FrancophonIA/ELRC3.0 huggingface dataset:
English: This leaflet was last revised in April 2019 Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u travnju 2019.
English: A small air bubble may be apparent: this is normal.
Croatian: Može biti vidljiv mjehurić zraka: to je normalno.
English: Ilumetri has not been studied in these patient populations.
Croatian: Ilumetri nije proučavan u ovim populacijama bolesnika.
English: o Do not touch this area again before giving the injection.
Croatian: o Nemojte ponovno dodirivati to mjesto prije davanja injekcije.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment.
Croatian: Potrebno je razmotriti prekid liječenja u bolesnika koji nisu pokazali odgovor nakon 28 tjedana liječenja.
English: Other medicines and Ilumetri
Croatian: Drugi lijekovi i Ilumetri
English: Look out for infections and allergic reactions
Croatian: Pazite na pojavu infekcija i alergijskih reakcija
English: Maintenance of Response
Croatian: Održanost odgovora
English: - DO NOT pull off the needle cover until you are ready to inject.
Croatian: - NEMOJTE skidati pokrov igle dok niste spremni za ubrizgavanje.
English: • Before you use Ilumetri pre-filled syringes, read and carefully follow all the step-by-step instructions.
Croatian: • Prije uporabe napunjenih štrcaljki Ilumetri, pažljivo pročitajte i slijedite korak po korak sve upute.
English: If you use more Ilumetri than you should
Croatian: Ako primijenite više Ilumetrija nego što ste trebali
English: One month after birth, the milk/serum ratio was ≤0.002.
Croatian: Mjesec dana nakon okota, omjer mlijeko/serum bio je ≤0,002.
English: In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
Croatian: U ljudi, u prvih nekoliko dana nakon poroda, protutijela se mlijekom mogu prenijeti novorođenčetu.
English: The effects of this medicine in pregnant women are not known.
Croatian: Učinci ovog lijeka u trudnica nisu poznati.
English: Talk to your doctor about when you will have your injections and follow-up appointments.
Croatian: Razgovarajte sa svojim liječnikom o tome kada treba primjenjivati injekcije i obavljati kontrolne preglede.
English: If you have forgotten or missed an Ilumetri injection, administer the dose as soon as possible.
Croatian: Ako ste zaboravili ili propustili injekciju lijeka Ilumetri, dajte si dozu što prije.
English: Ilumetri can potentially cause serious side effects, including infections and allergic reactions.
Croatian: Ilumetri potencijalno može uzrokovati ozbiljne nuspojave, uključujući infekcije i alergijske reakcije.
English: What Ilumetri looks like and contents of the pack
Croatian: Kako Ilumetri izgleda i sadržaj pakiranja
English: • Repeat the procedure with the second syringe in a different location of your skin if you are administering a dose of 200 mg.
Croatian: • Ponovite postupak s drugom štrcaljkom, na drugom mjestu na koži ako primjenjujete dozu od 200 mg.
English: • Take a carton pack out of the refrigerator and place the original and unopened carton pack on a clean and flat working surface.
Croatian: • Izvadite iz hladnjaka kartonsku kutiju i stavite originalnu i neotvorenu kartonsku kutiju na čistu i ravnu radnu površinu.
English: No data are available on the response to live or inactivated vaccines.
Croatian: Nema dostupnih podataka o odgovoru na živa ili inaktivirana cjepiva.
English: For further information on elimination of tildrakizumab, see section 5.2.
Croatian: Za dodatne informacije o eliminaciji tildrakizumaba, pogledati dio 5.2.
English: Keep the instructions for use and refer to them as needed.
Croatian: Čuvajte upute za primjenu i pročitajte ih ponovno po potrebi.
English: Remove the used syringe
Croatian: Uklonite upotrijebljenu štrcaljku
English: Wait for 30 minutes (if stored in the refrigerator)
Croatian: Pričekajte 30 minuta (ako ste lijek čuvali u hladnjaku)
English: In patients with certain characteristics (e.g. high disease burden, body weight ≥ 90 kg) 200 mg may provide greater efficacy.
Croatian: U bolesnika s određenim značajkama (npr. visoko opterećenje bolešću, tjelesna težina ≥ 90 kg) 200 mg može imati veću djelotvornost.
English: Air bubbles may be present; there is no need to remove them.
Croatian: Moguća je prisutnost mjehurića zraka; ne treba ih uklanjati.
English: Ilumetri has the potential to increase the risk of infection (see section 4.8).
Croatian: Ilumetri ima potencijal povećanja rizika od infekcije (vidjeti dio 4.8).
English: Baseline PGA score was marked or severe in 33.4% of patients.
Croatian: Početni rezultat PGA bio je zamjetan ili težak u 33,4% bolesnika.
English: 2132JH Hoofddorp, Netherlands
Croatian: 2132JH Hoofddorp, Nizozemska
English: Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy.
Croatian: Psoriasis Area and Severity Indeks, PASI) od ≥12, i koji su bili kandidati za fototerapiju ili sistemsku terapiju.
English: If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab.
Croatian: Ako je bolesnik primio živo virusno ili bakterijsko cjepivo, preporučuje se pričekati najmanje 4 tjedna prije početka liječenja tildrakizumabom.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: Studies in mouse tumor models showed that selective inhibition of IL-23p19 does not increase carcinogenic risk.
Croatian: Ispitivanja na modelima mišjih tumora su pokazala da selektivna inhibicija IL-23p19 ne povećava rizik od karcinoma.
English: The clinical significance of these findings is unknown.
Croatian: Nije poznat klinički značaj tih nalaza.
English: Before using the pre-filled syringes:
Croatian: Prije primjene napunjenih štrcaljki:
English: Quality of Life/Patient-reported Outcomes
Croatian: Kvaliteta života / Ishodi prema izvješću bolesnika
English: DLQI Score 0 or 1 (%)
Croatian: Rezultat DLQI 0 ili 1 (%)
English: Inspect the medicine
Croatian: Pregledajte lijek
English: - The upper arm is only suitable when someone else is injecting you.
Croatian: - Nadlaktica je prikladna samo kada Vam lijek ubrizgava netko drugi.
English: Interactions with other immunosuppressive agents or phototherapy
Croatian: Interakcije s drugim imunosupresivima ili fototerapijom
English: What Ilumetri is and what it is used for
Croatian: Što je Ilumetri i zašto se koristi
English: *No imputation of missing data.
Croatian: *Bez imputacije podataka koji nedostaju.
English: A total of 15.4% of study patients had a history of psoriatic arthritis.
Croatian: Ukupno 15,4 % bolesnika uključenih u ispitivanje imalo je anamnezu psorijatičnog artritisa.
English: What Ilumetri is and what it is used for What you need to know before you use Ilumetri How to use Ilumetri
Croatian: Što je Ilumetri i zašto se koristi Što morate znati prije nego počnete primjenjivati Ilumetri Kako primjenjivati Ilumetri
English: If you feel the need, you can use a sticky plaster to cover the injection site.
Croatian: Ako smatrate da je potrebno, za prekrivanje mjesta ubrizgavanja možete upotrijebiti flaster.
English: Stop using Ilumetri and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction (see 4.
Croatian: Prekinite s primjenom lijeka Ilumetri i odmah recite svojem liječniku ili zatražite liječničku pomoć ako primijetite bilo kakve znakove koji upućuju na moguću ozbiljnu infekciju ili alergijsku reakciju (pogledajte dio 4., Moguće nuspojave).
English: • If there is some residual fluid or a tiny bit of blood, clean the injection site with a cotton ball or gauze pad WITHOUT applying any pressure.
Croatian: • Ako ima zaostale tekućine ili male količine krvi, očistite mjesto ubrizgavanja jastučićem vate ili gaze BEZ primjene pritiska.
English: † p≤0.001 versus placebo; ‡ p≤0.001 versus etanercept; ¥ p≤0.05 versus etanercept.
Croatian: † p≤ 0,001 naspram placeba; ‡ p≤ 0,001 naspram etanercepta; ¥ p≤0,05 naspram etanercepta.
English: What you need to know before you use Ilumetri Do not use Ilumetri:
Croatian: Što morate znati prije nego počnete primjenjivati Ilumetri Nemojte primjenjivati Ilumetri:
English: Tildrakizumab has limited extravascular distribution with volume of distribution (Vd) values ranging from 76.9 to 106 mL/kg.
Croatian: Tildrakizumab ima ograničenu ekstravaskularnu distribuciju s rasponom vrijednosti volumena distribucije (Vd) od 76,9 do 106 ml/kg.
English: Mean baseline Dermatology Life Quality Index (DLQI) ranged from 13.0 to 14.8.
Croatian: Dermatology Life Quality Indeks, DLQI) bio je u rasponu od 13,0 do 14,8.
English: Population pharmacokinetic modelling indicated that exposure decreased as body weight increased.
Croatian: Model populacijske farmakokinetike ukazivao je na smanjenje izloženosti s povećanjem tjelesne težine.
English: Very common side effects (may affect more than 1 in 10 people): - Upper respiratory infections
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - infekcije gornjih dišnih puteva
English: This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
Croatian: Tako se aktivira sigurnosni mehanizam koji će nakon davanja injekcije osigurati potpuno uvlačenje igle.
English: Week 28 Week 64 Week 28 Week 64
Croatian: 28. tjedan 64. tjedan 28. tjedan 64. tjedan
English: Proportion of Patients with PASI 90 response over time up to Week 64 (Full Analysis Set Part 3*)
Croatian: Udio bolesnika s odgovorom PASI 90 u razdoblju do 64. tjedna (Potpuni skup podataka za analizu, 3. dio*)
English: Interactions with cytochrome p450
Croatian: Interakcije s citokromom p450
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC17 Mechanism of action
Croatian: Farmakoterapijska skupina: imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC17
English: If you notice any of the following, contact your doctor immediately: - Swelling of the face, lips or throat - Breathing difficulties As these may be signs of an allergic reaction.
Croatian: Ako primijetite bilo što od navedenog, odmah se obratite liječniku: - oticanje lica, usana ili grla - otežano disanje Ovo mogu biti znakovi teške alergijske reakcije.
English: EXP Removal from refrigerator date:
Croatian: Datum vađenja iz hladnjaka:
English: These 355 patients on placebo were subsequently crossed over to tildrakizumab.
Croatian: Tih 355 bolesnika koji su primali placebo naknadno su prebačeni (cross over) na primanje tildrakizumaba.
English: Population PK analysis indicated a 31% higher bioavailability in healthy subjects compared to patients.
Croatian: Populacijska farmakokinetička analiza ukazala je na 31% veću bioraspoloživost u zdravih ispitanika u odnosu na bolesnike.
English: For instructions on how to inject Ilumetri yourself, see ‘Instructions for use' at the end of this leaflet.
Croatian: Za upute o načinu ubrizgavanja lijeka Ilumetri pogledajte „Upute za primjenu” na kraju ove upute.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti hoće li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Ilumetri uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Of all patients, 35.8% had received prior phototherapy, 41.1% had received prior conventional systemic therapy, 16.7% had received prior biologic therapy for the treatment of plaque psoriasis.
Croatian: Od svih bolesnika, 35,8 % ih je prethodno primalo fototerapiju, 41,1 % je primalo konvencionalnu sistemsku terapiju, 16,7 % je prethodno primalo terapiju biološkim lijekovima za liječenje plak psorijaze.
English: No dose recommendations can be made.
Croatian: Ne mogu se dati preporuke za doziranje.
English: • Clean the injection site with an alcohol wipe and allow the skin to dry.
Croatian: • Očistite mjesto ubrizgavanja alkoholnom maramicom i pustite da se koža osuši.
English: 90-degree angle.
Croatian: pod kutem od 90 stupnjeva.
English: Once taken out of the refrigerator, do not store tildrakizumab above 25ºC or refrigerate it again.
Croatian: Nakon što ga jednom izvadite iz hladnjaka, nemojte čuvati tildrakizumab na temperaturi iznad 25ºC, niti ga vraćati u hladnjak.
English: Week 28 Week 52 Week 28 Week 52
Croatian: 28. tjedan 52. tjedan 28. tjedan 52. tjedan
English: The median baseline PASI score ranged from 17.7 to 18.4 across treatment groups.
Croatian: Medijan početnog rezultata PASI bio je u rasponu od 17,7 do 18,4 u svim skupinama liječenja.
English: Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
Croatian: Intravenske doze do najviše 10 mg/kg sigurno su primjenjivane u kliničkim ispitivanjima.
English: A field for the date is provided on the carton to record the removal from refrigerator date.
Croatian: Na kutiji se nalazi polje za datum koje služi za bilježenje datuma vađenja iz hladnjaka.
English: Pregnancy, breastfeeding and fertility
Croatian: Trudnoća, dojenje i plodnost
English: Contents of the pack and other information What Ilumetri contains
Croatian: Sadržaj pakiranja i druge informacije Što sadrži Ilumetri
English: The effect of Ilumetri on human fertility has not been evaluated.
Croatian: Učinak lijeka Ilumetri na plodnost čovjeka još nije procijenjen.
English: The decision to stop using Ilumetri should be discussed with your doctor.
Croatian: Odluku o prekidu primjene Ilumetri trebate razmotriti sa svojim liječnikom.
English: Clinically important active infection, e.g. active tuberculosis (see section 4.4).
Croatian: Klinički značajna aktivna infekcija, npr. aktivna tuberkuloza (vidjeti dio 4.4).
English: Ilumetri is not recommended for use in children and adolescents under 18 years of age.
Croatian: Ilumetri se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ilumetri in one or more subsets of the paediatric population in the treatment of plaque psoriasis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Ilumetri u jednoj ili više podskupina pedijatrijske populacije u liječenju plak psorijaze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Croatian: Tildrakizumab pripada skupini lijekova pod nazivom inhibitori interleukina (IL).
English: The safety and efficacy of Ilumetri in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.
Croatian: Nije procijenjivana sigurnost i djelotvornost lijeka Ilumetri u kombinaciji s drugim imunosupresivima, uključujući biološke, niti u kombinaciji s fototerapijom.
English: Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines.
Croatian: Prije započinjanja liječenja tildrakizumabom treba razmotriti provođenje svih odgovarajućih imunizacija u skladu s važećim smjernicama za imunizaciju.
English: Solution for injection (injection)
Croatian: Otopina za injekciju (injekcija)
English: PRODUCT DESCRIPTION
Croatian: OPIS PROIZVODA
English: Results from a drug-drug interaction study conducted in plaque psoriasis subjects suggest that tildrakizumab had no clinically relevant effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Croatian: Rezultati ispitivanja interakcija među lijekovima provedenog u ispitanika s plak psorijazom ukazuju da tildrakizumab nije imao klinički značajan učinak na CYP1A2, CYP2C9, CYP2C19, CYP2D6 i CYP3A4.
English: Ilumetri is available in unit packs containing 1 pre-filled syringe and packs comprising 2 pre-filled syringes.
Croatian: Ilumetri je dostupan u jediničnim pakiranjima koja sadrže 1 napunjenu štrcaljku i u pakiranjima koja sadrže 2 napunjene štrcaljke.
English: This medicine works by blocking the activity of a protein called IL-23, a substance found in the body which is involved in normal inflammatory and immune responses and which is present at increased levels in diseases such as psoriasis.
Croatian: Ovaj lijek djeluje tako što blokira aktivnost proteina pod nazivom IL-23, tvari koja se nalazi u tijelu i sudjeluje u normalnim upalnim i imunološkim odgovorima, a u bolestima poput psorijaze je prisutna u povećanim razinama.
English: Pull off the needle cover
Croatian: Skinite pokrov igle
English: • Remove the needle from the skin entirely before letting go of the blue plunger.
Croatian: • Izvucite cijelu iglu iz kože prije otpuštanja plavog klipa.
English: Results obtained at weeks 12, 28 and beyond (up to week 64 in reSURFACE 1 and up to week 52 in reSURFACE 2) are presented in Table 2 and Table 3.
Croatian: Rezultati dobiveni u 12. i 28. tjednu i kasnije (do 64. tjedna u ispitivanju reSURFACE 1 i do 52. tjedna u ispitivanju reSURFACE 2) prikazani su u Tablici 2 i Tablici 3.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i najmanje 17 tjedana nakon liječenja.
English: Prior to use, a visual inspection of the pre-filled syringe is recommended.
Croatian: Prije uporabe preporučuje se vizualna provjera napunjene štrcaljke.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks.
Croatian: U nekih bolesnika s početnim djelomičnim odgovorom može doći do naknadnog poboljšanja uz terapiju koja se nastavlja i nakon 28 tjedana.
English: o A complete dose is administered if the blue plunger cannot go any further, and there are no spills.
Croatian: o Cijela doza je primjenjena ako plavi klip ne može ići dalje i ne izlijeva se tekućina.
English: *The number of doses administered refers only to tildrakizumab groups.
Croatian: * Broj primijenjenih doza odnosi se samo na skupine liječene tildrakizumabom.
English: o After the blue plunger is released, the safely lock will draw the needle inside the needle guard.
Croatian: o Nakon otpuštanja plavog klipa, sigurnosni mehanizam će uvući iglu u štitnik igle.
English: Maintenance and durability of PASI 90 Response.
Croatian: Slika 1. Održanost i trajnost odgovora PASI 90.
English: Elderly No dose adjustment is required (see section 5.2).
Croatian: Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of Ilumetri in comparison to placebo.
Croatian: Integrirana su tri klinička ispitivanja (faze IIb i dva ispitivanja faze III) za procjenu sigurnosti lijeka Ilumetri u usporedbi s placebom.
English: This is what Ilumetri pre-filled syringe looks like:
Croatian: Napunjene štrcaljke Ilumetri izgledaju ovako:
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedljivosti bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: No effects on fertility parameters such as reproductive organs, menstrual cycle length, and/or hormones were observed in male and female cynomolgus monkeys that were administered tildrakizumab at doses resulting in >100 times the human exposure at the recommended clinical dose based on AUC.
Croatian: Nisu zabilježeni učinci na parametre plodnosti, poput reproduktivnih organa, trajanja menstrualnog ciklusa i/ili hormone u mužjaka i ženki makaki majmuna kojima je davan tildrakizumab u dozama koje su prema AUC-u rezultirale >100 puta većom izloženošću u odnosu na izloženost u ljudi pri preporučenim kliničkim dozama.
English: Tildrakizumab is a humanized IgG1/k monoclonal antibody that specifically binds to the p19 protein subunit of the interleukin-23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor.
Croatian: Tildrakizumab je humano monoklonsko protutijelo IgG1/κ koje se specifično veže na p19 proteinsku podjedinicu citokina interleukin-23 (IL-23) bez vezivanja na IL-12 i sprječava njegovu interakciju s IL-23 receptorom.
English: At week 12 and across studies, tildrakizumab was associated with statistically significant improvement in Health-related Quality of Life as assessed by the DLQI (Table 2).
Croatian: U 12. tjednu, u svim ispitivanjima, tildrakizumab je bio povezan sa statistički značajnim poboljšanjem kvalitete života povezane sa zdravljem prema procjeni DLQI (Tablica 2).
English: After repeated dosing to pregnant cynomolgus monkeys, serum concentrations were quantifiable in the fetus, but the reproduction toxicity studies did not reveal any untoward effects.
Croatian: Nakon ponovljenog doziranja u gravidnih makaki majmunica, zabilježene su mjerljive koncentracije tildrakizumaba u serumu ploda, ali ispitivanja reproduktivne toksičnosti nisu otkrila nikakve neželjene učinke.
English: Overall demographic and baseline characteristics in reSURFACE1 and reSURFACE2 studies were consistent across individual trials.
Croatian: Ukupne demografske i osnovne karakteristike u ispitivanjima reSURFACE 1 i reSURFACE 2 bile su dosljedne kroz pojedinačna ispitivanja.
English: Its colour may vary from colourless to slightly yellow.
Croatian: Njezina boja može varirati od bezbojne do svijetlo žute.
English: IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.
Croatian: IL-23 je citokin koji se prirodno pojavljuje i sudjeluje u upalnim i imunološkim odgovorima.
English: • Press down the blue plunger until it can go no further.
Croatian: • Potisnite plavi klip prema dolje dokle ide.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni tildrakizumaba u trudnica ograničeni (manje od 300 trudnoća).
English: • Leave the pre-filled syringe in the Ilumetri carton (with the lid closed) and let it sit at room temperature for 30 minutes.
Croatian: • Ostavite napunjenu štrcaljku u kutiji Ilumetri (sa zatvorenim poklopcem) i neka stoji na sobnoj temperaturi 30 minuta kako bi se zagrijala.
English: Patients receiving Ilumetri should be closely monitored for signs and symptoms of active TB during and after treatment.
Croatian: Bolesnike koji primaju Ilumetri nužno je pozorno pratiti zbog moguće pojave znakova i simtoma aktivnog TBC-a tijekom i nakon liječenja.
English: • On a clean, well-lit work surface, place the: - alcohol wipes - cotton ball or gauze pad
Croatian: • Na čistu, dobro osvijetljenu radnu površinu stavite: - alkoholne maramice - jastučić od vate ili od gaze - flaster - spremnik za odlaganje oštrih predmeta
English: In the active comparator study (reSURFACE 2), patients were also randomised to receive etanercept 50 mg twice weekly for 12 weeks, and weekly thereafter up to 28 weeks.
Croatian: U ispitivanju s aktivnim komparatorom (reSURFACE 2), bolesnici su također randomizirani za primanje etanercepta od 50 mg dvaput tjedno tijekom 12 tjedana, a zatim jednom tjedno do 28 tjedana.
English: - Check the expiration date on the carton and pre-filled syringe and discard if the date has passed.
Croatian: - Provjerite rok valjanosti na kutiji i napunjenoj štrcaljki i bacite je ako je navedeni datum prošao.
English: The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain.
Croatian: Najčešće nuspojave su infekcije gornjeg respiratornog trakta, glavobolja, gastroenteritis, mučnina, proljev, bol na mjestu davanja injekcije i bol u leđima.