natgillin/translations-raw huggingface dataset:
Inhalation use Blister (alu) 3 inhalers (3 x 30 doses) (multipack)
Za inhaliranje Pretisni omot (alu) 3 inhalatorji (3 x 30 odmerkov) (skupno pakiranje)
Strength Pharmaceutical form
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
Wash your hands
Umijte si roke
Collect all the materials you need
Zberite ves material, ki ga potrebujete
Date of first authorisation: 17 september 2018
Datum prve odobritve: 17. september 2018
This leaflet was last revised in April 2019 Other sources of information
Navodilo je bilo nazadnje revidirano aprila 2019 Drugi viri informacij
Do not warm in any other way.
Zdravila ne ogrevajte na noben drug način.
• Wash your hands thoroughly with soap and water.
• Roke si temeljito umijte z milom in vodo.
You may see 1 or 2 drops of liquid and that is okay.
Morda boste videli 1 ali 2 kapljici tekočine, to je v redu.
Air bubbles may be present; there is no need to remove them.
Morda so prisotni zračni mehurčki; teh ni treba odstraniti.
Number of patients PASI 75a (%)
Število bolnikov PASI 75a (%)
EXP Removal from refrigerator date:
EXP Datum odstranitve iz hladilnika:
Maximum concentration was reached at 6.2 days after injection.
Največja koncentracija je bila dosežena 6,2 dneva po injiciranju.
Patients were 18 to 82 years old, with a mean age of 45.9.
Bolniki so bili stari od 18 do 82 let s povprečno starostjo 45,9.
These include vaccines and immunosuppressants (medicines that affect the immune system).
To vključuje cepiva in imunosupresive (zdravila, ki vplivajo na delovanje imunskega sistema).
Your symptoms may return upon discontinuation.
Vaši simptomi se lahko po prekinitvi vrnejo.
In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
Pri ljudeh se v prvih nekaj dneh po rojstvu protitelesa lahko prenesejo v novorojenca prek mleka.
**These patients were switched to placebo at week 28.
**Ti bolniki so v 28. tednu prešli na placeb.
Look out for infections and allergic reactions
Bodite pozorni na okužbe in alergijske reakcije
Quality of Life/Patient-reported Outcomes
Kakovost življenja/izidi zdravljenja, kot jih poročajo bolniki
n = number of patients in the full analysis set for which data was available, after imputation when applicable.
n = število bolnikov v celotni množici za analizo, za katero so bili podatki razpoložljivi, po imputaciji, kjer je primerno.
Maintenance of Response
Ohranjanje odziva
Week 12 (2 doses)*
12 teden (2 odmerka)*
This is because it has not yet been evaluated in this group of patients.
Zdravila namreč v tej skupini bolnikov še niso ocenili.
Wait for 30 minutes (if stored in the refrigerator)
Počakajte 30 minut (če je shranjeno v hladilniku)
The effects of this medicine in pregnant women are not known.
Učinki tega zdravila na nosečnice niso znani.
Important points to know
Pomembne točke za upoštevanje
One month after birth, the milk/serum ratio was ≤0.002.
En mesec po rojstvu je bilo razmerje med mlekom in serumom ≤ 0,002.
A small air bubble may be apparent: this is normal.
Morda bo viden majhen zračni mehurček, to je normalno.
Population PK analysis indicated a 31% higher bioavailability in healthy subjects compared to patients.
Populacijska FK analiza je pokazala 31 % večjo biološko razpoložljivost pri zdravih osebah v primerjavi z bolniki.
These 355 patients on placebo were subsequently crossed over to tildrakizumab.
Teh 355 bolnikov, ki so prejemali placebo, je pozneje prešlo na tildrakizumab.
Thereafter, resume dosing at the regularly scheduled interval.
Nato z odmerjanjem nadaljujte v rednih načrtovanih intervalih.
No data are available on the response to live or inactivated vaccines.
Podatki o odzivu na živa ali inaktivirana cepiva niso razpoložljivi.
Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks.
Pri nekaterih bolnikih z začetnim delnim odzivom se stanje ob nadaljevanju zdravljenja, daljšem kot 28 tednov, lahko izboljša.
In patients with certain characteristics (e.g. high disease burden, body weight ≥ 90 kg) 200 mg may provide greater efficacy.
Pri bolnikih z nekaterimi značilnostmi (npr. veliko breme bolezni, telesna masa ≥ 90 kg) morda večjo učinkovitost zagotavlja 200 mg.
The safety and efficacy of Ilumetri in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.
Varnosti in učinkovitosti zdravila Ilumetri v kombinaciji z drugimi imunosupresivi, vključno z biološkimi, ali fototerapijo, niso ovrednotili.
The liquid should be clear.
Tekočina mora biti bistra.
Your doctor will decide for how long you need to take Ilumetri.
Vaš zdravnik se bo odločil, kako dolgo morate uporabljati zdravilo Ilumetri.
In this short period, a risk to the newborns/infants cannot be excluded.
Tveganja za dojenega novorojenčka/otroka ne moremo izključiti.
Proportion of Patients with PASI 90 response over time up to Week 64 (Full Analysis Set Part 3*)
Delež bolnikov z odzivom PASI 90 glede na čas do 64. tedna (celotna množica za analizo, 3. del*)
The clinical significance of these findings is unknown.
Klinična značilnost teh izsledkov ni znana.
Pre-treatment evaluation for tuberculosis
Ocena tuberkuloze pred zdravljenjem
A total of 15.4% of study patients had a history of psoriatic arthritis.
Skupaj je 15,4 % bolnikov v študiji imelo v anamnezi psoriatični artritis.
Stop using Ilumetri and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction (see 4.
Prenehajte uporabljati zdravilo Ilumetri in se takoj povejte zdravniku ali poiščite zdravniško pomoč, če opazite kakršne koli znake, ki kažejo na možno resno okužbo ali alergijsko reakcijo (glejte poglavje 4.
Studies in mouse tumor models showed that selective inhibition of IL-23p19 does not increase carcinogenic risk.
Študije na modelih tumorja pri miših kažejo, da selektivno zaviranje IL-23p19 ne poveča kancerogenega tveganja.
Very common side effects (may affect more than 1 in 10 people): - Upper respiratory infections
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - okužba zgornjih dihal
• Take a carton pack out of the refrigerator and place the original and unopened carton pack on a clean and flat working surface.
• Škatlo vzemite iz hladilnika in položite originalno in zaprto kartonsko pakiranje na čisto in ravno delovno površino.
No dose recommendations can be made.
Priporočil za njegovo odmerjanje ni mogoče dati.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Zaradi boljše sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije danega zdravila.
The median baseline PASI score ranged from 17.7 to 18.4 across treatment groups.
Mediani rezultat PASI ob izhodišču je bil od 17,7 do 18,4 v vseh skupinah zdravljenja.
Talk to your doctor about when you will have your injections and follow-up appointments.
Z zdravnikom se pogovorite o tem, kdaj boste prejemali injekcije in kdaj morate prihajati na kontrolne preglede.
- DO NOT pull off the needle cover until you are ready to inject.
- NE odstranite pokrovčka za iglo, dokler niste pripravljeni na injiciranje.
Take a pack from the refrigerator (if stored in the refrigerator)
Pakiranje vzemite iz hladilnika (če je shranjeno v hladilniku)
Week 28 Week 64 Week 28 Week 64
28. teden 64. teden 28. teden 64. teden
For further information on elimination of tildrakizumab, see section 5.2.
Za več podatkov o izločanju tildrakizumaba glejte poglavje 5.2.
• Repeat the procedure with the second syringe in a different location of your skin if you are administering a dose of 200 mg.
• Postopek z drugo injekcijsko brizgo ponovite na drugem mestu kože, če si dajete odmerek 200 mg.
In pooled Phase 2b and Phase 3 analyses 7.3% of Ilumetri-treated patients developed antibodies to Ilumetri.
V združenih analizah faze 2b in faze 3 so se pri 7,3 % bolnikov, zdravljenih z zdravilom Ilumetri, razvila protitelesa na zdravilo Ilumetri.
Mean baseline Dermatology Life Quality Index (DLQI) ranged from 13.0 to 14.8.
Povprečna ocena dermatološkega indeksa kakovosti življenja (Dermatology Life Quality Index, DLQI) je bila od 13,0 do 14,8.
Maintenance and durability of PASI 90 Response.
Vzdrževanje in trajnost odziva PASI 90.
o DO NOT touch the blue plunger yet.
o NE dotikajte se še modrega bata.
PREPARATION 1.
PRIPRAVA 1.
Interactions with other immunosuppressive agents or phototherapy
Medsebojno delovanje z drugimi imunosupresivi ali fototerapijo
If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab.
Pri bolnikih, ki so prejeli živa virusna ali bakterijska cepiva, je priporočljivo počakati vsaj 4 tedne pred uvedbo zdravljenja s tildrakizumabom.
However, the physician should ensure appropriate follow-up of patients.
Vendar pa mora zdravnik za bolnike vedno zagotoviti ustrezne kontrolne preglede.
DLQI Score 0 or 1 (%)
Rezultat DLQI 0 ali 1 (%)
Injection sites should be alternated.
Mesta injiciranja je treba spreminjati.
• Press down the blue plunger until it can go no further.
• Pritiskajte modri bat navzdol, dokler ne gre več.
Adverse reactions (Table 1) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: 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); and not known (cannot be estimated from available data).
Neželeni učinki (preglednica 1) so navedeni po organskih sistemih klasifikacije MedDRA in s pogostnostjo po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
For instructions on how to inject Ilumetri yourself, see ‘Instructions for use' at the end of this leaflet.
Za navodila o samo-injiciranju zdravila Ilumetri glejte poglavje “Navodila za uporabo” na koncu tega navodila.
Results from a drug-drug interaction study conducted in plaque psoriasis subjects suggest that tildrakizumab had no clinically relevant effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Rezultati študije interakcij med zdravili pri bolnikih s psoriazo v plakih kažejo, da tildrakizumab nima klinično pomembnega vpliva na CYP1A2, CYP2C9, CYP2C19, CYP2D6 in CYP3A4.
Baseline PGA score was marked or severe in 33.4% of patients.
Izhodiščni rezultat PGA je bil pri 33,4 % bolnikov močno izražen ali resen.
Pregnancy, breastfeeding and fertility
Nosečnost, dojenje in plodnost
This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
S tem aktivirate varnostni mehanizem, ki zagotovi, da se bo igla po injiciranju uvlekla.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Ilumetri, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Ilumetri can potentially cause serious side effects, including infections and allergic reactions.
Zdravilo Ilumetri lahko poslabša resne neželene učinke, vključno z okužbami in alergijskimi reakcijami.
The solution pH is in the range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg.
Razpon pH-vrednosti raztopine je med 5,7 in 6,3, osmolalnost pa je med 258 in 311 mOsm/kg.
The European Medicines Agency has deferred the obligation to submit the results of studies with Ilumetri in one or more subsets of the paediatric population in the treatment of plaque psoriasis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Ilumetri za eno ali več podskupin pediatrične populacije za zdravljenje psoriaze s plaki (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If you have forgotten or missed an Ilumetri injection, administer the dose as soon as possible.
Če ste pozabili ali izpustili injekcijo zdravilo Ilumetri, naslednji odmerek uporabite čim prej.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
A total of 1,768 patients were evaluated (705 patients on 100 mg, 708 patients on 200 mg and 355 patients on placebo).
Ocenili so skupaj 1.768 bolnikov (705 bolnikov, ki so prejemali 100 mg, 708 bolnikov, ki so prejemali 200 mg in 355 bolnikov, ki so prejemali placebo).
After repeated dosing to pregnant cynomolgus monkeys, serum concentrations were quantifiable in the fetus, but the reproduction toxicity studies did not reveal any untoward effects.
Po ponavljajočem odmerjanju brejim opicam cynomolgus je bilo možno koncentracije v serumu pri plodu določiti, vendar študije reproduktivne toksičnosti niso pokazale nobenih neželenih učinkov.
What you need to know before you use Ilumetri Do not use Ilumetri:
Kaj morate vedeti, preden boste uporabili zdravilo Ilumetri Ne uporabljajte zdravila Ilumetri:
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC17 Mechanism of action
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC17
The decision to stop using Ilumetri should be discussed with your doctor.
O odločitvi, da prenehate uporabljati zdravilo Ilumetri, se morate posvetovati z zdravnikom.
Most of the following side effects are mild.
Naslednji neželeni učinki so povečini blagi.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
Population pharmacokinetic modelling indicated that exposure decreased as body weight increased.
Populacijsko modeliranje farmakokinetike je pokazalo, da se je izpostavljenost z večanjem telesne mase manjšala.
What Ilumetri is and what it is used for
Kaj je zdravilo Ilumetri in za kaj ga uporabljamo
Patients receiving Ilumetri should be closely monitored for signs and symptoms of active TB during and after treatment.
Bolnike, ki prejmejo zdravilo Ilumetri, je treba skrbno spremljati za znake in simptome aktivne TB med zdravljenjem in po njem.
Clinically important active infection, e.g. active tuberculosis (see section 4.4).
Klinično pomembna aktivna okužba (npr. aktivna tuberkuloza, glejte poglavje 4.4).
Overall demographic and baseline characteristics in reSURFACE1 and reSURFACE2 studies were consistent across individual trials.
Splošne demografske in izhodiščne značilnosti v študijah reSURFACE1 in reSURFACE2 so bile v posameznih preskušanjih skladne.
*No imputation of missing data.
*Brez imputacije za manjkajoče podatke.
Inspect the medicine
Zdravilo preglejte
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women.
Podatkov o uporabi tildrakizumaba pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Results obtained at weeks 12, 28 and beyond (up to week 64 in reSURFACE 1 and up to week 52 in reSURFACE 2) are presented in Table 2 and Table 3.
Rezultati, pridobljeni v 12. in 28. tednu ter kasneje (do 64. tedna v študiji reSURFACE 1 in do 52. tedna v študiji reSURFACE 2), so predstavljeni v preglednici 2 in preglednici 3.
Other evaluated outcomes included the proportion of patients who achieved PASI 90, PASI 100, the proportion of patients with DLQI 0 or 1, and maintenance of efficacy up to 52/64 weeks.
Drugi ocenjeni izidi so vključevali dežel bolnikov, ki so dosegli PASI 90, PASI 100 delež bolnikov z DLQI 0 ali 1 in ohranjanje učinkovitosti do 52/64 tednov.
Gastrointestinal disorders Gastroenteritis
Bolezni prebavil gastroenteritis
Tildrakizumab has limited extravascular distribution with volume of distribution (Vd) values ranging from 76.9 to 106 mL/kg.
Tildrakizumab ima omejeno ekstravaskularno porazdelitev s porazdelitvenim volumnom od 76,9 do 106 ml/kg.
p-values calculated using the Cochran-Mantel-Haenszel (CMH) test stratified by body weight (≤90 kg, >90 kg) and prior exposure to biologic therapy for psoriasis (yes/no).
Vrednosti p, izračunane po Cochran- Mantel- Haenszelovem (CMH) testu, stratificirane po telesni masi (≤ 90 kg, > 90 kg) in predhodno izpostavljenostjo biološkim zdravilom za psoriazo (da/ne).
- DO NOT inject into scars, stretch marks, or blood vessels.
- NE injicirajte v brazgotine, strije ali krvne žile.
• Before you use Ilumetri pre-filled syringes, read and carefully follow all the step-by-step instructions.
• Preden začnete uporabljati zdravilo Ilumetri napolnjene injekcijske brizge, preberite in natančno upoštevajte navodila po korakih.
Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3).
Razpoložljivi toksikološki podatki pri opicah cynomolgus so 28. dan po rojstvu pokazali zanemarljive ravni zdravila Ilumetri v mleku (glejte poglavje 5.3).
† p≤0.001 versus placebo; ‡ p≤0.001 versus etanercept; ¥ p≤0.05 versus etanercept.
† p ≤ 0,001 v primerjavi s placebom; ‡ p ≤ 0,001 v primerjavi z etanerceptom; ¥ p ≤ 0,05 v primerjavi z etanerceptom.
Of all patients, 35.8% had received prior phototherapy, 41.1% had received prior conventional systemic therapy, 16.7% had received prior biologic therapy for the treatment of plaque psoriasis.
Od vseh bolnikov se jih je 35,8 % predhodno zdravilo s fototerapijo, 41,1 % se jih je predhodno zdravilo z običajno sistemsko terapijo in 16,7 % se je predhodno zdravilo z biološko terapijo za zdravljenje psoriaze v plakih.
This medicine works by blocking the activity of a protein called IL-23, a substance found in the body which is involved in normal inflammatory and immune responses and which is present at increased levels in diseases such as psoriasis.
To zdravilo deluje tako, da zavira aktivnost beljakovine, imenovane IL-23, ki je snov, ki jo najdemo v telesu, in je vključena pri normalnem vnetnem in imunskem odgovoru, in je pri boleznih, kot je luskavica, prisotna v zvišanih ravneh.
Solution for injection (injection)
Raztopina za injiciranje (injekcija)
Ilumetri has the potential to increase the risk of infection (see section 4.8).
Zdravilo Ilumetri lahko poveča tveganje za okužbe (glejte poglavje 4.8).
Remove the used syringe
Odstranite uporabljeno injekcijsko brizgo
Other medicines and Ilumetri
Druga zdravila in zdravilo Ilumetri
Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Tildrakizumab je humanizirano monoklonsko protitelo IgG1/k, izdelano v ovarijskih celicah kitajskega hrčka (Chinese Hamster Ovary, CHO) s tehnologijo rekombinantne DNA.
Interactions with cytochrome p450
Medsebojno delovanje s citokromom p450
Ilumetri has not been studied in these patient populations.
Zdravila Ilumetri v teh skupinah bolnikov niso proučevali.
Possible side effects).
Možni neželeni učinki).
Talk to your doctor, pharmacist or nurse before using Ilumetri: - If you experience allergic reactions with symptoms such as chest tightness, wheezing, swelling of the face, lips or throat do not inject more Ilumetri and contact your doctor immediately.
Pred začetkom uporabe zdravila Ilumetri se posvetujte z zdravnikom ali farmacevtom: - če imate alergijske reakcije s simptomi, kot so tiščanje v prsnem košu, piskanje, oteklost obraza, ustnic ali žrela, si zdravila Ilumetri ne injicirajte več in se takoj posvetujte z zdravnikom;
Prior to initiating treatment with Ilumetri, patients should be evaluated for tuberculosis (TB) infection.
Pred uvedbo zdravljenja z zdravilom Ilumetri je treba pri bolnikih oceniti okužbo s tuberkulozo (TB).
Before using the pre-filled syringes:
Pred uporabo napolnjene injekcijske brizge:
Week 28 Week 52 Week 28 Week 52
28. teden 52. teden 28. teden 52. teden
Steady-state is achieved by 16 weeks with the clinical regimen of 0, 4, and every 12 weeks thereafter, with 1.1-fold accumulation in exposure between week-1 and week-12 independent of dose.
Stanje dinamičnega ravnovesja je doseženo do 16. tedna s kliničnim režimom v 0. in 4. tednu, nato pa vsakih 12 tednov, z 1,1-kratno akumulacijo pri izpostavljenosti med 1. in 12. tednom, neodvisno od odmerka.
Using Ilumetri will benefit you by improvements of skin clearance and reducing your symptoms.
Uporaba zdravila Ilumetri vam pomaga k izboljšanju videza kože in zmanjšanja simptomov.
Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Tildrakizumab spada v skupino zdravil, imenovanih zaviralci interlevkina (IL).
No data are available with the concomitant use of Ilumetri and live vaccines.
Podatkov o sočasni uporabi zdravila Ilumetri in živih cepiv ni na voljo.
• Leave the pre-filled syringe in the Ilumetri carton (with the lid closed) and let it sit at room temperature for 30 minutes.
• Napolnjeno injekcijsko brizgo pustite v škatli za zdravilo Ilumetri (z zaprtim pokrovom) in jih pustite 30 minut na sobni temperaturi.
Patients treated with Ilumetri should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5).
Bolniki, zdravljeni z zdravilom Ilumetri, med zdravljenjem in še vsaj 17 tednov po zdravljenju ne smejo prejeti živih cepiv (glejte poglavje 4.5).
Elderly No dose adjustment is required (see section 5.2).
Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
Studies reSURFACE 1 and reSURFACE 2 assessed the changes from baseline at Week 12 in the two coprimary endpoints: 1) PASI 75 and 2) PGA of “0” (cleared) or “1” (minimal), with at least a 2-point improvement from baseline.
V študijah reSURFACE 1 in reSURFACE 2 so ocenjevali spremembe v 12. tednu od izhodišča za dva sestavljena opazovana dogodka: 1) PASI 75 in 2) PGA "0" (čisto) ali "1" (minimalno), z vsaj 2-točkovnim izboljšanjem od izhodišča.
Small-molecule metabolic pathways (e.g., CYP450 enzymes, glucuronosyltransferases) do not contribute to its clearance.
Presnovne poti z majhnimi molekulami (npr. encimi CYP450, glukuronoziltransferaze) ne prispevajo k očistku.
In the active comparator study (reSURFACE 2), patients were also randomised to receive etanercept 50 mg twice weekly for 12 weeks, and weekly thereafter up to 28 weeks.
V študiji z aktivnim primerjanim zdravilom (reSURFACE 2) so bili bolniki prav tako randomizirani tako, da so 12 tednov prejemali 50 mg etanercepta dvakrat na teden, nato pa do 28 tednov enkrat na teden.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
Ženske v rodni dobi morajo med zdravljenjem in še vsaj 17 tednov po zdravljenju uporabljati učinkovito kontracepcijsko metodo.
Ilumetri is available in unit packs containing 1 pre-filled syringe and packs comprising 2 pre-filled syringes.
Zdravilo Ilumetri je na voljo v enotah pakiranja, ki vsebujejo 1 napolnjeno injekcijsko brizgo in pakiranja,ki vsebujejo 2 napolnjeni injekcijski brizgi.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
No apparent association between the development of antibodies to Ilumetri to lower efficacy and the development of treatment emergent adverse events was observed.
Očitne povezave med razvojem protiteles na zdravilo Ilumetri na manjšo učinkovitost in razvojem neželenih učinkov zaradi zdravljenja niso opazili.
Animal carcinogenicity studies have not been conducted with tildrakizumab.
Študij kancerogenosti na živalih s tildrakizumabom niso izvedli.
08740 Sant Andreu de la Barca, Barcelona, Spain
08740 Sant Andreu de la Barca, Barcelona, Španija