natgillin/translations-raw huggingface dataset:
Mycamine hætteglas der skal bruges (mg/ hætteglas)
Mycamine vial to be used (mg/vial)
Mængde natriumchlorid (0, 9%) eller glucose (5%), der skal tilsættes hvert hætteglas
Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
London, den 20. marts 2007 Ref. dok.
Ref.
Den 16. november 2006 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori det anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet Mycograb, pulver til injektionsvæske, opløsning, 2 mg/ ml, til behandling af invasiv candidiasis hos voksne i kombination med amphotericin B eller en lipidformulering af amphotericin B.
On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.
Ansøgeren anmodede om fornyet overvejelse af udtalelsen.
The applicant requested a re- examination of the opinion.
Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 20. marts 2007 afslaget på ansøgningen om markedsføringstilladelse.
After having considered the grounds for this request, the CHMP re- examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2007.
Ved invasiv candidiasis har svampeinfektionen gennem blodet bredt sig til indre organer som f. eks. lever, milt og nyrer.
In invasive candidiasis, the fungal infection spreads to the internal organs such as the liver, spleen and kidneys via the bloodstream.
Invasiv candidiasis er en livstruende sygdom.
Invasive candidiasis is a life-threatening disease..
Da invasive svampeinfektioner er sjældne, blev Mycograb udpeget som "lægemiddel til sjældne sygdomme" den 5. december 2001.
Because the number of patients with invasive fungal infections is low, Mycograb was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 5 December 2001.
Ved at bindes til hsp90 blokerer efungumab dette proteins normale funktioner.
By attaching to hsp90, efungumab blocks the protein’ s normal activities.
Efungumab fremstilles ved "rekombinant DNA- teknik":
Efungumab is produced by a method known as ‘ recombinant DNA technology’.
Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
This means that it is made by a bacterium that has received a gene (DNA), which makes it able to produce the substance.
Hovedundersøgelsen af lægemidlets virkning omfattede 139 voksne patienter med invasiv candidiasis.
The main study of the medicine’ s effects involved 139 adults with invasive candidiasis.
5 dage efter ophør af behandlingen med Mycograb eller placebo).
The effectiveness was measured by looking at the percentage of patients responding to treatment, based on improvement of their symptoms (including fever) and elimination of the fungus from samples, as measured on day 10 (5 days after the end of Mycograb or placebo treatment).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgningen om markedsføringstilladelse?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Årsagen hertil er dog ikke klar.
The medicine is associated with ‘ cytokine release syndrome’, a condition that can cause nausea, vomiting, pain and also hypertension (high blood pressure), but the reason for this is not clear.
Mycophenolate mofetil Teva er et lægemiddel, som indeholder det aktive stof mycophenolate mofetil.
Mycophenolate mofetil Teva is a medicine containing the active substance mycophenolate mofetil.
Mycophenolate mofetil Teva er et ‘ generisk lægemiddel ’.
Mycophenolate mofetil Teva is a ‘ generic medicine’.
Det betyder, at Mycophenolate mofetil Teva er identisk med et ‘ referencelægemiddel ’, som allerede er godkendt i Den Europæiske Union (EU), og som hedder CellCept.
This means that Mycophenolate mofetil Teva is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called CellCept.
Mycophenolate mofetil Teva anvendes til forebyggelse af, at kroppen afstøder en transplanteret nyre, et transplanteret hjerte eller en transplanteret lever.
Mycophenolate mofetil Teva is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Det anvendes sammen med ciclosporin og corticosteroider (andre lægemidler, der anvendes til at forebygge organafstødning).
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Behandling med Mycophenolate mofetil Teva bør indledes og opretholdes af en kvalificeret specialist i transplantationer.
Mycophenolate mofetil Teva treatment should be initiated and maintained by a qualified transplant specialist.
Den måde, hvorpå Mycophenolate mofetil Teva skal gives, og i hvilken dosis afhænger af arten af organtransplantationen og af patientens alder og størrelse.
The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Ved nyretransplantater er den anbefalede dosis 1, 0 g to gange dagligt, idet behandlingen skal indledes inden for 72 timer efter transplantationen.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Hos børn mellem to og 18 år beregnes Mycophenolate mofetil Teva- dosis afhængigt af højde og vægt.
In children aged between two and 18 years, the dose of Mycophenolate mofetil Teva is calculated depending on height and weight.
Ved hjertetransplantater er den anbefalede dosis til voksne 1, 5 g to gange dagligt, idet behandlingen skal indledes inden for fem dage efter transplantationen.
For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Ved levertransplantater bør der gives mycophenolate mofetil som infusion (drop i en vene) inden for de første fire dage efter transplantationen, inden patienten skifter over til 1, 5 g Mycophenolate mofetil Teva to gange dagligt, så hurtigt som patienten kan tåle det.
For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Mycophenolate mofetil Teva twice a day as soon as it can be tolerated.
Mycophenolate mofetil Teva anbefales ikke til anvendelse hos børn efter hjerte - eller levertransplantation, da der mangler oplysninger om dets virkninger på denne gruppe.
Mycophenolate mofetil Teva is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Dosis skal eventuelt tilpasses hos patienter med lever - eller nyresygdom.
The dose may need to be adjusted in patients with liver or kidney disease.
De nærmere oplysninger fremgår af produktresuméet (også er en del af denne EPAR).
For more information, see the Summary of Product Characteristics (also part of the EPAR).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non- commercial or commercial purposes, provided the EMEA is acknowledged Hvordan virker Mycophenolate mofetil Teva?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non-commercial or commercial purposes, provided the EMEA is acknowledged enzyme called ‘ inosine monophosphate dehydrogenase’.
Det omdannes i kroppen til mycophenolsyre, som blokerer et enzym kaldet ‘ inosinmonofosfatdehydrogenase ’.
This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Ved at forebygge produktionen af ny dna reducerer Mycophenolate mofetil Teva hyppigheden, med hvilken lymfocytterne formerer sig.
By preventing the production of new DNA, Mycophenolate mofetil Teva reduces the rate at which the lymphocytes multiply.
Dette gør dem mindre effektive til at genkende og angribe det transplanterede organ, hvorved det mindsker risikoen for, at organet afstødes.
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Da Mycophenolate mofetil Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de producerer samme mængder af det aktive stof i kroppen).
Because Mycophenolate mofetil Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).
Hvilken fordel og risiko er der forbundet med Mycophenolate mofetil Teva?
What are the benefit and risk of Mycophenolate mofetil Teva?
Da Mycophenolate mofetil Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/ risk- forholdet for at være det samme som for referencelægemidlet.
Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Mycophenolate mofetil Teva i overensstemmelse med EU’ s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Cellcept.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva has been shown to have comparable quality and to be bioequivalent to Cellcept.
Det var derfor CHMP' s opfattelse, at fordelene opvejer de identificerede risici som for CellCept.
Therefore, the CHMP’ s view was that, as for CellCept, the benefit outweighs the identified risk.
Andre oplysninger om Mycophenolate mofetil Teva:
Other information about Mycophenolate mofetil Teva:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mycophenolate mofetil Teva til Teva Pharma B. V. den 21 februar 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Mycophenolate mofetil Teva to Teva Pharma B. V. on 21 February 2008.
Den fuldstændige EPAR for Mycophenolate mofetil Teva findes her.
The full EPAR for Mycophenolate mofetil Teva can be found here.
Den fuldstændige EPAR for referencelægemidlet findes også på EMEA’ s websted.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
EU- nummer EU/ 1/ 07/ 439/ 001 EU/ 1/ 07/ 439/ 002 EU/ 1/ 07/ 439/ 003 EU/ 1/ 07/ 439/ 004
EU/ 1/ 07/ 439/ 001 EU/ 1/ 07/ 439/ 002 EU/ 1/ 07/ 439/ 003 EU/ 1/ 07/ 439/ 004
Særnavn Mofetil mycophenolate Mofetil mycophenolate Mofetil mycophenolate Mofetil mycophenolate
Mycophenolate mofetil Teva Mycophenolate mofetil Teva Mycophenolate mofetil Teva Mycophenolate mofetil Teva
Styrke 250 mg 250 mg 500 mg 500 mg
250 mg 250 mg 500 mg 500 mg
Lægemiddelform Kapsler, hårde Kapsler, hårde fimovertrukne tabletter fimovertrukne tabletter
Capsule, hard Capsule, hard Film-coated tablet Film-coated tablet
Emballage Blister Blister Blister Blister
blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu)
Paknings- størrelse 100 300 50 150
100 capsules 300 capsules 50 tablets 150 tablets
6. 1
Excipient For a full list of excipients, see section 6.1
Kapselens ” hoved ” er uigennemsigtig lyseblå printet ” M ” aksialt med sort blæk.
Hard capsule (capsule) The capsule body is caramel opaque, printed with ‘ 250’ axially in black ink The capsule cap is light blue opaque printed ‘ M’ axially in black ink.
Mycophenolate mofetil Teva er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre -, hjerte -, eller levertransplantater.
Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Oralt Mycophenolate mofetil Teva bør gives indenfor 72 timer efter transplantation.
Adults: oral Mycophenolate mofetil Teva should be initiated within 72 hours following transplantation.
Den anbefalede dosis til nyretransplantationspatienter er 1, 0 g administreret to gange daglig (døgndosis, 2 g).
The recommended dose in renal transplant patients is 1.0 g administered twice daily (2 g daily dose).
Mycophenolate mofetil Teva kapsler må kun ordineres til patienter med en legemsoverflade på mindst 1, 25 m2.
Children and adolescents: the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily). Mycophenolate mofetil Teva capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
1, 5 g).
Patients with a body surface are of 1.25 to 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 750 mg twice daily (1.5 g daily dose).
4. 8) end hos voksne, kan det blive nødvendigt forbigående at nedsætte dosis eller afbryde behandlingen, under behørig hensyntagen til relevante kliniske faktorer, inklusive bivirkningssværhedsgraden.
Patients with a body surface area greater than 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Oralt Mycophenolate mofetil Teva bør gives indenfor 5 døgn efter transplantation.
2 Adults: oral Mycophenolate mofetil Teva should be initiated within 5 days following transplantation.
Den anbefalede dosis til hjertetransplantationspatienter er 1, 5 g administreret to gange daglig (døgndosis, 3 g).
The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Der er ingen data vedrørende hjertetransplantationer hos børn, bør ikke anvendes til denne gruppe af patienter, før end yderligere data er tilgængelig til at understøtte dette.
Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Voksne: mycophenolatmofetil skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes så snart det tåles.
Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Mycophenolate mofetil Teva initiated as soon after this as it can be tolerated.
Den anbefalede orale Mycophenolate mofetil Teva dosis til levertransplantationspatienter er 1, 5 g to gange daglig (en døgndosis på 3 g).
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Der er ingen data vedrørende levertransplantationer hos børn, derfor anbefales det ikke til anvendelse hos denne patientgruppe før end yderligere data, til at understøtte dette, er tilgængelig.
Children and adolescents: no data are available for paediatric hepatic transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Anvendelse til ældre (≥ 65 år)
Use in elderly ( 65 years)
Den anbefalede dosering på 1, 0 g administreret to gange daglig til nyretransplantationspatienter og 1, 5 g administreret to gange daglig til hjerte - eller levertransplanterede patienter er passende til ældre.
The recommended dose of 1.0 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Anvendelse ved nyreinsufficiens
Use in renal impairment
Hos nyretransplanterede patienter med svær, kronisk nyreinsufficiens (glomerulær filtration < 25 ml min- 1 1, 73 m- 2), bortset fra den umiddelbare post- transplantionsperiode, bør doser på mere end 1 g administreret to gange dagligt undgås.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Dosisregulering er ikke nødvendig hos patienter, der oplever forsinket nyretransplantatfunktion post - operativt (se pkt.
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
Anvendelse ved svær nedsættelse af leverfunktionen
Use in severe hepatic impairment
Det er ikke nødvendigt med dosisjusteringer hos patienter med svær leverparenchymlidelse.
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Der findes ingen tilgængelige data for hjertetransplantaterede patienter med svær leverparenchymsygdom.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Behandling under afstødningsepisoderne
Treatment during rejection episodes
Nyretransplantatafstødning medfører ingen ændringer af MPA’ s farmakokinetik; dosisreduktion eller afbrydelse af Mycophenolate mofetil Teva er ikke nødvendig.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of Mycophenolate mofetil Teva is not required.
Der er ikke grundlag for justering af Mycophenolate mofetil Teva- dosis efter afstødning af hjertetransplantat.
There is no basis for Mycophenolate mofetil Teva dose adjustment following cardiac transplant rejection.
Overfølsomhed over for det aktive stof, over for mycophenolatsyre eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance, to mycophenolic acid or any of the excipients.
4. 6).
Mycophenolate mofetil Teva is contraindicated in women who are breast-feeding (see section 4.6).
Risikoen synes snarere at være relateret til intensiteten og varigheden af immunosuppression end til brugen af et bestemt middel.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Mycophenolate mofetil Teva, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
For at minimere risikoen for hudkræft må det
As general advice to
3 generelt tilrådes, at udsættelse for sollys og ultraviolet (UV) lys begrænses ved, at der bæres beskyttende beklædning, og ved at der anvendes en solblokker med en høj beskyttelsesfaktor.
3 minimise the risk for skin cancer, exposure to sunlight and ultra violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Patienter, som får Mycophenolate mofetil Teva, skal have besked om straks at indberette alle tegn på infektion, uventede blodudtrækninger, blødning eller andre manifestationer af knoglemarvsdepression.
Patients receiving Mycophenolate mofetil Teva should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
4. 8).
Patients treated with immunosuppressants, including Mycophenolate mofetil Teva, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Patienter på Mycophenolate mofetil Teva bør have foretaget fuldstændig blodtælling hver uge den første måned, to gange om måneden den anden og tredie behandlingsmåned og derefter en gang om måneden igennem det første år.
Patients taking Mycophenolate mofetil Teva should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1. 3 103/ μl), skal behandlingen med Mycophenolate mofetil Teva måske afbrydes eller stoppes.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/ l) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
4. 5).
Patients should be advised that during treatment with Mycophenolate mofetil Teva vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Eftersom mycophenolatmofetil er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet inklusive sjældne tilfælde af ulceration, blødning og perforation bør Mycophenolate mofetil Teva administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
Because mycophenolate has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Mycophenolate mofetil Teva should be administered with caution in patients with active serious digestive system disease.
Af teoretiske grunde bør det derfor undgås til patienter med sjældne arvelig mangel på hypoxantin- guanin - fosforibosyltransferase (HGPRT) såsom Lesch- Nyhan og Kelley- Seegmiller syndrom.
On theoretical grounds, therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley- Seegmiller syndrome.
Mycophenolate mofetil Teva bør ikke administreres samtidig med azathioprin, da en sådan samtidig administration ikke er blevet undersøgt.
It is recommended that Mycophenolate mofetil Teva should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
I betragtning af cholestyramins signifikante reduktion af MPA- AUC (areal under kurven) skal man på grund af risikoen for at reducere virkningen af Mycophenolate mofetil Teva være forsigtig med samtidig administration af Mycophenolate mofetil Teva og lægemidler, som interfererer med det enterohepatiske kredsløb.
In view of the significant reduction in the AUC (area under the curve) of MPA by cholestyramine, caution should be used in the concomitant administration of Mycophenolate mofetil Teva with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Mycophenolate mofetil Teva.
4. 5).
The risk-benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
4 for, at mycophenolatmofetil og aciclovir, eller deres prodrugs, f. eks. valaciclovir, vil konkurrere om den tubulære sekretion, og at der kan ske yderligere forhøjelser af koncentrationerne af begge stoffer.
Because MPAG plasma concentrations are increased in 4 the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e. g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.