FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).
Croatian: smanjenje broja crvenih krvnih stanica; smanjenje broja bijelih krvnih stanica; smanjen broj neutrofila (vrsta bijelih krvnih stanica); nizak broj krvnih pločica; rak kože (osim melanoma); ograničeno oticanje kože (angioedem); koprivnjača (izdignute mrlje crvene ili blijede kože koje često svrbe); upala oka; psorijaza (novonastala ili pogoršanje postojeće); upala krvnih žila koja zahvaća više organa; povišene vrijednosti jetrenih enzima u krvi (u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost povišenih jetrenih enzima u krvi je česta); grčevi i bol u trbuhu, proljev, gubitak težine ili krv u stolici (znakovi problema s crijevima).
English: Paediatric population Vaccinations
Croatian: Pedijatrijska populacija Cijepljenje
English: Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Croatian: Alternativno, 50 mg može biti primjenjivano dva puta tjedno 12 tjedana iza čega slijedi 25 mg dva puta tjedno ili 50 mg jednom tjedno.
English: The SensoReady pen contains a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection).
Croatian: SensoReady brizgalica sadrži bistru ili blago opalescentnu, bezbojnu ili blago žućkastu otopinu za injekciju (injekciju).
English: Preparing the Erelzi pre-filled syringe
Croatian: Priprema Erelzi napunjene štrcaljke
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Etanercept was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Croatian: Etanercept se pokazao značajno uspješnijim od placeba u svim pokazateljima odgovora prema kriterijima ACR kao i prema svim ostalim kriterijima aktivnosti reumatoidnog artritisa koji nisu obuhvaćeni kriterijima ACR, kao npr. jutarnja ukočenost.
English: After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature.
Croatian: Nakon što izvadite štrcaljku iz hladnjaka, pričekajte približno 15-30 minuta kako bi otopina Erelzija u štrcaljki postigla sobnu temperaturu.
English: Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Croatian: U svih bolesnika, a pogotovo u onih koji su pod povećanim rizikom od raka kože,
English: Paediatric plaque psoriasis outcomes at 12 weeks Etanercept 0.8 mg/kg Once Weekly (N = 106)
Croatian: Etanercept 0,8 mg/kg jednom tjedno (N = 106)
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001).
Croatian: U bolesnika s psorijatičnim artritisom liječenih etanerceptom rezultat indeksa nesposobnosti je bio značajno bolji u svim vremenskim točkama određivanja u odnosu na placebo (p<0,001).
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
Croatian: • Znakovi lupusa ili sindroma nalik lupusu, kao što su promjene tjelesne težine, uporan kašalj,
English: Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months.
Croatian: Također je primijećena značajna prednost za etanercept u kombinaciji s metotreksatom u usporedbi s etanerceptom kao monoterapijom i s metotreksatom kao monoterapijom nakon 24 mjeseca.
English: • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately.
Croatian: • Alergijske reakcije: ako Vi ili dijete osjetite simptome alergijske reakcije kao što su stezanje u prsištu, piskanje pri disanju, omaglica ili osip, nemojte više ubrizgavati Erelzi i odmah se obratite svom liječniku.
English: In a group of 7,416 patients treated with etanercept in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Croatian: Ukupno 18 limfoma je zabilježeno u 7416 bolesnika liječenih etanerceptom u kliničkim ispitivanjima s bolesnicima oboljelim od reumatoidnog artritisa, psorijatičkog artritisa, ankilozantnog spondilitisa i psorijaze.
English: In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).
Croatian: dvostruko slijepim fazama kontroliranih kliničkih ispitivanja koja su dozvoljavala istodobno liječenje etanerceptom i metotreksatom, učestalost (kumulativna incidencija) štetnih događaja povišenih jetrenih enzima bila je 4,18% (česta učestalost).
English: The long-term safety and effectiveness of etanercept 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Croatian: Nakon gore spomenutih 48 tjedana ispitivanja dugotrajna sigurnost primjene i djelotvornost etanercepta u dozi 0,8 mg/kg (do 50 mg) primijenjenog jednom tjedno procijenjena je u otvorenom produžetku ispitivanja do 2 godine u kojoj je sudjelovao 181 pedijatrijski bolesnik s plak psorijazom.
English: Patients in this study received a dose of 25 mg or 50 mg etanercept, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg etanercept twice weekly for an additional 24 weeks.
Croatian: Bolesnici su primali etanercept u dozi od 25 mg ili 50 mg ili placebo dva puta tjedno kroz 12 tjedana, a nakon toga su svi bolesnici u otvorenom dijelu ispitivanja primali 25 mg etanercepta dvaput tjedno tijekom dodatna 24 tjedna.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 50 mg, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 50 mg, odnosno zanemarive količine natrija.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept (see section 4.8).
Croatian: Pri uzimanju etanercepta primijećeni su slučajevi teških infekcija, sepse, tuberkuloze i oportunističkih infekcija, uključujući i invazivne gljivične infekcije, listeriozu i legionelozu (vidjeti dio 4.8).
English: There have been reports of IBD and uveitis in JIA patients being treated with etanercept (see section 4.8).
Croatian: Bilo je prijava pojave upalne bolesti crijeva i uveitisa u bolesnika s JIA liječenih etanerceptom (vidjeti dio 4.8).
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Croatian: crvenilo i krvarenje na mjestu uboda), infekcije (kao infekcije gornjih dišnih puteva, bronhitis, infekcije mokraćnog mjehura i kožne infekcije), alergijske reakcije, razvoj autoprotutijela, svrbež i vrućica.
English: These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Croatian: bakterijemiju, bronhitis, burzitis, celulitis, kolecistitis, proljev, divertikulitis, endokarditis (suspektni), gastroenteritis, hepatitis B, herpes zoster, ulkus noge, infekcije usne šupljine, osteomijelitis, otitis,
English: Erelzi 50 mg injection etanercept SC
Croatian: Erelzi 50 mg injekcija etanercept SC
English: Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Croatian: U bolesnika tjelesne težine 62,5 kg ili više može se primjenjivati doza iz napunjene štrcaljke ili napunjene brizgalice koje sadrže fiksnu dozu.
English: Citric acid anhydrous Sodium citrate dihydrate Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina, bezvodna natrijev citrat dihidrat natrijev klorid saharoza
English: However, your doctor may determine an alternative frequency at which to inject Erelzi.
Croatian: Međutim, liječnik može odrediti drukčiju učestalost primjene Erelzija.
English: After your injection:
Croatian: Nakon injekcije:
English: Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept.
Croatian: Jedna napunjena štrcaljka sadrži 25 mg etanercepta ili 50 mg etanercepta.
English: In studies when adult patients received concurrent treatment with etanercept plus anakinra, a higher rate of serious infections compared to etanercept alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count ˂ 1,000/mm3).
Croatian: U ispitivanjima u kojima su odrasli bolesnici primali istodobno etanercept i anakinru opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo etanerceptom, dok je 2% bolesnika (3/139)
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and ϕ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Croatian: c: Remisija je definirana kao DAS < 1,6 p-vrijednosti za usporedbu parova: † = p<0,05 za usporedbu etanercept + metotreksat u odnosu na metotreksat te ϕ = p<0,05 za usporedbu etanercept + metotreksat u odnosu na etanercept.
English: Do not use the pen if the expiry date has passed.
Croatian: Ne upotrebljavajte brizgalicu ako je istekao rok valjanosti.
English: Erelzi solution for injection in pre-filled syringe
Croatian: Erelzi otopina za injekciju u napunjenoj štrcaljki
English: Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Croatian: etanercepta nije zabilježena toksičnost koja bi ograničavala dozu, kao ni toksičnost prema ciljnim organima prilikom primjene u cinomolgus majmuna u dozi od 15 mg/kg supkutano, dva puta tjedno, tijekom 4 ili 26 uzastopnih tjedana, a pri toj su dozi serumske koncentracije lijeka izmjerene na osnovi
English: • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Croatian: Erelzi se propisuje i za liječenje sljedećih bolesti u djece i adolescenata: • Kod sljedećih oblika juvenilnog idiopatskog artritisa kad liječenje metotreksatom nije dovoljno dobro djelovalo ili nije bilo pogodno:
English: Before your injection:
Croatian: Prije primjene injekcije:
English: Allergic reactions associated with etanercept administration have been reported commonly.
Croatian: Alergijske reakcije Alergijske reakcije često su povezane s primjenom etanercepta.
English: • Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
Croatian: • Znakovi poremećaja živaca, kao što su utrnulost ili bockanje, poremećaji vida, bol u oku,
English: EU/1/17/1195/009 1 pre-filled SensoReady pen EU/1/17/1195/010 2 pre-filled SensoReady pens EU/1/17/1195/011 4 pre-filled SensoReady pens
Croatian: EU/1/17/1195/009 1 napunjena SensoReady brizgalica EU/1/17/1195/010 2 napunjene SensoReady brizgalice EU/1/17/1195/011 4 napunjene SensoReady brizgalice
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe” or “Instructions for use of the Erelzi SensoReady pen”.
Croatian: Iscrpne upute za primjenu dane su u uputi o lijeku, u dijelu 7, “Upute za primjenu napunjene štrcaljke Erelzi” ili „Upute za primjenu Erelzi SensoReady brizgalice“.
English: A biexponential curve is required to describe the concentration time curve of etanercept.
Croatian: Za opis odnosa koncentracija etanercepta - vrijeme nužna je bieksponencijalna krivulja.
English: DSGAb, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving etanercept 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Croatian: Nisu rađene statističke usporedbe s placebom u 24. tjednu u ispitivanjima 2 i 4 budući da je izvorna placebo skupina počela primati etanercept 25 mg dva puta tjedno ili 50 mg jednom tjedno od
English: All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on Erelzi, they should seek immediate medical advice.
Croatian: Sve bolesnike i roditelje/staratelje treba savjetovati da hitno zatraže savjet liječnika ako u tijeku liječenja Erelzijem bolesnik razvije bilo kakve znakove i simptome koji upućuju na krvne diskrazije ili infekcije (npr. perzistirajuća povišena temperatura, upala grla, modrice, krvarenja, bljedilo).
English: • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Erelzi.
Croatian: • Hepatitis B: obavijestite svog liječnika ako Vi ili dijete imate ili ste ikad imali hepatitis B.
English: After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the pen to reach room temperature.
Croatian: Nakon što izvadite napunjenu brizgalicu iz hladnjaka, pričekajte približno 15-30 minuta kako bi otopina Erelzija u brizgalici postigla sobnu temperaturu.
English: Erelzi is only available as 25 mg pre-filled syringe and 50 mg pre-filled syringe and pre-filled pen.
Croatian: Erelzi je dostupan samo kao napunjena štrcaljka od 25 mg, te napunjena štrcaljka i napunjena brizgalica od 50 mg.
English: Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving etanercept compared with control patients, particularly in patients with psoriasis.
Croatian: NMSC-a u bolesnika koji su dobivali etanercept u usporedbi s bolesnicima u kontrolnoj skupini, posebno u bolesnika sa psorijazom.
English: The largest of these trials (n = 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Croatian: U najveće od navedenih ispitivanja (n = 277) bili su uključeni bolesnici u dobi od 18 do 70 godina koji su imali aktivni ankilozantni spondilitis definiran bodovanjem prema vizualnoj analognoj skali (VAS) ≥ 30 za prosječno trajanje i intenzitet jutarnje ukočenosti i uz VAS bodovanje
English: Erelzi is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady pen).
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj brizgalici Erelzi dolazi u jednokratnoj napunjenoj štrcaljki uloženoj u brizgalicu trokutastog oblika s prozirnim prozorčićem i naljepnicom (SensoReady brizgalica).
English: Erelzi is available as 25 mg strength and 50 mg strength.
Croatian: Erelzi je dostupan u jačini od 25 mg i jačini od 50 mg.
English: To help you remember, it may be helpful to write in a diary which day(s) of the week Erelzi should be used.
Croatian: Radi lakšeg pamćenja, može Vam pomoći vođenje dnevnika i bilježenje dana kada trebate primijeniti
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mg•hr/l vs. 316 mg•hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept twice weekly (n = 16), respectively.
Croatian: kod primjene etanercepta u dozi od 50 mg jednom tjedno (n = 21) naspram primjene etanercepta u dozi od 25 mg dvaput tjedno (n = 16) iznosili su Cmax od 2,4 mg/l naspram 2,6 mg/l, Cmin od 1,2 mg/l naspram 1,4 mg/l, a djelomični AUC od 297 mgh/l naspram 316 mgh/l.
English: 2 pre-filled SensoReady pens
Croatian: 2 napunjene SensoReady brizgalice
English: Erelzi 25 mg solution for injection in pre-filled syringe EU/1/17/1195/001
Croatian: Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki EU/1/17/1195/001
English: The syringe inside the pen is made from clear type I glass with a stainless steel 27 gauge ½ inch needle and an inner rubber needle cap, containing 1.0 ml of solution.
Croatian: I s iglom od nehrđajućeg čelika, veličine igle 27 gauge i 1,27 cm, s unutarnjim gumenim poklopcem igle, a sadrži 1,0 ml otopine.
English: Erelzi 50 mg solution for injection in pre-filled syringe EU/1/17/1195/005
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki EU/1/17/1195/005
English: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately.
Croatian: Ako Vi ili dijete osjetite simptome alergijske reakcije kao što su stezanje u prsištu, piskanje pri disanju, omaglica ili osip, nemojte više ubrizgavati Erelzi i odmah se obratite svom liječniku.
English: Adult patients treated with etanercept and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either etanercept or anakinra alone (historical data).
Croatian: U odraslih bolesnika koji su istodobno liječeni etanerceptom i anakinrom opažena je povećana stopa ozbiljnih infekcija u usporedbi s bolesnicima koji su liječeni samo etanerceptom ili samo anakinrom
English: Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash
Croatian: (uključujući novonastalu ili pogoršanje postojeće i pustularnu, u prvom redu na dlanovima i tabanima), urtikarija,
English: 4 pre-filled syringes with a needle guard.
Croatian: 4 napunjene štrcaljke sa štitnikom igle.
English: Erelzi 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg etanercepta (etanerceptum).
English: Erelzi 50 mg solution for injection in pre-filled pen EU/1/17/1195/009
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj brizgalici EU/1/17/1195/009
English: Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Croatian: Etanercept je pokazao statistički značajno veće poboljšanje u odnosu na početak do 12. tjedna u usporedbi s placebom u većini procjena kvalitete života vezane uz zdravlje i fizičke funkcije,
English: There have been rare reports of CNS demyelinating disorders in patients treated with etanercept (see section 4.8).
Croatian: U bolesnika liječenih etanerceptom bilo je rijetkih prijava demijelinizacijskih poremećaja SŽS (vidjeti dio 4.8).
English: Multipack: 8 (2 packs of 4) pre-filled syringes with a needle guard.
Croatian: Višestruko pakiranje: 8 (2 pakiranja po 4) napunjenih štrcaljki sa štitnikom igle.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Sandoz GmbH Schaftenau
English: Baseline Week 52
Croatian: 52. tjedan
English: The solution is clear or slightly opalescent, colourless to slightly yellowish.
Croatian: Otopina je bistra ili blago opalescentna, bezbojna do blago žućkasta.
English: and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Croatian: 75 kilodaltona (p75).
English: Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Croatian: (80%) ili kortikosteroidima (24%).
English: 2 pre-filled syringes with a needle guard
Croatian: 2 napunjene štrcaljke sa štitnikom igle
English: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single non-steroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Croatian: Bolesnici su ostali na stabilnoj dozi jednog nesteroidnog protuupalnog lijeka i/ili prednizona (<0,2 mg/kg/na dan ili maksimalno 10 mg).
English: Caution should be exercised in patients being treated with Erelzi who have a previous history of blood dyscrasias.
Croatian: Pri liječenju Erelzijem potreban je oprez u bolesnika u kojih u anamnezi postoji pojava krvnih diskrazija.
English: Post-marketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept.
Croatian: U razdoblju nakon stavljanja lijeka u promet u bolesnika liječenih etanerceptom vrlo su rijetko prijavljeni slučajevi pojave karcinoma
English: • Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
Croatian: oteklinu (sa ili bez boli), uporan kašalj, prisutnost kvržica ili izraslina na koži • Znakovi autoimune reakcije (kada se stvaraju protutijela koja mogu oštetiti normalno tkivo u tijelu) kao što su bol, svrbež, slabost i poremećeno disanje, razmišljanje, osjet ili vid
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Erelzi in patients who have congestive heart failure (CHF).
Croatian: Liječnici moraju biti oprezni prilikom propisivanja Erelzija bolesnicima koji boluju od kongestivnog zatajenja srca.
English: Multipack: 24 (6 packs of 4) pre-filled syringes with a needle guard.
Croatian: Višestruko pakiranje: 24 (6 pakiranja po 4) napunjene štrcaljke sa štitnikom igle.
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled SensoReady pen after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici SensoReady napunjene brizgalice iza oznake „Rok valjanosti“ ili EXP.
English: • Free lines to record brand name and batch number
Croatian: • prazni retci za evidentiranje zaštićenog naziva i broja serije lijeka.