natgillin/translations-raw huggingface dataset:
If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab. 
Pri bolnikih, ki so prejeli živa virusna ali bakterijska cepiva, je priporočljivo počakati vsaj 4 tedne pred uvedbo zdravljenja s tildrakizumabom.
However, the physician should ensure appropriate follow-up of patients. 
Vendar pa mora zdravnik za bolnike vedno zagotoviti ustrezne kontrolne preglede.
DLQI Score 0 or 1 (%) 
Rezultat DLQI 0 ali 1 (%)
Injection sites should be alternated. 
Mesta injiciranja je treba spreminjati.
• Press down the blue plunger until it can go no further. 
• Pritiskajte modri bat navzdol, dokler ne gre več.
Adverse reactions (Table 1) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data). 
Neželeni učinki (preglednica 1) so navedeni po organskih sistemih klasifikacije MedDRA in s pogostnostjo po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
For instructions on how to inject Ilumetri yourself, see ‘Instructions for use' at the end of this leaflet. 
Za navodila o samo-injiciranju zdravila Ilumetri glejte poglavje “Navodila za uporabo” na koncu tega navodila.
Results from a drug-drug interaction study conducted in plaque psoriasis subjects suggest that tildrakizumab had no clinically relevant effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4. 
Rezultati študije interakcij med zdravili pri bolnikih s psoriazo v plakih kažejo, da tildrakizumab nima klinično pomembnega vpliva na CYP1A2, CYP2C9, CYP2C19, CYP2D6 in CYP3A4.
Baseline PGA score was marked or severe in 33.4% of patients. 
Izhodiščni rezultat PGA je bil pri 33,4 % bolnikov močno izražen ali resen.
Pregnancy, breastfeeding and fertility 
Nosečnost, dojenje in plodnost
This activates the safety mechanism that will ensure full retraction of the needle after the injection is given. 
S tem aktivirate varnostni mehanizem, ki zagotovi, da se bo igla po injiciranju uvlekla.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Ilumetri, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Ilumetri can potentially cause serious side effects, including infections and allergic reactions. 
Zdravilo Ilumetri lahko poslabša resne neželene učinke, vključno z okužbami in alergijskimi reakcijami.
The solution pH is in the range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg. 
Razpon pH-vrednosti raztopine je med 5,7 in 6,3, osmolalnost pa je med 258 in 311 mOsm/kg.
The European Medicines Agency has deferred the obligation to submit the results of studies with Ilumetri in one or more subsets of the paediatric population in the treatment of plaque psoriasis (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Ilumetri za eno ali več podskupin pediatrične populacije za zdravljenje psoriaze s plaki (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If you have forgotten or missed an Ilumetri injection, administer the dose as soon as possible. 
Če ste pozabili ali izpustili injekcijo zdravilo Ilumetri, naslednji odmerek uporabite čim prej.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
A total of 1,768 patients were evaluated (705 patients on 100 mg, 708 patients on 200 mg and 355 patients on placebo). 
Ocenili so skupaj 1.768 bolnikov (705 bolnikov, ki so prejemali 100 mg, 708 bolnikov, ki so prejemali 200 mg in 355 bolnikov, ki so prejemali placebo).
After repeated dosing to pregnant cynomolgus monkeys, serum concentrations were quantifiable in the fetus, but the reproduction toxicity studies did not reveal any untoward effects. 
Po ponavljajočem odmerjanju brejim opicam cynomolgus je bilo možno koncentracije v serumu pri plodu določiti, vendar študije reproduktivne toksičnosti niso pokazale nobenih neželenih učinkov.
What you need to know before you use Ilumetri Do not use Ilumetri: 
Kaj morate vedeti, preden boste uporabili zdravilo Ilumetri Ne uporabljajte zdravila Ilumetri:
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC17 Mechanism of action 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC17
The decision to stop using Ilumetri should be discussed with your doctor. 
O odločitvi, da prenehate uporabljati zdravilo Ilumetri, se morate posvetovati z zdravnikom.
Most of the following side effects are mild. 
Naslednji neželeni učinki so povečini blagi.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. 
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
Population pharmacokinetic modelling indicated that exposure decreased as body weight increased. 
Populacijsko modeliranje farmakokinetike je pokazalo, da se je izpostavljenost z večanjem telesne mase manjšala.
What Ilumetri is and what it is used for 
Kaj je zdravilo Ilumetri in za kaj ga uporabljamo
Patients receiving Ilumetri should be closely monitored for signs and symptoms of active TB during and after treatment. 
Bolnike, ki prejmejo zdravilo Ilumetri, je treba skrbno spremljati za znake in simptome aktivne TB med zdravljenjem in po njem.
Clinically important active infection, e.g. active tuberculosis (see section 4.4). 
Klinično pomembna aktivna okužba (npr. aktivna tuberkuloza, glejte poglavje 4.4).
Overall demographic and baseline characteristics in reSURFACE1 and reSURFACE2 studies were consistent across individual trials. 
Splošne demografske in izhodiščne značilnosti v študijah reSURFACE1 in reSURFACE2 so bile v posameznih preskušanjih skladne.
*No imputation of missing data. 
*Brez imputacije za manjkajoče podatke.
Inspect the medicine 
Zdravilo preglejte
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. 
Podatkov o uporabi tildrakizumaba pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Results obtained at weeks 12, 28 and beyond (up to week 64 in reSURFACE 1 and up to week 52 in reSURFACE 2) are presented in Table 2 and Table 3. 
Rezultati, pridobljeni v 12. in 28. tednu ter kasneje (do 64. tedna v študiji reSURFACE 1 in do 52. tedna v študiji reSURFACE 2), so predstavljeni v preglednici 2 in preglednici 3.
Other evaluated outcomes included the proportion of patients who achieved PASI 90, PASI 100, the proportion of patients with DLQI 0 or 1, and maintenance of efficacy up to 52/64 weeks. 
Drugi ocenjeni izidi so vključevali dežel bolnikov, ki so dosegli PASI 90, PASI 100 delež bolnikov z DLQI 0 ali 1 in ohranjanje učinkovitosti do 52/64 tednov.
Gastrointestinal disorders Gastroenteritis 
Bolezni prebavil gastroenteritis
Tildrakizumab has limited extravascular distribution with volume of distribution (Vd) values ranging from 76.9 to 106 mL/kg. 
Tildrakizumab ima omejeno ekstravaskularno porazdelitev s porazdelitvenim volumnom od 76,9 do 106 ml/kg.
p-values calculated using the Cochran-Mantel-Haenszel (CMH) test stratified by body weight (≤90 kg, >90 kg) and prior exposure to biologic therapy for psoriasis (yes/no). 
Vrednosti p, izračunane po Cochran- Mantel- Haenszelovem (CMH) testu, stratificirane po telesni masi (≤ 90 kg, > 90 kg) in predhodno izpostavljenostjo biološkim zdravilom za psoriazo (da/ne).
- DO NOT inject into scars, stretch marks, or blood vessels. 
- NE injicirajte v brazgotine, strije ali krvne žile.
• Before you use Ilumetri pre-filled syringes, read and carefully follow all the step-by-step instructions. 
• Preden začnete uporabljati zdravilo Ilumetri napolnjene injekcijske brizge, preberite in natančno upoštevajte navodila po korakih.
Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3). 
Razpoložljivi toksikološki podatki pri opicah cynomolgus so 28. dan po rojstvu pokazali zanemarljive ravni zdravila Ilumetri v mleku (glejte poglavje 5.3).
† p≤0.001 versus placebo; ‡ p≤0.001 versus etanercept; ¥ p≤0.05 versus etanercept. 
† p ≤ 0,001 v primerjavi s placebom; ‡ p ≤ 0,001 v primerjavi z etanerceptom; ¥ p ≤ 0,05 v primerjavi z etanerceptom.
Of all patients, 35.8% had received prior phototherapy, 41.1% had received prior conventional systemic therapy, 16.7% had received prior biologic therapy for the treatment of plaque psoriasis. 
Od vseh bolnikov se jih je 35,8 % predhodno zdravilo s fototerapijo, 41,1 % se jih je predhodno zdravilo z običajno sistemsko terapijo in 16,7 % se je predhodno zdravilo z biološko terapijo za zdravljenje psoriaze v plakih.
This medicine works by blocking the activity of a protein called IL-23, a substance found in the body which is involved in normal inflammatory and immune responses and which is present at increased levels in diseases such as psoriasis. 
To zdravilo deluje tako, da zavira aktivnost beljakovine, imenovane IL-23, ki je snov, ki jo najdemo v telesu, in je vključena pri normalnem vnetnem in imunskem odgovoru, in je pri boleznih, kot je luskavica, prisotna v zvišanih ravneh.
Solution for injection (injection) 
Raztopina za injiciranje (injekcija)
Ilumetri has the potential to increase the risk of infection (see section 4.8). 
Zdravilo Ilumetri lahko poveča tveganje za okužbe (glejte poglavje 4.8).
Remove the used syringe 
Odstranite uporabljeno injekcijsko brizgo
Other medicines and Ilumetri 
Druga zdravila in zdravilo Ilumetri
Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. 
Tildrakizumab je humanizirano monoklonsko protitelo IgG1/k, izdelano v ovarijskih celicah kitajskega hrčka (Chinese Hamster Ovary, CHO) s tehnologijo rekombinantne DNA.
Interactions with cytochrome p450 
Medsebojno delovanje s citokromom p450
Ilumetri has not been studied in these patient populations. 
Zdravila Ilumetri v teh skupinah bolnikov niso proučevali.
Possible side effects). 
Možni neželeni učinki).
Talk to your doctor, pharmacist or nurse before using Ilumetri: - If you experience allergic reactions with symptoms such as chest tightness, wheezing, swelling of the face, lips or throat do not inject more Ilumetri and contact your doctor immediately. 
Pred začetkom uporabe zdravila Ilumetri se posvetujte z zdravnikom ali farmacevtom: - če imate alergijske reakcije s simptomi, kot so tiščanje v prsnem košu, piskanje, oteklost obraza, ustnic ali žrela, si zdravila Ilumetri ne injicirajte več in se takoj posvetujte z zdravnikom;
Prior to initiating treatment with Ilumetri, patients should be evaluated for tuberculosis (TB) infection. 
Pred uvedbo zdravljenja z zdravilom Ilumetri je treba pri bolnikih oceniti okužbo s tuberkulozo (TB).
Before using the pre-filled syringes: 
Pred uporabo napolnjene injekcijske brizge:
Week 28 Week 52 Week 28 Week 52 
28. teden 52. teden 28. teden 52. teden
Steady-state is achieved by 16 weeks with the clinical regimen of 0, 4, and every 12 weeks thereafter, with 1.1-fold accumulation in exposure between week-1 and week-12 independent of dose. 
Stanje dinamičnega ravnovesja je doseženo do 16. tedna s kliničnim režimom v 0. in 4. tednu, nato pa vsakih 12 tednov, z 1,1-kratno akumulacijo pri izpostavljenosti med 1. in 12. tednom, neodvisno od odmerka.
Using Ilumetri will benefit you by improvements of skin clearance and reducing your symptoms. 
Uporaba zdravila Ilumetri vam pomaga k izboljšanju videza kože in zmanjšanja simptomov.
Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors. 
Tildrakizumab spada v skupino zdravil, imenovanih zaviralci interlevkina (IL).
No data are available with the concomitant use of Ilumetri and live vaccines. 
Podatkov o sočasni uporabi zdravila Ilumetri in živih cepiv ni na voljo.
• Leave the pre-filled syringe in the Ilumetri carton (with the lid closed) and let it sit at room temperature for 30 minutes. 
• Napolnjeno injekcijsko brizgo pustite v škatli za zdravilo Ilumetri (z zaprtim pokrovom) in jih pustite 30 minut na sobni temperaturi.
Patients treated with Ilumetri should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5). 
Bolniki, zdravljeni z zdravilom Ilumetri, med zdravljenjem in še vsaj 17 tednov po zdravljenju ne smejo prejeti živih cepiv (glejte poglavje 4.5).
Elderly No dose adjustment is required (see section 5.2). 
Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
Studies reSURFACE 1 and reSURFACE 2 assessed the changes from baseline at Week 12 in the two coprimary endpoints: 1) PASI 75 and 2) PGA of “0” (cleared) or “1” (minimal), with at least a 2-point improvement from baseline. 
V študijah reSURFACE 1 in reSURFACE 2 so ocenjevali spremembe v 12. tednu od izhodišča za dva sestavljena opazovana dogodka: 1) PASI 75 in 2) PGA "0" (čisto) ali "1" (minimalno), z vsaj 2-točkovnim izboljšanjem od izhodišča.
Small-molecule metabolic pathways (e.g., CYP450 enzymes, glucuronosyltransferases) do not contribute to its clearance. 
Presnovne poti z majhnimi molekulami (npr. encimi CYP450, glukuronoziltransferaze) ne prispevajo k očistku.
In the active comparator study (reSURFACE 2), patients were also randomised to receive etanercept 50 mg twice weekly for 12 weeks, and weekly thereafter up to 28 weeks. 
V študiji z aktivnim primerjanim zdravilom (reSURFACE 2) so bili bolniki prav tako randomizirani tako, da so 12 tednov prejemali 50 mg etanercepta dvakrat na teden, nato pa do 28 tednov enkrat na teden.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment. 
Ženske v rodni dobi morajo med zdravljenjem in še vsaj 17 tednov po zdravljenju uporabljati učinkovito kontracepcijsko metodo.
Ilumetri is available in unit packs containing 1 pre-filled syringe and packs comprising 2 pre-filled syringes. 
Zdravilo Ilumetri je na voljo v enotah pakiranja, ki vsebujejo 1 napolnjeno injekcijsko brizgo in pakiranja,ki vsebujejo 2 napolnjeni injekcijski brizgi.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
No apparent association between the development of antibodies to Ilumetri to lower efficacy and the development of treatment emergent adverse events was observed. 
Očitne povezave med razvojem protiteles na zdravilo Ilumetri na manjšo učinkovitost in razvojem neželenih učinkov zaradi zdravljenja niso opazili.
Animal carcinogenicity studies have not been conducted with tildrakizumab. 
Študij kancerogenosti na živalih s tildrakizumabom niso izvedli.
08740 Sant Andreu de la Barca, Barcelona, Spain 
08740 Sant Andreu de la Barca, Barcelona, Španija
The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain. 
Najpogostejši neželeni učinki so okužbe zgornjih dihal, glavobol, gastroenteritis, navzea, driska, bolečina na mestu injiciranja in bolečina v hrbtu.
Tildrakizumab is a humanized IgG1/k monoclonal antibody that specifically binds to the p19 protein subunit of the interleukin-23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor. 
Tildrakizumab je humanizirano monoklonsko protitelo IgG1/k, ki se specifično veže na p19, proteinsko podenoto citokinov interlevkina-23 (IL-23) brez vezave na IL-12 in zavira njegovo interakcijo z receptorjem IL-23.
• Remove the needle from the skin entirely before letting go of the blue plunger. 
• Iglo do konca odstranite iz kože, preden izpustite modri bat.
IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. 
IL-23 je naravno prisoten citokin, ki sodeluje pri vnetnem in imunskem odzivu.
o After the blue plunger is released, the safely lock will draw the needle inside the needle guard. 
o Ko izpustite modri bat, bo varnostni zaklep iglo povlekel v varovalo za iglo.
If a patient develops a serious infection, the patient should be closely monitored and Ilumetri should not be administered until the infection resolves. 
Če se pri bolniku razvije resna okužba, ga je treba skrbno spremljati, zdravila Ilumetri pa ni dovoljeno dajati, dokler okužba ne izzveni.
At week 12 and across studies, tildrakizumab was associated with statistically significant improvement in Health-related Quality of Life as assessed by the DLQI (Table 2). 
V 12. tednu in v vseh študijah je bil tildrakizumab povezan s statistično značilnim izboljšanjem kakovosti življenja, povezane z zdravjem, ocenjene z vprašalnikom DLQI (preglednica 2).
Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines. 
Tildrakizumab zavira sproščanje provnetnih citokinov in kemokinov.
- The upper arm is only suitable when someone else is injecting you. 
- Nadlaket je primerno mesto le, če vam zdravilo injicira kdo drug.
Contents of the pack and other information What Ilumetri contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ilumetri
PGA of “clear” or “minimal” with ≥2 
PGA “čisto” ali “minimalno” z izboljšanjem stopnje ≥ 2 od izhodiščaa
• If there is some residual fluid or a tiny bit of blood, clean the injection site with a cotton ball or gauze pad WITHOUT applying any pressure. 
• Če opazite preostanek tekočine ali malenkost krvi, si mesto injiciranja očistite z bombažno blazinico ali zložencem in NE pritiskajte.
Keep the instructions for use and refer to them as needed. 
Navodila za uporabo shranite in po potrebi preberite ponovno.
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately. 
V primeru prevelikega odmerjanja je pri bolniku priporočljivo spremljanje znakov ali simptomov neželenih učinkov in takojšnja uvedba ustreznega simptomatičnega zdravljenja.
Ilumetri is not recommended for use in children and adolescents under 18 years of age. 
Uporaba zdravila Ilumetri se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let.
Population pharmacokinetic analysis indicated that age did not have a clinically significant influence on the clearance of tildrakizumab in adult subjects with plaque psoriasis. 
Analiza populacijske farmakokinetike je pokazala, da starost ni imela kliničnega pomembnega vpliva na očistek tildrakizumaba pri odraslih osebah s psoriazo v plakih.
Ronda General Mitre, 151 08022 Barcelona Spain 
Ronda General Mitre, 151 08022 Barcelona Španija
Patients should be instructed to inject the full amount of Ilumetri according to the instructions provided in the package leaflet. 
Bolnikom je treba naročiti, da si injicirajo celotno količino zdravila Ilumetri v skladu z navodili v navodilu za uporabo.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Ilumetri 100 mg injection tildrakizumab SC 
Ilumetri 100 mg injekcija tildrakizumab SC
1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x ½” needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device. 
1 ml raztopine v napolnjeni injekcijski brizgi iz stekla vrste I z iglo iz nerjavnega jekla 29G x ½”, prekrito s ščitnikom za iglo in togim ščitnikom iz polipropilena, prevlečenega s fluropolimerom, zamaškom z batom, sestavljenem v pasivnem zaščitnem pripomočku.
Improvements were maintained over time with at week 52, 63.7% (100 mg) and 73.3% (200 mg) in reSURFACE 1, and 68.8% (100 mg) and 72.4% (200 mg) in reSURFACE 2 of patients who were PASI 75 responders at week 28 having a DLQI of 0 or 1. 
Izboljšanja so se s časom ohranila do 52. tedna, 63,7 % (100 mg) in 73,3 % (200 mg) v reSURFACE 1 in 68,8 % (100 mg) in 72,4 % (200 mg) v reSURFACE 2 bolnikov, ki so bili PASI 75 odzivni v 28. tednu, je imelo DLQI 0 ali 1.
- Choose a different location for the second injection. 
- Za drugo injekcijo izberite drugo mesto injiciranja.
c No imputation for missing data. 
c Brez imputacije za manjkajoče podatke.
What Ilumetri is and what it is used for What you need to know before you use Ilumetri How to use Ilumetri 
Kaj je zdravilo Ilumetri in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ilumetri Kako uporabljati zdravilo Ilumetri Možni neželeni učinki
Ronda General Mitre, 151 08022 Barcelona, Spain 
Ronda General Mitre, 151 08022 Barcelona, Španija
- Check the expiration date on the carton and pre-filled syringe and discard if the date has passed. 
- Preverite datum izteka roka uporabnosti na škatli in napolnjeni injekcijski brizgi ter zdravilo zavrzite, če je datum potekel.
No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of tildrakizumab was conducted. 
Formalnih preskušanj učinka jetrne ali ledvične okvare na farmakokinetiko tildrakizumaba niso izvedli.
o A complete dose is administered if the blue plunger cannot go any further, and there are no spills. 
o Celotni odmerek ste uporabili, ko se modri bat ne more več premikati naprej in ni nič razlito.
The safety and efficacy of Ilumetri in children and adolescents under 18 years of age has not yet been established and therefore Ilumetri is not recommended for use in children or adolescents. 
Varnost in učinkovitost zdravila Ilumetri pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani, zato se uporaba zdravila Ilumetri pri otrocih in mladostnikih ne priporoča.
Ilumetri 200 mg --> Placebo** 
Zdravilo Ilumetri 200 mg --> placebo**
If you have administered more Ilumetri than you should or the dose has been administered sooner than according to your doctor's prescription, tell your doctor. 
Če menite, da ste si dali več zdravila Ilumetri, kot bi smeli, ali pa da ste odmerek prejeli prej, kot vam je predpisal zdravnik, se posvetujte z zdravnikom.
Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment. 
Pri bolnikih, ki se po 28 tednih niso odzvali na zdravljenje, je treba razmisliti o prekinitvi zdravljenja.
In a pre- and postnatal development toxicity study in monkeys, no related increase in pregnancy loss was observed at exposures up to 85 times the human exposure at the recommended dose. 
V študiji razvojne toksičnosti pred rojstvom in po njem pri opicah niso opazili povezanega povečanja prekinitev nosečnosti pri izpostavljenostih, ki so za 85-krat presegale izpostavljenost priporočenim odmerkom pri ljudeh.
In case your dose is 200 mg, you will need to use 2 pre-filled syringes each time you administer the product. 
Če potrebujete 200-mg odmerek, boste morali vsakič uporabiti 2 napolnjeni injekcijski brizgi.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Ilumetri. 
Če niste prepričani, ali katera od zgornjih trditev velja za vas, se pogovorite z zdravnikom ali medicinsko sestro, preden začnete uporabljati zdravilo Ilumetri.