og fatal, opportunistisk infektion i CNS forårsaget af John Cunningham (JC)-virus.
PML is a rare, often rapidly progressive and fatal, opportunistic infection of the CNS that is caused by the John Cunningham (JC) virus.
Plasmaferese kan fremskynde fjernelsen af belatacept.
Plasmapheresis may accelerate removal of belatacept.
De fleste reaktioner var ikke alvorlige, milde til moderate og opstod ikke igen.
Most events were not serious, were mild to moderate in intensity, and did not recur.
Dato for første markedsføringstilladelse: 17. juni 2011
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011
Sørg for altid at have dette kort på dig samt en liste over al den medicin, som du anvender, ved ethvert besøg til lægen eller andet sundhedspersonale.
Please make sure you have this card with you at all times and a list of all your other medicines with you at any visit to a healthcare professional.
Derfor er de prækliniske studier, der er foretaget med abatacept, blevet anvendt til at understøtte belatacepts sikkerhed ud over de studier, der er foretaget med belatacept.
Therefore, preclinical studies conducted with abatacept have been used to support the safety of belatacept in addition to the studies conducted with belatacept.
Den fortyndede opløsning skal administreres som intravenøs infusion med en relativ konstant hastighed i løbet af 30 minutter.
The diluted solution must be administered as an intravenous infusion at a relatively constant rate over 30 minutes.
Tabel 4: Forekomst af infektioner per behandlingsgruppe (%)
Table 4: Infections occurring by treatment group (%)
Du bør bære beskyttende beklædning og anvende solcreme med høj beskyttelsesfaktor.
Wear protective clothing and use a sunscreen with a high protection factor.
Ved år 3 var hyppigheden for NODM 8% med belatacept og 10% med ciclosporin.
At Year 3, the incidence of NODM was 8% with belatacept and 10% with ciclosporin.
Lægen vil muligvis undersøge dine symptomer for at udelukke PML, PTLD eller andre infektioner.
Your doctor may need to investigate your symptoms to rule out PML, PTLD or other infections.
Belatacept forventes ikke at afbryde den enterohepatiske recirkulation af MPA.
Belatacept is not expected to interrupt the enterohepatic recirculation of MPA.
PTLD-tilfældene varierede efter serostatus.
Cases of PTLD varied by serostatus.
Efter fortynding og fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks.
After dilution, and from a microbiological point of view, the product should be used immediately.
Du må ikke køre eller arbejde med maskiner, hvis du føler dig træt eller utilpas efter behandling med NULOJIX.
However you should not drive or operate any machines if you are feeling tired or unwell after receiving NULOJIX.
Den højere beregnede GFR, der blev observeret hos belataceptbehandlede patienter i forhold til ciclosporinbehandlede patienter i løbet af de første 3 år, blev opretholdt under langtidsopfølgningen.
The higher calculated GFR observed in belatacept-treated patients relative to ciclosporin-treated patients during the first 3 years was maintained over the long-term extension period.
CMV-profylakse anbefales i mindst 3 måneder efter transplantation, især hos patienter med øget risiko for CMV-infektion.
CMV prophylaxis is recommended for at least 3 months after transplantation, particularly for patients at increased risk for CMV infection.
Som regel var antistoftitrene lave, ikke vedvarende og kunne ofte ikke detekteres ved fortsat behandling.
In general, antibody titers were low, not usually persistent, and often became undetectable with continued treatment.
Det vides ikke om disse fund udgør en risiko for udvikling af autoimmune sygdomme hos mennesker, der eksponeres in utero for abatacept eller belatacept.
It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept.
Dette patient informationskort indeholder oplysninger, som kan være nyttige for dig og advare andre læger om, at du har en transplanteret nyre og behandles med en kraftig medicin for at nyren skal blive ved med at fungere.
This Patient Alert Card includes information that will be helpful to you and alert other doctors that you have a transplanted kidney and are on a potent medicine to keep your kidney working.
Efter administration anbefales det at skylle intravenøsslangen med infusionsvæske for at sikre at den fulde dosis administreres.
Following administration, it is recommended that the intravenous line be flushed with infusion fluid to ensure administration of the complete dose.
Sprøjten er opdelt i enheder på 0,5 ml og den beregnede dosis skal derfor afrundes til den nærmeste 0,5 ml.
Syringes are marked in units of 0.5 ml; therefore, the calculated dose should be rounded to the nearest 0.5 ml.
Sikkerhed og effekt ved genbehandling med belatacept er ikke blevet undersøgt.
The safety and efficacy of retreatment with belatacept has not been studied.
Lægen vil rådgive dig om sikker prævention.
Your doctor will advise you about using a reliable contraceptive.
Terapeutisk monitorering af belatacept er ikke nødvendig.
Therapeutic monitoring of belatacept is not required.
Contrada Fontana del Ceraso 03012 Anagni (FR) - Italien
Contrada Fontana del Ceraso 03012 Anagni (FR) - Italy
Profylakse af pneumocystis pneumoni anbefales i mindst 6 måneder efter transplantation.
Pneumocystis pneumonia prophylaxis is recommended for at least 6 months following transplantation.
Ni ud af 14 tilfælde af PTLD hos belatacept-behandlede patienter var lokaliseret i CNS; i observationsperioden var 8 af 14 tilfælde med dødelig udgang (6 af de fatale tilfælde omfattede CNS).
Nine of 14 cases of PTLD in belatacept-treated patients were located in the CNS; within the observation period, 8 of 14 cases were fatal (6 of the fatal cases involved the CNS).
Lægen vil rådgive dig.
Your doctor will advise you what to do.
Den virale status blev ikke undersøgt i belatacept-studiet, men da dette virus er udbredt hos aber, forekom det sandsynligvis også hos disse aber.
The viral status was not determined in the belatacept study but, as this virus is prevalent in monkeys, it was likely present in these monkeys as well.
Dette forhindrer aggregation.
This will avoid aggregate formation.
I den første måned efter transplantation blev en mætning af CD86 på 85% opretholdt.
During the first month post-transplantation, 85% saturation of CD86 was maintained.
I et seks måneders og 1-årigt toksicitetsforsøg med cynomolgus-aber med henholdsvis belatacept og abatacept blev der ikke observeret signifikant toksicitet.
In a six-month and one-year toxicity study in cynomolgus monkeys with belatacept and abatacept, respectively, no significant toxicity was observed.
Leverbetændelse (cytolytisk hepatitis)
Liver inflammation (cytolytic hepatitis)
Datoer for NULOJIX-behandling:
Dates of NULOJIX Treatment:
I alt 45 ud af 847 patienter (5,3%) udviklede antistoffer under behandling med belatacept.
A total of 45 of 847 patients (5.3%) developed antibodies during treatment with belatacept.
Beslutningen om at holde op med NULOJIX skal tages i samråd med lægen og en anden behandling vil normalt blive påbegyndt.
The decision to stop using NULOJIX should be discussed with your doctor and another therapy will generally be started.
Indledende fase
Initial phase
Udsættelse for sollys og ultraviolet (UV) lys bør begrænses ved at bære beskyttende beklædning og anvende solcreme med høj beskyttelsesfaktor.
Exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Dette forhindrer dannelsen af skum.
This will avoid foam formation.
T-celler sørger for at opretholde kroppens evne til at modstå sygdomme og infektioner.
T-cells are cells responsible for maintaining your body's ability to resist disease and infections.
Dannelse af anti-belatacept antistoffer var ikke associeret med ændret clearance af belatacept.
Anti-belatacept antibody development was not associated with altered clearance of belatacept.
Fjern forseglingen fra hætteglasset, og tør toppen af med en alkohol-serviet.
Remove the flip off seal from the vial and wipe the top with an alcohol swab.
Den normaliserede immunogenicitetsfrekvens for eksponeringsvarighed var imidlertid den samme (2,0-2,1 per 100 patientår) i de tre studier.
However, immunogenicity rate normalised for duration of exposure was consistent at 2.0 to 2.1 per 100 patient years among the three studies.
Den potentielle indvirkning af allerede eksisterende antistoffer mod belatacept bør tages i betragtning ved overvejelser om genbehandling med belatacept efter længerevarende behandlingsophør, især hos patienter, som ikke har været i kontinuerlig immunsuppressiv behandling.
The potential impact of pre-existing antibodies to belatacept should be taken into account when considering retreatment with belatacept following prolonged discontinuation, particularly in patients who have not received continuous immunosuppression.