natgillin/translations-raw huggingface dataset:
90.7 mg/g gel in sachet and Kentera 90.7 mg/g gel in a metering pump 4.2 Posology and method of administration […] Elderly population
Velja za vse formulacije: Kentera 3,9 mg/24 h transdermalni obliž, Kentera 90,7 mg/g gel v vrečici in Kentera 90,7 mg/g gel v odmerni črpalki 4.2.
Date of first authorisation: 26 April 2019
Datum prve odobritve: 26 April 2019
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However, this observation is based on a limited number of subjects.
Vendar to opažanje temelji na omejenem številu preiskovancev.
• if you have tuberculosis (TB).
• če imate tuberkulozo (TB).
67061 Ludwigshafen Germany
67061 Ludwigshafen Nemčija
• Do not inject through clothes
• Ne injicirajte skozi oblačila.
Campoverde di Aprilia (LT) ITALY
Campoverde di Aprilia (LT) Italija
Weeks After Re-Randomisation
Tedni po ponovni randomizaciji
• It is normal to see bubbles in the window
• Normalno je, da v okencu vidite mehurčke.
• if the expiry date (EXP) has passed
• če je rok uporabnosti (EXP) že pretekel,
• Do not inject into areas affected by psoriasis
• Ne injicirajte v predele, ki jih je prizadela psoriaza.
Thereafter, dosing should be resumed at the regular scheduled time.
Potem je treba uporabo zdravila nadaljevati ob redno predvidenem času.
If you stop treatment, your symptoms may come back.
Če zdravilo prenehate uporabljati, se vam simptomi lahko ponovijo.
All comparisons achieved p<0.001
Vse primerjave so dosegle p < 0,001
• if the liquid has ever been frozen (even if thawed)
• če je bila tekočina kdaj zmrznjena (tudi če se je odtalila),
Slowly take your thumb off the plunger.
Počasi odmaknite palec z bata.
Elderly (aged 65 years and over)
Starejši bolniki (stari 65 let ali več)
Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.
Znano je, da se človeški IgG izločajo v materino mleko prvih nekaj dni po rojstvu, a se njihova koncentracija kmalu potem zelo zmanjša; tveganja za dojenega otroka med tem kratkim obdobjem tako ni mogoče izključiti.
Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.
Držite telo brizge z eno roko med palcem in kazalcem, kot bi držali svinčnik.
The same information is also available at the following URL: www.skyrizi.eu
Iste informacije so na voljo tudi na naslednjem URL: www.skyrizi.eu
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13% of patients.
Najpogosteje opisani neželeni učinki so bile okužbe zgornjih dihal, ki so se pojavile pri 13 % bolnikov.
DLQI 0 or 1
DLQI 0 ali 1
sPGA of clear or almost clear (0 or 1)
Ocena sPGA čisto ali skoraj čisto (0 ali 1)
• You may see a drop of liquid at the end of the needle.
• Na koncu igle se lahko pojavi kapljica tekočine.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 - 8 °C).
Week 16
16. teden
• swelling of the face, lips, tongue or throat
• oteklost obraza, ustnic, jezika ali žrela,
If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab.
Če je bolnik prejel živo cepivo (virusno ali bakterijsko), je priporočljivo počakati vsaj 4 tedne pred začetkom zdravljenja z risankizumabom.
The safety and efficacy of Skyrizi in children and adolescents aged 6 to 18 years have not yet been established.
Varnost in učinkovitost zdravila Skyrizi pri otrocih in mladostnikih od 6. do 18. leta starosti še nista ugotovljeni.
Do not inject into the same place.
Ne injicirajte obeh na isto mesto.
RZB = risankizumab UST = ustekinumab PBO = placebo p<0.001 at each time point
RZB = risankizumab UST = ustekinumab PBO = placebo p < 0,001 na vseh časovnih točkah
Gender or race
Spol ali rasa
No dose adjustment is required (see section 5.2).
Odmerka ni potrebno prilagoditi (glejte poglavje 5.2).
• if you are using, have recently used or might use any other medicines.
• če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Start with one syringe for the first injection.
Začnite z eno injekcijsko brizgo za prvo injekcijo.
• Repeat Steps 2 through 6 with the second syringe
• Ponovite korake od 2. do 6. še z drugo brizgo.
• if you have an infection, including active tuberculosis, which your doctor thinks is important.
• če imate kakšno okužbo (vključno z aktivno tuberkulozo), ki je po zdravnikovi presoji pomembna.
• if you currently have an infection or if you have an infection that keeps coming back.
• če imate trenutno kakšno okužbo, ali če imate kakšno okužbo, ki se ponavlja.
This is because it is not known how this medicine will affect the baby.
Ni namreč znano, kakšen vpliv ima to zdravilo lahko na otroka.
• Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
• Zdravila Skyrizi ne segrevajte na noben drug način (na primer v mikrovalovni pečici ali v vroči vodi).
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Če želite poslušati ali zaprositi za kopijo tega navodila v <Braillovi pisavi>, <velikem tisku> ali <zvočnem posnetku>, se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Very common: may affect more than 1 in 10 people • upper respiratory infections with symptoms such as sore throat and stuffy nose
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 oseb • okužba zgornjih dihal s simptomi, kot so vneto grlo in zamašen nos
Your doctor will decide if you can keep using Skyrizi.
Zdravnik bo presodil, ali lahko še naprej uporabljate zdravilo Skyrizi.
Results are presented in Table 4.
Rezultati so prikazani v preglednici 4.
Table 1: List of adverse reactions in clinical studies
Preglednica 1: Seznam neželenih učinkov v kliničnih študijah
It reduces the inflammation.
Tako zmanjša vnetje.
• Special disposal container (not included in the carton)
• poseben vsebnik za odlaganje (ni priložen v škatli)
For more information and support on Skyrizi go to www.skyrizi.eu or scan this code.
Za več informacij in za podporo o zdravilu Skyrizi obiščite www.skyrizi.eu ali skenirajte to kodo.
Concomitant immunosuppressive therapy or phototherapy
Sočasno imunosupresivno zdravljenje ali fototerapija
• injection site reactions (such as redness or pain)
• reakcije na mestu injiciranja (kot sta rdečina ali bolečina)
Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement.
Iglo v celoti zabodite v kožo pod kotom približno 45 stopinj s hitrim, kratkim gibom.
As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab.
Tako kot pri vseh terapevtskih beljakovinah tudi pri risankizumabu obstaja možnost imunogenosti.
Risankizumab clearance and volume of distribution increase as body weight increases which may result in reduced efficacy in subjects with high body weight (>130 kg).
Očistek in volumen porazdelitve risankizumaba se povečujeta s povečevanjem telesne mase, kar ima lahko za posledico zmanjšano učinkovitost pri osebah z visoko telesno maso (>130 kg).
If you forget to use Skyrizi, inject a dose as soon as you remember.
Če ste pozabili uporabiti zdravilo Skyrizi, injicirajte odmerek takoj, ko se spomnite.
Pull the needle out of the skin while keeping the syringe at the same angle.
Izvlecite iglo iz kože, medtem ko brizgo držite pod istim kotom.
A total of 9.8% of study subjects had a history of diagnosed psoriatic arthritis.
Skupno je imelo 9,8 % preiskovancev v študiji anamnezo diagnosticiranega psoriatičnega artritisa.
The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Varnosti in učinkovitosti risankizumaba v kombinaciji z imunosupresivi, vključno z biološkimi zdravili, ali fototerapijo niso ocenili.
The safety profile of risankizumab with up to 77 weeks of exposure was consistent with the profile observed up to 16 weeks.
Varnostni profil risankizumaba pri izpostavljenosti do 77 tednov je bil skladen s profilom, opaženim pri izpostavljenosti do 16 tednov.
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines.
Pred uvedbo zdravljenja z risankizumabom je treba razmisliti o dokončanju vseh ustreznih imunizacij v skladu s trenutnimi imunizacijskimi smernicami.
Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Nekaterim bolnikom, ki se na začetku zdravljenja odzovejo le delno, se lahko stanje pozneje izboljša z nadaljevanjem zdravljenja več kot 16 tednov.
Removing the needle cover:
Odstranite pokrovček igle:
• Your doctor, pharmacist or nurse will tell you how to return the full special disposal container
• Zdravnik, farmacevt ali medicinska sestra vam bodo povedali, kako vrniti polni vsebnik za odlaganje.
• feeling tired or short of breath, cough which will not go away
• občutek utrujenosti, težko dihanje ali kašelj, ki ne izgine,
Maintenance of response
Vzdrževanje odziva
Comprehensive instructions for use are provided in the package leaflet.
Izčrpna navodila za uporabo so vključena v navodilu za uporabo.
You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself.
Skupaj z zdravnikom, farmacevtom ali medicinsko sestro se boste odločili, ali naj si zdravilo injicirate sami.
For most subjects, antibodies to risankizumab including neutralising antibodies were not associated with changes in clinical response or safety.
Pri večini preiskovancev protitelesa proti risankizumabu, vključno z nevtralizirajočimi protitelesi, niso bila povezana s spremembami kliničnega odziva ali varnosti.
• if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na risankizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The needle will then be covered by the needle guard.
Ščitnik igle bo nato pokril iglo.
The rate of serious infections was 1.7 events per 100 subject-years (see section 4.4).
Delež resnih okužb je bil 1,7 na 100 let izpostavljenosti preiskovancev (glejte poglavje 4.4).
Each pre-filled syringe is for single use only.
Vsaka napolnjena injekcijska brizga je le za enkratno uporabo.
Figure 2: Time course of PASI 90 after re-randomisation in IMMVENT
Slika 2: Časovni potek PASI 90 po ponovni randomizaciji v študiji IMMVENT
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Odkritje nastajanja protiteles proti zdravilu je močno odvisno od senzitivnosti in specifičnosti preizkusa.
Results 28 weeks after re-randomisation are presented in Table 5 and Figure 2.
Rezultati 28 tednov po ponovni randomizaciji so prikazani v preglednici 5 in na sliki 2.
Gently pinch the area of cleaned skin with your other hand and hold it firmly.
Nežno stisnite očiščeni predel kože z drugo roko in ga trdno držite.
Return this medicine to the pharmacy
Zdravilo vrnite v lekarno:
20 and water for injections.
polisorbat 20 in voda za injekcije.
Skyrizi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Zdravilo Skyrizi je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki injekcijske brizge in na zunanji ovojnini poleg oznake "EXP".
Check the liquid in the syringe.
Preverite tekočino v injekcijski brizgi.
Hold the syringe with the covered needle pointing down, as shown.
Primite injekcijsko brizgo s pokrito iglo obrnjeno navzdol, kot je prikazano.
In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution.
Pri bolnikih s kronično okužbo, anamnezo ponavljajoče se okužbe ali z znanimi dejavniki tveganja za okužbo, je treba risankizumab uporabljati previdno.
A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman.
Potrebno je sprejeti odločitev glede prenehanja/prekinitve zdravljenja z risankizumabom, pri tem pa upoštevati koristi dojenja za otroka in koristi zdravljenja z risankizumabom za žensko.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of risankizumab in pregnant women.
Podatkov o uporabi risankizumaba pri nosečnicah ni ali jih je malo (manj kot 300 izidov nosečnosti).
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection.
Pred uvedbo zdravljenja z risankizumabom je potrebno bolnike pregledati za okužbo s tuberkulozo (TB).
Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as:
Nemudoma se posvetujte z zdravnikom ali poiščite zdravniško pomoč, če se vam pojavijo simptomi resne okužbe, na primer:
2 Injections Required
Potrebni sta 2 injekciji
IL-23 is a cytokine that is involved in inflammatory and immune responses.
IL-23 je citokin, ki sodeluje pri vnetnih in imunskih odzivih.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Upoštevati je treba aditivni učinek sočasnega jemanja zdravil, ki vsebujejo sorbitol (ali fruktozo), in sorbitola (ali fruktoze), ki ga vnesemo s hrano.
• warm, red and painful skin, or a painful skin rash with blisters
• topla, rdeča in boleča koža ali boleč kožni izpuščaj z mehurji.
• The needle guard will not activate unless all the liquid is injected
• Ščitnik igle se ne aktivira, dokler ni injicirana vsa tekočina.
The incidence of injection site reactions is numerically higher in the anti-drug antibodypositive compared with anti-drug antibody-negative groups over short-term (16 weeks: 2.7% vs 1.3%) and longer term treatment (>52 weeks: 5.0% vs 3.3%).
Incidenca reakcij na mestu injiciranja je številčno večja pri skupini, ki je pozitivna na protitelesa proti zdravilu v primerjavi s skupino, ki je negativna na protitelesa proti zdravilu, pri kratkoročnem (16 tednov: 2,7 % proti 1,3 %) in dolgoročnem zdravljenju (> 52 tednov: 5,0 % proti 3,3 %).
What Skyrizi is and what it is used for 2.
Kaj je zdravilo Skyrizi in za kaj ga uporabljamo 2.
As a precautionary measure, it is preferable to avoid the use of risankizumab during pregnancy.
Iz previdnosti se je uporabi risankizumaba med nosečnostjo bolje izogniti.
Patients should be instructed to inject 2 pre-filled syringes for the full 150 mg dose and to read the ‘Instructions for use' provided in the package leaflet before administration.
Bolnikom je treba naročiti, da si morajo za celoten 150-mg odmerek injicirati 2 napolnjeni injekcijski brizgi ter da morajo pred uporabo zdravila prebrati "Navodila za uporabo" v navodilu, priloženem zdravilu.
Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of infections was 75.5 events per 100 subject-years.
V celotnem programu psoriaze, vključno z dolgoročno izpostavljenostjo risankizumabu, je bil delež okužb 75,5 na 100 let izpostavljenosti preiskovancev.
Uncommon: may affect up to 1 in 100 people • small raised red bumps on the skin
Občasni: pojavijo se lahko pri največ 1 od 100 oseb • majhne, dvignjene bulice na koži
Do not stop using Skyrizi without talking to your doctor first.
Ne prenehajte uporabljati zdravila Skyrizi, ne da bi se prej posvetovali z zdravnikom.
These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2).
Na splošno ni pričakovati, da bi ta stanja pomembno vplivala na farmakokinetiko monoklonskih protiteles, zato prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Slowly push the plunger all the way in until all of the liquid is injected.
Počasi potisnite bat do konca, dokler ne injicirate vse tekočine.
AbbVie (as logo)
AbbVie (kot logo)
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC18
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov Oznaka ATC: L04AC18
• fever, flu-like symptoms, night sweats
• zvišana telesna temperatura, gripi podobni simptomi, nočno znojenje,
• PASI 90 continued to receive adalimumab
• PASI 90 so še naprej prejemali adalimumab.
This medicine is given as 2 injections under your skin (called ‘subcutaneous injections').
Zdravilo Skyrizi se uporablja v 2 podkožnih injekcijah (to imenujemo "subkutano injiciranje").
Following subcutaneous dosing of risankizumab, peak plasma concentrations were achieved between 3-14 days after dosing with an estimated absolute bioavailability of 89%.
Po subkutani uporabi risankizumaba je bila največja koncentracija v plazmi dosežena od 3 do 14 dni po uporabi ter z ocenjeno absolutno biološko uporabnostjo 89 %.
Of the 2,234 subjects with plaque psoriasis exposed to risankizumab, 243 were 65 years or older and 24 subjects were 75 years or older.
Od 2234 preiskovancev s psoriazo v plakih, izpostavljenih risankizumabu, je bilo 243 starih 65 let ali več in 24 starih 75 let ali več.
This medicine works by stopping a protein in the body called ‘IL-23', which causes inflammation.
To zdravilo deluje tako, da blokira telesno beljakovino "IL-23", ki povzroča vnetje.
Before injecting, patients may remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringes from the carton.
Pred injiciranjem lahko bolniki vzamejo škatlo iz hladilnika in pustijo, da doseže sobno temperaturo (pri tem ne sme biti izpostavljena neposredni sončni svetlobi), tj. od 15 do 30 minut, ne da bi napolnjeno injekcijsko brizgo vzeli iz škatle.
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo bolnika nadzorovati za znake in simptome neželenih učinkov ter nemudoma uvesti ustrezno simptomatsko zdravljenje.
Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment (see section 5.2).
Bolniki, ki se zdravijo z risankizumabom, ne smejo prejeti živih cepiv med zdravljenjem in še vsaj 21 tednov po zdravljenju (glejte poglavje 5.2).
Anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS), improved in the risankizumab group at week 16 compared with the placebo group.
Anksioznost in depresija, merjeni z lestvico HADS (Hospital Anxiety and Depression Scale), sta se v skupini, ki je prejemala risankizumab, izboljšali v 16. tednu v primerjavi s placebo skupino.
Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone.
Podrobne in posodobljene informacije o zdravilu so vam na voljo, če s pametnim telefonom skenirate QR-kodo, ki je spodaj in na zunanji ovojnini.
No dose adjustment based on body weight is currently recommended.
Prilagoditev odmerka glede na telesno maso trenutno ni priporočljiva.
The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.
Večina primerov ni bila resna, bili so blagi do zmerni in niso povzročili prenehanja uporabe risankizumaba.
If a dose is missed, the dose should be administered as soon as possible.
V primeru izpuščenega odmerka je treba odmerek uporabiti čim prej.
Prior to use, a visual inspection of each pre-filled syringe is recommended.
Pred uporabo je priporočljivo vsako napolnjeno injekcijsko brizgo pregledati.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
Table 5: Efficacy results 28 weeks after re-randomisation in IMMVENT Switched to Risankizumab (N=53) n (%)
Preglednica 5: Rezultati učinkovitosti 28 tednov po ponovni randomizaciji v študiji IMMVENT Prehod na risankizumab (N = 53) n (%)
The European Medicines Agency has deferred the obligation to submit the results of studies with risankizumab 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 risankizumabom za eno ali več podskupin pediatrične populacije za zdravljenje psoriaze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Week 52 249 (81.9) PASI 100
52. teden 249 (81,9) PASI 100
Across all studies, 30.9% of subjects were naïve to any systemic therapy (including non-biologic and biologic), 38.1% had received prior phototherapy or photochemotherapy, 48.3% had received prior non-biologic systemic therapy, 42.1% had received prior biologic therapy, and 23.7% had received at least one anti-TNF alpha agent for the treatment of psoriasis.
V vseh študijah skupaj je bilo 30,9 % bolnikov, ki dotlej niso prejemali nobene sistemske terapije (vključno z nebiološkimi in biološkimi zdravili), 38,1 % jih je bilo predhodno zdravljenih s fototerapijo ali fotokemoterapijo, 48,3 % jih je predhodno prejemalo nebiološka sistemska zdravila, 42,1 % jih je predhodno prejemalo biološka zdravila in 23,7 % jih je prejemalo vsaj eno zdravilo proti TNF- alfa za zdravljenje psoriaze.
Baseline sPGA score was severe in 19.3% of subjects and moderate in 80.7% of subjects.
Izhodiščna ocena sPGA je bila huda pri 19,3 % preiskovancev in zmerna pri 80,7 % preiskovancev.
Therapeutic IgG monoclonal antibodies are typically degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs.
Terapevtska monoklonska protitelesa IgG se tipično po kataboličnih poteh razgradijo v majhne peptide in aminokisline, enako kot endogeni IgG.
The efficacy and safety of risankizumab was assessed in 2,109 subjects with moderate to severe plaque psoriasis in four multicentre, randomised, double-blind studies (ULTIMMA-1, ULTIMMA-2, IMMHANCE, and IMMVENT).
Učinkovitost in varnost risankizumaba so ocenili pri 2109 preiskovancih z zmerno do hudo psoriazo v plakih v štirih multicentričnih, randomiziranih, dvojno slepih študijah (ULTIMMA-1, ULTIMMA-2, IMMHANCE in IMMVENT).
Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on 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); and very rare (< 1/10,000).
Neželeni učinki risankizumaba iz kliničnih študij (preglednica 1) so našteti po organskem sistemu MedDRA in razvrščeni 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) in zelo redki (< 1/10.000).
• Inject the second syringe straight after the first injection but at least 3 cm away from the first injection
• Z drugo brizgo injicirajte takoj za prvo, vendar vsaj 3 cm stran od prve injekcije.
Among the few subjects (approximately 1%; 7/1,000 at week 16 and 6/598 at week 52) with high antibody titers (>128), clinical response appeared to be reduced.
Med maloštevilnimi preiskovanci (približno 1 %; 7/1.000 v 16. tednu in 6/598 v 52. tednu) z visokimi titri protiteles (> 128) se je klinični odziv zmanjšal.
Percent of Subjects
Odstotek preiskovancev
It also reduces symptoms of psoriasis such as burning, itching, pain, redness and scaling.
Zmanjšuje tudi simptome psoriaze, na primer pekoč občutek, srbenje, bolečino, pordelost in luščenje.