natgillin/translations-raw huggingface dataset:
If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 160 mg (v štirih 40 mg injekcijah na dan ali v dveh 40 mg injekcijah dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
(poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in PedACR (PedACR - American College of Rheumatology pediatric) odzivom.
Paediatric Crohn's disease
Crohnova bolezen pri pediatričnih bolnikih
Doses of 20 or 40 mg of adalimumab were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg adalimumaba v subkutani injekciji vsak drugi teden s placebom vsak vmesni teden ali vsak teden;
The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later.
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40-mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden z začetkom dva tedna kasneje.
Some patients who experience decrease in their response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg Hefiya every week or 80 mg every other week.
Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hefiya 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Hefiya na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I-V.
V študijah revmatoidnega artritisa I−V so pri bolnikih ob več različnih časih testirali protitelesa v serumu.
• Hefiya pre-filled syringe/s (see Figure A).
• napolnjen(a) injekcijski(a) peresnik(a) (glejte sliko A).
No dose-limiting toxicity was observed during clinical trials.
V kliničnih študijah niso opazili toksičnih učinkov, ki bi omejevali odmerek.
low dose 20 / 10 mg eow N = 95
majhni odmerek 20/10 mg vsak drugi teden N = 95
• inflammation of the eye lid and eye swelling;
• vnetje veke in otekanje oči;
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi adipinska kislina citronska kislina monohidrat natrijev klorid manitol polisorbat 80 klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
Hefiya is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Zdravilo Hefiya je na voljo v injekcijski brizgi za enkratno uporabo iz prozornega stekla tipa I z iglo iz nerjavečega jekla s ščitnikom za iglo z držalom, z gumijastim pokrovčkom za iglo in s plastičnim batom, ki vsebuje 0,8 ml raztopine.
Hefiya is only available as 40 mg pre-filled syringe / pre-filled pen.
Zdravilo Hefiya je na voljo samo v 40 mg napolnjeni injekcijski brizgi/napolnjenem injekcijskem peresniku.
The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Običajni začetni odmerek je 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
Ask your doctor or pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte z zdravnikom ali farmacevtom.
Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Po dajanju zdravila Hefiya se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
The recommended dose of Hefiya for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Priporočeno odmerjanje zdravila Hefiya za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
• Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
• Če je priporočeni odmerek manj kot 40 mg, ne smete uporabljati 40 mg napolnjenega injekcijskega peresnika.
Hefiya 40 mg solution for injection in single-use pre-filled SensoReady pen Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Zdravilo Hefiya je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo, v peresniku trikotne oblike s prozornim okencem in oznako (peresnik SensoReady®).
There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Uporaba adalimumaba pri otrocih, starih manj kot 6 let, za to indikacijo ni primerna.
• psoriasis,
• luskavice (psoriaze),
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections), followed by 40 mg given every other week starting one week after the initial dose.
Običajni začetni odmerek za odrasle z neinfekcijskim uveitisom je 80 mg (kot dve 40 mg injekciji), čemur sledi odmerek 40 mg, ki se ga daje vsaka dva tedna, z začetkom en teden po začetnem odmerku.
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 %, 26.4 % (92 / 349) and 37.8 % (132 / 349) of patients achieved PASI 75 response at week 12 and 24, respectively.
V odprti podaljšani študiji je odziv PASI 75 doseglo 93 od 349 (26,6 %) 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.
In period A, patients received placebo or adalimumab at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
V obdobju A so bolniki dobivali placebo ali adalimumab v začetnem odmerku 80 mg in potem 40 mg vsak drugi teden, začenši en teden po začetnem odmerku.
The recommended Hefiya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Priporočena shema odmerjanja zdravila Hefiya med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution.
En napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba v 0,8 ml raztopine.
In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated patients.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali adalimumab,
Hefiya is available as a pre-filled syringe and a pre-filled pen (SensoReady).
Zdravilo Hefiya je lahko na voljo v napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku (SensoReady).
Your Hefiya single-use pre-filled SensoReady pen
Vaš napolnjeni injekcijski peresnik SensoReady zdravila Hefiya za enkratno uporabo
Discontinuation of Hefiya therapy should be considered in patients with confirmed significant haematologic abnormalities.
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Hefiya.
• bruising;
• srbenje;
Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
Med uporabo adalimumaba so poročali o neželenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom sta vnetni bolezni sklepov,
Table 19 Ps study IV efficacy results at 16, 26 and 52 weeks endpoint week 16 placebo-controlled week 26 placebo-controlled week 52 open-label placebo N = 108
Preglednica 19 študija pri psoriazi IV - rezultati učinkovitosti po 16, 26 in 52 tednih končna točka
The syringe inside the pen is made of type I glass with a stainless steel needle and an inner rubber needle cap, containing 0.8 ml of solution.
Brizga v peresniku je narejena iz prozornega stekla tipa I z iglo iz nerjavečegaa jekla, notranjim gumijastim pokrovčkom za iglo in gumijasto zaporko, ki vsebuje 0,8 ml raztopine.
Hefiya can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Zmanjša lahko tudi bolečino, ki je pogosto povezana s to boleznijo.
• diverticulitis (inflammation and infection of the large intestine);
• divertikulitis (vnetje in okužba debelega črevesa);
The usual Hefiya dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Običajni začetni odmerek zdravila Hefiya pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali po dve 40 mg injekciji na dan dva zaporedna dneva), nato 80 mg (kot dve 40 mg injekciji) dva tedna pozneje in nato 40 mg vsaka dva tedna.
Hefiya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Zdravilo Hefiya 40 mg raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi je na voljo kot bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta raztopina.
Adalimumab / methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
Mood alterations (including depression), anxiety, insomnia
Psihiatrične motnje pogosti spremembe razpoloženja (vključno z depresijo),
The recommended Hefiya dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Priporočena shema odmerjanja zdravila Hefiya pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciranov obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciranov obliki dveh 40 mg injiciranj v enem dnevu).
The recommended dose of Hefiya for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Priporočeni začetni odmerek zdravila Hefiya za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
Uncommon (may affect up to 1 in 100 people)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
MARKETING AUTHORISATION NUMBERS
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
The recommended dose of Hefiya is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Priporočeno odmerjanje zdravila Hefiya je začetni odmerek 8 mg (kot dve 40-mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
Hefiya is administered via subcutaneous injection.
Zdravilo Hefiya se odmerja v obliki subkutane injekcije.
The recommended dose of Hefiya for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Uveitis pri pediatričnih bolnikih Priporočeni odmerek zdravila Hefiya pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
Mannitol
OVOJNINAH
Table 6 Undesirable effects
Neželeni učinki
Nervous system disorders*
Bolezni živčevja*
There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Uporaba adalimumaba pri otrocih, mlajših od 12 let, za to indikacijo ni primerna.
Multipack containing 6 (3 packs of 2) pre-filled syringes in a blister Packs of 1 and 2 pre-filled pens
Pakiranja po 1 in 2 napolnjeni injekcijski brizgi v pretisnem omotu Večkratno pakiranje, ki vsebuje 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg v pretisnem omotu.
Adalimumab 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 adalimumab group (at week
standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (po 48 tednih).
Treatment with Hefiya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Hefiya prekiniti.
One 0.8 ml pre-filled syringe contains 40 mg adalimumab.
En 0,8 ml napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
navzeja in bruhanje pogosti gastrointestinalna krvavitev, dispepsija, bolezen gastroezofagealnega refluksa, Sjögrenov sindrom občasni pankreatitis, disfagija, edem obraza redki intestinalna perforacija1)
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hefiya.
nesteroidnih protivnetnih zdravil ali analgetikov.
double-blind response at week 68
dvojno slepa Odziv v 68. tednu placebo N = 153
Psychiatric disorders
KLINIČNI PODATKI
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Pri bolnikih, zdravljenih z adalimumabom, so poročali o tuberkulozi, vključno z reaktivacijo in novimi pojavi tuberkuloze.
• trouble breathing, swallowing;
• težave pri dihanju, požiranju;
Each 0.8 ml single-dose pre-filled syringe contains 40 mg of adalimumab.
Ena 0,8 ml napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
• scar;
• kap;
Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441 bolnikov, zdravljenih z adalimumabom.
In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg / ml during the induction period.
Pri bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
Children and adolescents from 2 years of age weighing 30 kg or more
Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več
B. PACKAGE LEAFLET
BESEDILO NA OMOTU
Inflammation
nespečnost
• do not shake the syringe.
• ne stresate injekcijske brizge.
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
(študije revmatoidnega artritisa I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
• dyspepsia (indigestion, bloating, heart burn);
• dispepsija (slaba prebava, napihnjenost, zgaga);
Preparing the syringe
Zaviranje vnetja
Paediatric plaque psoriasis
Psoriaza v plakih pri pediatričnih bolnikih
Vaccinations
Cepljenja
• You might get infections more easily while you are receiving Hefiya treatment.
• Med zdravljenjem z zdravilom Hefiya se lahko poveča dovzetnost za okužbe.
double-blind response at week 12
dvojno slepa odziv v 12. tednu placebo N = 94
Cardiac arrest
Srčno popuščanje
The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Običajni začetni odmerek za odrasle z luskavico (psoriazo) je 80 mg (kot dve 40-mg injekciji v enem dnevu), nato pa 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
Room spinning sensation (vertigo) and vision disturbances may occur after taking Hefiya.
Po dajanju zdravila Hefiya se lahko pojavita vrtoglavica (občutek vrtenja prostora) in poslabšanje vida.
Figure 2: Kaplan-Meier curves summarizing time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Slika 2: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednem
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
** vključno pri podaljšanih študijah brez placeba vključno s podatki iz spontanega poročanja
analysis
analiza zdravljenje
Hefiya dose for paediatric patients with uveitis Patient weight
Odmerjanje zdravila Hefiya pri pediatričnih bolnikih z uveitisom
b among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0-10;
b med bolniki z izhodiščnim rezultatom 3 ali več pri ocenjevanju bolečine, povezane s hidradenitis suppurativa, po numerični ocenjevalni lestvici od 0 do 10; 0 = brez bolečin na koži, 10 = najhujša možna bolečina na koži.
Hefiya therapy should not be continued in patients failing to respond within this time period.
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Hefiya ni priporočljivo nadaljevati.
Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
Giving your injection:
Injiciranje:
• Do not freeze the syringes.
• Injekcijskih brizg ne zamrzujte.
• headache;
• glavobol;
Hepato-biliary disorders*
maligni melanom**
clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a of those receiving corticosteroids at baseline
* p < 0,05 za parno primerjavo deležev med adalimumabom in placebom * p < 0,001 za parno primerjavo deležev med adalimumabom in placebom a od tistih, ki so izhodiščno prejemali kortikosteroide
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 adalimumab, 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).
V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov,
placebo adalimumab 40 mg eow week 52
placebo adalimumab 40 mg vsak drugi teden
• low blood measurements for red blood cells;
• nizke krvne vrednosti za rdeče krvne celice; • povečani lipidi v krvi;
• increased sweating;
čezmerno znojenje,
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
Leucopaenia (including neutropaenia and agranulocytosis), anaemia
zelo pogosti levkopenija (vključno z nevtropenijo in agranulocitozo), anemija pogosti levkocitoza, trombocitopenija občasni idiopatska trombocitopenična purpura
a assessments in ankylosing spondylitis b
ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis
• high blood measurements for white blood cells;
• visoke krvne vrednosti za bele krvne celice; • nizke krvne vrednosti za trombocite;
Keep the pre-filled syringe / pre-filled pen in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• hearing loss, buzzing;
• občutek siljenja na bruhanje, bruhanje;
The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later.
Običajni začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Figure I: hold the syringe
Slika I: Držite injekcijsko brizgo
Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Benigne, maligne in neopredeljene novotvorbe
Tabulated list of adverse reactions
Seznam neželenih učinkov v preglednici
at the investigator's discretion if the subject met the clinical response criterion
2 Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.