natgillin/translations-raw huggingface dataset:
Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:
Nekateri bolniki so imeli med jemanjem zdravila Onglyza in tiazolidindionov naslednje neželene učinke:
OUTER CARTON Onglyza 5 mg film-coated tablets
ZUNANJA ŠKATLA Onglyza 5 mg filmsko obložene tablete
CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 5 mg tablets
KOLEDARSKI PRETISNI OMOTI (NEPERFORIRANI) Onglyza 5 mg tablete
The HbA1c change for saxagliptin 5 mg plus metformin (n=177) compared to metformin plus placebo (n=147) was -0.5% at Week 76.
Sprememba HbA1c je bila 76. teden v skupini s 5 mg saksagliptina v kombinaciji z metforminom (n = 177) -0,5 % v primerjavi s skupino s placebom v kombinaciji z metforminom (n = 147).
OUTER CARTON Onglyza 2.5 mg film-coated tablets
ZUNANJA ŠKATLA Onglyza 2,5 mg filmsko obložene tablete
Metabolism and nutrition disorders Hypoglycaemia
Prehranske in presnovne motnje hipoglikemija zelo pogosti dislipidemija občasni hipertrigliceridemija občasni
Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza.
Med uporabo zdravila Onglyza in nekaterih zdravil proti sladkorni bolezni, ki spadajo v isto skupino kot zdravilo Onglyza, so opažali izpuščaj (glejte poglavje 4).
CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 2.5 mg tablets
KOLEDARSKI PRETISNI OMOTI (NEPERFORIRANI) Onglyza 2,5 mg tablete
An add-on to metformin placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Saksagliptin kot dodatek zdravljenju z metforminom Narejena je bila 24-tedenska s placebom kontrolirana študija za oceno učinkovitosti in varnosti saksagliptina v kombinaciji z metforminom pri bolnikih, ki med monoterapijo z metforminom glikemije niso imeli ustrezno urejene (HbA1c od 7 % do 10 %).
You should stop taking Onglyza and contact a doctor immediately if you notice any of the following serious side effects:
Če opazite katerega od naslednjih resnih neželenih učinkov, morate nehati jemati zdravilo Onglyza in se nemudoma posvetovati z zdravnikom:
Some patients have had the following side effects while taking Onglyza and a sulphonylurea:
Nekateri bolniki so imeli med jemanjem zdravila Onglyza in sulfonilsečnine naslednje neželene učinke:
Talk to your doctor before you take Onglyza if you are pregnant or plan to become pregnant.
Če ste noseči ali nameravate zanositi, se posvetujte z zdravnikom, preden vzamete zdravilo Onglyza.
Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Pri vseh testiranih živalskih vrstah so ob izpostavljenosti, ki je bila vsaj 7-krat tolikšna kot izpostavljenost pri RHD, opazili imunske spremembe: minimalno, neprogresivno limfoidno hiperplazijo v vranici, bezgavkah in kostnem mozgu, brez neželenih posledic.
The HbA1c change for saxagliptin 5 mg plus metformin (n=31) compared to placebo plus metformin (n=15) was -0.8% at Week 102.
Sprememba HbA1c je bila po 102 tednih v skupini s 5 mg saksagliptina in metforminom (n = 31) -0,8 % v primerjavi s skupino s placebom in metforminom (n = 15).
Improvements in HbA1c and PPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Izboljšanji HbA1c in postprandialne glukoze sta se ohranili do 76. tedna po zdravljenju s 5 mg saksagliptina.
There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
V šestih dvojno slepih kontroliranih kliničnih študijah varnosti in učinkovitosti, narejenih za ovrednotenje učinkov saksagliptina na urejenost glikemije, je bilo randomiziranih 4.148 bolnikov s sladkorno boleznijo tipa 2, vključno s 3.021 bolniki, ki so dobivali zdravilo Onglyza.
An add-on placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with glibenclamide in patients with inadequate glycaemic control at enrollment (HbA1c 7.5-10%) on a sub-maximal dose of glibenclamide alone.
Saksagliptin kot dodatek zdravljenju z glibenklamidom Narejena je bila 24-tedenska s placebom kontrolirana študija za oceno učinkovitosti in varnosti saksagliptina v kombinaciji z glibenklamidom pri bolnikih, ki ob vključitvi z uporabo submaksimalnega odmerka samega glibenklamida niso imeli ustrezno urejene glikemije (HbA1c od 7,5 % do 10 %).
A total of 4,148 patients with type 2 diabetes, including 3,021 patients treated with, saxagliptin were randomised in 6 double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
V 6 dvojno slepih kontroliranih kliničnih študijah varnosti in učinkovitosti, narejenih za ovrednotenje učinkov saksagliptina na urejenost glikemije, je bilo v celoti randomiziranih 4.148 bolnikov s sladkorno boleznijo tipa 2, vključno s 3.021 bolniki, ki so dobivali saksagliptin.
Onglyza 5 mg film-coated tablets saxagliptin
Onglyza 5 mg filmsko obložene tablete saksagliptin
A placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with a thiazolidinedione (TZD) in patients with inadequate glycaemic control (HbA1c 7-10.5%) on TZD alone.
Saksagliptin kot dodatek zdravljenju s tiazolidindionom Narejena je bila 24-tedenska s placebom kontrolirana študija za oceno učinkovitosti in varnosti saksagliptina v kombinaciji s tiazolidindionom pri bolnikih, ki med monoterapijo s tiazolidindionom niso imeli ustrezno urejene glikemije (HbA1c od 7 % do 10,5 %).
Glycaemic control
Urejenost glikemije
Improvements in HbA1c, PPG and FPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Izboljšanja HbA1c, postprandialne glukoze in glukoze v plazmi na tešče so se ohranila do 76. tedna po zdravljenju s 5 mg saksagliptina.
Onglyza 2.5 mg film-coated tablets Saxagliptin
Onglyza 2,5 mg filmsko obložene tablete saksagliptin
Reproductive system and breast disorders
Motnje reprodukcije in dojk erektilna disfunkcija občasni
• Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, stomach ache and vomiting.
ki je po navadi posledica okužbe (gastroenteritis), okužba sinusov z bolečinami in občutkom polnosti v licih in za očmi (sinuzitis), glavobol, bolečine v trebuhu in bruhanje.
Immune system disorders Hypersensitivity reactions
Organski sistemi Neželeni učinki
2 from baseline HbA1c (%) at Week 24
Povprečna sprememba HbA1c od izhodišča (%) 24. teden
This is one 2.5 mg tablet once a day.
Po enem 50 mg odmerku
Radiographic changes were assessed in IMPACT 2.
Spremembe na rentgenskih slikah so ocenjevali v študiji IMPACT 2.
• Blood test result showing ‘antibodies' against your own body.
• rezultati krvnih preiskav, ki kažejo "protitelesa" proti lastnemu telesu.
The potential contribution of exposure to inflixumab and/or the severity of the underlying disease in these outcomes remains unclear.
Morebitni prispevek izpostavljenosti infliksimabu in/ali resnost obstoječe bolezni pri teh izidih ostajata nejasna.
• Medicines that affect your immune system.
• Zdravila, ki vplivajo na vaš imunski sistem.
• Depression, problems sleeping
• depresija, težave s spanjem,
Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Priporočljivo je redno pregledovanje kože, predvsem za tiste bolnike z dejavniki tveganja za kožnega raka.
• Eye problems, including red eyes and infections
• težave z očmi, vključno z rdečimi očmi in okužbami,
List of allergies:
Seznam alergij:
It is important that you and your doctor record the brand name and batch number of your medicine.
Pomembno je, da si vi in vaš zdravnik zabeležita ime in številko serije vašega zdravila.
Date of first authorisation: 26/05/2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26/05/2016
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
• It is recommended that when Flixabi is prepared for infusion, it is used as soon as possible (within 3 hours).
• Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Flixabi, uporabi čim prej (v 3 urah).
• You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na infliksimab ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
• Reduce the signs and symptoms of your disease,
• zmanjšanje znakov in simptomov vaše bolezni,
Clinical Response a
Klinični odziv a
• Lack of interest or emotion
• pomanjkanje interesa ali čustev,
EU/1/16/1106/001 1 vial EU/1/16/1106/002 2 vials EU/1/16/1106/003 3 vials EU/1/16/1106/004 4 vials EU/1/16/1106/005 5 vials
EU/1/16/1106/001 1 viala EU/1/16/1106/002 2 viali EU/1/16/1106/003 3 viale EU/1/16/1106/004 4 viale EU/1/16/1106/005 5 vial
The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Učinkovitost infliksimaba do 54. tedna so ocenjevali v preskušanju ACT 1.
Write the new expiry date on the carton including day/month/year.
Na škatlo napišite novi datum izteka roka uporabnosti, ki naj vključuje dan/mesec/leto.
• In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
• Pri nekaterih bolnikih, ki prejemajo zdravilo infliksimab, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
The interval between the last maintenance dose and the first reinduction dose ranged from 35-231 days.
Časovni razmik med zadnjim vzdrževalnim odmerkom zdravila in prvim odmerkom pri ponovni uporabi uvodne sheme je bil od 35 do 231 dni.
In this situation, do not return to refrigerated storage again.
V tem primeru ga ne smete shraniti nazaj v hladilnik.
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 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
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 (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Median (Interquartile range) Patients with no deterioration/patients evaluated (%)
(interkvartilni razmik) bolniki brez poslabšanja/ pregledani bolniki (%)
Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2
Preglednica 9 Učinki na ACR in PASI v študijah IMPACT in IMPACT 2
including bovine tuberculosis (disseminated BCG infection), see section 4.4
* vključno z bovino tuberkulozo (razsejano okužbo BCG), glejte poglavje 4.4
Do not use Flixabi if any of the above applies to you.
Ne uporabljajte zdravila Flixabi, če menite, da se katero od zgoraj navedenih stanj nanaša na vas.
• If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
• Če ste prekinili zdravljenje z infliksimabom za več kot 16 tednov, obstaja večje tveganje za pojav alergijskih reakcij ob ponovni uvedbi zdravljenja.
• Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
• nenormalne vrednosti beljakovine v krvi, imenovane faktor komplementa, ki je del imunskega sistema.
The concomitant use of Flixabi with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Sočasne uporabe zdravila Flixabi s temi biološkimi zdravili ne priporočamo zaradi možnosti povečanega tveganja za okužbe in drugih možnih farmakoloških interakcij.
If you are 65 or older,
Če ste stari 65 let ali več, je to tveganje večje.
Mean ± SD
± SD
All patients administered Flixabi are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Vse bolnike, ki prejmejo zdravilo Flixabi, je treba opazovati najmanj 1 do 2 uri po infuziji zaradi akutnih z infuzijo povezanih reakcij.
Granulomatous lesion.
granulomatozne lezije
Patients who have inflammatory diseases already take medicines to treat their problem.
Bolniki z vnetnimi boleznimi že prejemajo zdravila za zdravljenje le-teh.
• This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to six months.
• To zdravilo lahko shranjujete tudi v originalni škatli zunaj hladilnika pri temperaturi do 25 °C za eno obdobje do 6 mesecev.
• Inflammation in the eye that may cause changes in the vision, including blindness
• vnetje očesa, ki lahko povzroči spremembe vida, vključno s slepoto,
Keep this card with you for 4 months after your dose of Flixabi, or in case of pregnancy for at least 6 months after the birth of your baby.
To kartico nosite s seboj še 4 mesece po svojem odmerku zdravila Flixabi ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu.
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
intersticijska pljučna bolezen (vključno s hitro napredujočo boleznijo, pljučno fibrozo in pnevmonitisom)
Flixabi is also used in adults and children 6 years of age or older for:
Zdravilo Flixabi se uporablja tudi za zdravljenje odraslih in otrok, starih 6 let in več, za:
• Changes in how your liver works, increase in liver enzymes (shown in blood tests)
• spremenjeno delovanje vaših jeter, povečanje vrednosti jetrnih encimov (pokaže se v izvidih krvnih preiskav),
The new expiry date must be written on the carton.
Novi datum izteka roka uporabnosti morate napisati na škatlo.
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.
Poskrbite, da boste ob vsakem obisku zdravstvenega delavca imeli s sabo tudi seznam vseh ostalih zdravil, ki jih uporabljate.
Flixabi should only be used during pregnancy if your doctor feels it is necessary for you.
Zdravilo Flixabi se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
For women taking infliximab including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Ženskam, ki prejemajo infliksimab, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
Instructions for use and handling - reconstitution, dilution and administration In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Navodila za uporabo in ravnanje z zdravilom - rekonstitucija, redčenje in infundiranje Zaradi izboljšanja sledljivosti bioloških zdravil morata biti jasno zabeležena lastniško ime in številka serije uporabljenega zdravila.
If you forget or miss your Flixabi infusion If you forget or miss an appointment to receive Flixabi, make another appointment as soon as possible.
Če ste pozabili ali izpustili odmerek zdravila Flixabi Če ste pozabili ali izpustili dogovorjen termin, da bi prejeli zdravilo Flixabi, se čim prej dogovorite za naslednjega.
Your doctor will test you to see if you have TB.
Zdravnik vas bo testiral, da bo ugotovil, ali imate tuberkulozo.
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Ključni izsledki o učinkovitosti zdravila iz študij IMPACT in IMPACT 2 so prikazani v spodnji preglednici 9:
• Cancer in children and adults
• rak pri otrocih in odraslih,
From a microbiological point of view, the product should be used as soon as possible but within 3 hours of reconstitution and dilution.
Z mikrobiološkega stališča pa morate raztopino uporabiti čim prej, najpozneje pa v roku 3 ur po rekonstituciji in redčenju.
Flixabi will be stored by the health professionals at the hospital or clinic.
Za shranjevanje zdravila Flixabi bodo poskrbeli zdravstveni delavci v bolnišnici ali kliniki.
There have also been post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Obstajajo tudi poročila iz obdobja trženja o novonastalem srčnem popuščanju, vključno s srčnim popuščanjem pri bolnikih brez znane predhodne srčno-žilne bolezni.
Flixabi may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
Zdravilo Flixabi lahko shranjujete pri temperaturi do 25 °C za eno obdobje do 6 mesecev, vendar ne smete prekoračiti originalnega datuma izteka roka uporabnosti.
Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Bistvenega pomena je tudi zgodnja prepoznava atipičnih kliničnih slik resnih okužb in tipičnih kliničnih slik redkih in neobičajnih okužb, da bi lahko čim bolj zmanjšali zamude pri njihovi diagnozi in zdravljenju.
Experimental data show that TNFα is essential for the clearing of intracellular infections.
Eksperimentalni podatki kažejo, da je TNFα bistven za odpravljanje znotrajceličnih okužb.
Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety followup.
Bolniki, ki se do 8. tedna niso odzvali na infliksimab (n = 15), niso več prejemali zdravila in so se vrnili na kontrolni pregled glede varnosti.
• Difficult or painful breathing, chest pain
• težko ali boleče dihanje, bolečine v prsih,
This will depend on your disease, weight and how well you respond to Flixabi.
To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Flixabi.
For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Za navodila za shranjevanje pri temperaturi do 25 °C pred rekonstitucijo zdravila glejte poglavje 6.3.
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Flixabi can be re-administered within 16 weeks following the last infusion.
Ponovna uporaba zdravila pri Crohnovi bolezni in revmatoidnem artritisu Če se znaki in simptomi bolezni ponovijo, lahko zdravilo Flixabi ponovno uporabite v roku 16 tednov po zadnji infuziji.
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, ga morate skrbno spremljati zaradi morebitnega pojava znakov in simptomov pozne preobčutljivosti.
Flixabi belongs to a group of medicines called ‘TNF blockers'.
Zdravilo Flixabi spada v skupino zdravil, ki se imenujejo "zaviralci TNF".
In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
In vivo infliksimab hitro tvori stabilne komplekse s humanim TNFα, ta proces pa poteka vzporedno z izgubo biološke aktivnosti TNFα.
There have been reports of active tuberculosis in patients receiving infliximab.
Bilo je nekaj poročil o aktivni tuberkulozi pri bolnikih, ki so prejemali infliksimab.
• Flixabi will be given to you by your doctor or nurse.
• Zdravilo Flixabi vam bo dal zdravnik ali medicinska sestra.
Because human immunoglobulins are excreted in milk, women must not breast-feed for at least 6 months after Flixabi treatment.
Ker pa se človeški imunoglobulini izločajo v materino mleko, matere ne smejo dojiti še najmanj 6 mesecev po zdravljenju z zdravilom Flixabi.
b 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.
3 Number of patients evaluated for ALT.
3 Število bolnikov, pri katerih so ovrednotili vrednost ALT.
Before reconstitution 4 years at 2°C - 8°C.
Pred rekonstitucijo: 4 leta pri temperaturi 2 °C-8 °C.
• Infections due to a weakened immune system
• okužbe zaradi oslabljenega imunskega sistema,
≥ 50% improvement PGA of cleared (0) or minimal (1)
≥ 50 % izboljšanje PGA brez plakov (0) ali minimalni (1)
What Flixabi is and what it is used for
Kaj je zdravilo Flixabi in za kaj ga uporabljamo
Subjects randomised Percentage ACR improvement Mean ± SD
Randomizirani preiskovanci Odstotek izboljšanja ACR Srednja vrednost ± SD
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 to 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 in 8 °C.
4 Median follow-up is based on patients treated.
4 Mediana dolžine spremljanja bolnikov je bila določena samo z upoštevanjem zdravljenih bolnikov.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Pri 178 od 580 v študijo vključenih bolnikov (30,7 %) so ugotovili hudo obliko bolezni (ocena CDAI > 300 in sočasna uporaba kortikosteroidov in/ali imunosupresivov), kar ustreza populaciji, opredeljeni v indikacijah (glejte poglavje 4.1).
Infliximab + MTX
infliksimab + MTX
It is important that you tell your baby's doctors and other health care professionals about your Flixabi use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Pomembno je, da zdravnike svojega otroka in druge zdravstvene delavce obvestite, da ste prejemali zdravilo Flixabi, da bodo lahko presodili, kdaj sme vaš dojenček prejeti katero koli cepivo, vključno z živimi cepivi, kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
(anaphylactic shock)
(anafilaktični šok),
• Melanoma (a type of skin cancer).
• melanom (vrsta kožnega raka),
Flixabi should only be used in children and adolescents if they are being treated for Crohn`s disease or ulcerative colitis.
Zdravilo Flixabi se sme pri otrocih in mladostnikih uporabljati samo za zdravljenje Crohnove bolezni ali ulceroznega kolitisa.
ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Odziv ACR (% bolnikov) N odziv ACR 20* odziv ACR 50* odziv ACR 70* Odziv PASI (% bolnikov)b
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Akutna z infuzijo povezana reakcija, vključno z anafilaktično reakcijo, lahko nastopi med infuzijo (t. j. v nekaj sekundah) ali v roku nekaj ur po infuziji.
• Low blood counts, including a severely decreased number of white blood cells.
• nizko število krvnih celic, vključno z močnim znižanjem števila belih krvnih celic.
If you feel tired, dizzy, or unwell after having Flixabi, do not drive or use any tools or machines.
Če se po prejemu zdravila Flixabi počutite utrujeni ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
c HAQ = Health Assessment Questionnaire; greater values indicate less disability.
c HAQ = vprašalnik za oceno zdravstvenega stanja; večje vrednosti pomenijo manjšo okvaro funkcije.