natgillin/translations-raw huggingface dataset:
Press a cotton ball or gauze over the injection site.
Na mesto injiciranja pritisnite kroglico vate ali kos gaze.
Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12,
Bolnike so ob izhodišču stratificirali glede na sočasno uporabo cDMARD in prisotnost zmerne do hude psoriaze (PASI ≥ 12, BSA ≥ 10 in sPGA ≥ 3).
Taltz is for subcutaneous injection.
Zdravilo Taltz je namenjeno za subkutano injiciranje.
Other medicines and Taltz
Shranjevanje zdravila Taltz
Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and PASI 100 response at Week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 15.8%]).
ACR 50 in PASI 100 v 24. tednu (zdravilo Taltz 36,0 % v primerjavi z ADA 27,9 %; p = 0,036; 95 % interval zaupanja [0,5 %, 15,8 %]).
There is limited information in subjects aged ≥ 75 years.
Podatki za bolnike, stare 75 let in več, so omejeni.
sPGA of “0” (clear) or
sPGA "0" (čisto)
At Week 24 the proportion of patients achieving a modified Psoriatic Arthritis Response Criteria (PsARC) response was greater in the Taltz-treated patients compared to placebo.
V 24. tednu je delež bolnikov, ki so dosegli odziv glede na prilagojene kriterije odzivnosti bolnikov s psoriatičnim artritisom (PsARC - Psoriatic Arthritis
• If you have questions or need help with your pre-filled syringe, call your doctor, pharmacist or nurse.
• Če imate vprašanja ali če potrebujete pomoč v zvezi s svojo napolnjeno injekcijsko brizgo, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
Ixekizumab administration to cynomolgus monkeys for 39 weeks at subcutaneous doses up to 50 mg/kg weekly produced no organ toxicity or undesirable effects on immune function (e.g. T-cell dependent antibody response and NK cell activity).
39 tednov ni povzročilo nobene toksičnosti za organe ali neželenih učinkov na delovanje imunskega sistema (npr. na odziv s protitelesi, odvisen od celic T in dejavnost celic NK).
Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [4.3%; 12.1%] ; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and superiority on PASI 100 at Week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were the major secondary endpoints in the study.
Pokazali so tudi neinferiornost zdravila Taltz (predhodno določena meja -12 %) glede na ADA pri odzivu ACR 50 (analiza ITT: zdravilo Taltz 50.5% v primerjavi z ADA 46.6%; 3,9-odstotna razlika v primerjavi z ADA; 95 % interval zaupanja [-4,3 %; 12,1 %]; analiza PPS za zdravilo Taltz; 52,3 %, ADA: 53,1%, razlika -0,8 % [IZ: -10,3 %; 8,7 %] ) in superiornost pri odzivu PASI 100 v 24. tednu (60,1 % pri zdravilu Taltz v primerjavi s 46,6 % pri ADA, p = 0,001), ki sta bila glavna sekundarna opazovana dogodka v študiji.
Injection button Lock ring Lock/unlock symbols
Simbol za zaklep/odklep
Infection rates observed in psoriatic arthritis clinical studies were similar to those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Stopnje okužb, ki so jih opazili v kliničnih študijah psoriatičnega artritisa, so bile podobne stopnjam, ki so jih opazili v študijah psoriaze s plaki, z izjemo pogostnosti neželenih učinkov gripe in konjunktivitisa, ki sta bila pogosta neželena učinka pri bolnikih s psoriatičnim artritisom.
Contents of the pack and other information
Shranjevanje zdravila Taltz Vsebina pakiranja in dodatne informacije
• The syringe must not be shaken.
• Brizge ne smete stresati.
No interaction was seen when Taltz was administered concomitantly with methotrexate (MTX) and/or corticosteroids in patients with psoriatic arthritis.
Ob sočasnem dajanju zdravila Taltz z metotreksatom (MTX) in/ali kortikosteroidi pri bolnikih s psoriatičnim artritisom niso opazili medsebojnega delovanja zdravil.
a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c p < 0.01 compared with placebo d Patients with Itch NRS > = 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306
a p < 0,001 v primerjavi s placebom b p < 0,001 v primerjavi z etanerceptom c p < 0,01 v primerjavi s placebom d Bolniki z oceno srbenja na lestvici NRS > = 4 v izhodišču: placebo N = 135, zdravilo Taltz 80 mg Q4W N = 293, zdravilo Taltz 80 mg Q2W N = 303, etanercept N = 306
There is no relevant use of Taltz in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
Smotrne uporabe zdravila Taltz pri otrocih, mlajših od 6 let, za zdravljenje zmerne do hude psoriaze s plaki, ni.
Taltz was efficacious in the maintenance of response in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.
Zdravilo Taltz je bilo učinkovito pri vzdrževanju odziva pri bolnikih, ki še niso bili zdravljeni s sistemsko terapijo ali biološkimi zdravili, niso bili izpostavljeni biološkim zdravilom/zaviralcem TNF oziroma pri bolnikih, pri katerih je bilo zdravljenje z biološkimi zdravili/zaviralci TNF neuspešno.
Placebo (N = 168)
Opazovani dogodki placebo (N = 168)
Some side effects are uncommon (may affect up to 1 in 100 people): - oral thrush (oral candidiasis).
Nekateri neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - glivična okužba v ustih (ustna kandidaza),
• If you have questions or need help with your pre-filled pen, call your doctor, pharmacist or nurse.
• Če imate vprašanja ali če potrebujete pomoč v zvezi s svojim napolnjenim injekcijskim peresnikom, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
DO NOT put the base cap back on.
NE nameščajte znova pokrovčka podnožja.
They will not harm you or affect your dose.
Ne bodo vam škodili, niti ne bodo vplivali na vaš odmerek.
Taltz contains sodium
Zdravilo Taltz vsebuje natrij
Maintained sPGA of “0” (clear) or “1” (minimal)
Vzdrževana ocena sPGA "0" (čisto) ali "1" (minimalno)
DO NOT put the needle cap back on.
NE nameščajte znova pokrovčka igle.
Package leaflet: Information for the patient Taltz 80 mg solution for injection in pre-filled syringe ixekizumab This medicine is subject to additional monitoring.
Navodilo za uporabo: informacije za bolnika Taltz 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku iksekizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
No effects on reproductive organs, menstrual cycles or sperm were observed in sexually mature cynomolgus monkeys that received ixekizumab for 13 weeks at a weekly subcutaneous dose of 50 mg/kg.
Pri spolno zrelih opicah vrste javanski makak, ki so 13 tednov prejemale iksekizumab v tedenskih subkutanih odmerkih po 50 mg/kg, niso opazili učinkov na reproduktivne organe, menstrualni cikel ali spermo.
INFORMATION IN BRAILLE
PODATKI V BRAILLOVI PISAVI Taltz
Patients receiving adalimumab or placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Bolniki, ki so prejemali adalimumab ali placebo, so bili znova randomizirani v razmerju 1 : 1 v skupini z zdravilom Taltz Q2W ali Q4W v 16. ali 24. tednu glede na svoj odziv na zdravljenje.
In all three studies, the co-primary endpoints were the proportion of patients who achieved a PASI 75 response (Psoriasis Area and Severity Index) and an sPGA of 0 (“clear”) or 1 (“minimal”) response at Week 12 versus placebo.
PASI 75 (Psoriasis Area and Severity Index - indeks jakosti psoriaze in telesne površine, prizadete s psoriazo) in odziv sPGA 0 ("čisto") ali 1 ("minimalno") v 12. tednu v primerjavi s placebom.
At Week 52, the mean change from baseline in mTSS was 0.27 for placebo/Taltz Q4W, 0.54 for Taltz Q4W/Taltz Q4W, and 0.32 for adalimumab/Taltz Q4W.
Q4W, 0,54 za Taltz Q4W/Taltz Q4W in 0,32 za adalimumab/Taltz Q4W.
Read the full Instructions for Use and the Patient Information Leaflet for Taltz inside this box to learn more about your medicine.
Preberite celotno Navodila za uporabo zdravila Taltz, ki je priloženo v tej škatli, da boste izvedeli več o vašem zdravilu.
ACR 20 response, n (%) Week 24
Odziv ACR 20, n (%) 24. teden
80 mg Q4W (induction) / Placebo (maintenance) (N = 191)
80 mg Q4W (indukcijsko zdravljenje) / placebo (vzdrževalno zdravljenje) (N=191)
Taltz is unlikely to influence your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Taltz najverjetneje nima vpliva na sposobnost upravljanja vozil in strojev.
Dispose of the pre-filled pen in a closable, puncture-resistant sharps container.
Zavrzite peresnik v zbiralnik za ostre predmete, ki je odporen proti vbodom s pokrovom in ga je mogoče zapreti.
80 mg Q2W (induction) / Placebo (maintenance) (N = 211)
80 mg Q2W (indukcijsko zdravljenje) / placebo (vzdrževalno zdravljenje) (N=211)
Patients receiving placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Bolniki, ki so prejemali placebo, so bili znova randomizirani v razmerju 1 : 1 v skupini z zdravilom Taltz Q2W ali Q4W v 16. ali 24. tednu glede na svoj odziv na zdravljenje.
Ask your doctor, nurse or pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Renal elimination of intact ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence clearance of ixekizumab.
Pričakujemo lahko, da je izločanje nespremenjenega iksekizumaba IgG MAb prek ledvic majhno in manj pomembno; protitelesa IgG
When you dispose of syringes and the sharps container:
Ko zavržete brizge v zbiralnik za ostre predmete:
However, approximately 1% of patients treated with Taltz had confirmed neutralising antibodies associated with low drug concentrations and reduced clinical response.
Kljub temu pa je imel približno 1 % bolnikov, zdravljenih z zdravilom Taltz, potrjena nevtralizirajoča protitelesa,
ACR 50 response, n (%) Week 24
Odziv ACR 50, n (%) 24. teden
do not use it. Use a new pre-filled pen for your injection.
Za injiciranje uporabite nov napolnjeni injekcijski peresnik.
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Če dojite ali načrtujete dojenje, se posvetujte z zdravnikom, preden boste uporabili to zdravilo.
Store in the original package in order to protect from light.
Shranjujte v originalni zunanji ovojnini, da bo zdravilo zaščiteno pred svetlobo.
Upper respiratory tract infectionb
Zelo pogosti okužbe zgornjih dihalnih potib
If you do not respond well enough to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease.
Če se na ta zdravila ne boste dovolj dobro odzvali, boste prejeli zdravilo
Taltz was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNFexposed and biologic/anti-TNF-failure patients.
Zdravilo Taltz je bilo učinkovito pri bolnikih, ki še niso bili zdravljeni s sistemsko terapijo ali biološkimi zdravili, niso bili izpostavljeni biološkim zdravilom/zaviralcem TNF oziroma pri bolnikih, pri katerih je bilo zdravljenje z biološkimi zdravili/zaviralci TNF neuspešno.
ACR 70 response, n (%) Week 24
Odziv ACR 70, n (%) 24. teden
80 mg Q2W (induction) / 80 mg Q4W (maintenance) (N = 221)
80 mg Q2W (indukcijsko zdravljenje) / 80 mg Q4W (vzdrževalno zdravljenje) (N=221)
A. It is okay to see a drop of liquid on the tip of the needle.
O: Kapljica tekočine na konici igle je povsem običajna.
A. It is normal to have air bubbles in the pre-filled pen.
O: Zračni mehurčki v napolnjenem injekcijskem peresniku so normalen pojav.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema Občasni nevtropenijag, trombocitopenijag
Efficacy and safety of Taltz was investigated in a multicenter, randomized, open-label, rater-blinded, parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
slepi za ocenjevalca, z vzporednima skupinama (SPIRIT-HSH), v kateri so zdravilo Taltz primerjali z adalimumabom (ADA) pri 566 bolnikih s PsA, ki se še niso zdravili z biološkimi imunomodulirajočimi protirevmatičnimi zdravili (bDMARD- biologic disease-modifying antirheumatic drugs).
Taltz 80 mg Q2W
zdravilo Taltz 80 mg Q2W
Push in the plunger.
Zavrzite peresnik.
Change in modified Total Sharp Score in SPIRIT-P1
Sprememba modificirane celotne Sharpove ocene v študiji SPIRIT-P1 Razlika v primerjavi s placebom (95-odstotni IZ)
Gently pinch and hold a fold of skin where you will inject.
Nežno primite kožno gubo na mestu injiciranja in jo držite.
Patients were randomised (1:1:1) to receive either placebo or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) for 12 weeks.
Bolniki so bili randomizirani (1:1:1) za prejemanje placeba ali zdravila Taltz (80 mg vsaka dva ali štiri tedne [Q2W ali Q4W] po 160
Itch NRS reduction
Znižanje ocene srbenja na lestvici NRS
Taltz was efficacious in biologic-naive, biologic-exposed and biologic-failure patients.
Zdravilo Taltz je bilo učinkovito pri bolnikih, ki predhodno niso bili zdravljeni z biološkim zdravilom, pri bolnikih, ki so bili izpostavljeni biološkemu zdravilu in pri bolnikih, pri katerih zdravljenje z biološkim zdravilom ni bilo uspešno.
Then gently let go of your skin.
Nežno izpustite kožno gubo.
Always use this medicine exactly as your doctor or nurse has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali medicinske sestre.
The efficacy and safety of Taltz were also evaluated versus etanercept (UNCOVER-2 and UNCOVER-3).
Učinkovitost in varnost zdravila Taltz so ovrednotili tudi v primerjavi z etanerceptom
53% of patients had concomitant use of MTX at a mean weekly dose of 15.8 mg. 67% of patients who had concomitant use of MTX had a dose of 15 mg or greater.
bolnikov, od katerih je 41 % sočasno uporabljalo MTX v povprečnem tedenskem odmerku 16,1 mg. 73,2 % bolnikov, ki so sočasno uporabljali MTX, je prejemalo odmerek 15 mg ali več.
(neutropenia).
(čisto)
• The pre-filled pen must not be shaken.
• Napolnjenega injekcijskega peresnika ne smete stresati.
The instructions for using the syringe, included with the package leaflet, must be followed carefully.
Skrbno upoštevajte navodila za uporabo brizge, ki so priložena navodilu za uporabo zdravila.
The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in either the plaque psoriasis or the psoriatic arthritis studies g Based on reported adverse events h Based on postmarketing reports i Adverse drug reactions in patients treated with ixekizumab in the plaque psoriasis and psoriatic arthritis clinical trials were similar with the exception of the frequencies of influenza (common) and conjunctivitis (common) in the psoriatic arthritis clinical trials
Povečana pogostnost reakcij na mestu injiciranja v kombiniranih skupinah Q2W in Q4W ni povzročila povečanega števila prekinitev zdravljenja v študijah psoriaze s plaki ali v študijah psoriatičnega artritisa.
Comprehensive instructions for administration are given in the package leaflet.
V navodilu za uporabo so podana obsežnejša navodila za dajanje zdravila.
The pre-filled syringe is for single use only.
Napolnjena injekcijska brizga je namenjena samo za enkratno uporabo.
Efficacy results at Week 12 in UNCOVER-3
Rezultati učinkovitosti v 12. tednu študije UNCOVER-3
Before using your pre-filled pen:
Pred uporabo napolnjenega injekcijskega peresnika:
EU/1/15/1085/001 1 pre-filled pen EU/1/15/1085/002 2 pre-filled pens EU/1/15/1085/003 3 pre-filled pens
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1085/001 1 napolnjeni injekcijski peresnik EU/1/15/1085/002 2 napolnjena injekcijska peresnika EU/1/15/1085/003 3 napolnjeni injekcijski peresniki
Very common
Pogosti navzea
Efficacy results at Week 12 in UNCOVER-1
Rezultati učinkovitosti v 12. tednu študije UNCOVER-1
EU/1/15/1085/004 1 pre-filled syringe EU/1/15/1085/005 2 pre-filled syringes EU/1/15/1085/006 3 pre-filled syringes
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1085/004 1 napolnjena injekcijska brizga EU/1/15/1085/005 2 napolnjeni injekcijski brizgi EU/1/15/1085/006 3 napolnjene injekcijske brizge
Read the “Instructions for Use” for the syringe carefully before using Taltz.
Pred uporabo zdravila Taltz natančno preberite „Navodila za uporabo“ brizge.
≥ 4d
NRS ≥ 4d
Nausea
Stegno
• DO NOT share or reuse your Taltz pre-filled syringe.
• Napolnjene injekcijske brizge Taltz NE delite z nikomer drugim in je ne uporabite znova.
Inspect the pre-filled pen.
Preglejte napolnjeni injekcijski peresnik.
Radiographic joint damage progression was inhibited by Taltz (Table 9) at Week 24, and the percentage of patients with no radiographic joint damage progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to Week 24 was 94.8% for Taltz Q2W(p<0.001),
Zdravilo Taltz je zavrlo rentgenografsko napredovanje poškodb sklepov (Preglednica 9) v 24. tednu in odstotek bolnikov brez rentgenografskega napredovanja poškodb sklepov (definiranih kot sprememba od izhodišča v mTSS ≤ 0,5) od randomizacije do 24. tedna je znašal 94,8 % za Taltz Q2W (p<0,001), 89,0 % za Taltz Q4W (p=0,026), 95,8 % za adalimumab (p<0,001), vsakokrat v primerjavi s 77,4 % za placebo.
Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c Patients with Itch NRS >= 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, Etanercept N = 312
a p < 0,001 v primerjavi s placebom b p < 0,001 v primerjavi z etanerceptom c Bolniki z oceno srbenja na lestvici NRS > = 4 v izhodišču: placebo N = 158, zdravilo Taltz 80 mg Q4W N = 313, zdravilo Taltz 80 mg Q2W N = 320, etanercept N = 312
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
• O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom,
Solution for injection in pre-filled pen.
FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b Patients with Itch NRS >= 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
a p < 0,001 v primerjavi s placebom b Bolniki z oceno srbenja na lestvici NRS >= 4 v izhodišču: placebo N = 374, zdravilo Taltz 80 mg Q4W N = 379, zdravilo Taltz 80 mg Q2W N = 391
Efficacy results at Week 12 in UNCOVER-2
Rezultati učinkovitosti v 12. tednu študije UNCOVER-2
Taltz is given by injection under your skin (subcutaneous injection).
Zdravilo Taltz dajemo s podkožno injekcijo (imenovano subkutana injekcija).
reduction ≥ 4b
NRS ≥ 4b
Taltz 80 mg Q2W (N = 351)
zdravilo Taltz 80 mg Q2W (N = 351)
Pack sizes of 1, 2, or 3 pre-filled syringes.
Pakiranja vsebujejo 1, 2 ali 3 napolnjene injekcijske brizge.
The pen must not be shaken.
Brizge ne smete stresati.
You should see the green plunger rod showing through the syringe body when the injection is complete.
Ko je injiciranje končano, mora biti zeleni potisni bat viden skozi ohišje brizge.
Sodium citrate Citric acid, anhydrous Sodium chloride Polysorbate 80
6.1 Seznam pomožnih snovi natrijev citrat brezvodna citronska kislina natrijev klorid polisorbat 80 voda za injekcije
The syringe is encased in a disposable, single-dose pen.
Brizga je vstavljena v enoodmerni peresnik za enkratno uporabo.
Taltz is injected under the skin (subcutaneous injection).
Zdravilo Taltz se injicira podkožno (subkutano injiciranje).
You must look out for signs of these conditions while you are using Taltz.
Med uporabo zdravila Taltz bodite pozorni na znake teh bolezni.
Patients were randomised (1:2:2:2) to receive either placebo, or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 12 weeks.
Bolniki so bili randomizirani (1:2:2:2) za prejemanje placeba ali zdravila Taltz (80 mg vsaka dva ali štiri tedne [Q2W ali Q4W] po 160
80 mg Q4W (induction) / 80 mg Q4W (maintenance)
80 mg Q4W (indukcijsko zdravljenje) / 80 mg Q4W (vzdrževalno zdravljenje) (N=195)
• Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step instructions.
• Preden uporabite napolnjeno injekcijsko brizgo zdravila Taltz, preberite in natančno upoštevajte podrobna navodila.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI NAPOLNJENE INJEKCIJSKE BRIZGE
The syringe is for ONE-TIME USE ONLY.
Brizga je namenjena SAMO ZA ENKRATNO UPORABO.
Back of arm
Blazinica za palec
- Keep this leaflet.
Zavrzite brizgo.
Taltz 80 mg Q4W (N = 386)
zdravilo Taltz 80 mg Q4W (N = 386)
Taltz 80 mg Q2W (N = 385)
zdravilo Taltz 80 mg Q2W (N = 385)
Instructions for use Taltz 80 mg solution for injection in pre-filled syringe
Navodila za uporabo Taltz 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi iksekizumab
Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Ena napolnjena injekcijska brizga vsebuje 80 mg iksekizumaba v 1 ml raztopine.
Commonly asked questions Q. What if I see air bubbles in the pre-filled pen?
V: Kaj moram narediti, če v napolnjenem injekcijskem peresniku opazim zračne mehurčke?
Before you use the TALTZ pre-filled syringe, read and carefully follow all the step-by-step instructions.
Preden uporabite napolnjeno injekcijsko brizgo zdravila TALTZ, preberite in natančno upoštevajte podrobna navodila.
Stop using Taltz and tell your doctor or seek medical help immediately if you get any of the following side effects.
Če opazite katerega koli od naslednjih neželenih učinkov, takoj prenehajte z uporabo zdravila Taltz in se posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč.
The instructions for using the pen, included with the leaflet, must be followed carefully.
Navodila za uporabo Skrbno upoštevajte navodila za uporabo peresnika, ki so priložena navodilu za uporabo zdravila.
Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Brizgo zavrzite v vsebnik za odlaganje igel oziroma po navodilih zdravnika, farmacevta ali medicinske sestre.
Taltz 80 mg solution for injection in pre-filled syringe ixekizumab
Taltz 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku iksekizumab
BSA≥10 and sPGA≥3).
Genitalno srbenje GPSS (izboljšanje za ≥ 3
Endpoints
točke)
Taltz contains the active substance ixekizumab.
Zdravilo Taltz vsebuje zdravilno učinkovino iksekizumab.
Taltz 80 mg Q2W (N = 433)
zdravilo Taltz 80 mg Q2W (N = 433)
Ixekizumab is a recombinant humanised monoclonal antibody produced in CHO cells.
Ena napolnjena injekcijska brizga vsebuje 80 mg iksekizumaba v 1 ml. Iksekizumab je rekombinantno humanizirano monoklonsko protitelo, izdelano v ovarijskih celicah kitajskega hrčka (Chinese Hamster Ovary - CHO).
Taltz 80 mg Q4W (N = 347)
zdravilo Taltz 80 mg Q4W (N = 347)
Taltz 80 mg solution for injection in pre-filled syringe.
Taltz 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi iksekizumab
Taltz 80 mg Q4W (N = 432)
zdravilo Taltz 80 mg Q4W (N = 432)
Expiration date
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
- bacterial skin infection.
danih s subkutanim injiciranjem.
Each pre-filled pen contains 80 mg ixekizumab in 1 ml.
En napolnjen injekcijski peresnik vsebuje 80 mg iksekizumaba v 1 ml raztopine.
• Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
• Peresnik zavrzite v zbiralnik za ostre predmete oziroma po navodilih zdravnika, farmacevta ali medicinske sestre.
• 1 cotton ball or piece of gauze
• 1 kroglico vate ali kos gaze
Elderly
Nadlaket
N with baseline GPSS Itch NRS Score ≥3 N=62 N=60 GPSS Genital Itch (≥3 point improvement) N with baseline SFQ Item 2 Score ≥2
N z izhodiščno oceno postavke 2 vprašalnika SFQ ≥ 2