natgillin/translations-raw huggingface dataset:
Keep the pre-filled pen in its package in order to protect from light. 
Napunjenu brizgalicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
After reconstitution each mL contains 10 mg of infliximab. 
Nakon rekonstitucije, svaki ml sadrži 10 mg infliksimaba.
Infliximab (Week 98) 
Infliksima b (98. tjedan
• Do not shake the syringe at any time. 
• Nemojte nikada tresti štrcaljku.
The incidence of anti-infliximab antibodies following the subcutaneous infliximab was demonstrated to be not higher than that of the intravenous infliximab and had no significant impact on efficacy (determined by disease activity score in 28 joints [DAS28] and American College of Rheumatology criteria 20 [ACR20]) and the safety profile. 
(definirano kao broj bodova za aktivnosti bolesti u 28 zglobova [DAS28] i kriterijem 20 Američkog reumatološkog društva [ACR20] i sigurnosnim profilom.
An association between development of antibodies to infliximab and reduced duration of response has also been observed with intravenously administered infliximab. 
Uočena je i povezanost između razvoja protutijela na infliksimab i kraćeg trajanja odgovora na terapiju kad se infuzija infliksimaba daje intravenski.
• The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Remsima over 
• Lijek će se primijeniti infuzijom (ukapavanjem) tijekom 2 sata u jednu od vena, obično na ruci.
• A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Remsima 
Kartica s podsjetnikom za bolesnika sadržavat će sljedeće ključne poruke: • podsjetnik bolesnicima da karticu s podsjetnikom za bolesnika pokažu svim zdravstvenim radnicima koji ih liječe, uključujući i u hitnim slučajevima, te obavijest zdravstvenim radnicima da bolesnik uzima Remsima
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established. 
Sigurnost i djelotvornost infliksimaba nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa.
Can be stored at room temperature (up to 25°C) for a single period up to 6 months, but not exceeding the original expiry date. 
Može se čuvati na sobnoj temperaturi (do 25°C) neprekinuto tijekom razdoblja od najviše 6 mjeseci,
The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years. 
Sigurnost i djelotvornost infliksimaba nisu ispitivani u djece mlađe od 6 godina koja boluju od
Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 ≤400) in a randomised, double-blinded, placebo-controlled, dose-response study. 
Djelotvornost liječenja jednokratnom dozom infliksimaba ispitana je u 108 bolesnika s aktivnom Crohnovom bolešću (indeks aktivnosti Crohnove bolesti, engl.
Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group. 
(73,6%), nego u onih koji su ih primali svakih 12 tjedana (38,0%), dok su ozbiljne infekcije prijavljene u 3 ispitanika koji su terapiju održavanja primali svakih 8 tjedana i u 4 ispitanika koji su je primali svakih 12 tjedana.
In rheumatoid arthritis patients who received the recommended repeated treatment dose regimens with methotrexate, 8% of patients developed antibodies to infliximab. 
Protutijela protiv infliksimaba razvila su se u 8% bolesnika s reumatoidnim artritisom koji su liječeni po preporučenom režimu ponavljane primjene s metotreksatom.
Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6, and then every 4 or 8 weeks thereafter. 
Bolesnici su primali ili placebo ili infliksimab u dozi od 3 mg/kg odnosno 10 mg/kg 0., 2. i 6. tjedna ispitivanja, a zatim svakih 4 ili 8 tjedana.
Remove the cap (see Figure D). 
Uklonite zatvarač (vidjeti Sliku D).
Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p<0.001 and 46.1% vs. 18.2%, p<0.001, respectively). 
skupinama liječenima infliksimabom (zbirni podaci) u 54. je tjednu zabilježen veći udio bolesnika u kliničkoj remisiji u odnosu na skupinu koja je primala placebo (34,6% naspram 16,5%, p < 0,001), kao i veći udio bolesnika u kojih je nastupilo cijeljenje sluznice (46,1% liječenih infliksimabom naspram
No rebound was observed. 
Opažen je povišen ALT
Use of live vaccines can result in clinical infections, including disseminated infections. 
Primjena živih cjepiva može dovesti do kliničkih infekcija, uključujući diseminirane infekcije.Ne preporučuje se istodobna primjena živih cjepiva s infliksimabom.
The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively). 
Broj hospitalizacija vezanih uz ulcerozni kolitis bio je značajno manji u skupinama koje su primale dozu infliksimaba od 5 mg/kg odnosno 10 mg/kg u odnosu na skupinu koja je primala placebo (prosječan broj hospitalizacija na 100 bolesnik-godina: 21 odnosno 19
• You may get infections more easily when you are being treated with Remsima. 
• Tijekom liječenja lijekom Remsima možete postati osjetljiviji na infekcije.
including infliximab in the post-marketing setting. 
≤ 18 godina), uključujući infliksimab nakon stavljanja u promet.
Remsima is a solution that is clear to opalescent, colourless to pale brown. 
Remsima je bistra do opalescentna, bezbojna do svijetlosmeđa otopina.
Each pack contains 1 pre-filled syringe with automatic needle guard with 2 alcohol pads, 2 pre-filled syringes with automatic needle guard with 2 alcohol pads or 4 pre-filled syringes with automatic needle guard with 4 alcohol pads. 
Jedno pakiranje sadrži 1 napunjenu štrcaljku s automatskim štitnikom igle s 2 jastučića natopljena alkoholom, 2 napunjene štrcaljke s automatskim štitnikom igle s 2 jastučića natopljena alkoholom ili 4 napunjene štrcaljke s automatskim štitnikom igle s 4 jastučića natopljena alkoholom.
placebo infliximab placebo infliximab placebo infliximab placebo infliximab 
placeb o infliksima b placeb o infliksima b placeb o infliksima b placeb o infliksima b
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab. 
U bolesnika liječenih lijekom infliksimab opažene su tuberkuloza, bakterijske infekcije uključujući sepsu i pneumoniju, invazivne gljivične, virusne i druge oportunističke infekcije.
The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate. 
i 102. tjedna u 428 bolesnika koji su imali aktivni reumatoidni artritis usprkos liječenju metotreksatom.
• When starting a new card, keep this card as a reference for 4 months after your last dose of Remsima. 
• Kada dobijete novu karticu nastavite čuvati staru (ovu) karticu za potrebe provjere još 4 mjeseca nakon posljednje doze lijeka Remsima.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR PRE-FILLED PEN 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU BRIZGALICU
• The expiration date has passed. 
• nakon isteka roka valjanosti.
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established. 
Sigurnost i djelotvornost infliksimaba nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze.
EU/1/13/853/012 1 pre-filled pen EU/1/13/853/013 2 pre-filled pens EU/1/13/853/014 4 pre-filled pens 
EU/1/13/853/012 1 napunjena brizgalica EU/1/13/853/013 2 napunjene brizgalice EU/1/13/853/014 4 napunjene brizgalice
Beginning at week 22, patients who initially responded to treatment and subsequently lost their response were eligible to cross over to active re-treatment every 8 weeks at a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised. 
Počevši od 22. tjedna, bolesnike koji su prvobitno odgovorili na liječenje, no u kojih se klinički odgovor kasnije izgubio, bilo je dopušteno prebaciti na aktivno ponovno liječenje svakih 8 tjedana,
Finish the injection (see Figure G). 
11. Završite ubrizgavanje (vidjeti Sliku G).
In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions). 
3 bolesnika prijavila moguću anafilaktičku reakciju (od kojih su 2 bile među ozbiljnim reakcijama na infuziju).
ACR 50 response* 
Odgovor PASI 75**
Remove the needle from the injection site (see Figure G). 
Izvucite iglu štrcaljke iz mjesta primjene (vidjeti Sliku G).
In clinical studies with intravenous infliximab, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8). 
U kliničkim su ispitivanjima s intravenskim infliksimabom reakcije kasne preosjetljivosti bile manje česte i javljale su se nakon što se infliksimab nije primjenjivao u razdoblju kraćem od godinu dana (vidjeti dijelove 4.4 i
Package leaflet: Information for the user Remsima 120 mg solution for injection in pre-filled syringe infliximab 
Uputa o lijeku: Informacije za korisnika Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki infliksimab
• Reactions at the injection site such as pain, swelling, redness or itching 
• Znakovi lokalne reakcije na mjestu injekcije kao što su crvenilo, bol, svrbež, oticanje,
Mucosal healing at Week 30a a p <0.001, for each infliximab treatment group vs. placebo. 
Cijeljenje sluznice u 8. tjednua Cijeljenje sluznice u 30. tjednua a p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s placebom.
Remsima 100 mg powder for concentrate for solution for infusion infliximab 
Remsima 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
HAQ change from baseline over timee (patients evaluated) 
Promjena HAQ-a od početne vrijednostie (evaluirani bolesnici) 87
Anaphylactic shock, vasculitis, sarcoid-like reaction 
anafilaktički šok, vaskulitis, reakcija nalik na sarkoidozu Psihijatrijski poremećaji Često:
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab intravenous administration (see section 4.4). 
Nakon stavljanja lijeka u promet bilo je slučajeva reakcija nalik anafilaksiji, uključujući edem grkljana/ždrijela i teški bronhospazam te napadaje, koje su se povezivale s intravenskom primjenom lijeka infliksimab (vidjeti dio 4.4).
• Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remsima. 
• Odmah obavijestite Vašeg liječnika ako dobijete simptome smanjenog broja krvnih stanica za vrijeme liječenja lijekom Remsima.
Place the pen on the injection site (see Figure E). 
Postavite brizgalicu na mjesto primjene (see Sliku E).
• slow down the damage in your joints, 
• usporilo oštećenje zglobova • poboljšala
Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections. 
(7/60 [12%]) i faringitis (5/60 [8%]).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Remsima. 
Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte s Vašim liječnikom ili ljekarnikom prije nego primite lijek Remsima.
Remsima 100 mg powder for concentrate infliximab 
Remsima 100 mg prašak za koncentrat infliksimab i.v.
Do not use if the solution is cloudy, discoloured or contains visible particulate matter. 
Ne smije se primjenjivati ako je otopina mutna, ako je promijenila boju ili sadrži vidljive strane čestice.
How Remsima is given 
Kako se primjenjuje Remsima
Remsima 120 mg solution for injection in pre-filled syringe Each 1 mL single dose pre-filled syringe contains 120 mg of infliximab*. 
Remsima 120 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica s jednokratnom dozom od 1 ml sadrži 120 mg infliksimaba*.
Remsima 120 mg solution for injection in pre-filled syringe with automatic needle guard Remsima 120 mg solution for injection in single-use pre-filled syringe with automatic needle guard. 
Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki s automatskim štitnikom igle Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki za jednokratnu primjenu s automatskim štitnikom igle.
Dispose of the syringe (see Figure H). 
Zbrinjavanje štrcaljke (vidjeti Sliku H).
In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses. 
3 mg/kg [n = 27] ili infliksimab u dozi od 6 mg/kg [n = 46]) ostvario učinkovito dvostruko povećanje titra kao odgovor na polivalentno pneumokokno cjepivo, što ukazuje na to da infliksimab nije utjecao na humoralne imunološke odgovore neovisne o T-stanicama.
Package leaflet: Information for the user Remsima 120 mg solution for injection in pre-filled pen infliximab 
Uputa o lijeku: Informacije za korisnika Remsima 120 mg otopina za injekciju u napunjenoj brizgalici infliksimab
Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled syringe. 
Lijek Remsima je bistra do opalescentna, bezbojna do svijetlosmeđa otopina koja dolazi u napunjenoj štrcaljki za jednokratnu primjenu.
* p-values represent each infliximab treatment group vs. AZA monotherapy. 
(p < 0,001)* * p-vrijednosti odnose se na usporedbu svake skupine koja je primala infliksimab sa skupinom koja je primala monoterapiju AZA.
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration (see section 4.4). 
Nakon stavljanja lijeka u promet bilo je slučajeva reakcija nalik anafilaksiji, uključujući edem grkljana/ždrijela i teški bronhospazam te napadaje, koje su se povezivale s primjenom lijeka infliksimab (vidjeti dio 4.4).
Packs of: 
Veličine pakiranja:
Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8). 
Razdoblje nakon stavljanja lijeka u promet Ozbiljne nuspojave infliksimaba u pedijatrijskih bolesnika spontano prijavljene nakon stavljanja lijeka u promet uključivale su zloćudne bolesti među kojima i hepatosplenički limfom T-stanica, prolazne poremećaje vrijednosti jetrenih enzima, sindrome slične lupusu i pozitivan nalaz autoprotutijela
Re-administration for rheumatoid arthritis 
Ponovna primjena u reumatoidnom artritisu
Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study. 
Titraciju doze u bolesnika s reumatoidnim artritisom podupiru podaci koji dolaze iz ispitivanja
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p <0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data). 
kako u 30. tjednu (22,3% naspram 7,2%, p < 0,001, zbirni podaci iz ispitivanja ACT 1 i ACT 2) tako i u 54. tjednu (21,0% naspram 8,9%, p = 0,022, podaci iz ispitivanja ACT 1).
b. Lift the pen from the injection site (see Figure H). 
Podignite brizgalicu s mjesta primjene (vidjeti Sliku H).
• Do not reuse the syringe. 
• Nemojte ponovno primijeniti istu štrcaljku.
• treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. 
• liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika koji nisu odgovorili na punu i odgovarajuću terapiju nekim kortikosteroidom i/ili imunosupresivom,
Remsima 120 mg solution for injection in pre-filled syringe infliximab 
Remsima 120 mg otopina za injekciju u napunjenoj brizgalici infliksimab
Do not recap the syringe. 
Nemojte vraćati zatvarač štrcaljke natrag na štrcaljku.
Ulcerative colitis Paediatric Ulcerative colitis 
Ulcerozni kolitis Ulcerozni kolitis u pedijatrijski h bolesnika
How to store Remsima 
Kako čuvati lijek Remsima
If you are not sure if any of the above applies to you, talk to your doctor before you are given Remsima. 
Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte sa svojim liječnikom prije nego primite lijek Remsima.
Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier. 
Ako ga ne uporabite do novog roka valjanosti ili roka valjanosti otisnutog na kutiji, ovisno o tome koji je raniji, lijek morate baciti.
• 4 prefilled syringes with automatic needle guard (1 mL sterile solution) with 4 alcohol pads. 
• 4 napunjene štrcaljke s automatskim štitnikom igle (1 ml sterilne otopine) s 4 jastučića natopljena alkoholom.
Do not use the syringe if the liquid is different to clear colourless or pale brown or contains particles in it. 
Nemojte primijeniti brizgalicu ako tekućina nije bistra i bezbojna ili svjetlosmeđa.
The following side effects have been observed with Remsima: 
Kod primjene lijeka Remsima opažene su sljedeće nuspojave:
Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in pre-filled pen 
Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki Remsima 120 mg otopina za injekciju u napunjenoj brizgalici
• Alcohol swab 
• jastučić natopljen alkoholom
Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation. 
listerioza, salmoneloza] i virusne infekcije [citomegalovirus]), parazitske infekcije, reaktivacija hepatitisa B
Remove the pen from the injection site. 
12. Uklonite brizgalicu s mjesta primjene.
Tel: +386 1 519 29 22 info@oktal-pharma.si 
OKTAL PHARMA d.o.o. Tel: +386 1 519 29 22 info@oktal-pharma.si
Table 1 Adverse reactions in clinical studies and from post-marketing experience 
Nuspojave u kliničkim ispitivanjima i nakon stavljanja lijeka u promet
• You should receive recommended vaccinations before starting Remsima treatment. 
• Prije početka liječenja lijekom Remsima trebate primiti sva preporučena cjepiva.
Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group. 
Prosječni početni NAPSI rezultati iznosili su 4,6 u skupini liječenoj infliksimabom i
• Tell your doctor straight away if you get symptoms of liver problems during treatment with Remsima. 
• Odmah obavijestite Vašeg liječnika ako dobijete simptome jetrenih tegoba za vrijeme liječenja lijekom Remsima.
Clinical response at Week 8a Clinical response at Week 30a Sustained response (clinical response at both Week 8 and Week 30) 
Postotak ispitanika s kliničkim odgovorom i održanim kliničkim odgovorom Klinički odgovor u 8. tjednua
Insert the syringe into the injection site (see Figure E). 
Ubodite iglu štrcaljke u odabrano mjesto primjene (vidjeti Sliku E).
Juvenile rheumatoid arthritis patients 
Pedijatrijska populacija Bolesnici s juvenilnim reumatoidnim artritisom
A total of 306 patients received 3 doses of infliximab 5 mg/kg at week 0, 2 and 6. 
3 doze infliksimaba u dozi od 5 mg/kg u 0., 2. i 6. tjednu.
Elderly 
Ungverjaland
Tell your doctor straight away if you get signs of TB during treatment with Remsima. 
Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Remsima dobijete znakove tuberkuloze.
Week 22 
6. tjedan 22. tjedan
Do not recap the pen. 
nemojte ponovno primijeniti istu brizgalicu..
Paediatric Crohn's disease patients 
Crohnova bolest u pedijatrijski h bolesnika
How to use Remsima 
Kako primjenjivati lijek Remsima
Remsima 120 mg solution for injection in pre-filled pen Remsima 120 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. 
Remsima 120 mg otopina za injekciju u napunjenoj brizgalici Remsima 120 mg otopina za injekciju u napunjenoj brizgalici za jednokratnu primjenu od strane bolesnika.
Each pack contains 1 pre-filled pen with 2 alcohol pads, 2 pre-filled pens with 2 alcohol pads or 4 pre-filled pens with 4 alcohol pads. 
Jedno pakiranje sadrži 1 napunjenu brizgalicu s 2 jastučića natopljena alkoholom, 2 napunjene brizgalice s 2 jastučića natopljena alkoholom ili 4 napunjene brizgalice s 4 jastučića natopljena alkoholom.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 
BROJ SERIJE<, OZNAKE DONACIJE I PROIZVODA>
The syringe is made from type I glass with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield. 
I s čepom klipa (elastomer presvučen flurotekom) i iglom s čvrstim štitnikom igle.
• Do not shake the pen at any time. 
• Nemojte nikada tresti brizgalicu.
The primary endpoints were the reduction of signs and symptoms as assessed by the ACR criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function. 
ATTRACT, granična vrijednost ACR-N za ASPIRE), sprečavanje strukturnog oštećenja zglobova te poboljšanje funkcionalne sposobnosti.
In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy. 
protutijela protiv infliksimaba otkrivena su u 14% bolesnika koji su primali neku imunosupresivnu terapiju te u 24% bolesnika koji nisu primali imunosupresivnu terapiju.
• 2 prefilled syringes with automatic needle guard (1 mL sterile solution) with 2 alcohol pads. 
• 2 napunjene štrcaljke s automatskim štitnikom igle (1 ml sterilne otopine) s 2 jastučića natopljena alkoholom.
Name patient: 
Zaštićeni naziv:
EU/1/13/853/001 1 vial EU/1/13/853/002 2 vials EU/1/13/853/003 3 vials EU/1/13/853/004 4 vials EU/1/13/853/005 5 vials 
EU/1/13/853/001 1 bočica EU/1/13/853/002 2 bočice EU/1/13/853/003 3 bočice EU/1/13/853/004 4 bočice EU/1/13/853/005 5 bočica
Remove the syringe from the injection site (see Figure G). 
11. Uklonite štrcaljku s mjesta primjene (vidjeti Sliku G).
• Do not reuse the pen. 
• Nemojte ponovno primijeniti istu brizgalicu.
Each pack contains 1 pre-filled syringe with 2 alcohol pads, 2 pre-filled syringes with 2 alcohol pads or 4 pre-filled syringes with 4 alcohol pads. 
Jedno pakiranje sadrži 1 napunjenu štrcaljku s 2 jastučića natopljena alkoholom, 2 napunjene štrcaljke s 2 jastučića natopljena alkoholom ili 4 napunjene štrcaljke s 4 jastučića natopljena alkoholom.