natgillin/translations-raw huggingface dataset:
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). 
Ozbiljne infekcije (uključujući upalu pluća, infekciju dubokih slojeva kože, infekciju zglobova, infekciju krvi i infekcije na različitim mjestima); pogoršanje kongestivnog zatajenja srca; nizak broj crvenih krvnih stanica, nizak broj bijelih krvnih stanica, nizak broj neutrofila (vrste 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).
Adult patients with psoriatic arthritis 
Odrasli bolesnici sa psorijatičnim artritisom
Study 3 
Ispitivanje 3
The pre-filled syringe is available in dose strengths of 25 mg and 50 mg. 
Napunjena štrcaljka dostupna je u jačinama od 25 mg i 50 mg.
Paediatric patients with juvenile idiopathic arthritis 
Pedijatrijski bolesnici s juvenilnim idiopatskim artritisom
Undesirable effects in paediatric patients with juvenile idiopathic arthritis 
Nuspojave u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom
Adult patients with plaque psoriasis 
Odrasli bolesnici s plak psorijazom
Allergic reactions associated with LIFMIOR administration have been reported commonly. 
Alergijske reakcije često su povezane s primjenom LIFMIORa.
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR 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. 
LIFMIOR se pokazao znatno 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.
Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo 
Odgovori bolesnika sa psorijatičnim artritisom u placebom kontroliranom ispitivanju Postotak bolesnika Placebo LIFMIOR
Immediate use is then recommended. 
Tada se preporučuje odmah primijeniti LIFMIOR.
Serious adverse reactions have also been reported for LIFMIOR. 
Prilikom primjene LIFMIORa također su prijavljene i ozbiljne nuspojave.
The safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA. 
Sigurnost i djelotvornost 50 mg LIFMIORa (dvije s.c. injekcije od 25 mg) jednom tjedno ispitivane su u dvostruko slijepom, placebom kontroliranom ispitivanju s 420 bolesnika s aktivnim RA.
The MYCLIC pen contains a clear, colourless to pale yellow or pale brown, solution for injection. 
Napunjena brizgalica MYCLIC sadrži bistru, bezbojnu do blijedožutu ili blijedosmeđu otopinu za injekciju.
Responses of Patients with Ankylosing Spondylitis in a Placebo-Controlled Trial Percent of Patients 
Odgovori bolesnika s ankilozantnim spondilitisom u placebom kontroliranom ispitivanju Postotak bolesnika
Study 4 
Ispitivanje 4
There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with LIFMIOR from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4). 
Nakon stavljanja lijeka u promet prijavljeni su slučajevi upalne bolesti crijeva i uveitisa u bolesnika s juvenilnim idiopatskim artritisom koji su liječeni LIFMIORom, uključujući i vrlo mali broj slučajeva ponovnog javljanja nuspojave nakon ponovne primjene lijeka (vidjeti dio 4.4).
Among patients with plaque psoriasis who received LIFMIOR, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy. 
Među bolesnicima s plak psorijazom koji su primali LIFMIOR zabilježen je značajan odgovor u usporedbi s placebom već za vrijeme prvog posjeta (nakon 2 tjedna) koji se održao do kraja 24. tjedna terapije.
Solution for injection in pre-filled syringe 
Otopina za injekciju u napunjenoj štrcaljki
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving LIFMIOR during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of openlabel extension therapy. 
U jednom ispitivanju u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom u dobi od 4 do 17 godina, 43 od 69 (62%) djece imalo je infekciju tijekom primanja LIFMIORa u toku tromjesečnog ispitivanja (prvi dio, otvoreno ispitivanje), a učestalost i težina infekcija bile su slične u 58 bolesnika koji su završili produljeno liječenje tijekom 12 mjeseci otvorenog ispitivanja.
• Blood disorders: Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. 
• Poremećaji krvne slike: ako dijete ima bilo koji od sljedećih simptoma, odmah potražite liječnički savjet: stalno povišenu tjelesnu temperaturu, grlobolju, krvne podljeve, krvarenje ili bljedilo.
Radiographic Progression: Comparison of LIFMIOR vs Methotrexate in Patients with RA of <3 Years Duration 
Radiološka progresija: usporedba LIFMIORa s metotreksatom u bolesnika s RA u trajanju od <3 godine
12 MYCLIC pre-filled pens 12 alcohol swabs 
12 napunjenih brizgalica MYCLIC 12 jastučića natopljenih alkoholom
The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis. 
Djelotvornost LIFMIORa ocijenjena je u 205 bolesnika sa psorijatičnim artritisom u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju.
Paediatric patients with plaque psoriasis 
Pedijatrijski bolesnici s plak psorijazom
• Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. 
• Poremećaji krvne slike: ako Vi ili dijete imate bilo koji od sljedećih simptoma, odmah potražite liječnički savjet: stalno povišenu tjelesnu temperaturu, grlobolju, krvne podljeve, krvarenje ili bljedilo.
Select a clean, well-lit, flat surface. 
Odaberite čistu, dobro osvijetljenu, ravnu površinu.
The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48. 
Srednje vrijednosti najnižih koncentracija u serumu u stanju dinamičke ravnoteže kretale su se od 1,6 do 2,1 μg/ml u 12., 24. i 48. tjednu.
4 MYCLIC pre-filled pens 4 alcohol swabs 
4 napunjene brizgalice MYCLIC 4 jastučića natopljenih alkoholom
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with LIFMIOR (see section 
Upalne bolesti crijeva i uveitis u bolesnika s juvenilnim idiopatskim artritisom (JIA) Bilo je prijava pojave upalne bolesti crijeva i uveitisa u bolesnika s JIA liječenih LIFMIORom (vidjeti dio 4.8).
50 mg solution for injection in pre-filled syringe EU/1/16/1165/008 
LIFMIOR 50 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1165/008
48 alcohol swabs 
48 jastučića natopljenih alkoholom
25 mg solution for injection in pre-filled syringe EU/1/16/1165/005 
LIFMIOR 25 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1165/005
Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs. 
Jedno pakiranje sadrži 4, 8, ili 24 jednodoznih bočica, 4, 8 ili 24 napunjenih štrcaljki koje sadrže vodu za injekcije, 4, 8 ili 24 igala, 4, 8 ili 24 nastavaka za bočicu i 8, 16 ili 48 jastučića natopljenih alkoholom.
In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis. 
U četvrtom ispitivanju ocjenjivana je sigurnost primjene i djelotvornost LIFMIORa 50 mg (dvije s.c. injekcije od 25 mg) primijenjenog jednom tjedno naspram 25 mg LIFMIORa primijenjenog dva puta tjedno u dvostruko slijepom, placebom kontroliranom ispitivanju 356 bolesnika s aktivnim ankilozantnim spondilitisom.
DSGA b, 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 LIFMIOR 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment. 
Nisu rađene statističke usporedbe s placebom u 24. tjednu u ispitivanjima 2 i 4 budući da je izvorna placebo skupina počela primati LIFMIOR 25 mg dva puta tjedno ili 50 mg jednom tjedno od 13. do 24. tjedna.
Patients in this study received a dose of 25 mg or 50 mg LIFMIOR, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg LIFMIOR twice weekly for an additional 24 weeks. 
2. Bolesnici su primali LIFMIOR 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 studije primali 25 mg LIFMIORa dva puta tjedno tijekom dodatna 24 tjedna.
In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon). 
U kontroliranim kliničkim ispitivanjima koja su dozvoljavala istodobno liječenje etanerceptom i metotreksatom, učestalost (kumulativna incidencija) autoimunog hepatitisa bila je 0,24% (manje česta učestalost).
2 MYCLIC pre-filled pens 2 alcohol swabs 
2 napunjene brizgalice MYCLIC 2 jastučića natopljenih alkoholom
In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon). 
U dvostruko slijepim fazama kontroliranih kliničkih ispitivanja etanercepta u svim indikacijama, učestalost (kumulativna incidencija) štetnih događaja povišenih jetrenih enzima u bolesnika koji su primali etanercept bez istodobne primjene metotreksata bila je 0,54% (manje česta učestalost).
4 vials of powder 
4 bočice s praškom
Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. 
U upalnom procesu reumatoidnog artritisa dominantni citokin je čimbenik nekroze tumora (TNF).
24a n = wk n = wk 
24a n =
Do not inject into areas where the skin is tender, bruised, red, or hard. 
Injekciju nemojte davati na mjestu gdje je koža osjetljiva, ima modrice ili je otvrdnula.
50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept. 
50 mg otopine za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg etanercepta.
Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients (see below, Undesirable effects in adults). 
Općenito, štetni događaji u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom po učestalosti i obliku bili su slični onima zabilježenim u odraslih bolesnika (pogledati u nastavku Nuspojave u odraslih bolesnika).
*see Description of selected adverse reactions, below. 
* vidjeti niže navedeni
Clinical Efficacy Results at 12 Months: Comparison of LIFMIOR vs Methotrexate vs LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration 
Rezultati kliničke djelotvornosti kroz 12 mjeseci: usporedba LIFMIORa prema metotreksatu i prema LIFMIORu u kombinaciji s metotreksatom u bolesnika s RA koji traje od 6 mjeseci do 20 godina
• 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 LIFMIOR. 
• Hepatitis B: obavijestite svog liječnika ako Vi ili dijete imate ili ste ikad imali hepatitis B.
25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept. 
25 mg otopine za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 25 mg etanercepta.
If the doctor has not given this instruction, please contact him/her. 
Obratite se liječniku ako Vam nije dao tu uputu.
LIFMIOR may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. 
LIFMIOR se može čuvati izvan hladnjaka na temperaturi do najviše 25C jednokratno do najdulje četiri tjedna poslije čega ga se ne smije staviti ponovo u hladnjak.
n = 90 wk 24a 
n = 90 tj.
Diagram 3. 
Slika 3.
Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with LIFMIOR. 
U razdoblju nakon stavljanja lijeka u promet u bolesnika liječenih LIFMIORom vrlo rijetko su prijavljeni slučajevi pojave karcinoma Merkelovih stanica.
OTHER MYCLIC Pre-filled pen 
Napunjena brizgalica MYCLIC
Detailed instructions on how to inject LIFMIOR are provided in section 7, “Using the MYCLIC pre-filled pen to inject LIFMIOR”. 
Detaljne upute kako ubrizgati LIFMIOR nalaze se u dijelu 7„Uporaba napunjene brizgalice MYCLIC za ubrizgavanje LIFMIORa“.
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly. 
Alternativno, može se primijeniti 50 mg dva puta tjedno do najviše 12 tjedana, nakon čega slijedi, ako je potrebno, liječenje dozom od 25 mg primijenjeno dva puta tjedno ili 50 mg jednom tjedno.
Instructions for preparing and giving an injection of LIFMIOR (See overleaf) 
Sadržaj pakiranja i druge informacije Upute za pripremu i primjenu injekcija LIFMIOR (vidjeti na poleđini)
The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and plastic plunger. 
I s iglom od nehrđajućeg čelika od 27G, gumenim pokrovom za iglu i plastičnim klipom.
You will be instructed by the child's doctor or his/her assistant on the technique of giving an injection and on the amount to be given to the child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection. 
Djetetov liječnik ili medicinska sestra pokazat će Vam pravilnu tehniku davanja injekcije i količinu koja će se davati djetetu.
The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. 
Smatra se da etanercept djeluje mehanizmom kompetitivne inhibicije vezanja TNF-a za TNFR-e na površini stanice čime inaktivira biološko djelovanje TNF-a i tako sprječava stanični odgovor posredovan TNF
The long-term safety and effectiveness of LIFMIOR 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 
Nakon gore spomenutih 48 tjedana ispitivanja dugotrajna sigurnost primjene i djelotvornost LIFMIORa 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.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for LIFMIOR 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept. 
Jedna napunjena štrcaljka sadrži 1,0 ml otopine, koja osigurava 50 mg etanercepta.
In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare). 
U kontroliranim kliničkim ispitivanjima etanercepta u svim indikacijama, učestalost (kumulativna incidencija) intersticijske plućne bolesti u bolesnika koji su primali etanercept bez istodobne primjene metotreksata bila je 0,06% (rijetka učestalost).
Paediatric population See Summary of the safety profile, above. 
Pedijatrijska populacija Vidjeti gore
LIFMIOR 25 mg solution for injection in pre-filled syringe LIFMIOR 50 mg solution for injection in pre-filled syringe 
LIFMIOR 25 mg otopina za injekciju u napunjenoj štrcaljki LIFMIOR 50 mg otopina za injekciju u napunjenoj štrcaljki etanercept
With experience, you will find the angle that is most comfortable for the child. Be careful not to push the needle into the skin too slowly, or with great force. 
Pripazite da ne gurate iglu kroz kožu presporo ili prevelikom snagom.
Diagram 6 
Slika 6
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. 
U djece i adolescenata liječenih antagonistima TNF-a ne može se isključiti rizik razvoja zloćudnih bolesti.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately. 
• 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 LIFMIOR i odmah se obratite svom liječniku.
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. 
Alternativno, može se davati 50 mg dva puta tjedno 12 tjedana, nakon čega slijedi 25 mg dva puta tjedno ili 50 mg jednom tjedno.
Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept. 
Jedna napunjena štrcaljka sadrži 0,5 ml otopine, koja osigurava 25 mg etanercepta.
Leave the white needle cap in place and wait approximately 15-30 minutes to allow the LIFMIOR solution in the pen to reach room temperature. 
Nemojte skinuti bijeli zatvarač igle i pričekajte 15 do 30 minuta da otopina LIFMIORa u brizgalici dosegne sobnu temperaturu.
Diagram 14 
Slika 14
The other ingredients in LIFMIOR are: Powder: Mannitol, sucrose and trometamol. 
Prašak: manitol, saharoza, trometamol.
70b a: 25 mg LIFMIOR SC twice weekly b: p < 0.001, LIFMIOR vs. placebo c: p < 0.01, LIFMIOR vs. placebo 
25 mg LIFMIORa supkutano, dva puta tjedno p < 0,001, LIFMIOR u odnosu na placebo p < 0,01, LIFMIOR u odnosu na placebo
In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon). 
U kontroliranim kliničkim ispitivanjima koja su dozvoljavala istodobno liječenje etanerceptom i metotreksatom, učestalost (kumulativna incidencija) intersticijske plućne bolesti bila je 0,47% (manje česta učestalost).
Detailed instructions on how to inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”. 
Detaljne upute kako ubrizgati LIFMIOR nalaze se u dijelu 7„Upute za pripremu i davanje injekcije LIFMIORa“.
When reconstituted, the solution contains 10 mg/ml of etanercept. 
Pripremljena otopina sadrži 10 mg/ml etanercepta.
Wipe the site where LIFMIOR is to be injected with the alcohol swab, using a circular motion. 
Obrišite mjesto uboda gdje će se ubrizgati LIFMIOR jastučićem vate natopljene alkoholom, kružnim pokretom.
Dispose of the used pen as instructed by your doctor, nurse or pharmacist. 
Brizgalicu odložite prema uputi liječnika, medicinske sestre ili ljekarnika.
The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein. 
Otopina bi trebala biti bistra do blago opalescentna, bezbojna do blijedožuta ili blijedosmeđa i može sadržavati male čestice proteina prozirne ili bijele boje.
If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin. 
Ako imate psorijazu, pokušajte izbjeći davanje injekcije izravno u odignuto, zadebljano, crveno ili ljuskavo područje kože.
• Uncommon (may affect up to 1 in 100 people): 
• Manje često (mogu se javiti u manje od 1 na 100 osoba):
Doses of 10 mg or 25 mg LIFMIOR were administered subcutaneously (SC) twice a week for up to 24 months. 
Primjenjivale su se doze od 10 mg ili 25 mg LIFMIORa, supkutano, dva puta tjedno tijekom najdulje 24 mjeseca.
Purple needle safety shield 
Ljubičasti sigurnosni štitnik igle
Doses of 10 mg or 25 mg LIFMIOR or placebo were administered subcutaneously twice a week for 6 consecutive months. 
Supkutano su primijenjene doze LIFMIORa od 10 mg ili 25 mg ili placebo, dva puta tjedno, tijekom šest uzastopnih mjeseci.
New onset cardiac failure congestive (see section 4.4) 
Novi nastupi kongestivnog srčanog zatajenja (vidjeti dio 4.4)
LIFMIOR may be stored at temperatures up to a maximum of 25° C for a single period of up to four weeks; after which, it should not be refrigerated again. 
LIFMIOR se može čuvati na temperaturi do maksimalno 25C jednokratno do najdulje četiri tjedna poslije čega se ne smije vratiti u hladnjak.
Caution should be exercised in patients being treated with LIFMIOR who have a previous history of blood dyscrasias. 
Pri liječenju LIFMIORom potreban je oprez u bolesnika u kojih u anamnezi postoji pojava krvnih diskrazija.
Cartons contain 4, 8 or 24 vials of LIFMIOR with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs. 
Kutija sadrži 4, 8, ili 24 bočice LIFMIORa s 4, 8 ili 24 otapalom napunjene štrcaljke, 4, 8 ili 24 igala, 4, 8, ili 24 nastavaka za iglu i 8, 16 ili 48 jastučića natopljenih alkoholom.
Purple needle safety shield extends to cover needle 
Ljubičasti sigurnosni štitnik za iglu proteže se preko igle i prekiva je
• Wipe the site where LIFMIOR is to be injected with a new alcohol swab, using a circular motion. 
• Obrišite mjesto uboda gdje će se ubrizgati LIFMIOR novim jastučićem vate natopljene alkoholom, kružnim pokretom.
• Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately. 
• Alergijske reakcije: ako dijete ima alergijsku reakciju kao što je stezanje u prsištu, piskanje pri disanju, omaglica ili osip, nemojte više ubrizgavati LIFMIOR i odmah se obratite svome liječniku.
Diagram 4 
Slika 4
• Place the vial upright on a clean, flat surface. 
• Postavite bočicu uspravno na čistu, ravnu površinu.
CARTON TEXT - (25 mg Pre-filled Syringe) - EU/1/16/1165/005-007 
TEKST NA KUTIJI - (Napunjena štrcaljka od 25 mg) - EU/1/16/1165/005-007
• Hepatitis B: Tell your doctor if the child has or has ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before the child begins treatment with LIFMIOR. 
• Hepatitis B: obavijestite svog liječnika ako dijete ima ili je ikad imalo hepatitis B.
LIFMIOR 25 mg powder and solvent for solution for injection. 
LIFMIOR 25 mg prašak i otapalo za otopinu za injekciju.