natgillin/translations-raw huggingface dataset:
• In some patients receiving treatment with medicines containing infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
• Pri nekaterih bolnikih, ki prejemajo infliksimab, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
Zessly is available in packs containing 1, 2, 3, 4, or 5 vials.
Zessly je na voljo v pakiranjih po 1, 2, 3, 4 ali 5 vial.
to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
(≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000
V okviru razvrstitve po organskih sistemih so neželeni učinki razvrščeni po naslednjih kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
For women taking Zessly including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Ženskam, ki prejemajo zdravilo Zessly, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
Prior therapy with PUVA, methotrexate, cyclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Predhodno terapijo s PUVA, metotreksatom, ciklosporinom ali acitretinom je prejelo 71,4 % bolnikov, čeprav ni nujno, da so bili odporni na uvodno terapijo.
What Zessly is and what it is used for
Kaj je zdravilo Zessly in za kaj ga uporabljamo
Study 4 (week-2 responders) % of Patients
Študija 4 (bolniki z odzivom v 2. tednu) % bolnikov
Zessly and Orencia should not be used together.
Zdravili Zessly in Orencia se ne smeta uporabljati skupaj.
All patients administered Zessly are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Vse bolnike, ki prejmejo zdravilo Zessly, je treba opazovati najmanj 1 do 2 uri po infuziji zaradi akutnih z infuzijo povezanih reakcij.
EU/1/18/1280/001 1 vial 100 mg EU/1/18/1280/002 2 vials 100 mg EU/1/18/1280/003 3 vials 100 mg EU/1/18/1280/004 4 vials 100 mg EU/1/18/1280/005 5 vials 100 mg
EU/1/18/1280/001 1 viala 100 mg EU/1/18/1280/002 2 viali 100 mg EU/1/18/1280/003 3 viale 100 mg EU/1/18/1280/004 4 viale 100 mg EU/1/18/1280/005 5 vial 100 mg
In the first study, (study 8), improvement in signs and symptoms was also observed as early as week 2.
V prvi študiji (študija 8) so tudi opazili izboljšanje znakov in simptomov bolezni že v 2. tednu.
Clinical Responsea Clinical Remission
Klinični odziva Klinična remisija
• Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Zessly treatment again.
• Povejte zdravniku, če ste se v preteklosti že zdravili z zdravili, ki vsebujejo infliksimab, in sedaj ponovno začenjate zdravljenje.
Your doctor will advise you what other medicines you must keep using while you are having Zessly.
Zdravnik vam bo svetoval, katera zdravila morate še naprej jemati tudi med zdravljenjem z zdravilom Zessly.
Zessly is also used in adults and children 6 years of age or older for:
Zdravilo Zessly se uporablja tudi za zdravljenje odraslih in otrok starih 6 let in več za:
• reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
• zmanjšanje števila nenormalnih odprtin (fistul), ki tvorijo povezavo med črevesjem in kožo, in ki jih niso odpravila druga zdravila ali kirurški poseg.
• The doctor will decide your dose and how often you will be given Zessly.
• Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Zessly treatment.
Ker pa se človeški imunoglobulini izločajo v materino mleko, matere ne smejo dojiti še najmanj 6 mesecev po zdravljenju z zdravilom Zessly.
Patients with no deterioration/patients evaluated (%)c
bolniki brez poslabšanja/ pregledani bolniki (%)c spreminjanje HAQ
INFECTIONS Before treatment with Zessly
OKUŽBE Pred zdravljenjem z zdravilom Zessly
N ≥ 90% improvement
N ≥ 90-% izboljšanje
Shortened infusions across adult indications
Skrajšane infuzije pri indikacijah za odrasle bolnike
For storage conditions up to 30°C before reconstitution of the medicinal product, see section 6.3.
Za pogoje shranjevanja do 30 °C pred rekonstitucijo zdravila glejte poglavje 6.3.
In all situations described below, the benefit/risk balance of Zessly therapy should be very carefully considered.
V vseh spodaj opisanih okoliščinah, je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Zessly.
Subjects randomised Percentage ACR improvement Mean ± SDa
Randomizirani preiskovanci Odstotek izboljšanja ACR Srednja vrednost ± SDa
The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Manjše število prospektivno zbranih podatkov o izpostavljenosti infliksimabu med nosečnostjo, ki se je končala z rojstvom živorojenega otroka z znanimi izidi, vključno s približno 1.100 primeri izpostavljenosti infliksimabu v prvem trimesečju, ne kaže na zvečano stopnjo malformacij pri novorojencih.
The requirements for submission of PSUR for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
(seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Zessly will generally be stored by the health professionals.
V glavnem bodo za shranjevanje zdravila Zessly poskrbeli zdravstveni delavci.
** PASI 75 response for study 10 not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for study 11.
** Odziv PASI 75 iz študije 10 ni vključen zaradi majhnega števila N; p < 0,001 za infliksimab v primerjavi s placebom v 24. tednu v študiji 11
• Zessly will be given to you by your doctor or nurse.
• Zdravilo Zessly vam bo dal zdravnik ali medicinska sestra.
Contents of the pack and other information What Zessly contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zessly
Study 13
Študija 13
Zessly is not likely to affect your ability to drive or use tools or machines.
Zdravilo Zessly verjetno ne vpliva na vašo sposobnost vožnje in upravljanja z orodji ali stroji.
In study 10 and study 11 in patients with active psoriatic arthritis, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
V študiji 10 in študiji 11 pri bolnikih z aktivnim psoriatičnim artritisom so opazili klinični odziv že v 2. tednu, ohranjen pa je bil tudi še v 98. tednu in 54. tednu.
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Zessly (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Pri skrbno izbranih odraslih bolnikih, ki so dobro prenesli vsaj 3 začetne 2-urne infuzije zdravila Zessly (uvajalna faza zdravljenja) in so trenutno na vzdrževalnem zdravljenju, lahko razmislite o skrajšanju naslednjih infuzij, vendar ne na manj kot 1 uro.
Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
ki so imeli razmik med odmerki skrajšan na manj kot 8 tednov, lahko obstaja večje tveganje za pojav neželenih učinkov.
Your doctor may recommend temporarily stopping Zessly.
Zdravnik bo morda priporočil začasno prekinitev zdravljenja z zdravilom Zessly.
≥ 50% improvement PGA of cleared (0) or minimal (1)
≥ 50-% izboljšanje PGA brez plakov (0) ali minimalni (1)
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Zessly, and in accordance with local recommendations.
V primeru diagnoze neaktivne (latentne) tuberkuloze, morate uvesti zdravljenje za latentno tuberkulozo z antituberkulozno terapijo, še pred uvedbo zdravila Zessly, v skladu z lokalnimi priporočili.
(pleurisy)
(furunkuloza)
• Treatment with TNF blockers such as Zessly may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
• Zdravljenje z zaviralci TNF, kot je zdravilo Zessly, lahko vodi do reaktivacije virusa hepatitisa B pri bolnikih, ki prenašajo ta virus, kar je lahko v nekaterih primerih življenjsko nevarno.
There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab.
Na voljo ni zadostnih podatkov o sočasni uporabi infliksimaba z drugimi biološkimi zdravili, ki se uporabljajo za enako zdravljenje kot infliksimab.
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
N ≥ 90-% izboljšanje ≥ 75-% izboljšanje ≥ 50-% izboljšanje
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Infliksimab prehaja skozi posteljico in so ga vse do 6. meseca po rojstvu zaznali v serumu dojenčkov.
Calculate the dose and the number of Zessly vials needed.
Izračunajte odmerek in število potrebnih vial zdravila Zessly.
Calculate the total volume of reconstituted Zessly solution required.
Izračunajte celoten volumen potrebne rekonstituirane raztopine zdravila Zessly.
If you received Zessly while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Če ste v času nosečnosti prejeli zdravilo Zessly, lahko cepljenje dojenčka s cepivom BCG (uporablja se za preprečevanje tuberkuloze) v obdobju 6 mesecev po rojstvu povzroči okužbo z resnimi zapleti, vključno s smrtjo.
The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from study 6 and study 7 and their extensions.
Podatke o odstotku preiskovancev, ki so jim opravili kolektomijo kadarkoli v času 54 tednov po prvi infuziji proučevanega zdravila iz študije 6 in študije 7 ter njihovih podaljšanj, so zbrali in jih združili.
Administration of Zessly should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Uporabo zdravila Zessly prekinite, če se pri bolniku pojavi nova resna okužba ali sepsa, in mu uvedite ustrezno protimikrobno ali protiglivično terapijo, dokler ne bo okužba obvladana.
• Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Zessly.
• Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Zessly in tudi med zdravljenjem z njim.
If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Če bolnik po daljšem obdobju ponovno prejme zdravilo Zessly, ga morate skrbno spremljati zaradi morebitnega pojava znakov in simptomov pozne preobčutljivosti.
In a 1-year clinical study with repeated infusions in patients with Crohn's disease, the incidence of serum sickness-like reactions was 2.4%.
V enoletni študiji z večkratnimi infuzijami zdravila pri bolnikih s Crohnovo boleznijo, je bila incidenca reakcij, podobnih serumski bolezni, 2,4 %.
This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
To vključuje bolezni, kot so multipla skleroza, GuillainBarréjev sindrom, če ste imeli napade krčev ali so vam diagnosticirali "optični nevritis".
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Zessly treatment.
Ženske v rodni dobi morajo za preprečevanje nosečnosti razmisliti o uporabi ustrezne kontracepcije in z njo nadaljevati še najmanj 6 mesecev po zaključku zdravljenja z zdravilom Zessly.
Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies
Protitelesa proti celičnemu jedru (ANA-anticelular antibodies)/protitelesa proti dvojnoverižni DNA (dsDNA)
CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
b CDAI < 150 tako v 30. tednu kot v 54. tednu, brez prejemanja kortikosteroidov v 3 mesecih pred 54. tednom pri bolnikih, ki so prejemali kortikosteroide na začetku študije
Zessly belongs to a group of medicines called ‘TNF blockers'.
Zdravilo Zessly spada v skupino zdravil, ki se imenujejo "zaviralci TNF".
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening
• huda alergijska reakcija, ki lahko povzroči izgubo zavesti in je lahko življenjsko nevarna (anafilaktični šok)
Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer .
Dosedanji podatki nekažejo, da zdravljenje z infliksimabom vpliva na tveganje za nastanek displazije ali karcinoma kolona.
• Children should receive recommended vaccinations before starting Zessly treatment.
• Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Zessly.
However,studies from the published literature in variousindications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggestthat non-live vaccinations received during treatment with anti-TNF therapies, including infliximab, may elicit a lower immune response than in patients not receiving anti-TNF therapy."
Vseeno pa študije iz objavljene literature za različne indikacije (npr. revmatoidni artritis, psoriaza, Crohnova bolezen) nakazujejo, da cepljenja z neživimi cepivi med prejemanjem anti-TNF terapije, vključno z infliksimabom, lahko izzovejo manjši imunski odgovor kot pri bolnikih, ki ne prejemajo anti-TNF terapije.
• Children and adults taking Zessly may have an increased risk of developing lymphoma or another cancer.
• Otroci in odrasli, ki prejemajo zdravilo Zessly, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
Zessly, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Zdravilo Zessly je v kombinaciji z metotreksatom indicirano za zmanjšanje znakov in simptomov ter izboljšanje funkcije sklepov:
In the second clinical study (study 9), improvement in signs and symptoms was observed as early as week 2.
V drugi klinični študiji (študija 9) so že v 2. tednu opazili izboljšanje znakov in simptomov bolezni.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C.
Če raztopina ni uporabljena takoj, je za pogoje in čas shranjevanja pred uporabo odgovoren uporabnik, in le-to ne sme trajati dlje kot 24 ur pri temperaturi med 2 °C-8 °C.
Table 9 Effects on ACR and PASI in patients with active psoriatic arthritis, data from study 10 and study 11
Učinki na ACR in PASI v študijah pri bolnikih z aktivnim psoriatičnim artritisom, podatki iz študije 10 in študije 11
There were no serious infusion reactions, and 2 subjects in the paediatric Crohn's disease study had non-serious anaphylactic reactions.
Ni bilo nobene resne z infuzijo povezane reakcije, dva preiskovanca v pediatrični študiji Chronove bolezni pa sta imela anafilaktično reakcijo, ki ni bila resna.
Children may receive some vaccines during treatment with Zessly but should not receive live vaccines while using Zessly.
Otroci lahko med zdravljenjem z zdravilom Zessly prejmejo nekatera cepiva, vendar med uporabo zdravila Zessly ne smejo prejeti živih cepiv.
Live vaccines/therapeutic infectious agents
Živa cepiva/povzročitelji okužb v terapevtske namene
Key efficacy results for study 10 and study 11 in patients with active psoriatic arthritis are shown in Table 9 below:
Ključni izsledki o učinkovitosti zdravila iz študije 10 in študije 11 pri bolnikih z aktivnim psoriatičnim artritisom so prikazani v spodnji Preglednici 9:
• 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 Zessly
• Opomnik za bolnike, da morajo pokazati opozorilno kartico za bolnika vsem zdravstvenim delavcem, ki sodelujejo pri zdravljenju (tudi v nujnih stanjih) ter sporočilo za zdravstvene delavce, da bolnik uporablja zdravilo Zessly.
Other medicines and Zessly
Druga zdravila in zdravilo Zessly
• Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
• hude alergijske reakcije (npr. anafilaksija), motnja v delovanju imunskega sistema (lupus), alergijske reakcije na tuje beljakovine
2 weeks after your 1st treatment
2 tedna po prvem odmerku tretji odmerek
• Tell your surgeon or dentist that you are having treatment with Zessly by showing them your patient reminder card.
• Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Zessly in mu pokažite svojo opozorilno kartico za bolnika.
Zessly contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free'.
Zdravilo Zessly vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Infliksimab je himerno človeško-glodalsko monoklonsko protitelo IgG1, pridobljeno iz ovarijskih celic kitajskega hrčka (CHO) s tehnologijo rekombinantne DNK.
• Tell your doctor before you are given Zessly if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
• Preden prejmete zdravilo Zessly, povejte zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katero koli drugo vrsto raka.
Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Infliksimab je monoklonsko protitelo - vrsta beljakovine, ki se veže na določeno tarčo v telesu, imenovano TNF (tumorje nekrotizirajoči faktor)
In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus CalmetteGuérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, so poročali o smrtnem izidu zaradi razsejane okužbe s Calmette-Guerinovim bacilom (BCG) po cepljenju s cepivom BCG po rojstvu.
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.
V študiji 1 so ocenjevali odziv v 30., 54. in 102. tednu v s placebom kontrolirani študiji, opravljeni pri 428 bolnikih, ki so imeli aktiven revmatoidni artritis kljub zdravljenju z metotreksatom.
Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below:
Zdravnik naj zabeleži tip in datum zadnjega presejaln-ega(ih) test-a(ov) za tuberkulozo (TBC):
The reduction in incidence of colectomy was also examined in another randomised, double-blind study in hospitalised patients (n = 45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Zmanjšanje incidence kolektomij so proučevali še v eni randomizirani, dvojno slepi študiji pri hospitaliziranih bolnikih (n = 45) z zmerno do močno aktivnim ulceroznim kolitisom, ki se niso odzvali na zdravljenje z intravenskimi kortikosteroidi in so imeli zato večje tveganje, da bo pri njih potrebna kolektomija.
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Na splošno bolniki, pri katerih se je pojavilo zvišanje ALT in AST, niso imeli simptomov in nenormalni izvidi so se zmanjšali ali normalizirali bodisi z nadaljevanjem ali z ukinitvijo zdravljenja z infliksimabom, ali pa ob prilagoditvi drugih sočasnih terapij.
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and
Bolniki v obeh študijah so imeli psoriazo s plaki (telesna površina [BSA] ≥ 10 % in indeks površine in jakosti psoriaze [PASI] ≥ 12).
• The medicine will be given as an infusion (drip) over a 2 hours into one of your veins,
• Zdravilo vam bodo dali v obliki infuzije (kapalne) (v času 2 ur) v eno od ven, običajno v roki.
• Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see ‘Re administration' below and section 4.4).
• Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni (glejte poglavje “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Drugi viri informacij
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Mediana dolžine spremljanja bolnikov je bila 0,8 let (incidenca 5,7 % [95-% IZ 2,65 %-10,6 %].
Concurrent administration with other biological therapeutics
Sočasna uporaba z drugimi biološkimi zdravili
Patients who develop a new infection while undergoing treatment with Zessly, should be monitored closely and undergo a complete diagnostic evaluation.
Tiste bolnike, pri katerih se med zdravljenjem z zdravilom Zessly pojavi nova okužba, je treba natančno spremljati in pri njih opraviti celotni diagnostični postopek.
The potential risk with the combination of AZA or 6-MP and Zessly should be carefully considered.
Natančno je treba pretehtati potencialno tveganje pri sočasnem dajanju AZA ali 6-MP z zdravilom Zessly.
2nd dose
drugi odmerek
What you need to know before you use Zessly You should not be given Zessly if:
Kaj morate vedeti, preden boste uporabili zdravilo Zessly Ne uporabljajte zdravila Zessly:
In the first clinical study, (study 10), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
V prvi klinični študiji (študija 10) so proučevali učinkovitost in varnost infliksimaba pri 104 bolnikih z aktivnim poliartikularnim psoriatičnim artritisom.
The combination of Zessly and abatacept is not recommended.
Kombiniranje zdravila Zessly in abatacepta torej ni priporočljivo.
Use of antituberculosis therapy should also be considered before the initiation of Zessly in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
O potrebi po predhodnem zdravljenju tuberkuloze premislite tudi, preden boste uvedli zdravilo Zessly pri bolniku, ki ima latentno ali aktivno tuberkulozo v pretekli anamnezi in pri katerem ni mogoče zagotovo potrditi, da je prejel zadostno zdravljenje.
Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have also been reported, some in close temporal association with infusion of infliximab.
Poročali pa so tudi o pojavih (nekaterih s smrtnim izidom) ishemije miokarda/miokardnega infarkta in aritmije, nekaterih v tesni časovni povezanosti z infundiranjem infliksimaba.
Study 10
Študija 10