natgillin/translations-raw huggingface dataset:
EU/1/13/853/006 EU/1/13/853/007 EU/1/13/853/008 EU/1/13/853/009 EU/1/13/853/010 EU/1/13/853/011 EU/1/13/853/012 EU/1/13/853/013 EU/1/13/853/014
EU/1/13/853/006 EU/1/13/853/007 EU/1/13/853/008 EU/1/13/853/009 EU/1/13/853/010 EU/1/13/853/011 EU/1/13/853/012 EU/1/13/853/013
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
stupnja III-IV (ejekcijska frakcija lijeve klijetke ≤ 35%) liječeno sa 3 infuzije lijeka infliksimab u dozi od 5 mg/kg odnosno 10 mg/kg ili je primalo placebo tijekom 6 tjedana.
Give the injection (see Figure F).
Ubrizgavanje injekcije (vidjeti Sliku F).
If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original bi-weekly dosing schedule.
bolesnike se mora uputiti da preskoče propuštenu dozu i da pričekaju do iduće predviđene doze, a zatim da nastave s prvobitnim doziranjem svaka dva tjedna.
Improvement from baseline in HAQ averaged over time from week 30 to week 54c Mean ± SDd a p <0.001, for each infliximab treatment group vs control.
Prosjek poboljšanja HAQ od početne vrijednosti tijekom razdoblja od 30. do 54. tjednac Prosječna vrijednost ± SDd a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu. b veće vrijednosti znače jače oštećenje zgloba.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED PEN
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA NAPUNJENU BRIZGALICU
At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
od 101 bolesnika liječenih lijekom infliksimab (dvoje koji su primali dozu od 5 mg/kg i sedmero koji su primali dozu od 10 mg/kg), dok je među 49 bolesnika koji su primali placebo zabilježen samo jedan smrtni slučaj.
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, sarcoidosis/sarcoid-like reaction, and serious infusion reactions (see section 4.4).
Najozbiljnije nuspojave povezane s primjenom TNF-blokatora, koje su prijavljene za infliksimab, uključuju reaktivaciju hepatitisa B (HBV), kongestivno zatajenje srca, teške infekcije (uključujući sepsu, oportunističke infekcije i tuberkulozu), serumsku bolest (reakcija kasne preosjetljivosti), hematološke reakcije, sistemski eritematozni lupus/sindrom sličan lupusu, demijelinizacijske poremećaje, poremećaje jetre i žuči, limfom, hepatosplenički limfom T-stanica,
Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25°C after removal from refrigeration.
Nakon rekonstitucije i razrjeđivanja: Dokazana je kemijska i fizikalna stabilnost razrijeđene otopine do 28 dana na temperaturi od 2°C do
Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Sigurnost i djelotvornost infliksimaba nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa.
Infliximab (Week 16)
Infliksima b (16. tjedan
In Crohn's disease patients who received maintenance treatment, antibodies to infliximab occurred overall in 3.3% of patients receiving immunosuppressants and in 13.3% of patients not receiving immunosuppressants.
3,3% bolesnika koji su primali imunosupresive i 13,3% bolesnika koji nisu primali imunosupresive razvilo protutijela protiv infliksimaba.
Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials with infliximab, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
Najčešće nuspojave prijavljene u kliničkim ispitivanjima s infliksimabom bile su infekcije gornjih dišnih puteva, koje su nastupile u 25,3% bolesnika liječenih infliksimabom u odnosu na 16,5%
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥220 ≤450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Infliksimab sa ili bez AZA ispitivao se u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom (SONIC) u 508 odraslih bolesnika sa srednje teškom do teškom Crohnovom bolešću
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