FrancophonIA/ELRC3.0 huggingface dataset:
English: How to prepare Shingrix:
Slovenian: Kako pripraviti cepivo Shingrix:
English: Shingrix elicited higher gE-specific immune responses (humoral and CMI) at 1 month post-dose 2 when compared to pre-vaccination levels.
Slovenian: Cepivo Shingrix je 1 mesec po 2. odmerku izzvalo večji imunski odziv (humoralni in CMI), specifičen za gE, v primerjavi z ravnjo pred cepljenjem.
English: • Shingles is caused by the same virus that causes chickenpox.
Slovenian: • Povzročitelj pasovca je isti virus, ki povzroča norice.
English: As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy.
Slovenian: Iz previdnosti se je uporabi cepiva Shingrix med nosečnostjo bolje izogniti.
English: Withdraw the entire contents of the vial containing the suspension into the syringe.
Slovenian: Potegnite celotno vsebino viale, ki vsebuje suspenzijo, v injekcijsko brizgo.
English: gE-specific CD4[2+] T cell response^
Slovenian: Za gE specifičen odziv celic T CD4[2+]^
English: 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose;
Slovenian: 3,8 % hudi/odmerek), mialgija (32,9 % skupno/odmerek, 2,9 % hudi/odmerek), utrujenost (32,2 % skupno/odmerek, 3,0 % hudi/odmerek) in glavobol (26,3 % skupno/odmerek, 1,9 % hudi/odmerek).
English: Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
Slovenian: Cepivo Shingrix ni indicirano za preprečevanje primarne okužbe z varicello (noricami).
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.
Slovenian: kontroliranih s placebom pri 5.887 odraslih, starih od 50 do 69 let, in 8.758 odraslih, starih ≥ 70 let.
English: What Shingrix looks like and contents of the pack
Slovenian: Izgled cepiva Shingrix in vsebina pakiranja
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
Slovenian: * PHN je bila opredeljena kot bolečine, povezane s herpesom zostrom, ocenjene z oceno ≥ 3 (na lestvici od 0 do 10), ki so trajale ali so se pojavile več kot 90 dni po nastanku izpuščaja herpesa zostra (z uporabo lestvice ZBPI [Zoster Brief Pain Inventory]).
English: Side effects reported after the marketing of Shingrix:
Slovenian: Neželeni učinki, poročani po prihodu cepiva Shingrix na trg:
English: The most common complication of shingles is:
Slovenian: Najpogostejši zaplet pasovca so:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeated dose toxicity, local tolerance, cardiovascular/respiratory safety pharmacology and toxicity to reproduction and development.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij akutne toksičnosti in toksičnosti pri ponavljajočih odmerkih, lokalnega prenašanja, srčno-žilne/dihalne varnostne farmakologije in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of recombinant Varicella Zoster Virus glycoprotein E adjuvanted with AS01B
Slovenian: Po rekonstituciji 1 odmerek (0,5 ml) vsebuje 50 mikrogramov rekombinantnega glikoproteina E virusa varicella zoster in kot adjuvans AS01B.
English: Shingrix cannot be used to prevent chickenpox (varicella).
Slovenian: Cepiva Shingrix ni mogoče uporabiti za preprečevanje noric (varicelle).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI 1 VIALA IN 1 VIALA 10 VIAL IN 10 VIAL
English: o Powder: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate.
Slovenian: o Prašek: saharoza, polisorbat 80, natrijev dihidrogenfosfat dihidrat, kalijev hidrogenfosfat.
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
Slovenian: ^ Za gE specifičen odziv celic T CD4[2+] = gE-specifična aktivnost celic T CD4+, merjena s preizkusom znotrajceličnega barvanja citokinov (ICS - intracellular cytokine staining) (celice T CD4[2+] = celice T
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.
Slovenian: Imunski odziv sočasno uporabljenih cepiv je bil nespremenjen, z izjemo nižje geometrijske sredine koncentracij (GMCs - geometric mean concentrations) za enega izmed antigenov oslovskega kašlja (pertaktin) pri sočasni uporabi cepiva
English: The humoral immunogenicity and CMI results are presented in Tables 3 and 4, respectively.
Slovenian: Rezultati humoralne imunogenosti so prikazani v preglednici 3 in rezultati celično posredovane imunosti v preglednici 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
Slovenian: Preiskovancem z vsaj eno potrjeno epizodo HZ je cepivo Shingrix v primerjavi s placebom značilno zmanjšalo največjo povprečno oceno bolečin med celotno epizodo HZ: povprečje = 3,9 v primerjavi s 5,5, vrednost p = 0,049 pri preiskovancih, starih ≥ 50 let (ZOE-50), in povprečje = 4,5 v primerjavi s 5,6, vrednost p = 0,043 pri preiskovancih, starih ≥ 70 let (ZOE-50 in ZOE-70 kumulativno).
English: Other complications of shingles are:
Slovenian: Drugi zapleti pasovca so:
English: The median duration of pain medication use was 32.0 and 44.0 days in the Shingrix and placebo group, respectively.
Slovenian: Uporaba zdravil proti bolečinam je med prejemniki cepiva Shingrix trajala mediano 32,0 dni in med prejemniki placeba mediano 44,0 dni.
English: A different injection site will be used for each vaccine.
Slovenian: Vsako cepivo vam bodo injicirali na drugo mesto.
English: • Shingles is a rash with blisters that is often painful.
Slovenian: Kaj je pasovec • Pasovec je izpuščaj z mehurji, ki je pogosto boleč.
English: Other medicines and Shingrix
Slovenian: Druga zdravila in cepivo Shingrix
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant for Shingrix
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Adjuvans za cepivo Shingrix
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.
Slovenian: V nekontrolirani klinični študiji III. faze z odprtim načrtom (Zoster-033) je 96 odraslih, starih ≥ 50 let, z zdravniško potrjeno anamnezo HZ, prejelo 2 odmerka cepiva Shingrix v razmaku 2 mesecev.
English: Very common injection site reactions (such as pain, redness, swelling), fatigue, chills, fever
Slovenian: Zelo pogosti reakcije na mestu injiciranja (na primer bolečina, pordelost, oteklina),
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).
Slovenian: kumulativno) značilno zmanjšalo oceno izrazitosti najhujše bolečine med celotno epizodo HZ (povprečje = 5,7 v primerjavi s 7,0, vrednost p = 0,032).
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Slovenian: Tako kot velja za vsa cepiva, tudi s tem cepivom zaščitnega imunskega odziva ni vedno mogoče doseči pri vseh cepljenih osebah.
English: If you are not sure, talk to your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: Table 1: Shingrix efficacy against HZ
Slovenian: Preglednica 1: Učinkovitost cepiva Shingrix proti HZ
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).
Slovenian: randomizirali na prejemanje 2 odmerkov cepiva Shingrix v razmaku 2 mesecev; preiskovanci so sočasno ali nesočasno s prvim odmerkom cepiva dobili inaktivirano cepivo proti sezonski gripi brez adjuvansa (N = 828; Zoster-004), cepivo PPV23 (N = 865; Zoster-035) ali dTPa cepivo, formulirano z
English: Powder and suspension for suspension for injection 1 vial: powder (antigen)
Slovenian: Prašek in suspenzija za suspenzijo za injiciranje 1 viala: prašek (antigen) 1 viala: suspenzija (adjuvans)
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).
Slovenian: ≥ 70 let (25 primerov v primerjavi z 284 primeri v kumulativni analizi študij ZOE-50 in ZOE-70).
English: Table 3: Humoral immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Slovenian: Preglednica 3: Humoralna imunogenost cepiva Shingrix pri odraslih, starih ≥ 50 let (kohorta PP za imunogenost)
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
Slovenian: Pomožne snovi: saharoza polisorbat 80 natrijev dihidrogenfosfat dihidrat kalijev hidrogenfosfat dioleoilfosfatidilholin holesterol natrijev klorid natrijev hidrogenfosfat, brezvodni kalijev dihidrogenfosfat voda za injekcije
English: Common injection site pruritus, malaise
Slovenian: Pogosti srbenje na mestu injiciranja, splošno slabo počutje
English: The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes.
Slovenian: Adjuvantni učinek AS01B je rezultat interakcije med MPL in
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.
Slovenian: V 4. letu po cepljenju je bila učinkovitost proti HZ 93,1 % (95 % IZ: 81,2; 98,2) pri odraslih, starih ≥ 50 let, in 87,9 % (95 % IZ: 73,3; 95,4) pri odraslih, starih ≥ 70 let.
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 odmerkov cepiva)
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).
Slovenian: Učinkovitost pri zmanjšanju BOI je bila 98,4 % (95 % IZ: 92,2, 100) pri preiskovancih, starih ≥ 50 let (ZOE-50), in 92,1 % (95 % IZ: 90,4, 93,8) pri preiskovancih, starih ≥ 70 let (ZOE-50 in ZOE-70
English: The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.
Slovenian: Dojenje Vpliva cepljenja mater s cepivom Shingrix na dojene otroke niso raziskali.
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).
Slovenian: starih ≥ 60 let (Zoster-024), kažejo, da se s cepivom izzvani imunski odziv (humoralni in CMI) po uporabi sheme 0 in 2 meseca ohrani do približno 6 let (N = 119).
English: Before administration:
Slovenian: Pred injiciranjem:
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema Občasni limfadenopatija
English: 1Adverse reactions from spontaneous reporting Reporting of suspected adverse reactions
Slovenian: 1Spontano prijavljeni neželeni učinki
English: Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Slovenian: SHINGRIX prašek in suspenzija za suspenzijo za injiciranje cepivo proti herpesu zostru (rekombinantno, z adjuvansom)
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
Slovenian: Cepivo Shingrix je v primerjavi s placebom značilno zmanjšalo pojavnost PHN tako pri odraslih, starih ≥ 50 let (0 primerov v primerjavi z 18 primeri v študiji ZOE-50), kot pri odraslih, starih ≥ 70 let
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen for Shingrix
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Antigen za cepivo Shingrix i.m.
English: Adjuvant
Slovenian: Adjuvans
English: Sodium dihydrogen phosphate dihydrate
Slovenian: Natrijev dihidrogenfosfat dihidrat Kalijev hidrogenfosfat
English: Fainting can occur before or after any needle injection.
Slovenian: Po injiciranju z iglo ali pred njim se lahko pojavi omedlevica.
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).
Slovenian: Podatkov, ki bi potrjevali uporabo cepiva Shingrix pri posameznikih z anamnezo HZ in pri slabotnih posameznikih, vključno s posamezniki s številnimi pridruženimi boleznimi, je malo (glejte poglavje
English: Not applicable.
Slovenian: ni znana.
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
Slovenian: 50 mikrogramov 3-O-dezacil-4'-monofosforil lipid A (MPL) iz Salmonella minnesota 50 mikrogramov
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).
Slovenian: 1 mesec po zadnjem odmerku cepiva je bila GMC anti-gE 47.758,7 m i.e./ml (95% IZ: 42.258,8; 53.974,4).
English: Store in a refrigerator (2°C - 8°C).
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C - 8 °C).
English: If either is observed, do not administer the vaccine.
Slovenian: Če opazite eno ali drugo, cepiva ne injicirajte.
English: Common (these may occur with up to 1 in 10 doses of the vaccine):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva):
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.
Slovenian: ZOE-70 je cepivo Shingrix značilno zmanjšalo s HZ povezane zaplete za 93,7 % (95 % IZ: 59,5; 99,9) pri odraslih, starih ≥ 50 let (1 primer v primerjavi s 16), in za 91,6 % (95 % IZ: 43,3; 99,8) pri odraslih, starih ≥ 70 let (1 primer v primerjavi z 12).
English: plant extract Quillaja saponaria Molina, fraction 21 (QS-21)
Slovenian: 1 z adjuvansom AS01B, ki vsebuje: rastlinski izvleček Quillaja saponaria Molina, frakcijo 21 (QS-21)
English: The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
Slovenian: Rekonstituirano cepivo je opalescentna, brezbarvna do bledo rjavkasta tekočina.
English: • The suspension is an opalescent, colourless to pale brownish liquid.
Slovenian: • Suspenzija je opalescentna, brezbarvna do bledo rjavkasta tekočina.
English: After reconstitution, one dose (0.5 ml) contains: Varicella Zoster Virus1 glycoprotein E antigen2
Slovenian: Po rekonstituciji en odmerek (0,5 ml) vsebuje: antigen glikoprotein E1 virusa varicella zoster2 50 mikrogramov
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.
Slovenian: 1 mesec po zadnjem odmerku cepiva pri uporabi sheme 0 in 6 mesecev je bila GMC anti-gE 38.153,7 m i.e./ml (95% IZ: 34.205,8; 42.557,3) in 44.376,3 m i.e./ml (95% IZ:
English: Pooled ZOE-50 and ZOE-70
Slovenian: Kumulativno ZOE-50 in ZOE-70
English: Suspension (AS01B Adjuvant System):
Slovenian: Suspenzija (adjuvantni sistem AS01B): Dioleoilfosfatidilholin Holesterol
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Slovenian: Vendar pa naj cepljenja ne bi odložili zaradi blagih okužb, npr. prehlada.
English: Efficacy of Shingrix
Slovenian: Učinkovitost cepiva Shingrix
English: ZOE-70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group.
Slovenian: Podatki za preiskovance, stare ≥ 70 let, izvirajo iz vnaprej določene kumulativne analize ZOE-50 in ZOE-70 (mTVC), ker te analize zagotavljajo najrobustnejše ocene učinkovitosti cepiva v tej starostni skupini.
English: METHOD OF ADMINISTRATION Mix with antigen
Slovenian: Zmešajte z antigenom.
English: METHOD OF ADMINISTRATION Mix with adjuvant
Slovenian: Zmešajte z adjuvansom.
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.
Slovenian: V odprti, multicentrični klinični študiji faze III (Zoster-048) so ocenili shemo cepljenja z dvema odmerkoma cepiva Shingrix v presledku 2 mesecev pri 215 odraslih, starejših od 65 let, ki so bili, v obdobju ≥5 let pred tem, cepljeni z živim oslabljenim cepivom proti HZ v primerjavi z 215
English: NAME OF THE MEDICINAL PRODUCT Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Slovenian: Navodilo za uporabo Shingrix prašek in suspenzija za suspenzijo za injiciranje cepivo proti herpesu zostru (rekombinantno, z adjuvansom)
English: Immunogenicity of Shingrix
Slovenian: Imunogenost cepiva Shingrix
English: Pharmacotherapeutic group: Varicella zoster vaccines, ATC code: J07BK03.
Slovenian: Oznaka ATC: J07BK03.
English: Table 4: Cell-mediated immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Slovenian: Preglednica 4: Celično posredovana imunogenost cepiva Shingrix pri odraslih, starih ≥ 50 let
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you receive Shingrix.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom,
English: Uncommon (these may occur with up to 1 in 100 doses of vaccine)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva)
English: The suspension is an opalescent, colourless to pale brownish liquid.
Slovenian: Suspenzija je opalescentna, brezbarvna do bledo rjavkasta tekočina.
English: Talk to your doctor or pharmacist before you receive Shingrix if:
Slovenian: Preden dobite cepivo Shingrix, se posvetujte z zdravnikom ali farmacevtom:
English: Shingrix
Slovenian: Cepivo Shingrix
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).
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Shingrix je na voljo kot viala z rjavim flip-off pokrovčkom, ki vsebuje prašek (antigen), in viala z modrozelenim flip-off pokrovčkom, ki vsebuje suspenzijo (adjuvans).
English: What Shingrix is and what it is used for
Slovenian: Kaj je cepivo Shingrix in za kaj ga uporabljamo Za kaj uporabljamo cepivo Shingrix
English: Pooled ZOE-50 and ZOE-70***
Slovenian: Kumulativno ZOE-50 in ZOE-70***
English: Pooled ZOE-50 and ZOE-70**
Slovenian: Kumulativno ZOE-50 in ZOE-70**
English: Very common myalgia Uncommon arthralgia
Slovenian: Zelo pogosti mialgija
English: Overall there was a general trend towards less severe HZ-related pain in subjects vaccinated with Shingrix compared to placebo.
Slovenian: Med preiskovanci, cepljenimi s cepivom Shingrix, je v primerjavi s prejemniki placeba obstajal trend k manj hudim bolečinam, povezanim s HZ.
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.
Slovenian: V klinični študiji III. faze z odprtim načrtom (Zoster-026) so 238 odraslih, starih ≥ 50 let, v enakem deležu randomizirali na prejemanje 2 odmerkov cepiva Shingrix v presledku ali 2 ali 6 mesecev.
English: Median fold increase of frequency vs. pre-vaccination (Q1; Q3)
Slovenian: Mediani mnogokratnik povečanja pogostnosti v primerjavi s stanjem pred cepljenjem (Q1; Q3)
English: For the full list of excipients, see section 6.1.
Slovenian: 3 Virus varicella zoster = VZV (Varicella Zoster Virus) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Median fold increase of concentrations vs. prevaccination (Q1; Q3)
Slovenian: Mediani mnogokratnik povečanja koncentracij v primerjavi s stanjem pred cepljenjem (Q1; Q3)
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.
Slovenian: Namenjeno je indukciji za antigen specifičnega celičnega in humoralnega imunskega odziva pri osebah z že obstoječo imunostjo proti VZV.
English: The immune response to Shingrix was unaffected by prior vaccination with live attenuated HZ vaccine.
Slovenian: Predhodno cepljenje z živim oslabljenim cepivom proti HZ ni vplivalo na imunski odziv na cepivo Shingrix.
English: How Shingrix works
Slovenian: Kako deluje cepivo Shingrix
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
Slovenian: ^ Imunski odziv anti-gE = raven protiteles proti gE, izmerjena z encimsko vezanim imunosorbentnim preizkusom za anti-gE (gE ELISA).
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.
Slovenian: Prejeli so bodisi dva odmerka cepiva Shingrix (N = 6.950) ali placeba (N = 6.950), uporabljenih v presledku 2 mesecev.
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.
Slovenian: V študiji ZOE-50 in ZOE-70 je bilo vključenih približno 13.000 preiskovancev z osnovnimi boleznimi, vključno z boleznimi, ki so povezane z večjim tveganjem za HZ.
English: How Shingrix is given
Slovenian: Kako se daje cepivo Shingrix
English: Complications related to shingles
Slovenian: Zapleti, povezani s pasovcem
English: CONDITIONS OR RESTRICTIONS REGARDING SYPPLY AND USE
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: - ZOE-50 (Zoster-006): 15,405 adults ≥ 50 years were randomised to receive two doses of either
Slovenian: - V študiji ZOE-70 (Zoster-022) so 13.900 odraslih, starih ≥ 70 let, randomizirali v dve skupini.
English: It is not known if Shingrix affects your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali cepivo Shingrix vpliva na sposobnost upravljanja vozil in strojev.