natgillin/translations-raw huggingface dataset:
Two neonatal deaths from monkeys administered tildrakizumab at maternal exposure of 85 times the human exposure at the recommended dose were attributed to possible viral infection and considered of uncertain relationship to the treatment. 
Dve smrti novorojencev opic, ki so jim dajali tildrakizumab z izpostavljenostjo matere, ki je za 85-krat presegala izpostavljenost priporočenim odmerkom pri ljudeh, so pripisali možni virusni okužbi in smatrali, da je razmerje z zdravljenjem negotovo.
Prior to use, a visual inspection of the pre-filled syringe is recommended. 
Pred uporabo je priporočljivo napolnjeno injekcijsko brizgo vizualno pregledati.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur. 
Bolnikom je treba naročiti, da se posvetujejo z zdravnikom, če opazijo znake ali simptome, ki kažejo na klinično pomembne kronične ali akutne okužbe.
- If you currently have an infection or if you have long-term or repeated infections. 
- če imate trenutno, dolgotrajno ali ponavljajočo okužbo; - če ste se nedavno cepili ali se nameravate cepiti.
• Clean the injection site with an alcohol wipe and allow the skin to dry. 
• Mesto injiciranja očistite z alkoholnim zložencem; počakajte, da se koža osuši.
Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3). 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
Live vaccines should not be given concurrently with Ilumetri (see section 4.4). 
Živih cepiv se ne sme dajati sočasno z zdravilom Ilumetri (glejte poglavje 4.4).
If a serious hypersensivity reaction occurs, administration of Ilumetri should be discontinued immediately and appropriate therapy initiated. 
Če se pojavi resna preobčutljivostna reakcija, je treba zdravljenje z zdravilom Ilumetri prekiniti in takoj uvesti ustrezno zdravljenje.
Patients randomised to tildrakizumab 100 mg or tildrakizumab 200 mg in Part 1 who were PASI 75 responders at week 28 (reSURFACE1). 
Bolniki, randomizirani tako, da so prejemali tildrakizumab 100 mg ali tildrakizumab 200 mg v 1. delu, ki so bili odzivni na PASI 75 v 28. tednu (reSURFACE1).
If you use more Ilumetri than you should 
Če ste uporabili večji odmerek zdravila Ilumetri, kot bi smeli
The safety and efficacy of Ilumetri in children and adolescents below the age of 18 years have not yet been established. 
Varnost in učinkovitost zdravila Ilumetri pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
- DO NOT use if the liquid contains visible particles or the syringe is damaged. 
- NE uporabljajte, če tekočina vsebuje vidne delce ali je injekcijska brizga poškodovana.
EU/1/18/1323/002 2 pre-filled syringes 
EU/1/18/1323/002 2 napolnjeni injekcijski brizgi
Caution should be exercised when considering the use of Ilumetri in patients with a chronic infection or a history of recurrent or recent serious infection. 
Pri presojanju uporabe zdravila Ilumetri pri bolnikih s kronično okužbo ali ponovljeno ali nedavno resno okužbo v anamnezi je potrebna previdnost.
The effect of Ilumetri on human fertility has not been evaluated. 
Učinka zdravila Ilumetri na sposobnost razmnoževanja pri ljudeh niso ovrednotili.
Concomitant medicines affecting Ilumetri pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways. 
Sočasno zdravljenje z zdravili, ki vplivajo na farmakokinetiko zdravila Ilumetri, se ne pričakuje, saj se iz telesa izloča v postopku splošne razgradnje beljakovin brez sodelovanja encimov citokroma P450 (CYP450), in se ne izloča skozi ledvice ali jetra.
a Long-term response in patients who were responders (had achieved at least PASI 75) to tildrakizumab at week 28. b No imputation for missing data. 
a Dolgoročni odziv pri bolnikih, ki so se odzvali (dosegli vsaj PASI 75) na tildrakizumab v 28. tednu.
Following administration of 100 mg or 200 mg of tildrakizumab, subjects who are 65 years or older (n=81 and n=82, respectively) had a similar tildrakizumab clearance as compared to subjects less than 65 years old (n=884). 
Po dajanju 100 mg ali 200 mg tildrakizumaba osebam, starim 65 let ali več (n = 81 oz. n = 82), je bil očistek tildrakizumaba primerljiv s tistim pri osebah, starih manj kot 65 let (n = 884).
Ilumetri has no or negligible influence on the ability to drive and use machines. 
Zdravilo Ilumetri nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter. 
Priporočeni odmerek zdravila Ilumetri je 100 mg s subkutano injekcijo v 0. in 4. tednu, nato pa vsak 12 teden.
Inject the full amount of tildrakizumab according to the instructions for use provided in the package leaflet. 
Injicirajte vso količino tildrakizumaba v skladu z navodili v navodilu za uporabo.
• While holding the body of the pre-filled syringe, remove the needle cover as shown and discard. 
• Telo napolnjene injekcijske brizge držite in medtem odstranite pokrovček za iglo, kot je prikazano, in ga zavrzite.
Use the syringe within 30 days after taking it out of the refrigerator or by the expiry date whichever occurs first. 
Injekcijsko brizgo uporabite v 30 dneh po tem, ko ste jo vzeli iz hladilnika, ali do dneva izteka roka uporabnosti, kar je prej.
In these studies, patients were randomised to either placebo or tildrakizumab (including 200 mg and 100 mg at 0, 4 and every twelve weeks thereafter [Q12W]), up to 52 or 64 weeks. 
V teh študijah so bili bolniki randomizirani tako, da so prejemali placebo ali tildrakizumab (vključno z 200 mg in 100 mg v 0. in 4. tednu, nato pa vsaka dva tedna, do 52 ali 64 tednov.
Ilumetri should not be injected into areas where the skin is affected by plaque psoriasis or is tender, bruised, red, hard, thick, or scaly. 
Zdravila Ilumetri se ne sme injicirati na mestih, kjer je koža občutljiva, poškodovana, pordela, trda, debela, luskasta ali prizadeta zaradi psoriaza v plakih.
Its colour may vary from colourless to slightly yellow. 
Barva se lahko razlikuje od brezbarvne do rumenkaste.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use an effective method of contraception whilst having treatment with Ilumetri and for at least 17 weeks after treatment. 
Če ste ženska v rodni dobi, vam odsvetujemo zanositev; med zdravljenjem z zdravilom Ilumetri in še vsaj 17 tednov po zdravljenju morate uporabljati učinkovito kontracepcijsko metodo.
Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines. 
Pred začetkom zdravljenja s tildrakizumabom je treba pretehtati možnost, da bolnik opravi vsa potrebna cepljenja v skladu z veljavnimi smernicami za cepljenje.
If you notice any of the following, contact your doctor immediately: - Swelling of the face, lips or throat - Breathing difficulties As these may be signs of an allergic reaction. 
Če opazite kaj od naslednjega, se takoj posvetujte z zdravnikom: - otekanje obraza, ustnic ali žrela; - težave z dihanjem.
The multicentre, randomised, double-blind, placebo-controlled trials reSURFACE 1 and reSURFACE 2 studies enrolled a total of 1,862 patients 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a Physician Global Assessment (PGA) score of ≥3 in the overall assessment (plaque thickness, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a 
V multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani preskušanji reSURFACE 1 in reSURFACE 2 je bilo skupaj vključenih 1.862 bolnikov, starih 18 let in več, s psoriazo s plaki, ki so imeli prizadete vsaj 10 % telesne površine, splošno oceno psoriaze po oceni raziskovalca (Physician Global Assessment, PGA) (debelina plaka, eritem in luščenje) ≥ 3 na lestvici resnosti od 0 do 5, rezultat ≥ 12 po indeksu izraženosti psoriaze in velikosti prizadete površine kože (Psoriasis Area and Severity Index, PASI) in so bili primerni kandidati za fototerapijo ali sistemsko zdravljenje.
If you forget to use Ilumetri 
Če ste pozabili uporabiti zdravilo Ilumetri
Single use only. 
Samo za enkratno uporabo.
A field for the date is provided on the carton to record the removal from refrigerator date. 
Na škatli je okence, v katero se zabeleži datum, ko se zdravilo vzame iz hladilnika.
Summary of Response Rates in Studies reSURFACE 1 and reSURFACE 2 
Povzetek stopenj odziva v študijah reSURFACE 1 in reSURFACE 2
*The number of doses administered refers only to tildrakizumab groups. 
*Število danih odmerkov se nanaša le na skupine z tildrakizumabom.
5347 JN Oss The Netherlands 
Organon Veersemeer 4 5347 JN Oss Nizozemska
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Ilumetri is used to treat a skin condition called plaque psoriasis, in adults with moderate to severe disease. 
Zdravilo Ilumetri se uporablja za zdravljenje bolezni kože, imenovane psoriaza s plaki, pri odraslih z zmerno do hudo boleznijo.
If you stop using Ilumetri 
Če ste prenehali uporabljati zdravilo Ilumetri
L-Histidine hydrochloride monohydrate Polysorbate 80 
L-histidinijev klorid monohidrat Polisorbat 80
Maintenance of Response in Studies reSURFACE 1 and reSURFACE 2 
Vzdrževanje odziva v študijah reSURFACE 1 in reSURFACE 2
W4 W8 W12 W16 W22 W28 W32 W36 W40 W44 W48 W52 W56 W60 W64 Ilumetri 100 mg --> Placebo** 
T4 T8 T12 T16 T22 T28 T32 T36 T40 T44 T48 T52 T56 T60 T64
Doses up to 10 mg/kg intravenously have been safely administered in clinical trials. 
V kliničnih preskušanjih je bilo intravensko dajanje odmerkov do 10 mg/kg varno.
Choose an injection site 
Izberite mesto injiciranja
Once taken out of the refrigerator, do not store tildrakizumab above 25ºC or refrigerate it again. 
Tildrakizumaba, ki ste ga vzeli iz hladilnika, ne shranjujte pri temperaturi nad 25 °C in ne dajajte nazaj v hladilnik.
• After inserting the needle, let go of the skin gently. 
• Po vstavitvi igle kožo nežno spustite.
What Ilumetri looks like and contents of the pack 
Izgled zdravila Ilumetri in vsebina pakiranja
Excipients: L-Histidine, L-Histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections. 
Pomožne snovi: L-histidin, L-histidinijev klorid monohidrat, polisorbat 80, saharoza in voda za injekcije.
After proper training in subcutaneous injection technique, you may inject Ilumetri yourself if your doctor determines that it is appropriate. 
Ko se naučite tehnike pravilnega subkutanega injiciranja, si lahko zdravilo Ilumetri injicirate sami, če zdravnik oceni, da je to ustrezno.
- If you have an infection which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs. 
- če ste alergični na tildrakizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate okužbo, za katero vaš zdravnik meni, da je pomembna, na primer aktivna tuberkuloza, ki je infekcijska bolezen, ki prizadene zlasti pljuča.
Furthermore, Ilumetri does not impact the pharmacokinetics of concomitant medicines metabolized by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2). 
Zdravilo Ilumetri prav tako ne vpliva na farmakokinetiko sočasnih zdravil, ki jih presnavljajo encimi CYP450, niti z neposrednimi niti s posrednimi mehanizmi (glejte poglavje 5.2).
In cynomolgus monkeys, there was negligible secretion of the product into breast milk. 
Pri opicah cynomolgus se je zdravilo v zanemarljivi količini izločalo v materino mleko.
• Remove the pre-filled syringe from the carton when ready to inject. 
• Napolnjeno injekcijsko brizgo vzemite iz škatle, ko ste pripravljeni na injiciranje.
Unopened pre-filled syringe of Ilumetri may be removed from the refrigeration and stored up to 25°C for a single period of up to 30 days. 
Neodprta napolnjena injekcijska brizga zdravila Ilumetri se lahko vzame iz hladilnika in za 30-dnevno obdobje shrani pri temperaturi do 25 °C.
This is what Ilumetri pre-filled syringe looks like: 
Zdravilo Ilumetri napolnjene injekcijske brizge je videti tako:
• Dispose of used syringe in a sharps disposal container right away after use and before injecting a second syringe. 
• Uporabljeno injekcijsko brizgo zavrzite v zbiralnik za ostre predmete, preden si injicirate drugo injekcijsko brizgo.
How to use Ilumetri 
Kako uporabljati zdravilo Ilumetri
Therefore, tildrakizumab does not impact the pharmacokinetics of concomitant medicines metabolized by CYP enzyme (see section 4.5). 
Tildrakizumab tako ne vpliva na farmakokinetiko sočasnih zdravil, ki jih presnavlja encim CYP (glejte poglavje 4.5).
Ilumetri has no or little effect on the ability to drive and use machines. 
Zdravilo Ilumetri nima vpliva ali ima blag vpliv na sposobnost vožnje in upravljanja strojev.
After taking a pre-filled syringe from the refrigerator, wait approximately 30 minutes to allow the Ilumetri solution in the syringe to reach room temperature (up to 25ºC). 
Ko napolnjene injekcijske brizge vzamete iz hladilnika, počakajte približno 30 minut, da se zdravilo Ilumetri raztopina v injekcijski brizgi ogreje na sobno temperaturo (do 25 °C).
Clearance values range from 2.04 to 2.52 mL/day/kg and the half-life was 23.4 days (23% CV) in subjects with plaque psoriasis. 
Pri osebah s psoriazo v plakih je razpon vrednosti očistka od 2,04 do 2,52 ml/dan/kg in razpolovni čas je bil 23,4 dni (23 % vrednosti očistka).
Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjene injekcijske brizge poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The pre-filled syringe should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature (up to 25ºC). 
Injekcijsko brizgo vzemite iz hladilnika 30 minut pred injiciranjem, da se ogreje na sobno temperaturo (do 25 ºC).
It is preferable to avoid the use of Ilumetri in pregnancy. 
Po možnosti se je treba uporabi zdravila Ilumetri med nosečnostjo izogniti.
Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of Ilumetri in comparison to placebo. 
Za ocenitev varnosti zdravila Ilumetri v primerjavi s placebom so bile vključene tri s placebom nadzorovane študije (ena faze 2b in dve faze 3).
Once removed from the refrigerator and stored under these conditions, discard after 30 days or by the expiry date printed on the container, whichever occurs first. 
Zdravilo, vzeto iz hladilnika in shranjeno v teh pogojih, je treba v 30 dneh ali do dneva izteka roka uporabnosti, kar je prej, zavreči.
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. 
Zdravilo Ilumetri je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
If you feel the need, you can use a sticky plaster to cover the injection site. 
Če menite, da je potrebno, lahko mesto injiciranja prekrijete z lepljivim obližem.
Tildrakizumab is catabolized into component amino acids by general protein degradation processes and is not eliminated by renal or hepatic pathways. 
Tildrakizumab se katabolizira v sestavino aminokislin v procesu splošne razgradnje beljakovin in se ne izloča po ledvični ali jetrni poti.
Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL. 
Ena napolnjena injekcijska brizga vsebuje 100 mg tildrakizumaba v 1 ml.
The maintenance of response in studies reSURFACE1 and reSURFACE2 are presented in Table 3. 
Ohranjen odziv v študijah reSURFACE1 in reSURFACE2 je predstavljen v preglednici 3.
Tildrakizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 50 mg to 400 mg following subcutaneous administration, with clearance being independent of dose. 
Pri osebah s psoriazo v plakih je bila farmakokinetika tildrakizumaba po subkutanem dajanju odvisna od odmerka v razponu odmerka od 50 mg do 400 mg, z očistkom, odvisnim od odmerka.
Common aIncluding nasopharyngitis. 
Pogosti aVključno z nazofaringitisom.
As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy. 
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Ilumetri bolje izogibati.
At steady state, following administration of 100 mg of tildrakizumab in subjects with moderate to severe plaque psoriasis geometric means (% CV) of AUC0-τ and Cmax values were respectively 305 μg·day/mL (41%) and 8.1 μg/mL (34%), whereas they were 612 μg·day/mL (40%) and 16.3 μg/mL (33%) following administration of 200 mg. 
V stanju dinamičnega ravnovesja so bile po dajanju 100 mg tildrakizumaba pri osebah z zmerno do hudo psoriazo v plakih geometrične srednje vrednosti (% CV) vrednosti AUC0-τ in Cmax 305 µg·dan/ml (41%) oz. 8,1 μg/ml (34 %), pri čemer so bile 612 μg·dan/ml (40 %) oz. 16,3 µg/ml (33 %) po dajanju 200 mg. Porazdelitev
Maintenance and durability of PASI 90 response over time is presented in Figure 1. 
Ohranjen odziv PASI 90 in njegovo vzdrževanje je predstavljeno na sliki 1.
After proper training in subcutaneous injection technique, patients may self-inject Ilumetri if a physician determines that it is appropriate. 
Ko se bolniki naučijo tehnike pravilnega subkutanega injiciranja, si lahko zdravilo Ilumetri injicirajo sami, če zdravnik oceni, da je to ustrezno.
Package leaflet: Information for the user Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab This medicine is subject to additional monitoring. 
Navodilo za uporabo Ilumetri 100 mg raztopina v napolnjeni injekcijski brizgi tildrakizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Ilumetri is administered by subcutaneous injection. 
Zdravilo Ilumetri je namenjeno za subkutano injiciranje.
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. 
Zdravilo Ilumetri je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze v plakih.
The geometric mean exposure (AUC0-τ at steady state) in adult patients weighing >90 kg following a 100 mg or 200 mg SC dose was predicted to be about 30% lower than in an adult patient weighing ≤90 kg (see section 4.2). 
Pri odraslih bolnikih, ki tehtajo > 90 kg, je bila po s.c. odmerku 100 mg ali 200 mg pričakovana geometrična povprečna izpostavljenost (AUC0-τ v stanju dinamičnega ravnovesja) približno 30 % nižja kot pri odraslih bolnikih, ki tehtajo ≤ 90 kg (glejte poglavje 4.2).
SMALL IMMEDIATE PACKAGING UNITS LABEL - PRE-FILLED SYRINGE 
MANJŠA STIČNA OVOJNINA NALEPKA - NAPOLNJENA INJEKCIJSKA BRIZGA
Each pre-filled syringe contains 100 mg of tildrakizumab. 
Ena napolnjena injekcijska brizga vsebuje 100 mg tildrakizumaba.
Ilumetri 200 mg 
Zdravilo Ilumetri 200 mg
It is unknown whether tildrakizumab is excreted in human milk. 
Ni znano, ali se tildrakizumab izloča v materino mleko.
Common side effects (may affect up to 1 in 10 people): - Gastroenteritis - Nausea - Diarrhoea - Injection site pain - Back pain - Headache 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - vnetje želodca in črevesa; - siljenje na bruhanje; - driska; - bolečina na mestu injiciranja; - bolečina v hrbtu;
You should not be given certain types of vaccines (live vaccines) while using Ilumetri. 
Med uporabo zdravila Ilumetri ne smete biti cepljeni z nekaterimi cepivi (živa cepiva).
If any of these side effects becomes severe, tell your doctor or pharmacist. 
Če postane kateri od teh neželenih učinkov resen, se posvetujte z zdravnikom ali farmacevtom.
Tildrakizumab is catabolized into component amino acids by general protein degradation processes. 
Tildrakizumab se razgradi v sestavne aminokisline v procesu splošne razgradnje beljakovin.
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. 
Zdravilo Ilumetri je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki so primerni za sistemsko zdravljenje.
o Do not touch this area again before giving the injection. 
o Do injiciranja se ne dotaknite več tega predela.
• Hold the pre-filled syringe steady. 
• Napolnjeno injekcijsko brizgo trdo držite.
o DO NOT use if pre-filled syringe or needle is bent. 
o NE uporabite, če je napolnjena injekcijska brizga ali igla upognjena.
Ilumetri 100 mg 
Zdravilo Ilumetri 100 mg
• The pre-filled syringes must not be shaken. 
• Napolnjenih injekcijskih brizg ni dovoljeno stresati.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. 
Ne uporabljajte, če vsebuje tekočina preprosto vidne delce, je motna ali izrazito rjava.
“minimal” with ≥2 grade improvement from Baselinea (%) 
PGA “čisto” ali “minimalno” z izboljšanjem stopnje ≥ 2 od izhodišča (%) PASI 90 (%)
Pack size of 1 pre-filled syringe or 2 pre-filled syringes. 
Velikost pakiranja je 1 napolnjena injekcijska brizga ali 2 napolnjeni injekcijski brizgi.
Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. 
Pred uvedbo zdravila Ilumetri pri bolnikih z latenntno ali aktivno TB v anamnezi, pri katerih ustreznega poteka zdravljenja ni mogoče potrditi, je treba razmisliti o zdravilih proti
Ilumetri is a sterile solution for injection in pre-filled syringe. 
Zdravilo Ilumetri je sterilna raztopina za injiciranje v napolnjeni injekcijski brizgi.
You must look out for signs of these conditions while you are taking Ilumetri. 
Med uporabo zdravila Ilumetri morate biti pozorni na znake teh bolezni.
List of adverse reactions MedDRA System Organ Class 
Seznam neželenih učinkov Organski sistem po MedDRA Prednostni izraz
The pre-filled syringe must not be shaken. 
Napolnjene injekcijske brizge ni dovoljeno stresati.
Each pre-filled syringe is for single use only. 
Ena napolnjena injekcijska brizga je namenjena samo za enkratno uporabo.
Solution for injection 1 pre-filled syringe 
Raztopina za injiciranje 1 napolnjena injekcijska brizga
Clean injection site 
Očistite mesto injiciranja
Do not use if the liquid contains visible particles, is cloudy or is distinctly brown. 
Ne uporabite, če vsebuje tekočina vidne delce, je motna ali razločno rjava.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, and repeated dose toxicity. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
No harmful effects were noted in neonates at maternal exposures up to 9 times the human exposure at the recommended dose. 
Po izpostavljenosti matere odmerkom, ki so za 9-krat presegali izpostavljenost priporočenim odmerkom za ljudi, niso pri novorojencih opazili nobenih škodljivih učinkov.
Pull off the needle cover 
Povlecite za pokrovček za iglo in ga odstranite
Ilumetri 100 mg solution for injection in pre-filled syringe. 
Ilumetri 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi.
Solution for injection 2 pre-filled syringes 
Raztopina za injiciranje 2 napolnjeni injekcijski brizgi
The pre-filled syringes are for single use only. 
Napolnjene injekcijske brizge so namenjene enkratni uporabi.
• Insert the entire needle into the pinched skin between your fingers, straight up and down at a 
• V kožo, stisnjeno s prsti, si vstavite celo iglo naravnost navzdol pod kotom 90 stopinj.