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); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).
Ozbiljne infekcije (uključujući upalu pluća, infekciju dubokih slojeva kože, infekciju zglobova, infekciju krvi i infekcije na različitim mjestima); pogoršanje kongestivnog zatajenja srca; smanjenje broja crvenih krvnih stanica; smanjenje broja bijelih krvnih stanica; smanjen broj neutrofila (vrsta bijelih krvnih stanica); nizak broj krvnih pločica; rak kože (osim melanoma); ograničeno oticanje kože (angioedem); koprivnjača (izdignute mrlje crvene ili blijede kože koje često svrbe); upala oka; psorijaza (novonastala ili pogoršanje postojeće); upala krvnih žila koja zahvaća više organa; povišene vrijednosti jetrenih enzima u krvi (u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost povišenih jetrenih enzima u krvi je česta); grčevi i bol u trbuhu, proljev, gubitak težine ili krv u stolici (znakovi problema s crijevima).
Enbrel 50 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Enbrel 50 mg otopina za injekciju u napunjenoj štrcaljki Enbrel je dostupan kao napunjena štrcaljka koja sadrži bistru, bezbojnu do blijedožuta ili blijedosmeđa u otopinu za injekciju (otopinu za injekciju).
Enbrel 25 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Enbrel 25 mg otopina za injekciju u napunjenoj štrcaljki Enbrel je dostupan kao napunjena štrcaljka koja sadrži bistru, bezbojnu do blijedožuta ili bijedosmeđa u otopinu za injekciju (otopinu za injekciju).
• The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17).
• Tri preporučena mjesta za injekciju Enbrela uključuju: (1) prednju stranu sredine natkoljenice; (2) trbuh, s iznimkom područja u krugu 5 cm oko pupka; te (3) vanjsku stranu nadlaktice (vidjeti sliku 17).
Doses of 10 mg or 25 mg Enbrel or placebo were administered subcutaneously twice a week for 6 consecutive months.
Supkutano su primijenjene doze Enbrela od 10 mg ili 25 mg ili placebo, dva puta tjedno, tijekom šest uzastopnih mjeseci.
• The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
• Tri preporučena mjesta za injekciju za Enbrel uključuju: (1) prednju stranu sredine natkoljenice; (2) trbuh, s iznimkom područja u krugu 5 cm oko pupka; te (3) vanjsku stranu nadlaktice (vidjeti sliku 9).
• With the needle still in the vial, hold the vial upside down at eye level.
• Dok je igla još u bočici, držite bočicu u razini očiju tako da bude okrenuta naopako.
The three recommended injection sites for Enbrel using a pre-filled syringe include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 1).
Tri preporučena mjesta za injekciju Enbrela pomoću napunjen štrcaljke uključuju: (1) prednju stranu sredine natkoljenice, (2) trbuh, s iznimkom područja u krugu 5 cm oko pupka te (3) vanjsku stranu nadlaktice (vidjeti sliku 1).
Choosing an injection site g.
Odabir mjesta uboda h.
Diagram 14
Slika 14.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, 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 Enbrel i odmah se obratite svom liječniku.
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).
 30 za najmanje 2 od sljedeća 3 parametra: opća procjena bolesnika, prosječne vrijednosti VAS za noćnu bol u leđima i ukupnu bol u leđima, prosječno 10 pitanja u Bath funkcionalnom indeksu ankilozantnog spondilitisa (Bath Ankylosing Spondylits Functional Index (BASFI)).
Cartons contain 4, 8 or 24 vials of Enbrel 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 Enbrela s 4, 8 ili 24 štrcaljke napunjene otapalom, 4, 8 ili 24 igle, 4, 8 ili 24 nastavka za bočicu i 8, 16 ili 48 jastučića natopljenih alkoholom.
• 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 Enbrel.
• Hepatitis B: obavijestite svog liječnika ako dijete ima ili je ikad imalo hepatitis B.
Before preparing the Enbrel solution, Enbrel 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.
Prije pripreme Enbrel otopine, Enbrel 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.
Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
Igle i štrcaljku odložite prema uputi liječnika, medicinske sestre ili ljekarnika.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, 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 Enbrel i odmah se obratite svom liječniku.
• Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
• Alergijske reakcije: ako dijete dobije alergijsku reakciju kao što je stezanje u prsištu, piskanje pri disanju, omaglica ili osip, nemojte više ubrizgavati Enbrel i odmah se obratite svom liječniku.
EU/1/99/126/003 4 vials EU/1/99/126/004 8 vials EU/1/99/126/005 24 vials
EU/1/99/126/003 4 bočice EU/1/99/126/004 8 bočica EU/1/99/126/005 24 bočice
The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate and sodium phosphate dibasic dihydrate, and water for injections.
Pomoćne tvari su saharoza, natrijev klorid, L-argininklorid, natrijev dihidrogenfosfat dihidrat, i natrijev hidrogenfosfat dihidrat i voda za injekcije.
If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Ako dijete ima alergijsku reakciju kao što je stezanje u prsištu, piskanje pri disanju, omaglica ili osip, nemojte više ubrizgavati Enbrel i odmah se obratite svom liječniku.
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.
24a n = 193 wk 12
n = 193 tj.12
Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
c: Remisija je definirana kao DAS <1,6 p-vrijednosti za usporedbu parova: † = p<0,05 za usporedbu Enbrel + metotreksat u odnosu na metotreksat te  = p<0,05 za usporedbu Enbrel + metotreksat u odnosu na Enbrel
Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
Ozbiljne alergijske reakcije (uključujući izraženo lokalizirano oticanje kože i piskanje pri disanju); limfomi (vrsta raka krvi); leukemija (rak koji zahvaća krv i koštanu srž); melanom (vrsta raka kože); istodobno smanjenje broja krvnih pločica, crvenih i bijeli krvnih stanica; poremećaji živčanog sustava (s jakom mišićnom slabošću i znakovima i simptomima sličnim onima u multiploj sklerozi ili upala vidnog živca ili leđne moždine); tuberkuloza; novi nastupi kongestivnog zatajenja srca; napadaji; lupus ili sindrom nalik lupusu (simptomi mogu uključivati osip produljenog trajanja, vrućicu, bol u zglobovima i umor);; osip kože koji može dovesti do teške pojave mjehura i guljenja kože; lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici); upala jetre izazvana reakcijom vlastitog imunološkog sustava (autoimuni hepatitis; u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost je manje česta), poremećaji imunološkog sustava koji mogu zahvatiti pluća, kožu i limfne čvorove (sarkoidoza); upala ili ožiljkasto zacjeljivanje pluća (u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost upale ili ožiljkastog zacjeljivanja pluća je manje česta).
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 nonsteroidal 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).
Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Iglu i štrcaljku odložite prema uputi liječnika, medicinske sestre ili ljekarnika.
4 pre-filled syringes 4 alcohol swabs
4 napunjene štrcaljke 4 jastučića natopljena alkoholom
1 Pre-filled syringe containing clear, colourless solvent (water for injections) 1 Needle
1 Enbrel bočica 1 napunjena štrcaljka s prozirnim, bezbojnim otapalom (voda za injekcije) 1 igla 1 nastavak za bočicu 2 jastučića natopljena alkoholom
Diagram 10
Slika 10.
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 poklopcem za iglu i plastičnim klipom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT - EU/1/99/126/002
TEKST NA NALJEPNICI BOČICE - EU/1/99/126/002
CARTON TEXT - EU/1/99/126/023-025 (25 mg Pre-filled Pen)
TEKST KUTIJE - EU/1/99/126/023-025 (napunjena brizgalica od 25 mg)
• Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion.
• Obrišite mjesto uboda gdje će se ubrizgati Enbrel jastučićem vate natopljene alkoholom, kružnim pokretom.
Each vial of Enbrel contains 10 mg etanercept.
Jedna bočica Enbrela sadrži 10 mg etanercepta.
EU/1/99/126/016 2 pre-filled syringes EU/1/99/126/017 4 pre-filled syringes EU/1/99/126/018 12 pre-filled syringes
EU/1/99/126/016 2 napunjene štrcaljke EU/1/99/126/017 4 napunjene štrcaljke EU/1/99/126/018 12 napunjenih štrcaljki
Week 52 scoreb
Na početku 52. tjedan
Enbrel 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
U procjeni erozije nakon 12 i 24 mjeseca, Enbrel 25 mg je bio značajno superioran metotreksatu.
2 pre-filled syringes 2 alcohol swabs
2 napunjene štrcaljke 2 jastučića natopljena alkoholom
24.8c
4.8 Nuspojave
Responses of Patients with Ankylosing Spondylitis in a Placebo-controlled Trial Percent of Patients
Odgovori bolesnika s ankilozantnim spondilitisom u placebom kontroliranom ispitivanju
CARTON TEXT - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
TEKST KUTIJE - EU/1/99/126/019-021 (napunjena brizgalica od 50 mg)
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
Šest zloćudnih bolesti je zabilježeno u bolesnika liječenih Enbrelom u kliničkim ispitivanjima trajanja duljeg od 2 godine u 351 bolesnika s ankilozantnim spondilitisom.
Each pack contains 4, 8 or 24 pens and 4, 8 or 24 alcohol swabs.
Jedno pakiranje sadrži 4, 8 ili 24 brizgalice i 4, 8 ili 24 jastučića natopljena alkoholom.
Cartons contain 4, 8, 12 or 24 pre-filled syringes of Enbrel and 4, 8, 12 or 24 alcohol swabs.
Kutije sadrže 4, 8, 12 ili 24 napunjene štrcaljke Enbrela i 4, 8, 12 ili 24 jastučića natopljenih alkoholom.
Pre-filled pen (MYCLIC) containing a 25 mg pre-filled syringe of Enbrel.
Napunjena brizgalica (MYCLIC) koja sadrži napunjenu štrcaljku Enbrela od 25 mg.
EU/1/99/126/013 4 pre-filled syringes EU/1/99/126/014 8 pre-filled syringes EU/1/99/126/015 24 pre-filled syringes EU/1/99/126/026 12 pre-filled syringes
EU/1/99/126/013 4 napunjene štrcaljke EU/1/99/126/014 8 napunjenih štrcaljki EU/1/99/126/015 24 napunjene štrcaljke EU/1/99/126/026 12 napunjenih štrcaljki
Then continue to inject the medicine on the usual day(s).
Nakon toga nastavite s primjenom Enbrela uobičajenim danima.
Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products as well as the parent compound.
Serumske vrijednosti etanercepta određivane su enzimskim imunotestom ELISA (engl.
Enbrel 25 mg solution for injection in pre-filled syringe Enbrel 50 mg solution for injection in pre-filled syringe
Enbrel 25 mg otopina za injekciju u napunjenoj štrcaljki Enbrel 50 mg otopina za injekciju u napunjenoj štrcaljki
Enbrel 10 mg powder and solvent for solution for injection for paediatric use etanercept
Enbrel 10 mg prašak i otapalo za otopinu za injekciju za pedijatrijsku primjenu etanercept
Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC prefilled pen after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i napunjenoj brizgalici MYCLIC iza oznake „Rok valjanosti“ ili EXP.
Pre-filled pen (MYCLIC) containing a 50 mg pre-filled syringe of Enbrel.
Napunjena brizgalica (MYCLIC) koja sadrži napunjenu štrcaljku Enbrela od 50 mg.
Enbrel 10 mg powder and solvent for solution for injection for paediatric use
Enbrel 10 mg prašak i otapalo za otopinu za injekciju za pedijatrijsku primjenu
Cartons contain 4, 8 or 24 pre-filled pens of Enbrel with 4, 8 or 24 alcohol swabs.
Kutije sadrže 4, 8, ili 24 napunjene brizgalice Enbrela s 4, 8 ili 24 jastučića natopljena alkoholom.
Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4, 8, 12 or 24 alcohol swabs.
Jedno pakiranje sadrži 4, 8, 12 ili 24 napunjenih štrcaljki i 4, 8, 12 ili 24 jastučića natopljenih alkoholom.
Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Nakon supkutane primjene etanercept se izlučuje u majčinom mlijeku u ljudi.
Enbrel 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.
Enbrel 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.
Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”.
Detaljne upute kako pripremiti i ubrizgati Enbrel nalaze se u dijelu 7„Upute za pripremu i davanje injekcije Enbrela“.
Enbrel 25 mg solution for injection in pre-filled pen Enbrel 50 mg solution for injection in pre-filled pen
Enbrel 25 mg otopina za injekciju u napunjenoj brizgalici Enbrel 50 mg otopina za injekciju u napunjenoj brizgalici
Clinical responses among nr-AxSpa patients who received Enbrel 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 spondiloatrtitisom bez radiološkog dokaza koji su primali Enbrel bili su uočljivi u vrijeme prvog posjeta (2 tjedna) i održani su kroz 2 godine liječenja.
Baseline scoreb Week 52 scoreb
Početni bodovi Bodovi nakon 52 tjedna Remisija
Enbrel 25 mg powder for solution for injection
Enbrel 25 mg prašak za otopinu za injekciju
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „Rok valjanosti“ ili EXP.
Enbrel 50 mg solution for injection in pre-filled syringe The active substance in Enbrel is etanercept.
Enbrel 50 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar Enbrela je etanercept.
Enbrel 50 mg solution for injection in pre-filled syringe EU/1/99/126/016
Enbrel 50 mg otopina za injekciju u napunjenoj štrcaljki EU/1/99/126/016
Do not inject into tender, bruised or hard skin.
Injekciju nemojte davati na mjestu gdje je koža osjetljiva, modra ili otvrdnula.
Enbrel 25 mg solution for injection in pre-filled syringe EU/1/99/126/013
Enbrel 25 mg otopina za injekciju u napunjenoj štrcaljki EU/1/99/126/013
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Preporučena doza Enbrela je 25 mg primijenjena dva puta tjedno ili 50 mg primijenjeno jednom tjedno.
EU/1/99/126/023 4 pre-filled pens EU/1/99/126/024 8 pre-filled pens EU/1/99/126/025 24 pre-filled pens
EU/1/99/126/023 4 napunjene brizgalice EU/1/99/126/024 8 napunjenih brizgalica EU/1/99/126/025 24 napunjene brizgalice
Doses of 10 mg or 25 mg Enbrel were administered SC twice a week for up to 24 months.
Primjenjivale su se doze od 10 mg ili 25 mg Enbrela, supkutano, dva puta tjedno tijekom najdulje 24 mjeseca.
Enbrel 25 mg solution for injection in pre-filled syringe The active substance in Enbrel is etanercept.
Enbrel 25 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar Enbrela je etanercept.
Cartons contain 2, 4 or 12 pre-filled pens of Enbrel with 2, 4 or 12 alcohol swabs.
Kutije sadrže 2, 4, ili 12 napunjenih brizgalica Enbrela s 2, 4 ili 12 jastučića natopljena alkoholom.
There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Enbrel.
U bolesnika koji su primali Enbrel nakon stavljanja u promet zabilježena su pogoršanja bolesti kongestivnog zatajenja srca, sa i bez ustanovljivih pospješujućih čimbenika.
Enbrel 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Enbrel 25 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 25 mg etanercepta.
The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles.
Otopina mora biti bistra i bezbojna do blijedožuta ili blijedom smeđa, bez grudica, pahuljica ili čestica.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.
• Hepatitis C: obavijestite svog liječnika ako Vi ili dijete imate hepatitis C.
Enbrel 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Enbrel 50 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg etanercepta.
It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein.
Trebala bi biti bistra ili blago opalescentna, bezbojna do blijedožuta ili blijedosmeđa i može sadržavati bijele ili gotovo prozirne čestice proteina.
Slovenija Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400
Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Enbrel 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 Enbrela 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.
The possibility exists for TNF-antagonists, including Enbrel, 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 Enbrel, postoji mogućnost utjecaja na obrambene reakcije bolesnika protiv infekcija i zloćudnih bolesti.
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 prozirne ili bijele čestice proteina.
Enbrel 25 mg solution for injection in pre-filled pen EU/1/99/126/023
Enbrel 25 mg otopina za injekciju u napunjenoj brizgalici EU/1/99/126/023
Doses of 10 mg or 25 mg Enbrel were administered subcutaneously (SC) twice a week for up to 24 months.
Primjenjivane su doze od 10 mg ili 25 mg Enbrela, supkutano, dva puta tjedno tijekom najdulje 24 mjeseca.
Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Jedna bočica Enbrela 25 mg sadrži 25 mg etanercepta.
Each MYCLIC pre-filled pen contains 25 mg of etanercept.
Jedna napunjena brizgalica MYCLIC sadrži 25 mg etanercepta.
Enbrel 25 mg powder and solvent for solution for injection
Enbrel 25 mg prašak i otapalo za otopinu za injekciju
EU/1/99/126/019 2 pre-filled pens EU/1/99/126/020 4 pre-filled pens EU/1/99/126/021 12 pre-filled pens
EU/1/99/126/019 2 napunjene štrcaljke EU/1/99/126/020 4 napunjene štrcaljke EU/1/99/126/021 12 napunjenih štrcaljki