natgillin/translations-raw huggingface dataset:
Patients were permitted to be either disease-modifying, anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Bolniki so bili lahko bodisi naivni za imunomodulirajoča antirevmatična zdravila bodisi so ohranili svojo prejšnjo revmatološko terapijo
RA Study IIIa**
revmatoidnem a artritisu II ** placebo/ MTXc Humirab / MTXc placebo Humirab placebo / MTXc Humirab / MTXc ACR
RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg Humira administered every other week c MTX = methotrexate **p < 0.01, Humira versus placebo
Študija pri revmatoidnem artritisu I po 24 tednih, študija pri revmatoidnem artritisu II po 26 tednih in študija pri revmatoidnem artritisu III po 24 in 52 tednih b 40 mg Humire vsak drugi teden c MTX = metotreksat ** p < 0, 01, Humira v prim. s placebom; NP = ni podatka
In addition, ACR response rates were 97 maintained in the majority of patients followed in the open-label extension phase to Week 104.
Poleg tega se je delež odziva po ACR ohranil pri večini bolnikov, ki so jih med odprto nadaljevalno fazo spremljali do 104. tedna.
In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
97 V študiji pri revmatoidnem artritisu IV je bil odziv 20 po ACR pri bolnikih, zdravljenih s Humiro in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0, 001).
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at week 52 and responses were sustained at Week 104 (see Table 4).
V študiji pri revmatoidnem artritisu V pri bolnikih z zgodnim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Humiro in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Humiro, odzivi pa so se ohranili do 104. tedna (glejte tabelo 4).
n=257
n = 274
n=268
72, 8%
p-valuea
0, 013
p-valuec
0, 043
98 Table 5 Radiographic Mean Changes Over 12 Months in RA Study III
Povprečne rentgenografske spremembe v 12 mesecih študije pri revmatoidnem artritisu III
Total Sharp Score Erosion score JSNd score
Ocena erozij Ocena ZSŠd a metotreksat b
99 In RA study III, improvement in physical function was maintained through Week 260 (60 months) of open-label treatment.
99 V študiji pri revmatoidnem artritisu III se je izboljšanje telesne funkcije in kakovosti življenja ohranilo vseskozi do 206. tedna (60. meseca) odprte faze zdravljenja.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/ methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at week 52, which was maintained through Week 104.
V študiji pri revmatoidnem artritisu V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s Humiro in metotreksatom po 52 tednih izboljšala bolj (p < 0, 001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Humiro; to se je ohranilo do 104. tedna.
100 Table 8 Ped ACR Responses in the JIA study
100 Tabela 8 Odzivi » Pediatric ACR (Ped ACR) « v študiji pri juvenilnem idiopatskem artritisu
Stratum Phase OL-LI 16 week
Stratum Faza Odprta uvajalna faza 16 tednov
Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA I and II.
Uporabo Humire 40 mg vsak drugi teden so pri bolnikih z zmernim do zelo aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
101 Table 9 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov)
Humira treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at Week 24) compared with 0.0 ± 1.9( p < 0.001) in the Humira group (at Week 48).
Sprememba je bila (povprečje ± standardni odklon) 0, 8 ± 2, 5 v skupini s placebom (po 24 tednih) in 0, 0 ± 1, 9; (p < 0, 001) v skupini s Humiro (po 48 tednih).
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
102 Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali Humiro, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
102 Table 10 Efficacy Responses in Placebo-Controlled AS Study – Study I Reduction of Signs and Symptoms
Tabela 10 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
103 skupin: placebo 0. in 2. teden, 160 mg Humire 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
103 Maintenance of clinical remission was evaluated in CD Study III (CHARM).
Vzdrževanje klinične remisije je ocenjevala študija pri Crohnovi bolezni III (CHARM).
At Week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Na 4. teden so bolnike randomizirali na 40 mg vsak drugi teden, 40 mg vsak teden ali placebo; v celoti je študija trajala 56 tednov.
CD Study I and CD Study II induction of remission and response rates are presented in Table 9.
Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje tabela 11.
Similar remission rates were observed for the 160/ 80 mg and 80/ 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/ 80 mg group.
Z indukcijskima shemama 160/ 80 mg in 80/ 40 mg so do 8. tedna ugotovili podobne deleže remisij; neželeni učinki so bili pogostejši v skupini s shemo 160/ 80 mg.
104 Table 12 Maintenance of Clinical Remission and Response (Percent of Patients)
Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
In CD Stusy I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at Week 4 in patients randomised to Humira 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Študiji pri Crohnovi bolezni I in II sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi s Humiro 80/ 40 mg in 160/ 80 mg, v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija pri Crohnovi bolezni III.
105 by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
105 nadaljnjim povečanjem odmerka skozi 12 tednov do največjega odmerka 25 mg, ali začetni odmerek 80 mg Humire in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
Table 13 Ps Study I (REVEAL)-Efficacy Results at 16 Weeks
Študija pri psoriazi I (REVEAL) Rezultati učinkovitosti po 16 tednih Humira 40 mg placebo vsak 2. teden n = 398 n = 814 n (%) n (%) 578 (70, 9) b a
In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “ loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
"Izguba ustreznega odziva" je bila opredeljena kot takšna ocena PASI po 33. tednu in 52. teden ali pred njim, da je bil odziv PASI < 50 glede na izhodišče, s porastom PASI vsaj 6 točk v primerjavi s 33. tednom.
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 and were evaluated at 12 weeks after dose escalation, 59/ 243 (24.3%) of patients regained PASI 75 response.
106 V odprti podaljšani študiji je odziv PASI 75 znova doseglo 59 od 243 (24, 3%) bolnikov, ki so jim zaradi odziva PASI pod 50 odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden ter so jih ocenili 12 tednov po povečanju odmerka.
106 Immunogenicity
Imunogenost
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week Following the administration of 24 mg/ m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ mL (102 %CV) Humira monotherapy and 10.9 ± 5.2 µg/ mL (47.7% CV) with concomitant methotrexate.
Najnižje koncentracije adalimumaba v serumu v stanju dinamičnega ravnovesja so naraščale približno sorazmerno odmerku po 20, 40 in 80 mg subkutano vsak drugi teden in vsak teden.
In patients with Crohn’ s disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ ml
107 Po uporabi 24 mg/ m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom je bila povprečna najnižja koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med monoterapijo s Humiro 5, 6 ± 5, 6 µg/ ml (koeficient variacije 102%) in med uporabo z metotreksatom 10, 9 ± 5, 2 µg/ ml (koeficient variacije 47, 7%).
107 during the induction period.
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg Humire na 0. teden, ki mu sledi 40 mg Humire 2. teden, med obdobjem indukcije najnižjo koncentracijo v serumu približno 5, 5 μg/ ml.
A loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.
Polnilni odmerek 160 mg Humire na 0. teden, ki mu sledi 80 mg Humire 2. teden, doseže med obdobjem indukcije najnižjo koncentracijo v serumu približno 12 μg/ ml.
6.4 Special precautions for storage
24 mesecev 108 6. 4 Posebna navodila za shranjevanje
108 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Humira 40 mg solution for injection in single-use pre-filled pen for patient use.
Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik.
Packs of: • 1 pre-filled pen with 1 alcohol pad in a blister. • 2 pre-filled pen, each with 1 alcohol pad, in a blister. • 4 pre-filled pen, each with 1 alcohol pad, in a blister. • 6 pre-filled pen, each with 1 alcohol pad, in a blister.
Pakiranja: • 1 napolnjen injekcijski peresnik z 1 alkoholnim zložencem v pretisnem omotu. • 2 napolnjena injekcijska peresnika, vsak z 1 alkoholnim zložencem v pretisnem omotu. • 4 napolnjeni injekcijski peresniki, vsak z 1 alkoholnim zložencem v pretisnem omotu. • 6 napolnjenih injekcijskih peresnikov, vsak z 1 alkoholnim zložencem v pretisnem omotu.
109 ANNEX II
109 DODATEK II
MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
110 A IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Abbott Bioresearch Center 100 Research Drive Worcester MA 01605 USA
Abbott Bioresearch Center 100 Research Drive Worcester MA 01605 ZDA
59.2 Barceloneta Puerto Rico 00617
59. 2 Barceloneta Puerto Rico 00617 ZDA
Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 D-65205 Wiesbaden Germany
Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2 D- 65205 Wiesbaden Nemčija
Prior to launch, the MAH shall ensure that the Educational programme implemented for currently authorised indications is extended to the potential prescribers concerned by the new indication, Juvenile Idiopathic Arthritis.
Pred začetkom trženja zdravila bo imetnik dovoljenja za promet zagotovil, da bo izobraževalni program, ki se izvaja za sedaj odobrene indikacije, razširjen k potencialnim predpisovalcem zdravila za novo indikacijo, juvenilni idiopatski artritis.
This programme shall ensure that physicians who intend to prescribe Humira are aware of:
Ta program bo zagotovil, da se bodo zdravniki, ki nameravajo predpisovati Humiro, zavedali:
- the risk of serious infections, sepsis, tuberculosis and other opportunistic infections
- tveganja resnih okužb, sepse, tuberkuloze in drugih oportunističnih okužb,
- the risk of heart failure
- tveganja srčnega popuščanja,
- the risk of central nervous system demyelination
- tveganja demielinacije osrednjega živčnega sistema,
- the risk of malignancies
- tveganja malignosti,
- the Patient Alert Card is to be given to patients using Humira
- da morajo bolniki, ki uporabljajo Humiro, prejeti opozorilno kartico bolnika.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet se zavezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so opredeljene v farmakovigilančnem načrtu, ki je bil sprejet v različici 2. 0 načrta za obvladovanje tveganja (“ RMP - Risk Management Plan ”), predloženem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet, in v vseh nadaljnjih posodobitvah RMP, s katerim soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
111 As per the CHMP guideline on the Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR)
111 V skladu z navodili odbora CHMP “ Guideline on the risk management systems for medicinal products for human use "mora biti posodobljen načrt za obvladovanje tveganja predložen istočasno z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
- when new information is received that may impact on the current Safety Specification,
- ob prejemu novih informacij, ki bi lahko vplivale na trenutne varnostne specifikacije,
Pharmacovigilance Plan or risk minimisation activities
farmakovigilančni načrt ali aktivnosti za zmanjševanje tveganja,
- within 60 days of an important (pharmacovigilance or minimisation) milestone being reached
- v roku 60 dni po dosegu pomembnega farmakovigilančnega mejnika ali pomembnega mejnika
- at the request of the EMEA
glede zmanjševanja tveganja,
The marketing authorisation holder should submit 6 monthly periodic safety update reports.
Imetnik dovoljenja za promet z zdravilom mora predložiti redno posodobljeno periodično poročilo o varnosti zdravila vsakih 6 mesecev.
112 ANNEX III
112 DODATEK III
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
114 PODATKI NA ZUNANJI OVOJNINI
Humira 40 mg solution for injection Adalimumab
Humira 40 mg raztopina za injiciranje adalimumab
One 0.8 ml vial contains 40 mg adalimumab
Ena 0, 8 ml viala vsebuje 40 mg adalimumaba.
1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle 2 alcohol pads
1 viala s 40 mg adalimumaba 1 sterilna injekcijska brizga s fiksirano iglo 2 alkoholna zloženca
Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Ltd Queenborough Kent ME11 5EL Velika Britanija
116 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
116 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
117 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humira 40 mg injection Subcutaneous use Adalimumab
Humira 40 mg injekcija subkutana uporaba adalimumab
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
118 PODATKI NA ZUNANJI OVOJNINI
Humira 40 mg solution for injection in pre-filled syringe Adalimumab
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
One 0.8 ml pre-filled syringe contains 40 mg adalimumab
Ena 0, 8 ml napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 PODATKI NA ZUNANJI OVOJNINI
2 pre-filled syringes, each containing 40 mg adalimumab 2 alcohol pads
2 napolnjeni injekcijski brizgi s po 40 mg adalimumaba 2 alkoholna zloženca
121 KEEP THE SYRINGE IN THE OUTER CARTON.10.
Brizgo shranjujte v zunanji ovojnini.
122 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
122 PODATKI NA ZUNANJI OVOJNINI
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
124 PODATKI NA ZUNANJI OVOJNINI
126 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
126 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
127 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
127 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Humira 40 mg injection Adalimumab Subcutaneous use
Humira 40 mg injekcija adalimumab subkutana uporaba
128 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
Humira 40 mg solution for injection in pre-filled syringe with needleguard Adalimumab
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo adalimumab
One 0.8 ml pre-filled syringe with needleguard contains 40 mg adalimumab
Ena 0, 8 ml napolnjena injekcijska brizga s ščitnikom za iglo vsebuje 40 mg adalimumaba.
130 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
130 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
132 PODATKI NA ZUNANJI OVOJNINI
Humira 40 mg solution for injection in pre-filled pen Adalimumab
Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
One 0.8 ml pre-filled pen contains 40 mg adalimumab
En 0, 8 ml napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
1 pre-filled pen, containing 40 mg adalimumab 1 alcohol pad
1 napolnjen injekcijski peresnik s 40 mg adalimumaba 1 alkoholni zloženec
134 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
134 PODATKI NA ZUNANJI OVOJNINI
2 pre-filled pens, each containing 40 mg adalimumab 2 alcohol pads
2 napolnjena injekcijska peresnika s po 40 mg adalimumaba 2 alkoholna zloženca
136 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
136 PODATKI NA ZUNANJI OVOJNINI
138 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
138 PODATKI NA ZUNANJI OVOJNINI
140 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
140 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
141 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
141 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
142 REMINDER STICKERS TEXT (included in pack)
142 BESEDILO ZA OPOZORILNE NALEPKE (priložene pakiranju)
143 PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE PACKAGE LEAFLET)
143 BESEDILO BOLNIKOVE OPOZORILNE IZKAZNICE (ni priložena pakiranju ali navodiliu za uporabo)
Humira Patient Alert Card
Humira - opozorilna izkaznica bolnika
This alert card contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira.
Ta opozorilna izkaznica vsebuje pomembne • Humire ne smete dobiti, če imate zmerno do varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete Humiro in med zdravljenjem z njo.
During Humira treatment:
hudo srčno popuščanje.
• Show this card to any doctor involved in your treatment.
Med zdravljenjem s Humiro: • • Če doživite simptome srčnega popuščanja To izkaznico pokažite vsakemu zdravniku, ki
Infections
vas zdravi.
• If you develop symptoms of heart failure (shortness of breath or swelling of the feet) seek medical attention immediately.
(težko dihanje ali otekanje nog), takoj poiščite zdravniško pomoč.
Dates of Humira treatment:
Okužbe Datumi zdravljenja s Humiro:
Humira increases the risk of getting infections.
Humira zvečuje tveganje za okužbe.
1 st injection: _______________________ Following injections: _______________________ _______________________
1. injekcija: _______________________ Naslednje injekcije: _______________________ _______________________
Prior to Humira treatment: • You should not be treated with Humira if you have a severe infection.
Zelo pomembno je, da zdravniku poveste, če ste kadarkoli imeli
_______________________ _______________________
_______________________ _______________________ • Za podrobnejše informacije glejte navodilo za uporabo Humire. • Poskrbite, da boste na vsak pregled pri
• You should be screened for tuberculosis.
tuberkulozo ali ste bili v tesnem stiku s kom, ki jo je imel.
Please record the dates of the last screening for tuberculosis below:
Spodaj zabeležite datume zadnjih presejalnih preiskav za tuberkulozo:
• See the Humira package leaflet for more information. • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
zdravniku prinesli spisek vseh drugih zdravil, ki jih uporabljate.
Tuberculin test: _______________ Chest X-ray: _______________ During Humira treatment:
Tuberkulinski test: _______________ Rentgenogram prsnih organov: ____________ Med zdravljenjem s Humiro: • Če se pri vas pojavijo simptomi, ki nakazujejo okužbo, npr. zvišanje telesne temperature, trdovraten kašelj, hujšanje ali brezvoljnost, takoj poiščite zdravniško pomoč.
• Keep this card with you for 5 months after the last Humira dose, since side effects may occur a long time after your last dose of Humira.
Bolnikovo ime: ____________________ Zdravnikovo ime: ____________________ Zdravnikov telefon: ____________________ • To izkaznico imejte pri sebi še 5 mesecev po zadnjem odmerku Humire, kajti neželeni učinki se lahko pojavijo še dolgo časa po zadnjem odmerku tega zdravila.
145 PACKAGE LEAFLET:
145 NAVODILO ZA UPORABO
Humira 40 mg solution for injection in vials Adalimumab
Humira 40 mg raztopina za injiciranje v viali adalimumab
You may need to read it again. − Your doctor must also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira.
To izkaznico imejte pri sebi.
Keep this Patient Alert Card with you. − If you have any further questions, please ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Do not pass it on to others.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
What Humira is and what it is used for 2.
Kaj je zdravilo Humira in za kaj ga uporabljamo 2.
Before you use Humira 3.
Kaj morate vedeti, preden boste uporabili zdravilo Humira 3.
How to use Humira 4.
Kako uporabljati zdravilo Humira 4.