FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may consider switching your Herceptin intravenous treatment to Herceptin subcutaneous treatment (and vice versa) if considered appropriate for you.
Slovenian: Zdravnik bo morda razmislil o prehodu z zdravljenja z intravensko obliko zdravila Herceptin na zdravljenje s podkožno obliko zdravila Herceptin (in obratno), če bo smatral, da je to za vas primerno.
English: It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed.
Slovenian: Pomembno je preveriti ovojnino zdravila in zagotoviti, da bolnik prejme pravilno obliko (intravensko ali subkutano s fiksnim odmerkom), kot mu je bila predpisana.
English: • You should use effective contraception during treatment with Herceptin and for at least 7 months after treatment has ended.
Slovenian: · Med zdravljenjem z zdravilom Herceptin in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
English: In addition, comparison of two years of Herceptin treatment versus one year of Herceptin treatment was performed.
Slovenian: Poleg tega so izvedli primerjavo dvoletnega zdravljenja z zdravilom Herceptin z enoletnim zdravljenjem z zdravilom Herceptin.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in Section 4.4.
Slovenian: Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju 4.4.
English: After aseptic dilution in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection, chemical and physical stability of Herceptin has been demonstrated for up to 30 days at 2 oC - 8oC, and 24 hours at temperatures not exceeding 30°C.
Slovenian: Po aseptičnem redčenju v polivinilkloridnih, polietilenskih ali polipropilenskih vrečkah, ki vsebujejo raztopino 9 mg/ml (0,9 %) natrijevega klorida za injiciranje, je kemijska in fizikalna stabilnost zdravila Herceptin dokazana do 30 dni pri temperaturi 2 °C-8 °C in 24 ur pri temperaturah, ki ne presežejo 30 °C.
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the Herceptin infusion.
Slovenian: V zelo redkih primerih so se infuzijski in pljučni simptomi pojavili več kot šest ur po začetku infuzije zdravila Herceptin.
English: No. patients with event p=0.0555 * defined as absence of any invasive cancer both in the breast and axillary nodes
Slovenian: p = 0,0555 * Definiran kot odsotnost kakršnega koli invazivnega raka v dojkah in aksilarnih bezgavkah IZ = interval zaupanja
English: The rate of serious infections (most of which were identified because of in-patient hospitalisation or prolongation of existing hospitalisation) was 4.4 % in the Herceptin intravenous formulation arm and 8.1 % in the Herceptin subcutaneous formulation arm.
Slovenian: Odstotek resnih okužb (večino so odkrili zaradi hospitalizacije bolnika ali podaljšanja obstoječe hospitalizacije) je bil 4,4 % v skupini z intravensko obliko zdravila Herceptin in 8,1 % v skupini s subkutano obliko.
English: Overall survival (death) - No. patients with event - No. patients without event
Slovenian: Celokupno preživetje (smrt) - št. bolnikov z dogodkom - št. bolnikov brez dogodka
English: The final results of study BO22227 at a median follow-up exceeding 70 months were also consistent with the known safety profile for Herceptin IV and Herceptin SC, and no new safety signals were observed.
Slovenian: Končni rezultati študije BO22227 pri mediani spremljanja, ki je presegla 70 mesecev, so bili v skladu z znanima varnostnima profiloma za intravensko in subkutano obliko zdravila Herceptin; novih varnostnih signalov niso opazili.
English: Most of the patients (79 %) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Slovenian: Pri večini bolnikov (79 %), pri katerih so se pojavile motnje v delovanju srca v teh preskušanjih, je prišlo do izboljšanja po standardnem zdravljenju za kongestivno srčno popuščanje.
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm).
Slovenian: Delež asimptomatskih motenj v delovanju srca je bil večji v skupini z dvoletnim zdravljenjem (8,1 % v primerjavi s 4,6 % v skupini z enoletnim zdravljenjem).
English: The interval between consecutive Herceptin subcutaneous formulation administrations should not be less than three weeks.
Slovenian: Interval med zaporednima odmerkoma zdravila Herceptin v subkutani obliki ne sme biti krajši od treh tednov.
English: • increased muscle tone or tension (hypertonia)
Slovenian: · povečan mišični tonus ali napetost
English: Herceptin is for single-use only.
Slovenian: Zdravilo Herceptin je le za enkratno uporabo.
English: The safety of continuation or resumption of Herceptin in patients who experience cardiac dysfunction has not been prospectively studied.
Slovenian: Varnosti nadaljevanja ali ponovnega dajanja zdravila Herceptin pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of Herceptin and paclitaxel, compared to paclitaxel alone (21.8 % versus 45.7 %; p=0.004).
Slovenian: Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo zdravila Herceptin in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Slovenian: Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C-8 °C, v hladilniku.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, you must tell your doctor, pharmacist or nurse before taking this medicine.
Slovenian: Nosečnost · Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden boste prejeli to zdravilo.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herceptin treatment.
Slovenian: Če bodo pri vas nastopili kakršni koli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih šest do osem tednov); lahko prejmete zdravila proti srčnemu popuščanju ali pa boste morda morali prenehati z zdravljenjem z zdravilom Herceptin.
English: Portsmouth, NH 03801 USA
Slovenian: Lonza Portsmouth 101 International Dr. Portsmouth, NH 03801 ZDA
English: Trastuzumab may persist in the circulation for up to 7 months after stopping Herceptin treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Slovenian: Trastuzumab je lahko po prenehanju zdravljenja z zdravilom Herceptin v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
English: No long-term animal studies have been performed to establish the carcinogenic potential of Herceptin, or to determine its effects on fertility in males.
Slovenian: Za ugotovitev kancerogenega potenciala zdravila Herceptin ali učinkov na plodnost pri moških niso opravili nobenih dolgotrajnih študij na živalih.
English: Severe adverse events (defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE grade ≥3) version 3.0) were equally distributed between both Herceptin formulations (52.3 % versus 53.5 % in the intravenous formulation versus subcutaneous formulation respectively).
Slovenian: Resni neželeni učinki (opredeljeni s kriteriji National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE stopnje ≥ 3), različica 3.0) so bili enakomerno porazdeljeni med obe obliki zdravila Herceptin (52,3 % pri intravenski obliki v primerjavi s 53,5 % pri subkutani obliki).
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up**
Slovenian: Post-hoc explorativna analiza z dogodki preživetja brez bolezni in simptomatskimi srčnimi dogodki Dolgoročno spremljanje**
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8 % to 34.0 % for IHC and 7.1 % to 42.6 % for FISH.
Slovenian: Študije stopnje HER2-pozitivnosti pri raku želodca s pomočjo imunohistokemije (IHC) in fluorescenčne hibridizacije in situ (FISH) ali kromogene hibridizacije in situ (CISH) so pokazale veliko variabilnost HER2-pozitivnosti - od 6,8 % do 34,0 % za metodo IHC in 7,1 % do 42,6 % za metodo FISH.
English: (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Slovenian: pogosti (³ 1/100 do < 1/10), občasni (³ 1/1000 do < 1/100), redki (³ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
English: A single dose study in rabbits and a 13-week repeat dose toxicity study in Cynomolgus monkeys were conducted.
Slovenian: Opravili so študijo z enim odmerkom pri zajcih in 13-tedensko študijo toksičnosti z večkratnim odmerjanjem pri opicah Cynomolgus.
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Slovenian: · imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-fluorouracilom in cisplatinom.
English: The median Tmax following subcutaneous administration was approximately 3 days, with high interindividual variability (range 1-14 days).
Slovenian: Mediani tmax je bil po subkutanem dajanju približno 3 dni, variabilnost med posamezniki je bila velika
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: Posodobljen RMP je treba predložiti: · na zahtevo Evropske agencije za zdravila; · ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: tender, or hard.
Slovenian: ima modrice, je nežna ali trda.
English: • blood infection.
Slovenian: · okužba krvi
English: The median duration of follow-up in the Herceptin arm was 3.8 years.
Slovenian: Mediana spremljanja v skupini, ki je prejemala zdravilo Herceptin, je bila 3,8 leta.
English: Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion.
Slovenian: Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herceptin in niso povezani le z infuzijo.
English: The efficacy of Herceptin in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Slovenian: Učinkovitost zdravila Herceptin v kombinaciji s paklitakselom pri bolnikih, ki niso prejeli predhodne kemoterapije z antraciklinom, ni bila proučevana.
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without Herceptin.
Slovenian: Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih in bolnicah z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina z zdravilomHerceptin ali brez njega.
English: No loading dose is required.
Slovenian: Uvajalni odmerek ni potreben.
English: 50 %, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Slovenian: 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
English: Once transferred from the vial to the syringe the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C and for 6 hours (cumulative time in the vial and the syringe) at ambient temperature (max. 30°C) in diffused daylight.
Slovenian: Potem ko zdravilo preide iz viale v injekcijsko brizgo, je fizikalno in kemično stabilno28 dni pri temperaturi od 2 °C do 8 °C in 6 ur (skupni čas v viali in injekcijski brizgi) pri sobni temperaturi (največ 30 °C) v razpršeni dnevni svetlobi.
English: Single doses of up to 960 mg of Herceptin subcutaneous formulation have been administered with no reported untoward effects.
Slovenian: 4.9 Preveliko odmerjanje Enkratne odmerke subkutane oblike zdravila Herceptin do 960 mg so dajali brez poročil o neželenih učinkih.
English: Trastuzumab washout period was assessed following subcutaneous administration using the population PK model.
Slovenian: Obdobje izpiranja trastuzumaba je bilo ocenjeno po subkutani aplikaciji zdravila s pomočjo populacijskega farmakokinetičnega modela.
English: If a pregnant woman is treated with Herceptin, or if a patient becomes pregnant while receiving Herceptin or within 7 months following the last dose of Herceptin, close monitoring by a multidisciplinary team is desirable.
Slovenian: Če se noseča ženska zdravi z zdravilom Herceptin ali če bolnica zanosi med zdravljenjem z zdravilom Herceptin ali v obdobju 7 mesecev po prejemu zadnjega odmerka zdravila Herceptin, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
English: (see section 6.2).
Slovenian: (glejte poglavje 4.4).
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without Herceptin, 60 % of the patients had received prior anthracycline-based adjuvant chemotherapy.
Slovenian: (100 mg/m2, infudirano v 1 uri) z zdravilom Herceptin ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na osnovi antraciklinov.
English: Body weight and serum alanine aminotransferase (SGPT/ALT) showed a statistically significant influence on PK, however, simulations demonstrated that no dose adjustments are required in EBC patients.
Slovenian: Telesna masa in serumska alanin-aminotransferaza (SGPT/ALT) sta imeli statistično pomemben vpliv na farmakokinetiko, vendar so simulacije pokazale, da prilagajanje odmerkov pri bolnikih z zgodnjim rakom dojk ni potrebno.
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied.
Slovenian: Kot prva metoda je priporočena imunohistokemijska metoda, v primerih, ko pa je potreben tudi status amplifikacije gena HER2, pa je treba uporabiti tehniko hibridizacije in situ s srebrom (SISH) ali FISH.
English: An absolute benefit of 13 percentage points in favour of the Herceptin arm was estimated in terms of 3-year event-free survival rate (65 % versus.
Slovenian: Absolutna korist 13 odstotnih točk v prid skupini, ki je prejemala zdravilo Herceptin, je bila ocenjena v smislu 3-letnega preživetja brez bolezni (65 % proti 52 %).
English: If the patient has missed a dose of Herceptin by more than one week, a re-loading dose of Herceptin should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Slovenian: Če je bolnik izpustil odmerek zdravila Herceptin za več kot en teden, mu je treba čim prej ponovno dati uvajalni odmerek zdravila Herceptin v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on therapy without additional clinical cardiac events.
Slovenian: Pri večini bolnikov s srčnimi simptomi in znaki klinične koristi zdravljenja z zdravilom Herceptin je nadaljevanje zdravljenja z njim potekalo brez dodatnih kliničnih zapletov v delovanju srca.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Slovenian: Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju Posebna opozorila in previdnostni ukrepi (poglavje 4.4).
English: In addition, treatment of lower body weight patients with Herceptin subcutaneous fixed dose in adjuvant EBC was not associated with increased safety risk, adverse events and serious adverse events, compared to the higher body weight patients.
Slovenian: Poleg tega adjuvantno zdravljenje bolnikov z zgodnjim rakom dojk s fiksnim odmerkom subkutane oblike zdravila Herceptin in manjšo telesno maso ni bilo povezano z večjim tveganjem za varnost, večjim številom neželenih učinkov in resnih neželenih učinkov v primerjavi z bolniki z večjo telesno maso.
English: In a method comparison study (study D008548) a high degree of concordance (>95 %) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Slovenian: V študiji za primerjavo metod (študija D008548) so med tehnikama SISH in FISH za ugotavljanje amplifikacije gena HER2 pri bolnikih z rakom želodca ugotovili visoko stopnjo ujemanja (> 95 %).
English: - capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles
Slovenian: kapecitabin - 1000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
English: * Observed with combination therapy following anthracyclines and combined with taxanes
Slovenian: * Opaženo pri kombinirani uporabi po antraciklinih in sočasno s taksani.
English: Other side effects can occur at any time during treatment with Herceptin.
Slovenian: Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herceptin.
English: Table 6 Efficacy Results from Study BO16348
Slovenian: Rezultati učinkovitosti študije BO16348
English: Cysts and polyps)
Slovenian: (vključno s cistami in polipi)
English: Some of these symptoms can be serious and some patients have died (see the section “Warnings and precautions”).
Slovenian: Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje Opozorila in previdnostni ukrepi).
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Slovenian: · Pripravo mora izvesti usposobljeno osebje v aseptičnih pogojih v skladu s pravili dobre prakse,
English: (95 % CI)
Slovenian: (95-% IZ)
English: In patients receiving Herceptin after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of Herceptin and a body mass index (BMI) >25 kg/m2.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Herceptin po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo zdravila Herceptin in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
English: Serious reactions to intravenous Herceptin have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Slovenian: Resne reakcije po intravensko dajanem zdravilu Herceptin so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
English: A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Slovenian: Štiri odstoten presežek volumna omogoča, da na nalepki naveden odmerek 150 mg res odvzamemo iz viale.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Le za subkutano uporabo.
English: Description of selected adverse reactions with the subcutaneous formulation
Slovenian: Opis izbranih neželenih učinkov pri subkutani obliki
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of 0.9 % sodium chloride solution.
Slovenian: Primerno količino raztopine je potrebno odvzeti iz viale in dodati polivinilkloridni, polietilenski ali polipropilenski infuzijski vrečki, ki vsebuje 250 ml 0,9 % raztopine natrijevega klorida.
English: The local reactions included erythema, pruritus, oedema, rash and pain at the site of the injection.
Slovenian: Lokalne reakcije so vključevale eritem, pruritus, edem, izpuščaj in bolečino na mestu injiciranja.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, betaagonists, and corticosteroids.
Slovenian: Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
English: If other medicines for subcutaneous use are used during the treatment course with Herceptin, a different injection site should be used.
Slovenian: Če med zdravljenjem z zdravilom Herceptin subkutano uporabljate tudi druga zdravila, morate uporabiti drugo mesto injiciranja.
English: For instructions on use and handling of Herceptin subcutaneous formulation refer to section 6.6.
Slovenian: Za navodila za pripravo in ravnanje s subkutano obliko zdravila Herceptin glejte poglavje 6.6.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Herceptin.
Slovenian: Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi zdravila Herceptin prišlo do smrtnih primerov;
English: carboplatin and trastuzumab; CI = confidence interval
Slovenian: ki jima sledita docetaksel in trastuzumab; IZ = interval zaupanja
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih kontuzija
English: Herceptin in the control arm, the addition of Herceptin to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence.
Slovenian: Herceptin v kontrolni skupini, je dodatek zdravila Herceptin kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Slovenian: Vendar pa je za paralelno oceno histologije in morfologije tumorja priporočljiva tehnika SISH.
English: In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
Slovenian: V tem preskušanju je 87 % vključenih bolnikov imelo bolezen, ki je bila IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen,
English: • acute accumulation of fluid in the lungs
Slovenian: · akutno nabiranje tekočine v pljučih
English: +1 Hypotension
Slovenian: +1hipotenzija vazodilatacija
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herceptin.
Slovenian: Če je mogoče, se po prekinitvi zdravljenja z zdravilom Herceptin do 7 mesecev izogibamo zdravljenju z antraciklini.
English: There are no immunogenicity data available for Herceptin in gastric cancer.
Slovenian: Za uporabo zdravila Herceptin pri raku želodca ni na voljo podatkov o imunogenosti.