FrancophonIA/ELRC3.0 huggingface dataset:
English: PsA study II with 12 -week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Croatian: Ispitivanjem PsA II u trajanju od 12 tjedana obuhvaćeno je 100 odraslih bolesnika koji nisu ostvarili odgovarajući odgovor na prethodno liječenje antireumatskim lijekovima koji modificiraju tijek bolesti.
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test.
Croatian: JSN rezultat p-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U testa
English: Beyond 16 weeks, patients with inadequate response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na Kromeya u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Injection button
Croatian: Otopina za injekciju
English: Table 11 Distribution of patients by age and adalimumab dose received during the OL LI phase
Croatian: Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: Your child's doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Croatian: Liječnik Vašeg djeteta može propisati i početnu dozu od 40 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
Croatian: Djeca i adolescenti u dobi od 6 i više godina, tjelesne težine od 15 kg do manje od 30 kg
English: Your child's doctor may prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Croatian: Liječnik Vašeg djeteta može propisati i početnu dozu od 80 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: • headache;
Croatian: • glavobolja,
English: d score methotrexate
Croatian: Klip štrcaljke
English: Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine od 10 kg do manje od 30 kg
English: Visual impairment, conjunctivitis, blepharitis, eye swelling
Croatian: Poremećaji oka često oštećenje vida, konjunktivitis, blefaritis, oticanje očiju manje često diplopija
English: Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Croatian: Srednja promjena od početne vrijednosti e n=91 za placebo i n=87 za adalimumab f
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double−blind, placebo−controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Croatian: U dva dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja, kroz 24 tjedna ispitivano je djelovanje adalimumaba u dozi od 40 mg svaka dva tjedna u 393 bolesnika s aktivnim ankilozantnim spondilitisom (srednja početna vrijednost aktivnosti bolesti [engl.
English: Your healthcare provider should show you how to prepare and inject Kromeya properly using the pre-filled syringe before you use it for the first time.
Croatian: Prije nego što primijenite ovaj lijek prvi puta, Vaš zdravstveni radnik Vam mora pokazati kako se Kromeya ispravno priprema i primjenjuje koristeći napunjenu brizgalicu.
English: • polyarticular juvenile idiopathic arthritis
Croatian: • poliartikularnog juvenilnog idiopatskog artritisa
English: 6.2 Position the pre-filled pen
Croatian: 6.2 Postavite napunjenu brizgalicu u poziciju
English: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Croatian: Psorijatični artritis i aksijalni spondiloartritis, uključujući ankilozantni spondilitis Nema relevantne primjene adalimumaba u djece u indikacijama ankilozantnog spondilitisa i psorijatičnog artritisa.
English: Induction dose
Croatian: Supkutana primjena
English: Kromeya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Croatian: Kromeya 40 mg otopina za injekciju (injekcija) u napunjenoj štrcaljki dolazi kao sterilna bistra, bezbojna otopina s 40 mg adalimumaba u 0,8 ml otopine.
English: • You might get infections more easily while you are receiving Kromeya treatment.
Croatian: • Dok primate lijek Kromeya, možete biti podložniji infekcijama.
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Croatian: Ako bolujete od ankilozantnog spondilitisa ili aksijalnog spondiloartritisa bez radiološkog dokaza AS-a, prvo će Vam biti dani drugi lijekovi, no ukoliko ti drugi lijekovi ne djeluju dovoljno dobro, bit će Vam propisan lijek Kromeya kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti−rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Croatian: Bath Ankylosing Spondilitis Disease Activity Index, BASDAI] bila je 6,3 u svim skupinama) koji nisu imali adekvatan odgovor na konvencionalnu terapiju. 79 bolesnika (20,1%) istodobno je bilo liječeno antireumatskim lijekovima koji modificiraju tijek bolesti, a 37 bolesnika (9,4%) glukokortikoidima.
English: The recommended dose of Kromeya for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Croatian: Preporučena doza lijeka Kromeya za pedijatrijske bolesnike s uveitisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 5).
English: • Top of the thighs.
Croatian: • prednjoj strani bedara.
English: Children, adolescents and adults from 6 years of age weighing 40 kg or more
Croatian: Djeca, adolescenti i odrasli u dobi od 6 i više godina, tjelesne težine 40 kg ili više
English: Paediatric ulcerative colitis
Croatian: Ulcerozni kolitis
English: Children and adolescents from 2 years of age weighing 30 kg or more
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine 30 kg ili više
English: Kromeya is administered by injection under the skin (by subcutaneous injection).
Croatian: Kromeya se primjenjuje potkožnom injekcijom (supkutana injekcija).
English: • paediatric plaque psoriasis
Croatian: • plak psorijaze u pedijatrijskoj populaciji
English: Needle Guard Spring
Croatian: Opruga štitnika igle
English: Non-infectious uveitis Age or body weight
Croatian: Nezarazni uveitis Dob ili tjelesna težina
English: Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Croatian: Liječnik može propisati i početnu dozu od 80 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: Intestinal perforation
Croatian: Indukcijska doza
English: 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Croatian: d rezultat metotreksat razlike između metotreksata i adalimumaba s obzirom na promjene ukupnog zbroja bodova na razini intervala pouzdanosti od 95% na osnovi analize ranga suženje zglobnih prostora (eng.
English: Hypertension, flushing, haematoma
Croatian: Krvožilni poremećaji često hipertenzija, navale crvenila, hematomi
English: • high blood measurements for white blood cells;
Croatian: • visoka razina leukocita (bijelih krvnih stanica),
English: Your doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Croatian: Liječnik može propisati i početnu dozu od 40 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: • 40 mg at week 0 and 20 mg at week 2
Croatian: < 40 kg • 40 mg u nultom tjednu i 20 mg u drugom tjednu
English: Kromeya 40 mg solution for injection (injection) in pre-filled pen is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Croatian: Kromeya 40 mg otopina za injekciju (injekcija) u napunjenoj brizgalici dolazi kao sterilna bistra, bezbojna otopina s 40 mg adalimumaba u 0,8 ml otopine.
English: Adalimumab 40 mg eow N=109
Croatian: Adalimuma b 40 mg svaki drugi tjedan N=109
English: Safety Cover
Croatian: Sigurnosni pokrov za iglu
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Croatian: Adalimumab je u 12. tjednu u odnosu na početne vrijednosti pokazao statistički značajno veće poboljšanje ukupnog rezultata HAQ-S i rezultata za fizičku komponentu (engl.
English: Children and adolescents from 2 years of age weighing less than 30 kg
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine manje od 30 kg
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and
Croatian: Ukupno je 76,5% (218/285) bolesnika kojima je liječenje ponovno uvedeno imalo PGA odgovor “bez bolesti” ili “minimalno” nakon 16
English: Needle cap Liquid-filled syringe Barrel (inside)
Croatian: Trup štrcaljke napunjene tekućinom (unutra)
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more
Croatian: Djeca, adolescenti i odrasli u dobi od 6 i više godina, tjelesne težine 30 kg ili više
English: Children, adolescents and adults from 2 years of age weighing 30 kg or more
Croatian: Djeca, adolescenti i odrasli u dobi od 2 i više godina, tjelesne težine 30 kg ili više
English: 2.6 Peel off the paper from the vial adapter packaging without taking the vial adaptor out of its packaging.
Croatian: 2.6 Odlijepite papirni pokrov s podloška u kojem se nalazi nastavak za bočicu, ali iz njega nemojte vaditi nastavak za bočicu.
English: /MTX (N = 38)
Croatian: Adalimumab/MTX (N=38)
English: Clear Needle Guard
Croatian: Prozirni štitnik igle
English: • cough;
Croatian: • kašalj,
English: If you take Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako primjenjujete lijek Kromeya.
English: Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Croatian: Manje često su u kliničkim ispitivanjima zabilježene alergijske reakcije povezane s adalimumabom koje nisu bile ozbiljne.
English: one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Početna doza 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: Clinical response * p value for Standard Dose versus Low Dose comparison.
Croatian: 26. tjedan Klinička remisija Klinički odgovor 52. tjedan Klinička remisija Klinički odgovor * p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: Step 2 Prepare Vial
Croatian: 2. korak Pripremite bočicu
English: Table 25 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Croatian: Tablica 25 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I - V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Croatian: U tim ispitivanjima, u 11,9% bolesnika liječenih adalimumabom i 8,1% bolesnika koji su primali placebo i aktivni kontrolni lijek i koji su prije početka liječenja imali negativan titar antinuklearnih protutijela zabilježen je pozitivan titar nakon 24 tjedna primjene lijeka.
English: Adverse reaction skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster),
Croatian: često sistemske infekcije (uključujući sepsu, kandidijazu i gripu), intestinalne infekcije (uključujući virusni gastroenteritis), infekcije kože i mekog tkiva (uključujući paronihiju, celulitis, impetigo, nekrotizirajući fasciitis i herpes zoster), infekcije uha, infekcije usne šupljine (uključujući herpes simpleks, herpes usne šupljine i infekcije zuba), infekcije reproduktivnog sustava (uključujući vulvovaginalne mikoze),
English: Pancytopenia
Croatian: Štrcaljka
English: Front view
Croatian: Sprijeda
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Croatian: Stoga se istodobna primjena adalimumaba i anakinre ne preporučuje (vidjeti dio 4.5).
English: Common
Croatian: Skupina
English: Kromeya therapy should not be continued in patients failing to respond within this time period.
Croatian: U bolesnika u kojih u ovom razdoblju ne bude odgovora, liječenje lijekom Kromeya ne treba nastaviti.
English: Paediatric plaque psoriasis
Croatian: Plak psorijaza u pedijatrijskoj populaciji
English: Kromeya 40 mg solution for injection in pre-filled pen adalimumab
Croatian: Kromeya 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: Each vial contains 40 mg of adalimumab in 0.8 ml of solution.
Croatian: Jedna bočica sadrži 40 mg adalimumaba u 0,8 ml otopine.
English: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Croatian: Jedna napunjena brizgalica od 0,8 ml sadrži 40 mg adalimumaba.
English: • trouble breathing, swallowing;
Croatian: • otežano disanje i gutanje,
English: Record injection and dispose components
Croatian: 7. korak Zabilježite injekciju i bacite komponente
English: Warning: Do not use the vial if the liquid is cloudy, colored or has particles or flakes in it. 2.4 Gently remove the yellow cap from the vial.
Croatian: Upozorenje: Nemojte upotrebljavati štrcaljku ako tekućina sadrži čestice ili je zamućena, obojena ili sadrži pahuljice.
English: (See section 4.5).
Croatian: (Tablica 14).
English: • urinary tract infection;
Croatian: • infekcije mokraćnih putova,
English: • The needle guard spring is not extended (Figure I).
Croatian: ⚫ opruga štitnika igle nije ispružena (slika I).
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Croatian: Ocjena psorijaze noktiju uključivala je modificirani indeks težine psorijaze noktiju (engl.
English: Crohn's disease Age or body weight
Croatian: Dob ili tjelesna težina
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Croatian: U pedijatrijskih bolesnika s umjerenom do teškom Crohnovom bolešću, otvorena indukcijska doza adalimumaba bila je 160/80 mg ili 80/40 mg u nultom, odnosno drugom tjednu, ovisno o graničnoj vrijednosti za tjelesnu težinu od 40 kg.
English: There is no relevant use of Kromeya in children aged less than 2 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 2 godine u ovoj indikaciji.
English: Table 19 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Croatian: Tablica 19 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula Standardna doza 40/20 mg svaki drugi tjedan
English: • increased lipids in the blood; • raised liver enzymes.
Croatian: • povišena razina bilirubina (vidljivo u nalazima krvne pretrage kojom se provjerava rad jetre).
English: One 0.8 mL vial contains 40 mg adalimumab
Croatian: Jedna bočica od 0,8 ml sadrži 40 mg adalimumaba.
English: If your child takes Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako Vaše dijete primjenjuje lijek Kromeya.
English: Warning: Do not touch where you aim to inject.
Croatian: Upozorenje: Nemojte dodirivati ciljno mjesto injiciranja.
English: Paediatric Crohn's disease
Croatian: Crohnova bolest u pedijatrijskoj populaciji
English: Clinical remission Mucosal healing
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Warning: Do not throw the vial away.
Croatian: Upozorenje: Ne bacajte bočicu u smeće.
English: Subcutaneous use Each item for single use only
Croatian: Svaki dio je samo je jednokratnu primjenu.
English: blood lactate dehydrogenase increased
Croatian: • gnojnog hidradenitisa u adolescenata
English: ear infections,
Croatian: • infekcije uha,
English: ANNEX II
Croatian: Tablica 11
English: Single use pre-filled syringe (adalimumab) for subcutaneous injection 40mg
Croatian: Komponente i bočica s lijekom (adalimumab) za potkožnu injekciju, za jednokratnu primjenu 40 mg/0.8 mL
English: Muscle spasms (including blood creatine phosphokinase increased)
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva vrlo često mišićno-koštana bol često spazmi mišića (uključujući povećanje razine kreatin fosfokinaze)
English: • Your child might get infections more easily while receiving Kromeya treatment.
Croatian: Vaše dijete počne primati lijek Kromeya Kako primjenjivati lijek Kromeya
English: Warning: Do not use if expiration date has passed.
Croatian: Upozorenje: Nemojte primjenjivati nakon isteka roka valjanosti.
English: • facial oedema (swelling);
Croatian: • edem (oticanje) lica,
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Croatian: Psoriasis Area and Severity Index, PASI]  12 ili  10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: Stratum
Croatian: BASDAI
English: • It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Croatian: • Ako Vaše dijete razvije simptome infekcije, poput vrućice, rana, osjećaja umora, problema sa zubima, važno je da to kažete svom liječniku.
English: Kromeya dose for paediatric patients with uveitis
Croatian: Tablica 5. Doza lijeka Kromeya za pedijatrijske bolesnike s uveitisom
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Kromeya.
Croatian: Nakon uzimanja lijeka Kromeya može se javiti osjećaj da se prostorija vrti (vrtoglavica) te smetnje vida.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Croatian: Adalimumab je značajno odgodio vrijeme do neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 3, P < 0,0001 iz log-rang testa).
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Croatian: Farmaceutski oblik Put primjene Pakiranje
English: Package size
Croatian: Sastav (koncentracija) Veličina pakiranja
English: Communication measures
Croatian: Komunikacijske mjere
English: The effectiveness of this measure should be considered in combination with other measures.
Croatian: Učinkovitost ove mjere valja razmotriti u kombinaciji s drugim mjerama.
English: Hence:
Croatian: Prema tome:
English: Protocols should include a representative sample of EU Member States.
Croatian: Protokoli trebaju obuhvaćati reprezentativni uzorak država članica EU-a.
English: Revised CMDh position
Croatian: Revidirano stajalište CMDh-a
English: • Proposals for additional risk minimisation measures and pharmacovigilance activities
Croatian: • Prijedlozi dodatnih mjera minimizacije rizika i farmakovigilancijskih aktivnosti
English: These include drug utilisation data from 11 EU Member States.
Croatian: Sadrže podatke o potrošnji lijeka u 11 država članica EU-a.
English: These views often reflected the current national medical practice and the debate in the medical community.
Croatian: Ova stajališta često odražavaju trenutačnu nacionalnu medicinsku praksu i rasprave u medicinskoj zajednici.
English: The primary outcomes should be common to all studied EU Member States.
Croatian: Primarni ishodi trebaju biti zajednički za sve države članice EU-a obuhvaćene ispitivanjem.
English: The PRAC discussed the above two points at its May meeting, taking into consideration information provided by the Member States.
Croatian: PRAC je održao raspravu o prethodnim dvama pitanjima na svojem sastanku održanom u svibnju, uzimajući u obzir informacije koje su dostavile države članice.
English: The PRAC also consulted an ad-hoc expert group and considered carefully views expressed during the meeting that took place on 18 December 2017.
Croatian: PRAC se također savjetovao s ad hoc stručnom skupinom i pažljivo razmotrio mišljenja izražena tijekom sastanka održanog 18. prosinca 2017.
English: Overall, the evidence for this indication is based on studies for which the sample size and the duration of follow-up are limited.
Croatian: Ukupno gledajući, dokazi za tu indikaciju temelje se na ispitivanjima u kojima su veličina uzorka i trajanje praćenja bili ograničeni.
English: The frequency of the training / reminders should be discussed at national level taking consideration particularities of each national healthcare system.
Croatian: O učestalosti osposobljavanja/podsjetnika valja raspravljati na nacionalnoj razini uzimajući u obzir posebnosti svakog nacionalnog sustava zdravstvene skrbi.
English: The PRAC adopted a recommendation on 11 January 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Croatian: PRAC je 11. siječnja 2018. donio preporuku koju je zatim razmatrao CMDh u skladu s člankom 107.k Direktive 2001/83/EZ.
English: This suggests that the previous communication measures although not sufficient to ensure full compliance, have had some effectiveness.
Croatian: To ukazuje na činjenicu da su prethodne komunikacijske mjere, iako nisu bile dostatne da zajamče potpunu sukladnost, bile donekle učinkovite.
English: This complicates effective risk minimisation in these patients.
Croatian: Zbog toga je u tih bolesnika otežana učinkovita minimizacija rizika.