natgillin/translations-raw huggingface dataset:
• When starting a new card, keep this card as a reference for 4 months after your last dose of
• Ko prejmete novo kartico, imejte to kartico pri sebi še 4 mesece po zadnjem odmerku zdravila
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
hepatosplenični limfom celic T (primarno pri mladostnikih in mlajših odraslih moških s Crohnovo boleznijo in ulceroznim kolitisom), karcinom Merklovih celic
• 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 Inflectra.
• Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Inflectra in tudi med zdravljenjem z njim.
In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (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 z bacilom Calmette-Guerin (BCG) po cepljenju s cepivom BCG po rojstvu.
Elevations of ALT ≥5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Opazili so zvišanje vrednosti ALT na ≥ 5-kratnik zgornje meje normalnih vrednosti (glejte Preglednico 2).
Placebo (Week 24)
Placebo (24. teden)
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
• resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza,
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
• lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah)
• A statement that the brand name and batch number should be recorded
• navedbo, da je treba zabeležiti ime in številko serije zdravila;
>54 weeks
> 54 tednov
Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon .
Analiza mononuklearnih celic iz lamine proprie, dobljenih z biopsijo črevesne sluznice, je pokazala, da zdravljenje z infliksimabom povzroči zmanjšanje števila celic, ki lahko tvorijo TNFα in interferon γ.
Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Infliksimab morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA).
• Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
• Zdravilo Inflectra vam bo dal zdravnik ali medicinska sestra v bolnišnici ali na kliniki.
In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
V enem kraku študije (skupina 2, n = 329) so bolnikom z nezadostnim odzivom na zdravilo omogočili titracijo tj. povečevanje odmerka v korakih po 1,5 mg/kg, od 3 do največ 9 mg/kg.
It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Priporočamo, da pri pediatričnih bolnikih, če je le mogoče, opravite vsa cepljenja v skladu s trenutno veljavnimi smernicami za cepljenje otrok, preden pri njih uvedete zdravljenje z infliksimabom.
Your doctor may recommend temporarily stopping Inflectra.
Vaš zdravnik vam bo mogoče začasno prekinil zdravljenje z zdravilom Inflectra.
(DMARDs), including methotrexate, has been inadequate.
(DMARD-disease modifying antirheumatic drugs), ki vplivajo na imunsko odzivnost, vključno z metotreksatom, ni zadosten.
In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 odraslih bolnikov zdravljenih z zdravilom infliksimab v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
>40 weeks
> 40 tednov
• Tell your doctor before you are given Inflectra if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Preden prejmete zdravilo Inflectra, povejte zdravniku, če ste kadarkoli živeli v ali potovali po krajih, kjer so pogoste okužbe, imenovane histoplasmoza, kokcidioidomikoza ali blastomikoza.
Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C - 8 °C and for an additional 24 hours at 25 C after removal from refrigeration.
Pokazali so, da je razredčena raztopina kemično in fizikalno stabilna do 28 dni pri temperaturi 2 °C8 °C ter dodatnih 24 ur pri 25 C, po tem ko se vzame iz hladilnika.
Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Zdravilo Inflectra se sme pri otrocih uporabljati samo za zdravljenje Chronove bolezni ali ulceroznega kolitisa.
The syringe needle should be inserted into the vial through the centre of the rubber stopper and the stream of water for injections directed to the glass wall of the vial.
Iglo je treba zabosti skozi osrednji del gumijastega zamaška viale in usmeriti curek vode za injekcije proti stekleni steni viale.
Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci tumorjenekrotizirajočega faktor alfa (TNFα), oznaka ATC: L04AB02
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje infliksimab, za vse podskupine pediatrične populacije z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom, psoriazo in Crohnovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Za zmanjšanje tveganja za pojav z infuzijo povezanih reakcij lahko bolnikom že prej date npr. antihistaminik, hidrokortizon in/ali paracetamol in upočasnite hitrost infundiranja, še posebej, če so se z infuzijo povezane reakcije pojavile že kdaj prej (glejte poglavje 4.4).
Use of anti-tuberculosis therapy should also be considered before the initiation of infliximab 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 infliksimab pri bolniku, ki ima latentno ali aktivno tuberkulozo v pretekli anamnezi in pri katerem ni mogoče zagotovo potrditi, da je prejel zadostno zdravljenje.
Please make sure you also have a list of all other medicines that you are using with you at any visit to a healthcare professional.
Pri vsakem obisku kateregakoli zdravstvenega delavca imejte pri sebi tudi seznam vseh drugih zdravil, ki jih jemljete.
The combination of infliximab and abatacept is not recommended.
Kombiniranje infliksimaba in abatacepta torej ni priporočljivo.
Every 6 to 8 weeks depending on your disease
6 tednov po prejetju prvega odmerka nadaljni odmerki vsakih 6 do 8 tednov, odvisno od vaše bolezni
In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever,
V preskušanju C0168T72 so bili najpogostejši neželeni učinki okužba zgornjih dihal, faringitis, bolečine v trebuhu, zvišana telesna temperatura in glavobol.
Inflectra and Orencia should not be used together.
Zdravili Inflectra in Orencia se ne smeta uporabljati skupaj.
However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C - 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Vendar, če je bila raztopina pripravljena v aseptičnih pogojih, jo lahko do 28 dni shranjujete v hladilniku pri temperaturi 2 C - 8 C ter dodatnih 24 ur pri temperaturi 25 °C, po tem ko jo vzamete iz hladilnika.
• Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
• imunske bolezni, ki lahko prizadenejo pljuča, kožo in bezgavke (na primer sarkoidoza)
ACR response (% of patients) N
Odziv ACR (% bolnikov)
Table 1 Adverse reactions in clinical studies and from post-marketing experience Infections and infestations Very common:
Preglednica 1 Neželeni učinki v kliničnih študijah in v obdobju trženja zdravila Infekcijske in parazitske bolezni zelo pogosti:
• Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
• Zdravniku povejte, če imate hepatitis B ali sumite, da ste prenašalec virusa hepatitis B.
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, tj. vrsta beljakovine, ki se veže na točno določeno tarčno mesto v telesu, imenovano TNF (tumorje nekrotizirajoči faktor) alfa.
The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) 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 (C0168Y06) 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.
• Low blood counts, including a severely decreased number of white blood cells
• nizko število krvnih celic, vključno z močnim znižanjem števila belih krvnih celic
While using Inflectra you should not receive live vaccines.
Med uporabo zdravila Inflectra ne smete prejeti živih cepiv.
What Inflectra is and what it is used for What you need to know before you use Inflectra How Inflectra will be given Possible side effects
Kaj je zdravilo Inflectra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Inflectra Kako boste dobivali zdravilo Inflectra Možni neželeni učinki
Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Analiza populacijske farmakokinetike na podlagi podatkov, pridobljenih pri bolnikih z ulceroznim kolitisom (n = 60), Crohnovo boleznijo (n = 112), juvenilnim revmatoidnim artritisom (n = 117) in boleznijo Kawasaki (n = 16) v starostni skupini od 2 mesecev do 17 let, je pokazala, da je izpostavljenost infliksimabu nelinearno odvisna od telesne mase.
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”).
Pri bolnikih, ki so jim psoriazo vzdrževalno zdravili z infliksimabom brez spremljajočega imunomodulatorja, so se pri približno 28 % razvila protitelesa proti infliksimabu (glejte poglavje 4.4: "Z infuzijo povezane reakcije in preobčutljivost'').
Had treatment with any medicine containing infliximab before
Predhodno ste se že zdravili s katerimkoli zdravilom, ki vsebuje infliksimab
• Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
• Pri nekaterih bolnikih, ki prejemajo infliksimab, so se pojavili simptomi motnje v delovanju imunskega sistema, ki ji pravimo lupus.
Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation.
Tiste bolnike, pri katerih se med zdravljenjem z infliksimabom pojavi nova okužba, je treba natančno spremljati in pri njih opraviti celotni diagnostični postopek.
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Preglednica 10 Povzetek odzivov PASI,vrednosti PGA in delež bolnikov z nohti brez psoriatičnih sprememb v 10., 24. in 50. tednu.
Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
27 od teh 108 bolnikov so zdravili s priporočenim odmerkom infliksimaba 5 mg/kg.
Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC AZA Monotherapy
Preglednica 6 Odstotek bolnikov, ki so dosegli klinično remisijo brez jemanja kortikosteroidov v 26. tednu, SONIC
• In case you have received Inflectra while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
• Če ste med nosečnostjo prejeli zdravilo Inflectra, je pomembno, da o tem obvestite zdravnika vašega dojenčka, preden dojenček prejme katerokoli cepivo.
Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test
Zdravnika prosite, naj spodaj zabeleži vrsto in datume zadnjih presejalnih testov za tuberkulozo (TBC):
Sustained remission(in remission at both week 8 and week 30)
Trajnejša remisija (remisija tako v 8. tednu kot v
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, further treatment with infliximab must not be given (see section 4.8).
Če se po zdravljenju z infliksimabom pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in je bolnik pozitiven na protitelesa proti dvojnoverižni DNA, ne sme več prejeti infliksimaba (glejte poglavje 4.8).
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Inflectra.
Ta opozorilna kartica za bolnika vsebuje pomembne informacije o varnosti, s katerimi morate biti seznanjeni, preden prejmete zdravilo Inflectra in med zdravljenjem s tem zdravilom.
Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis.
Bolnika ne smete več zdraviti z infliksimabom, če dobi resno okužbo ali sepso.
• It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB.
• Zelo pomembno je, da zdravniku poveste, če ste kdaj imeli tuberkulozo ali ste bili v tesnem stiku z bolnikom s tuberkulozo.
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 infliximab.
Pri bolnikih, ki imajo več dejavnikov tveganja oziroma pomembne dejavnike tveganja za tuberkulozo in pri katerih je bil test na latentno tuberkulozo negativen, premislite, ali bi bilo treba pri njih pred uvedbo infliksimaba najprej zdraviti tuberkulozo.
Inflectra infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Infuzije zdravila Inflectra morajo bolniku dajati kvalificirani zdravstveni delavci, ki so usposobljeni za ugotavljanje morebitnih težav pri infundiranju zdravil.
Immune system disorder
Motnja v delovanju imunskega sistema
If these medicines do not work well enough, you will be given Inflectra which you will take with another medicine called methotrexate to:
Če ta zdravila ne bodo dovolj dobro delovala, boste prejeli zdravilo Inflectra skupaj z zdravilom, imenovanim metotreksat, za:
Before starting treatment with infliximab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Pred začetkom zdravljenja z infliksimabom morate vse bolnike pregledati in preiskati, da ugotovite morebitno aktivno ali neaktivno (latentno) tuberkulozo.
Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Pri oceni po DLQI (p < 0,001) so dokazali bistveno izboljšanje glede na začetne vrednosti, pa tudi glede ocen telesne in duševne komponente po SF 36 (p < 0,001 za primerjavo vsake komponente).
Infusion reactions and hypersensitivity
Z infuzijo povezane reakcije in preobčutljivost
ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Odziv ACR 20* 5(10 %) Odziv ACR 50* 0(0 %) Odziv ACR 70* 0(0 %) Odziv PASI (% bolnikov)
Children may receive some vaccines during treatment with Inflectra but should not receive live vaccines while using Inflectra.
Otroci lahko med zdravljenjem z zdravilom Inflectra prejmejo nekatera cepiva, vendar med uporabo zdravila Inflectra ne smejo prejeti živih cepiv.
• Tell your doctor if you think you might be at risk of contracting hepatitis B.
• Povejte svojemu zdravniku, če mislite, da pri vas obstaja možnost, da bi se okužili s hepatitisom B.
• Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
• Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni, čemur naj sledijo infuzije v odmerku 5 mg/kg na vsakih 8 tednov (glejte “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
• you are allergic to proteins that come from mice,
• če ste alergični na glodalske proteine,
• Children should receive recommended vaccinations before starting Inflectra treatment.
• Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Inflectra.
During Inflectra treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Med zdravljenjem z zdravilom Inflectra je treba optimizirati druge sočasne terapije, npr. s kortikosteroidi in zdravili za zaviranje imunske odzivnosti.
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.
meningitis, oportunistične okužbe (npr. invazivne glivične okužbe [pnevmocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske okužbe [okužbe z atipičnimi mikobakterijami, listerioza, salmoneloza] in virusne okužbe [s citomegalovirusom]), okužbe s paraziti, reaktivacija hepatitisa B
• Blood problems such as anaemia or low white blood cell count
• težave s krvjo, kot na primer anemija ali nizko število belih krvnih celic
* including bovine tuberculosis (disseminated BCG infection), see section 4.4
nenormalna vrednost faktorja komplementa * vključno z bovino tuberkulozo (razsejano okužbo BCG), glejte poglavje 4.4
Subjects randomised Percentage ACR improvement Mean ± SD
Odstotek izboljšanja ACR
• Tell your surgeon or dentist that you are having treatment with Inflectra by showing them your patient reminder card.
• Obvestite svojega kirurga ali zobozdravnika, da prejemate zdravilo Inflectra in mu pokažite svojo opozorilno kartico za bolnika.
Inflectra treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Zdravljenje z zdravilom Inflectra mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
• If you get any side effects, talk to your doctor.
• Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom.
• Chills, a build-up of fluid under the skin causing swelling
• mrzlica, kopičenje vode pod kožo, ki povzroča otekanje
• Infection due to a live vaccine because of a weakened immune system.
• okužba zaradi živega cepiva kot posledica oslabljenega imunskega sistema
Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p=0.001).
Dodatno so pri 55 % bolnikov zdravljenih z infliksimabom dosegli zapiranje vseh fistul, v primerjavi s 13 % bolnikov, ki so prejemali placebo (p = 0,001).
• Talk to your doctor if you recently have had or are due to have a vaccine.
• Obvestite svojega zdravnika, če ste bili pred kratkim cepljeni ali boste cepljeni.
• Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
• možni znaki raka, vključno z, vendar ne omejeno na otekanje bezgavk, izgubo telesne mase, zvišano telesno temperaturo, nenavadnimi kožnimi vozliči, spremembami kožnih znamenj ali barve kože ali nenavadnimi krvavitvami iz nožnice;
Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate infliximab therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
Pri bolnikih s fistulirajočo Crohnovo boleznijo z akutnimi gnojnimi fistulami ne smete uvesti terapije z infliksimabom, dokler ne izključite možnosti, da obstaja nekje vir okužbe, na primer absces (glejte poglavje 4.3).
Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Viala iz stekla tipa 1 z (butilnim) gumijastim zamaškom in aluminijastim tesnilom s »flip-off« sistemom.
More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Dodatni znaki z alergijo povezanih učinkov, ki se lahko pojavijo do 12 dni po prejemu injekcije, so bolečine v mišicah, zvišana telesna temperatura, bolečine v sklepih ali v čeljusti, vnetje žrela ali glavobol;
Inflectra contains the active substance infliximab, which is of human and mouse origin.
Zdravilo Inflectra vsebuje učinkovino infliksimab, ki je človeško-glodalskega izvora.
Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
limfom, ne-Hodgkinov limfom, Hodgkinova bolezen, levkemija, melanom, rak materničnega vratu neznana pogostnost:
Inflectra must be given concomitantly with methotrexate.
Zdravilo Inflectra morate uporabljati sočasno z metotreksatom.
By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders.
Do 26. tedna, tj. dvajset tednov po zadnjem uvodnem odmerku, je 30 % bolnikov iz skupine, ki je prejemala 5 mg/kg, in 13,8 % bolnikov iz skupine, ki je prejemala 3 mg/kg, imelo odziv PASI 75.
• Tell your doctor before you are given Inflectra if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
• Preden začnete uporabljati zdravilo Inflectra, povejte svojemu zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katerokoli drugo vrsto raka.