FrancophonIA/ELRC3.0 huggingface dataset:
English: A significantly greater proportion of patients treated with TALTZ achieved a reduction in the PROs of severity of genital pain, genital itch, impact of genital psoriasis on sexual activity, and Dermatology Quality of Life Index (DLQI).
Slovenian: Bistveno večji delež bolnikov, zdravljenih z zdravilom TALTZ, je dosegel zmanjšanje izraženosti PRO za genitalno bolečino, genitalno srbečico, vpliv genitalne psoriaze na spolno dejavnost in dermatološki indeks kakovosti življenja (Dermatology Quality of Life Index - DLQI).
English: Taltz should not be resumed until the infection resolves.
Slovenian: Zdravila Taltz ne smete znova predpisati, dokler okužba ne mine.
English: Of these, 4,500 patients were exposed to Taltz for at least one year, cumulatively representing 13,645.6 patient years of exposure.
Slovenian: Od teh bolnikov je bilo 4500 bolnikov izpostavljenih zdravilu Taltz vsaj eno leto, kar skupaj predstavlja 13645,6 bolnik-let izpostavljenosti.
English: Using Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to do normal daily activities), and slowing down the damage to the joints.
Slovenian: Uporaba zdravila Taltz vam bo pomagala omejiti znake in simptome bolezni, izboljšati telesno zmogljivost (sposobnost opravljanja običajnih vsakodnevnih dejavnosti) ter upočasniti nastajanje poškodb v sklepih.
English: Note: patients who were rescued at week 16 or discontinued or with missing data were imputed as non-responders for week 24 analyses.
Slovenian: Opomba: bolniki, ki so prejeli rešilno zdravljenje v 16. tednu ali pa so prenehali jemati zdravilo oz. so njihovi podatki manjkali, so bili za analize v 24. tednu upoštevani kot neodzivni na zdravljenje.
English: Serious infections occurred in 13 (0.6 %) of patients treated with Taltz and in 3 (0.4 %) of patients treated with placebo (see section 4.4).
Slovenian: Do resnih okužb je prišlo pri 13 (0,6 %) bolnikih, zdravljenih z zdravilom Taltz, in pri 3 (0,4 %) bolnikih, zdravljenih s placebom (glejte poglavje 4.4).
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Taltz and for at least 10 weeks after the last Taltz dose.
Slovenian: Če ste ženska v rodni dobi, morate paziti, da se zaščitite pred zanositvijo in uporabljate ustrezno kontracepcijo v času, ko uporabljate zdravilo Taltz in še najmanj 10 tednov po zadnjem odmerku zdravila Taltz.
English: The second loud click tells you that your injection is complete.
Slovenian: Drugi glasni klik vam pove, da je injiciranje zaključeno.
English: In the population PK analysis, mean serum clearance was 0.0161 L/hr.
Slovenian: V analizi populacijske farmakokinetike je bil povprečni serumski očistek 0,0161 l/uro.
English: to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: 1/1.000), zelo redki (< 1/10.000).
English: 1b Gather the supplies for your injection:
Slovenian: 1b Pripravite vse, kar boste potrebovali za injiciranje:
English: Make sure to keep the needle in place.
Slovenian: Prepričajte se, da bo igla ostala pri miru.
English: If you see any of the following, DO NOT USE the syringe, and dispose of it as directed:
Slovenian: Če opazite kar koli od naslednjega, NE UPORABLJAJTE brizge, temveč jo zavrzite po navodilih:
English: Taltz-treated patients reported improvements in health-related quality of life as measured by the Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p<0.001).
Slovenian: Bolniki, zdravljeni z zdravilom Taltz, so poročali o izboljšanju kakovosti življenja, povezane z zdravjem, kot so ocenili z vprašalnikom za oceno zdravja SF-36 PCS (Physical Component Summary of the Short Form-36 Health Survey) (p<0,001).
English: decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Treba se je odločiti, ali naj mati med zdravljenjem preneha dojiti ali prekine zdravljenje z zdravilom Taltz, ob upoštevanju koristi dojenja za otroka in koristi zdravljenja za mater.
English: • If you have vision problems, DO NOT use the pre-filled syringe without help from a person trained to use it.
Slovenian: • Če imate težave z vidom, NE uporabljajte napolnjenega injekcijskega peresnika brez pomoči osebe, ki je usposobljena za njegovo uporabo.
English: Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Slovenian: Iksekizumab sodi v skupino zdravil, imenovanih zaviralci interlevkina (IL).
English: Taltz can be left out of the fridge for up to 5 days at a temperature not above 30 ºC.
Slovenian: Zdravilo Taltz lahko pustite zunaj hladilnika največ 5 dni, pri temperaturi, ki ne presega 30 ºC.
English: Over the entire treatment period infections were reported in 52.8 % of patients treated with Taltz (46.9 per 100 patient years).
Slovenian: V celotnem obdobju zdravljenja so o okužbah poročali pri 52,8 % bolnikov, zdravljenih z zdravilom Taltz (46,9 na 100 bolnik-let).
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment.
Slovenian: Pri bolnikih, ki se po 16 do 20 tednih niso odzvali na zdravljenje, je treba razmisliti o prekinitvi zdravljenja.
English: Number of patients (N) randomized
Slovenian: Število randomiziranih bolnikov (N)
English: Contents of the pack and other information What Taltz contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Taltz
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov na plodnost (glejte poglavje 5.3).
English: The second click tells you that your injection is complete.
Slovenian: Drugi klik vam pove, da je injiciranje zaključeno.
English: Cytochrome P450 Substrates
Slovenian: Substrati citokroma P450
English: You may give or get an infection
Slovenian: S tem bi lahko prenesli okužbo ali pa bi dobili okužbo.
English: You will hear a second loud click in about 5 to 10 seconds after the first one.
Slovenian: Približno 5 do 10 sekund po prvem kliku boste slišali drugi glasni klik.
English: You should not stop using Taltz without speaking to your doctor first.
Slovenian: Zdravila Taltz ne smete prenehati uporabljati, ne da bi se pred tem pogovorili z zdravnikom.
English: Table 7 Efficacy Results at Week 12 in Adults with Genital Psoriasis in Trial IXORA-Q; NRI a Endpoints
Slovenian: Rezultati učinkovitosti v 12. tednu pri odraslih bolnikih z genitalno psoriazo v preskušanju IXORA-Q; NRI a
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostosti so neželeni učinki zdravila navedeni po padajoči resnosti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Taltz in one or more subsets of the paediatric population in the treatment of plaque psoriasis and psoriatic arthritis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odstopila od zahteve za predložitev rezultatov študij z zdravilom Taltz za eno ali več podskupin pediatrične populacije za zdravljenje psoriaze s plaki in psoriatičnega artritisa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8).
Slovenian: Zdravljenje z zdravilom Taltz je povezano s povečano stopnjo okužb, kot so okužbe zgornjih dihalnih poti, oralna kandidaza, konjunktivitis in glivične okužbe kože (glejte poglavje 4.8).
English: For example, if your last injection was in your left thigh, your next injection should be in your right thigh, your abdomen, or the back of either arm.
Slovenian: Na primer: če ste si nazadnje injicirali zdravilo v levo stegno, si morate naslednjo injekcijo dati v desno stegno, trebuh ali nadlaket (hrbtno stran roke).
English: This medicine works by neutralising the activity of a protein called IL-17A, which promotes psoriasis and psoriatic arthritis.
Slovenian: To zdravilo deluje tako, da nevtralizira aktivnost beljakovine, imenovane IL-17A, ki pripomore k nastanku psoriaze in psoriatičnega artritisa.
English: Approximately 25 % of patients treated with Taltz achieved a PASI score < 5 by Week 2, more than 55 % achieved the PASI score < 5 by Week 4, and increased to 85 % by Week 12 (compared to 3 %, 14 % and 50 % for etanercept).
Slovenian: Približno 25 % bolnikov, zdravljenih z zdravilom Taltz, je doseglo oceno PASI < 5 do 2. tedna, več kot 55 % je doseglo oceno PASI < 5 do 4. tedna, ta delež pa se je povečal na 85 % do 12. tedna (v primerjavi s 3 %, 14 % in 50 % za etanercept).
English: Based on population pharmacokinetic analysis with a limited number of elderly patients (n = 94 for age ≥ 65 years and n = 12 for age ≥ 75 years), clearance in elderly patients and patients less than 65 years of age was similar.
Slovenian: Glede na analizo populacijske farmakokinetike z omejenim številom starejših bolnikov (n = 94 za starost ≥ 65 let in n = 12 za starost ≥ 75 let), je bil očistek pri starejših bolnikih in pri bolnikih, mlajših od 65 let, podoben.
English: Elevated concentrations of IL-17A have been implicated in the pathogenesis of psoriasis by promoting keratinocyte proliferation and activation, as well as in the pathogenesis of psoriatic arthritis.
Slovenian: Povečane koncentracije IL-17A so bile vpletene v patogenezo psoriaze prek spodbujanja proliferacije in aktivacije keratinocitov ter v patogenezo psoriatičnega artritisa.
English: In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz.
Slovenian: V obeh kliničnih študijah, ki sta vključevali aktivno primerjalno zdravilo (UNCOVER-2 in UNCOVER-3), je stopnja resnih neželenih dogodkov znašala 1,9 % tako za etanercept kot za zdravilo Taltz, stopnja prekinitve zdravljenja zaradi neželenih dogodkov pa je bila 1,2 % za etanercept in 2,0 % za zdravilo Taltz.
English: Slowly push the plunger all the way in until all the medicine is injected.
Slovenian: Počasi potiskajte bat do konca, dokler ne injicirate vsega zdravila.
English: Taltz reduces the signs and symptoms of the disease.
Slovenian: Zdravilo Taltz zmanjšuje znake in simptome bolezni.
English: Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (< 3 pM) and specificity to interleukin 17A (both IL-17A and IL-17A/F).
Slovenian: Iksekizumab je monoklonsko protitelo IgG4, ki se z visoko afiniteto (< 3 pM) in specifično veže na interlevkin 17A (IL-17A in IL-17A/F).
English: Ixekizumab is a monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous immunoglobulins.
Slovenian: Biotransformacija Iksekizumab je monoklonsko protitelo, zato predvidevamo, da se razgradi v manjše peptide in aminokisline prek katabolnih poti, na enak način kot endogeni imunoglobulini.
English: A significantly greater proportion of patients treated with Taltz achieved a DLQI 0 or 1.
Slovenian: Bistveno večji delež bolnikov, zdravljenih z zdravilom Taltz, je dosegel oceno DLQI 0 ali 1.
English: Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.
Slovenian: Izdelovalec Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italija.
English: Based on psoriatic skin biopsy data from a phase I study, there was a dose-related trend towards decreased epidermal thickness, number of proliferating keratinocytes, T cells, and dendritic cells, as well as reductions in local inflammatory markers from baseline to day 43.
Slovenian: Na podlagi podatkov biopsije psoriatične kože iz študije 1. faze je obstajal z odmerkom povezan trend k zmanjšanju debeline epidermija, števila proliferirajočih keratinocitov, celic T in dendritičnih celic, pa tudi k zmanjšanju označevalcev lokalnih vnetij od izhodišča do 43. dneva.
English: PASI score, percent improvement at each post baseline visit (mBOCF)) in the Intentto-Treat Population during the Induction Dosing Period - UNCOVER-2 and UNCOVER-3
Slovenian: Ocena PASI, odstotkovno izboljšanje ob vsakem obisku po izhodišču (mBOCF) v populaciji, namenjeni za zdravljenje, v obdobju indukcijskega odmerjanja - UNCOVER-2 in UNICOVER-3
English: If you have forgotten to inject a dose of Taltz, talk to your doctor.
Slovenian: Če ste si pozabili injicirati odmerek zdravila Taltz, se posvetujte z zdravnikom.
English: In addition, the corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000
Slovenian: Pri tem ustrezna kategorija pogostnosti posameznega neželenega učinka temelji na naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do <
English: • Do not recycle the filled sharps container.
Slovenian: • Polnega zbiralnika za ostre predmete ne reciklirajte.
English: The rate of infections was 21.5 % for etanercept and 26.0 % for Taltz, with the majority of the events mild to moderate in severity.
Slovenian: Stopnja okužb je bila 21,5 % za etanercept in 26,0 % za zdravilo Taltz, pri čemer je bila večina neželenih dogodkov blage do zmerne jakosti.
English: In general, neutropenia did not require discontinuation of Taltz.
Slovenian: Na splošno zaradi nevtropenije ni bilo potrebno prekiniti zdravljenja z zdravilom Taltz.
English: What you need to know before you use Taltz Do not use Taltz
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Taltz Ne uporabljajte zdravila Taltz
English: The mean elimination half-life, as estimated from population pharmacokinetic analysis, is 13 days in patients with plaque psoriasis.
Slovenian: Povprečna razpolovna doba izločanja, kot jo lahko ocenimo iz analize populacijske farmakokinetike, je pri bolnikih s psoriazo s plaki 13 dni.
English: Taltz should not be used with live vaccines.
Slovenian: Zdravila Taltz se ne sme uporabljati skupaj z živimi cepivi.
English: If seal is broken, do not use.
Slovenian: Če vam pade na trdo podlago, ga ne uporabljajte.
English: What Taltz is and what it is used for
Slovenian: Kaj je zdravilo Taltz in za kaj ga uporabljamo
English: The solution is clear and colourless to slightly yellow.
Slovenian: Raztopina je bistra in brezbarvna do rahlo rumenkasta.
English: In vitro binding assays confirmed that ixekizumab does not bind to human Fcγ receptors I, IIa, and IIIa or to complement component C1q.
Slovenian: Preskusi vezave in vitro so potrdili, da se iksekizumab ne veže na človeške receptorje Fcγ I, IIa in IIIa ali na komponento komplementa C1q.
English: - After the first dose, you will use an 80 mg dose (one injection) at Weeks 2, 4, 6, 8, 10, and 12.
Slovenian: - Po prvem odmerku boste uporabili odmerek 80 mg (ena injekcija) v 2., 4., 6., 8., 10. in 12. tednu.
English: Did I get my complete injection?
Slovenian: Ali sem prejel/-a celoten odmerek tega injiciranja?
English: Following a single subcutaneous dose of ixekizumab in patients with psoriasis, mean peak concentrations were achieved within 4 to 7 days, across a dose range of 5 to 160 mg.
Slovenian: Po enkratnem subkutanem odmerku iksekizumaba so bile pri bolnikih s psoriazo povprečne največje koncentracije dosežene v 4 do 7 dneh, pri razponu odmerkov od 5 do 160 mg.
English: 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.
Slovenian: Po prehodu z režima odmerjanja 80 mg Q2W na režim odmerjanja 80 mg Q4W v 12. tednu, bi bilo stanje dinamičnega ravnovesja doseženo po približno 10 tednih.
English: Q. How can I tell if my injection is complete?
Slovenian: V: Kako vem, da je injiciranje končano?
English: ACR 50 and PASI 100 in patients with ≥3% BSA psoriasis skin involvement at baseline, n (%)
Slovenian: Odziva ACR 50 in PASI 100 pri bolnikih s psoriazo s prizadetostjo kože ≥ 3 % BSA v izhodišču, n (%)
English: The percentage of patients achieving PASI 75 was significantly greater for Taltz compared with placebo and etanercept as early as Week 1.
Slovenian: Delež bolnikov, ki so dosegli PASI 75, je bil pomembno večji pri zdravilu Taltz v primerjavi s placebom in etanerceptom že v 1. tednu.
English: The bioavailability of Taltz in psoriatic arthritis patients was in the range of 61-84% on the basis of the population pharmacokinetic model.
Slovenian: Biološka uporabnost zdravila Taltz je na podlagi modela populacijske farmakokinetike pri bolnikih s psoriatičnim artritisom znašala 61-84 %.
English: UNCOVER-3 enrolled 1,346 patients.
Slovenian: Študija UNCOVER-3 je vključevala 1346 bolnikov.
English: Of all patients, 14.9 % had received at least one anti-TNF alpha agent, and 8.7 % had received an anti-IL-12/IL-23.
Slovenian: Od vseh bolnikov jih je 14,9 % prejelo najmanj en zaviralec TNFα (zaviralec tumorske nekroze α), 8,7 % pa jih je prejelo zaviralec interlevkinov IL-12/IL-23.
English: ACR 20 response in SPIRIT-P1 over time up to Week 24
Slovenian: Odziv ACR 20 v študiji SPIRIT-P1 v obdobju do 24. tedna
English: Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have been reported without any serious adverse events.
Slovenian: Poročali so o primerih prevelikega odmerjanja do 240 mg, subkutano, ob enkratnem dajanju v kliničnih študijah, ki pa niso imeli nobenih resnih neželenih dogodkov.
English: If you have received more Taltz than you should or the dose has been given sooner than prescribed, inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Taltz, kot bi smeli Če ste prejeli večji odmerek zdravila Taltz, kot bi smeli, ali če ste prejeli odmerek prej, kot je bilo predpisano, obvestite zdravnika.
English: Neutralisation of IL-17A by ixekizumab inhibits these actions.
Slovenian: Nevtralizacija IL-17A , ki jo povzroči iksekizumab, zavira te učinke.
English: A weekly subcutaneous dose of 50 mg/kg to monkeys is approximately 19 times the 160 mg starting dose of Taltz and in monkeys results in exposure (AUC) that is at least 61-fold higher than the predicted mean steady-state exposure in humans administered the recommended dose regimen.
Slovenian: Tedenski subkutani odmerek 50 mg/kg, ki so ga dali opicam, je približno 19-kratnik 160-miligramskega začetnega odmerka zdravila Taltz in pri opicah povzroči izpostavljenost (AUC), ki je najmanj 61-krat večja od predvidene povprečne izpostavljenosti v stanju dinamičnega ravnovesja pri človeku, ki prejema priporočeni režim odmerjanja.
English: Keep the Instructions for Use and refer to them as needed.
Slovenian: Navodila za uporabo shranite in jih po potrebi znova preberite.
English: Superiority of ixekizumab versus ustekinumab was also demonstrated in the subgroups stratified by weight.
Slovenian: Večja učinkovitost iksekizumaba v primerjavi z ustekinumabom je bila dokazana tudi v podskupinah, stratificiranih glede na telesno maso.
English: Efficacy results in SPIRIT-P1 and SPIRIT-P2 at week 24
Slovenian: Rezultati učinkovitosti v študijah SPIRIT-P1 in SPIRIT-P2 v 24. tednu SPIRIT-P1
English: Minimal Disease Activity (MDA) n (%) Week 24
Slovenian: Minimalna aktivnost bolezni (MDA), n (%) 24. teden
English: Efficacy and safety of ixekizumab was also investigated in a double-blind study compared to ustekinumab with ixekizumab being superior on the primary study objective (PASI 90 response at week 12, Table 6).
Slovenian: Učinkovitost in varnost iksekizumaba so preučevali tudi v dvojno slepi študiji, kjer so ga primerjali z ustekinumabom in kjer se je iksekizumab izkazal za učinkovitejšega za primarni opazovani dogodek študije (odziv PASI 90 v 12. tednu, preglednica 6).
English: These improvements in nail, scalp and palmoplantar psoriasis were maintained at Week 60 in patients treated with Taltz who were sPGA (0,1) responders at Week 12.
Slovenian: Ta izboljšanja psoriaze nohtov, lasišča in palmoplantarne psoriaze so se ohranila v 60. tednu pri bolnikih, zdravljenih z zdravilom Taltz, ki so se v 12. tednu odzvali z oceno sPGA (0,1).
English: Change from baseline at Week 24, LSM (SE)
Slovenian: Sprememba od izhodišča v 24 tednu, LSM (SE)
English: Of the 3,866 patients enrolled in these placebo-controlled studies, 64 % had received prior systemic therapy (biologic, conventional systemic or psoralen and ultraviolet A (PUVA)), 43.5 % had received prior phototherapy, 49.3 % had received prior conventional systemic therapy, and 26.4 % had received prior biologic therapy for the treatment of psoriasis.
Slovenian: Od 3866 bolnikov, vključenih v te s placebom nadzorovane študije, jih je 64 % prejelo predhodno sistemsko terapijo (biološko, konvencionalno sistemsko terapijo ali psoralen in obsevanje z ultravijolično svetlobo A (PUVA)), 43,5 % jih je prejelo predhodno fototerapijo, 49,3 % jih je prejelo predhodno konvencionalno sistemsko terapijo, 26,4 % pa jih je prejelo predhodno biološko terapijo za zdravljenje psoriaze.
English: In SPIRIT-P1 and SPIRIT-P2, similar responses for ACR 20/50/70 were seen in patients with psoriatic arthritis regardless of whether they were on concomitant cDMARDs, including MTX treatment, or not.
Slovenian: V študijah SPIRIT-P1 in SPIRIT-P2 so opazili podobne odzive za ACR 20/50/70 pri bolnikih s psoriatičnim artritisom, ne glede na to, ali so sočasno prejemali konvencionalna imunomodulirajoča protirevmatična zdravila, vključno z zdravljenjem z MTX, ali ne.
English: Postmarketing Phase 3b, direct comparative study
Slovenian: Neposredna primerjalna študija faze 3b, opravljena v obdobju trženja
English: Laboratory assessment of neutropenia and thrombocytopenia In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia.
Slovenian: Laboratorijska ocena nevtropenije in trombocitopenije V študijah psoriaze s plaki se je pri 9 % bolnikov, ki so prejemali zdravilo Taltz, pojavila nevtropenija.
English: Mean (SD) Cmax,ss, and C trough,ss estimates are 21.5 (9.16) µg/ml, and 5.23 (3.19) µg/ml.
Slovenian: Povprečne ocene (SD) Cmax,ss, in C trough,ss so 21,5 (9,16) µg/ml in 5,23 (3,19) µg/ml.
English: Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30 ºC.
Slovenian: Zdravilo Taltz lahko hranite zunaj hladilnika največ 5 dni, pri temperaturi, ki ne presega 30 ºC.
English: Tinea infection, Herpes simplex (mucocutaneous)c
Slovenian: Pogosti glivične okužbe kože, herpes simpleks (mukokutani)c
English: Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported.
Slovenian: Poročali so o resnih preobčutljivostnih reakcijah, vključno z nekaj primeri anafilaksije, angioedema, urtikarije in, redko, resnih zapoznelih (10-14 dni po injiciranju) preobčutljivostnih reakcij, ki so vključevale široko razširjeno urtikarijo, dispnejo in visoke titre protiteles.
English: This medicine is for single use only.
Slovenian: To zdravilo je namenjeno samo za enkratno uporabo.
English: Exposure (AUC) increased proportionally over a dose range of 5 to 160 mg given as a subcutaneous injection.
Slovenian: Izpostavljenost (AUC) je naraščala sorazmerno z odmerkom v razponu odmerkov od 5 do 160 mg,