FrancophonIA/ELRC3.0 huggingface dataset:
English: Preclinical studies have been conducted with zinc acetate and with other zinc salts.
Croatian: Provedene su pretklinička ispitivanja sa cinkovim acetatom i s drugim cinkovim solima.
English: CLINICAL PARTICULARS
Croatian: KLINIČKI PODACI
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Croatian: Zabilježene nuspojave navedene su dolje, prema organskom sustavu i učestalosti.
English: 4.2 Posology and method of administration
Croatian: 4.2 Doziranje i način primjene
English: Wilzin is available in hard capsules of 25 mg or 50 mg.
Croatian: Wilzin je dostupan u tvrdim kapsulama od 25 mg ili 50 mg.
English: Three cases of acute oral overdose with zinc salts (sulphate or gluconate) have been reported in the literature.
Croatian: U literaturi su zabilježena tri slučaja akutnog oralnog predoziranja cinkovim solima (sulfatom ili glukonatom).
English: The elimination of zinc results primarily from faecal excretion with relatively little from urine and sweat.
Croatian: Eliminacija cinka prvenstveno je posljedica izlučivanja stolicom uz relativno malo putem mokraće i znoja.
English: Capsule shell gelatin titanium dioxide (E171) sunset yellow FCF (E110)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) sunset yellow FCF (E110)
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: • Pregnant women:
Croatian: • Trudnice:
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: The recommended dosage 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.
Croatian: Preporučena doza je sljedeća: - od 1 do 6 godina: 25 mg dva puta dnevno - od 6 do 16 godina ako je tjelesna težina ispod 57 kg: 25 mg tri puta dnevno - od 16 godina ili ako je tjelesna težina iznad 57 kg: 50 mg tri puta dnevno.
English: For the different dose regimens Wilzin is available in hard capsules of 25 mg or 50 mg.
Croatian: Za različite sheme doziranja Wilzin je dostupan u obliku tvrdih kapsula od 25 mg ili 50 mg.
English: Capsule with orange opaque cap and body, imprinted "93-377”.
Croatian: Kapsula s narančastom neprozirnom kapicom i tijelom, s otisnutom oznakom "93-377”.
English: 5.1 Pharmacodynamic properties
Croatian: 5.1 Farmakodinamička svojstva
English: See the package leaflet for further information.
Croatian: Za dodatne informacije pogledajte Uputu o lijeku.
English: Printing ink black iron oxide (E172) shellac
Croatian: Tinta za označavanje crni željezov oksid (E172) šelak
English: What Wilzin is and what it is used for Before you take Wilzin How to take Wilzin Possible side effects 5 How to store Wilzin Further information
Croatian: Kako uzimati Wilzin 4. Moguće nuspojave 5. Kako čuvati Wilzin 6.
English: INSTRUCTIONS ON USE
Croatian: 15. UPUTE ZA UPORABU
English: OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 25 mg hard capsules)
Croatian: VANJSKA KARTONSKA KUTIJA I NALJEPNICA NA BOCI (Wilzin 25 mg tvrde kapsule)
English: Pregnancy
Croatian: Trudnoća
English: OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 50 mg hard capsules)
Croatian: VANJSKA KARTONSKA KUTIJA I NALJEPNICA NA BOCI (Wilzin 50 mg tvrde kapsule)
English: Gastrointestinal disorders common:
Croatian: Poremećaji probavnog sustava često:
English: Fractional zinc absorption is negatively correlated with zinc intake.
Croatian: Udio apsorpcije cinka negativno korelira s unosom cinka.
English: affects 1 to 10 users in 100
Croatian: pojavljuju se kod 1 do 10 na 100 bolesnika
English: A. LABELLING
Croatian: OZNAČAVANJE
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: The most common undesirable effect is gastric irritation.
Croatian: Najčešća nuspojava je iritacija želuca.
English: Capsule with aqua blue opaque cap and body, imprinted "93-376”.
Croatian: Kapsula s vodeno plavom neprozirnom kapicom i tijelom, s otisnutom oznakom "93-376”.
English: The liver is the main storage for zinc and hepatic zinc levels are increased during maintenance therapy with zinc.
Croatian: Jetra je glavno mjesto pohrane cinka te je razina cinka u jetri povećana tijekom terapije održavanja cinkom.
English: The same dose did not produce any symptoms except for vomiting in an adolescent who was treated by whole-bowel irrigation.
Croatian: Ista doza kod adolescenta koji je liječen ispiranjem čitavog crijeva nije dovela do nikakvih simptoma osim povraćanja.
English: Zinc is excreted in human breast milk and zinc-induced copper deficiency in the breast-fed baby may occur.
Croatian: Cink se izlučuje u majčino mlijeko te kod dojenog djeteta može doći do deficijencije bakra uzrokovane cinkom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET/ DATUM OBNOVE ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: gastric irritation
Croatian: iritacija želuca
English: SPECIAL STORAGE CONDITIONS
Croatian: POSEBNE MJERE ČUVANJA
English: HOW TO STORE WILZIN
Croatian: KAKO ČUVATI WILZIN
English: Investigations common:
Croatian: Pretrage često:
English: affects 1 to 10 users in 10,000
Croatian: pojavljuju se kod 1 do 10 na 10 000 bolesnika
English: Tél/Tel: +32 2 46101 36
Croatian: Tel: +32 2 46101 36
English: Repeat-dose toxicity studies have established that the NOEL (No Observed Effect Level) is about 95 mg zinc/kg body weight (about 48 times the human therapeutic dose).
Croatian: No Observed Effect Level) oko 95 mg cinka/kg tjelesne težine (oko 48 puta viša od terapijske doze kod ljudi).
English: affects less than 1 user in 10,000
Croatian: • vrlo rijetko: pojavljuju se kod manje od 1 na 10 000 bolesnika
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA
English: As copper deficiency may also cause myeloneuropathy, physicians should be alert to sensory and motor symptoms and signs which may potentially indicate incipient neuropathy or myelopathy in patients treated with Wilzin.
Croatian: Kako deficijencija bakra također može uzrokovati mijeloneuropatiju, liječnici trebaju paziti na osjetilne I motoričke simptome
English: PHARMACOLOGICAL PROPERTIES
Croatian: FARMAKOLOŠKA SVOJSTVA
English: 6.6 Special precautions for disposal
Croatian: 6.6 Posebne mjere za zbrinjavanje
English: Read the package leaflet before use.
Croatian: Prije uporabe pročitati Uputu o lijeku.
English: NAME OF THE MEDICINAL PRODUCT
Croatian: NAZIV GOTOVOG LIJEKA
English: • 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.
Croatian: • Za djecu i adolescente: Uobičajena doza je: - od 1 do 6 godina: 1 tvrda kapsula Wilzina od 25 mg dva puta dnevno - od 6 do 16 godina ako je tjelesna težina manja od 57 kg: 1 tvrda kapsula Wilzina od 25 mg tri puta dnevno
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: PHARMACEUTICAL PARTICULARS
Croatian: FARMACEUTSKI PODACI
English: • common:
Croatian: • često:
English: 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).
Croatian: Jedna tvrda kapsula sadrži 25 mg cinka (što odgovara 83,92 mg cinkovog acetat dihidrata) ili 50 mg cinka (što odgovara 167,84 mg cinkovog acetat dihidrata).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: POPIS POMOĆNIH TVARI
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: : +33 (0)1 47 73 64 58 Франция
Croatian: : +33 1 47 73 64 58 Francuska
English: Wilzin 25 mg hard capsules Wilzin 50 mg hard capsules zinc
Croatian: Wilzin 25 mg tvrde kapsule Wilzin 50 mg tvrde kapsule cink
English: Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate).
Croatian: Svaka tvrda kapsula sadrži 25 mg cinka (što odgovara 83,92 mg cinkovog acetat dihidrata).
English: Breast-feeding Breast-feeding should be avoided if you are on Wilzin therapy.
Croatian: Ukoliko ste na terapiji Wilzinom trebate izbjegavati dojenje.
English: Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate) .
Croatian: Svaka tvrda kapsula sadrži 50 mg cinka (što odgovara 167,84 mg cinkovog acetat dihidrata).
English: 6.4 Special precautions for storage
Croatian: 6.4 Posebne mjere pri čuvanju lijeka
English: affects 1 to 10 users in 1,000
Croatian: • manje često: pojavljuju se kod 1 do 10 na 1000 bolesnika
English: EXPIRY DATE
Croatian: Prijavljivanje nuspojava
English: Wilzin 50 mg hard capsules
Croatian: Wilzin 50 mg tvrde kapsule
English: Lactation
Croatian: Dojenje
English: Wilzin 25 mg hard capsules
Croatian: Wilzin 25 mg tvrde kapsule
English: Other medicinal products
Croatian: Drugi lijekovi
English: Common:
Croatian: Često:
English: Recordati Rare Diseases Immeuble "Le Wilson" 70, avenue du Général de Gaulle F-92800 Puteaux France or
Croatian: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux Francuska ili
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France
Croatian: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F-92800 Puteaux Francuska
English: Recordati Rare Diseases Τηλ: +33 1 47 73 64 58 Γαλλία
Croatian: Recordati Rare Diseases Tél : +33 1 47 73 64 58 Γαλλία
English: affects more than 1 user in 10
Croatian: • vrlo često: pojavljuju se kod više od 1 na 10 bolesnika
English: Oral use.
Croatian: Za primjenu kroz usta.
English: 4.8 Undesirable effects
Croatian: 4.8 Nuspojave
English: MANUFACTURER'S BATCH NUMBER
Croatian: 13. BROJ SERIJE
English: Excipients: Each capsule contains 1.75 mg of sunset yellow FCF (E110)
Croatian: Svaka kapsula sadrži 1,75 mg boju sunset yellow FCF (E110) Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
English: Recordati Rare Diseases Tel: +33 1 47 73 64 58 Franza
Croatian: Recordati Rare Diseases Tel : +33 1 47 73 64 58 France
English: Jaba Recordati S.A. Tel: +351 21 432 95 00
Croatian: Tel: +351 21 432 95 00
English: Wilzin 50 mg hard capsules Zinc
Croatian: Wilzin 50 mg tvrde kapsule cink
English: 6.3 Shelf life
Croatian: 6.1 Popis pomoćnih tvari
English: Other anti-copper agents
Croatian: Drugi lijekovi za snižavanje bakra
English: Wilzin 25 mg hard capsules Zinc
Croatian: Wilzin 25 mg tvrde kapsule cink
English: Simi:+46 8 545 80 230 Svíþjóð
Croatian: Sími: +46 8 545 80 230 Svíþjóð
English: United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333
Croatian: Tel : +44 (0)1491 414333
English: LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČAVANJE I UPUTA O LIJEKU
English: EXP
Croatian: OBLIK
English: Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francuska
Croatian: Recordati Rare Diseases Teл.: +33 (0)1 47 73 64 58 Франция
English: Batch
Croatian: Nuspojave
English: These safety concerns are related to:
Croatian: Te zabrinutosti u pogledu sigurnosti odnose se na:
English: Scientific conclusions
Croatian: Znanstveni zaključci
English: It is noted that in some cases increase of blood pressure was documented.
Croatian: Uočeno je da je u nekim slučajevima zabilježen porast krvnog tlaka.
English: Annex IV
Croatian: Prilog IV.
English: • In addition, several fatal cases were identified both in the literature and in the Eudravigilance database.
Croatian: • Osim toga, nekoliko smrtnih slučajeva utvrđeno je u literaturi i u bazi podataka Eudravigilance.
English: Fatal cases
Croatian: smrtni slučajevi
English: Immune-mediated reactions
Croatian: imunosno posredovane reakcije
English: The EC requested the Agency to give its opinion on whether the marketing authorisation for this product should be maintained, varied, suspended or revoked.
Croatian: Europska komisija zatražila je od Agencije da iznese svoje mišljenje o tome treba li odobrenje za stavljanje u promet ovog lijeka zadržati, izmijeniti, obustaviti ili opozvati.
English: Overall summary of the scientific evaluation by the PRAC
Croatian: Cjelokupan sažetak znanstvene procjene PRAC-a
English: 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.
Croatian: Unatoč tim preporukama, u većini slučajeva nije bilo moguće predvidjeti te kardiovaskularne reakcije prije otpusta iz bolnice, a reakcije su nastupile izvan bolnice.
English: 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.
Croatian: Osim toga, Europska komisija zatražila je da Agencija što je prije moguće iznese svoje mišljenje o potrebi uvođenja privremenih mjera kako bi se zajamčila sigurna i učinkovita primjena ovog lijeka.
English: In addition, several cases of autoimmune hepatitis (AIH) including fatalities were reported.
Croatian: Osim toga, prijavljeno je nekoliko slučajeva autoimunog hepatitisa (AIH) uključujući smrtne slučajeve.
English: Information from some fatal cases indicates that current recommendations for monitoring may be insufficient.
Croatian: Informacije o nekim smrtnim slučajevima ukazuju na to da bi postojeće preporuke za praćenje mogle biti nedostatne.
English: Many of these cases were life-threatening or fatal.
Croatian: Mnogi od tih slučajeva bili su opasni po život ili su imali smrtni ishod.
English: 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.
Croatian: Na temelju prethodno navedenog, Europska komisija pokrenula je 11. travnja 2019. postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 i od Agencije zatražila ocjenjivanje navedenih zabrinutosti u pogledu sigurnosti i njihovog utjecaja na omjer koristi i rizika za lijek Lemtrada odobren centraliziranim postupkom.
English: According to existing recommendations, observation for infusion associated reactions (IARs) should be undertaken during and for two hours after infusion.
Croatian: Prema postojećim preporukama, promatranje reakcija povezanih s infuzijom treba provoditi tijekom infuzije i dva sata nakon infuzije.
English: 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.
Croatian: Tijekom postupka jedinstvene procjene periodičkog izvješća o neškodljivosti (PSUSA) za lijek Lemtrada u razdoblju od 13. rujna 2017. do 12. rujna 2018. bile su dostupne ograničene informacije o novim i ozbiljnim zabrinutostima u pogledu sigurnosti, uključujući nedostatak podrobnih informacija o pojedinačnim slučajevima, što je onemogućilo temeljitu procjenu.
English: It is therefore questioned whether the current risk minimisation measures are able to mitigate the risk of occurrence of these cardiovascular reactions.
Croatian: Stoga se postavlja pitanje mogu li postojeće mjere svođenja rizika na najmanju moguću mjeru ublažiti rizik od pojave tih kardiovaskularnih reakcija.
English: The current recommendation relates only to provisional measures recommended by the PRAC for Lemtrada based on the preliminary data available at this time.
Croatian: Sadašnja se preporuka odnosi samo na privremenu mjeru koju preporučuje PRAC za lijek Lemtrada na temelju trenutačno dostupnih preliminarnih podataka.
English: On this basis, the authors of the papers hypothesise that an autoimmune reaction could be directed at CNS in rare cases.
Croatian: Na temelju toga autori navedenih radova pretpostavljaju da bi autoimuna reakcija u rijetkim slučajevima mogla biti usmjerena na središnji živčani sustav.
English: 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):
Croatian: Tijekom jedinstvene procjene periodičkog izvješća o neškodljivosti (PSUSA) za lijek Lemtrada (EMEA/H/C/PSUSA/00010055/201809), pored poznatog sigurnosnog profila alemtuzumaba istaknute su sljedeće nove i ozbiljne zabrinutosti u pogledu sigurnosti za koje Odbor za procjenu rizika u području farmakovigilancije (PRAC) smatra da su vrlo zabrinjavajući:
English: 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.
Croatian: Ograničene informacije, uključujući nedostatak podrobnih informacija o pojedinačnim slučajevima, onemogućile su temeljitu procjenu njihovog utjecaja na omjer rizika i koristi lijeka Lemtrada s obzirom na vremensko ograničenje za ocjenu u okviru PSUSA postupka.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Lemtrada (alemtuzumab).
Croatian: Posljedično tomu, Odbor preporučuje izmjene uvjeta odobrenja za stavljanje u promet lijeka Lemtrada (alemtuzumab).
English: 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.
Croatian: Slučajevi hemofagocitne limfohistiocitoze i autoimunog hepatitisa upućuju na to da unatoč preporukama za intenzivno praćenje i oprez u pogledu imunosno posredovanih reakcija do 48 mjeseci nakon posljednjeg ciklusa liječenja nije bilo moguće poduzeti odgovarajuće mjere za njihovo pravovremeno otkrivanje.
English: 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.
Croatian: Uska vremenska povezanost s infuzijom alemtuzumaba zajednička je tim kardiovaskularnim reakcijama jer je većina slučajeva nastupila tijekom liječenja ili unutar jednog do tri dana od posljednje infuzije.
English: Autoimmune disorders are an important identified risk for alemtuzumab.
Croatian: Autoimuni poremećaji važan su utvrđen rizik pri primjeni alemtuzumaba.
English: • 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.
Croatian: Uredbe (EZ) br. 726/2004 koji je proizašao iz podataka o farmakovigilanciji za lijek Lemtrada, posebno u pogledu potrebe donošenja privremenih mjera u skladu s člankom 20. stavkom 3. Uredbe (EZ) br. 726/2004, uzimajući u obzir osnove utvrđene u članku 116.
English: 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.
Croatian: S obzirom na ozbiljnost primijećenih događaja te dok se ne dovrši detaljan pregled podataka, potrebno je ograničiti izloženost novih bolesnika alemtuzumabu uvođenjem izmjena u informacije o lijeku.
English: 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.
Croatian: Nekoliko ozbiljnih rizika u vezi s primjenom alemtuzumaba rezultiralo je smrtnim ishodom unatoč praćenju bolesnika i pridržavanju postojećih mjera svođenja rizika na najmanju moguću mjeru, kao što je premedikacija.
English: HLH is a life-threatening condition of severe hyperinflammation caused by uncontrolled proliferation of activated lymphocytes and macrophages.
Croatian: HLH je po život opasno stanje teške hiperinflamacije uzrokovane nekontroliranim širenjem aktiviranih limfocita i makrofaga.
English: - Fatal cases: Several fatal cases were identified during the PSUSA procedure, which indicate that the current recommendations for monitoring may be insufficient.
Croatian: - smrtni slučajevi: tijekom PSUSA postupka utvrđeno je nekoliko smrtnih slučajeva koji ukazuju na to da bi postojeće preporuke za praćenje mogle biti nedostatne.
English: Many of those were life-threatening or fatal.
Croatian: Mnogi su bili opasni po život ili su imali smrtni ishod.
English: 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.
Croatian: Osim toga, postoje ozbiljne sumnje u pogledu toga jesu li postojeće mjere svođenja rizika na najmanju moguću mjeru dostatne za odgovarajuće upravljanje rizicima povezanima s alemtuzumabom u postojećoj ciljnoj populaciji.
English: Grounds for PRAC recommendation Whereas
Croatian: Razlozi za preporuku PRAC-a Budući da:
English: 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.
Croatian: S obzirom na prethodno navedeno, Odbor smatra da omjer koristi i rizika za lijek Lemtrada (alemtuzumab) ostaje povoljan uz uvjet dogovorenih privremenih izmjena informacija o lijeku.
English: • The PRAC reviewed the available data on cardiovascular reactions, including data provided by the marketing authorisation holder in the context of the PSUSA procedure.
Croatian: • PRAC je pregledao dostupne podatke o kardiovaskularnim reakcijama, uključujući podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet u okviru PSUSA postupka.
English: The temporal onset corresponded to the time of reconstitution of the immune system after depletion of B- and T-lymphocytes following Lemtrada treatment.
Croatian: Vrijeme nastupanja odgovaralo je vremenu rekonstitucije imunosnog sustava nakon deplecije B i T limfocita nakon liječenja lijekom Lemtrada.
English: Thus, it is questioned whether the current risk minimisation measures are effective.
Croatian: Stoga se postavlja pitanje jesu li postojeće mjere svođenja rizika na najmanju moguću mjeru učinkovite.
English: The mechanism by which alemtuzumab exerts its therapeutic effects in MS is unknown but may involve immunomodulation through the depletion and repopulation of lymphocytes.
Croatian: Mehanizam kojim alemtuzumab ostvaruje svoje terapijske učinke u multiploj sklerozi nije poznat, no mogao bi uključivati imunomodulatorno djelovanje putem deplecije i repopulacije limfocita.