natgillin/translations-raw huggingface dataset:
Patients originally randomised to Taltz and who were responders at Week 12 (i.e., sPGA score of 0,1) in UNCOVER-1 and UNCOVER-2 were re-randomised to an additional 48 weeks of one of the following treatment regimens: placebo, or Taltz (80 mg every four or twelve weeks [Q4W or Q12W]).
Bolesnici izvorno randomizirani za primanje lijeka Taltz koji su ostvarili odgovor u 12. tjednu (tj. sPGA rezultat od 0, 1) u ispitivanjima UNCOVER-1 i UNCOVER-2 bili su ponovno randomizirani za dodatnih 48 tjedana primjene jednoga od sljedećih režima: placeba ili lijeka Taltz (80 mg svaka
Respiratory, thoracic and mediastinal disorders
Laboratorijska ocjena neutropenije i trombocitopenije
• 1 sharps container for disposal of pre-filled pen
• 1 spremnik za oštre predmete za zbrinjavanje brizgalica
For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
Preporučeni režim doziranja za bolesnike s psorijatičnim artritisom koji istodobno imaju i umjerenu do tešku plak psorijazu jednak je onome za plak psorijazu.
Pack sizes of 1, 2, or 3 pre-filled syringes.
Veličine pakiranja: 1, 2 ili 3 napunjene brizgalice.
At Week 12, significantly more subjects in the TALTZ group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 independent of baseline BSA (baseline BSA 1% - <10% resp. ≥10%: sPGA of Genitalia ‘'0” or “1”: Taltz 71%, resp. 75%; placebo: 0%, resp. 13%).
U 12. je tjednu značajno više ispitanika u skupini koja je primala Taltz nego u skupini koja je primala placebo postiglo sPGA rezultat za genitalije 0/1 i sPGA rezultat 0/1, neovisno o zahvaćenoj površini tijela na početku ispitivanja (početna zahvaćena površina 1% - <10%, odgovor
Laboratory assessment of neutropenia and thrombocytopenia In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia.
U 9% bolesnika koji su primali Taltz u ispitivanjima plak psorijaze razvila se neutropenija.
Efficacy results at Week 12 in UNCOVER-1
Rezultati za djelotvornost u 12. tjednu ispitivanja UNCOVER-1
Efficacy results at Week 12 in UNCOVER-3
Rezultati za djelotvornost u 12. tjednu ispitivanja UNCOVER-3
ACR 50 and PASI 100 in patients with ≥3% BSA psoriasis skin involvement at baseline, n (%)
ACR 50 i PASI 100 u bolesnika kojima je na početku ispitivanja koža zahvaćena psorijazom iznosila
Injection site reactionsf a Placebo-controlled clinical studies (phase III) in moderate to severe plaque psoriasis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 12 weeks of treatment duration, or in active psoriatic arthritis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 24 weeks of treatment duration.
Placebom kontrolirana klinička ispitivanja (faze III) provedena u bolesnika s umjerenom do teškom plak psorijazom izloženih iksekizumabu u dozi od 80 mg svaka 2 tjedna, iksekizumabu u dozi od 80 mg svaka 4 tjedna ili placebu tijekom liječenja u trajanju do 12 tjedana, ili u bolesnika s aktivnim psorijatičnim artritisom izloženih iksekizumabu u dozi od 80 mg svaka 2 tjedna, iksekizumabu u dozi od 80 mg svaka 4 tjedna ili placebu tijekom liječenja u trajanju do 24 tjedna.
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, disease duration, baseline body weight, baseline psoriasis involvement, baseline CRP, baseline DAS28-CRP, concomitant corticosteroid use, and previous treatment with a biologic.
početnoj tjelesnoj težini, početnoj zahvaćenosti psorijazom, početnoj vrijednosti CRP-a, početnom DAS28-CRP rezultatu, istodobnoj primjeni kortikosteroida i prethodnom liječenju biološkim lijekom.
The pre-filled syringe is for single use only.
Napunjena brizgalica namijenjena je samo za jednokratnu uporabu.
• DO NOT share or reuse your Taltz pre-filled syringe.
• NEMOJTE dijeliti Taltz napunjenu štrcaljku s drugim osobama i nemojte je ponovno upotrijebiti.
You should see the green plunger rod showing through the syringe body when the injection is complete.
Kada injiciranje završi, trebali biste vidjeti zeleni potisnik klipa kroz tijelo štrcaljke.
Possible serious infection (may affect up to 1 in 100 people) - the signs may include: - fever, flu-like symptoms, night sweats - feeling tired or short of breath, cough which will not go away - warm, red and painful skin, or a painful skin rash with blisters
Moguća ozbiljna infekcija (može se javiti u do 1 na 100 osoba) - znakovi mogu uključivati: - vrućicu, simptome nalik gripi, noćno znojenje
SFQ-item 2 score, “0” (never limited) or
Rezultat za 2. pitanje SFQ upitnika, "0" (nikada nisu ograničili) ili "1" (rijetko su ograničili) a Kratice: NRI (engl.
Solution for injection in pre-filled pen.
OBLIK Otopina za injekciju u napunjenoj brizgalici.
Itch NRS reduction
Smanjenje NRS rezultata za svrbež od
• Read the Taltz Package Leaflet inside this box to learn more about your medicine.
• Za više informacija o lijeku pročitajte uputu o lijeku Taltz koja se nalazi u ovoj kutiji.
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),
Taltz je inhibirao radiološku progresiju oštećenja zglobova (Tablica 9.) u 24. tjednu, te je postotak bolesnika bez radiološke progresije oštećenja zglobova (koja se definirala kao promjena početnog mTSS rezultata za ≤ 0,5 bodova) od randomizacije do 24. tjedna iznosio je 94,8% uz Taltz svaka 2 tjedna (p<0.001), 89,0% uz Taltz svaka 4 tjedna (p=0,026), 95,8% uz adalimumab (p<0,001), sve u usporedbi sa 77,4% uz placebo.
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.
Očekuje se da će bubrežna eliminacija nepromijenjenog iksekizumaba, koji je IgG monoklonsko protutijelo, biti niska i od neznatne važnosti.
Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12,
Bolesnici su na početku ispitivanja bili stratificirani prema istodobnoj primjeni konvencionalnih DMARD-ova (cDMARD) i prisutnosti umjerene do teške psorijaze (PASI ≥ 12, zahvaćenost ≥ 10% površine tijela i sPGA ≥ 3).
• If you have questions or need help with your pre-filled pen, call your doctor, pharmacist or nurse.
• Ako imate pitanja ili trebate pomoć s napunjenom brizgalicom, obratite se svom liječniku,
The safety profile observed in patients with psoriatic arthritis treated with Taltz is consistent with the safety profile in plaque psoriasis with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Sigurnosni profil zabilježen u bolesnika s psorijatičnim artritisom liječenih lijekom Taltz u skladu je sa sigurnosnim profilom kod plak psorijaze, uz izuzetak učestalosti gripe i konjunktivitisa,
Taltz Q4W (N = 107)
Taltz svaka 4 tjedna (N = 107)
In patients with concomitant moderate to severe psoriasis and psoriatic arthritis, Taltz Q2W dose regimen showed significantly higher response rate for PASI75, PASI 90 and PASI 100 compared to placebo (p<0.001) and demonstrated clinically meaningful benefit over the Q4W dose regimen.
2 tjedna doveo je do značajno viših stopa odgovora PASI 75, PASI 90 i PASI 100 u usporedbi s placebom (p < 0,001) te je pokazao klinički značajnu korist u odnosu na režim primjene svaka
They will not harm you or affect your dose.
Neće Vam naškoditi niti utjecati na dozu.
The treatment responses on Taltz were significantly greater than those on placebo as early as week 1 for ACR 20, week 4 for ACR 50 and week 8 for ACR 70 and persisted through week 24.
4. tjednu prema ACR 50 te u 8. tjednu prema ACR 70, a održali su se do kraja 24. tjedna.
Baseline score, mean (SD) 17.6 (28.62) 19.2 (32.68) 15.2 (28.86) 15.9 (27.37)
Odgovor ACR 20, n (%) tjedan 32 (30,2) 62 (57,9) 64 (62,1) 58 (57,4)
Efficacy results at Week 12 in UNCOVER-2
Rezultati za djelotvornost u 12. tjednu ispitivanja UNCOVER-2
Significant improvements in itch severity were seen at Week 1 in patients treated with Taltz.
U bolesnika liječenih lijekom Taltz primijećena su značajna poboljšanja svrbeža u 1. tjednu.
• The pre-filled pen must not be shaken.
• Napunjena brizgalica ne smije se tresti.
What Taltz looks like and contents of the pack
Kako Taltz izgleda i sadržaj pakiranja Taltz je otopina u prozirnoj staklenoj štrcaljki.
Taltz Q2W (N = 103)
Taltz svaka 2 tjedna (N = 103)
Some side effects are common (may affect up to 1 in 10 people): - nausea (feeling sick).
Neke nuspojave su česte (mogu se javiti u do 1 na 10 osoba):
- Cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)
- gljivične infekcije (tinea) poput atletskog stopala - bol u stražnjem dijelu grla - herpes usta, na koži i na sluzinci (herpes simpleks, mukokutani)
The pen must not be shaken.
Štrcaljka se ne smije tresti.
Taltz 80 mg Q4W
Taltz 80 mg svaka 4 tjedna
INFORMATION IN BRAILLE
16. PODACI NA BRAILLEOVOM PISMU Taltz
Read the full Patient Information Leaflet for Taltz inside this box to learn more about your medicine.
Za više informacija o ovom lijeku, pročitajte cjelovitu uputu o lijeku Taltz koja se nalazi u ovoj kutiji.
Immune system disorders
Poremećaji dišnog sustava,
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
Kratice: N = broj bolesnika u populaciji koju se namjeravalo liječiti (engl. intent-to-treat, ITT) Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom b Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 374, Taltz 80 mg svaka 4 tjedna N = 379, Taltz 80 mg svaka 2 tjedna N = 391
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.
Psoriatic Arthritis Response Criteria, PsARC) bio je veći među bolesnicima liječenima lijekom Taltz nego među onima koji su primali placebo.
How to store Taltz
Moguće nuspojave Kako čuvati Taltz
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.
Psoriasis Area and Severity Index; indeks proširenosti i težine psorijaze) i odgovor sPGA 0 („čisto“) ili 1 („minimalno“) u odnosu na 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
Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom b p < 0,001 u usporedbi s etanerceptom c Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 158, Taltz 80 mg svaka 4 tjedna N = 313, Taltz 80 mg svaka 2 tjedna N = 320, etanercept N = 312
Sodium citrate Citric acid, anhydrous Sodium chloride Polysorbate 80
6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina, bezvodna natrijev klorid polisorbat 80 voda za injekcije
Patients receiving placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Bolesnici koji su primali placebo bili su ponovno randomizirani u omjeru 1:1 za primanje lijeka Taltz svaka 2 tjedna ili svaka 4 tjedna u 16. ili 24. tjednu, ovisno o statusu postignutog odgovora.
When you dispose of the pre-filled pen and the sharps container:
Pri zbrinjavanju brizgalice i spremnika za oštre predmete:
Taltz 80 mg Q2W (N = 351)
Taltz 80 mg svaka 2 tjedna (N = 351)
Thrombocytopenia may persist, fluctuate or be transient.
Trombocitopenija može biti trajna,
CLINICAL PARTICULARS 4.1 Therapeutic indications
4.1 Terapijske indikacije Plak psorijaza
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections
- infekcije gornjih dišnih putova praćene simptomima poput grlobolje i začepljena nosa
Taltz was efficacious in biologic-naive, biologic-exposed and biologic-failure patients.
Taltz je bio djelotvoran u bolesnika prethodno neliječenih biološkim lijekovima, onih prethodno izloženih biološkim lijekovima i onih koji nisu odgovorili na prethodno liječenje biološkim lijekovima.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava manje često neutropenijag, trombocitopenijag
(nasopharyngitis).
(supkutana injekcija).
Commonly asked questions Q. What if I see air bubbles in my syringe?
Što ako vidim mjehuriće zraka u štrcaljki?
Tinea infection, Herpes simplex (mucocutaneous)c
herpes simpleks, genitalni herpes, herpesvirusni dermatitis i genitalni herpes simpleks.
Remove the pre-filled pen from your skin.
Dignite brizgalicu s kože.
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
Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom b p < 0,001 u usporedbi s etanerceptom c p < 0,01 u usporedbi s placebom d Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 135, Taltz 80 mg svaka 4 tjedna N = 293, Taltz 80 mg svaka 2 tjedna N = 303, etanercept N = 306
Instructions for use Taltz 80 mg solution for injection in pre-filled syringe
Upute za uporabu Taltz 80 mg otopina za injekciju u napunjenoj štrcaljki iksekizumab
“1” (rarely limited) a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no effect at all on patient's life.
Questionnaire) = Upitnik o učestalosti spolne aktivnosti; b Ukupan DLQI rezultat 0,1 znači da stanje kože nema nikakvog utjecaja na bolesnikov život. sPGA rezultat “0” ili “1” znači “čisto” ili
Grey syringe plunger
Sivi klip štrcaljke
Taltz 80 mg Q4W (N = 386)
Taltz 80 mg svaka 4 tjedna (N = 386)
Commonly asked questions Q. What if I see air bubbles in the pre-filled pen?
Što ako vidim mjehuriće zraka u napunjenoj brizgalici?
Keep this medicine out of the sight and reach of children.
Kako čuvati Taltz Lijek čuvajte izvan pogleda i dohvata djece.
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a biologic.
Djelotvornost i sigurnost lijeka Taltz dokazana je neovisno o dobi, spolu, rasi, tjelesnoj težini,
Taltz 80 mg Q2W (N = 385)
Taltz 80 mg svaka 2 tjedna (N = 385)
NA
O.
Taltz 80 mg solution for injection in pre-filled syringe ixekizumab
Taltz 80 mg otopina za injekciju u napunjenoj brizgalici iksekizumab
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.
za primanje placeba ili lijeka Taltz (80 mg svaka dva ili četiri tjedna nakon početne doze od 160 mg)
• Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Brizgalicu zbrinite u spremnik za oštre predmete ili sukladno uputama svog liječnika, ljekarnika ili medicinske sestre.
You may inject in your abdomen (stomach area), in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you.
Lijek možete injicirati u trbuh, bedro ili stražnji dio nadlaktice.
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
iNuspojave zabilježene u bolesnika liječenih iksekizumabom u kliničkim ispitivanjima primjene kod plak psorijaze i psorijatičnog artritisa bile su slične, uz izuzetak učestalosti gripe (često) i konjunktivitisa (često) u kliničkim ispitivanjima kod psorijatičnog artritisa.
Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years of age or older and 36 patients were 75 years of age or older.
301 bolesnik imao 65 ili više godina, dok je 36 bolesnika imalo 75 ili više godina.
Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders.
Kratice: N = broj bolesnika u populaciji uključenoj u analizu
Taltz 80 mg Q4W (N = 347)
Taltz 80 mg svaka 4 tjedna (N = 347)
Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Jedna napunjena brizgalica sadrži 80 mg iksekizumaba u 1 ml otopine.
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
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1085/004 1 napunjena štrcaljka
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
EU/1/15/1085/002 2 napunjene brizgalice
Water for injections
Gumb za injiciranje
Taltz 80 mg Q4W (N = 432)
Taltz 80 mg svaka 4 tjedna (N = 432)
Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution.
Jedna napunjena štrcaljka sadrži 80 mg iksekizumaba u 1 ml otopine.
Influenzai, Rhinitis, Oral candidiasisd, Conjunctivitisi, Cellulitise
Infekcije i infestacije vrlo često infekcija gornjih dišnih putovab često tinea, herpes simpleks (mukokutani)c manje često gripai, rinitis, oralna kandidijazad, konjunktivitisi, celulitise
After switching from the 80 mg Q2W dosing regimen to the 80 mg Q4W dosing regimen at Week 12, steady state would be achieved after approximately 10 weeks.
Nakon prelaska s režima doziranja 80 mg svaka 2 tjedna na režim doziranja 80 mg svaka 4 tjedna u
Patients on Taltz Q2W or Q4W remained on their originally assigned dose of Taltz.
Bolesnici koji su primali Taltz svaka 2 tjedna ili svaka 4 tjedna nastavili su primati dozu lijeka Taltz za koju su prvotno bili randomizirani.
Serious allergic reaction (may affect up to 1 in 1,000 people) - the signs may include: - difficulty breathing or swallowing - low blood pressure, which can cause dizziness or light-headedness - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps
Ozbiljna alergijska reakcija (može se javiti u do 1 na 1000 osoba) - znakovi mogu uključivati: - otežano disanje ili gutanje
Before you use the TALTZ pre-filled syringe, read and carefully follow all the step-by-step instructions.
Prije nego što upotrijebite TALTZ napunjenu štrcaljku, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
Taltz 80 mg Q2W (N = 433)
Taltz 80 mg svaka 2 tjedna (N = 433)
Taltz 80 mg solution for injection in pre-filled syringe.
NAZIV LIJEKA Taltz 80 mg otopina za injekciju u napunjenoj štrcaljki.
Concomitant cDMARDs included MTX, leflunomide and sulfasalazine.
Celulitis uključuje stafilokokni celulitis i celulitis vanjskog uha te erizipel.
What is in this leaflet
U svim je ispitivanjima
a p<0.05; b p<0.01; c p<0.001 compared with placebo.
*p < 0,01 u odnosu na ADA; †p < 0,05 u odnosu na ADA.
Before you use the Taltz pre-filled pen, read and carefully follow all the step-by-step instructions.
Prije nego što upotrijebite Taltz napunjenu brizgalicu, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
Package leaflet: Information for the patient Taltz 80 mg solution for injection in pre-filled syringe ixekizumab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Taltz 80 mg otopina za injekciju u napunjenoj štrcaljki iksekizumab
Instructions for use Taltz 80 mg solution for injection in pre-filled pen
Upute za uporabu Taltz 80 mg otopina za injekciju u napunjenoj brizgalici iksekizumab
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
Broj bolesnika s početnim GPSS NRS rezultatom za svrbež ≥3
• Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step instructions.
• Prije nego što upotrijebite Taltz napunjenu štrcaljku, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
Subjects randomized to TALTZ received an initial dose of 160 mg followed by 80 mg every 2 weeks for 12 weeks.
Ispitanici randomizirani za liječenje lijekom Taltz primili su početnu dozu od 160 mg, a zatim dozu od
1 ml solution in a type I clear glass syringe.
6.5 Vrsta i sadržaj spremnika 1 ml otopine u prozirnoj staklenoj štrcaljki (staklo tipa I).
ACR 70 response, n (%) Week 24
PASI 90, n (%)
Package leaflet: Information for the patient Taltz 80 mg solution for injection in pre-filled pen ixekizumab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Taltz 80 mg otopina za injekciju u napunjenoj brizgalici iksekizumab
• Before you use the Taltz pre-filled pen, read and carefully follow all the step-by-step instructions.
• Prije nego što upotrijebite Taltz napunjenu brizgalicu, pročitajte i pažljivo slijedite sve upute za uporabu korak-po-korak.
Upper respiratory tract infectionb
Infekcija gornjih dišnih putova uključuje nazofaringitis i infekciju gornjih dišnih putova.
Some side effects are uncommon (may affect up to 1 in 100 people): - oral thrush (oral candidiasis).
Neke nuspojave su manje česte (mogu se javiti u do 1 na 100 osoba):
IXE Q2 (N=103)
IKS svaka 2 tj. (N=103)
Taltz Q2W (N = 123)
PASI 100: Taltz (N=283)
80 mg Q4W (induction) / 80 mg Q4W (maintenance)
80 mg svaka 4 tjedna (terapija održavanja) (N
Taltz is injected under the skin (subcutaneous injection).
Taltz se injicira pod kožu
- The active substance is ixekizumab.
Što Taltz sadrži - Djelatna tvar je iksekizumab.
This process is called remodelling.
Taj se proces zove preoblikovanje.
This will help to prevent dehydration.
To će pomoći u sprečavanju dehidracije.
Aclasta with food and drink
Aclasta s hranom i pićem
Currently available data for children aged 5 to 17 years are described in section 5.1.
Trenutno dostupni podaci za djecu u dobi od 5 do 17 godina opisani su u dijelu 5.1.
The educational programme contains the following:
Program izobrazbe sadrži sljedeće:
Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.
Aclasta može djelovati duže od jedne godine, a liječnik će Vam reći ako se trebate ponovo liječiti.
The duration of the trial was one year.
Ispitivanje je trajalo jednu godinu.
Your doctor will let you know when to return for your next dose.
Liječnik će Vam objasniti kada ćete se vratiti po sljedeću dozu.
You must not be given Aclasta if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Ne smijete primati Aclastu ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
The clinical relevance of these findings is unknown.
Kliniči značaj tih nalaza nije poznat.
What Aclasta is and what it is used for
Što je Aclasta i za što se koristi
Other medicines and Aclasta
Drugi lijekovi i Aclasta
All clinical fractures were verified based on the radiographic and/or clinical evidence.
Svi klinički prijelomi su bili potvrđeni na temelju radiološkog i/ili kliničkog dokaza.