natgillin/translations-raw huggingface dataset:
This is a higher recurrence rate than generally reported in observational studies in unvaccinated individuals with a history of HZ.
To je višja stopnja ponovitve, kot je na splošno poročano v opazovalnih študijah pri necepljenih posameznikih z zgodovino HZ.
Month 38**
38. mesec**
Healthcare professionals therefore need to weigh the benefits and risks of HZ vaccination on an individual basis.
Zdravstveni delavci morajo zato pretehtati koristi in tveganja cepljenja proti HZ za vsakega posameznika posebej.
The most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose;
Najpogosteje poročani neželeni učinki so bili bolečina na mestu injiciranja (68,1 % skupno/odmerek,
Month 3*
3. mesec*
There were 9 reports of suspected HZ in 6 subjects over a one-year follow up period.
V tej študiji je bilo 9 primerov domnevnega HZ pri 6 posameznikih v 1-letnem obdobju spremljanja.
Vaccine efficacy [95% CI]
Učinkovitost cepiva (%) [95 % IZ]
The adjuvant (AS01B) is used to improve the body's response to the vaccine.
Adjuvans (AS01B) je uporabljen za izboljšanje telesnega odziva na cepivo.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ali če ste pred nedavnim dobili katero koli drugo cepivo.
Subcutaneous administration is not recommended.
Subkutana uporaba ni priporočljiva.
Number of HZ cases
Število primerov HZ
The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.
Cepivo je namenjeno samo za profilaktično uporabo in ne za zdravljenje že razvite klinične bolezni.
• you are allergic (hypersensitive) to the active substances or any of the other ingredients of this vaccine (listed in section 6).
• če ste alergični (preobčutljivi) na učinkovine ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
Shake gently until the powder is completely dissolved.
Rahlo pretresite, dokler se prašek povsem ne raztopi.
For intramuscular injection only, preferably in the deltoid muscle.
Samo za intramuskularno injiciranje, po možnosti v deltoidno mišico.
Fatigue and malaise may occur following administration (see section 4.8).
Po cepljenju se lahko pojavita utrujenost in slabo počutje (glejte poglavje 4.8).
As a consequence of the high vaccine efficacy against HZ, a low number of breakthrough cases were accrued, and it was therefore not possible to draw firm conclusions on these study objectives.
Zaradi velike učinkovitosti cepiva proti HZ je bilo zajeto le majhno število prebojnih primerov, zato trdni sklepi o teh raziskovalnih ciljih niso bili mogoči.
The vaccines should be administered at different injection sites.
Cepivi je treba injicirati na različni mesti.
N GMC (mIU/ml) (95% CI)
N GMC (m i.e./ml) (95 % IZ)
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden dobite to cepivo.
This helps your immune system (the body's natural defences) stay prepared to fight the virus and protect you against shingles and its complications.
To pomaga imunskemu sistemu (naravni obrambi organizma), da ostane pripravljen na boj z virusom in vas tako zaščiti pred pasovcem in njegovimi zapleti.
An immunological correlate of protection has not been established; therefore the level of immune response that provides protection against HZ is unknown.
Imunološki korelat zaščite ni ugotovljen, zato raven imunskega odziva, ki zagotavlja zaščito pred HZ,
Reactions reported as severe lasted 1 to 2 days.
Hudi neželeni učinki so trajali 1 do 2 dni.
Non-clinical data show that AS01B induces a local and transient activation of the innate immune system through specific molecular pathways.
Predklinični podatki kažejo, da AS01B inducira lokalno in prehodno aktivacijo prirojenega imunskega sistema preko specifičnih molekularnih poti.
• skin infections, weakness, muscle paralysis and loss of hearing or vision - these are less common.
• okužbe kože, šibkost, ohromelost mišic (paraliza) in izguba sluha ali vida - ti so manj pogosti.
The administration of Shingrix to immunocompromised subjects should be based on careful consideration of potential benefits and risks.
Uporaba cepiva Shingrix pri imunokompromitiranih osebah mora temeljiti na skrbni oceni možnih koristi in tveganj.
The use of Shingrix should be in accordance with official recommendations.
Uporaba cepiva Shingrix mora biti v skladu z uradnimi priporočili.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website
To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
This protein is not infectious.
Beljakovina ni kužna.
Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination.
Cepivo Shingrix ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev 2-3 dni po cepljenju.
CI Confidence interval
IZ Interval zaupanja.
As with other vaccines, an adequate immune response may not be elicited in these individuals.
Kot pri drugih cepivih, zadosten imunski odziv morda ne bo dosežen pri teh posameznikih.
Therefore tell the doctor or nurse if you fainted with a previous injection.
Zato morate zdravniku ali medicinski sestri povedati, če ste kdaj v preteklosti omedleli, ko ste dobili injekcijo.
The primary vaccination schedule consists of two doses of 0.5 ml each: an initial dose followed by a second dose 2 months later.
Osnovna shema cepljenja obsega dva odmerka po 0,5 ml: začetni odmerek, ki mu sledi drugi odmerek čez 2 meseca.
• The other ingredients are:
• Druge sestavine cepiva so:
you may get pain which can last for months or years and may be severe.
Ko mehurji pasovca izginejo, se lahko pojavijo bolečine, ki lahko trajajo več mesecev ali let in so lahko hude.
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).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom Shingrix za eno ali več podskupin pediatrične populacije za preprečevanje reaktivacije virusa varicella zoster (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years.
Odrasli v starosti od 50 do 69 let imajo lahko več neželenih učinkov kot odrasli v starosti ≥ 70 let.
Number of evaluable subjects
Število ocenljivih preiskovancev
If either is observed, do not reconstitute the vaccine.
Če opazite eno ali drugo, cepiva ne rekonstituirajte.
• You will be informed when you should come back for the second dose of Shingrix.
• Povedali vam bodo, kdaj morate priti po naslednji odmerek cepiva Shingrix.
No cases of visceral disease or stroke were reported during these studies.
V teh študijah niso zabeležili nobenega primera visceralne bolezni ali možganske kapi.
Change the needle so that you are using a new needle to administer the vaccine.
Zamenjajte iglo, tako da boste za injiciranje cepiva uporabili novo iglo.
Efficacy against HZ-related complications other than PHN
Učinkovitost proti zapletom, povezanim s HZ (drugi kot PHN)
• Shingrix is given as an injection into a muscle (usually in the upper arm).
• Cepivo Shingrix se daje kot injekcija v mišico (po navadi na nadlahti).
As with all vaccines, Shingrix may not fully protect all people who are vaccinated.
Tako kot velja za vsa cepiva, tudi cepivo Shingrix ne more povsem zaščititi vseh cepljenih oseb.
• scars where the blisters have been.
• brazgotine na mestih, kjer so bili mehurji.
The use of Shingrix in subjects with other confirmed or suspected immunosuppressive or immunodeficient conditions is under investigation.
Uporabo cepiva Shingrix pri osebah z drugimi potrjenimi ali domnevnimi stanji imunske supresije ali imunske pomanjkljivosti trenutno raziskujejo.
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvi PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
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).
Cepivo je treba injicirati takoj po rekonstituciji; če to ni mogoče, ga morate shraniti v hladilniku (2 °C - 8 °C).
• long-lasting nerve pain - called post-herpetic neuralgia or PHN.
• dolgotrajne bolečine živcev - imenujemo jih postherpetična nevralgija (s kratico PHN).
Subjects with a history of HZ prior to vaccination
Preiskovanci z anamnezo HZ pred cepljenjem
As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness.
Tako kot velja za druga cepiva, je treba tudi cepljenje s cepivom Shingrix odložiti pri osebah z akutno, hudo febrilno boleznijo.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1272/001 - 1 vial and 1 vial EU/1/18/1272/002 - 10 vials and 10 vials
EU/1/18/1272/001 - 1 viala in 1 viala EU/1/18/1272/002 - 10 vial in 10 vial
Post-hoc analysis of efficacy against confirmed HZ undertaken in patients with common conditions (chronic kidney disease, chronic obstructive pulmonary disease, coronary artery disease, depression or diabetes mellitus), indicates that the vaccine efficacy is aligned with the overall HZ efficacy.
Post hoc analiza učinkovitosti proti potrjenemu HZ pri preiskovancih s pogostimi osnovnimi boleznimi (kronična ledvična bolezen, kronična obstruktivna pljučna bolezen, bolezen koronarnih arterij, depresija, sladkorna bolezen) kaže, da se učinkovitost sklada s celokupno učinkovitostjo proti HZ.
Adverse reactions reported are listed according to the following frequency: Very common
Opisani neželeni učinki so navedeni po naslednji razvrstitvi pogostnosti:
10 vials: powder (antigen) 10 vials: suspension (adjuvant)
10 vial: prašek (antigen) 10 vial: suspenzija (adjuvans)
The benefit of Shingrix in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.
Korist cepiva Shingrix za preprečevanje PHN je mogoče pripisati učinku cepiva na preprečevanje HZ.
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.
Rezultati učinkovitosti proti HZ in PHN, ugotovljeni v prilagojeni celotni cepljeni kohorti (mTVCmodified Total Vaccinated Cohort), tj. izključujoč tiste odrasle, ki niso prejeli drugega odmerka cepiva ali so imeli potrjeno diagnozo HZ v enem mesecu po drugem odmerku, so predstavljeni v preglednicah 1 in 2.
The median anti-gE antibody concentration was greater than 7-fold above the baseline pre-vaccination median concentration.
Mediana koncentracija protiteles proti gE je bila več kot 7-krat večja od izhodiščne mediane koncentracije pred cepljenjem.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance.
Rekonstituirano cepivo je treba pregledati glede prisotnosti tujih delcev in/ali spremenjenega videza.
The need for booster doses following the primary vaccination schedule has not been established (see section 5.1).
Potreba po obnovitvenih odmerkih po opravljenem osnovnem cepljenju ni bila dokazana (glejte poglavje 5.1).
were ≥50 years of age, received at least one dose of Shingrix, which was shown to be immunogenic and well-tolerated.
73 oseb starih ≥ 50 let, je prejelo vsaj en odmerek cepiva Shingrix, ki se je izkazalo za imunogeno in so ga prejemniki dobro prenašali.
• Suspension for 1 dose in a vial
• Suspenzijo za 1 odmerek v viali
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.
Cepivo Shingrix je na voljo v velikosti pakiranja z 1 vialo praška in 1 vialo suspenzije ali v velikosti pakiranja z 10 vialami praška in 10 vialami suspenzije.
However, do not drive or use machines if you are feeling unwell.
Toda če se ne počutite dobro, ne vozite in ne upravljajte strojev.
The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance.
Prašek in suspenzijo je treba pregledati glede prisotnosti tujih delcev in/ali spremenjenega videza.
Shingrix can be given at the same time as other vaccines.
Cepivo Shingrix se lahko uporabi hkrati z drugimi cepivi.
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).
Imunske odzive na cepivo Shingrix so ocenili v podskupini preiskovancev iz študij učinkovitosti III. faze ZOE-50 [humoralna imunost in celično posredovana imunost (CMI - cell-mediated immunity)] in ZOE-70 (humoralna imunost).
• After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
• Ko prebolite norice, ostane virus, ki jih povzroča, v telesu v živčnih celicah.
Shingles may lead to complications.
Pasovec lahko povzroči zaplete.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica) kot psihološki odziv na injiciranje z iglo.
Rare hypersensitivity reactions including rash, urticaria, angioedema1
Redki preobčutljivostne reakcije vključno z izpuščajem, urtikarijo, angioedemom1
• allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• alergijske reakcije vključno z izpuščajem, koprivnico (urtikarijo), oteklostjo obraza, jezika ali grla, ki lahko povzroči težko požiranje ali dihanje (angioedem).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Med znaki alergijske reakcije so lahko srbeč izpuščaj na koži, zasoplost in otekanje obraza ali jezika.
The glycoprotein E is a protein present in the Varicella Zoster Virus.
Glikoprotein E je beljakovina v virusu varicella zoster.
If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose (see section 5.1).
Če je potrebna prilagodljivost cepilne sheme, se drugi odmerek lahko da med 2 in 6 mesecev po prvem odmerku (glejte poglavje 5.1).
The median frequency of gE-specific CD4[2+] T cells was greater than 3.7-fold above baseline prevaccination median frequency.
Mediana pogostnost za gE specifičnih celic T CD4[2+] je bila več kot 3,7-krat večja od izhodiščne mediane pogostnosti pred cepljenjem.
The burden-of-illness (BOI) score incorporates the incidence of HZ with the severity and duration of acute and chronic HZ-related pain over a 6 month period following rash onset.
Ocena bremena bolezni (BOI - burden-of-illness) združuje pojavnost HZ z izrazitostjo in trajanjem akutnih in kroničnih s HZ povezanih bolečin med 6-mesečnim obdobjem po pojavu izpuščaja.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, embrionalni/fetalni razvoj, porod ali postnatalni razvoj (glejte poglavje 5.3).
Immunogenicity in subjects receiving 2 doses of Shingrix 6 months apart
Imunogenost pri preiskovancih, ki so prejeli 2 odmerka cepiva Shingrix v presledku 6 mesecev
The safety and efficacy of Shingrix in children and adolescents have not been established.
Pediatrična populacija Varnost in učinkovitost cepiva Shingrix pri otrocih in mladostnikih nista bili dokazani.
This will maximise the protection offered by Shingrix.
Tako boste dosegli največjo zaščito, ki jo lahko ponudi cepivo Shingrix.
• The powder is white.
• Prašek je bele barve.
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.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu cepiva Shingrix na sposobnost vožnje in upravljanja strojev niso izvedli.
Add the entire contents of the syringe into the vial containing the powder.
Dodajte celotno vsebino injekcijske brizge v vialo, ki vsebuje prašek.
INFORMATION IN BRAILLE Justification for not including Braille accepted.
INFORMACIJE V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
The powder and the suspension must be reconstituted prior to administration.
Prašek in suspenzijo je treba pred uporabo rekonstituirati.
What you need to know before you receive Shingrix 3.
Kaj morate vedeti, preden boste dobili cepivo Shingrix 3.
• swollen glands in the neck, armpit or groin
• otekle bezgavke na vratu, pazduhi ali dimljah
N Number of evaluable subjects at the specified time point (for the GMC) CI
N Število ocenljivih preiskovancev na posamezni časovni točki (za geometrično sredino koncentracij).
• Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).
• Suspenzija za 1 odmerek v viali (steklo tipa I) z zamaškom iz butilne gume.
If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose.
Če je potrebna prilagodljivost cepilne sheme, se drugi odmerek lahko daje med 2 in 6 meseci po prvem odmerku.
• Powder for 1 dose in a vial
• Prašek za 1 odmerek v viali
• you have a bleeding problem or bruise easily.
• če imate težave s strjevanjem krvi ali ste nagnjeni k podplutbam.
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.
Morda pri vas obstaja večja verjetnost, da se vam pojavi zvišana telesna temperatura in/ali mrzlica pri sočasnem dajanju 23-valentnega pnevmokoknega polisaharidnega cepiva s cepivom Shingrix.
Shingrix reminds your body about the virus that causes shingles.
Cepivo Shingrix vaše telo spomni na virus, ki povzroča pasovec.
What Shingrix is and what it is used for 2.
Kaj je cepivo Shingrix in za kaj ga uporabljamo 2.
Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.
Cepivo Shingrix je treba previdno uporabljati pri osebah s trombocitopenijo ali kakšno koagulacijsko motnjo, ker se jim lahko po intramuskularnem injiciranju pojavi krvavitev.
Age (years)
Starost (leta)
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Kot pri vseh cepivih, ki se injicirajo, je treba zagotoviti ustrezno medicinsko obravnavo in nadzor za primere anafilaktičnih reakcij po uporabi cepiva.
Two phase I/II clinical studies, Zoster-001 and Zoster-015, were conducted in subjects with autologous hematopoietic stem cell transplant or HIV infection.
faze, Zoster-001 in Zoster-015, so izvedli pri preiskovancih z avtologno presaditvijo hematopoetskih matičnih celic ali z okužbo s HIV.
Confidence interval GMC Geometric Mean Concentration Q1; Q3 First and third quartiles
GMC Geometrična sredina koncentracij Q1; Q3 Prvi in tretji kvartil
There are no data from the use of Shingrix in pregnant women.
Podatkov o uporabi cepiva Shingrix pri nosečnicah ni.
Number of PHN* cases
Število primerov PHN*
• Sometimes, after many years, if your immune system (the body's natural defences) becomes weaker (due to age, an illness or a medicine you are taking), the virus can cause shingles.
• Če vam imunski sistem oslabi (zaradi starosti, kakšne bolezni ali zdravila, ki ga jemljete), se lahko virus znova aktivira.
Subjects with a history of HZ were excluded from ZOE-50 and ZOE-70.
Preiskovanci z anamnezo HZ so bili izključeni iz ZOE-50 in ZOE-70.
Number of PHN cases
Število primerov PHN
Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older (see section 5.1).
Cepivo Shingrix je indicirano za preprečevanje herpesa zostra (HZ) in postherpetične nevralgije (PHN) pri odraslih, starih 50 let ali več (glejte poglavje 5.1).
Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see section 5.1).
Cepivo Shingrix se lahko daje po enaki shemi posameznikom, predhodno cepljenim z živim oslabljenim cepivom proti HZ (glejte poglavje 5.1).
It is unknown whether Shingrix is excreted in human milk.
Ni znano, ali se cepivo Shingrix izloča v materino mleko.
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.
Cepivo Shingrix je cepivo, ki pomaga odrasle osebe zaščititi pred pasovcem (herpesom zostrom) in pred postherpetično nevralgijo (PHN), to je dolgotrajna bolečina živcev, ki sledi pasovcu.
Anti-gE immune response^
Imunski odziv anti-gE^
Safety and immunogenicity data on a limited number of immunocompromised subjects with human immunodeficiency virus (HIV) or haematopoietic stem cell transplant (HCT) are available (see section 5.1).
Sistemska imunosupresivna zdravila in imunska pomanjkljivost Na voljo so podatki o varnosti in imunogenosti, zbrani pri majhnem številu imunokompromitiranih oseb, okuženih z virusom humane imunske pomanjkljivosti (HIV) ali z opravljeno presaditvijo hematopoetskih matičnih celic (glejte poglavje 5.1).
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
To cepivo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar pomeni, da je praktično "brez natrija".
Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih učinkov na plodnost samcev ali samic (glejte poglavje 5.3).
Adverse reactions reported during post-marketing surveillance are also tabulated below.
Tudi neželeni učinki, poročani med spremljanjem cepiva po pridobitvi dovoljenja za promet, so navedeni spodaj v preglednici.
• generally feeling unwell
• splošno slabo počutje.
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).
Cepivo Shingrix se lahko daje sočasno z inaktiviranim cepivom proti sezonski gripi brez adjuvansa, 23-valentnim pnevmokoknim polisaharidnim cepivom (PPV23) ali cepivom proti davici, tetanusu in oslovskemu kašlju z zmanjšano vsebnostjo antigenov (dTPa).
* Over a median follow-up period of 3.1 years ** Over a median follow-up period of 4.0 years
** V medianem obdobju spremljanja 4,1 leta.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
One pack of Shingrix consists of:
Eno pakiranje cepiva Shingrix vsebuje:
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.
Pri preiskovancih s potrjenim HZ ni bilo mogoče dokazati dodatnega zmanjšanja pojavnosti PHN, ker je bilo število primerov HZ v cepljeni skupini majhno.