natgillin/translations-raw huggingface dataset:
In the clinical trial of patients with multiple myeloma (CA204004), invasive SPMs have been observed in 6.9% of patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 4.1% of patients treated with lenalidomide and dexamethasone (N = 317).
V kliničnem preskušanju, izvedenem pri bolnikih z multiplim mielomom (študija CA204004), so invazivne SPN opazili pri 6,9 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (N = 318), in 4,1 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom (N = 317).
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja nočno znojenje pogosti ni poročil
Upper respiratory tract infection
zvišana telesna temperatura mrzlica visok krvni tlak
Response to therapy Relapsed
Odziv na zdravljenje Ponovitev
In a clinical trial of patients with multiple myeloma (CA204004), deep vein thromboses were reported in 7.2% of patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 3.8% of patients treated with lenalidomide and dexamethasone (N = 317).
V kliničnem preskušanju, izvedenem pri bolnikih z multiplim mielomom (študija CA204004), so o globoki venski trombozi poročali pri 7,2 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (N = 318), in 3,8 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom (N = 317).
Second Primary Malignancies are known to be associated with lenalidomide exposure which was extended in patients treated with Empliciti combined with lenalidomide and dexamethasone vs. lenalidomide and dexamethasone.
Za sekundarne primarne novotvorbe je znano, da so povezane z izpostavljenostjo lenalidomidu, ki pa je bila pri bolnikih, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, daljša kot pri bolniki, ki so se zdravili z lenalidomidom in deksametazonom.
There were no SPM events reported in patients treated in the Empliciti combined with pomalidomide and dexamethasone study arm (N = 60) and 1 (1.8%) in patients treated in the pomalidomide and dexamethasone arm (N = 55) in study CA204125.
V študiji CA204125 pri bolnikih v skupini, ki se je zdravila z zdravilom Empliciti v kombinaciji s pomalidomidom in deksametazonom (N = 60) o primerih SPN niso poročali, pri bolnikih v skupini, ki se je zdravila s pomalidomidom in deksametazonom (N = 55), pa so poročali o 1 primeru (1,8 %).
Refer to the Summary of Product Characteristics for requirements regarding contraception due to presence and transmission in sperm and for additional detail.
Za zahteve glede kontracepcije zaradi prisotnosti in prenosa s spermo ter nadaljnje podrobnosti glejte ustrezen povzetek glavnih značilnosti zdravila.
Non-melanoma skin cancer was reported in 3.1% and 1.6% of patients treated with Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone, respectively.
O pojavu nemelanomskega kožnega raka so poročali pri 3,1 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, in pri 1,6 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih reakcija, povezana z infundiranjem pogosti občasni a
How to store Empliciti
Shranjevanje zdravila Empliciti
Table 4: Infusion rate for Empliciti 20 mg/kg
Tabela 4: Hitrost infundiranja zdravila Empliciti v odmerku 20 mg/kg
Fatal infections were infrequent and were reported in 2.5% of Empliciti combined with lenalidomide and dexamethasone and 2.2% of lenalidomide and dexamethasone treated patients.
O njih so poročali pri 2,5 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, in pri 2,2 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom.
If the infusion is well tolerated the infusion rate may be increased in a stepwise fashion as described in Table 3.
Če bolnik infundiranje dobro prenaša, se hitrost infundiranja lahko postopoma povečuje, kot je prikazano v tabeli 3.
Elotuzumab 10 mg/kg was administered intravenously each week for the first 2 cycles and every 2 weeks thereafter.
Bolniki so prva 2 cikla prejemali elotuzumab v odmerku 10 mg/kg vsak teden nato pa na vsaka 2 tedna.
Figure 1: CA204004 Progression free survival
Študija CA204004: Preživetje brez napredovanja bolezni
If the infusion is well tolerated, the infusion rate maybe increased in a stepwise fashion as described in Table 4.
Če bolnik infundiranje dobro prenaša, se hitrost infundiranja lahko postopoma povečuje, kot je prikazano v tabeli 4.
However, if you get an infusion reaction (fever, chills, high blood pressure see section 4 “Possible side effects”), do not drive, cycle or use machines until the reaction stops.
V primeru pojava infuzijske reakcije (zvišana telesna temperatura, mrzlica, visok krvni tlak, glejte poglavje 4
Empliciti at 10 mg/kg dose should be initiated at an infusion rate of 0.5 mL/min.
Hitrost infundiranja zdravila Empliciti v odmerku 10 mg/kg Infundiranje zdravila Empliciti v odmerku 10 mg/kg je treba začeti s hitrostjo infundiranja 0,5 ml/min.
In a clinical trial of patients with multiple myeloma (CA204004), infections were reported in 81.4% of patients in the Empliciti combined with lenalidomide and dexamethasone arm (N = 318) and 74.4% in lenalidomide and dexamethasone arm (N = 317).
V kliničnem preskušanju, izvedenem pri bolnikih z multiplim mielomom (študija CA204004), so o okužbah poročali pri 81,4 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (N = 318), in pri 74,4 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom (N = 317).
Management of infusion reaction
Ukrepanje v primeru infuzijske reakcije
Table 2: Infusion rate for Empliciti 10 mg/kg
Tabela 2: Hitrost infundiranja zdravila Empliciti v odmerku 10 mg/kg
Table 3: Infusion rate for Empliciti 10 mg/kg
Tabela 3: Hitrost infundiranja zdravila Empliciti v odmerku 10 mg/kg
Empliciti should be initiated at an infusion rate of 0.5 mL/min for 10 mg/kg dose and 3 mL/min for 20 mg/kg dose.
Infundiranje zdravila Empliciti v odmerku 10 mg/kg je treba začeti s hitrostjo infundiranja 0,5 ml/min, infundiranje zdravila Empliciti v odmerku 20 mg/kg pa je treba začeti s hitrostjo infundiranja 3 ml/min.
Solid tumours were reported in 2.5% and 1.9% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
O pojavu solidnih tumorjev so poročali pri 2,5 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, in pri 1,9 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom.
Empliciti at 20 mg/kg dose should be initiated at an infusion rate of 3 mL/min.
Hitrost infundiranja zdravila Empliciti v odmerku 20 mg/kg Infundiranje zdravila Empliciti v odmerku 20 mg/kg je treba začeti s hitrostjo infundiranja 3 ml/min.
No dose adjustment for Empliciti is required for patients with mild hepatic impairment (total bilirubin [TB] ≤ to the upper limit of normal [ULN] and AST > ULN or TB < 1 to 1.5 × ULN and any AST).
Pri bolnikih z blago okvaro jeter (vrednost skupnega bilirubina [SB] ≤ od zgornje meje normalne [ZMN] vrednosti in vrednost AST > od ZMN vrednosti ali vrednost SB < od 1 do 1,5 × ZMN vrednosti in katera koli vrednost AST) odmerka zdravila Empliciti ni treba prilagajati.
Table 3: Infusion rate for Empliciti 20 mg/kg
Tabela 3: Hitrost infundiranja zdravila Empliciti v odmerku 20 mg/kg
The powder is white to off white whole or fragmented cake.
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Prašek je v obliki belega do sivobelega, celega ali razdrobljenega skupka.
An open-label study (CA204007) evaluated the pharmacokinetics of elotuzumab in combination with lenalidomide and dexamethasone in patients with multiple myeloma with varying degrees of renal impairment (classified using the CrCl values).
Pri bolnikih z multiplim mielomom z različnimi stopnjami okvare ledvic (razvrstitev na osnovi vrednosti CrCl) so farmakokinetiko elotuzumaba v kombinaciji z lenalidomidom in deksametazonom ovrednotili v odprti študiji (študija CA204007).
All grades
Pogostnost stopnje
Deep vein thrombosis Common
Žilne bolezni globoka venska tromboza pogosti pogosti
Lymphopeniab 90 17.6 Headache
nazofari ngitis okužba zgornjih dihal limfopen ijab glavobol 88 17,2
Empliciti 400 mg powder for concentrate elotuzumab
IME ZDRAVILA Empliciti 400 mg prašek za koncentrat elotuzumab
Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab
Empliciti 400 mg prašek za koncentrat za raztopino za infundiranje elotuzumab
If well tolerated, the infusion rate may be increased stepwise as described in Table 2.
Če bolnik to hitrost dobro prenaša, lahko hitrost infundiranja postopoma povečujete, kot je prikazano v tabeli 2.
Empliciti 300 mg powder for concentrate elotuzumab
IME ZDRAVILA Empliciti 300 mg prašek za koncentrat elotuzumab
Dexamethasone (mg) intravenously Dexamethasone (mg) orally  75 years old 28 28 28 28 28 40 40 40 Dexamethasone (mg) orally > 75 years old 8 8 8 8 8 20 20 20 Day of Cycle 1 8 15 22 1 8 15 22
Deksametazon (mg) peroralno Dan cikla 1 8 15 22 1 8 15 22
HR [95% CI]
Razmerje ogroženosti [95 % IZ]
Empliciti 300 mg powder for concentrate for solution for infusion elotuzumab
Empliciti 300 mg prašek za koncentrat za raztopino za infundiranje elotuzumab
Pneumoniab
ZDRAVILOM
Tell your doctor or nurse straight away if you feel unwell during infusion.
Če se med infundiranjem zdravila počutite slabo, o tem nemudoma obvestite zdravnika ali medicinsko sestro.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C protected from light.
V tem primeru čas shranjevanja ne sme biti daljši od 24 ur pri temperaturi od 2 °C do 8 °C in zaščiteno pred svetlobo.
300 mg powder for concentrate
FARMACEVTSKA OBLIKA IN VSEBINA 300 mg praška za koncentrat
PHARMACEUTICAL FORM AND CONTENTS
Druga zdravila in zdravilo Empliciti
Empliciti is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Verjetnost vpliva zdravila Empliciti na sposobnost upravljanja vozil in strojev je majhna.
The administration of the reconstituted and diluted solution must be initiated at an infusion rate of 0.5 mL/min.
Hitrost infundiranja zdravila Empliciti v odmerku 10 mg/kg Rekonstituirano in razredčeno raztopino je treba začeti infundirati s hitrostjo 0,5 ml/min.
Tell your doctor or nurse straight away if you get any of the infusion reactions listed at the top of section 4.
V primeru pojava katere koli infuzijske reakcije, ki so navedene na začetku poglavja 4, o tem nemudoma obvestite zdravnika ali medicinsko sestro.
400 mg powder for concentrate
FARMACEVTSKA OBLIKA IN VSEBINA 400 mg praška za koncentrat
For men taking Empliciti
Moški, ki se zdravijo z zdravilom Empliciti
Prior therapies Lines of prior therapy = 1 Lines of prior therapy = 2 or 3 Prior thalidomide exposure No prior immunomodulatory exposure
Linije predhodnega zdravljenja = 2 ali 3
Your doctor may decide not to continue Empliciti treatment if you have a strong infusion reaction.
V primeru pojava hude infuzijske reakcije se zdravnik lahko odloči, da zdravljenja z zdravilom Empliciti ne bo nadaljeval.
Discard the solution if any particulate matter or discolouration is observed.
Če opazite kakršne koli trdne delce ali spremembo barve, raztopino zavrzite.
The PRAC adopted a recommendation on 8 February 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 8. februarja 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
Furthermore, the individual case reports of hepatobiliary toxicity show a substantial proportion of cases with noncompliance with the safety restrictions.
Tudi posamezna poročila o primerih hepatobiliarne toksičnosti kažejo precejšen delež primerov neupoštevanja varnostnih omejitev.
This included additional materials to communicate on the previous measures, reduction of the pack size, and introduction of a new warning regarding genetic risk factors.
Ti ukrepi so vključevali dodatna gradiva za obveščanje o predhodnih ukrepih, zmanjšanje velikosti pakiranja in uvedbo novega opozorila o genetskih dejavnikih tveganja.
Additionally a facilitatory effect on gamma-aminobutyric acid A receptors has been described.
Poleg tega so opisali tudi facilitatorni učinek na receptorje gama-aminobutirične kisline A.
Flupirtine is a ‘selective neuronal potassium channel opener' that acts by opening Kv7 potassium channels leading to functional N-methyl-D-aspartate receptor antagonism.
Flupirtin je „selektivni odpiralec kalijevih kanalčkov v živčnih celicah“, ki z odpiranjem kalijevih kanalčkov Kv7 povzroči funkcionalni antagonizem receptorjev za N-metil-D-aspartat.
Based on the review of all data available at the time, the PRAC concluded that flupirtine is associated with an increased risk of hepatotoxicity.
Na podlagi pregleda vseh razpoložljivih podatkov v tistem času je odbor PRAC zaključil, da je flupirtin povezan s povečanim tveganjem za hepatotoksičnost.
It was noted that no medical guidelines recommending the use of flupirtine in any pain indication could be identified.
Našli niso nobenih medicinskih smernic, v katerih bi bila priporočena uporaba flupirtina za katero koli bolečinsko indikacijo.
In 2017, results of observational studies imposed as an outcome of this urgent union procedure indicated a low degree of compliance with the authorised terms of use of flupirtinecontaining medicinal products and more specifically, with the above-mentioned restrictions and risk minimisations measures.
Leta 2017 so rezultati opazovalnih študij, zahtevanih kot izid tega nujnega postopka Unije, pokazali nizko stopnjo skladnosti z odobrenimi pogoji uporabe zdravil, ki vsebujejo flupirtin, konkretno z zgoraj omenjenimi omejitvami in ukrepi za zmanjšanje tveganja.
These included the restriction of the maximum treatment duration to two weeks, a contraindication in patients with pre-existing liver disease or taking concomitantly other medication known to cause drug liver injury and weekly monitoring of liver functions.
Ti so vključevali omejitev najdaljšega trajanja zdravljenja na dva tedna, kontraindikacijo pri bolnikih z obstoječo boleznijo jeter ali bolnikih, ki sočasno jemljejo druga zdravila, ki znano povzročajo poškodbo jeter, ter tedensko spremljanje delovanja jeter.
In view of the recent study results and as cases of liver injury continue to be reported, the German national competent authority (BfArM) considered that the impact of the risk of liver injury on the benefit-risk balance of these medicinal products and the adequacy of the related risk minimisation measures, should be reviewed.
Glede na nedavne rezultate študije in ker so še naprej poročali o primerih poškodbe jeter, je nemški pristojni nacionalni organ (BfArM) ocenil, da je treba pregledati vpliv tveganja za poškodbo jeter na razmerje med tveganji in koristmi teh zdravil in ustreznost povezanih ukrepov za zmanjšanje tveganja.
Data from spontaneous reports and the literature confirm the risk of unpredictable and potentially fatal liver injury associated to the use of flupirtine-containing medicinal products.
Podatki iz spontanih poročil in literature potrjujejo tveganje za nepredvidljivo in potencialno usodno poškodbo jeter, povezano z uporabo zdravil, ki vsebujejo flupirtin.
On 19 October 2017, the BfArM therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of flupirtine-containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Zato je agencija BfArM je 19. oktobra 2017 na podlagi farmakovigilančnih podatkov sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni vpliv navedenih pomislekov na razmerje med koristmi in tveganji zdravil, ki vsebujejo flupirtin, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
The MAHs were required to conduct a drug utilisation study (DUS) to characterise prescribing practices and a post-authorisation safety study (PASS) to evaluate the effectiveness of the risk minimisation activities.
Od imetnikov dovoljenj za promet z zdravilom se je zahtevala izvedba študije o uporabi zdravil (DUS) za ugotavljanje prakse pri predpisovanju in študije varnosti po pridobitvi dovoljenja za promet (PASS) za ovrednotenje učinkovitosti ukrepov za zmanjšanje tveganja.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for flupirtine-containing medicinal products (see Annex I).
• odbor PRAC je obravnaval postopek na podlagi farmakovigilančnih podatkov v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo flupirtin (glejte Prilogo I);
• The PRAC considered that there is no new significant information on the demonstrated efficacy of flupirtine in the management of acute (nociceptive) pain (mild, moderate and severe).
• odbor PRAC je ocenil, da ni nobenih novih pomembnih informacij o dokazani učinkovitosti flupirtina pri obvladovanju akutne (nociceptivne) bolečine (blage, zmerne in hude);
In 2013, an urgent union procedure under Article 107i of Directive 2001/83/EC (EMEA/H/A-107i/1363) was initiated further to the increased reporting of hepatotoxicity reactions in association with flupirtine.
Leta 2013 je bil sprožen nujni postopek Unije v skladu s členom 107i Direktive 2001/83/ES (EMEA/H/A-107i/1363) zaradi povečanega poročanja o hepatotoksičnih reakcijah v povezavi s flupirtinom.
• The PRAC reviewed all newly available safety and efficacy data, including information provided by the marketing authorisation holders on cases of liver injury, results of observational studies, data available in EudraVigilance and the scientific literature, in the context of the data reviewed in the previous procedure EMEA/H/A-107i/1363 and in relation to the risk of hepatotoxicity associated to flupirtine-containing medicinal products.
• odbor PRAC je pregledal vse novo razpoložljive podatke o varnosti in učinkovitosti, vključno z informacijami, ki so jih predložili imetniki dovoljenj za promet z zdravilom, o primerih poškodbe jeter, rezultati opazovalnih študij, podatki, ki so na voljo v sistemu EudraVigilance, in znanstveno literaturo, in sicer v kontekstu podatkov, pregledanih v okviru predhodnega postopka EMEA/H/A-107i/1363 ter v povezavi s tveganjem za hepatotoksičnost, povezano z zdravili, ki vsebujejo flupirtin;
The PRAC discussed whether further risk minimisation would sufficiently minimise the risk of hepatotoxicity.
Odbor PRAC je razpravljal o tem, ali bi nadaljnji ukrepi za zmanjšanje tveganja v zadostni meri zmanjšali tveganje za hepatotoksičnost.
The PRAC is of the opinion that the results of the newly available studies support the efficacy of flupirtine in the management of acute (nociceptive) pain (mild, moderate and severe) previously demonstrated in clinical trials.
Odbor PRAC meni, da rezultati novih razpoložljivih študij podpirajo učinkovitost flupirtina pri obvladovanju akutne (nociceptivne) bolečine (blage, zmerne in hude), kar so predhodno dokazali v kliničnih preskušanjih.
• Considering the new reports of liver injury, together with the results of observational studies, indicating a very low compliance to the measures recommended in 2013 to minimise the risk of hepatotoxicity, the PRAC concluded that these measures have not been effective in adequately minimising the risk of hepatotoxicity.
• glede na nova poročila o poškodbah jeter in rezultate opazovalnih študij, ki kažejo na zelo slabo upoštevanje ukrepov, priporočenih leta 2013, za zmanjšanje tveganja za hepatotoksičnost, je odbor PRAC zaključil, da ti ukrepi niso učinkoviti pri ustreznem zmanjševanju tveganja za hepatotoksičnost;
These measures were communicated to the relevant healthcare professional (HCP) in a letter and educational materials was implemented to inform prescribers and patients of the risk and associated measures to minimise it.
O teh ukrepih so z dopisom obvestili ustrezne zdravstvene delavce, z izobraževalnimi gradivi pa so zdravnike, ki predpisujejo zdravilo, in bolnike seznanili s tveganjem in povezanimi ukrepi za njegovo zmanjšanje.
• The PRAC concluded that the safety data confirm that the use of flupirtine-containing medicinal products is associated with a risk of unpredictable and potentially fatal liver injury.
• odbor PRAC je zaključil, da podatki o varnosti potrjujejo, da je uporaba zdravil, ki vsebujejo flupirtin, povezana s tveganjem za nepredvidljivo in potencialno usodno poškodbo jeter;
At the time, the PRAC considered that the benefit-risk balance would remain favourable in the management of acute pain when treatment with other analgesics (e.g. non-steroidal anti-inflammatory drugs, weak opioids) is contraindicated provided that a number of risk minimisation measures were implemented.
Odbor PRAC je takrat ocenil, da bo razmerje med tveganji in koristmi pri zdravljenju akutne bolečine še naprej ugodno, kadar je zdravljenje z drugimi analgetiki (npr. nesteroidnimi protivnetnimi zdravili, šibkimi opioidi) kontraindicirano, pod pogojem, da se uvede vrsta ukrepov za zmanjšanje tveganja.
The PRAC concluded that while the use of flupirtine-containing products has decreased, the measures implemented have been ineffective to minimise the hepatotoxicity risk to an acceptable level.
Odbor PRAC je zaključil, da čeprav se je uporaba zdravil, ki vsebujejo flupirtin, zmanjšala, so uvedeni ukrepi neučinkoviti pri zmanjševanju tveganja za hepatotoksičnost na sprejemljivo raven.
However, considering the failure of the previous measures, the absence of risk factors sensitive enough to predict the risk of hepatotoxicity, the clinical setting where these medicinal products are used, the PRAC could not identify further measures that would ensure effective minimisation of the risk of hepatotoxicity associated to the use of flupirtine-containing medicinal products.
Vendar glede na neuspešnost predhodnih ukrepov, odsotnost dejavnikov tveganja, ki bi bili dovolj občutljivi za napoved tveganja za hepatotoksičnost, in klinično okolje, v katerem se ta zdravila uporabljajo, odbor PRAC ni mogel določiti nadaljnjih ukrepov, ki bi zagotovili učinkovito zmanjšanje tveganja za hepatotoksičnost, povezano z uporabo zdravil, ki vsebujejo flupirtin.
Despite their limitations, the six observational studies conducted consistently showed a substantial lack of compliance with the measures required to minimise the risk of hepatotoxicity.
Šest opazovalnih študij je kljub omejitvam pokazalo precejšnje neupoštevanje ukrepov, zahtevanih za zmanjšanje tveganja za hepatotoksičnost.
The PRAC considered all newly available safety and efficacy data, including information provided by the marketing authorisation holders on cases of liver injury, results of the above mentioned observational studies (DUS and PASS), data available in EudraVigilance and the scientific literature, in the context of the data reviewed in the previous Article 107i procedure.
Odbor PRAC je ocenil vse novo razpoložljive podatke o varnosti in učinkovitosti, vključno z informacijami, ki so jih predložili imetniki dovoljenj za promet z zdravilom, o primerih poškodb jeter, rezultati zgoraj omenjenih opazovalnih študij (DUS in PASS), podatki, ki so na voljo v sistemu EudraVigilance, in znanstveno literaturo, in sicer v kontekstu podatkov, pregledanih v okviru predhodnega postopka v skladu s členom 107i.
The Committee, as a consequence, considers that the benefit-risk balance of flupirtine-containing medicinal products is no longer favourable.
Posledično odbor PRAC meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo flupirtin, ni več ugodno.