natgillin/translations-raw huggingface dataset:
• Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils (furunculosis)
• ozbiljne kožne bolesti kao što su toksična epidermalna nekroliza, Stevens-Johnsonov sindrom i akutna generalizirana egzantematozna pustuloza • drugi problemi s kožom kao što su multiformni eritem, lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici), mjehurići na koži i ljuštenje kože ili gnojni čirevi (furunkuloza)
• Ankylosing spondylitis (Bechterew's disease)
• ankilozantni spondilitis (Bechterewljeva bolest) • psorijazu
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
U bolesnika liječenih TNF-blokatorima, uključujući infliksimab, prijavljeni su melanom i karcinom Merkelovih stanica (vidjeti dio 4.8).
Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
osip, svrbež, hiperhidroza, suha koža, gljivični dermatitis,
Tell your doctor straight away if you get symptoms of low blood counts during treatment with Zessly.
Odmah obavijestite Vašeg liječnika ako dobijete simptome smanjenog broja krvnih stanica za vrijeme liječenja lijekom Zessly.
Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), akutna generalizirana egzantematozna pustuloza (AGEP), lihenoidne reakcije Nepoznato: pogoršanje simptoma dermatomiozitisa
• Pain.
• bol
• You may get infections more easily when you are being treated with Zessly.
• Tijekom liječenja lijekom Zessly možete postati osjetljiviji na infekcije.
• Pain in the joints, muscles or back
• bol u zglobovima, mišićima ili leđima • infekcije mokraćnih puteva
• Collection of blood outside the blood vessels (haematoma) or bruising
• nedostatna opskrba krvlju, oticanje vena • nakupljanje krvi izvan krvnih žila (hematom) ili nastanak modrica
Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Prosječna vrijednost ± SDa Promjena od početnog ukupnog broja bodova prema van der Heijdeovoj modifikaciji Sharpove bodovne skaleb
b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Analiza je temeljena na bolesnicima s psorijazom noktiju na početku ispitivanja (81,8% bolesnika).
Clinical response at week 8a Clinical response at week 30a Sustained response (clinical response at both week 8 and week 30)a
(klinički odgovor i u 8. i u 30. tjednu)a
Nervous system disorders Very common:
Poremećaji živčanog sustava Vrlo često: glavobolja
In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section
Nakon stavljanja lijeka u promet, u bolesnika koji su primali infliksimab prijavljeni su slučajevi žutice i hepatitisa, koji je u nekim slučajevima imao obilježja autoimunog hepatitisa (vidjeti dio 4.4).
infliximab (week 24)
Infliksima b (24. tjeda n)
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Na temelju opservacijskog ispitivanja provedenog u sjevernoj Europi, opažen je povećan rizik (OR, 95% CI; p-vrijednost) za carski rez (1,50; 1,14-1,96; p = 0,0032), prijevremeni porođaj
Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Psorijatični artritis Plak psorijaza 1 Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24, and 50.
Sažeti prikaz PASI odgovora, PGA odgovora i postotka bolesnika bez psorijatičnih promjena na noktima u 10., 24. i 50. tjednu, ispitivanje 13
infliximab (week 54)
Infliksima b (54. tjeda n)
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.
Fistula Response (%) a Complete fistula response (%) b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Odgovor fistula (%) a Potpuni odgovor fistula (%) b a
• Signs of serious skin problems such as reddish-target-like spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body.
često s mjehurima u sredini, koje se javljaju na području trupa, zatim velika područja na kojima se koža ljušti i peruta (eksfolijativni poremećaj), vrijedovi u ustima, grlu i nosu te na spolnim organima i očima ili gnojni prištići koji se mogu proširiti po tijelu.
Common (may affect up to 1 in 10 people)
Česte: mogu se javiti u do 1 na 10 osoba
PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2)
PGA čist (0) ili minimalan (1) PGA čist (0), minimalan (1) ili blag (2) Svi nokti bez psorijatičnih promjenac
During the 24-week double blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22
Tijekom 24 tjedana dvostruko slijepe faze ispitivanja, bolesnici su primali ili infliksimab u dozi od 5 mg/kg ili placebo u 0., 2., 6., 14. i 22. tjednu (100 bolesnika u svakoj skupini).
• Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
• Bolesnici s teškim oblikom reumatoidnog artritisa, koji već dugo vremena boluju od te bolesti,
Discontinuation of Zessly should be considered if these disorders develop.
Ako se razviju ovakvi poremećaji, treba razmotriti prekid primjene lijeka Zessly.
• Kidney infections
• infekcije bubrega
The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies 12 and 13.
Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa,
The following side effects have been observed with medicines containing infliximab:
Kod primjene lijeka infliksimab opažene su sljedeće nuspojave:
• Some patients receiving treatment with medicines containing infliximab have developed serious liver problems.
Jetrene tegobe • U nekih bolesnika koji primaju infliksimab razvile su se ozbilljne jetrene tegobe.
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
poremećaj pigmentacije Rijetko: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom,
Package leaflet: Information for the user Zessly 100 mg powder for concentrate for solution for infusion infliximab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za korisnika Zessly 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
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).
(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 18,2% bolesnika koji su primali placebo, p < 0,001).
ACR 20 response* 5 (10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0 (0%) 24 (46%) 35 (45%) ACR 70 response* 0 (0%) 15 (29%) 27 (35%) PASI response (% of patients)b
ACR odgovor (% bolesnika) N Odgovor ACR 20* Odgovor ACR 50* Odgovor ACR 70* PASI odgovor (% bolesnika)b
Induction treatment in fistulising active Crohn's disease
Uvodna terapija u fistulirajućoj, aktivnoj Crohnovoj bolesti
Neutropenia, leukopenia, anaemia, lymphadenopathy.
leukopenija, neutropenija i trombocitopenija.
including infliximab in the post-marketing setting.
≤ 18 godina), uključujući infliksimab, nakon stavljanja tih lijekova u promet.
Myocardial ischaemia/myocardial infarction.
sinkopa, bradikardija Rijetko: cijanoza, perikardijalni izljev Nepoznato: ishemija miokarda/infarkt miokarda
• These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
• Te infekcije mogu biti ozbiljne, a uključuju tuberkulozu, virusne infekcije, gljivične infekcije,
• You should receive recommended vaccinations before starting Zessly treatment.
• Prije početka liječenja lijekom Zessly trebate primiti sva preporučena cjepiva.
Table 1 Undesirable effects in clinical studies and from post-marketing experience
Nuspojave u kliničkim ispitivanjima i nakon stavljanja lijeka u promet
Zessly is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).
Zessly je indiciran za liječenje umjerene do teške plak psorijaze u odraslih bolesnika u kojih je druga sustavna terapija, uključujući ciklosporin, metotreksat ili PUVA terapiju, nedjelotvorna,
Heart problems
Srčani poremećaji
Paediatric ulcerative colitis (6 to 17 years)
Ulcerozni kolitis u pedijatrijskih bolesnika (6 do 17 godina)
Twenty four of these patients (75.0%) regained clinical response after crossing over.
Nakon toga se klinički odgovor vratio u 24 bolesnika (75,0%).
* 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 patients who develop HBV reactivation, Zessly should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Zessly te uvesti djelotvorne antivirusne lijekove uz odgovarajuće suportivno liječenje.
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Često: novonastala psorijaza ili pogoršanje postojeće uključujući pustularnu psorijazu (primarno palmarnu i plantarnu), urtikarija,
usually in your arm. After the third treatment, your doctor may decide to give your dose of
Nakon treće doze liječnik može odlučiti primijeniti dozu lijeka Zessly tijekom jednog sata.
Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap. Zessly is available in packs containing 1, 2, 3, 4 or 5 vials.
Staklena bočica (staklo tip 1) s gumenim čepom i aluminijskim prstenom zaštićenim plastičnom kapicom.
• Infection due to a live vaccine because of a weakened immune system.
• privremeni gubitak vida tijekom ili unutar 2 sata od infuzije • infekcija uzrokovana primjenom živog cjepiva zbog oslabljenog imunološkog sustava
Concurrent administration of TNF-alpha inhibitor and anakinra
Istodobna primjena inhibitora TNFα i anakinre
Zessly infliximab
Monoterapija infliksimabom
infliximab (week 16)
Infliksima b (16. tjeda n)
Study 1 evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
tjedna u 428 bolesnika koji su imali aktivni reumatoidni artritis usprkos liječenju metotreksatom.
Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30, and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
u 59,1% (13/22) u 30. tjednu te u 68,2% (15/22) bolesnika u 54. tjednu.
Percentage of subjects in clinical response and in sustained clinical response
Postotak ispitanika s kliničkim odgovorom i održanim kliničkim odgovorom Klinički odgovor u 8. tjednua
Tell your doctor straight away if you get symptoms of liver problems during treatment with Zessly.
Odmah obavijestite Vašeg liječnika ako dobijete simptome jetrenih tegoba za vrijeme liječenja lijekom Zessly.
Each Zessly vial contains 100 mg infliximab.
Jedna bočica lijeka Zessly sadrži 100 mg infliksimaba.
• Chills, a build up of fluid under the skin causing swelling
• zimica, nakupljanje tekućine ispod kože koje uzrokuje oticanje • osjećaj utrnulosti i trnci
It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth (see section 4.4).
Također se ne preporučuje davati živa cjepiva dojenčadi koja su in utero bila izložena infliksimabu, najmanje 6 mjeseci nakon rođenja
Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Vrlo često: infekcija gornjih dišnih puteva, sinusitis Često: infekcija donjih dišnih puteva (npr. bronhitis, pneumonija), dispneja, epistaksa
Discontinuation of Zessly therapy should be considered in patients with confirmed significant haematologic abnormalities.
U bolesnika s potvrđenim značajnim hematološkim poremećajima treba razmotriti prekid liječenja lijekom Zessly.
A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
(CDAI ≥ 220 i ≤ 400) primilo jednokratnu infuziju infliksimaba u dozi od 5 mg/kg u nultom tjednu.
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 study 6 & study 7 data) and week 54 (21.0% vs. 8.9%, p = 0.022, study 6 data).
kako u 30. tjednu (22,3% naspram 7,2%, p < 0,001, zbirni podaci iz ispitivanja 6 i ispitivanja 7) tako i u 54. tjednu (21,0% naspram 8,9%, p = 0,022, podaci iz ispitivanja 6).
In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: “Infusion reactions and hypersensitivity”).
Približno 28% bolesnika s psorijazom liječenih infliksimabom kao terapijom održavanja bez istodobnog liječenja imunomodulatorima razvilo je protutijela na infliksimab
Pyelonephritis.
Manje često: pijelonefritis
Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Rijetko: limfom, ne-Hodgkinov limfom, Hodgkinova bolest, leukemija, melanom, rak cerviksa Nepoznato: hepatosplenički limfom T-stanica (prvenstveno u adolescenata i mlađih odraslih muškaraca s Crohnovom bolešću i ulceroznim kolitisom), karcinom Merkelovih stanica
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 na infliksimab otkrivena su u 14% bolesnika koji su primali neku imunosupresivnu terapiju te u 24% bolesnika koji nisu primali imunosupresivnu terapiju.
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.
salmoneloza] i virusne infekcije [citomegalovirus]), parazitske infekcije, reaktivacija hepatitisa B
Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebocontrolled studies 8 and 9 in patients with active ankylosing spondylitis (Bath Ankylosing
placebom kontrolirana ispitivanja 8 i 9 u bolesnika s aktivnim ankilozantnim spondilitisom (rezultat ≥ 4 prema Bath indeksu aktivnosti ankilozantnog spondilitisa [engl.
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).
sarkoidozu/ reakciju nalik na sarkoidozu, intestinalne ili perianalne apscese (kod Crohnove bolesti) i ozbiljne reakcije vezane uz infuziju (vidjeti dio 4.4).
Tell your doctor straight away if you get signs of infection during treatment with Zessly.
Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Zessly dobijete simptome infekcije.
Infliximab does not cross react with TNFα from species other than human and chimpanzee.
Infliksimab pokazuje križnu reakciju samo s TNFα ljudi i čimpanza, ali ne i drugih vrsta, stoga su konvencionalni neklinički podaci o sigurnosti primjene lijeka ograničeni.
infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Bolesnici su primili infuzije infliksimaba u dozi od 3 mg/kg odnosno 5 mg/kg ili placeba u 0., 2. i 6. tjednu.
Zessly 100 mg powder for concentrate infliximab
Zessly 100 mg prašak za koncentrat infliksimab samo za i.v. primjenu
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Zessly.
Treba razmotriti primjenu antituberkulozne terapije prije početka liječenja lijekom Zessly u bolesnika koji imaju brojne ili značajne čimbenike rizika za tuberkulozu, a rezultati testa na latentnu tuberkulozu su im negativni.
Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Često: bol u prsištu, umor, vrućica, reakcije na mjestu injekcije, zimica,
Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Zessly.
Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Zessly dobijete simptome neke bolesti živčanog sustava.
In patients treated with Zessly, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
U bolesnika liječenih lijekom Zessly u kojih se razvije ozbiljna sistemska bolest treba posumnjati na neku invazivnu gljivičnu infekciju poput aspergiloze, kandidijaze, pneumocistoze, histoplazmoze, kokcidioidomikoze ili blastomikoze.
Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after birth.
Vaše dijete ne smije primiti "živo cjepivo", kao što je BCG
During Zessly treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Tijekom liječenja lijekom Zessly treba optimalno prilagoditi istodobnu terapiju drugim lijekovima,
Study 13
ispitivanje 1
AZA Monotherapy infliximab Monotherapy infliximab + AZA Combination Therapy
Kombinirana terapija infliksimab + AZA
• Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
• otežano ili bolno disanje, bol u prsnom košu • krvarenje u želucu ili crijevima, proljev, loša probava, žgaravica, zatvor
Disodium succinate hexahydrate Succinic acid
6.1 Popis pomoćnih tvari dinatrijev sukcinat heksahidrat sukcinatna kiselina saharoza polisorbat 80
• Severely decreased numbers of white blood cells have been reported in infants born to women treated with infliximab during pregnancy.
• U dojenčadi čije su majke tijekom trudnoće liječene infliksimabom prijavljeno je značajno smanjenje bijelih krvnih stanica.
Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Slučajevi zloćudnih bolesti, uključujući limfom, prijavljeni su i nakon stavljanja lijeka u promet
At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Djelotvornost infliksimaba tijekom 54. tjedna ispitivala se u ispitivanju 6. U 54. je tjednu klinički odgovor imalo 44,9% bolesnika u objema skupinama liječenima infliksimabom, u odnosu na 19,8%
Tell your doctor straight away if you get signs of TB during treatment with Zessly.
Odmah obavijestite svog liječnika ako tijekom liječenja lijekom Zessly dobijete simptome tuberkuloze.
Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
U bolesnika koji imaju povećan rizik za razvoj maligne bolesti jer su teški pušači mogućnost liječenja infliksimabom treba razmotriti uz oprez.
A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
primijećeno je nakon 54 tjedna u svim skupinama bolesnika koji su primali infliksimab (Tablica 3).
Percentage of subjects in clinical remission and sustained remission
Postotak ispitanika u kliničkoj remisiji i održanoj remisiji Klinička remisija u 8. tjednua
• Eye problems including blurred or reduced vision, puffy eyes or sties
• problemi s očima uključujući zamagljen ili oslabljen vid, natečene oči ili ječmenac • novonastalo zatajenje srca ili pogoršanje postojećeg, usporen ritam srca
Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Često: gastrointestinalno krvarenje, proljev, dispepsija, gastroezofagealni refluks, konstipacija Manje često: perforacija crijeva, stenoza crijeva, divertikulitis, pankreatitis, heilitis
For results see Table 6.
Zbirni podaci iz ispitivanja 6 i 7
Allergic respiratory symptom.
Često: alergijske reakcije dišnog sustava
The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active
Djelotvornost liječenja jednokratnom dozom infliksimaba ispitana je u 108 bolesnika s aktivnom Crohnovom bolešću (indeks aktivnosti Crohnove bolesti, engl.
Elevations of ALT ≥ 5 x Upper
≥ 5 x GGN
All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
AZA ili MTX (35% ih je na početku ispitivanja primalo i kortikosteroide).
• Liver failure
• otečeni limfni čvorovi
Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis (studies 10 and 11).
U drugom ispitivanju (ispitivanje 11), djelotvornost i sigurnost primjene infliksimaba ispitivane su u 200 bolesnika s aktivnim psorijatičnim artritisom (≥ 5 otečenih zglobova i ≥ 5 bolnih zglobova).
Percentage of subjects with mucosal healing
Postotak ispitanika s cijeljenjem sluznice
• Psoriasis, skin problems such as eczema and hair loss
• psorijaza, problemi s kožom kao što su ekcemi i gubitak kose • reakcije na mjestu davanja injekcije kao što su bol, oteklina, crvenilo ili svrbež
After preparation each ml contains 10 mg of infliximab.
jedan ml sadrži 10 mg infliksimaba.
• Tell your doctor before you are given Zessly if you are a carrier of hepatitis B or have ever had it.
• Prije nego počnete primati Zessly, obavijestite svog liječnika ako ste nositelj virusa hepatitisa B
Placebo → infliximab 5 mg/kg (at week 24)
5 mg/kg (u 24. tjednu)
Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Manje često: zatajenje srca (novonastalo ili pogoršanje postojećeg), aritmija,
Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Zessly.
Prije, tijekom i nakon liječenja lijekom Zessly bolesnike se mora pomno nadzirati kako bi se uočile infekcije, uključujući tuberkulozu.