FrancophonIA/ELRC3.0 huggingface dataset:
English: The following instructions explain how to inject Humira.
Croatian: U sljedećim uputama objašnjeno je kako ubrizgati lijek Humira.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira.
Croatian: Unatoč profilaksi tuberkuloze, zabilježeni su slučajevi reaktivacije tuberkuloze u bolesnika liječenih lijekom Humira.
English: The caps, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.
Croatian: Kapice, alkoholom natopljeni jastučić, vata ili gaza, blister i pakiranje se mogu baciti u kućni otpad.
English: When the injection is completed, slowly pull the pre-filled pen from the skin.
Croatian: Kada je ubrizgavanje završeno, polako odmaknite napunjenu brizgalicu od kože.
English: In RA studies I-IV, Humira-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Croatian: U ispitivanjima RA I - IV, bolesnici liječeni lijekom Humira postigli su statistički značajno bolje odgovore ACR 20 i 50 u usporedbi s placebom već jedan do dva tjedna nakon početka liječenja.
English: The white needle sleeve will cover the needle tip.
Croatian: Bijela navlaka za iglu će prekriti vrh igle.
English: Prescribers should exercise caution in considering the use of Humira in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Humira should be considered if any of these disorders develop.
Croatian: Propisivači moraju biti oprezni prilikom razmatranja liječenja lijekom Humira u bolesnika s otprije postojećim ili nedavno nastalim demijelinizirajućim poremećajima središnjeg ili perifernog živčanog sustava; ako se razvije bilo koji od tih poremećaja, treba razmotriti prekid liječenja lijekom Humira.
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Croatian: Ipak, nakon stavljanja lijeka u promet zaprimljene su prijave zatajenja jetre kao i manje teških poremećaja jetre koji mogu prethoditi zatajenju jetre, kao što je hepatitis, uključujući autoimuni hepatitis, u bolesnika koji su primali adalimumab.
English: Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests.
Croatian: Neke nuspojave zabilježene uz lijek Humira mogu biti bez simptoma te se mogu otkriti samo krvnim pretragama, a uključuju sljedeće:
English: If you forget to use Humira
Croatian: Ako ste zaboravili primijeniti lijek Humira
English: • Do not remove the needle cover while allowing Humira to reach room temperature
Croatian: • Nemojte uklanjati pokrov igle dok lijek Humira postiže sobnu temperaturu.
English: This risk may increase if you have problems with your lungs.
Croatian: Taj rizik može biti povećan ako imate tegobe s plućima.
English: Patients treated with Humira had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Croatian: U bolesnika liječenih lijekom Humira rizik od razbuktavanja bolesti značajno se smanjio tijekom prvih 12 tjedana liječenja.
English: If your child has active tuberculosis, do not use Humira.
Croatian: Ako Vaše dijete ima aktivnu tuberkulozu, nemojte primjenjivati lijek Humira.
English: • DO NOT pull the white plunger rod completely out of the syringe.
Croatian: • NE izvlačite klip štrcaljke u potpunosti van iz štrcaljke.
English: Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Croatian: Humira se može davati i kao monoterapija ako bolesnik ne podnosi metotreksat ili kada nastavak terapije metotreksatom nije prikladan (za djelotvornost monoterapije vidjeti dio 5.1).
English: Press the plum activator button and count slowly for 10 seconds.
Croatian: Pritisnite bordo tipku za aktivaciju i polako brojite 10 sekundi.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposureresponse relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Croatian: Djelotvornost adalimumaba u liječenju adolescentnih bolesnika s gnojnim hidradenitisom predviđa se na temelju dokazane djelotvornosti i povezanosti izloženosti i odgovora u odraslih bolesnika s gnojnim hidradenitisom kao i vjerojatnosti da su tijek bolesti, patofiziologija i učinici lijeka u suštini slični kao u odraslih osoba pri istim razinama izloženosti.
English: Lift the pre-filled pen straight up from the injection site.
Croatian: Podignite napunjenu brizgalicu ravno s mjesta ubrizgavanja.
English: Your symptoms may return if you stop using Humira.
Croatian: Simptomi se mogu vratiti ako prestanete primjenjivati lijek Humira.
English: For more information on vaccines, see the “Warnings and precautions” section.
Croatian: Za više informacija o cjepivima pogledajte dio „Upozorenja i mjere opreza“.
English: • facial oedema (swelling of the face) associated with allergic reactions
Croatian: • edem lica (oticanje lica) povezan s alergijskim reakcijama
English: • Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface.
Croatian: • Odstranite pokrovnu kapicu s igle na štrcaljki, pazeći pritom da ne dotaknete iglu ili da igla ne dotakne neku od površina.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Humira, who are chronic carriers of this virus (i.e. surface antigen positive).
Croatian: Zabilježena je reaktivacija hepatitisa B u bolesnika koji su primali antagoniste TNF-a, uključujući lijek Humira, i koji su bili su kronični nositelji tog virusa (tj. pozitivni na površinski antigen), a bilo je i slučajeva sa smrtnim ishodom.
English: The white needle sleeve will move down over the needle and lock into place over the needle tip.
Croatian: Bijela navlaka za iglu će se pomaknuti dolje preko igle i sjesti čvrsto na svoje mjesto preko vrha igle.
English: Your doctor may recommend temporary discontinuation of Humira.
Croatian: Liječnik može preporučiti privremeni prekid terapije lijekom Humira.
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which Humira 40mg was administered every week.
Croatian: Bolesnici koji su sudjelovali u ispitivanjima HS-I i HS-II mogli su sudjelovati u otvorenom produžetku ispitivanja u kojem se Humira primjenjivala svaki tjedan u dozi od 40 mg.
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements
Croatian: Kartica s podsjetnikom za bolesnika (odrasle i djecu) sadrži sljedeće ključne elemente - infekcije, uključujući tuberkulozu
English: • neuropathy;
Croatian: • neuropatija,
English: Administration of Humira should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Primjena lijeka Humira mora se obustaviti ako bolesnik razvije novu ozbiljnu infekciju ili sepsu te je potrebno započeti odgovarajuću antimikrobnu ili antifungalnu terapiju sve dok se infekcija ne stavi pod kontrolu.
English: Tell your doctor immediately if you notice any of the following • severe rash, hives or other signs of allergic reaction;
Croatian: Primijetite li išta od dolje navedenog, odmah obavijestite svog liječnika • težak osip, koprivnjaču ili druge znakove alergijske reakcije,
English: The pivotal controlled studies involved 6,089 patients receiving Humira and 3,801 patients receiving placebo or active comparator during the controlled period.
Croatian: Pivotalna kontrolirana ispitivanja uključivala su 6089 bolesnika liječenih lijekom Humira i 3801 bolesnika koji je primao placebo ili neki aktivni usporedni lijek tijekom kontroliranog razdoblja.
English: 73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
Croatian: Psoriasis Study I i II 73% uključenih bolesnika prethodno je primalo sistemsku terapiju ili fototerapiju.
English: Injection site pain of Humira 40 mg/0.4 ml was assessed in two randomised, active control, single-blind, two-period crossover studies.
Croatian: Bol na mjestu primjene lijeka Humira od 40 mg/0,4 ml ocjenjivala se u dvama randomiziranim, aktivnim lijekom kontroliranim, jednostruko slijepim, ukriženim ispitivanjima s dva razdoblja.
English: HS Study II
Croatian: Ispitivanje HS II
English: Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Croatian: Radiološke su pretrage pokazale da Humira smanjuje brzinu progresije oštećenja perifernih zglobova u bolesnika s poliartikularnim simetričnim podtipovima bolesti (vidjeti dio 5.1) te da poboljšava fizičku funkciju.
English: Placebo/ MTX
Croatian: Placebo/ MTXa
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with Humira.
Croatian: U ispitivanju nr-axSpA II ocjenjivalo se ukidanje terapije u bolesnika s aktivnim nr-axSpA koji su postigli remisiju tijekom otvorenog liječenja lijekom Humira.
English: Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
Croatian: Nakon što ste je izvadili iz hladnjaka i čuvali na sobnoj temperaturi, štrcaljku morate iskoristiti u roku od 14 dana ili je baciti, čak i ako ste je vratili u hladnjak.
English: There is limited experience in the initiation of treatment with Humira alone.
Croatian: Iskustvo sa započinjanjem liječenja samo lijekom Humira je ograničeno.
English: During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.
Croatian: Tijekom 52 tjedna ispitivanja UC-I i UC-II, zamijećene su niže stope hospitalizacija zbog bilo kojeg uzroka i hospitalizacija povezanih s ulceroznim kolitisom u skupini liječenoj adalimumabom u odnosu na skupinu koja je primala placebo.
English: In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Croatian: U ispitivanju RA IV, odgovor ACR 20 u bolesnika liječenih lijekom Humira uz standardnu skrb bio je statistički značajno bolji nego u bolesnika koji su primali placebo uz standardnu skrb (p<0,001).
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the Humira group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Croatian: Približno dvostruko veći udio bolesnika u skupini koja je u prvih 12 tjedana ispitivanja HS-I i HS-II primala placebo, naspram onih koji su liječeni lijekom Humira, doživio je pogoršanje apscesa (23,0% naspram 11,4%) i drenirajućih fistula (30,0% naspram 13,9%).
English: c Inactive Disease Partial Flare Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Croatian: Djelomično razbuktavanje bolestid a Međunarodno društvo za ocjenu spondiloartritisa b Početna vrijednost definirala se kao vrijednost na početku razdoblja otvorenog liječenja kada bolesnici imaju aktivnu bolest.
English: • Your child's belly (abdomen) at least 5 cm from his/her belly button (navel)
Croatian: • djetetov trbuh (abdomen) barem 5 cm od pupka
English: Humira in combination with methotrexate, is indicated for:
Croatian: U kombinaciji s metotreksatom, Humira je indicirana za:
English: Median time to disease flare
Croatian: Medijan vremena do razbuktavanja bolesti
English: The recommended doses for Humira in each of the approved uses are shown in the following table.
Croatian: U sljedećoj tablici prikazane su preporučene doze lijeka Humira u svakoj odobrenoj primjeni.
English: • It is normal to see a drop of liquid at the end of the needle
Croatian: • Normalno je da se na vrhu igle pojavi kap tekućine
English: Amongst those who responded at Week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received Humira throughout the study.
Croatian: Među bolesnicima koji su imali odgovor u 16. tjednu (n=144), pedijatrijski odgovori ACR 30/50/70/90 održali su se i do šest godina u otvorenom produžetku ispitivanja u bolesnika koji su uzimali lijek Humira tijekom cijeloga ispitivanja.
English: Humira demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA<10% and ≥5% (40% of patients)).
Croatian: Humira je ostvarila povoljan terapijski učinak u bolesnika s psorijazom noktiju i različitim stupnjevima zahvaćenosti kože (≥ 10% tjelesne površine [60% bolesnika] te < 10% i ≥ 5% tjelesne površine [40% bolesnika]).
English: The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.
Croatian: Pokrov igle, alkoholom natopljeni jastučić, vata ili gaza, blister i pakiranje mogu se baciti u kućni otpad.
English: Your doctor will decide if your child should receive Humira.
Croatian: Liječnik će odlučiti treba li dijete primiti lijek Humira.
English: • Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
Croatian: • Koristeći se palcem ili komadom gaze, na 10 sekundi pritisnite mjesto ubrizgavanja.
English: Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Croatian: U ispitivanju Psoriasis Study I (REVEAL) ocijenjeno je 1212 bolesnika u tri razdoblja liječenja.
English: Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Croatian: Plak psorijaza je kožna bolest koja uzrokuje crvene, perutave, krastave mrlje na koži prekrivene srebrnastim ljuskicama.
English: Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Croatian: Ispitanici (n=215, 54,7%) koji nisu uspjeli postići ASAS 20 u 12., 16. ili 20. tjednu ranije su prebačeni u otvoreni dio ispitivanja i dobivali su 40 mg adalimumaba supkutano svaki drugi tjedan.
English: In subjects treated with Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Croatian: 84% ispitanika liječenih lijekom Humira koji nisu imali radiološku progresiju od početka ispitivanja do 48. tjedna ispitivanja (n=102) nije imalo radiološku progresiju bolesti ni nakon 144 tjedna terapije.
English: Amongst those who responded (Pediatric ACR 30) at Week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received Humira throughout this time period.
Croatian: Među onima koji su odgovorili na terapiju (pedijatrijski odgovor ACR 30) u 24. tjednu (n=27 od 30 bolesnika), pedijatrijski odgovori ACR 30 održali su se do 60 tjedana u otvorenom produžetku ispitivanja u bolesnika koji su primali lijek Humira kroz ovo razdoblje.
English: Of those patients who had a response at Week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at Week 52.
Croatian: Od bolesnika koji su imali odgovor u 8. tjednu, u 52. tjednu je njih 47% imalo klinički odgovor, 29% ih je bilo u remisiji, 41% je imalo zacjeljivanje sluznice, a 20% bilo je u remisiji bez primjene steroida
English: In a study of 64 patients with rheumatoid arthritis that were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.
Croatian: U ispitivanju 64 bolesnika s reumatoidnim artritisom liječena lijekom Humira nije zabilježeno smanjenje odgođene preosjetljivosti, sniženje razina imunoglobulina niti promjene broja efektorskih T i B stanica, NK stanica, monocita/makrofaga i neutrofila.
English: • tremor (shaking)
Croatian: • tremor (nevoljno drhtanje)
English: Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.
Croatian: Stvaranje protutijela bilo je manje kada se Humira davala zajedno s metotreksatom nego kada se primjenjivala kao monoterapija.
English: • swollen face, hands, feet
Croatian: • otečeno lice, šake, stopala
English: Check the liquid in the pre-filled syringe.
Croatian: Pregledajte tekućinu u napunjenoj štrcaljki.
English: • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: • steroidima ili lijekovima za ublažavanje boli, uključujući i nesteroidne protuupalne lijekove (NSAIL).
English: Once removed from the refrigerator for room temperature storage, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator.
Croatian: Nakon što ste je izvadili iz hladnjaka i čuvali na sobnoj temperaturi, brizgalicu morate iskoristiti u roku od 14 dana ili je baciti, čak i ako ste je vratili u hladnjak.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
Croatian: • autoimuni hepatitis (upala jetre uzrokovana vlastitim tjelesnim imunološkim sustavom)
English: Österreich AbbVie GmbH Tel: +43 1 20589-0
Croatian: AbbVie GmbH Tel: +43 1 20589-0
English: Some of these hepatosplenic T-cell lymphomas with Humira have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Croatian: Neki od tih hepatospleničnih T-staničnih limfoma povezanih s primjenom lijeka Humira javili su se u mladih odraslih bolesnika koji su istodobno bili liječeni azatioprinom ili 6-merkaptopurinom zbog upalne bolesti crijeva.
English: Subjects may also have previously lost response or been intolerant to infliximab.
Croatian: Sudjelovati su mogli i bolesnici koji su izgubili odgovor na prethodno liječenje infliksimabom ili koji ga nisu podnosili.
English: The proportions of subjects with PedACR50/70/90 at Week 12 and Week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Croatian: tjednu bio je 90,3%/61,3%/38,7%, odnosno 83,3%/73,3%/36,7%.
English: • new onset or worsening of psoriasis
Croatian: • nova pojava ili pogoršanje psorijaze
English: The decision to stop using Humira should be discussed with your child's doctor.
Croatian: Odluku o prekidu primjene lijeka Humira potrebno je raspraviti s liječnikom Vašeg djeteta.
English: Humira Dose for Paediatric Patients with Crohn's disease
Croatian: Doza lijeka Humira za pedijatrijske bolesnike s Crohnovom bolešću
English: Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
Croatian: ≥ 3 prema brojčanoj ocjenskoj ljestvici od 0 - 10; 0 = bez kožne boli, 10 = nezamislivo jaka kožna bol.
English: Slowly push the plunger all the way in until all of the liquid is injected and the pre-filled syringe is empty.
Croatian: Polako pritisnite klip do kraja, dok ne ubrizgate svu otopinu i napunjena štrcaljka ostane prazna.
English: Some patients who have not responded by Week 4 may benefit from continued maintenance therapy through Week 12.
Croatian: Nekim bolesnicima koji ne odgovore na terapiju do 4. tjedna mogao bi koristiti nastavak terapije održavanja do 12. tjedna.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Croatian: Iako nije statistički značajno, većina bolesnika pokazala je kliničko poboljšanje sekundarnih mjera ishoda kao što su broj mjesta zahvaćenih entezitisom, broj osjetljivih zglobova, broj otečenih zglobova, pedijatrijski odgovor
English: The Humira pre-filled syringe is available in a pack containing 1 pre-filled syringe for patient use with 1 alcohol pad.
Croatian: Napunjena štrcaljka lijeka Humira dostupna je u pakiranju koje sadrži 1 napunjenu štrcaljku za uporabu od strane bolesnika i 1 jastučić natopljen alkoholom.
English: • Paediatric uveitis
Croatian: • nezaraznog uveitisa
English: • There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.
Croatian: • Vrlo se rijetko javljaju slučajevi određene vrste raka u djece i odraslih bolesnika liječenih lijekom Humira ili nekim drugim TNF blokatorom.
English: • sicca syndrome (including dry eyes and dry mouth)
Croatian: • sicca (suhi) sindrom (uključujući suhoću očiju i suhoću usta)
English: • Hold the pre-filled syringe at eye level with one hand so you can see the air in the pre-filled syringe
Croatian: • Jednom rukom držite napunjenu štrcaljku u razini očiju da biste vidjeli zrak u njoj
English: • blood in urine
Croatian: • krv u mokraći
English: Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.
Croatian: Humira može biti dostupna u obliku bočice, napunjene štrcaljke i/ili napunjene brizgalice.
English: Humira can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease.
Croatian: Humira može smanjiti broj nodula i apscesa koje imate te ublažiti bol koja često prati ovu bolest.
English: In controlled Phase 3 trials of Humira in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks.
Croatian: U kontroliranim ispitivanjima faze III u kojima se Humira primjenjivala u bolesnika s Crohnovom bolešću i ulceroznim kolitisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 52 tjedna,
English: • If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section
Croatian: • Ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Table 18 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Croatian: Tablica 18 Odgovor, remisija i cijeljenje sluznice u Ispitivanju UC-II (postotak bolesnika)
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Croatian: U pivotalnim kontroliranim ispitivanjima u odraslih i djece, reakcije na mjestu primjene (eritem i/ili svrbež, krvarenje, bol ili oticanje) pojavile su se u 12,9% bolesnika liječenih lijekom Humira u usporedbi sa 7,2% bolesnika koji su dobivali placebo ili aktivni kontrolni lijek.
English: Placebo/MTXHumira/MTX (95% Confidence Interval p-value
Croatian: Placebo/MTX - Humira/MTX (interval pouzdanosti od 95%b)
English: • If you are over 65 years you may be more likely to get infections while taking Humira.
Croatian: • Ako ste stariji od 65 godina, postoji veća mogućnost da dobijete infekciju dok primjenjujete lijek Humira.
English: • Humira should only be used during a pregnancy if needed.
Croatian: • Humira se tijekom trudnoće smije primjenjivati samo ako je to neophodno.
English: Firmly push the pre-filled pen down against the injection site before starting the injection.
Croatian: Čvrsto pritisnite napunjenu brizgalicu na mjesto ubrizgavanja prije početka ubrizgavanja.