FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (≥ 1/1,000 to < 1/100) Hepatic enzyme increased Not known (cannot be estimated from the available data)
Croatian: Manje često (≥1/1000 i < 1/100) Povišene razine jetrenih enzima Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: The majority of CAPS patients in Study 03-AR-0298 developed anakinra anti-drug antibodies.
Croatian: Većina bolesnika s CAPS-om u kliničkom ispitivanju 03-AR-0298 razvila je antitijela protiv lijeka s anakinrom.
English: Medicines called tumour necrosis factor (TNF-α) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.
Croatian: Lijekovi pod nazivom inhibitori faktora tumorske nekroze (TNF-α) poput etanercepta ne smiju se upotrebljavati istodobno s Kineretom jer mogu povećati rizik od infekcija.
English: INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF KINERET
Croatian: UPUTE ZA PRIPREMU I PRIMJENU INJEKCIJE KINERETA
English: A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Croatian: Formalne studije toksikoloških i toksikokinetičkih interakcija u štakora nisu dokazale da Kineret mijenja toksikološki ili farmakokinetički profil metotreksata.
English: Data from mice over expressing IL-1ra and IL-1ra mutant knock-out mice, did not indicate an increased risk of tumour development.
Croatian: Podaci dobiveni na miševima s prekomjernom ekspresijom IL-1ra i mutiranim „knock-out“ IL-1ra miševima nisu ukazivali na povećani rizik od razvoja tumora.
English: The pre-filled syringe should not be shaken.
Croatian: Napunjenu štrcaljku ne smije se tresti.
English: - The active substance is anakinra.
Croatian: - Djelatna tvar je anakinra.
English: Significant improvements are seen in the pain, tender joint count, physical function (HAQ score), acute phase reactants and in the patient's and physician's global assessment.
Croatian: Značajna poboljšanja viđena su kod procjene boli, broja osjetljivih zglobova, fizičke funkcije (HAQ rezultat), reaktanata akutne faze i opće procjene od strane bolesnika i od strane liječnika.
English: For more information on neutropenia see section 4.8.
Croatian: Za više informacija o neutropeniji vidjeti dio 4.8.
English: Population pharmacokinetic analysis demonstrated that the mean plasma clearance value after subcutaneous bolus administration was approximately 14% higher in men than in women and approximately 10% higher in subjects < 65 years than in subjects ≥ 65 years.
Croatian: Farmakokinetičke analize na populaciji pokazale su da je prosječna vrijednost klirensa u plazmi nakon supkutane bolusne injekcije bila za približno 14% viša u muškaraca nego u žena te približno 10% viša u ispitanika mlađih od 65 godina i onih starijih od 65 godina.
English: None of the syringe or needle shield components are made with natural rubber latex.
Croatian: Nijedna komponenta štrcaljke niti štitnika igle ne sadrži lateks prirodnu gumu.
English: What you need to know before you use Kineret Do not use Kineret
Croatian: Što morate znati prije nego počnete primjenjivati Kineret
English: Spontaneous mutations in the CIAS1/NLRP3 gene have been identified in a majority of patients with CAPS.
Croatian: Spontane mutacije u genu CIAS1/NLRP3 utvrđene su u većine bolesnika s CAPS-om.
English: inflammation, and pain.
Croatian: ekhimoza, upala i bol.
English: Child
Croatian: Dijete
English: This would be clinically relevant for CYP450 substrates with a narrow therapeutic index (e.g. warfarin and phenytoin).
Croatian: To može biti od kliničkog značaja za supstrate CYP450 s uskim terapijskim indeksom (npr. varfarin i fenitoin).
English: If Kineret treatment is continued during serious infections to reduce the risk for a disease flare, careful monitoring is required.
Croatian: Ako se liječenje Kineretom tijekom ozbiljnih infekcija nastavi kako bi se smanjio rizik od ponovnog izbijanja bolesti, potrebno je pažljivo praćenje.
English: A rapid and sustained decrease in the levels of the inflammatory biomarkers; serum amyloid A (SAA), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and a normalization of inflammatory hematological changes are seen.
Croatian: Primijećeno je brzo i trajno smanjenje razina upalnih biomarkera; serumskog amiloida A (SAA), C-reaktivnog proteina (CRP) i brzine sedimentacije eritrocita te normalizacija upalnih hematoloških parametara.
English: Patients with Still's disease have an increased risk of spontaneous development of MAS.
Croatian: Bolesnici sa Stillovom bolešću imaju povećan rizik od spontanog razvoja MAS-a.
English: Kineret must be injected under your skin (subcutaneous) daily.
Croatian: Kineret treba svaki dan injicirati pod kožu (supkutano).
English: The influence of demographic covariates on the pharmacokinetics of anakinra was studied using population pharmacokinetic analysis encompassing 341 patients receiving daily subcutaneous injection of anakinra at doses of 30, 75, and 150 mg for up to 24 weeks.
Croatian: Utjecaj demografskih kovarijanti na farmakokinetiku anakinre proučavan je uporabom analiza populacijske farmakokinetike koja je obuhvatila 341 bolesnika koji su supkutanom injekcijom dnevno dobivali anakinru u dozama od 30, 75 i 150 mg do 24 tjedna.
English: Make sure you know what Kineret dose your doctor has prescribed; 20 to 90 mg, 100 mg or higher.
Croatian: Morate znati koju Vam je dozu Kinereta liječnik propisao; dozu od 20 do 90 mg, 100 mg ili višu.
English: Immediately discard the needle cover.
Croatian: Pokrov igle odmah bacite.
English: Mean (SD) estimates of clearance (CL/F) and volume of distribution (Vd/F) by population analysis of data from two PK studies in 35 RA patients were 105(27) ml/min and 18.5(11) l, respectively.
Croatian: Srednje (SD) vrijednosti klirensa (CL/F) i volumena distribucije (Vd/F) dobivene analizom populacijskih podataka iz dva farmakokinetička ispitivanja u 35 bolesnika s RA iznosile su 105(27) ml/min odnosno 18,5(11) l.
English: In RA, CAPS and in Still's disease, your body produces too much of a cytokine called interleukin-1.
Croatian: Ako imate RA, CAPS ili Stillovu bolest, Vaše tijelo stvara previše citokina zvanog interleukin-1.
English: CIAS1/NLRP3 encodes for cryopyrin, a component of the inflammasome.
Croatian: CIAS1/NLRP3 kodira kriopirin, komponentu inflamasoma.
English: Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret.
Croatian: ukupna incidencija malignih bolesti nije porasla tijekom 3 godine izlaganja bolesnika Kineretu.
English: The recommended dose is either 20 to 90 mg or 100 mg.
Croatian: Preporučena doza je od 20 do 90 mg ili 100 mg.
English: The efficacy and safety of Kineret in patients with AST/ALT ≥ 1.5 x upper level of normal have not been evaluated.
Croatian: Djelotvornost i sigurnost Kinereta u bolesnika s vrijednostima AST/ALT ≥1,5 x u odnosu na gornju granicu normale nije ocijenjena.
English: • alcohol wipes or similar; and
Croatian: • alkoholom natopljene vatice ili tome slično i
English: Hold the syringe barrel and gently remove the cover from the needle without twisting.
Croatian: Držite tijelo štrcaljke i polako skinite pokrov s igle bez uvrtanja.
English: How do you or the person injecting you, use the Kineret pre-filled syringe?
Croatian: Kako ćete Vi ili osoba koja Vam injicira Kineret upotrijebiti napunjenu štrcaljku Kinereta?
English: No dose adjustment are expected to be required.
Croatian: Ne očekuje se potreba za prilagodbom doze.
English: For RA, Kineret is used to treat the signs and symptoms of the disease in adults (age 18 years and over) in combination with another medicine called methotrexate.
Croatian: U slučaju RA, Kineret se koristi za ublažavanje znakova i simptoma bolesti u odraslih (starih 18 i više godina) u kombinaciji s drugim lijekom koji se zove metotreksat.
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible.
Croatian: Ako se razvije MAS ili se na njega sumnja, treba što prije procijeniti stanje bolesnika i započeti liječenje.
English: • The used pre-filled syringe and any gauze or tissue with Kineret solution should be disposed of in accordance with local requirements.
Croatian: • Korištenu napunjenu štrcaljku i sve gaze i maramice s otopinom Kinereta valja zbrinuti u skladu s lokalnim propisima.
English: No effects on embryo-foetal development in the rabbit were observed at doses 100 times the human dose.
Croatian: Nisu primijećeni učinci na embriofetalni razvoj u kunića pri dozama 100 puta većim od doze za ljude.
English: How to prepare a 20 to 90 mg dose
Croatian: Kako pripremiti dozu od 20 do 90 mg
English: Symptoms of lung disease can be e.g. shortness of breath during light exercise, morning cough, and difficulties breathing.
Croatian: Simptomi bolesti pluća mogu biti npr. nedostatak zraka tijekom lagane tjelovježbe, kašalj koji se javlja ujutro i otežano disanje.
English: Kineret was temporarily stopped in one patient, all other patients continued Kineret treatment during the infections.
Croatian: Primjena Kinereta privremeno je prekinuta u jednog bolesnika, svi ostali bolesnici nastavili su primati Kineret za trajanja infekcije.
English: Clinical efficacy and safety in RA
Croatian: Klinička djelotvornost i sigurnost u RA
English: Dose increases may become necessary within 1-2 months based on therapeutic response.
Croatian: Ovisno o terapijskom odgovoru, unutar 1-2 mjeseca može biti potrebno povisiti dozu.
English: If you feel unwell in any way you should contact your doctor or nurse immediately.
Croatian: Ako se ne osjećate dobro na bilo koji način, odmah se obratite svom liječniku ili medicinskoj sestri.
English: Additional information on MAS is provided below.
Croatian: Dodatne informacije o MAS-u navedene su u nastavku.
English: These study data are insufficient to demonstrate efficacy and, therefore, Kineret is not recommended for paediatric use in JIA.
Croatian: Podaci dobiveni u ispitivanju nisu dostatni kao dokaz djelotvornosti te se stoga primjena Kinereta ne preporučuje u pedijatrijskih bolesnika s JIA.
English: Frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: It is recommended that neutrophil counts be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly during the first 6 months of treatment and quarterly hereafter.
Croatian: Preporučuje se broj neutrofilnih leukocita odrediti prije početka liječenja Kineretom i za vrijeme uzimanja Kinereta, svaki mjesec tijekom prvih 6 mjeseci liječenja i nakon toga kvartalno.
English: The pre-filled syringe has an outer rigid plastic needle shield attached to an inner needle cover.
Croatian: Napunjena štrcaljka ima pričvršćen vanjski kruti plastični štitnik igle na unutarnji pokrov igle.
English: Disinfect the skin by using the alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Croatian: Dezinficirajte kožu primjenom alkoholne maramice i uhvatite nabor kože između palca i kažiprsta bez stiskanja.
English: Very common (≥ 1/10)
Croatian: Vrlo često (≥ 1/10)
English: Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Croatian: Stoga se može očekivati da će antagonist receptora IL-1 poput anakinre tijekom liječenja dovesti do normalizacije u stvaranju enzima CYP450.
English: Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
Croatian: Kineret se može davati kao monoterapija ili u kombinaciji s drugim protuupalnim lijekovima i lijekovima koji modificiraju tijek bolesti (DMARD-ovima).
English: The presence of these particles does not affect the quality of the product.
Croatian: Prisutnost ovih čestica ne utječe na kakvoću lijeka.
English: Kineret has been studied in 36 CAPS patients, 15 SJIA patients and 71 patients with other forms of JIA, aged 8 months to <18 years, for up to 5 years.
Croatian: Kineret je ispitivan u 36 ispitanika s CAPS-om, 15 bolesnika sa SJIA i 71 bolesnika s drugim oblicima JIA, u dobi od 8 mjeseci do <18 godina, do najdulje 5 godina.
English: In a published prospective, uncontrolled, observational cohort study of 20 patients with new-onset SJIA Kineret was used as initial therapy after failure to respond to NSAIDs, but before the use of DMARDs, systemic glucocorticoids, or other biologic agents.
Croatian: U objavljenom prospektivnom, nekontroliranom, opservacijskom kohortnom ispitivanju u 20 bolesnika s novonastalim SJIA Kineret se primjenjivao kao početna terapija nakon izostanka odgovora na NSAIL-ove, ali prije primjene DMARD-ova, sistemskih glukokortikoida ili drugih bioloških lijekova.
English: If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Croatian: Ako imate pitanja o tome kako injicirati, obratite se svom liječniku, medicinskoj sestri ili ljekarniku za pomoć.
English: As a precautionary measure, it is preferable to avoid the use of anakinra during pregnancy and in woman of childbearing potential not using contraception.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka anakinra tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: The MAH shall ensure that in each Member State where Kineret is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe or use Kineret have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja osigurat će da u svakoj pojedinoj državi članici u kojoj se Kineret stavlja na tržište svi zdravstveni radnici i bolesnici/njegovatelji za koje se očekuje da će propisivati ili primjenjivati
English: The absorption process is the rate-limiting factor for the disappearance of anakinra from the plasma after subcutaneous injection.
Croatian: Postupak apsorpcije je čimbenik koji ograničava brzinu nestanka anakinre iz plazme nakon supkutane injekcije.
English: Both episodes of neutropenia resolved over time with continued Kineret treatment.
Croatian: Obje epizode neutropenije povukle su se s vremenom kontinuiranim liječenjem Kineretom.
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with Still's disease.
Croatian: Macrophage activation syndrome, MAS) poznat je, životno ugrožavajući poremećaj koji se može razviti u bolesnika sa Stillovom bolešću.
English: In RA patients, no unexpected accumulation of anakinra was observed after daily subcutaneous doses for up to 24 weeks.
Croatian: U bolesnika s RA nije primijećeno neočekivano nakupljanje anakinre nakon supkutanih doza lijeka primjenjivanih dnevno u trajanju do 24 tjedna.
English: The safety profile in paediatric patients was similar to that seen in adult populations and no clinically relevant new adverse reactions were seen.
Croatian: Sigurnosni profil u pedijatrijskih bolesnika bio je sličan onomu u odrasloj populaciji te nisu primijećene klinički značajne nuspojave.
English: The solution should not be used if it is discoloured or cloudy, or if any particles other than translucent-to-white particles are present.
Croatian: Otopina se ne smije primijeniti ako je promijenila boju, ako je zamućena ili ako su prisutne neke druge čestice osim prozirnih do bijelih čestica.
English: Physicians should be attentive to symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
Croatian: Liječnici trebaju paziti na pojavu simptoma infekcije ili pogoršanja Stillove bolesti, jer su to poznati okidači za MAS.
English: Hypersensitivity to the active substance or to to any of the excipients listed in section 6.1 or to E. coli derived proteins.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na proteine porijeklom iz E. coli.
English: Store in original carton in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: - Increased total blood cholesterol levels.
Croatian: - Povišene razine ukupnog kolesterola u krvi.
English: In the severe form of CAPS, long-term treatment improves the systemic inflammatory organ manifestations of the eye, inner ear, and CNS.
Croatian: Kod teških oblika CAPS-a dugotrajno liječenje poboljšava manifestacije sustavne upale na oku, unutarnjem uhu i središnjem živčanom sustavu.
English: Neutrophil decreases occurred more frequently in patients receiving Kineret compared with placebo.
Croatian: Smanjenje broja neutrofila događalo se češće u bolesnika koji primaju Kineret u usporedbi s placebom.
English: Similar rates were obtained for the groups on the SOC level, except for eye disorders with 55 AEs (rate 0.5), whereof 35 ocular hyperemia (which could also be a symptom of CAPS) in the CIAS1 group, and 4 AEs in the non-CIAS1 group (rate 0.1).
Croatian: Slične stope dobivene su i na razini organskih sustava, osim za poremećaje vida gdje je prijavljeno 55 štetnih događaja (stopa od 0,5), od čega 35 slučajeva okularne hiperemije (koja može biti i simptom CAPS-a) u skupini CIAS1 i 4 štetna događaja u skupini ne-CIAS1 (stopa od 0,1).
English: During post-marketing use hepatic events, not affecting liver function, have been reported.
Croatian: Tijekom postmarketinške primjene prijavljeni su hepatički događaji koji nisu utjecali na funkciju jetre.
English: Anakinra inhibits responses elicited by IL-1 in vitro, including the induction of nitric oxide and prostaglandin E2 and/or collagenase production by synovial cells, fibroblasts, and chondrocytes.
Croatian: Anakinra inhibira odgovore potaknute interleukinom-1 in vitro uključujući indukciju dušikova oksida i prostaglandina E2 i/ili stvaranje kolagenaze u sinovijalnim stanicama, fibroblastima i hondrocitima.
English: Still's disease, in addition to various degrees of arthritis, is characterised by systemic inflammatory features such as spiking fever, skin rash, hepatosplenomegaly, serositis, and increased acute phase reactants driven by IL-1 activity.
Croatian: Stillova bolest je, osim različitim stupnjevima artritisa, karakterizirana sistemskim upalnim značajkama kao što su intermitentna vrućica, osip na koži, hepatosplenomegalija, serozitis i povišeni reaktanti akutne faze zbog aktivnosti IL-1.
English: Pulmonary Events
Croatian: Plućni događaji
English: - if you are allergic to anakinra or any of the other ingredients of this medicine, listed in section 6; - if you are allergic to other products that are produced by DNA technology using the micro organism E. coli; - if you have neutropenia (low white blood cell count) determined after a blood test.
Croatian: - ako ste alergični na anakinru ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.); - ako ste alergični na druge lijekove koji su dobiveni tehnologijom DNK pomoću mikroorganizma
English: Neither did anakinra increase the incidence of chromosomal abnormalities or micronuclei in bone marrow cells in mice.
Croatian: Anakinra nije ni povećala incidenciju kromosomskih abnormalnosti ili abnormalnosti u mikrojezgrama stanica koštane srži u miševa.
English: Kineret is eliminated by glomerular filtration and subsequent tubular metabolism.
Croatian: Oštećenje funkcije bubrega Kineret se eliminira glomerularnom filtracijom i zatim tubularnim metabolizmom.
English: • the top of the thighs
Croatian: • gornji dio bedra
English: Analysis of treatment-emergent AEs classified by presence of CIAS1 mutation showed that there were no major differences between the CIAS1 and non-CIAS1 groups in overall AE reporting rates, 7.4 and 9.2, respectively.
Croatian: Analiza štetnih događaja povezanih s liječenjem klasificiranih prema prisutnosti mutacije gena CIAS1 pokazala je da ne postoje značajne razlike između skupina CIAS1 i ne-CIAS1 u ukupnoj stopi prijavljenih štetnih događaja, odnosno da one iznose 7,4 za CIAS1 i 9,2 za ne-CIAS1.
English: In 43 CAPS patients followed for up to 5 years the frequency of serious infections was 0.1/year, the most common being pneumonia and gastroenteritis.
Croatian: U 43 bolesnika s CAPS-om praćenih najdulje do 5 godina učestalost ozbiljnih infekcija iznosila je 0,1/godišnje, najčešće u obliku upale pluća i gastroenteritisa.
English: Infections have been noted in all organ systems and have been reported in patients receiving Kineret alone or in combination with immunosuppressive agents.
Croatian: Infekcije su zabilježene u svim organskim sustavima te su prijavljene u bolesnika koji su primali samo Kineret ili Kineret u kombinaciji s imunosupresivnim lijekovima.
English: The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1,790 RA patients ≥ 18 years of age with varying degrees of disease severity.
Croatian: Sigurnost i djelotvornost anakinre u kombinaciji s metotreksatom dokazana je u 1790 bolesnika s RA u dobi ≥ 18 godina s različitim stupnjevima težine bolesti.
English: Untreated CAPS patients are characterized by increased CRP, SAA and IL-6 relative to normal serum levels.
Croatian: Bolesnici s neliječenim CAPS-om imaju povišene razine CRP-a, SAA-a i IL-6 u odnosu na normalne razine u serumu.
English: • If your doctor has prescribed a 100 mg dose you should continue to the “How to prepare a
Croatian: • Ako Vam je liječnik propisao dozu od 100 mg, idite na odjeljak „Kako pripremiti dozu od
English: The infections observed consisted primarily of bacterial events such as cellulitis, pneumonia, and bone and joint infections.
Croatian: Primijećene infekcije sastojale su se prvenstveno od bakterijskih infekcija poput celulitisa, upale pluća i infekcija kosti i zglobova.
English: The active substance of Kineret is anakinra, this works in the same way as your natural interleukin-1 blocking protein.
Croatian: Djelatna tvar Kinereta je anakinra koja radi na isti način kao Vaša prirodna bjelančevina koji blokira interleukin-1.
English: CAPS: Data in elderly patients are limited.
Croatian: CAPS: Podaci za starije osobe su ograničeni.
English: In clinical studies of RA, 775 patients treated with daily Kineret doses of 30 mg, 75 mg, 150 mg, 1 mg/kg or 2 mg/kg, there was an increase of 2.4% to 5.3% in total cholesterol levels 2 weeks after start of Kineret treatment, without a dose-response relationship.
Croatian: U kliničkim ispitivanjima reumatoidnog artritisa u 775 bolesnika liječenih dnevnim dozama Kinereta od 30 mg, 75 mg, 150 mg, 1 mg/kg ili 2 mg/kg, dva tjedna nakon početka liječenja Kineretom došlo je do povećanja razine ukupnog kolesterola za 2,4% do 5,3%, neovisno o dozi.
English: RA patients may be at a higher risk (on average 2-3 fold) for the development of lymphoma.
Croatian: Bolesnici s RA mogu biti u većem riziku od razvoja limfoma (u prosjeku 2-3 puta).
English: CAPS: Adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above
Croatian: CAPS: Odrasli, adolescenti, djeca i dojenčad u dobi od 8 mjeseci i stariji s tjelesnom težinom od najmanje 10 kg ili više
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.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi/rizik,
English: No data are available on either the effects of live vaccination or on the secondary transmission of infection by live vaccines in patients receiving Kineret.
Croatian: Nema dostupnih podataka o učincima cijepljenja živim cjepivima ili o sekundarnom prijenosu infekcije živim cjepivima u bolesnika koji primaju Kineret.