natgillin/translations-raw huggingface dataset:
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”.
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“.
A biexponential curve is required to describe the concentration time curve of etanercept.
Za opis odnosa koncentracija etanercepta - vrijeme nužna je bieksponencijalna krivulja.
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.
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
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.
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).
• 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.
• Hepatitis B: obavijestite svog liječnika ako Vi ili dijete imate ili ste ikad imali hepatitis B.
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.
Nakon što izvadite napunjenu brizgalicu iz hladnjaka, pričekajte približno 15-30 minuta kako bi otopina Erelzija u brizgalici postigla sobnu temperaturu.
Erelzi is only available as 25 mg pre-filled syringe and 50 mg pre-filled syringe and pre-filled pen.
Erelzi je dostupan samo kao napunjena štrcaljka od 25 mg, te napunjena štrcaljka i napunjena brizgalica od 50 mg.
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.
NMSC-a u bolesnika koji su dobivali etanercept u usporedbi s bolesnicima u kontrolnoj skupini, posebno u bolesnika sa psorijazom.
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).
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
Erelzi is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady pen).
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).
Erelzi is available as 25 mg strength and 50 mg strength.
Erelzi je dostupan u jačini od 25 mg i jačini od 50 mg.
To help you remember, it may be helpful to write in a diary which day(s) of the week Erelzi should be used.
Radi lakšeg pamćenja, može Vam pomoći vođenje dnevnika i bilježenje dana kada trebate primijeniti
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.
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.
2 pre-filled SensoReady pens
2 napunjene SensoReady brizgalice
Erelzi 25 mg solution for injection in pre-filled syringe EU/1/17/1195/001
Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki EU/1/17/1195/001
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.
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.
Erelzi 50 mg solution for injection in pre-filled syringe EU/1/17/1195/005
Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki EU/1/17/1195/005
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.
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.
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).
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
Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash
(uključujući novonastalu ili pogoršanje postojeće i pustularnu, u prvom redu na dlanovima i tabanima), urtikarija,
4 pre-filled syringes with a needle guard.
4 napunjene štrcaljke sa štitnikom igle.
Erelzi 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg etanercepta (etanerceptum).
Erelzi 50 mg solution for injection in pre-filled pen EU/1/17/1195/009
Erelzi 50 mg otopina za injekciju u napunjenoj brizgalici EU/1/17/1195/009
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.
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,
There have been rare reports of CNS demyelinating disorders in patients treated with etanercept (see section 4.8).
U bolesnika liječenih etanerceptom bilo je rijetkih prijava demijelinizacijskih poremećaja SŽS (vidjeti dio 4.8).
Multipack: 8 (2 packs of 4) pre-filled syringes with a needle guard.
Višestruko pakiranje: 8 (2 pakiranja po 4) napunjenih štrcaljki sa štitnikom igle.
Name and address of the manufacturer(s) responsible for batch release
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Sandoz GmbH Schaftenau
Baseline Week 52
52. tjedan
The solution is clear or slightly opalescent, colourless to slightly yellowish.
Otopina je bistra ili blago opalescentna, bezbojna do blago žućkasta.
and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
75 kilodaltona (p75).
Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
(80%) ili kortikosteroidima (24%).
2 pre-filled syringes with a needle guard
2 napunjene štrcaljke sa štitnikom igle
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).
Bolesnici su ostali na stabilnoj dozi jednog nesteroidnog protuupalnog lijeka i/ili prednizona (<0,2 mg/kg/na dan ili maksimalno 10 mg).
Caution should be exercised in patients being treated with Erelzi who have a previous history of blood dyscrasias.
Pri liječenju Erelzijem potreban je oprez u bolesnika u kojih u anamnezi postoji pojava krvnih diskrazija.
Post-marketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept.
U razdoblju nakon stavljanja lijeka u promet u bolesnika liječenih etanerceptom vrlo su rijetko prijavljeni slučajevi pojave karcinoma
• 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;
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
Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Erelzi in patients who have congestive heart failure (CHF).
Liječnici moraju biti oprezni prilikom propisivanja Erelzija bolesnicima koji boluju od kongestivnog zatajenja srca.
Multipack: 24 (6 packs of 4) pre-filled syringes with a needle guard.
Višestruko pakiranje: 24 (6 pakiranja po 4) napunjene štrcaljke sa štitnikom igle.
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.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici SensoReady napunjene brizgalice iza oznake „Rok valjanosti“ ili EXP.
• Free lines to record brand name and batch number
• prazni retci za evidentiranje zaštićenog naziva i broja serije lijeka.
• Instruction to immediately seek for medical attention after detection of symptoms suggestive for infection
• upute da u slučaju simptoma koji mogu upućivati na infekciju valja odmah potražiti pomoć liječnika
4 pre-filled SensoReady pens
4 napunjene SensoReady brizgalice
EU/1/17/1195/013 8 pre-filled syringes EU/1/17/1195/004 12 pre-filled syringes EU/1/17/1195/014 24 pre-filled syringes
EU/1/17/1195/013 8 napunjenih štrcaljki EU/1/17/1195/004 12 napunjenih štrcaljki EU/1/17/1195/014 24 napunjene štrcaljke
By looking through the viewing window, the solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.
Kad se pogleda kroz kontrolni prozorčić, otopina bi trebala biti bistra do blago opalescentna, bezbojna ili blago žućkasta i može sadržavati male prozirne ili bijele čestice proteina.
1 pre-filled SensoReady pen
1 napunjena SensoReady brizgalica
4 pre-filled SensoReady pens.
4 SensoReady napunjene brizgalice.
Among patients with ankylosing spondylitis who received etanercept, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Među bolesnicima s ankilozantnim spondilitisom koji su primali etanercept, klinički odgovor bio je očit u trenutku prvog kontrolnog pregleda (nakon 2 tjedna), a zadržan je i tijekom trajanja terapije od
164 n = 193 n = 196 n = 196 n = 46 n = 96 n = 90
24a n = 193 tj.12
Efficacy response in placebo-controlled nr-AxSpa study: percent of patients achieving endpoints
Odgovor djelotvornosti u placebom kontroliranom ispitivanju nr-AxSpa: Postotak bolesnika koji su postigli mjere ishoda Dvostruko slijepi klinički odgovori u 12. tjednu
The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
Preporučena doza je 25 mg etanercepta primijenjeno dva puta na tjedan ili 50 mg etanercepta primijenjeno jednom tjedno.
4.1 Therapeutic indications
4.1 Terapijske indikacije Reumatoidni artritis
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
Šest zloćudnih bolesti je zabilježeno u bolesnika liječenih etanerceptom u kliničkim ispitivanjima trajanja duljeg od 2 godine u 351 bolesnika s ankilozantnim spondilitisom.
Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months.
primijećena je značajna prednost za etanercept kao monoterapiju u usporedbi s metotreksatom kao monoterapijom nakon 24 mjeseca.
Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i napunjenoj štrcaljki iza oznake „Rok valjanosti“ ili EXP.
In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
184 bolesnika je također primilo polivalentno pneumokokno polisaharidno cjepivo u 4. tjednu.
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi pre-filled syringe”.
Detaljne upute kako ubrizgati Erelzi nalaze se u dijelu 7„Upute za primjenu napunjene štrcaljke Erelzi“.
Undesirable effects in paediatric patients with plaque psoriasis
Nuspojave u pedijatrijskih bolesnika s plak psorijazom
Clinical responses among nr-AxSpa patients who received etanercept were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Klinički odgovori među bolesnicima s aksijalnim spondiloartritisom bez radiološkog dokaza koji su primali etanercept bili su uočljivi u vrijeme prvog posjeta (2 tjedna) i održani su kroz 2 godine liječenja.
1 pre-filled syringe with a needle guard
1 napunjena štrcaljka sa štitnikom igle
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi SensoReady pen”.
Detaljne upute kako ubrizgati Erelzi nalaze se u dijelu 7„Upute za primjenu Erelzi SensoReady napunjene brizgalice“.
4 pre-filled syringes with a needle guard
4 napunjene štrcaljke sa štitnikom igle
Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months.
7,5 mg tjedno do maksimalnih 20 mg tjedno te se s primjenom nastavilo tijekom najdulje 24 mjeseca.
A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Za liječenje djece s juvenilnim idiopatskim artritisom (JIA) tjelesne težine manje od 25 kg bile bi prikladnije bočiceErelzi jačine 10 mg.
25 mg BIW
25 mg.
Merkel cell carcinoma (see section 4.4)
Karcinom Merkelovih stanica (vidjeti dio
INSTRUCTIONS ON USE ‘QR code to be included' + www.erelzi.eu 16.
15. UPUTE ZA UPORABU „Treba navesti QR kod“ + www.erelzi.eu 16. PODACI NA BRAILLEOVOM PISMU Erelzi 25 mg
Keep the pre-filled syringes and the pre-filled pens in the outer carton in order to protect from light.
Napunjene štrcaljke i napunjene brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Erelzi to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Prije propisivanja Erelzija u osoba koje već neko vrijeme boluju, ili su nedavno oboljele, ili u kojih postoji povećana opasnost od razvoja demijelinizirajuće bolesti, preporučuje se pažljivo procijeniti odnos rizika i koristi, uključujući neurološku procjenu.
Erelzi 25 mg injection etanercept SC
Erelzi 25 mg injekcija etanercept s.c.
The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly.
Preporučena doza etanercepta je 25 mg primijenjeno dva puta tjedno ili 50 mg primijenjeno jednom tjedno.
Each pre-filled syringe contains 25 mg etanercept.
Jedna napunjena štrcaljka sadrži 25 mg etanercepta.
Among patients with psoriatic arthritis who received etanercept, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Klinički odgovor u bolesnika s psorijatičnim artritisom koji su primali etanercept zamijećen je u vrijeme prve kontrole (4 tjedna) i održan je tijekom svih 6 mjeseci liječenja.
CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
kroničnu upalnu demijeliniziraj uću polineuropatiju demijeliniziraj uću polineuropatiju i multifokalnu motoričku neuropatiju (vidjeti dio 4.4), napadaj
Additionally, the pharmacokinetics of etanercept in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
ankilozantnim spondilitisom i plak psorijazom je slična.
Erelzi 25 mg solution for injection in pre-filled syringe.
Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki.
Erelzi 25 mg solution for injection in pre-filled syringe etanercept
Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki etanercept (etanerceptum)
Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
atipične mikobakterijsk e, virusne infekcije i Legionellu)*
EU/1/17/1195/005 1 pre-filled syringe EU/1/17/1195/006 2 pre-filled syringes EU/1/17/1195/007 4 pre-filled syringes
EU/1/17/1195/005 1 napunjena štrcaljka EU/1/17/1195/006 2 napunjene štrcaljke EU/1/17/1195/007 4 napunjene štrcaljke
The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Odrasli bolesnici s psorijatičnim artritisom Djelotvornost etanercepta ocijenjena je u 205 bolesnika sa psorijatičnim artritisom u randomiziranom,
The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Tekućina treba biti bistra ili blago opalescentna, bezbojna do blago žućkasta i može sadržavati male bijele ili gotovo prozirne čestice proteina.
Erelzi 50 mg solution for injection in pre-filled syringe.
Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki.
Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
U procjeni erozije nakon 12 i 24 mjeseca, etanercept 25 mg je bio značajno superioran metotreksatu.
Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.
Višestruko pakiranje: 12 (3 pakiranja po 4) napunjenih štrcaljki sa štitnikom igle.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 25 MG PRE-FILLED SYRINGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)NAPUNJENA ŠTRCALJKA OD 25 MG
Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use.
Tijekom primjene etanercepta slučajevi središnje demijelinizacije prijavljeni su rijetko, dok su slučajevi periferne demijelinizacije prijavljeni vrlo rijetko.
You have been prescribed a 50 mg strength of Erelzi.
Erelzija od 50 mg.
What you need for your injection: Included in the carton:
Što Vam još treba za injekciju: • Alkoholni tupfer
Breast-feeding
Etanercept
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
24 mjeseca bio je veći kod kombinacije etanercepta s metotreksatom u usporedbi sa skupinom koja je uzimala samo etanercept i koja je uzimala samo metotreksat (62%, 50% odnosno 36%, p < 0,05).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 25 MG PRE-FILLED SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE - NAPUNJENA ŠTRCALJKA OD 25 MG
Erelzi 50 mg solution for injection in pre-filled syringe etanercept
Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki Etanercept (etanerceptum)
Elderly
Vaskulitis
Carefully remove the needle cap from the syringe.
Kako se koristi Erelzi napunjena štrcaljka Pažljivo maknite poklopac igle sa štrcaljke.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED PEN LABEL - 50 MG PRE-FILLED PEN
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NALJEPNICI NAPUNJENE BRIZGALICE - NAPUNJENA BRIZGALICA OD 50 MG
The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.
Otopina bi trebala biti bistra do blago opalescentna, bezbojna do blijedožuta i može sadržavati male prozirne ili bijele čestice proteina.
Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis,
Teški štetni događaji uključivali su vodene kozice praćene znakovima i simptomima aseptičnog meningitisa uz oporavak bez posljedica (vidjeti također dio 4.4), apendicitis, gastroenteritis, depresiju/poremećaj osobnosti, kožni ulkus, ezofagitis/gastritis, septični šok uzrokovan streptokokom grupe A, dijabetes melitus tipa
Posology and administration are the same as for adults 18-64 years of age.
Doziranje i način primjene jednaki su kao i u odraslih osoba starosti
EU/1/17/1195/001 1 pre-filled syringe EU/1/17/1195/002 2 pre-filled syringes EU/1/17/1195/003 4 pre-filled syringes
EU/1/17/1195/001 1 napunjena štrcaljka EU/1/17/1195/002 2 napunjene štrcaljke EU/1/17/1195/003 4 napunjene štrcaljke
Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.
Napunjene SensoReady brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
A 25 mg strength of Erelzi is available for doses of 25 mg.
Za doze od 25 mg dostupna je jačina
The possibility exists for TNF-antagonists, including Erelzi, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Budući da je TNF medijator upale te mijenja stanični imunološki odgovor, za sve antagoniste TNF-a, uključivši Erezli, postoji mogućnost utjecaja na obrambene reakcije bolesnika protiv infekcija i zloćudnih bolesti.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 25 MG PRE-FILLED SYRINGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDINIČNOG PAKIRANJA - NAPUNJENA ŠTRCALJKA OD 25 MG
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe".
Iscrpne upute za primjenu nalaze se u uputi o lijeku, dio 7 “Upute za primjenu napunjene štrcaljke Erelzi”.
Store your boxed pen in a refrigerator, between 2 °C to 8 °C and out of the sight and reach of children.
Čuvajte kutiju sa svojom brizgalicom u hladnjaku na temperaturi između 2 °C do