FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness.
Croatian: Kao i kod drugih cjepiva, primjenu cjepiva Shingrix treba odgoditi u osoba s teškom akutnom bolešću praćenom vrućicom.
English: Concomitant use with other vaccines is not recommended due to lack of data.
Croatian: Zbog nedostatka podataka ne preporučuje se istodobna primjena s drugim cjepivima.
English: How to store Shingrix • Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Shingrix • Cjepivo čuvajte izvan pogleda i dohvata djece.
English: • swollen glands in the neck, armpit or groin
Croatian: • otečene žlijezde u vratu, pazusima ili preponama
English: N GMC (mIU/ml) (95% CI)
Croatian: Geometrijska srednja vrijednost koncentracije (mIU/ml) (95% CI)
English: This facilitates the recruitment and activation of antigen presenting cells carrying gE-derived antigens in the draining lymph node, which in turn leads to the generation of gE-specific CD4+ T cells and antibodies.
Croatian: To pridonosi privlačenju i aktivaciji antigen-prezentirajućih stanica koje nose antigene dobivene od glikoproteina E (gE) u drenirajućem limfnom čvoru, što pak dovodi do nastanka CD4+ T-stanica i protutijela specifičnih za gE.
English: If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose.
Croatian: Ako je potrebna fleksibilnost u rasporedu primjene, druga se doza može primijeniti između 2 mjeseca i 6 mjeseci nakon prve doze.
English: The need for booster doses following the primary vaccination schedule has not been established (see section 5.1).
Croatian: Nije utvrđena potreba za dozama docjepljivanja nakon primarnog cijepljenja (vidjeti dio 5.1).
English: Side effects reported during clinical trials with Shingrix:
Croatian: Nuspojave prijavljene tijekom kliničkih ispitivanja s cjepivom Shingrix:
English: Adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years.
Croatian: U odraslih osoba u dobi od 50 do 69 godina može se javiti više nuspojava nego u onih u dobi od ≥ 70 godina.
English: • you have a bleeding problem or bruise easily.
Croatian: • ako imate tegoba s krvarenjem ili ste skloni nastanku modrica.
English: Rare hypersensitivity reactions including rash, urticaria, angioedema1
Croatian: Poremećaji imunološkog sustava rijetko reakcije preosjetljivosti, uključujući osip, urtikariju, angioedem1
English: By combining the VZV specific antigen (gE) with an adjuvant system (AS01B), Shingrix is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against VZV.
Croatian: Kombiniranjem antigena specifičnog za VZV (gE) i adjuvans sustava (AS01B), Shingrix je oblikovan tako da inducira odgovore stanične i humoralne imunosti specifične za taj antigen u osoba s otprije postojećom imunošću protiv VZV-a.
English: The median anti-gE antibody concentration was greater than 7-fold above the baseline pre-vaccination median concentration.
Croatian: Medijan koncentracije protutijela na gE bio je više od 7 puta veći od medijana početne koncentracije, prije cijepljenja.
English: • Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).
Croatian: • Suspenzija za 1 dozu u bočici (staklo tip I) s čepom (butilna guma).
English: There were 9 reports of suspected HZ in 6 subjects over a one-year follow up period.
Croatian: Tijekom jednogodišnjeg razdoblja praćenja prijavljeno je 9 slučajeva sumnje na HZ u 6 ispitanika.
English: 1Adverse reactions from spontaneous reporting Reporting of suspected adverse reactions
Croatian: 1 Nuspojave iz spontanog prijavljivanja
English: It is not known if Shingrix affects your ability to drive or use machines.
Croatian: Nije poznato utječe li Shingrix na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Anti-gE immune response^
Croatian: Imunološki odgovor protiv gE^
English: you may get pain which can last for months or years and may be severe.
Croatian: Nakon što mjehurići na nastali kod herpes zostera zacijele, može Vam se javiti bol koja može potrajati mjesecima ili godinama i koja može biti jaka.
English: The median duration of pain medication use was 32.0 and 44.0 days in the Shingrix and placebo group, respectively.
Croatian: Medijan trajanja primjene lijekova za liječenje boli iznosio je 32,0 dana u skupini koja je primila Shingrix te 44,0 dana u skupini koja je primila placebo.
English: Adverse reactions reported are listed according to the following frequency: Very common
Croatian: Prijavljene nuspojave navedene su prema sljedećim kategorijama učestalosti: vrlo često (≥ 1/10)
English: Other medicines and Shingrix
Croatian: Drugi lijekovi i Shingrix
English: Do not administer the vaccine intravascularly or intradermally.
Croatian: Cjepivo se ne smije primijeniti intravaskularno ni intradermalno.
English: There are no data from the use of Shingrix in pregnant women.
Croatian: Nema podataka o primjeni cjepiva Shingrix u trudnica.
English: Shingrix contains sodium and potassium
Croatian: Shingrix sadrži natrij i kalij
English: • Suspension for 1 dose in a vial
Croatian: • suspenzije za 1 dozu u bočici
English: The safety profile presented below is based on a pooled analysis of data generated in placebo controlled clinical studies on 5,887 adults 50-69 years of age and 8,758 adults ≥ 70 years of age.
Croatian: Sigurnosni profil prikazan u nastavku temelji se na analizi objedinjenih podataka prikupljenih u placebom kontroliranim kliničkim ispitivanjima provedenima u 5887 odraslih osoba u dobi od
English: gE-specific CD4[2+] T cell response^
Croatian: Odgovor CD4[2+] T-stanica specifičnih za gE^
English: BATCH NUMBER LOT
Croatian: 13. BROJ SERIJE LOT
English: If either is observed, do not reconstitute the vaccine.
Croatian: Ako se primijeti bilo što od toga, cjepivo se ne smije rekonstituirati.
English: The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease, and stroke.
Croatian: Ocjenjivale su se sljedeće komplikacije HZ-a: vaskulitis uzrokovan HZ-om, diseminirana bolest, očna bolest, neurološka bolest, visceralna bolest i moždani udar.
English: (See section 4.4)
Croatian: (vidjeti dio 5.3).
English: Antigen Adjuvant
Croatian: Antigen Adjuvans
English: 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms
Croatian: 1 virus varicella zoster 2 adjuvantirano s AS01B, koji sadrži: ekstrakt biljke Quillaja saponaria Molina, frakcija 21 (QS-21) 50 mikrograma 3-O-dezacil-4'-monofosforil lipid A (MPL) iz bakterije Salmonella minnesota 50 mikrograma
English: Shingrix is a vaccine that helps to protect adults against shingles (herpes zoster) and post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.
Croatian: Shingrix je cjepivo koje pomaže zaštititi odrasle osobe od herpes zostera i postherpetičke neuralgije (PHN), dugotrajne boli uzrokovane oštećenjem živaca koja se javlja nakon herpes zostera.
English: You may be more likely to experience fever and/or shivering when 23-valent pneumococcal polysaccharide vaccine is given at the same time as Shingrix.
Croatian: Veća je vjerojatnost da ćete doživjeti vrućicu i/ili drhtanje kada se 23-valentno polisaharidno cjepivo protiv pneumokoka primjenjuje istodobno sa cjepivom Shingrix.
English: ATP According-To-Protocol ^ gE-specific CD4[2+] T cell response = gE-specific CD4+ T cell activity, measured by intracellular cytokine staining (ICS) assay (CD4[2+] T cells = CD4+ T cells expressing at least 2 of 4 selected immune markers) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
Croatian: ^ Odgovor CD4[2+] T-stanica specifičnih za gE = aktivnost CD4+ T-stanica specifičnih za gE, izmjerena unutarstaničnim bojanjem citokina (engl. intracellular cytokine staining, ICS) (CD4[2+] T-stanice = CD4+ T-stanice koje eksprimiraju najmanje 2 od 4 odabrana biljega imunosti) * 3. mjesec = 1 mjesec nakon 2. doze ** 38. mjesec = 3 godine nakon 2 doze
English: METHOD OF ADMINISTRATION Mix with antigen
Croatian: Pomiješati s antigenom
English: • Powder for 1 dose in a vial
Croatian: • praška za 1 dozu u bočici
English: The humoral immunogenicity and CMI results are presented in Tables 3 and 4, respectively.
Croatian: Rezultati za humoralnu i stanično posredovanu imunost navedeni su u Tablici 3 odnosno Tablici 4.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Shingrix in one or more subsets of the paediatric population in prevention of Varicella Zoster Virus reactivation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja cjepiva Shingrix u jednoj ili više podskupina pedijatrijske populacije u sprječavanju reaktivacije virusa varicella zoster
English: Table 2: Shingrix efficacy against PHN
Croatian: Tablica 2: Djelotvornost cjepiva Shingrix protiv PHN-a
English: Shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.
Croatian: Shingrix dolazi u pakiranju koje sadrži 1 bočicu s praškom plus 1 bočicu sa suspenzijom ili u pakiranju koje sadrži 10 bočica s praškom plus 10 bočica sa suspenzijom.
English: • scars where the blisters have been.
Croatian: • ožiljci na mjestima gdje su bili mjehurići
English: The most common complication of shingles is:
Croatian: Najčešća komplikacija herpes zostera je:
English: Data from a phase II, open-label, single group, follow-up clinical study in adults ≥ 60 years (Zoster024) indicate that the vaccine-induced immune response (humoral and CMI) persists up to approximately 6 years following a 0, 2-month schedule (N= 119).
Croatian: Podaci iz otvorenog kliničkog ispitivanja faze II s jednom skupinom, provedenog radi praćenja odraslih ispitanika u dobi od ≥ 60 godina (Zoster-024) ukazuju na to da cjepivom induciran imunološki odgovor (humoralna i stanično posredovana imunost) traje do približno 6 godina nakon cijepljenja prema rasporedu primjene u 0. i 2. mjesecu (N=119).
English: An immunological correlate of protection has not been established; therefore the level of immune response that provides protection against HZ is unknown.
Croatian: Budući da nije utvrđen imunološki korelat zaštite, nije poznato koja razina imunološkog odgovora pruža zaštitu od herpes zostera.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Croatian: Kao i kod svakog cjepiva, zaštitni imunološki odgovor možda se neće postići u svih cijepljenih osoba.
English: • Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
Croatian: • Prašak za 1 dozu u bočici (staklo tip I) s čepom (butilna guma)
English: The immune responses to Shingrix were evaluated in a subset of subjects from the phase III efficacy studies ZOE-50 [humoral immunity and cell-mediated immunity (CMI)] and ZOE-70 (humoral immunity).
Croatian: Imunološki odgovori na cjepivo Shingrix ocjenjivali su se u podskupini ispitanika iz ispitivanja djelotvornosti, ispitivanja faze III ZOE-50 (humoralna imunost i stanično posredovana imunost) i
English: It is unknown whether Shingrix is excreted in human milk.
Croatian: Nije poznato izlučuje li se Shingrix u majčino mlijeko.
English: Fainting can occur before or after any needle injection.
Croatian: Prije ili nakon bilo koje injekcije iglom može doći do nesvjestice.
English: What Shingrix is and what it is used for
Croatian: Što je Shingrix i za što se koristi
English: After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of recombinant Varicella Zoster Virus glycoprotein E adjuvanted with AS01B
Croatian: Nakon rekonstitucije, 1 doza (0,5 ml) sadrži 50 mikrograma rekombinantnog glikoproteina E virusa varicella zoster adjuvantiranih s AS01B
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije cjepiva vidjeti u dijelu 6.3.
English: Add the entire contents of the syringe into the vial containing the powder.
Croatian: Dodajte sav sadržaj štrcaljke u bočicu s praškom.
English: Shingrix cannot be used as a treatment if you already have shingles or shingles-related complications.
Croatian: Shingrix se ne može koristiti za liječenje ako već imate herpes zoster ili s njime povezane komplikacije.
English: Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Croatian: Shingrix prašak i suspenzija za suspenziju za injekciju Cjepivo protiv herpes zostera (rekombinantno, adjuvantirano)
English: Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe.
Croatian: Izvucite sav sadržaj bočice s rekonstituiranim cjepivom u štrcaljku.
English: This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (39 mg) kalija po dozi, tj. zanemarive količine kalija.
English: In three phase III, controlled, open-label clinical studies, adults ≥ 50 years of age were randomised to receive 2 doses of Shingrix 2 months apart administered either concomitantly at the first dose or nonconcomitantly with an unadjuvanted inactivated seasonal influenza vaccine (N=828; Zoster-004), a PPV23 vaccine (N=865; Zoster-035) or a dTpa vaccine formulated with 0.3 milligrams Al3+ (N=830; Zoster-042).
Croatian: U tri kontrolirana, otvorena klinička ispitivanja faze III, odrasle osobe u dobi od ≥ 50 godina bile su randomizirane za primanje 2 doze cjepiva Shingrix u razmaku od 2 mjeseca i neadjuvantiranog inaktiviranog sezonskog cjepiva protiv gripe (N=828; Zoster-004), PPV23 cjepiva (N=865; Zoster035) ili dTpa cjepiva formuliranog s 0,3 miligrama Al3+ (N=830; Zoster-042), bilo istodobno s prvom dozom cjepiva Shingrix ili odvojeno.
English: Table 1: Shingrix efficacy against HZ
Croatian: Tablica 1: Djelotvornost cjepiva Shingrix protiv HZ-a
English: The use of Shingrix in subjects with other confirmed or suspected immunosuppressive or immunodeficient conditions is under investigation.
Croatian: Ispituje se primjena cjepiva Shingrix u osoba s drugim potvrđenim stanjima koja uzrokuju imunosupresiju ili imunodeficijenciju ili sumnjom na takva stanja.
English: Incidence rate per person years
Croatian: Stopa incidencije na 1000 osobagodina
English: As with other vaccines, an adequate immune response may not be elicited in these individuals.
Croatian: Kao i kod svakog cjepiva, u tih se osoba možda neće postići odgovarajući imunološki odgovor.
English: After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2°C - 8°C).
Croatian: Cjepivo treba primijeniti odmah nakon rekonstitucije; ako to nije moguće, treba ga čuvati u hladnjaku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1272/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1272/001
English: What you need to know before you receive Shingrix
Croatian: Što morate znati prije nego primite Shingrix Ne smijete primiti Shingrix
English: Other complications of shingles are:
Croatian: Ostale komplikacije herpes zostera su:
English: Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
Croatian: Shingrix nije indiciran za prevenciju primarne infekcije virusom varicella zoster (vodenih kozica).
English: ATP According-To-Protocol ^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
Croatian: ^ Imunološki odgovor protiv gE = razine protutijela na gE, izmjerene imunoenzimskim testom na protutijela na gE (engl. anti-gE enzyme-linked immunosorbent assay, gE ELISA) * 3. mjesec = 1 mjesec nakon 2. doze ** 38. mjesec = 3 godine nakon 2 doze
English: The anti-gE GMC at 1 month after the last vaccine dose was 47,758.7 mIU/ml (95% CI: 42,258.8; 53,974.4).
Croatian: Geometrijska srednja vrijednost koncentracije protutijela na gE mjesec dana nakon posljednje doze cjepiva iznosila je 47 758,7 mIU/ml (95% CI: 42 258,8; 53 974,4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant for Shingrix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Adjuvans za Shingrix
English: were ≥50 years of age, received at least one dose of Shingrix, which was shown to be immunogenic and well-tolerated.
Croatian: 135 odraslih osoba, od kojih je njih 73 bilo u dobi od ≥ 50 godina, primilo najmanje jednu dozu cjepiva Shingrix, koja se pokazala imunogenom i dobro podnošljivom.
English: N Number of evaluable subjects at the specified time point (for the GMC) CI
Croatian: N Broj ocjenjivih ispitanika u određenoj vremenskoj točki (za geometrijsku srednju vrijednost koncentracije) CI interval pouzdanosti
English: Ireland GlaxoSmithKline (Ireland) Ltd
Croatian: GlaxoSmithKline (Cyprus) Ltd
English: Varicella Zoster Virus1 glycoprotein E antigen2,3
Croatian: Antigen glikoprotein E virusa varicella zoster1,2,3
English: Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).
Croatian: Shingrix dolazi u bočici sa smeđim zatvaračem koja sadrži prašak (antigen) i bočici s plavo-zelenim zatvaračem koja sadrži suspenziju (adjuvans).
English: There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities (see section 5.1).
Croatian: Postoje ograničeni podaci koji podupiru primjenu cjepiva Shingrix u osoba s HZ-om u anamnezi te u onemoćalih osoba, uključujući one s većim brojem popratnih bolesti (vidjeti dio 5.1).
English: METHOD OF ADMINISTRATION Mix with adjuvant
Croatian: Pomiješati s adjuvansom
English: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheria-tetanusacellular pertussis vaccine (dTpa).
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Shingrix se može dati istodobno s neadjuvantiranim inaktiviranim sezonskim cjepivom protiv gripe, 23-valentnim polisaharidnim cjepivom protiv pneumokoka (PPV23) ili s nestaničnim cjepivom protiv difterije, tetanusa i pertusisa sa smanjenim sadržajem antigena (dTpa).
English: Shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster vaccine.
Croatian: Shingrix se može primijeniti ako ste prethodno bili cijepljeni sa živim atenuiranim cjepivom protiv herpes zostera.
English: Very common gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain)
Croatian: Poremećaji probavnog sustava vrlo često gastrointestinalni simptomi (uključujući mučninu, povraćanje, proljev i/ili bol u abdomenu)
English: • Shingles is caused by the same virus that causes chickenpox.
Croatian: • Herpes zoster uzrokuje isti virus koji izaziva i vodene kozice.
English: How Shingrix works
Croatian: Kako Shingrix djeluje
English: Powder and suspension for suspension for injection.
Croatian: Prašak i suspenzija za suspenziju za injekciju.
English: The median frequency of gE-specific CD4[2+] T cells was greater than 3.7-fold above baseline prevaccination median frequency.
Croatian: Medijan učestalosti CD4[2+] T-stanica specifičnih za gE bio je više od 3,7 puta veći od medijana učestalosti na početku ispitivanja, prije cijepljenja.
English: In a phase III, uncontrolled, open-label clinical study (Zoster-033), 96 adults ≥ 50 years of age with a physician-documented history of HZ received 2 doses of Shingrix 2 months apart.
Croatian: U nekontroliranom, otvorenom kliničkom ispitivanju faze III (Zoster-033) sudjelovalo je 96 odraslih osoba u dobi od ≥ 50 godina koje su u amanezi imale HZ koji je dokumentirao liječnik i koje su primile 2 doze cjepiva Shingrix u razmaku od 2 mjeseca.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: This is a higher recurrence rate than generally reported in observational studies in unvaccinated individuals with a history of HZ.
Croatian: Ta je stopa rekurencije viša od onih koje se obično bilježe u opservacijskim ispitivanjima necijepljenih osoba s HZ-om u anamnezi (vidjeti dio 4.4).
English: In subjects with at least one confirmed HZ episode, Shingrix significantly reduced the maximum average pain score versus placebo over the entire HZ episode (mean = 3.9 vs. 5.5, P-value = 0.049 and mean = 4.5 vs. 5.6, P-value = 0.043, in subjects ≥ 50 years (ZOE-50) and ≥ 70 years (ZOE-50 and
Croatian: U ispitanika s najmanje jednom potvrđenom epizodom HZ-a Shingrix je značajno smanjio najveći rezultat za prosječnu bol naspram placeba tijekom cijele epizode HZ-a (srednja vrijednost = 3,9 naspram 5,5; p-vrijednost = 0,049 u ispitanika u dobi od ≥ 50 godina [ZOE-50]; srednja vrijednost = 4,5 naspram 5,6; p-vrijednost = 0,043 u ispitanika u dobi od ≥ 70 godina [objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70]).
English: Withdraw the entire contents of the vial containing the suspension into the syringe.
Croatian: Izvucite sav sadržaj bočice sa suspenzijom u štrcaljku.
English: After reconstitution, one dose (0.5 ml) contains: Varicella Zoster Virus1 glycoprotein E antigen2
Croatian: Nakon rekonstitucije jedna doza (0,5 ml) sadrži: antigen glikoprotein E virusa varicella zoster1,2
English: The adverse reactions of fever and shivering were more frequent when PPV23 vaccine is coadministered with Shingrix.
Croatian: Nuspojave vrućice i drhtanja bile su češće pri istodobnoj primjeni PPV23 cjepiva i cjepiva Shingrix.
English: Shingrix cannot be used to prevent chickenpox (varicella).
Croatian: Shingrix se ne može koristiti za sprječavanje vodenih kozica (varičela).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen for Shingrix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Antigen za Shingrix i.m.
English: • Powder and suspension for suspension for injection.
Croatian: • Prašak i suspenzija za suspenziju za injekciju.
English: The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.
Croatian: Nije se ispitivao učinak na dojenčad nakon primjene cjepiva Shingrix njihovim majkama.
English: 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing:
Croatian: 2 s adjuvansom AS01B, koji sadrži:
English: • Shingles is a rash with blisters that is often painful.
Croatian: • Herpes zoster je osip praćen pojavom mjehurića i često je bolan.
English: 10 VIALS AND 10 VIALS
Croatian: 1 BOČICA I 1 BOČICA 10 BOČICA I 10 BOČICA
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Croatian: Nju može pratiti nekoliko neuroloških znakova kao što su prolazne smetnje vida,
English: The anti-gE GMC at 1 month after the last vaccine dose was 38,153.7 mIU/ml (95% CI: 34,205.8; 42,557.3) and 44,376.3 mIU/ml (95% CI: 39,697.0; 49,607.2) following the 0, 6-month schedule and the 0, 2-month schedule, respectively.
Croatian: Geometrijska srednja vrijednost koncentracije protutijela na gE mjesec dana nakon posljednje doze cjepiva iznosila je 38 153,7 mIU/ml (95% CI: 34 205,8; 42 557,3) nakon primjene prema rasporedu u 0. i 6. mjesecu odnosno 44 376,3 mIU/ml (95% CI: 39 697,0; 49 607,2). nakon primjene prema rasporedu u 0. i 2. mjesecu.
English: The efficacy in reducing BOI was 98.4% (95% CI: 92.2; 100) in subjects ≥ 50 years (ZOE-50) and 92.1% (95% CI: 90.4; 93.8) in subjects ≥ 70 years (ZOE-50 and ZOE-70 pooled).
Croatian: Djelotvornost u smanjivanju tereta bolesti iznosila je 98,4% (95% CI: 92,2; 100) u ispitanika u dobi od ≥ 50 godina (ZOE-50) te 92,1% (95% CI: 90,4; 93,8) u ispitanika u dobi od ≥ 70 godina (objedinjeni podaci iz ispitivanja ZOE-50 i ZOE-70).