natgillin/translations-raw huggingface dataset:
PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal antiinflammatory drug therapy and of these, approximately 50 % were taking methotrexate. 
V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z nesteroidnimi protivnetnimi zdravili; približno 50 % od teh je jemalo metotreksat.
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels. 
Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni,
• adults with non-infectious uveitis with inflammation affecting the back of the eye. 
• odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa,
Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab-treated patients. 
Endoskopske študije črevesne sluznice so pokazale znake celjenja sluznice pri bolnikih, zdravljenih z adalimumabom.
Methotrexate should be continued during treatment with Hefiya. 
Med zdravljenjem z zdravilom Hefiya je treba še naprej uporabljati metotreksat.
For patients who dose-escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg / ml (40 / 20 mg, weekly) and 6.7 ± 3.5 μg / ml (20 / 10 mg, weekly). 
Pri bolnikih, ki so prešli iz režima vsak drugi teden na režim vsak teden, so bile srednje (± SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 μg/ml (40/20 mg, tedensko) in 6,7 ± 3,5 μg/ml (20/10 mg, tedensko).
In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo. 
V študiji I so v primerjavi s placebom ugotovili tudi značilno izboljšanje telesne in duševne komponente ocene SF-36.
Hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate. 
Zdravilo Hefiya je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 8). 
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 8).
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash); 
• kožni vaskulitis (vnetje krvnih žil v koži); • sindrom Stevens-Johnson (smrtno nevarna reakcija z gripi podobnimi simptomi in mehurjastim izpuščajem);
At week 52, 42.9 % of patients who received adalimumab / methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy. 
Po 52. tednih je klinično remisijo (DAS28 (CRP) < 2,6) doseglo 42,9 % bolnikov, ki so dobivali kombinirano terapijo z adalimumabom/metotreksatom, 20,6 % bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4 % bolnikov, ki so dobivali adalimumab v monoterapiji.
After 12 weeks of therapy, patients who had received adalimumab in period A were re-randomised in period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35). 
Po 12 tednih terapije so bolnike, ki so prejemali adalimumab v obdobju A, ponovno randomizirali v obdobju B v eno izmed treh skupin zdravljenja (adalimumab 40 mg vsak teden, adalimumab 40 mg vsak drugi teden ali placebo od 12. do 35. tedna).
117 / 276 patients from CD study I and 272 / 777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy. 
Med odprtim obdobjem zdravljenja z adalimumabom so vsaj 3 leta spremljali 117/276 bolnikov iz študije I Crohnove bolezni ter 272/777 bolnikov iz študij II in III Crohnove bolezni.
• symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness; 
• simptome težav z živci, kot je mravljinčenje; omrtvelost, dvojni vid ali šibkost rok ali nog,
Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Hefiya is an initial dose of 40 mg, followed by 40 mg one week later. 
Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Hefiya je začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
• swollen face, hands, feet; 
• oteklost obraza, dlani in stopal;
• a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel; 
• razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev žile;
Myocardial infarction1), arrhythmia, congestive heart failure 
pogosti tahikardija občasni miokardni infarkt1) aritmija kongestivno srčno popuščanje redki zastoj srca
No other disease-modifying anti-rheumatic drugs were allowed. 
Uporaba drugih imunomodulirajočih zdravil ni bila dovoljena.
There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied. 
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti adalimumaba pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
• sicca syndrome (including dry eyes and dry mouth); 
• Sjögrenov sindrom (vključno s suhimi očmi in suhimi usti);
In study UC-II, among those treated with adalimumab who were in remission at week 8, 21 / 41 (51 %) were in remission at week 52. 
V študiji UC-II je bilo 21/41 bolnikov (51 %), ki so bili zdravljeni z adalimumabom in so dosegli remisijo 8. teden, v remisiji 52. teden.
• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hefiya treatment. 
Nosečnost in dojenje • Premisliti morate o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom Hefiya.
Hefiya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. 
Zdravilo Hefiya je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
The usual dose regimen is 40 mg adalimumab initially followed by 20 mg two weeks later. 
Običajni začetni odmerek je 40 mg adalimumaba, ki mu sledi 20 mg dva tedna kasneje.
Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. 
Luskavica v plakih je vnetna bolezen kože, pri kateri nastajajo rdeče, kosmičaste, krastave lise na koži,
Hefiya is injected under the skin (subcutaneous use). 
Zdravilo Hefiya se injicira pod kožo (subkutana uporaba).
Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14). 
Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so bili zdravljeni z adalimumabom v primerjavi s placebom (preglednica 14).
• sensation of heart beating rapidly; 
• občutek hitrega bitja srca;
Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer. 
let ali več zdravljenih 19 preiskovancev, od tega 11 iz izhodiščne starostne skupine od 4 do 12 let in 8 iz izhodiščne starostne skupine od 13 do 17 let.
The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis. 
Varnost in učinkovitost adalimumaba so ocenili v multicentrični, randomizirani, dvojno slepi študiji pri 46 pediatričnih bolnikih (starih od 6 do 17 let) z zmernim artritisom, povezanim z entezitisom.
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3 %, respectively [P = 0.014]). 
V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo
Hefiya is intended for the treatment of the following inflammatory diseases: 
Zdravilo Hefiya je namenjeno za zdravljenje vnetnih bolezni, opisanih spodaj:
All patients received a 2-week standardised dose of prednisone 60 mg / day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15. 
tedenski standardizirani odmerek prednizolona 60 mg/dan, čemur je sledil obvezen program postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 15. tedna.
Plaque psoriasis in adults and children 
Luskavica (psoriaza) v plakih pri odraslih in otrocih
The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies. 
Varnost in učinkovitost večkratnih odmerkov adalimumaba so ocenili pri odraslih z zmernim do hudo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12 z endoskopsko podoceno 2 do 3) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
Figure H: start your injection 
Slika H: Sprožite injiciranje
The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1) 
Tveganja in koristi neprekinjenega dolgotrajnega zdravljenja je treba periodično ovrednotiti (glejte podatke za odrasle bolnike v poglavju 5.1).
Bath ankylosing spondylitis disease activity index c ankylosing spondylitis disease activity score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) 
d povprečna sprememba od začetka zdravljenja e n = 91 placebo in n = 87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein)
In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo. 
V študiji UC-II je 248 bolnikov dobilo 160 mg adalimumaba 0. teden, 80 mg 2. teden in nato 40 mg vsak drugi teden, 246 bolnikov pa je dobivalo placebo.
Hypersensitivity, allergies (including seasonal allergy) 
Bolezni imunskega sistema* pogosti preobčutljivost, alergije (vključno s sezonsko alergijo)
clinical remission clinical response week 52 
52. teden klinična remisija klinični odziv
Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased 
Preiskave pogosti koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA),
In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. 
V eksploracijskem kliničnem preskušanju infliksimaba, antagonista TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate. 
Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
• low blood measurements for white blood cells, red blood cells and platelet count. 
• nizke vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections. 
Pomožne snovi: adipinska kislina, citronska kislina monohidrat, natrijev klorid, manitol, polisorbat 80, klorovodikova kislina, natrijev hidroksid, voda za injekcije.
***, ** statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo. 
***, ** Statistično značilno s p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med adalimumabom in placebom.
These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning). 
Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali drugi nenavadni kužni organizmi,
• signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing; 
• znake in simptome okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi, pekoč občutek med uriniranjem, občutek šibkosti ali utrujenosti ali kašelj,
Vaccine 
Cepiva
Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 14 days or discarded, even if it is later returned to the refrigerator. 
Ko ga enkrat namesto v hladilniku shranjujete pri sobni temperaturi, morate napolnjen injekcijski peresnik porabiti v 14 dneh ali zavreči, tudi če ga pozneje vrnete v hladilnik.
Ulcerative colitis is an inflammatory disease of the bowel. 
Ulcerozni kolitis je vnetna bolezen črevesa.
Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis. 
Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba adalimumaba pri pediatrični populaciji za indikaciji ankilozni spodilitis in psoriatični artritis ni primerna.
Table 11 distribution of patients by age and adalimumab dose received during the OL LI phase age group number of patients at baseline n (%) Minimum, median and maximum dose 
Preglednica 11 porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo starostna skupina izhodiščno število bolnikov n (%)
HS study I 
študija HS I
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4). 
Ugotovljeni delež nemelanomskih rakov je približno 0,2 na 1000 bolnikov-let zdravljenja in limfomov približno 0,3 na 1000 bolnikov-let zdravljenja (glejte poglavje 4.4).
• rheumatoid arthritis, 
• revmatoidnega artritisa,
Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III). 
Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kvalitete življenja (vključno z IMPACT III) glede na začetek študije.
N (%) 
N neuspeh N (%)
Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8). 
Merklovih celic pri bolnikih, zdravljenih z TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
• skin infections (including cellulitis and shingles); 
• okužbe kože (vključno s celulitisom in pasovcem);
Hefiya dose for patients with polyarticular juvenile idiopathic arthritis 
Odmerjanje zdravila Hefiya pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
Starting your injection: 
Začetek injiciranja:
Choosing your injection site: 
Izbira mesta injiciranja:
Psoriatic arthritis 
Psoriatični artritis
Surgery or dental procedures 
Kirurški poseg ali poseg na zobeh
• that Hefiya treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations 
• obvestilo, da lahko zdravljenje z zdravilom Hefiya poveča tveganje o okužb, vključno s tuberkulozo; o raka;
Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1) 
karcinom Merklovih celic (nevroendokrini karcinom kože) 1)
Place the following items on a clean, flat surface. 
Na čisto, ravno površino pripravite naslednje.
• do not open the outer box until you are ready to use the syringe. 
• ne odpirate zunanje škatle, dokler niste pripravljeni na uporabo injekcijske brizge.
Exposure-response relationships between adalimumab concentration and efficacy in paediatric patients with severe chronic plaque psoriasis were established for PASI 75 and PGA clear or minimal, respectively. 
Razmerji med izpostavljenostjo in odzivom med koncentracijo adalimumaba in učinkovitostjo pri pediatričnih bolnikih s hudo kronično psoriazo v plakih sta bili za PASI 75 (PASI - Psoriasis Area and Severity Index) in za PGA (PGA - Physician's Global Assessment) čisto ali minimalno.
If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. 
Če se simptomi srčnega popuščanja (npr. težko dihanje ali otekanje nog) pojavijo na novo ali se poslabšajo, se morate takoj obrniti na svojega zdravnika.
These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients. 
Ta preskušanja so vključile bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 0,8 ml odmerek, kar v bistvu pomeni ‘brez natrija'.
• Do not give Hefiya to children with polyarticular juvenile idiopathic arthritis below the age of 
• Zdravila Hefiya ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.
There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events. 
Med prisotnostjo protiteles proti adalimumabu in pojavnostjo neželenih učinkov ni očitne korelacije.
• Keep the syringes in the original carton until ready to use to protect from light. 
• Injekcijske brizge hranite v originalni ovojnini, dokler niso pripravljene za uporabo, za zagotovitev zaščite pred svetlobo.
The Hefiya 40 mg pre-filled syringe should not be used in children or adolescents weighing less than 40 kg with Crohn's disease, since it is not possible to administer doses less than 40 mg. 
Zdravila Hefiya 40 mg napolnjena injekcijska brizga ne smete uporabljati pri otrocih ali mladostnikih s Crohnovo boleznijo, ki tehtajo manj kot 40 kg, saj ni mogoče dati odmerka, manjšega od 40 mg.
Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity. 
Predklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Hefiya dose for paediatric patients with Crohn's disease 
Odmerjanje zdravila Hefiya pri pediatričnih bolnikih s Crohnovo boleznijo
− The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections. 
- Druge sestavine zdravila so adipinska kislina, citronska kislina monohidrat, natrijev klorid, manitol, polisorbat 80, klorovodikova kislina, natrijev hidroksid in voda za injekcije.
Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo. 
Zdravljenje z adalimumabom je pokazalo statistično večje izboljšanje skupnega števila točk v HAQ-S vprašalniku in točk v telesni komponenti (Physical Component Score (PCS)) v SF-36 vprašalniku od začetka do 12. tedna v primerjavi s placebom.
By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15). 
Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so neprekinjeno prejemali adalimumab v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
Thus, it is not possible to use Hefiya for children who require less than a full 40 mg dose. 
Zato zdravila Hefiya ni mogoče uporabljati pri otroci, ki potrebujejo manj kot polni odmerek 40 mg.
You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. 
S koščkom vate ali gaze 10 sekund pritiskajte na mesto injiciranja.
• injection site reactions (including pain, swelling, redness or itching); 
• reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem);
• sensation disorders such as tingling, prickling or numbness; 
• motnje v občutenju kot so ščemenje, zbadanje ali omrtvelost;
• psoriatic arthritis, 
• psoriatičnega artritisa,
The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1). 
Tveganja in koristi neprekinjenega dolgotrajnega zdravljenja je treba periodično pretehtati (glejte poglavje 5.1).
Some cases have had a fatal outcome. 
Nekaj primerov se je končalo s smrtjo.
• low blood measurements for phosphate; 
• nizke krvne vrednosti za fosfat;