FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy results against HZ and PHN observed in the modified Total Vaccinated Cohort (mTVC), i.e. excluding adults who did not receive the second dose of vaccine or who had a confirmed diagnosis of HZ within one month after the second dose, are presented in Table 1 and Table 2, respectively.
Croatian: U Tablici 1 i Tablici 2 navode se rezultati za djelotvornost protiv HZ-a i PHN-a opaženi u modificiranoj kohorti svih cijepljenih ispitanika (engl. modified Total Vaccinated Cohort, mTVC), u koju nisu bile uključene odrasle osobe koje nisu primile drugu dozu cjepiva ili koje su imale potvrđenu dijagnozu HZ-a unutar mjesec dana nakon primjene druge doze.
English: Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ni neizravne učinke na plodnost mužjaka ili ženki
English: Table 3: Humoral immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Croatian: Tablica 3: Humoralna imunogenost cjepiva Shingrix u odraslih osoba u dobi od ≥ 50 godina
English: Median frequency (Q1; Q3)
Croatian: (Q1; Q3)
English: Belgium
Croatian: BELGIJA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1272/001 - 1 vial and 1 vial EU/1/18/1272/002 - 10 vials and 10 vials
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1272/001 - 1 bočica i 1 bočica
English: 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms 3 glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology
Croatian: 50 mikrograma 3-O-dezacil-4'-monofosforil lipid A (MPL) iz bakterije Salmonella minnesota 50 mikrograma
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava manje često limfadenopatija
English: The studies were not designed to demonstrate efficacy in subgroups of frail individuals, including those with multiple comorbidities, although these subjects were not excluded from the studies.
Croatian: uključujući one s većim brojem popratnih bolesti, iako ti ispitanici nisu bili isključeni iz ispitivanja.
English: CONDITIONS OR RESTRICTIONS REGARDING SYPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: In the fourth year after vaccination, the efficacy against HZ was 93.1 % (95% CI: 81.2; 98.2) and 87.9% (95% CI: 73.3; 95.4) in adults ≥ 50 years and adults ≥ 70 years, respectively.
Croatian: U četvrtoj godini nakon cijepljenja djelotvornost protiv HZ-a iznosila je 93,1% (95% CI: 81,2; 98,2) u odraslih osoba u dobi od ≥ 50 godina te 87,9% (95% CI: 73,3; 95,4) u odraslih osoba u dobi od ≥ 70 godina.
English: ≥70 years, especially for general adverse reactions such as myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms.
Croatian: Incidencija nuspojava bila je viša u ispitanika u dobi od 50 do 69 godina u usporedbi s onima u dobi od ≥ 70 godina, osobito za opće nuspojave poput mialgije, umora, glavobolje, drhtanja, vrućice i gastrointestinalnih simptoma.
English: A further reduction of PHN incidence in subjects with confirmed HZ could not be demonstrated due to the limited number of HZ cases in the vaccine group.
Croatian: Zbog ograničenog broja slučajeva HZ-a u skupini koja je primila cjepivo nije se moglo dokazati dodatno smanjenje incidencije PHN-a u ispitanika s potvrđenim HZ-om.
English: If either is observed, do not administer the vaccine.
Croatian: Ako se primijeti bilo što od toga, cjepivo se ne smije primijeniti.
English: Shingrix must be reconstituted prior to administration.
Croatian: Kako pripremiti cjepivo Shingrix: Shingrix se prije primjene mora rekonstituirati.
English: • stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain)
Croatian: • želučane i probavne tegobe (uključujući mučninu, povraćanje, proljev i/ili bol u trbuhu) • bol u mišićima (mialgija)
English: (≥1/10,000 to <1/1,000)
Croatian: često (≥ 1/100 i < 1/10) manje često (≥ 1/1000 i < 1/100) rijetko (≥ 1/10 000 i < 1/1000) vrlo rijetko (< 1/10 000)
English: NAME OF THE MEDICINAL PRODUCT Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Croatian: Uputa o lijeku: Informacije za korisnika Shingrix prašak i suspenzija za suspenziju za injekciju Cjepivo protiv herpes zostera (rekombinantno, adjuvantirano)
English: * PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI) CI Confidence interval ** Over a median follow-up period of 4.1 years *** Over a median follow-up period of 4.0 years
Croatian: * PHN se definirao kao bol povezana s herpesom zosterom koja ne prolazi ili koja se javila više od 90 dana nakon nastupa osipa uzrokovanog herpesom zosterom, a ocijenjena je s ≥ 3 boda (na ljestvici od 0 do 10) u kratkom upitniku o boli kod herpes zostera (engl.
English: Very common (these may occur with more than 1 in 10 doses of the vaccine):
Croatian: Vrlo često (mogu se javiti kod više od 1 na 10 doza cjepiva): • glavobolja
English: Subjects with a history of HZ were excluded from ZOE-50 and ZOE-70.
Croatian: Ispitanici s HZ-om u anamnezi nisu bili uključeni u ispitivanja ZOE-50 i ZOE-70.
English: Shingrix significantly decreased the incidence of HZ compared with placebo in subjects ≥ 50 years (6
Croatian: Shingrix je značajno snizio incidenciju PHN-a u odnosu na placebo u odraslih osoba u dobi od
English: What Shingrix is used for
Croatian: Za što se Shingrix koristi
English: Immunogenicity in individuals previously vaccinated with live attenuated herpes zoster (HZ) vaccine In a phase III, open-label, multicentre clinical study (Zoster-048), a 2 dose schedule of Shingrix 2 months apart was assessed in 215 adults ≥ 65 years of age with a previous history of vaccination with live attenuated HZ vaccine ≥ 5 years earlier compared to 215 matched subjects who had never received live attenuated HZ vaccine.
Croatian: U otvorenom, multicentričnom kliničkom ispitivanju faze III (Zoster-048), shema cijepljenja s 2 doze cjepiva Shingrix u razmaku od 2 mjeseca bila je ispitivana u 215 odraslih osoba u dobi od ≥ 65 godina koji su prethodno cijepljeni živim atenuiranim HZ cjepivom prije 5 ili više godina u usporedbi s 215 ispitanika u usklađenoj kontrolnoj skupini koji nisu nikad ranije cijepljeni živim atenuiranim HZ cjepivom.
English: Excipients: sucrose polysorbate 80 sodium dihydrogen phosphate dihydrate dipotassium phosphate dioleoyl phosphatidylcholine cholesterol sodium chloride disodium phosphate anhydrous potassium dihydrogen phosphate water for injections
Croatian: saharoza polisorbat 80 natrijev dihidrogenfosfat dihidrat kalijev hidrogenfosfat dioleoilfosfatidilkolin kolesterol natrijev klorid natrijev hidrogenfosfat, bezvodni kalijev dihidrogenfosfat voda za injekcije
English: The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
Croatian: Rekonstituirano cjepivo je opalescentna, bezbojna do blijedosmećkasta tekućina.
English: vs. 210 cases in ZOE-50) and in subjects ≥ 70 years (25 vs. 284 cases in the pooled analysis of ZOE50 and ZOE-70).
Croatian: ≥ 50 godina (0 naspram 18 slučajeva u ispitivanju ZOE-50) i onih u dobi od ≥ 70 godina (4 naspram 36 slučajeva u analizi objedinjenih podataka iz ispitivanja ZOE-50 i ZOE-70).
English: Immunogenicity of Shingrix
Croatian: Imunogenost cjepiva Shingrix
English: Shingrix elicited higher gE-specific immune responses (humoral and CMI) at 1 month post-dose 2 when compared to pre-vaccination levels.
Croatian: Mjesec dana nakon primjene druge doze cjepiva Shingrix imunosni odgovori (humoralna i stanično posredovana imunost) specifični za gE bili su viši u usporedbi s razinama prije cijepljenja.
English: Approximately 13,000 subjects with underlying medical conditions, including conditions associated with a higher risk of HZ, were enrolled in ZOE-50 and ZOE-70.
Croatian: U ispitivanja ZOE-50 i ZOE-70 bilo je uključeno približno 13 000 ispitanika s podležećim medicinskim stanjima, uključujući stanja povezana s višim rizikom od HZ-a.
English: In the pooled analysis of ZOE-50 and ZOE70, Shingrix significantly reduced these HZ-related complications by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults ≥ 50 years (1 vs. 16 cases) and adults ≥ 70 years (1 vs. 12 cases), respectively.
Croatian: Shingrix je značajno snizio stopu tih komplikacija povezanih s HZ-om za 93,7% (95% CI: 59,5; 99,9) u odraslih osoba u dobi od ≥ 50 godina (1 naspram 16 slučajeva) te 91,6% (95% CI: 43,3; 99,8) u odraslih osoba u dobi od ≥ 70 godina (1 naspram 12 slučajeva).
English: Confidence interval GMC Geometric Mean Concentration Q1; Q3 First and third quartiles
Croatian: N Broj ocjenjivih ispitanika u određenoj vremenskoj točki Q1; Q3 prvi i treći kvartil
English: Subjects with a history of HZ prior to vaccination
Croatian: Ispitanici koji su prije cijepljenja imali HZ u anamnezi
English: Shingrix significantly decreased the incidence of PHN compared with placebo in adults ≥ 50 years (0 vs. 18 cases in ZOE-50) and in adults ≥ 70 years (4 vs. 36 cases in the pooled analysis of ZOE-50 and
Croatian: Shingrix je značajno snizio incidenciju HZ-a u odnosu na placebo u ispitanika u dobi od ≥ 50 godina (6 naspram 210 slučajeva u ispitivanju ZOE-50) i onih u dobi od ≥ 70 godina (25 naspram 284 slučaja u analizi objedinjenih podataka iz ispitivanja ZOE-50 i ZOE-70).
English: Shingrix (N=7,695) or placebo (N=7,710) administered 2 months apart, - ZOE-70 (Zoster-022): 13,900 adults ≥ 70 years were randomised to receive two doses of either Shingrix (N=6,950) or placebo (N=6,950) administered 2 months apart.
Croatian: Provedena su dva placebom kontrolirana ispitivanja djelotvornosti cjepiva Shingrix faze III, zaslijepljena za ispitivača: - ZOE-50 (Zoster-006): 15 405 odraslih osoba u dobi od ≥ 50 godina bilo je randomizirano za primanje dvije doze cjepiva Shingrix (N=7695) ili placeba (N=7710), primijenjene u razmaku od 2 mjeseca - ZOE-70 (Zoster-022): 13 900 odraslih osoba u dobi od ≥ 70 godina bilo je randomizirano za primanje dvije doze cjepiva Shingrix (N=6950) ili placeba (N=6950), primijenjene u razmaku od 2 mjeseca Ispitivanja nisu bila dizajnirana tako da pokažu djelotvornost u podskupinama onemoćalih osoba,
English: Median fold increase of concentrations vs. prevaccination (Q1; Q3)
Croatian: Medijan faktora povećanja koncentracije u odnosu na onu prije cijepljenja (Q1; Q3)
English: • The suspension is an opalescent, colourless to pale brownish liquid.
Croatian: • Suspenzija je opalescentna, bezbojna do blijedosmećkasta tekućina.
English: Store in a refrigerator (2°C - 8°C).
Croatian: (2°C - 8°C).
English: N Number of evaluable subjects at the specified time point Q1; Q3 First and third quartiles *** The gE-specific CD4[2+] data in the ≥70 years of age group were generated in ZOE-50 because CD4+ T
Croatian: *** Podaci za CD4[2+] T-stanice specifične za gE u dobnoj skupini ≥ 70 godina dobiveni su u ispitivanju ZOE-50 jer se aktivnost CD4+ T-stanica nije ocjenjivala u ispitivanju ZOE-70
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH POWDER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji cjepiva prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
English: The immune responses of the co-administered vaccines were unaffected, with the exception of lower geometric mean concentrations (GMCs) for one of the pertussis antigens (pertactin) when Shingrix is co-administered with the dTpa vaccine.
Croatian: Geometric Mean Concentration) za jedan od antigena pertusisa (pertaktin) pri istodobnoj primjeni cjepiva Shingrix s dTpa cjepivom.
English: Efficacy of Shingrix
Croatian: Djelotvornost cjepiva Shingrix
English: Number of evaluable subjects
Croatian: Broj ispitanika koje se moglo ocijeniti
English: A different injection site will be used for each vaccine.
Croatian: Svako od tih cjepiva primijenit će se na drugom mjestu.
English: ZOE-70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group.
Croatian: Podaci za ispitanike u dobi od ≥ 70 godina proizlaze iz unaprijed specificiranih analiza objedinjenih podataka iz ispitivanja ZOE-50 i ZOE-70 (mTVC) jer te analize daju najrobusnije procjene djelotvornosti cjepiva u navedenoj dobnoj skupini.
English: Uncommon (these may occur with up to 1 in 100 doses of vaccine)
Croatian: Manje često (mogu se javiti kod do 1 na 100 doza cjepiva):
English: The suspension is an opalescent, colourless to pale brownish liquid.
Croatian: Suspenzija je opalescentna, bezbojna do blijedosmećkasta tekućina.
English: Shingrix significantly reduced the maximum worst pain score versus placebo over the entire HZ episode (mean = 5.7 vs. 7.0, P-value = 0.032).
Croatian: (objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70) značajno smanjio najveći rezultat za najgoru bol naspram placeba tijekom cijele epizode HZ-a (srednja vrijednost = 5,7 naspram 7,0; p-vrijednost = 0,032).
English: Very common injection site reactions (such as pain, redness, swelling), fatigue, chills, fever
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često reakcije na mjestu injiciranja (poput boli, crvenila, oticanja), umor, zimica,
English: 1 vial: suspension (adjuvant)
Croatian: 1 bočica: prašak (antigen) 1 bočica: suspenzija (adjuvans)
English: Common injection site pruritus, malaise
Croatian: vrućica često pruritus na mjestu injiciranja, malaksalost
English: Number of HZ cases
Croatian: Broj slučajeva
English: Prior to immunisation
Croatian: Prije cijepljenja
English: Overall there was a general trend towards less severe HZ-related pain in subjects vaccinated with Shingrix compared to placebo.
Croatian: Učinak cjepiva Shingrix na bol povezanu s HZ-om Sveukupno je u ispitanika cijepljenih cjepivom Shingrix primijećen opći trend prema manjoj težini boli povezane s HZ-om nego u onih koji su primili placebo.
English: Median fold increase of frequency vs. prevaccination (Q1; Q3)
Croatian: Medijan faktora povećanja učestalosti u odnosu na razdoblje prije cijepljenja (Q1; Q3)
English: Very rare
Croatian: Ukupno je
English: How Shingrix is given
Croatian: Kako se primjenjuje Shingrix
English: 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose;
Croatian: Najčešće prijavljene nuspojave bile su bol na mjestu injiciranja (ukupno po dozi: 68,1%; teške nuspojave po dozi: 3,8%), mialgija (ukupno po dozi: 32,9%; teške nuspojave po dozi: 2,9%), umor (ukupno po dozi: 32,2%; teške nuspojave po dozi: 3,0%) i glavobolja (ukupno po dozi: 26,3%; teške nuspojave po dozi: 1,9%).
English: • allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Croatian: • alergijske reakcije, uključujući osip, izdignut osip praćen svrbežom (koprivnjača), oticanje lica,
English: 4.7 Effects on ability to drive and use machines No studies on the effects of Shingrix on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka cjepiva Shingrix na sposobnost upravljanja vozilima i rada sa strojevima.
English: In subjects ≥ 70 years with at least one confirmed HZ episode (ZOE-50 and ZOE-70 pooled), Shingrix significantly reduced the use and the duration of HZ-related pain medication by 39.0% (95% CI: 11.9; 63.3) and 50.6% (95% CI: 8.8; 73.2), respectively.
Croatian: Shingrix je značajno smanjio uporabu analgetika i trajanje liječenja boli povezane s HZ-om za 39,0% (95% CI: 11,9; 63,3) odnosno 50,6% (95% CI: 8,8; 73,2).
English: Adjuvant
Croatian: Adjuvans
English: In a phase III, open-label clinical study (Zoster-026) where 238 adults ≥ 50 years of age were equally randomised to receive 2 doses of Shingrix 2 or 6 months apart, the humoral immune response following the 0, 6-month schedule was demonstrated to be non-inferior to the response with the 0, 2month schedule.
Croatian: ≥ 50 godina bilo ravnomjerno randomizirano za primanje 2 doze cjepiva Shingrix u razmaku od 2 ili 6 mjeseci, pokazalo se da je humoralni imunološki odgovor nakon cijepljenja prema rasporedu primjene u 0. i 6. mjesecu bio neinferioran odgovoru nakon cijepljenja prema rasporedu primjene u 0. i 2. mjesecu.
English: o Suspension: Dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate anhydrous, potassium dihydrogen phosphate and water for injections.
Croatian: o Prašak: saharoza, polisorbat 80, natrijev dihidrogenfosfat dihidrat, kalijev hidrogenfosfat o Suspenzija: dioleoilfosfatidilkolin, kolesterol, natrijev klorid, bezvodni natrijev hidrogenfosfat, kalijev dihidrogenfosfat i voda za injekcije
English: Talk to your doctor or pharmacist before you receive Shingrix if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primite Shingrix: • ako imate tešku infekciju praćenu visokom tjelesnom temperaturom (vrućicom).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: Table 4: Cell-mediated immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Croatian: ≥ 50 godina (ATP kohorta za imunogenost)
English: ZOE-70 pooled), respectively).
Croatian: ZOE-70 (humoralna imunost).
English: Pooled ZOE-50 and ZOE-70
Croatian: Objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70
English: Pooled ZOE-50 and ZOE-70**
Croatian: Objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70**
English: Pooled ZOE-50 and ZOE-70***
Croatian: Objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70***
English: o Powder: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate.
Croatian: Prašak (antigen gE): saharoza polisorbat 80 natrijev dihidrogenfosfat dihidrat kalijev hidrogenfosfat
English: The immune response to Shingrix was unaffected by prior vaccination with live attenuated HZ vaccine.
Croatian: Prethodno cijepljenje živim atenuiranim HZ cjepivom nije utjecalo na imunološki odgovor na Shingrix.
English: How to store Shingrix
Croatian: Moguće nuspojave Kako čuvati Shingrix
English: Common (these may occur with up to 1 in 10 doses of the vaccine):
Croatian: Često (mogu se javiti kod do 1 na 10 doza cjepiva): • svrbež na mjestu primjene injekcije (pruritus)
English: Musculoskeletal and connective tissue disorders
Croatian: parestezija i toničko-kloničke kretnje udova tijekom oporavka.
English: Data in subjects ≥ 70 years of age are sourced from the pre-specified pooled analyses of ZOE-50 and ZOE
Croatian: U ispitanika u dobi od ≥ 70 godina s najmanje jednom potvrđenom epizodom HZ-a (objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70)
English: Efficacy against Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) In two phase III, placebo-controlled, observer-blind efficacy studies of Shingrix:
Croatian: Djelotvornost protiv herpes zostera (HZ) i postherpetičke neuralgije (PHN)
English: Slovenija GlaxoSmithKline d.o.o.
Croatian: GlaxoSmithKline Biologicals s.a.
English: Sodium chloride
Croatian: BOČICA S PRAŠKOM
English: Number of PHN* cases
Croatian: PHN-a*
English: • muscle pain (myalgia)
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: • pain, redness and swelling where the injection is given
Croatian: • bol, crvenilo i oticanje na mjestu primjene injekcije • umor, zimica, vrućica
English: Tél/Tel: + 32 10 85 52 00
Croatian: Τηλ: + 357 22 39 70 00
English: Method of administration
Croatian: Medijan učestalosti
English: 1 Injection set = injection syringe + 2 injection needles + cleansing swab.
Croatian: 1 injekcijski set = štrcaljka za injekciju + 2 igle za injekciju + tupfer za čišćenje
English: Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Sastav (koncentracija)
English: Blister (PVC/PVdC/Alu) 100 x 1 capsules (unit dose)
Croatian: Blister (PVC/PVdC /Al) 100 x 1 kapsula (jedinična doza)
English: Blister (PVC/PVdC/Alu) 50 x 1 tablets
Croatian: Blister (PVC/PVdC /Al) 50 x 1 tableta (jedinična doza)
English: Further information on Feraccru can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Feraccru možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This overview was last updated in 03-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran: 03-2018.
English: The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach.
Croatian: Preporučena doza je jedna kapsula dvaput na dan, jedna ujutro i jedna navečer, natašte.
English: Treatment duration depends on the severity of the iron deficiency, but generally at least 12 weeks of treatment are required.
Croatian: Trajanje liječenja ovisi o razini manjka željeza, no uglavnom je potrebno liječenje u trajanju od najmanje 12 tjedana.
English: Feraccru is available as capsules (30 mg).
Croatian: Feraccru je dostupan u obliku kapsula (30 mg).
English: Feraccru received a marketing authorisation valid throughout the EU on 18 February 2016.
Croatian: Lijek Feraccru dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 18 veljače 2016.
English: In addition, around 65% of patients taking Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.
Croatian: Nadalje, u otprilike 65 % bolesnika koji su uzimali Feraccru dosegnuta je normalna razina hemoglobina u usporedbi s 10 % bolesnika koji su dobivali placebo.
English: Feraccru (ferric maltol) EMA/162888/2018
Croatian: Feraccru (željezov (III) maltolat) EMA/162888/2018
English: Severe side effects include abdominal pain, constipation and diarrhoea.
Croatian: Teške nuspojave uključuju abdominalnu bol, zatvor i proljev.
English: Other information about Feraccru
Croatian: Ostale informacije o lijeku Feraccru
English: What measures are being taken to ensure the safe and effective use of Feraccru?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Feraccru?
English: What is Feraccru and what is it used for?
Croatian: Što je Feraccru i za što se koristi?
English: Side effects reported with Feraccru are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Feraccru pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: For more information about using Feraccru, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Feraccru pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: When taken by mouth, it is absorbed by the cells of the gut; the iron is then released from the compound and transported and stored in the body, helping to restore normal levels in patients with iron deficiency.
Croatian: Kad se lijek uzima kroz usta, stanice crijeva ga apsorbiraju; željezo se zatim otpušta iz spoja i prenosi te pohranjuje u tijelu čime pomaže pri ponovnoj uspostavi normalnih razina u bolesnika s manjkom željeza.
English: The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity.
Croatian: Najčešće nuspojave lijeka Feraccru (mogu se javiti u više od 1 na 10 osoba) jesu simptomi koji utječu na crijeva poput abdominalne (trbušne) boli, flatulencije (puštanje vjetrova), zatvora, nelagode u trbuhu i napuhnutosti te proljeva; te su nuspojave uglavnom blagog do umjerenog intenziteta.