FrancophonIA/ELRC3.0 huggingface dataset:
English: In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Croatian: U eksplorativnom kliničkom ispitivanju u kojem se ocjenjivala primjena drugog TNF-blokatora, infliksimaba, u bolesnika s umjerenom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB) prijavljeno je više slučajeva zloćudnih bolesti, većinom pluća te glave i vrata, u bolesnika liječenih infliksimabom u odnosu na bolesnike u kontrolnoj skupini.
English: What Simponi contains The active substance is golimumab.
Croatian: Što Simponi sadrži Djelatna tvar je golimumab.
English: No dose adjustment is required in the elderly.
Croatian: Starije osobe (≥ 65 godina) Nije potrebna prilagodba doze u starijih osoba.
English: Improvements in key measures of disease activity were observed at the first assessment (week 4) after the initial Simponi administration and were maintained through week 24.
Croatian: Poboljšanja u ključnim mjerilima aktivnosti bolesti zabilježena su na prvom kontrolnom pregledu nakon početne primjene lijeka Simponi (4. tjedan) i održala su se do 24. tjedna.
English: • A statement that the brand name and batch number should be recorded.
Croatian: • Napomenu da treba zabilježiti zaštićeno ime i broj serije lijeka.
English: Do not lift the pre-filled pen from the skin during the injection.
Croatian: Nemojte podizati napunjenu brizgalicu s kože tijekom injiciranja.
English: • Infection of the joints or the tissue around them
Croatian: • infekcija zglobova ili okolnog tkiva
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports the dosing regimen of golimumab 30 mg/m2 every 4 weeks in children with pJIA.
Croatian: Populacijsko farmakokinetičko/farmakodinamičko modeliranje i simulacija u djece s pJIA potvrdili su povezanost između izloženosti golimumabu u serumu i kliničke djelotvornosti te podupiru režim doziranja golimumaba u dozi od 30 mg/m2 svaka 4 tjedna u djece s pJIA.
English: Gently, press the plunger up with your thumb until it stops.
Croatian: Palcem nježno potisnite klip sve dok se ne zaustavi.
English: If you do not respond well enough to these medicines, you will be given Simponi in combination with methotrexate to treat the disease.
Croatian: Ako ne odgovorite dobro na te lijekove, dobit ćete Simponi u kombinaciji s metotreksatom za liječenje te bolesti.
English: Symptoms of lymphoma can include swelling of the lymph nodes, weight loss, or fever.
Croatian: Simptomi limfoma mogu uključivati oticanje limfnih čvorova, gubitak tjelesne težine ili vrućicu.
English: • Store in a refrigerator (2°C-8°C).
Croatian: • Čuvati u hladnjaku (2°C-8°C).
English: Symptoms of nervous system disease can include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Croatian: Simptomi bolesti živčanog sustava mogu uključivati promjene u vidu, slabost u rukama ili nogama, obamrlost ili trnce u bilo kojem dijelu tijela.
English: Do not attempt to use any leftover medicine in the pre-filled pen.
Croatian: Nemojte pokušavati primijeniti lijek preostao u napunjenoj brizgalici.
English: If you do not respond well enough to these medicines, you may be given Simponi to:
Croatian: Ako na te lijekove ne odgovorite dobro, možete dobiti Simponi kako bi se:
English: • Sinus infection
Croatian: • infekcija sinusa
English: At week 52, 15% of patients in the Simponi 50 mg + MTX group achieved a major clinical response compared with 7% of patients in the placebo + MTX group (p = 0.018).
Croatian: U 52. tjednu, 15% bolesnika u skupini koja je primala Simponi 50 mg i MTX postignut je glavni klinički odgovor u odnosu na 7% bolesnika u skupini koja je primala placebo i MTX (p = 0,018).
English: You will find detailed “Instructions for Use” included with this leaflet.
Croatian: Detaljne "Upute za uporabu" navedene su u ovoj uputi o lijeku.
English: The diagram below (see figure 1) shows what the “SmartJect” pre-filled pen looks like.
Croatian: Na donjem crtežu (vidjeti sliku 1) prikazano je kako izgleda napunjena brizgalica "SmartJect".
English: • Slow down the damage to your bones and joints.
Croatian: • Usporilo razaranje kostiju i zglobova.
English: Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Croatian: Treba ponovno razmotriti nastavak liječenja u bolesnika u kojih se unutar tog razdoblja ne uoče dokazi o koristi terapije.
English: If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines.
Croatian: Ako imate ankilozantni spondilitis ili aksijalni spondiloartritis bez radiološkog dokaza, najprije ćete dobiti druge lijekove.
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Simponi.
Croatian: Ako niste sigurni odnosi li se nešto od navedenog na Vas, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene lijeka Simponi.
English: Statistically significant responses in BASDAI 50, 70 and 90 (p ≤ 0.017) were also seen at weeks 14 and 24.
Croatian: U 14. i 24. tjednu primijećeni su statistički značajni odgovori i za BASDAI 50, 70 i 90 (p ≤ 0,017).
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports that the dosing regimen of golimumab 50 mg every 4 weeks in children with pJIA of at least 40 kg achieves similar exposures to those shown to be efficacious in adults.
Croatian: Populacijsko farmakokinetičko/farmakodinamičko modeliranje i simulacija u djece s pJIA potvrdili su povezanost između izloženosti golimumabu u serumu i kliničke djelotvornosti te podupiru nalaz da se režimom doziranja golimumaba u dozi od 50 mg svaka 4 tjedna u djece s pJIA i tjelesnom težinom od najmanje 40 kg postižu razine izloženosti slične onima koje su se pokazale djelotvornima u odraslih.
English: • Check the expiration date printed or written on the carton.
Croatian: • Provjerite datum isteka roka valjanosti koji je otisnut ili zapisan na kutiji.
English: Simponi is available in packs containing 1 pre-filled pen.
Croatian: Simponi je dostupan u pakiranju koje sadrži 1 napunjenu brizgalicu.
English: Among 159 subjects randomised to Simponi 50 mg + MTX, 96 were still on this treatment at week 104.
Croatian: Od 159 ispitanika randomiziranih u skupinu koja je primala Simponi 50 mg i MTX, 96 je i dalje bilo na toj terapiji u 104. tjednu.
English: • If you cannot see the expiration date through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the expiration date to the viewing window.
Croatian: • Ako ne vidite datum, držite štrcaljku za tijelo i okrećite zaštitni poklopac igle dok se datum ne pojavi na prozorčiću.
English: Do not press the plunger while inserting the needle.
Croatian: Nemojte pritiskati klip dok uvodite iglu pod kožu.
English: • Hold the body of the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the area of skin that you previously cleaned.
Croatian: • Držite napunjenu štrcaljku između kažiprsta i srednjaka jedne ruke, a palac stavite na vrh glave klipa.
English: • Feeling numb or having a tingling feeling
Croatian: • osjećaj utrnulosti ili trnaca
English: • This medicine can also be stored out of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton.
Croatian: • Ovaj se lijek može čuvati i izvan hladnjaka na temperaturama do najviše 25°C tijekom jednokratnog razdoblja od najviše 30 dana, pri čemu se ne smije premašiti originalni rok valjanosti otisnut na kutiji.
English: The diagram below (see figure 1) shows what the pre-filled syringe looks like.
Croatian: Na donjem crtežu (vidjeti sliku 1) prikazano je kako izgleda napunjena štrcaljka.
English: SINGLE-USE
Croatian: JEDNOKRATNA UPORABA
English: Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6).
Croatian: Živa cjepiva/terapijski infektivni agensi Živa cjepiva ne smiju se davati istodobno s golimumabom (vidjeti dijelove 4.4 i 4.6).
English: Due to the higher sensitivity and the improved drug tolerance, a higher incidence of antibodies to golimumab was expected to be detected with the drug-tolerant EIA method compared to the EIA method.
Croatian: Zbog veće osjetljivosti i poboljšane otpornosti na lijek, očekivalo se da će se EIA metodom otpornom na lijek utvrditi veća incidencija protutijela na golimumab nego EIA metodom.
English: AFTER
Croatian: POSLIJE
English: Do not use the 5-centimetre area around your belly-button.
Croatian: Nemojte primijeniti injekciju u područje unutar 5 cm od pupka.
English: A part of the pre-filled syringe, the needle cover, contains latex.
Croatian: Jedan dio napunjene brizgalice, zaštitni poklopac za iglu, sadrži lateks.
English: Pain as assessed by the Total Back Pain and Nocturnal Back Pain VAS, and disease activity as measured by ASDAS-C also showed statistically significant improvement from baseline to week 16 in patients treated with Simponi 50 mg compared to placebo (p < 0.0001).
Croatian: Bol procijenjena pomoću VAS za bol u cijelim leđima i noćnu bol u leđima i aktivnost bolesti mjerena pomoću ASDAS-C pokazali su statistički značajno poboljšanje od početka do 16. tjedna u bolesnika liječenih lijekom Simponi u dozi od 50 mg u usporedbi s placebom (p < 0,0001).
English: In an exploratory clinical study, patients with severe persistent asthma received a golimumab loading dose (150% of the assigned treatment dose) subcutaneously at week 0 followed by golimumab 200 mg, golimumab 100 mg or golimumab 50 mg every 4 weeks subcutaneously through week 52.
Croatian: U jednom eksplorativnom kliničkom ispitivanju bolesnici s teškom perzistentnom astmom primili su udarnu dozu golimumaba supkutano (150% predviđene terapijske doze) u nultom tjednu, a zatim doze od 200 mg golimumaba, 100 mg golimumaba, ili 50 mg golimumaba supkutano svaka 4 tjedna, do 52. tjedna.
English: When 50 mg golimumab was administered subcutaneously to patients with RA, PsA or AS every 4 weeks, serum concentrations reached steady state by week 12.
Croatian: Kad je golimumab u dozi od 50 mg primijenjen supkutano u bolesnika s RA, PsA ili AS svaka 4 tjedna, njegove su serumske koncentracije dosegle stanje dinamičke ravnoteže do 12. tjedna.
English: In GO-FORWARD and GO-AFTER, statistically significant improvements were observed in fatigue as measured by functional assessment of chronic illness therapy-fatigue scale (FACIT-F).
Croatian: U ispitivanjima GO-FORWARD i GO-AFTER zabilježeno je statistički značajno poboljšanje parametra umora, mjereno ljestvicom umora sustava upitnika Funkcionalne procjene terapije kroničnih bolesti (FACIT-F).
English: If you have ulcerative colitis you will first be given other medicines.
Croatian: Ako imate ulcerozni kolitis, najprije ćete dobiti druge lijekove.
English: At week 48, 53% and 55% of children in the Simponi + MTX group and placebo + MTX group, respectively, were ACR Ped 30 responders, and 40% and 28% of children in the Simponi + MTX group and placebo + MTX group, respectively, achieved inactive disease.
Croatian: U 48. tjednu, 53% djece u skupini koja je primala Simponi + MTX te 55% djece u skupini koja je primala placebo + MTX ostvarilo je odgovor ACR Ped 30, dok je 40% djece koja su primala Simponi + MTX i 28% djece koja su primala placebo + MTX postiglo neaktivnu bolest.
English: It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion.
Croatian: Nije poznato izlučuje li se golimumab u majčino mlijeko niti dolazi li do sustavne apsorpcije nakon hranjenja.
English: In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious adverse events (SAEs), and serious infections in patients age 65 or older who received golimumab were observed compared with younger patients.
Croatian: U ispitivanjima faze III u bolesnika s RA, PsA, AS i UC općenito nije bilo razlika što se tiče ukupnih štetnih događaja, ozbiljnih štetnih događaja i ozbiljnih infekcija između bolesnika starih 65 godina ili starijih koji su primali golimumab, u odnosu na mlađe bolesnike.
English: Following induction doses of 200 mg and 100 mg golimumab at week 0 and 2, respectively, and maintenance doses of 50 mg or 100 mg golimumab subcutaneously every 4 weeks thereafter to patients with UC, serum golimumab concentrations reached steady state approximately 14 weeks after the start of therapy.
Croatian: Nakon uvodnih doza golimumaba od 200 mg u 0. tjednu i 100 mg u 2. tjednu te doza održavanja od 50 mg ili 100 mg primijenjenih supkutano svaka 4 tjedna nakon toga u bolesnika s ulceroznim kolitisom, koncentracije golimumaba u serumu dostigle su stanje dinamičke ravnoteže približno 14 tjedana nakon početka terapije.
English: At week 16, all ACR Ped components demonstrated clinically relevant improvement from baseline (see Table 8).
Croatian: U 16. tjednu, sve su komponente odgovora ACR Ped pokazivale klinički značajno poboljšanje u odnosu na početnu vrijednost (vidjeti Tablicu 8).
English: Change from baseline n reflects randomised patients * p = 0.015
Croatian: Početni broj bodova Promjena u odnosu na početni broj bodova n je broj randomiziranih bolesnika * p = 0,015
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: At week 52, patients entered an open label long-term extension.
Croatian: U 52. tjednu bolesnici su ušli u dugotrajnu, otvorenu fazu nastavka ovog ispitivanja.
English: The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4).
Croatian: Najčešće prijavljene ozbiljne nuspojave golimumaba bile su ozbiljne infekcije (uključujući sepsu, pneumoniju, tuberkulozu, invazivne gljivične i oportunističke infekcije), demijelinizirajući poremećaji, reaktivacija virusa hepatitisa B, kongestivno zatajenje srca, autoimuni procesi (sindrom nalik lupusu), hematološke reakcije, ozbiljna sistemska preosjetljivost (uključujući anafilaktičku reakciju), vaskulitis, limfom i leukemiju (vidjeti dio 4.4).
English: Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Croatian: Simptomi mogu uključivati promjene vida, slabost u rukama ili nogama, utrnulost ili trnci u bilo kojem dijelu tijela.
English: • Failure of the bone marrow to produce blood cells
Croatian: • zatajenje koštane srži u stvaranju krvnih stanica
English: Excipient with known effect Each pre-filled pen contains 18.45 mg sorbitol (E420) per 45 mg dose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena brizgalica sadrži 18,45 mg sorbitola (E420) po dozi od 45 mg.
English: The pen should not be shaken.
Croatian: Brizgalicu se ne smije tresti.
English: • Pull the needle cover straight off and throw it away after your injection.
Croatian: • Povucite poklopac s igle i bacite ga u otpad nakon injekcije.
English: Vaccinations/therapeutic infectious agents
Croatian: Cijepljenje/terapijski infektivni agensi
English: • Superficial fungal infections
Croatian: • površinske gljivične infekcije
English: A subcutaneous injection of 50 mg golimumab to healthy subjects produced a mean  standard deviation maximum serum concentration (Cmax) of 3.1  1.4 g/mL.
Croatian: Jednom supkutanom injekcijom u dozi od 50 mg golimumaba u zdravih dobrovoljaca postignuta je srednja vrijednost serumske koncentracije (Cmax) od 3,1 ± 1,4 g/ml (± standardna devijacija).
English: At week 16, all ACR Ped components demonstrated clinically relevant improvement from baseline (see Table 3).
Croatian: U 16. tjednu, sve su komponente odgovora ACR Ped pokazivale klinički značajno poboljšanje u odnosu na početnu vrijednost (vidjeti Tablicu 3).
English: Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis
Croatian: Manje često: sepsa koja uključuje septički šok, pijelonefritis Rijetko: tuberkuloza, oportunističke infekcije (npr. invazivne gljivične infekcije [histoplazmoza, kokcidioidomikoza, pneumocitoza], bakterijske, atipične mikobakterijske infekcije i infekcije protozoama), reaktivacija hepatitisa B, bakterijski artritis, infektivni burzitis
English: Inject the medicine
Croatian: Injicirajte lijek
English: Concurrent administration of TNF-antagonists and abatacept In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Croatian: U kliničkim ispitivanjima istodobna primjena TNF-antagonista i abatacepta bila je povezana s povećanim rizikom od infekcija, uključujući i ozbiljne infekcije, u odnosu na primjenu samo TNF-antagonista, a pritom nije došlo do povećanja kliničkog učinka.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti nuspojave su navedene od ozbiljnih prema manje ozbiljnim.
English: Choosing and preparing the injection site (see figure 2)
Croatian: Odabir i priprema mjesta injekcije (vidjeti sliku 2)
English: In these studies, Simponi demonstrated clinically meaningful and statistically significant improvement in HAQ DI from baseline versus control at week 24.
Croatian: U tim ispitivanjima je s lijekom Simponi postignuto klinički vrijedno i statistički značajno poboljšanje rezultata HAQ DI u 24. tjednu u odnosu na početne vrijednosti, u usporedbi s kontrolnom skupinom.
English: Do not put the cap back on, this may damage the hidden needle.
Croatian: Nemojte vraćati poklopac na brizgalicu da ne biste oštetili skrivenu iglu.
English: Do not press on the orange needle guard before the injection.
Croatian: Nemojte pritiskati narančasti štitnik igle prije injiciranja.
English: Patients entered an open label long-term extension at week 52.
Croatian: Bolesnici su ušli u dugotrajni produžetak ispitivanja otvorenog tipa u 52. tjednu.
English: Symptoms of TB include persistent cough, weight loss, tiredness, fever or night sweats.
Croatian: Simptomi tuberkuloze uključuju uporan kašalj, gubitak tjelesne težine, umor, vrućicu ili noćno znojenje.
English: Autoimmune antibodies
Croatian: Autoimuna protutijela
English: In the controlled and uncontrolled periods of pivotal trials through 1 year of follow-up, 3.5% of golimumab-treated patients and 2.3% of control patients were newly ANA-positive (at titres of 1:160 or greater).
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja, tijekom jednogodišnjeg praćenja 3,5% bolesnika liječenih golimumabom i 2,3% bolesnika u kontrolnoj skupini postalo je po prvi puta pozitivno na antinuklearna protutijela (ANA) (s titrom od 1:160 ili višim).
English: • Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)
Croatian: • reakcije na mjestu injekcije (uključujući crvenilo, otvrdnuće, bol, stvaranje modrica, svrbež,
English: • For patients weighing at least 40 kg, the recommended dose is 50 mg given once a month, on the same date each month.
Croatian: • Za bolesnike tjelesne težine od najmanje 40 kg preporučena doza je 50 mg primijenjeno jedanput na mjesec, istog dana u mjesecu.
English: Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.
Croatian: U bolesnika u kojih nema dokazane terapijske koristi nakon 3 do 4 dodatne doze od 100 mg treba ponovno razmotriti nastavak terapije.
English: • If you cannot see the liquid through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the liquid to the viewing window (see figure 2).
Croatian: • Ako ne vidite tekućinu, držite napunjenu štrcaljku za tijelo i okrećite zaštitni poklopac igle dok se tekućina ne pojavi na prozorčiću (vidjeti sliku 2).
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy.
Croatian: Prije uvođenja golimumaba u bolesnika koji su boravili ili putovali u područja za koja su karakteristične endemske invazivne gljivične infekcije, kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza, treba pažljivo odvagnuti koristi i rizike liječenja golimumabom.
English: During the placebo-controlled portion of the study, the incidence (95% CI) of all malignancies per 100 subject-years of follow-up was 3.19 (1.38, 6.28) in the golimumab group.
Croatian: Tijekom dijela ispitivanja s kontrolom placeba incidencija svih malignoma (95% CI) na 100 ispitanik-godina praćenja iznosila je u skupini liječenoj golimumabom 3,19 (1,38; 6,28).
English: Treatment with concomitant immunomodulators (azathioprine, 6-mercaptopurine and MTX) resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without immunomodulators (1% (4/308) versus 3% (22/638), respectively).
Croatian: Istodobna primjena imunomodulatora (azatioprina, 6-merkaptopurina i metotreksata) rezultirala je manjim udjelom bolesnika s protutijelima na golimumab (1% (4/308)), u odnosu na bolesnike koji uz golimumab nisu primali imunomodulatore (3% (22/638)).
English: Simponi is supplied in a single use pre-filled pen called SmartJect or as a single use pre-filled syringe.
Croatian: Simponi je dostupan u napunjenoj brizgalici za jednokratnu primjenu koja se zove SmartJect ili u napunjenoj štrcaljki za jednokratnu primjenu.
English: Preparing for use of the pre-filled syringe Choosing and preparing the injection site Injecting the medicine After the injection
Croatian: Priprema za uporabu napunjene brizgalice Odabir i priprema mjesta injekcije Ubrizgavanje lijeka
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of golimumab therapy.
Croatian: U bolesnika s već postojećim ili novonastalim demijelinizacijskim bolestima prije početka liječenja golimumabom treba pažljivo procijeniti koristi i rizike anti-TNF terapije.
English: The medicine should be injected within 5 minutes after the needle cover has been removed.
Croatian: Lijek morate injicirati u roku od 5 minuta nakon skidanja poklopca.
English: Rare side effects (may affect up to 1 in 1,000 people):
Croatian: Rijetke nuspojave (javljaju se u do 1 na 1000 osoba):
English: Check expiry date (see figure 2)
Croatian: Provjerite rok valjanosti (vidjeti sliku 2)
English: Simponi is supplied in a single use pre-filled pen called VarioJect.
Croatian: Simponi je dostupan u napunjenoj brizgalici za jednokratnu primjenu koja se zove VarioJect.