FrancophonIA/ELRC3.0 huggingface dataset:
English: The immunogenicity profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Croatian: Profil imunogenosti mepolizumaba u bolesnika s teškom refraktornom eozinofilnom astmom (n=998) liječenih tijekom medijana od 2,8 godina (raspon od 4 tjedna do 4,5 godina) u otvorenim produžecima ispitivanja bio je sličan onome opaženome u placebom kontroliranim ispitivanjima.
English: The safety profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Croatian: Sigurnosni profil mepolizumaba u bolesnika s teškom refraktornom eozinofilnom astmom (n=998) liječenih tijekom medijana od 2,8 godina (raspon od 4 tjedna do 4,5 godina) u otvorenim produžecima ispitivanja bio je sličan onome opaženome u placebom kontroliranim ispitivanjima.
English: If you may have had a similar reaction to any injection or medicine: Tell your doctor before you or your child are given Nucala
Croatian: Ako ste možda imali sličnu reakciju na bilo koju injekciju ili lijek: obavijestite o tome svog liječnika prije nego što Vi ili Vaše dijete primite lijek Nucala
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80.
Croatian: Drugi sastojci su saharoza, natrijev hidrogenfosfat heptahidrat i polisorbat 80.
English: Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably using a 2
Croatian: Rekonstituirajte sadržaj bočice s 1,2 ml sterilne vode za injekcije; preporučljivo uz pomoć štrcaljke volumena 2 do 3 ml i igle debljine 21 gauge.
English: The pack should be discarded if left out of the refrigerator for more than 7 days.
Croatian: Lijek treba baciti ako je bio izvan hladnjaka dulje od 7 dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (MULTIPACK ONLY WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (SAMO VIŠESTRUKO PAKIRANJE BEZ PLAVOG OKVIRA)
English: The Nucala pre-filled pen or pre-filled syringe should be used for subcutaneous injection only.
Croatian: Lijek Nucala u napunjenoj brizgalici ili napunjenoj štrcaljki smije se primijeniti samo supkutanom injekcijom.
English: Nucala is available in a pack containing 1 vial, or in multipacks with 3 individual vials.
Croatian: Nucala je dostupna u pakiranju koje sadrži 1 bočicu ili višestrukom pakiranju s 3 pojedinačne bočice.
English: • Dispose of the used syringe and needle cap according to local requirements.
Croatian: • Zbrinite upotrijebljenu brizgalicu i zatvarač igle sukladno lokalnim propisima.
English: The recommended dose for adults and adolescents aged 12 years and older is 100 mg. You will have 1 injection every four weeks.
Croatian: Preporučena doza za odrasle i adolescente u dobi od 12 i više godina je 100 mg.
English: A caregiver can also inject Nucala into the upper arm.
Croatian: Njegovatelj može injicirati lijek Nucala i u nadlakticu.
English: Nucala is available in a pack containing 1 pre-filled pen, or in a multipack comprised of 3 x 1 pre-filled pen.
Croatian: Nucala je dostupna u pakiranju koje sadrži 1 napunjenu brizgalicu ili u višestrukom pakiranju koje sadrži 3 pakiranja s 1 napunjenom brizgalicom.
English: Nucala should be prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma.
Croatian: 4.2 Doziranje i način primjene Lijek Nucala moraju propisati liječnici s iskustvom u dijagnosticiranju i liječenju teške refraktorne eozinofilne astme.
English: Inspection window
Croatian: Prozorčić za
English: Exacerbation rate per year Mepolizumab vs. placebo Rate ratio (95% CI)
Croatian: Stopa egzacerbacija na godinu Mepolizumab naspram placeba Omjer stopa (95% CI)
English: Safely, throw the pre-filled syringe away if it has been kept out of the refrigerator for more than 7 days.
Croatian: Oprezno, bacite napunjenu štrcaljku ako je bila izvan hladnjaka dulje od 7 dana.
English: • Nucala pre-filled pen
Croatian: • Nucala napunjena brizgalica
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Croatian: Drugi sastojci su saharoza, natrijev hidrogenfosfat heptahidrat, citratna kiselina hidrat, polisorbat 80, dinatrijev edetat dihidrat, voda za injekcije.
English: Safely, throw the pen away if it has been kept out of the refrigerator for more than 7 days.
Croatian: Oprezno, bacite brizgalicu ako je bila izvan hladnjaka dulje od 7 dana.
English: Primary endpoint Frequency of clinically significant exacerbations
Croatian: Učestalost klinički značajnih egzacerbacija
English: Nucala is available in a pack containing 1 pre-filled syringe or in multipacks comprised of 3 x 1 pre-filled syringes.
Croatian: Nucala je dostupna u pakiranju koje sadrži 1 napunjenu štrcaljku ili u višestrukom pakiranju koje sadrži 3 pakiranja s 1 napunjenom štrcaljkom.
English: Time out of refrigeration should not exceed a maximum of 7 days when protected from light and stored below 30°C.
Croatian: Štrcaljka se smije čuvati izvan hladnjaka najviše 7 dana ako je zaštićena od svjetlosti i ako se čuva na temperaturi ispod 30°C.
English: The Nucala pre-filled syringe can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30°C), when protected from light.
Croatian: Nucala napunjena brizgalica može se izvaditi iz hladnjaka i čuvati u neotvorenoj kutiji do 7 dana na sobnoj temperaturi (do 30°C), ako je zaštićena od svjetlosti.
English: Asthma exacerabations
Croatian: Egzacerbacije astme
English: Nucala 100 mg solution for injection in pre-filled syringe Each 1 ml pre-filled syringe contains 100 mg of mepolizumab.
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka od 1 ml sadrži 100 mg mepolizumaba.
English: Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled syringe.
Croatian: Nucala dolazi u obliku 1 ml bistre do opalescentne, bezbojne do blijedožute ili blijedosmeđe otopine u napunjenoj štrcaljki za jednokratnu uporabu.
English: Exacerbations rate per year Percent reduction Rate ratio (95% CI) p-value
Croatian: Stopa egzacerbacija na godinu Postotak smanjenja Omjer stopa (95% CI) p-vrijednost
English: Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet.
Croatian: Cjelovite upute za supkutanu primjenu lijeka Nucala u napunjenoj brizgalici ili napunjenoj štrcaljki navedene su na kraju upute o lijeku.
English: This magnitude of blood eosinophils reduction was maintained in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies.
Croatian: Taj se opseg smanjenja razine eozinofila u krvi održao u bolesnika s teškom refraktornom eozinofilnom astmom (n=998) liječenih tijekom medijana od 2,8 godina (raspon od 4 tjedna do
English: Excipients
Croatian: Zaustavnik
English: Solution for injection (injection) A clear to opalescent, colourless to pale yellow to pale brown solution
Croatian: Otopina za injekciju (injekcija) Bistra do opalescentna, bezbojna do blijedožuta ili blijedosmeđa otopina.
English: Solution for injection in pre-filled pen Multipack: 3 pre-filled pens (3 packs of 1 pre-filled pen).
Croatian: Otopina za injekciju u napunjenoj brizgalici Višestruko pakiranje: 3 napunjene brizgalice (3 pakiranja od 1 napunjene brizgalice).
English: Dispose 9.
Croatian: Zbrinite štrcaljku 9.
English: • Peel back the film cover from the tray.
Croatian: • Skinite pokrovni film s podloška.
English: Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled pen.
Croatian: Nucala dolazi u obliku 1 ml bistre do opalescentne, bezbojne do blijedožute ili blijedosmeđe otopine u napunjenoj brizgalici za jednokratnu uporabu.
English: - Check that the inspection window is filled with the yellow indicator.
Croatian: • Ako ne čujete drugi 'klik': - Provjerite je li žuti indikator ispunio prozorčić za provjeru.
English: Excipients: Sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80
Croatian: Pomoćne tvari: saharoza, natrijev hidrogenfosfat heptahidrat i polisorbat 80
English: • Remove the clear needle cap from the pen by firmly pulling it straight off.
Croatian: • Skinite prozirni zatvarač igle tako da ga snažno povučete ravno s brizgalice.
English: n
Croatian: A.
English: Solution for injection in pre-filled pen.
Croatian: Otopina za injekciju u napunjenoj brizgalici.
English: Inject yourself in thighs or abdomen
Croatian: Injicirajte lijek u bedro ili trbuh
English: • Holding the middle of the pen, carefully take it out of the tray.
Croatian: • Pažljivo izvadite brizgalicu iz podloška držeći je za središnji dio.
English: Make sure you have within reach:
Croatian: Pobrinite se da Vam nadohvat ruke budu:
English: Nucala 100 mg powder for solution for injection
Croatian: Nucala 100 mg prašak za otopinu za injekciju
English: If a dose of Nucala is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Croatian: Javite se svom liječniku ili bolnici što je prije moguće kako biste dogovorili novi termin.
English: Do not put the needle cap back onto the syringe.
Croatian: Nemojte vraćati zatvarač igle na štrcaljku da se ne biste ozlijedili iglom.
English: Rate ratio (95% CI) p-value
Croatian: Omjer stopa (95% CI) p-vrijednost
English: Nucala pre-filled pen is for use under the skin only (subcutaneous).
Croatian: Nucala napunjena brizgalica namijenjena je samo za primjenu pod kožu (supkutano).
English: If necessary, the Nucala pre-filled pen and pre-filled syringe can be removed from the refrigerator and kept in the unopened pack for up to 7 days at room temperature (up to 30°C), when protected from light.
Croatian: Lijek Nucala u napunjenoj brizgalici i napunjenoj štrcaljki može se po potrebi izvaditi iz hladnjaka i čuvati u neotvorenom pakiranju do 7 dana na sobnoj temperaturi (do 30°C), ako je zaštićen od svjetlosti.
English: • If someone else gives you the injection, they can also use your upper arm. Do not inject where your skin is bruised, tender, red or hard.
Croatian: Nemojte injicirati u područja na kojima je koža prekrivena modricama, osjetljiva na dodir, crvena ili tvrda.
English: Do not stop injections of Nucala unless your doctor advises you to. Interrupting or stopping the treatment with Nucala may cause your asthma symptoms and attacks to come back.
Croatian: Privremeni ili trajni prekid liječenja lijekom Nucala može uzrokovati ponovnu pojavu simptoma i napadaja astme.
English: • chest tightness, cough, difficulty breathing
Croatian: Simptomi mogu uključivati: • stezanje u prsnom košu, kašalj, otežano disanje
English: After reconstitution, each ml of solution contains 100 mg mepolizumab.
Croatian: Nakon rekonstitucije, jedan mililitar otopine sadrži 100 mg mepolizumaba.
English: This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
Croatian: • Polagano podignite palac kako bi se klip vratio natrag, a igla uvukla u tijelo štrcaljke.
English: Step-by-step instructions for use
Croatian: 15. UPUTE ZA UPORABU
English: 1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj brizgalici 1 ml otopine u staklenoj štrcaljki (staklo tipa I) s pričvršćenom iglom (nehrđajući čelik) koja je uložena u napunjenu brizgalicu.
English: Nucala 100 mg powder for solution for injection mepolizumab
Croatian: Nucala 100 mg prašak za otopinu za injekciju mepolizumab
English: Take out your pre-filled syringe
Croatian: Izvadite napunjenu štrcaljku
English: Nucala 100 mg solution for injection in pre-filled pen Nucala 100 mg solution for injection in pre-filled syringe
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj brizgalici Nucala 100 mg otopina za injekciju u napunjenoj štrcaljki
English: The liquid should be clear to opalescent, colourless to pale yellow to pale brown.
Croatian: Otopina mora biti bistra do opalescentna, bezbojna do blijedožuta ili blijedosmeđa.
English: Sodium phosphate dibasic heptahydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari saharoza natrijev hidrogenfosfat heptahidrat polisorbat 80
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (INDIVIDUAL PACKS INCLUDING BLUE BOX)
Croatian: KUTIJA (POJEDINAČNA PAKIRANJA UKLJUČUJUĆI PLAVI OKVIR)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL FOR PRE-FILLED PEN MULTIPACK (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA ZA VIŠESTRUKO PAKIRANJE NAPUNJENIH BRIZGALICA (S PLAVIM OKVIROM)
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kongestija nosa često
English: PARTICULARS TO APPEAR ON OUTER PACKAGING MULTIPACK CARTON (3 PACKS OF 1 VIAL - WITH BLUE BOX)
Croatian: KUTIJA VIŠESTRUKOG PAKIRANJA (3 PAKIRANJA OD 1 BOČICE - S PLAVIM
English: Take out your pre-filled pen
Croatian: Izvadite napunjenu brizgalicu
English: Powder for solution for injection 1vial
Croatian: Prašak za otopinu za injekciju
English: • If necessary, the pre-filled syringe may be kept at room temperature, up to 30°C, for no more than
Croatian: • Napunjena brizgalica može se po potrebi čuvati na sobnoj temperaturi, do 30°C, tijekom najviše 7 dana ako se čuva u originalnoj kutiji.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - NAPUNJENA BRIZGALICA
English: Do not touch the yellow needle guard with your fingers.
Croatian: Nemojte prstima dodirivati žuti štitnik igle kako ne biste prerano aktivirali brizgalicu i ozlijedili se iglom.
English: If you may have had a similar reaction to any injection or medicine: Tell your doctor before you or your child are given Nucala.
Croatian: Ako ste možda imali sličnu reakciju na bilo koju injekciju ili lijek: obavijestite o tome svog liječnika prije nego što primite lijek Nucala.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING INTERMEDIATE CARTON - PRE-FILLED SYRINGE MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA MEĐUPAKIRANJU UNUTARNJA KUTIJA - VIŠESTRUKO PAKIRANJE NAPUNJENIH ŠTRCALJKI (BEZ PLAVOG OKVIRA)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - NAPUNJENA ŠTRCALJKA
English: Multipack comprising 3 (3 packs of 1) vials
Croatian: Višestruko pakiranje koje sadrži 3 (3 pakiranja od 1) bočice
English: Mean Change from Baseline (SE) Difference (mepolizumab vs. placebo) 95% CI p-value
Croatian: Razlika (mepolizumab naspram placeba) 95% CI p-vrijednost
English: The recommended dose for adults and adolescents is 100 mg. You will be given 1 injection every four weeks.
Croatian: Preporučena doza za odrasle i adolescente je 100 mg.
English: Remove the needle cap
Croatian: Skinite zatvarač igle
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - FOR PRE-FILLED SYRINGE MULTIPACK (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA - VIŠESTRUKO PAKIRANJE NAPUNJENIH ŠTRCALJKI (S PLAVIM OKVIROM)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE ŠTRCALJKE
English: Rare side effects
Croatian: Sekundarne mjere ishoda
English: Know your pre-filled pen
Croatian: Upoznajte se sa svojom napunjenom brizgalicom
English: GlaxoSmithKline Trading Services Ltd. Currabinny
Croatian: GlaxoSmithKline Trading Services Ltd.
English: Do not stop receiving injections of Nucala unless your doctor advises you to. Interrupting or stopping the treatment with Nucala may cause your asthma symptoms and attacks to come back.
Croatian: Prestanak liječenja lijekom Nucala Nemojte prestati s primjenom lijeka Nucala osim ako Vam to ne preporuči Vaš liječnik.
English: Reduction of exacerbation rate by baseline blood eosinophil count
Croatian: Smanjenje stope egzacerbacija prema početnoj vrijednosti eozinofila u krvi
English: Remove the clear needle cap
Croatian: Skinite prozirni zatvarač igle
English: What you need to know before you use Nucala Do not use Nucala:
Croatian: Što je Nucala i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Nucala Kako primjenjivati lijek Nucala
English: Each vial contains 100 mg mepolizumab.
Croatian: Jedna bočica sadrži 100 mg mepolizumaba.
English: Multipack comprising 3 (3 packs of 1) pre-filled pens
Croatian: 1 napunjena brizgalica Višestruko pakiranje koje sadrži 3 (3 pakiranja od 1) napunjene brizgalice
English: GlaxoSmithKline, s.r.o.
Croatian: GlaxoSmithKline S.p.A.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING INTERMEDIATE CARTON - PRE-FILLED PEN MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA MEĐUPAKIRANJU UNUTARNJA KUTIJA - VIŠESTRUKO PAKIRANJE NAPUNJENIH BRIZGALICA (BEZ PLAVOG OKVIRA)
English: Package leaflet: Information for the user Nucala 100 mg powder for solution for injection mepolizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Nucala 100 mg prašak za otopinu za injekciju mepolizumab
English: Nucala 100 mg solution for injection in pre-filled syringe mepolizumab
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj brizgalici mepolizumab
English: Multipack: 3 pre-filled syringes (3 packs of 1 pre-filled syringe).
Croatian: Otopina za injekciju u napunjenoj štrcaljki Višestruko pakiranje: 3 napunjene štrcaljke (3 pakiranja od 1 napunjene štrcaljke).
English: No impairment of fertility was observed in a fertility and general reproduction toxicity study in mice performed with an analogous antibody that inhibits IL-5 in mice.
Croatian: Nije opažen poremećaj plodnosti u ispitivanju plodnosti i opće reproduktivne toksičnosti u miševa,
English: Exp: Month-Year
Croatian: Stopa egzacerbacija/godina
English: Know your pre-filled syringe
Croatian: Upoznajte se sa svojom napunjenom štrcaljkom
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Croatian: GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 (0) 10 85 52 00
English: respectively.
Croatian: Supkutano.
English: Exacerbation rate per year
Croatian: Postotak smanjenja
English: Package leaflet: Information for the user Nucala 100 mg solution for injection in pre-filled syringe mepolizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Nucala 100 mg otopina za injekciju u napunjenoj štrcaljki mepolizumab
English: Stopper
Croatian: Priprema
English: Package leaflet: Information for the user Nucala 100 mg solution for injection in pre-filled pen mepolizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Nucala 100 mg otopina za injekciju u napunjenoj brizgalici mepolizumab
English: Store syringe in the original carton in order to protect from light.
Croatian: Štrcaljku čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Inject 6.
Croatian: Injicirajte lijek 6. Skinite prozirni zatvarač igle
English: Nucala 100 mg solution for injection in pre-filled syringe
Croatian: Nucala 100 mg otopina za injekciju u napunjenoj štrcaljki mepolizumab
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Srednja vrijednost promjene od početne vrijednosti (SE)
English: Each 1 mL pre-filled syringe contains 100 mg of mepolizumab.
Croatian: Jedna napunjena štrcaljka od 1 ml sadrži 100 mg mepolizumaba.
English: Step by step instructions for using the pre-filled pen
Croatian: Upute za uporabu napunjene brizgalice korak po korak
English: Each 1 ml pre-filled syringe contains 100 mg mepolizumab.
Croatian: Jedna napunjena brizgalica od 1 ml sadrži 100 mg mepolizumaba.
English: Do not use if the expiry date has passed.
Croatian: Nemojte upotrijebiti štrcaljku ako joj je istekao rok valjanosti.
English: Sodium phosphate dibasic heptahydrate Citric acid monohydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari saharoza natrijev hidrogenfosfat heptahidrat citratna kiselina hidrat polisorbat 80 dinatrijev edetat dihidrat voda za injekcije
English: PC: SN: NN:
Croatian: Exp: mj. - god.
English: {text}
Croatian: {tekst}
English: Annex <III> <IV>
Croatian: Prilog <III.> <IV.>
English: Timetable for the implementation of this position
Croatian: Raspored provedbe ovog stajališta
English: Adoption of CMDh position: {Month Year} CMDh meeting
Croatian: Usvajanje stajališta CMDh-a: Sastanak CMDh-a u {mjesec godina}
English: <Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)>
Croatian: <Izmjene koje treba unijeti u odgovarajuće dijelove informacija o lijeku (novi tekst je podcrtan i podebljan, obrisani tekst je precrtan)>
English: Amendments to the product information of the nationally authorised medicinal product(s)
Croatian: Izmjene informacija o lijeku nacionalno odobrenog(ih) lijeka(ova)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {active substance(s) as EURD list entry}, the scientific conclusions are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za {djelatna(e) tvar(i) prema EURD popisu}, znanstveni zaključci su sljedeći:
English: On the basis of the scientific conclusions for {active substance(s) as EURD list entry} the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing {active substance(s) as EURD list entry} is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za {djelatna(e) tvar(i) prema EURD popisu}, CMDh smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) {djelatna(e) tvar(i) prema EURD popisu} nepromijenjen, uz predložene izmjene informacija o lijeku.
English: <Annex III>
Croatian: <Prilog III.>
English: The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied.
Croatian: Stajalište je CMDh-a da je potrebna izmjena odobrenja za stavljanje lijeka u promet za lijekove u sklopu ove jedinstvene ocjene PSUR-a.
English: Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder): {DD/MM/YYYY}
Croatian: Provedba stajališta u državama članicama (nositelj odobrenja za stavljanje lijeka u promet predaje izmjenu): {DD/MM/GGGG}
English: Transmission to National Competent Authorities of the translations of the annexes to the position: {DD/MM/YYYY}
Croatian: Dostava prijevoda priloga stajalištu nadležnim nacionalnim tijelima: {DD/MM/GGGG}
English: To the extent that additional medicinal products containing {active substance(s) as EURD list entry} are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that the concerned Member States and applicant/marketing authorisation holders take due consideration of this CMDh position.
Croatian: CMDh je preporučio da države članice i podnositelji zahtjeva/nositelji odobrenja za stavljanje lijeka u promet na koje se to odnosi, uzmu u obzir ovo stajalište CMDh-a za dodatne lijekove koji sadrže {djelatna(e) tvar(i) prema EURD popisu} trenutno odobrene u EU-u ili koji će biti predmetom budućeg postupka odobravanja u EU-u.
English: <Summary of Product Characteristics>
Croatian: <Sažetak opisa svojstava lijeka>