FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204125, a clinical trial in patients with multiple myeloma comparing Empliciti combined with pomalidomide and dexamethasone treatment (N = 60) to pomalidomide and dexamethasone treatment (N = 55), is shown in Table 7.
Croatian: Tablici 7 prikazane su stope nuspojava (svih stupnjeva i 3./4. stupnja) prilagođene za izloženost u ispitivanju CA204125, kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom u kojem se liječenje lijekom Empliciti u kombinaciji s pomalidomidom i deksametazonom (N = 60) uspoređivalo s liječenjem pomalidomidom i deksametazonom (N = 55).
English: In the clinical trials of patients with multiple myeloma infusion reactions were reported in approximately 10% of premedicated patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 3% of premedicated patients treated with Empliciti combined with pomalidomide and dexamethasone (N = 60) (see section 4.4).
Croatian: U kliničkim ispitivanjima provedenima u bolesnika s multiplim mijelomom reakcije na infuziju prijavljene su u približno 10% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom (N = 318) koji su primili premedikaciju te 3% bolesnika liječenih lijekom Empliciti u kombinaciji s pomalidomidom i deksametazonom (N = 60) koji su primili premedikaciju (vidjeti dio 4.4).
English: The recommended dose of Empliciti is 10 mg/kg administered intravenously every week on days 1, 8, 15, and 22 of each treatment cycle for the first two cycles and then 20 mg/kg administered on day 1 of each treatment cycle thereafter.
Croatian: Preporučena doza lijeka Empliciti tijekom prva dva ciklusa liječenja iznosi 10 mg/kg intravenski i primjenjuje se svaki tjedan, tj. 1., 8., 15. i 22. dana, a nakon toga iznosi 20 mg/kg i primjenjuje se 1. dana svakog ciklusa liječenja.
English: Grade 3-4 infections were noted in 13.3% and 21.8% of Empliciti combined with pomalidomide and dexamethasone and pomalidomide and dexamethasone treated patients, respectively.
Croatian: Infekcije 3./4. stupnja primijećene su u 13,3% bolesnika liječenih lijekom Empliciti u kombinaciji s pomalidomidom i deksametazonom te 21,8% onih liječenih pomalidomidom i deksametazonom.
English: How to store Empliciti
Croatian: Kako čuvati Empliciti
English: Eligible patients were randomised in a 1:1 ratio to receive either Empliciti in combination with lenalidomide and dexamethasone or lenalidomide and dexamethasone (Ld).
Croatian: Bolesnici koji su zadovoljavali uvjete za sudjelovanje u ispitivanju randomizirani su u omjeru 1:1 za primanje lijeka Empliciti u kombinaciji s lenalidomidom i deksametazonom ili za primanje lenalidomida i deksametazona (Ld).
English: These reactions are presented by system organ class and by frequency.
Croatian: Ove su nuspojave prikazane prema klasifikaciji organskih sustava i učestalosti.
English: Transfer the withdrawn volumes of all vials needed according to the calculated dose for this patient into one single infusion bag made of polyvinyl chloride or polyolefin containing the calculated volume of diluent.
Croatian: Volumene izvučene iz svih bočica potrebne za izračunatu dozu za tog bolesnika prebacite u samo jednu infuzijsku vrećicu načinjenu od polivinilklorida ili poliolefina koja sadrži izračunati volumen 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekcije ili 5%-tne otopine glukoze za injekcije.
English: Table 9: CA204004 Efficacy results for subsets
Croatian: Tablica 9: Rezultati za djelotvornost u podskupinama u ispitivanju CA204004
English: b The term lymphopenia includes the following terms: lymphopenia and lymphocyte count decreased.
Croatian: b Pojam "limfopenija" uključuje sljedeće pojmove: limfopeniju i smanjen broj limfocita.
English: IV use.
Croatian: PRILOG III.
English: Empliciti has not been studied in patients with moderate (TB > 1.5 to 3 × ULN and any AST) or severe (TB > 3 × ULN and any AST) hepatic impairment (see section 5.2).
Croatian: Empliciti se nije ispitivao u bolesnika s umjerenim (ukupni bilirubin > 1,5 do 3 × GGN i bilo koja vrijednost AST-a) ili teškim (ukupni bilirubin > 3 × GGN i bilo koja vrijednost AST-a) oštećenjem funkcije jetre (vidjeti dio 5.2).
English: Infusion rate for Empliciti 20 mg/kg
Croatian: Brzina infuzije lijeka Empliciti 20 mg/kg
English: 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.
Croatian: Infekcije sa smrtnim ishodom nisu bile česte, a prijavljene su u 2,5% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom te u 2,2% onih koji su liječeni lenalidomidom i deksametazonom.
English: Infusion rate for Empliciti 10 mg/kg
Croatian: Brzina infuzije lijeka Empliciti 10 mg/kg
English: Oropharyngeal pain
Croatian: Orofaringealna bol
English: PFS (ITT) Hazard Ratio [95% CI] Stratified log-rank test p-valuea Median PFS in months [95% CI]
Croatian: PFS (ITT) Omjer hazarda [95% CI] p-vrijednost stratificiranog log-rang testa a
English: CA204004 is a randomised, open-label study was conducted to evaluate the efficacy and safety of Empliciti in combination with lenalidomide and dexamethasone (E-Ld) in patients with multiple myeloma who have received one to three prior therapies.
Croatian: Empliciti u kombinaciji s lenalidomidom i deksametazonom (CA204004) Ispitivanje CA204004 bilo je randomizirano otvoreno ispitivanje provedeno radi ocjenjivanja djelotvornosti i sigurnosti lijeka Empliciti u kombinaciji s lenalidomidom i deksametazonom (E-Ld) u bolesnika s multiplim mijelomom koji su prethodno primili jednu do tri terapije.
English: 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.
Croatian: Poznato je da su druge primarne zloćudne bolesti povezane s izlaganjem lenalidomidu, koje je bilo dugotrajnije u bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom nego u onih liječenih lenalidomidom i deksametazonom.
English: Empliciti at 20 mg/kg dose should be initiated at an infusion rate of 3 mL/min.
Croatian: Infuziju lijeka Empliciti u dozi od 20 mg/kg treba započeti brzinom od 3 ml/min.
English: Infections and infestations
Croatian: Infekcije i infestacije Herpes zostera
English: Management of infusion reaction
Croatian: Zbrinjavanje reakcije na infuziju
English: Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204004, a clinical trial in patients with multiple myeloma comparing Empliciti combined with lenalidomide and dexamethasone treatment (N = 318) to lenalidomide and dexamethasone treatment (N = 317), is shown in Table 6.
Croatian: U Tablici 6 prikazane su stope nuspojava (svih stupnjeva i 3./4. stupnja) prilagođene za izloženost u ispitivanju CA204004, kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom u kojem se liječenje lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom (N = 318) uspoređivalo s liječenjem lenalidomidom i deksametazonom (N = 317).
English: The incidence of SPMs was higher with Empliciti treatment than with control (see section 4.4).
Croatian: Incidencija drugih primarnih zloćudnih bolesti bila je viša u bolesnika liječenih lijekom Empliciti nego u kontrolnoj skupini (vidjeti dio 4.4).
English: Empliciti contains sodium
Croatian: Empliciti sadrži natrij
English: Lymphopeniab 90 17.6 Headache
Croatian: Leukopenija 70 13,7
English: Empliciti 300 mg powder for concentrate for solution for infusion Each vial contains 300 mg elotuzumab*.
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Empliciti 300 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 300 mg elotuzumaba*.
English: On weeks with Empliciti infusion, dexamethasone was administered before Empliciti as a divided dose: subjects  75 years an oral dose of 28 mg and an intravenous dose of 8 mg, and in subjects > 75 years an oral dose of 8 mg and an intravenous dose of 8 mg. On weeks without an Empliciti infusion and in the control group, dexamethasone was administered in subjects  75 years as an oral dose of 40 mg and in subjects > 75 years as an oral dose of 20 mg dexamethasone.
Croatian: U tjednima kada se nije primjenjivala infuzija lijeka Empliciti,deksametazon se davao prije lijeka Empliciti, podijeljen u dvije doze: ispitanici u dobi od  75 godina primali su peroralnu dozu od 28 mg i intravensku dozu od 8 mg, dok su ispitanici u dobi od > 75 godina primali peroralnu dozu od 8 mg i intravensku dozu od 8 mg.
English: Uncommon a The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, and herpes virus infection.
Croatian: Manje često a Pojam "herpes zoster" obuhvaća sljedeće pojmove: herpes zoster, oralni herpes i infekciju virusom herpesa.
English: Hypoaesthesia 1
Croatian: Hipoestezij a
English: EU/1/16/1088/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1088/001
English: Discard the solution if any particulate matter or discolouration is observed.
Croatian: Otopina se ne smije upotrijebiti ako se uoče čestice ili promjena boje.
English: Empliciti should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Empliciti treba prije primjene vizualno pregledati kako bi se utvrdilo sadrži li krute čestice i je li promijenio boju.
English: The flip-off seal button colour is ivory for the 300 mg presentation and blue for the 400 mg presentation.
Croatian: "Flip-off" kapica bočice od 300 mg je boje bjelokosti, dok je "flip off" kapica bočice od 400 mg plave boje.
English: Frequency overall
Croatian: Ukupna učestalost
English: Discard any unused portion left in the vial.
Croatian: Bacite sav lijek koji preostane u bočici.
English: Refractory
Croatian: Nuspojave
English: Each vial contains 400 mg elotuzumab.
Croatian: TVARI Jedna bočica sadrži 400 mg elotuzumaba.
English: Lymphopeniab 10 21.0 Pneumoniac
Croatian: Pneumonijac 80 15,6
English: Grade 3-4 infections were noted in 28% and 24.3% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
Croatian: Infekcije 3./4. stupnja primijećene su u 28% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom te 24,3% onih koji su liječeni lenalidomidom i deksametazonom.
English: 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).
Croatian: U kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom (CA204004), slučajevi duboke venske tromboze prijavljeni su u 7,2% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom (N = 318) te 3,8% onih koji su liječeni lenalidomidom i deksametazonom (N = 317).
English: 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).
Croatian: U kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom (CA204004), infekcije su prijavljene u 81,4% bolesnika u skupini liječenoj lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom (N = 318) te u 74,4% bolesnika u skupini koja je liječena lenalidomidom i deksametazonom (N = 317).
English: EU/1/16/1088/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1088/002
English: On days that Empliciti is administered, dexamethasone should be given as 28 mg orally once daily between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti on days 1, 8, 15, and 22 of repeated 28-day cycles.
Croatian: Onih dana kada se primjenjuje i Empliciti, tj. 1., 8., 15. i 22. dana ponavljajućih 28-dnevnih ciklusa, deksametazon treba davati peroralno u dozi od 28 mg jedanput na dan 3 - 24 sata prije primjene lijeka Empliciti te intravenski u dozi od 8 mg 45 - 90 minuta prije primjene lijeka Empliciti.
English: Decreased sensitivity, especially in the skin Allergic reactions (hypersensitivity) Pain in the mouth/throat region/sore throat
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) bol u prsištu krvni ugrušci u venama (tromboza) bolan kožni osip praćen mjehurićima (herpes zoster) noćno znojenje promjene raspoloženja smanjena osjetljivost, osobito kože alergijske reakcije (preosjetljivost) bol u ustima/području grlu/grlobolja
English: Solid tumours were reported in 2.5% and 1.9% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
Croatian: Solidni tumori prijavljeni su u 2,5% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom te 1,9% onih koji su liječeni lenalidomidom i deksametazonom.
English: Each vial contains 300 mg elotuzumab.
Croatian: TVARI Jedna bočica sadrži 300 mg elotuzumaba.
English: Empliciti 400 mg powder for concentrate for solution for infusion.
Croatian: Empliciti 400 mg prašak za koncentrat za otopinu za infuziju.
English: Hazard Ratio [97.61% CI]
Croatian: Omjer hazarda [97,61% CI] p-vrijednost stratificiranog log-rang testaa
English: Preparation and administration of Empliciti
Croatian: Priprema i primjena lijeka Empliciti
English: Empliciti 300 mg powder for concentrate for solution for infusion.
Croatian: Empliciti 300 mg prašak za koncentrat za otopinu za infuziju.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOČICE
English: p-valued Complete Response (CR + sCR)e n (%)
Croatian: p-vrijednostd Potpun odgovor (CR + sCR)
English: Your doctor may decide not to continue Empliciti treatment if you have a strong infusion reaction.
Croatian: Ako dobijete jaku reakciju na infuziju, liječnik će možda odlučiti ne nastaviti liječenje lijekom Empliciti.
English: Table 4: Infusion rate for Empliciti 20 mg/kg
Croatian: Tablica 4: Brzina infuzije lijeka Empliciti u dozi od 20 mg/kg
English: 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.
Croatian: Nemelanomski oblici raka kože prijavljeni su u 3,1% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom te 1,6% onih koji su liječeni lenalidomidom i deksametazonom.
English: Table 2: Infusion rate for Empliciti 10 mg/kg
Croatian: Tablica 2: Brzina infuzije lijeka Empliciti u dozi od 10 mg/kg
English: If well tolerated, the infusion rate may be increased stepwise as described in Table 2.
Croatian: Ako bolesnik dobro podnosi infuziju, njezina se brzina može postupno povećavati na način opisan u Tablici 2.
English: Median OS in months [95% CI]
Croatian: Medijan OS-a u mjesecima [95% CI]
English: 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).
Croatian: U kliničkom ispitivanju provedenom u bolesnika s multiplim mijelomom (CA204004), invazivne druge primarne zloćudne bolesti prijavljene su u 6,9% bolesnika liječenih lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom (N = 318) te 4,1% onih koji su liječeni lenalidomidom i deksametazonom (N = 317).
English: How Empliciti is given
Croatian: Kako se primjenjuje Empliciti
English: If the infusion is well tolerated the infusion rate may be increased in a stepwise fashion as described in Table 3.
Croatian: Ako bolesnik dobro podnosi infuziju, njezina se brzina može postupno povećavati na način opisan u Tablici
English: Very Good Partial Response (VGPR) n (%) Partial Response (RR/PR) n (%) Combined Responses (CR+sCR+VGPR) n (%) Overall Survivalg Hazard Ratio [95.4% CI] Stratified log-rank test p-value
Croatian: Djelomičan odgovor (RR/PR) n (%) Objedinjeni odgovori (CR+sCR+VGPR) n (%) Ukupno preživljenjeg
English: Table 3: Infusion rate for Empliciti 10 mg/kg
Croatian: Tablica 3: Brzina infuzije lijeka Empliciti u dozi od 10 mg/kg
English: Table 3: Infusion rate for Empliciti 20 mg/kg
Croatian: Tablica 3: Brzina infuzije lijeka Empliciti u dozi od 20 mg/kg
English: Figure 3: CA204125 Progression free survival per investigator
Croatian: Preživljenje bez progresije bolesti prema ocjeni ispitivača u ispitivanju CA204125
English: Cough
Croatian: Kašaljd
English: Patients should be monitored for the development of SPMs.
Croatian: Bolesnike je potrebno nadzirati zbog mogućeg razvoja drugih primarnih zloćudnih bolesti.
English: Empliciti 400 mg powder for concentrate elotuzumab
Croatian: NAZIV LIJEKA Empliciti 400 mg prašak za koncentrat elotuzumab
English: Empliciti 300 mg powder for concentrate elotuzumab
Croatian: NAZIV LIJEKA Empliciti 300 mg prašak za koncentrat elotuzumab
English: Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab
Croatian: Empliciti 400 mg prašak za koncentrat za otopinu za infuziju elotuzumab
English: Prior bortezomib exposure No prior bortezomib exposure
Croatian: Prethodno izlaganje talidomidu Bez prethodnog izlaganja imunomodulatorima
English: Day of Cycle 1 Premedication
Croatian: Dan ciklusa 1.
English: 14 (4.4)f
Croatian: 3./4. stupanj
English: The Summary of Product Characteristics for all medicinal products used in combination with Empliciti must be consulted before starting therapy.
Croatian: Prije početka terapije moraju se proučiti sažeci opisa svojstava lijeka svih lijekova koji se primjenjuju u kombinaciji s lijekom Empliciti.
English: Empliciti 300 mg powder for concentrate for solution for infusion elotuzumab
Croatian: Empliciti 300 mg prašak za koncentrat za otopinu za infuziju elotuzumab
English: p-valuec Complete Response (CR + sCR)d n (%)
Croatian: b n (%) [95% CI] p-vrijednostc Potpun odgovor (CR + sCR)d n (%)
English: 28-Day Cycles 3+
Croatian: Ciklus 1. i 2. 28-dnevni ciklus 3. i svi sljedeći 28-dnevni ciklusi
English: 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.
Croatian: U ispitivanju CA204125, druga primarna zloćudna bolest nije prijavljena ni u jednog bolesnika u skupini liječenoj lijekom Empliciti u kombinaciji s pomalidomidom i deksametazonom (N = 60), dok je u skupini liječenoj pomalidomidom i deksametazonom (N = 55) prijavljen 1 slučaj (1,8%).
English: Figure 1: CA204004 Progression free survival
Croatian: Preživljenje bez progresije bolesti u ispitivanju CA204004
English: 400 mg powder for concentrate
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ 400 mg prašak za koncentrat
English: Lymphopeniac
Croatian: Limfopenija b
English: 300 mg powder for concentrate
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ 300 mg prašak za koncentrat
English: Herpes zosterd 51 10.0 Oropharyngeal pain
Croatian: Herpes zosterd Reakcija na infuziju Bol u prsištu
English: 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.
Croatian: PRAC je 8. veljače 2018. usvojio preporuku koju je zatim razmatrao CMDh u skladu s člankom 107.k Direktive 2001/83/EZ.
English: Furthermore, the individual case reports of hepatobiliary toxicity show a substantial proportion of cases with noncompliance with the safety restrictions.
Croatian: Nadalje, pojedinačna izvješća o slučajevima hepatobilijarne toksičnosti pokazuju značajan broj slučajeva nesukladnosti sa sigurnosnim ograničenjima.
English: 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.
Croatian: Te su mjere obuhvaćale dodatne materijale s informacijama o prethodnim mjerama, smanjenje veličine pakiranja i uvođenje novog upozorenja o genetskim rizičnim čimbenicima.
English: Having reviewed the PRAC recommendation, the CMDh agrees with the PRAC overall conclusions and grounds for recommendation.
Croatian: Stajalište CMDh-a Nakon što je pregledao preporuku PRAC-a, CMDh je suglasan s općim znanstvenim zaključcima i razlozima za preporuku PRAC-a.
English: Additionally a facilitatory effect on gamma-aminobutyric acid A receptors has been described.
Croatian: Osim toga, opisan je učinak facilitatora za A receptore gama-aminomaslačne kiseline.
English: Flupirtine is a ‘selective neuronal potassium channel opener' that acts by opening Kv7 potassium channels leading to functional N-methyl-D-aspartate receptor antagonism.
Croatian: Flupirtin je „selektivan neuronski otvarač kalijevih kanala” koji djeluje na način da otvara kalijeve kanale Kv7, zbog čega djeluje kao antagonist
English: Based on the review of all data available at the time, the PRAC concluded that flupirtine is associated with an increased risk of hepatotoxicity.
Croatian: Na temelju preispitivanja svih tada dostupnih podataka, PRAC je zaključio da je flupirtin povezan s povećanim rizikom od hepatotoksičnosti.
English: It was noted that no medical guidelines recommending the use of flupirtine in any pain indication could be identified.
Croatian: Primijećeno je da nije moguće utvrditi medicinske smjernice kojima se preporučuje primjena flupirtina za bilo kakvu indikaciju boli.
English: • 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).
Croatian: • PRAC je razmotrio postupak proveden sukladno članku 31. Direktive 2001/83/EZ na temelju podataka iz farmakovigilancije za lijekove koji sadrže flupirtin (vidjeti Prilog I.).
English: 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.
Croatian: Tijekom 2017. ishodi promatračkih ispitivanja zatraženih kao ishod ovog hitnog postupka Unije pokazali su nizak stupanj sukladnosti s odobrenim uvjetima primjene lijekova koji sadrže flupirtin te, konkretnije, s prethodno navedenim ograničenjima i mjerama za smanjivanje rizika.
English: • 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).
Croatian: • PRAC je zaključio da ne postoje novi značajni podatci o dokazanoj djelotvornosti flupirtina u liječenju akutne (nociceptivne) boli (blage, umjerene i snažne).
English: Further, the PRAC could not identify conditions which if fulfilled in the future would demonstrate a positive benefit-risk balance for these products in their current indication.
Croatian: Nadalje, PRAC nije mogao utvrditi uvjete koji bi, kada bi bili ispunjeni, u budućnosti pokazali pozitivan omjer koristi i rizika za te lijekove u njihovoj trenutačnoj indikaciji.
English: 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.
Croatian: BfArM je pokrenuo postupak upućivanja na temelju članka 31. Direktive 2001/83/EZ, koji je proizašao iz podataka o farmakovigilanciji, te je od PRAC-a zatražio procjenu učinka gore navedenih problema na omjer koristi i rizika za lijekove koji sadrže flupirtin i izdavanje preporuke o tome treba li odgovarajuća odobrenja za stavljanje u promet zadržati, izmijeniti, privremeno oduzeti ili ukinuti.