natgillin/translations-raw huggingface dataset:
You can help by reporting any side effects you may get.
Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenem učinku cepiva, ki bi se utegnil pojaviti pri vas.
Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe.
Potegnite celotno vsebino viale, ki vsebuje rekonstituirano cepivo, v injekcijsko brizgo.
Median frequency (Q1; Q3)
Mediana pogostnost (Q1; Q3)
Do not administer the vaccine intravascularly or intradermally.
Cepiva ne smete dati intravaskularno ali intradermalno.
The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease, and stroke.
Ocenjeni s HZ povezani zapleti so bili: HZ vaskulitis, diseminirana bolezen, očesna bolezen,
Effect of Shingrix on HZ-related pain
Vpliv cepiva Shingrix na bolečine, povezane s HZ
Table 2: Shingrix efficacy against PHN
Preglednica 2: Učinkovitost cepiva Shingrix proti PHN
Contents of the pack and other information What Shingrix contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Shingrix
• The active substances are:
• Učinkovina je:
Shingrix cannot be used as a treatment if you already have shingles or shingles-related complications.
Cepiva Shingrix ni mogoče uporabiti za zdravljenje, če že imate pasovec ali z njim povezane zaplete.
• Powder and suspension for suspension for injection.
• Prašek in suspenzija za suspenzijo za injiciranje.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassiumfree'.
To cepivo vsebuje manj kot 1 mmol kalija (39 mg) na odmerek, kar pomeni, da je praktično "brez kalija".
• stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain)
• težave z želodcem in prebavo (vključno s slabostjo, bruhanjem, drisko in/ali bolečinami v želodcu)
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.
To olajša zbiranje in aktivacijo antigen predstavitvenih celic, ki nosijo antigene, ki izvirajo iz gE, v drenažne bezgavke.
Shingrix is given to adults 50 years and above.
Cepivo Shingrix se uporablja pri odraslih od 50. leta starosti naprej.
6.6 Special precautions for disposal and other handling 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).
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom 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).
There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.
Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost odmerka cepiva
• feeling tired, chills, fever
utrujenost, mrzlica, zvišana telesna temperatura
Shingrix contains sodium and potassium
Cepivo Shingrix vsebuje natrij in kalij
• itching where the injection is given (pruritus)
• srbenje na mestu injiciranja (pruritus)
• Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
• Prašek za 1 odmerek v viali (steklo tipa I) z zamaškom iz butilne gume.
Shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster vaccine.
Cepivo Shingrix lahko dobite tudi, če ste že bili predhodno cepljeni z živim oslabljenim cepivom proti herpesu zostru.
Age group (years)
Starostna skupina (leta)
Shingrix must be reconstituted prior to administration.
Cepivo Shingrix morate pred dajanjem rekonstituirati.
o Suspension: Dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate anhydrous, potassium dihydrogen phosphate and water for injections.
o Suspenzija: dioleoilfosfatidilholin, holesterol, natrijev klorid, brezvodni natrijev hidrogenfosfat, kalijev dihidrogenfosfat in voda za injekcije.
How to prepare Shingrix:
Kako pripraviti cepivo Shingrix:
Shingrix elicited higher gE-specific immune responses (humoral and CMI) at 1 month post-dose 2 when compared to pre-vaccination levels.
Cepivo Shingrix je 1 mesec po 2. odmerku izzvalo večji imunski odziv (humoralni in CMI), specifičen za gE, v primerjavi z ravnjo pred cepljenjem.
• Shingles is caused by the same virus that causes chickenpox.
• Povzročitelj pasovca je isti virus, ki povzroča norice.
As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy.
Iz previdnosti se je uporabi cepiva Shingrix med nosečnostjo bolje izogniti.
Withdraw the entire contents of the vial containing the suspension into the syringe.
Potegnite celotno vsebino viale, ki vsebuje suspenzijo, v injekcijsko brizgo.
gE-specific CD4[2+] T cell response^
Za gE specifičen odziv celic T CD4[2+]^
3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose;
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).
Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
Cepivo Shingrix ni indicirano za preprečevanje primarne okužbe z varicello (noricami).
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.
kontroliranih s placebom pri 5.887 odraslih, starih od 50 do 69 let, in 8.758 odraslih, starih ≥ 70 let.
What Shingrix looks like and contents of the pack
Izgled cepiva Shingrix in vsebina pakiranja
* 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
* 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]).
Side effects reported after the marketing of Shingrix:
Neželeni učinki, poročani po prihodu cepiva Shingrix na trg:
The most common complication of shingles is:
Najpogostejši zaplet pasovca so:
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.
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.
After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of recombinant Varicella Zoster Virus glycoprotein E adjuvanted with AS01B
Po rekonstituciji 1 odmerek (0,5 ml) vsebuje 50 mikrogramov rekombinantnega glikoproteina E virusa varicella zoster in kot adjuvans AS01B.
Shingrix cannot be used to prevent chickenpox (varicella).
Cepiva Shingrix ni mogoče uporabiti za preprečevanje noric (varicelle).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 VIAL
PODATKI NA ZUNANJI OVOJNINI 1 VIALA IN 1 VIALA 10 VIAL IN 10 VIAL
o Powder: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate.
o Prašek: saharoza, polisorbat 80, natrijev dihidrogenfosfat dihidrat, kalijev hidrogenfosfat.
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
^ 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
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.
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
The humoral immunogenicity and CMI results are presented in Tables 3 and 4, respectively.
Rezultati humoralne imunogenosti so prikazani v preglednici 3 in rezultati celično posredovane imunosti v preglednici 4.
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
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).
Other complications of shingles are:
Drugi zapleti pasovca so:
The median duration of pain medication use was 32.0 and 44.0 days in the Shingrix and placebo group, respectively.
Uporaba zdravil proti bolečinam je med prejemniki cepiva Shingrix trajala mediano 32,0 dni in med prejemniki placeba mediano 44,0 dni.
A different injection site will be used for each vaccine.
Vsako cepivo vam bodo injicirali na drugo mesto.
• Shingles is a rash with blisters that is often painful.
Kaj je pasovec • Pasovec je izpuščaj z mehurji, ki je pogosto boleč.
Other medicines and Shingrix
Druga zdravila in cepivo Shingrix
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant for Shingrix
IME ZDRAVILA IN POT(I) UPORABE Adjuvans za cepivo Shingrix
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.
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.
Very common injection site reactions (such as pain, redness, swelling), fatigue, chills, fever
Zelo pogosti reakcije na mestu injiciranja (na primer bolečina, pordelost, oteklina),
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).
kumulativno) značilno zmanjšalo oceno izrazitosti najhujše bolečine med celotno epizodo HZ (povprečje = 5,7 v primerjavi s 7,0, vrednost p = 0,032).
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Tako kot velja za vsa cepiva, tudi s tem cepivom zaščitnega imunskega odziva ni vedno mogoče doseči pri vseh cepljenih osebah.
If you are not sure, talk to your doctor or pharmacist.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Table 1: Shingrix efficacy against HZ
Preglednica 1: Učinkovitost cepiva Shingrix proti HZ
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).
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
Powder and suspension for suspension for injection 1 vial: powder (antigen)
Prašek in suspenzija za suspenzijo za injiciranje 1 viala: prašek (antigen) 1 viala: suspenzija (adjuvans)
vs. 210 cases in ZOE-50) and in subjects ≥ 70 years (25 vs. 284 cases in the pooled analysis of ZOE50 and ZOE-70).
≥ 70 let (25 primerov v primerjavi z 284 primeri v kumulativni analizi študij ZOE-50 in ZOE-70).
Table 3: Humoral immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Preglednica 3: Humoralna imunogenost cepiva Shingrix pri odraslih, starih ≥ 50 let (kohorta PP za imunogenost)
Excipients: sucrose polysorbate 80 sodium dihydrogen phosphate dihydrate dipotassium phosphate dioleoyl phosphatidylcholine cholesterol sodium chloride disodium phosphate anhydrous potassium dihydrogen phosphate water for injections
Pomožne snovi: saharoza polisorbat 80 natrijev dihidrogenfosfat dihidrat kalijev hidrogenfosfat dioleoilfosfatidilholin holesterol natrijev klorid natrijev hidrogenfosfat, brezvodni kalijev dihidrogenfosfat voda za injekcije
Common injection site pruritus, malaise
Pogosti srbenje na mestu injiciranja, splošno slabo počutje
The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes.
Adjuvantni učinek AS01B je rezultat interakcije med MPL in
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.
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.
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Redki (pojavijo se lahko pri največ 1 od 1.000 odmerkov cepiva)
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).
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
The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.
Dojenje Vpliva cepljenja mater s cepivom Shingrix na dojene otroke niso raziskali.
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).
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).
Before administration:
Pred injiciranjem:
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema Občasni limfadenopatija
1Adverse reactions from spontaneous reporting Reporting of suspected adverse reactions
1Spontano prijavljeni neželeni učinki
Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
SHINGRIX prašek in suspenzija za suspenzijo za injiciranje cepivo proti herpesu zostru (rekombinantno, z adjuvansom)
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
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
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen for Shingrix
IME ZDRAVILA IN POT(I) UPORABE Antigen za cepivo Shingrix i.m.
Sodium dihydrogen phosphate dihydrate
Natrijev dihidrogenfosfat dihidrat Kalijev hidrogenfosfat
Fainting can occur before or after any needle injection.
Po injiciranju z iglo ali pred njim se lahko pojavi omedlevica.
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).
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
Not applicable.
ni znana.
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
50 mikrogramov 3-O-dezacil-4'-monofosforil lipid A (MPL) iz Salmonella minnesota 50 mikrogramov
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).
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).
Store in a refrigerator (2°C - 8°C).
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C - 8 °C).
If either is observed, do not administer the vaccine.
Če opazite eno ali drugo, cepiva ne injicirajte.
Common (these may occur with up to 1 in 10 doses of the vaccine):
Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva):
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.
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).
plant extract Quillaja saponaria Molina, fraction 21 (QS-21)
1 z adjuvansom AS01B, ki vsebuje: rastlinski izvleček Quillaja saponaria Molina, frakcijo 21 (QS-21)
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
Rekonstituirano cepivo je opalescentna, brezbarvna do bledo rjavkasta tekočina.
• The suspension is an opalescent, colourless to pale brownish liquid.
• Suspenzija je opalescentna, brezbarvna do bledo rjavkasta tekočina.
After reconstitution, one dose (0.5 ml) contains: Varicella Zoster Virus1 glycoprotein E antigen2
Po rekonstituciji en odmerek (0,5 ml) vsebuje: antigen glikoprotein E1 virusa varicella zoster2 50 mikrogramov
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.
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:
Pooled ZOE-50 and ZOE-70
Kumulativno ZOE-50 in ZOE-70
Suspension (AS01B Adjuvant System):
Suspenzija (adjuvantni sistem AS01B): Dioleoilfosfatidilholin Holesterol
However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Vendar pa naj cepljenja ne bi odložili zaradi blagih okužb, npr. prehlada.
Efficacy of Shingrix
Učinkovitost cepiva Shingrix
ZOE-70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group.
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.
METHOD OF ADMINISTRATION Mix with antigen
Zmešajte z antigenom.
METHOD OF ADMINISTRATION Mix with adjuvant
Zmešajte z adjuvansom.
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.
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
NAME OF THE MEDICINAL PRODUCT Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Navodilo za uporabo Shingrix prašek in suspenzija za suspenzijo za injiciranje cepivo proti herpesu zostru (rekombinantno, z adjuvansom)
Immunogenicity of Shingrix
Imunogenost cepiva Shingrix
Pharmacotherapeutic group: Varicella zoster vaccines, ATC code: J07BK03.
Oznaka ATC: J07BK03.
Table 4: Cell-mediated immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Preglednica 4: Celično posredovana imunogenost cepiva Shingrix pri odraslih, starih ≥ 50 let
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you receive Shingrix.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom,
Uncommon (these may occur with up to 1 in 100 doses of vaccine)
Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva)
The suspension is an opalescent, colourless to pale brownish liquid.
Suspenzija je opalescentna, brezbarvna do bledo rjavkasta tekočina.
Talk to your doctor or pharmacist before you receive Shingrix if:
Preden dobite cepivo Shingrix, se posvetujte z zdravnikom ali farmacevtom:
Shingrix
Cepivo Shingrix
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).
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).
What Shingrix is and what it is used for
Kaj je cepivo Shingrix in za kaj ga uporabljamo Za kaj uporabljamo cepivo Shingrix
Pooled ZOE-50 and ZOE-70***
Kumulativno ZOE-50 in ZOE-70***
Pooled ZOE-50 and ZOE-70**
Kumulativno ZOE-50 in ZOE-70**
Very common myalgia Uncommon arthralgia
Zelo pogosti mialgija
Overall there was a general trend towards less severe HZ-related pain in subjects vaccinated with Shingrix compared to placebo.
Med preiskovanci, cepljenimi s cepivom Shingrix, je v primerjavi s prejemniki placeba obstajal trend k manj hudim bolečinam, povezanim s HZ.
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.
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.
Median fold increase of frequency vs. pre-vaccination (Q1; Q3)
Mediani mnogokratnik povečanja pogostnosti v primerjavi s stanjem pred cepljenjem (Q1; Q3)
For the full list of excipients, see section 6.1.
3 Virus varicella zoster = VZV (Varicella Zoster Virus) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Median fold increase of concentrations vs. prevaccination (Q1; Q3)
Mediani mnogokratnik povečanja koncentracij v primerjavi s stanjem pred cepljenjem (Q1; Q3)
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.
Namenjeno je indukciji za antigen specifičnega celičnega in humoralnega imunskega odziva pri osebah z že obstoječo imunostjo proti VZV.