natgillin/translations-raw huggingface dataset:
Reproduction toxicology studies performed with different zinc salts showed no clinically relevant evidence of embryotoxicity, foetotoxicity or teratogenicity.
Študije toksičnosti za razmnoževanje, opravljene z različnimi cinkovimi solmi, niso pokazale znakov klinično pomembne toksičnosti za zarodek ali plod ali znakov teratogenosti.
Wilzin 50 mg is an orange opaque hard capsule imprinted “93-377”.
Wilzin 50 mg je oranžna neprozorna trda kapsula z napisom "93-377”.
ANNEX III
DODATEK III
• Do not use Wilzin after the expiry date stated on the bottle and the carton, after EXP.
• Zdravila Wilzin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid-morning, between breakfast and lunch.
Če bolnikov želodec ne prenaša zdravila, kar se pogosto dogaja pri jutranjem odmerku, lahko bolnik ta odmerek preloži na sredino dopoldneva, na čas med zajtrkom in kosilom.
MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
Three cases of acute oral overdose with zinc salts (sulphate or gluconate) have been reported in the literature.
V literaturi so poročali o treh primerih akutnega peroralnega prevelikega odmerka cinkovih soli (sulfata ali glukonata).
The faecal excretion is in the greatest part due to the passage of unabsorbed zinc but it is also due to endogenous intestinal secretion.
Daleč največji del izločanja z blatom gre na račun prehoda neabsorbiranega cinka, nekaj pa tudi na račun endogenega izločanja v črevo.
The other ingredients are maize starch and magnesium stearate.
Pomožni snovi sta koruzni škrob in magnezijev stearat.
Conversely, the effectiveness of some medicines, such as iron, tetracyclines or fluoroquinolones (antibiotics), may be reduced by Wilzin.
Obratno lahko Wilzin zmanjšuje učinkovitost nekaterih zdravil, na primer železa, tetraciklinov, fluorokinolonov (antibiotiki).
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije
The elimination of zinc results primarily from faecal excretion with relatively little from urine and sweat.
Cink se odstranjuje iz telesa predvsem z izločanjem v blatu, razmeroma malo pa se ga izloča v urinu in znoju.
Other anti-copper agents
Druga sredstva proti bakru
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• For adults: The usual dose is 1 hard capsule of Wilzin 50 mg (or 2 hard capsules of Wilzin 25 mg) three times daily with a maximum dose of 1 hard capsule of Wilzin 50 mg (or 2 hard capsules of Wilzin 25 mg) five times daily.
• Za odrasle: Običajni odmerek je 1 trda kapsula Wilzina 50 mg (ali 2 trdi kapsuli Wilzina 25 mg) trikrat na dan, pri čemer je največji odmerek ena trda kapsula Wilzina 50 mg (ali 2 trdi kapsuli Wilzina 25 mg) petkrat na dan.
Zinc induces the production of metallothionein in the enterocyte, a protein that binds copper thereby preventing its transfer into the blood.
Cink v enterocitu sproži nastajanje metalotioneina, beljakovine, ki veže baker in s tem prepreči njegov prenos v kri.
Capsule shell gelatin titanium dioxide (E171) brilliant blue FCF (E133)
Ovoj kapsule želatina titanov dioksid (E171) briljantno modro FCF (E133)
4.2 Posology and method of administration
4.2 Odmerjanje in način uporabe
The capsule shell contains gelatin, titanium dioxide (E171) and either brilliant blue FCF (E133) for Wilzin 25 mg, or sunset yellow FCF (E110) for Wilzin 50 mg.
Ovojnica kapsule vsebuje želatino, titanov dioksid (E171) in bodisi briljantno modro FCF (E133) pri Wilzinu 25 mg ali sončno rumeno FCF (E110) pri Wilzinu 50 mg. Tiskarsko črnilo vsebuje črni železov oksid (E172) in šelak.
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Read all of this leaflet carefully before you start taking this medicine.
Pred začetkom jemanja natančno preberite navodilo!
Zinc is excreted in human breast milk and zinc-induced copper deficiency in the breast-fed baby may occur.
Cink se izloča v materino mleko in pri dojenčku se lahko pojavi pomanjkanje bakra, povzročeno s cinkom.
Date of first authorisation: 13 October 2004 Date of latest renewal: 13 October 2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 13 oktober 2004
In this leaflet:
Navodilo vsebuje:
Please discuss the matter with your Wilson's disease doctor if this affects you.
Če to velja za vas, so pogovorite o tem s svojim zdravnikom - specialistom za Wilsonovo bolezen.
Wilzin is available in hard capsules of 25 mg or 50 mg.
Wilzin je na voljo v trdih kapsulah po 25 mg in 50 mg.
The liver is the main storage for zinc and hepatic zinc levels are increased during maintenance therapy with zinc.
Glavno skladišče cinka so jetra in raven cinka v jetrih se med vzdrževalnim zdravljenjem s cinkom zviša.
Other medicinal products
Druga zdravila
What Wilzin contains
Kaj vsebuje zdravilo Wilzin
This leaflet was last approved in
Navodilo je bilo odobreno
Wilzin 25 mg is an aqua blue hard capsule imprinted "93-376”.
Wilzin 25 mg je pariško modra trda kapsula z napisom "93-376”.
HOW TO TAKE WILZIN
KAKO JEMATI ZDRAVILO WILZIN
Capsule with orange opaque cap and body, imprinted "93-377”.
Kapsula z oranžnim neprozornim pokrovom in telesom, z napisom "93-377”.
The recommended dose is as follows: - from 1 to 6 years: 25 mg twice daily - from 6 to 16 years if bodyweight under 57 kg: 25 mg three times daily - from 16 years or if bodyweight above 57 kg: 50 mg three times daily.
Priporočen odmerek je: - od 1 do 6 let: 25 mg dvakrat na dan - od 6 do 16 let, če je telesna masa manjša od 57 kg: 25 mg trikrat na dan - od 16 let naprej ali če je telesna masa večja od 57 kg: 50 mg trikrat na dan.
HOW TO STORE WILZIN
KAKO SHRANITI ZDRAVILO WILZIN
Medicinal product subject to medical prescription.
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
Capsule shell gelatin titanium dioxide (E171) sunset yellow FCF (E110)
Ovoj kapsule želatina titanov dioksid (E171) sončno rumena FCF (E110)
Monitoring may detect evidence of insufficient treatment (copper excess) or excessive treatment (copper deficiency), both of which can be harmful, particularly to growing children and pregnant women.
Spremljanje utegne odkriti znake nezadostnega zdravljenja (presežek bakra) ali čezmernega zdravljenja (pomanjkanje bakra).
Driving and using machines No studies of the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
5.2 Pharmacokinetic properties
5.2 Farmakokinetične lastnosti
Blood and lymphatic system disorders uncommon: sideroblastic anaemia, leukopenia
sideroblastna anemija, levkopenija
Printing ink black iron oxide (E172) shellac
Tiskarsko črnilo črni železov oksid (E172) šelak
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.
OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 25 mg hard capsules)
ZUNANJA KARTONASTA ŠKATLA IN ETIKETA NA PLASTENKI (Wilzin 25 mg trde kapsule)
OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 50 mg hard capsules)
ZUNANJA KARTONASTA ŠKATLA IN ETIKETA NA PLASTENKI (Wilzin 50 mg trde kapsule)
• For children and adolescents: The usual dose is: - from 1 to 6 years: 1 hard capsule of Wilzin 25 mg twice daily - from 6 to 16 years if bodyweight under 57 kg: 1 hard capsule of Wilzin 25 mg three times daily - from 16 years or if bodyweight above 57 kg: 2 hard capsules of Wilzin 25 mg or 1 hard capsule of Wilzin 50 mg three times daily.
• Za otroke in mladostnike: Običajni odmerek je: - od 1 do 6 let: 1 trda kapsula Wilzina 25 mg dvakrat na dan - od 6 do 16 let, če je telesna masa manjša od 57 kg: 1 trda kapsula Wilzina 25 mg trikrat na dan - od 16 let naprej ali če je telesna masa večja od 57 kg: 2 trdi kapsuli Wilzina 25 mg ali 1 trda kapsula Wilzina 50 mg trikrat na dan.
6.4 Special precautions for storage
6.4 Posebna navodila za shranjevanje
LABELLING AND PACKAGE LEAFLET
OZNAČEVANJE IN NAVODILO ZA UPORABO
For the different dose regimens Wilzin is available in hard capsules of 25 mg or 50 mg.
Za različne sheme odmerkov je Wilzin na voljo v 25-miligramskih in 50-miligramskih trdih kapsulah.
Copper accumulation in the liver leads to hepatocellular injury and eventual cirrhosis.
Kopičenje bakra v jetrih povzroči okvaro jetrnih celic in končno cirozo.
2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Capsule with aqua blue opaque cap and body, imprinted "93-376”.
Kapsula s pariško modrim neprozornim pokrovom in telesom, z napisom "93-376”.
affects 1 to 10 users in 100
pojavijo se pri 1 do 10 bolnikih od 100 bolnikov občasni:
There is no difference in dose between symptomatic and presymptomatic patients.
Odmerjanje pri presimptomatskih bolnikih je enako kot pri simptomatskih bolnikih.
If you forget to take Wilzin: Do not take a double dose to make up for a forgotten individual dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate) or 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).
Ena trda kapsula vsebuje 25 mg cinka (kar ustreza 83,92 mg cinkovega acetata dihidrata) ali 50 mg cinka (kar ustreza 167,84 mg cinkovega acetata dihidrata).
• very rare:
zelo pogosti:
5.1 Pharmacodynamic properties
5.1 Farmakodinamične lastnosti
The bound copper is then eliminated in the stool following desquamation of the intestinal cells.
Vezani baker se nato po odluščenju črevesnih celic odstrani iz telesa z blatom.
Common:
Pogosti:
The active substance is zinc.
Zdravilna učinkovina je cink.
affects more than 1 user in 10
pojavijo se pri več kot 1 od 10 bolnikov pogosti:
affects 1 to 10 users in 1,000
pojavijo se pri 1 do 10 bolnikih od 1000 bolnikov redki:
Wilzin is a life-long therapy.
Zdravljenje z Wilzinom traja vse življenje.
Wilzin should be taken on an empty stomach, separated from mealtimes.
Jemanje zdravila Wilzin skupaj s hrano in pijačo Wilzin morate jemati na prazen želodec, ločeno od obrokov.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 25 mg cinka (kar ustreza 83,92 mg cinkovega acetata dihidrata).
EU/1/04/286/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/286/001
Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800Puteaux
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 50 mg cinka (kar ustreza 167,84 mg cinkovega acetata dihidrata).
EU/1/04/286/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/286/002
Wilzin 25 mg hard capsules Wilzin 50 mg hard capsules zinc
Wilzin 25 mg trde kapsule Wilzin 50 mg trde kapsule cink
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Francija
affects less than 1 user in 10,000
pojavijo se pri manj kot 1 bolnikih od 10000 bolnikov neznana pogostnost:
Please consult your doctor if you plan to become pregnant.
Če načrtujete zanositev, se posvetujte z zdravnikom.
affects 1 to 10 users in 10,000
pojavijo se pri 1 do 10 bolnikih od 10000 bolnikov zelo redki:
BEFORE YOU TAKE WILZIN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO WILZIN
Wilzin 50 mg hard capsules
Wilzin 50 mg trde kapsule
Always take Wilzin exactly as your doctor has told you.
Pri jemanju zdravila Wilzin natančno upoštevajte zdravnikova navodila.
Wilzin 25 mg hard capsules
Wilzin 25 mg trde kapsule
Adverse drug reactions
Neželeni učinki zdravila
Breast-feeding Breast-feeding should be avoided if you are on Wilzin therapy.
Dojenje Če se zdravite z Wilzinom, se izogibajte dojenju.
B. PACKAGE LEAFLET
B. NAVODILO ZA UPORABO
Oral use.
NAVODILO ZA UPORABO
Caution should be exercised when switching patients with portal hypertension from a chelating agent to Wilzin, when such patients are doing well and the treatment is tolerated.
Kadar bolnikom s portalno hipertenzijo, ki se zdravijo s kakim kelatorjem, ki jim gre dobro in ki dobro prenašajo zdravljenje, zamenjujemo kelator z Wilzinom, je potrebna previdnost.
Excipients: Each capsule contains 1.75 mg of sunset yellow FCF (E110)
Ena kapsula vsebuje 1,75 mg vsebuje barvilo oranžno FCF (E110) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Wilzin 50 mg hard capsules Zinc
Wilzin 50 mg trde kapsule cink
Wilzin 25 mg hard capsules Zinc
Wilzin 25 mg trde kapsule cink
GENERAL CLASSIFICATION FOR SUPPLY
SEZNAM POMOŽNIH SNOVI
You should check with your doctor or pharmacist if you are not sure.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
- Keep this leaflet.
- Navodilo shranite.
6.3 Shelf life
6.3 Rok uporabnosti
It is noted that in some cases increase of blood pressure was documented.
Treba je opozoriti, da so v nekaterih primerih dokumentirali zvišanje krvnega tlaka.
These safety concerns are related to:
Varnostni pomisleki so povezani z naslednjimi pojavi:
Scientific conclusions
Znanstveni zaključki
Overall summary of the scientific evaluation by the PRAC
Splošni povzetek znanstvenega vrednotenja odbora PRAC
Immune-mediated reactions
Imunsko posredovane reakcije
In addition, the EC requested the Agency to give its opinion, as soon as possible, as to whether provisional measures were necessary to ensure the safe and effective use of this medicinal product.
Poleg tega je agencijo prosila, naj čim prej poda mnenje o tem, ali so potrebni začasni ukrepi za zagotovitev varne in učinkovite uporabe tega zdravila.
Fatal cases
Smrtni primeri
The EC requested the Agency to give its opinion on whether the marketing authorisation for this product should be maintained, varied, suspended or revoked.
Evropska komisija je agencijo zaprosila za mnenje o tem, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
• In addition, several fatal cases were identified both in the literature and in the Eudravigilance database.
• poleg tega so v literaturi in v zbirki podatkov Eudravigilance našli več smrtnih primerov.
Despite these recommendations, in the majority of cases it was not possible to predict these cardiovascular reactions prior to hospital discharge, and reactions occurred outside a hospital setting.
Kljub tem priporočilom v večini primerov teh srčno-žilnih reakcij ni bilo mogoče napovedati pred odpustom iz bolnišnice, reakcije pa so se pojavile zunaj bolnišničnega okolja.
Information from some fatal cases indicates that current recommendations for monitoring may be insufficient.
Informacije o nekaterih smrtnih primerih kažejo, da so trenutna priporočila za spremljanje morda nezadostna;
The cases of HLH and AIH suggest that despite the recommendations for intensive monitoring and alertness to immune mediated reactions until 48 months following last treatment course, it has not been possible to take adequate measures to detect them early enough.
Primeri HLH in AIH kažejo, da kljub priporočilom za intenzivno spremljanje in pozornosti na imunsko posredovane reakcije še 48 mesecev po zadnjem ciklu zdravljenja ni bilo mogoče ustrezno ukrepati in jih odkriti še dovolj zgodaj.
Several of the serious risks in relation to alemtuzumab resulted in fatal outcomes despite monitoring of the patients and adherence to the current risk minimisation measures such as pre-medication.
Več resnih tveganj v povezavi z alemtuzumabom je privedlo do smrtnih izidov kljub spremljanju bolnikov in upoštevanju trenutnih ukrepov za zmanjšanje tveganja, kot je premedikacija.
Common to these cardiovascular reactions was a close temporal relationship to an alemtuzumab infusion, as the majority of cases occurred during the treatment course or within 1-3 days after the last infusion.
Skupna tem srčno-žilnim reakcijam je bil tesna časovna povezava z infuzijo alemtuzumaba, saj se je večina primerov pojavila med ciklom zdravljenja ali v 1-3 dneh po zadnji infuziji.
Many of these cases were life-threatening or fatal.
Številni od teh primerov so bili smrtno nevarni ali usodni.
In view of the seriousness of the events observed and until a thorough review of the data is finalised, it is appropriate to limit exposure of new patients to alemtuzumab by introducing amendments to the product information.
Glede na resnost opaženih dogodkov in dokler ne bo končan temeljit pregled podatkov, je primerno omejiti izpostavljenost novih bolnikov alemtuzumabu z uvedbo sprememb informacij o zdravilu.
During the assessment procedure of the periodic safety update report (PSUSA) for Lemtrada covering the period between 13 September 2017 and 12 September 2018, limited information was available on new emerging and serious safety concerns, including lack of detailed information on the individual cases, precluding a thorough evaluation.
Med postopkom ocenjevanja rednega posodobljenega poročila o varnosti zdravila (PSUSA) za zdravilo Lemtrada, ki je zajemalo obdobje med 13. septembrom 2017 in 12. septembrom 2018, so bile na voljo omejene informacije o novo nastalih in resnih varnostnih pomislekih, vključno s pomanjkanjem podrobnih informacij o posameznih primerih, kar je preprečilo temeljito ovrednotenje.
- Fatal cases: Several fatal cases were identified during the PSUSA procedure, which indicate that the current recommendations for monitoring may be insufficient.
- Smrtni primeri: V postopku PSUSA je bilo ugotovljenih več smrtnih primerov, kar kaže, da so trenutna priporočila za spremljanje morda nezadostna.
Many of those were life-threatening or fatal.
Številne med njimi so bile smrtno nevarne ali usodne.
During the assessment of the periodic safety update report (PSUSA) for Lemtrada (EMEA/H/C/PSUSA/00010055/201809), the following new emerging and serious safety concerns were highlighted in addition to the known safety profile of alemtuzumab, which raised major concerns to the Pharmacovigilance Risk Assessment Committee (PRAC):
Med ocenjevanjem rednega posodobljenega poročila o varnosti zdravila (PSUSA) za zdravilo Lemtrada (EMEA/H/C/PSUSA/00010055/201809) so bili poleg že znanega varnostnega profila alemtuzumaba poudarjeni naslednji novo nastali in resni varnostni pomisleki, kar je pri Odboru za oceno tveganja na področju farmakovigilance (PRAC) vzbudilo večjo zaskrbljenost:
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Lemtrada, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
• odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil v zvezi z zdravilom Lemtrada začet na podlagi farmakovigilančnih podatkov, zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004, ob upoštevanju razlogov iz člena 116 Direktive 2001/83/ES;
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Lemtrada (alemtuzumab).
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Lemtrada (alemtuzumab).
In view of the above, the European Commission (EC) initiated on 11 April 2019 a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency to assess the above safety concerns and their impact on the benefit-risk balance for the centrally authorised medicinal product Lemtrada.
Na podlagi zgornjih podatkov je Evropska komisija 11. aprila 2019 sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in od agencije zahtevala, da oceni zgornje pomisleke o varnosti in njihov vpliv na razmerje med tveganji in koristmi zdravila Lemtrada, odobrenega po centraliziranem postopku.
as to whether the risk minimisation measures currently in place are sufficient to adequately manage the risks associated to alemtuzumab in the current target population.
obstajajo resni dvomi, ali so trenutno uveljavljeni ukrepi za zmanjšanje tveganja zadostni za ustrezno obvladovanje tveganj, povezanih z alemtuzumabom, pri trenutni ciljni populaciji.
It is therefore questioned whether the current risk minimisation measures are able to mitigate the risk of occurrence of these cardiovascular reactions.
Zato je vprašljivo, ali je s trenutnimi ukrepi za zmanjšanje tveganja mogoče zmanjšati tveganje za pojav teh srčno-žilnih reakcij.
Autoimmune disorders are an important identified risk for alemtuzumab.
Avtoimunske bolezni so pomembno ugotovljeno tveganje pri alemtuzumabu.
The current recommendation relates only to provisional measures recommended by the PRAC for Lemtrada based on the preliminary data available at this time.
Trenutno priporočilo se nanaša zgolj na začasne ukrepe, ki jih je za zdravilo Lemtrada priporočil odbor PRAC na osnovi predhodnih podatkov, ki so ob tem času na voljo.
In addition, several cases of autoimmune hepatitis (AIH) including fatalities were reported.
Poleg tega so poročali o več primerih avtoimunskega hepatitisa (AIH), vključno s smrtnimi primeri.
Limited information, including lack of detailed information on the individual cases, precluded a thorough evaluation of their impact on the benefit risk of Lemtrada in view of the time constraints for the PSUSA assessment.
Zaradi omejenih informacij, vključno s pomanjkanjem podrobnih informacij o posameznih primerih, ni bilo mogoče temeljito ovrednotiti njihovega vpliva na razmerje med tveganji in koristmi zdravila Lemtrada glede na časovne omejitve ocenjevanja PSUSA.
In view of the above, the Committee considers that the benefit-risk balance of Lemtrada (alemtuzumab) remains favourable subject to the agreed provisional amendments to the product information.
Odbor je glede na zgoraj navedeno menil, da je razmerje med tveganji in koristmi zdravila Lemtrada (alemtuzumab) še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
Although efficacy of alemtuzumab in RRMS patients is well established, these emerging and serious safety concerns may impact the benefit-risk balance of Lemtrada.
Čeprav je učinkovitost alemtuzumaba pri bolnikih z RRMS dobro dokazana, lahko ti porajajoči se in resni varnostni pomisleki vplivajo na razmerje med tveganji in koristmi zdravila Lemtrada.
On this basis, the authors of the papers hypothesise that an autoimmune reaction could be directed at CNS in rare cases.
Na podlagi tega so avtorji člankov postavili hipotezo, da je v redkih primerih avtoimunska reakcija lahko usmerjena proti centralnemu živčnemu sistemu.
This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
To priporočilo ne posega v končne zaključke potekajočega postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
Thus, it is questioned whether the current risk minimisation measures are effective.
Zato je učinkovitost trenutnih ukrepov za zmanjšanje tveganja vprašljiva.
New life-threatening and potentially fatal immune- mediated reactions were identified.
Ugotovljene so bile nove smrtno nevarne in potencialno usodne imunsko posredovane reakcije.