natgillin/translations-raw huggingface dataset:
• Holding the area where the vial and vial adapter connect between your fingers, gently swirl the vial by rotating your wrist until all of the powder has dissolved and the liquid in the vial is clear and colourless. 
• Med prsti držite del, kjer sta viala in nastavek za vialo združena, previdno vrtite vialo, tako da rotirate zapestje, dokler se ves prašek ne raztopi in je tekočina v viali bistra in brezbarvna.
In the subset of subjects with ITP > 12 months of duration, the overall subject incidence of platelet response was 93.7% (n = 59) and was similar across age groups. 
V podskupini bolnikov, ki so imeli ITP > 12 mesecev, je bila incidenca odgovora trombocitov 93,7 % (n = 59) in je bila podobna med starostnimi skupinami.
It is not known whether romiplostim is present in human milk. 
Ni znano, ali se romiplostim pojavi v materinem mleku.
If individual patient dose is < 23 mcg 
Če je odmerek za posameznega bolnika < 23 µg
Nplate should be administered once weekly as a subcutaneous injection. 
Zdravilo Nplate je treba dajati enkrat na teden v subkutani injekciji.
• or cancer of white blood cells (multiple myeloma); 
• ali rak belih krvnih celic (multipli mielom),
If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed. 
Če se učinkovitost ohrani, pojavi pa se nenormalen razmaz periferne krvi, je treba slediti ustrezni klinični presoji; v poštev pride biopsija kostnega mozga in znova je treba oceniti tveganje in koristi uporabe romiplostima ter pretehtati alternativne možnosti zdravljenja ITP.
If you have been given less Nplate than you should, you may not experience any physical symptoms but your blood platelet counts may become low and this may increase the risk of bleeding. 
Če ste dobili manjši odmerek zdravila Nplate, kot bi morali, morda ne boste imeli nobenega telesnega simptoma, toda število trombocitov se vam lahko zmanjša in to lahko poveča tveganje za krvavitve.
Seventy-three percent of non-splenectomised patients receiving romiplostim were able to reduce the dose by more than 25% or discontinue concurrent ITP medical therapies by the end of the study compared to 50% of placebo treated patients (see section 4.5). 
Triinsedemdeset odstotkov nesplenektomiranih bolnikov, ki so prejemali romiplostim, je lahko do konca študije zmanjšalo odmerek sočasnih zdravil za ITP za več kot 25 % ali je lahko ta zdravila celo opustilo; med bolniki, ki so prejemali placebo, je bilo takšnih 50 % (glejte poglavje 4.5).
• Using a new alcohol swab clean vial stopper. 
• Z novim alkoholnim zložencem očistite zamašek viale.
RECONSTITUTION PACK INNER CARTON WITHOUT BLUE BOX 
NOTRANJA OVOJNINA KOMPLETA ZA PRIPRAVO BREZ MODREGA OKENCA
Due to the interindividual variable platelet response, in some patients platelet count may abruptly fall below 50 x 10 
Zaradi razlik v odzivu trombocitov med posamezniki se lahko nekaterim bolnikom po zmanjšanju odmerka ali prenehanju zdravljenja število trombocitov nenadoma zmanjša pod 50 x 10
Of those 22 subjects, 17 subjects had ITP > 12 months of duration (14 subjects received romiplostim and 3 subjects received placebo). 
Od teh 22 bolnikov je 17 bolnikov imelo ITP > 12 mesecev (14 bolnikov je prejelo romiplostim in 3 bolniki so prejeli placebo).
• Discard the empty syringe into sharps or hazard container. 
• Zavrzite prazno brizgo v vsebnik za ostre ali nevarne odpadke.
Individual patient dose (mcg) 
Odmerek za posameznega bolnika (µg)
Holding the pre-filled syringe of water for injections with one hand, bend the tip of the white plastic cover downward with your other hand. 
Z eno roko držite napolnjeno injekcijsko iglo z vodo za injekcije in z drugo roko upognite navzdol konico belega plastičnega pokrovčka.
• Do make sure the correct amount of liquid for your dose remains in the syringe. 
• Prepričajte se, da je v brizgi ostala pravilna količina tekočine za vaš odmerek.
After injecting, activate the pink safety cover by pushing the cover forward using the same hand until you hear and/or feel it click/lock. 
Po injiciranju aktivirajte rožnati varnostni pokrovček tako, da ga z isto roko potisnete naprej, dokler ne zaslišite klika in/ali ne čutite, da se je zaskočil.
The vial contents may be swirled gently and inverted during dissolution. 
Vsebino viale morate med raztapljanjem previdno vrteti in obračati.
Volume to administer (mL) = 10 mcg / 125 mcg/mL = 0.08 mL 
Količina za aplikacijo (ml) = 10 µg /125 µg/ml = 0,08 ml
Remove the plastic cap from Nplate powder vial and clean rubber stopper using the provided alcohol swab. 
Odstranite plastično zaporko z viale praška zdravila Nplate in očistite gumijasti zamašek s priloženim alkoholnim zložencem.
Contents of the pack and other information Instructions for preparing and giving an injection of Nplate 
Shranjevanje zdravila Nplate Vsebina pakiranja in dodatne informacije Navodila za pripravo in injiciranje zdravila Nplate
If you use more Nplate than you should 
Če ste uporabili večji odmerek zdravila Nplate, kot bi smeli
• constipation; 
• mrzlica,
While 5.8% and 3.9% of the subjects were positive for developing binding antibodies to romiplostim and TPO respectively, only 2 subjects (0.4%) were positive for neutralising antibodies to romiplostim but these antibodies did not cross react with endogenous TPO. 
Pozitiven izvid vezavnih protiteles proti romiplostimu je imelo 5,8 % bolnikov in proti TPO 3,9 % bolnikov, toda samo 2 bolnika (0,4 %) sta imela pozitiven izvid nevtralizirajočih protiteles proti romiplostimu, vendar ta protitelesa niso navzkrižno reagirala z endogenim TPO.
Gently tap the syringe with your fingers to separate the bubbles from the liquid. 
Previdno s prsti potrkajte po brizgi, da se bodo mehurčki ločili iz tekočine.
Uncommon: may affect up to 1 in 100 people (may show up in blood or urine tests) 
Občasni: lahko se pojavijo pri največ 1 od 100 bolnikov (lahko se pokažejo na preiskavah krvi ali urina)
The volume of distribution of romiplostim following intravenous administration of romiplostim decreased nonlinearly from 122, 78.8, to 48.2 mL/kg for intravenous doses of 0.3, 1.0 and 10 mcg/kg, respectively in healthy subjects. 
Volumen porazdelitve po intravenski uporabi romiplostima se je pri zdravih preiskovancih nelinearno zmanjševal od 122 ml/kg po odmerku 0,3 µg/kg preko 78,8 ml/kg po odmerku 1,0 µg/kg do 48,2 ml/kg po odmerku 10 µg/kg.
• Select your injection site. 
• Izberite mesto injiciranja.
Once the seal is broken, pull cover off to separate the grey rubber cap from the clear plastic tip on the syringe. 
Ko je zapečateni del prelomljen, pokrovček snemite, da boste sivo gumijasto zaporko odstranili s prozorne plastične konice na brizgi.
• influenza; localised infection; inflammation of the passages in the nose and throat (nasopharyngitis); 
• gripa, lokalizirana okužba, vnetje nosnih prehodov in žrela (nazofaringitis),
4 vials. 
4 viale
A total of 31 subjects (47.7%) used concurrent ITP therapy during the study including 23 subjects (35.4%) who used rescue medication and 5 subjects (7.7%) who used concurrent ITP medication at baseline. 
Skupaj je 31 bolnikov (47,7 %) med preskušanjem prejemalo sočasna zdravila za ITP, vključno s 23 bolniki (35,4 %), ki so uporabljali rešilno zdravilo, in 5 bolnikov (7,7 %), ki so sočasno uporabljali zdravila za ITP na začetku preskušanja.
It must be clear and colourless and fully dissolved. 
Biti mora bistra, brezbarvna in ves prašek mora biti raztopljen.
• When Nplate is completely dissolved, remove the empty syringe by twisting it anti-clockwise off of the vial adapter. 
• Ko je zdravilo Nplate povsem raztopljeno, odstranite prazno brizgo tako, da jo odvijete z nastavka za vialo v smeri, nasprotni urinemu kazalcu.
• injection site reactions; 
• reakcije na mestu injiciranja,
The median (Q1, Q3) duration of treatment was 135.0 weeks (95.0 weeks, 184.0 weeks). 
trajanja zdravljenja je bila 135,0 tednov (95,0 tednov, 184,0 tednov).
Injection site reactions were also related to romiplostim administration. 
Z uporabo romiplostima so bile povezane tudi reakcije na mestu injiciranja.
Thrombotic/thromboembolic complications 
Trombotični/tromboembolični zapleti
Of the 22 subjects, 2 subjects had pre-existing binding non-neutralising romiplostim antibodies at baseline. 
Od 22 bolinkov sta 2 bolnika imela že obstoječa vezavna ne-nevtralizirajoča protitelesa proti romiplostimu na začetku.
• Keeping the vial on a table, and keeping the vial adapter in the plastic packaging, line up spike on the vial adapter to the centre of the stopper on the vial. 
• Medtem ko imate vialo na mizi in nastavek za vialo v plastičnem pakiranju, uravnajte konico nastavka za vialo s središčem zamaška na viali.
• If you stop taking Nplate a low blood platelet count (thrombocytopenia) is likely to reoccur. 
• Če nehate jemati zdravilo Nplate, se bo premajhno število trombocitov (trombocitopenija) verjetno znova pojavilo.
Depression Abnormal dreams 
Psihiatrične motnje nespečnost depresija nenormalne sanje
The platelet counts of ITP patients who received 6 weekly doses of 1 or 3 mcg/kg of romiplostim were within the range of 50 to 450 x 10 
Pri večini bolnikov z ITP, ki so prejeli 6 tedenskih odmerkov 1 ali 3 µg/kg romiplostima, je bilo število trombocitov 50 do 450 x 10
Do ensure that the plunger remains in the syringe. 
Poskrbite, da bat ostane v brizgi.
The most common adverse reactions in paediatric ITP patients 1 year and older were upper respiratory tract infection, rhinitis, cough, oropharyngeal pain, upper abdominal pain, diarrhoea, rash, pyrexia, contusion (reported very commonly (≥ 1/10)), and pharyngitis, conjunctivitis, ear infection, gastroenteritis, sinusitis, purpura, urticaria and peripheral swelling (reported commonly (≥ 1/100 to 
Najpogostejši neželeni učinki pri pediatričnih bolnikih z ITP, starih 1 leto ali več, so bili okužba zgornjega dihalnega trakta, rinitis, kašelj, orofaringealna bolečina, bolečina v zgornjem delu trebuha, driska, izpuščaj, pireksija, zmedenost (poročani zelo pogosto (≥ 1/10)) in faringitis, konjuktivitis, vnetje ušesa, gastroenteritis, sinusitis, purpura, urtikarija in periferno zatekanje (poročani pogosto (≥ 1/100 do < 1/10)).
Romiplostim is known to cross the placental barrier in rats and may be transmitted from the mother to the developing foetus and stimulate foetal platelet production. 
Znano je, da romiplostim pri podganah prehaja skozi placentno pregrado in tako lahko preide od matere v razvijajoči se plod in pri njem povzroči nastajanje trombocitov.
In both placebo-controlled, double-blind studies, patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the study (corticosteroids, danazol and/or azathioprine). 
V obeh s placebom kontroliranih, dvojno slepih študijah so lahko bolniki, ki so že prejemali zdravila za ITP po stalni odmerni shemi, ta zdravila ves čas študije jemali še naprej (kortikosteroidi, danazol in/ali azatioprin).
In 1-month rat and monkey toxicology studies, a mild decrease in red blood cell count, haematocrit and haemoglobin was observed. 
V eno-mesečnih toksikoloških študijah pri podganah in opicah so opazili blago znižanje števila eritrocitov, hematokrita in hemoglobina.
In both adult placebo-controlled, double-blind studies, patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the study (corticosteroids, danazol and/or azathioprine). 
V obeh s placebom kontroliranih, dvojno slepih študijah odraslih bolnikov so lahko bolniki, ki so že prejemali zdravila za ITP po stalni odmerni shemi, ta zdravila ves čas študije jemali še naprej (kortikosteroidi, danazol in/ali azatioprin).
Treatment with romiplostim resulted in statistically significantly greater incidence of platelet response compared with placebo (p = 0.0147). 
Zdravljenje z romiplostimom je imelo za posledico statistično značilno višjo incidenco odziva trombocitov v primerjavi s placebom (p = 0,0147).
Myelofibrosis has been observed in the bone marrow of rats at all tested dose levels. 
V kostnem mozgu podgan so pri vseh testiranih višinah odmerkov opažali mielofibrozo.
Initial reconstitution of romiplostim with designated volumes of sterile water for injections results in a concentration of 500 mcg/mL in all vial sizes. 
Začetna rekonstitucija romiplostima z določenimi volumni sterilne vode za injekcije ima kot rezultat koncentracijo 500 µg/ml v vialah vseh velikosti.
Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML (see section 4.4). 
V opaženih primerih napredovanja bolezni iz MDS v AML je bilo napredovanje bolezni v AML verjetnejše pri bolnikih, ki so imeli izhodiščno razvrstitev MDS RAEB-1 (glejte poglavje 4.4).
See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials. 
Za informacije o zvišanju retikulina, ugotovljenem v kliničnih preskušanjih romiplostima, glejte poglavje 4.8.
After reconstitution: 24 hours when stored at 25°C or in a refrigerator (2ºC - 8ºC) if kept in the original vial and protected from light. 
Po pripravi: 24 ur v primeru shranjevanja pri 25 °C ali v hladilniku (2 °C do 8 °C), če je zdravilo v originalni viali in zaščiteno pred svetlobo.
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. 
Po prevelikem odmerjanju se lahko število trombocitov čezmerno poveča in povzroči trombotične/tromboembolične zaplete.
A loss of response or failure to maintain a platelet response with romiplostim treatment within the recommended dosing range should prompt a search for causative factors, including immunogenicity (see section 4.8) and increased bone marrow reticulin (see above). 
V primeru neodzivnosti ali neuspešnega vzdrževanja odziva trombocitov pri zdravljenju z romiplostimom v priporočenem razponu odmerkov je treba takoj iskati vzročne dejavnike, vključno z imunogenostjo (glejte poglavje 4.8) in zvišanjem retikulina v kostnem mozgu (glejte zgoraj).
In study S4, 62 subjects were randomised in a 2:1 ratio to receive romiplostim (n = 42) or placebo (n = 20) and stratified into 1 of 3 age cohorts. 
Študija S4 je vključevala 62 bolnikov, ki so bili randomizirani v razmerju 2:1 na skupino, ki je prejemala romiplostim (n = 42), ali skupino, ki je prejemala placebo (n = 20), in razdeljeni v eno od treh starostnih skupin.
In study S5, 22 subjects were randomised in a 3:1 ratio to receive romiplostim (n = 17) or placebo (n = 5). 
V študiji S5 je bilo 22 bolnikov randomiziranih v razmerju 3:1 na skupino, ki je prejemala romiplostim (n = 17), ali na skupino, ki je prejemala placebo (n = 5).
• Do not roll vial between palms. 
• Ne vrtite viale med dlanmi.
• bruising (contusion). 
• podplutbe (kontuzija).
The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains. 
Vsaka enoverižna podenota je na C-terminalnem delu kovalentno vezana na peptidno verigo, ki ima 2 vezavna odseka za TPO.
No overall differences in safety or efficacy have been observed between older and younger patients in the placebo-controlled studies. 
S placebom kontrolirane študije na splošno niso pokazale razlik v varnosti in učinkovitosti med starejšimi in mlajšimi bolniki.
Nplate should be used with caution in these populations. 
Zdravilo Nplate morate zato pri njih uporabljati previdno.
Platelets are the cells in your blood that help seal cuts and form blood clots. 
Trombociti (krvne ploščice) so krvne celice, ki sodelujejo pri zaprtju ran in nastanku krvnih strdkov.
It is very important that you prepare Nplate properly and take the correct dose (see section 7. 
Zelo pomembno je, da zdravilo Nplate pripravite pravilno in da uporabite pravilen odmerek (glejte poglavje 7, Navodila za pripravo in injiciranje zdravila Nplate, na koncu tega navodila).
Medication errors including overdose and underdose have been reported in patients receiving Nplate, dose calculation and dose adjustment guidelines should be followed (see section 4.2). 
Pri bolnikih, ki so prejemali zdravilo Nplate, so poročali o napakah pri uporabi zdravila, vključno s prevelikim in premajhnim odmerjanjem, upoštevati je potrebno smernice za izračun odmerka in prilagoditev odmerka (glejte poglavje 4.2).
No. (%) patients with durable platelet response with stable dose e 
vrednost p Št. (%) bolnikov s trajnim odzivom trombocitov s stabilnim odmerkom e
Very low platelet counts can cause bruising and serious bleeding. 
Če je trombocitov zelo malo, se lahko pojavijo podplutbe ali resne krvavitve.
Multiple myeloma Myelofibrosis 
multipli mielom mielofibroza
• Immediately discard used Nplate vial into an appropriate waste container. 
• Uporabljeno vialo zdravila Nplate takoj zavrzite v ustrezen vsebnik za odpadke.
13 mm vial adapter x1 
1 x nastavek za vialo 13 mm
If you have been given more Nplate than you should, you may not experience any physical symptoms but your blood platelet counts may rise to very high levels and this may increase the risk of blood clotting. 
Če ste dobili večji odmerek zdravila Nplate, kot bi smeli, morda ne boste imeli nobenega telesnega simptoma, toda število trombocitov se vam lahko zelo poveča in to lahko poveča tveganje strjevanja krvi.
The median (Q1, Q3) of most frequent dose received by subjects during the treatment period was 5.0 mcg/kg (1.0 mcg/kg, 10.0 mcg/kg). 
Mediana (Q1, Q3) najbolj pogosto prejetega odmerka med trajanjem zdravljenja je bila 5,0 µg/kg (1,0 µg/kg, 10,0 µg/kg).
Myocardial infarction Heart rate increased 
Srčne bolezni palpitacije miokardni infarkt povečana srčna frekvenca
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 3 events of thrombocytosis were reported, n = 271. 
Na podlagi analize vseh odraslih bolnikov z ITP, ki so prejemali romiplostim v 4 kontroliranih in 5 nekontroliranih kliničnih preskušanjih, so poročali o 3 primerih trombocitoze, n = 271.
Remove clear needle shield from prepared needle by holding syringe in one hand and carefully pulling shield straight off with the other hand. 
Odstranite prozorni ščitnik igle s pripravljene igle tako, da držite brizgo v eni roki in z drugo roko previdno potegnete ščitnik naravnost z nje.
Note: From a microbiological point of view, the product must be used immediately after reconstitution. 
Opomba: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po pripravi.
Platelet counts should be assessed monthly thereafter. 
Potem je treba število trombocitov kontrolirati vsak mesec.
Do not use this medicine after the expiry date which is stated on the vial label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Underdose may result in lower than expected platelet counts and potential for bleeding. 
Premajhno odmerjanje lahko povzroči manjše število trombocitov od pričakovanega in s tem možnost krvavitev.
• Do visually inspect the dissolved liquid for particles and/or discolouration. 
• Preglejte raztopino za delce in/ali obarvanje.
In another ITP clinical trial, no accumulation in serum concentrations was observed after 6 weekly doses of romiplostim (3 mcg/kg). 
V drugem kliničnem preskušanju ITP po 6 tedenskih odmerkih romiplostima (3 µg/kg) niso opazili kopičenja koncentracije v serumu.
75 kg patient is initiated at 1 mcg/kg of romiplostim. 
Zdravljenje 75 kg bolnika se začne z 1 µg/kg romiplostima.
In the subset of subjects with ITP > 12 months of duration, the incidence of durable response was also significantly greater in the romiplostim arm compared with the placebo arm (p = 0.0022). 
V podskupini bolnikov, ki so imeli ITP > 12 mesecev, je bila incidenca trajnega odziva na zdravljenje tudi značilno višja v skupini, ki je prejemala romiplostim, v primerjavi s skupino, ki je prejemala placebo (p = 0,0022).
Thrombocytopenia after cessation of treatment 
Trombocitopenija po prenehanju zdravljenja
A loss of response or failure to maintain a platelet response with romiplostim within the recommended dosing range should prompt a search for causative factors (see section 4.4, loss of response to romiplostim). 
V primeru pojava neodzivnosti zdravila ali nezmožnosti za vzdrževanje odziva trombocitov pri zdravljenju z romiplostimom v priporočenem odmernem območju je treba poiskati vzročne dejavnike (glejte poglavje 4.4, izguba odziva na romiplostim).
Carton containing 1 or 4 vials of either 125 micrograms (beige cap), 250 micrograms (red cap) or 500 micrograms of romiplostim (blue cap). 
Eno pakiranje vsebuje 1 ali 4 viale, v katerih je 125 mikrogramov (zaporka bež barve), 250 mikrogramov (zaporka rdeče barve) ali 500 mikrogramov romiplostima (zaporka modre barve).
• Step 3a: Attach clear plastic plunger rod to pre-filled sterile water syringe by placing the threaded end of the plunger rod into the syringe and carefully twisting the rod clockwise onto the grey syringe plunger, until you feel a slight resistance. 
• Korak 3a: Namestite prozorno plastično držalo bata na napolnjeno brizgo s sterilno vodo tako, da tisti del držala, na katerem je navoj, vstavite v brizgo in držalo v smeri urinega kazalca previdno privijate v sivi bat brizge, dokler ne začutite rahlega upora.
In the subset of subjects with ITP > 12 months of duration, 29 subjects (46.0%) used concurrent ITP therapy during the study including 21 subjects (33.3%) who used rescue medication and 5 subjects (7.9%) who used concurrent ITP medication at baseline. 
V podskupini bolnikov, ki so imeli ITP > 12 mesecev, je 29 bolnikov (46,0 %) uporabljalo sočasno zdravljenje za ITP med preskušanjem, vključno z 21 bolniki (33,3 %), ki so uporabljali rešilno zdravilo, in 5 bolniki (7,9 %), ki so uporabljali sočasna zdravila za ITP na začetku preskušanja.
The resulting concentration is 125 mcg/mL. 
Koncentracija je tako 125 µg/ml.
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 4 events of thrombocytopenia after cessation of treatment were reported, n = 271 (see section 4.4). 
Na podlagi analize vseh odraslih bolnikov z ITP, ki so prejemali romiplostim v 4 kontroliranih in 5 nekontroliranih kliničnih preskušanjih, so poročali o 4 primerih trombocitopenije po prenehanju zdravljenja, n = 271 (glejte poglavje 4.4).
Across all subjects, the median (Q1, Q3) number of months with platelet response was 30.0 months (13.0 months, 43.0 months) and the median (Q1, Q3) time on study was 35.0 months (23.0 months, 47.0 months). 
V skupini vseh bolnikov je znašala mediana (Q1, Q3) števila mesecev z odgovorom trombocitov 30,0 mesecev (13,0 mesecev, 43,0 mesecev) in mediana (Q1, Q3) časa vključenosti v preskušanje je znašala 35,0 mescev (23,0 mesecev, 47,0 mesecev).
• Remove clear needle shield by holding syringe in one hand and carefully pulling shield straight off with the other hand. 
• Odstranite prozorni ščitnik igle tako, da držite brizgo v eni roki in z drugo roko previdno potegnete ščitnik naravnost z nje.
• Note: It may take up to 2 minutes for the powder to completely dissolve. 
• Opomba: Da se prašek povsem raztopi, lahko traja do 2 minuti.