natgillin/translations-raw huggingface dataset:
• swelling in the hands and feet (oedema peripheral); 
• oteklost rok in nog (periferni edemi),
In the two adult placebo-controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)). 
V dveh placebo kontroliranih preskušanjih odraslih bolnikov je 9 bolnikov poročalo o krvavitvi, ki je bila ocenjena kot resna (5 [6,0 %] romiplostim, 4 [9,8 %] placebo; razmerje obetov [romiplostim/placebo] = 0,59; 95 % IZ = (0,15, 2,31)).
Nplate should be injected once per week in order to keep your platelet counts up. 
Zdravilo Nplate je treba za vzdrževanje večjega števila trombocitov injicirati enkrat na teden.
In the two placebo-controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)). 
V dveh s placebom kontroliranih študijah je pri 9 bolnikih prišlo do krvavitve, ki je bila ocenjena za resno (5 [6,0 %] romiplostim, 4 [9,8 %] placebo, razmerje obetov [romiplostim/placebo] = 0,59; 95 % IZ = (0,15, 2,31)).
May be removed from the refrigerator for a period of 30 days at room temperature (up to 25ºC) when stored in the original carton. 
Če je zdravilo shranjeno v originalni ovojnini, ga lahko vzamete iz hladilnika za 30 dni pri sobni temperaturi (do 25 °C).
Platelet counts above the normal range present a risk for thrombotic/thromboembolic complications. 
Zvišano število trombocitov pomeni tveganje za trombotične/tromboembolične zaplete.
Dilution Guidelines: 
Navodilo za redčenje:
A subject's actual body weight at initiation of therapy should be used to calculate dose. 
Za izračun odmerka morate uporabiti bolnikovo dejansko telesno maso na začetku zdravljenja.
Concentration after dilution 
Koncentracija po redčenju
Injection safety needle x1 
1 x varnostno iglo za injiciranje
Talk to your doctor, pharmacist or nurse before using Nplate. 
Pred začetkom uporabe zdravila Nplate se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Prepare sterile water syringe 
3. korak: Priprava brizge s sterilno vodo
• Do make sure liquid is fully dissolved before removing syringe. 
• Preden odstranite brizgo, se prepričajte, da je zdravilo v tekočini povsem raztopljeno.
• fever (pyrexia); 
• zvišana telesna temperatura (pireksija),
Do make sure solution is fully dissolved before removing syringe. 
Preden odstranite brizgo, se prepričajte, da je zdravilo v raztopini povsem raztopljeno.
Nplate 125 micrograms powder for solution for injection 
Nplate 125 mikrogramov prašek za raztopino za injiciranje
Preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection only must be used for dilution. 
Za redčenje uporabite le sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez dodanih konzervansov.
No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients. 
Med bolniki, zdravljenimi z zdravilom Nplate, in bolniki, zdravljenimi s placebom, niso opazili statistično pomembnih razlik v celokupni incidenci krvavitev.
Muscle tightness Muscular weakness Shoulder pain Muscle twitching 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija mialgija spazmi mišic bolečina v okončini bolečine v hrbtu bolečine v kosteh napetost mišic šibkost mišic bolečina v rami trzanje mišic
EU/1/08/497/006 - 1 pack 
EU/1/08/497/006 - 1 pakiranje
The subject prevalence of rescue medication use showed a trend towards a reduction over the course of the study: from 24.6% (weeks 1 to 12) to < 13.0% (weeks 13 to 216), then 0% after week 216 until the end of the study. 
Prevalenca uporabe rešilnega zdravila je kazala trend zmanjševanja v času preskušanja; od 24,6 % (1. do 12. teden) do < 13,0 % (13. do 216. teden) in nato 0 % od tedna 216 do konca preskušanja.
Pulmonary embolism* 
Bolezni imunskega sistema preobčutljivost**
1 plunger rod for pre-filled syringe. 
1 držalo bata za napolnjeno injekcijsko brizgo.
• Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL. 
• Zdravilo Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1,2 ml sterilne vode za injekcije, s čimer dobimo 1 ml uporabne količine.
- Keep this leaflet. 
• Previdno vrtite vialo.
Study S3 (131) was an open-label randomised 52 week trial in subjects who received romiplostim or medical standard of care (SOC) treatment. 
Rezultati študij v primerjavi s standardno oskrbo pri nesplenektomiranih bolnikih Študija S3 (131) je bila odprto randomizirano 52-tedensko preskušanje pri bolnikih, ki so prejemali zdravljenje z romiplostimom ali s standardno zdravstveno oskrbo.
Romiplostim pharmacokinetics appear not affected by age, weight and gender to a clinically significant extent. 
Starost, telesna masa in spol po vsem sodeč nimajo klinično pomembnega vpliva na farmakokinetiko romiplostima.
Prepare injection site with a new alcohol swab. 
Z novim alkoholnim zložencem pripravite mesto za injiciranje.
• Attach 1 mL syringe to vial adapter of the dissolved Nplate by twisting the syringe tip clockwise onto the vial adapter until you feel a slight resistance. 
• Namestite 1 ml brizgo na nastavek za vialo raztopljenega zdravila Nplate tako, da konico brizge v smeri urinega kazalca zasučete v nastavek za vialo, dokler ne začutite rahlega upora.
Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection 
Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje
An additional overfill is included in each vial to ensure that 125 micrograms of romiplostim can be delivered. 
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 125 mikrogramov romiplostima.
For the storage condition after dilution of the reconstituted medicinal product see section 6.3. 
Za pogoje shranjevanja po redčenju rekonstituiranega zdravila glejte poglavje 6.3.
• headache; 
• glavobol,
(≥ 50 x 10 
(95 % IZ)
= 125 mcg in 0.25 mL 500 mcg/mL 
= 125 µg v 0,25 ml
The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 30.8% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study. 
Prevalenca sočasne uporabe zdravil za ITP je kazala trend zmanjševanja v obdobju študije: od 30,8 % (1. do 12. teden) do < 20,0 % (13. do 240. teden) in nato 0 % od tedna 240 do konca preskušanja.
Vomiting 
Trombocitoza
• rash; 
• driska,
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
POSTOPEK IN POT UPORABE ZDRAVILA
Prepare vial for use, attach vial adapter 
2. korak: Priprava viale za uporabo, namestitev nastavka za vialo
• indigestion (dyspepsia); 
• šibkost (astenija),
• nausea; 
• bolečine,
• Common: may affect up to 1 in 10 people 
• Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
• low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia) 
• nizko število trombocitov (trombocitopenija) in nizko število trombocitov (trombocitopenija) po prenehanju uporabe zdravila Nplate,
Attach safety needle to the filled administration syringe by twisting needle clockwise into syringe Luer lock tip. 
To naredite tako, da iglo v smeri urnega kazalca zasučete na konico nastavka Luer na brizgi.
An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered (see vial content table below). 
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 125 µg romiplostima (glejte tabelo Vsebina viale spodaj).
• redness of the skin (flushing); 
• pordelost kože (zardevanje),
= 250 mcg in 0.50 mL 500 mcg/mL 
= 250 µg v 0,50 ml 500 µg/ml
An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered (see vial content table below). 
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 µg romiplostima (glejte tabelo Vsebina viale spodaj).
• Visually confirm that the needle tip is covered. 
• Poglejte in se prepričajte, da je konica igle pokrita.
• Once the seal is broken, pull the white plastic cover off. You will see grey rubber in the cap. 
• Ko je zapečaten del prelomljen, snemite dol bel plastični pokrovček.
EU/1/08/497/008 - 1 pack 
EU/1/08/497/008 - 1 pakiranje
• Wipe the site where Nplate is to be injected with an alcohol swab, using a circular motion. 
• Z novim alkoholnim zložencem s krožnim gibom obrišite mesto, kamor boste injicirali zdravilo Nplate.
An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered (see vial content table below). 
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 µg romiplostima (glejte tabelo Vsebina viale spodaj).
- The other ingredients are mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20. 
- Druge sestavine zdravila so manitol (E421), saharoza, L-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
In a randomised placebo-controlled trial in MDS adult subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo. 
V randomiziranem, s placebom kontroliranem preskušanju pri odraslih bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim, v primerjavi z bolniki, ki so prejemali placebo, povečanje števila primerov napredovanja bolezni iz MDS v AML in prehodna povečanja števila blastnih celic.
An additional overfill is included in each vial to ensure that 500 micrograms of romiplostim can be delivered. 
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 mikrogramov romiplostima.
• Do dispose of any left-over Nplate in proper waste container. 
• Zavrzite morebitni preostanek zdravila Nplate v ustrezen vsebnik za odpadke.
= 500 mcg in 1.00 mL 500 mcg/mL 
= 500 µg v 1,00 ml 500 µg/ml
Solvent for Nplate Water for injections 
Vehikel za zdravilo Nplate voda za injekcije
Vial containing 500 micrograms of romiplostim. 
Ena viala vsebuje 500 mikrogramov romiplostima.
Romiplostim serum levels appear inversely related to platelet counts. 
Koncentracija romiplostima v serumu je obratno sorazmerna številu trombocitov.
Withdraw all of the medicinal product solution into the administration syringe. 
Izvlecite vso raztopino zdravila v brizgo za injiciranje.
The reconstituted solution should be clear and colourless and should not be administered if particulate matter and/or discolouration are observed. 
Pred uporabo morate raztopino pregledati in se prepričati, da ne vsebuje delcev in ni obarvana.
• When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. 
• Ko je brizga prazna, iglo izvlecite iz kože.
Nplate 250 micrograms powder for solution for injection 
Nplate 250 mikrogramov prašek za raztopino za injiciranje
How to store Nplate 
Shranjevanje zdravila Nplate
c Number of weeks with platelet response is defined as number of weeks with platelet counts ≥ 50 x 109/L during study weeks 2-25. 
Prehodni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 109/l, ugotovljeno 4- ali večkrat od 2. do 25. tedna, a brez trajnega odziva.
An additional overfill is included in each vial to ensure that 250 micrograms of romiplostim can be delivered. 
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 mikrogramov romiplostima.
In a randomised placebo-controlled trial in MDS subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo. 
V randomiziranem, s placebom kontroliranem preskušanju pri bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim, v primerjavi z bolniki, ki so prejemali placebo, povečanje števila primerov napredovanja bolezni iz MDS v AML in prehodna povečanja števila blastnih celic.
Portal vein thrombosis Increase in transaminase 
Bolezni jeter, žolčnika in žolčevodov tromboza portalne vene zvišanje transaminaz
Vial containing 250 micrograms of romiplostim. 
Ena viala vsebuje 250 mikrogramov romiplostima.
Eye disorder Eye pruritus Lacrimation increased Papilloedema Visual disturbances 
Očesne bolezni konjunktivalna krvavitev motnja akomodacije slepota očesne težave srbenje oči močnejše solzenje papiledem motnje vida
Upper respiratory tract infection 
Infekcijske in parazitske bolezni okužba zgornjega respiratornega trakta gastroenteritis gripa lokalizirana okužba nazofaringitis
EU/1/08/497/005 - 1 pack EU/1/08/497/006 - 4 pack 
EU/1/08/497/005 - 1 pakiranje EU/1/08/497/006 - 4 pakiranja
1 mL Luer-lock tip syringe x1 
1 sterilno 1 ml brizgo z nastavkom Luer 1 sterilno varnostno iglo
After dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25ºC when the diluted product was held in a disposable syringe, or 4 hours in a refrigerator (2ºC - 8ºC) when the diluted product was held in the original vial. 
Če je redčeno zdravilo shranjeno v originalni viali, sta kemična in fizikalna stabilnost med uporabo dokazani za 4 ure v hladilniku (2 °C do 8 °C).
Aplastic anaemia Bone marrow failure Leucocytosis Splenomegaly Thrombocythaemia Platelet count increased 
Bolezni krvi in limfatičnega sistema motnja kostnega mozga* trombocitopenija* anemija aplastična anemija odpoved kostnega mozga levkocitoza splenomegalija trombocitemija povečano število trombocitov nenormalno število trombocitov
The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 31.7% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study. 
Prevalenca sočasne uporabe zdravil za ITP je kazala trend zmanjševanja v času preskušanja; od 31,7 % (1. do 12. teden) do < 20,0 % (13. do 240. teden) in nato 0 % od tedna 240 do konca preskušanja.
Do not over tighten. 
Ne privijte preveč.
• Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL. 
• Zdravilo Nplate 125 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,44 ml sterilne vode za injekcije, s čimer dobimo 0,25 ml uporabne količine.
Nplate 125 micrograms powder for solution for injection romiplostim 
Nplate 125 mikrogramov prašek za raztopino za injiciranje romiplostim
Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL. 
Zdravilo Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,72 ml sterilne vode za injekcije, tako nastane 0,5 ml uporabne količine.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealna bolečina***
No clinical sequelae were reported in association with the elevated platelet counts in any of the 3 subjects. 
Pri nobenem od teh 3 bolnikov niso zabeležili kliničnih posledic zvišanega števila trombocitov.
Romiplostim 
angioedem
Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration - a syringe with graduations of 0.01 mL should be used. 
Posebno pozornost je treba nameniti temu, da iz viale potegnete ustrezno količino zdravila Nplate za subkutano dajanje.
• Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL. 
• Zdravilo Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,72 ml sterilne vode za injekcije, s čimer dobimo 0,5 ml uporabne količine.
EU/1/08/497/007 - 1 pack EU/1/08/497/008 - 4 pack 
EU/1/08/497/007 - 1 pakiranje EU/1/08/497/008 - 4 pakiranja
Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL. 
Zdravilo Nplate 125 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,44 ml sterilne vode za injekcije; tako nastane 0,25 ml uporabne količine.
After dissolving, a deliverable amount of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL). 
Po raztapljanju vsebuje uporabna količina 0,25 ml raztopine 125 mikrogramov romiplostima (500 mikrogramov/ml).
Remove 1 mL administration syringe from package. 
Vzemite 1 ml brizgo za injiciranje zdravila iz njenega pakiranja.
Attach the 1 mL syringe to vial adapter of reconstituted solution by twisting the syringe tip onto the vial adapter until you feel a slight resistance. 
Namestite 1 ml brizgo na nastavek za vialo pripravljene raztopine, tako da konico brizge zasučete v nastavek za vialo, dokler ne začutite rahlega upora.
Rhinorrhoea Dry throat Dyspnoea Nasal congestion Painful respiration 
pljučna embolija* kašelj rinoreja suho žrelo dispneja zamašenost nosu bolečine pri dihanju
Turn clockwise to lock into Luer lock tip. 
Zavrtite v smeri urinega kazalca, da boste iglo namestili na konico nastavka Luer.
After dissolving, a deliverable amount of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL). 
Po raztapljanju vsebuje uporabna količina 0,5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ml).
After dissolving, a deliverable amount of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL). 
Po raztapljanju vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ml).
• joint pain (arthralgia); 
• bolečine v sklepih (artralgija),
Prepare new syringe for injection Step 6. 
Odpnite brizgo za injiciranje z nastavka za vialo.
Injection site reaction Peripheral swelling*** 
Infekcijske in parazitske bolezni okužba zgornjega respiratornega trakta rinitis***
• upper abdominal pain; 
• bolečina v zgornjem delu trebuha,
• Check and remove all air bubbles in the syringe. 
• Preverite, ali so v brizgi zračni mehurčki, in jih odstranite.
Platelet counts should be assessed weekly until a stable platelet count 
Število trombocitov je treba kontrolirati vsak teden, dokler ni doseženo stabilno število trombocitov (≥ 50 x 10
Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20. 
Manitol (E421), saharoza, l-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
Nplate 250 micrograms powder for solution for injection romiplostim 
Nplate 250 mikrogramov prašek za raztopino za injiciranje romiplostim
• itchy, runny or blocked nose (rhinitis); 
• srbeč in zamašen nos, izcedek iz nosu (rinitis),
Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL. 
Nplate 500 mikrogramov prašek za raztopino za injiciranje Zdravilo Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1,2 ml sterilne vode za injekcije, tako nastane 1 ml uporabne količine.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 25ºC in disposable syringes, or 4 hours in a refrigerator (2ºC - 8ºC) in the original vials, protected from light. 
Čas običajno ne sme presegati 4 ure pri 25 °C za brizgo za enkratno uporabo ali 4 ure v hladilniku (2 °C do 8 °C) za originalno vialo, zaščiteno pred svetlobo.
Nplate 500 micrograms powder for solution for injection romiplostim 
Nplate 500 mikrogramov prašek za raztopino za injiciranje romiplostim
Decreased appetite Dehydration Gout 
Presnovne in prehranske motnje neprenašanje alkohola anoreksija zmanjšanje teka dehidracija protin
1 vial of powder for solution for injection. 
prašek za raztopino za injiciranje 1 viala
• tiredness (fatigue); 
• srbeč izpuščaj (urtikarija).
Reproductive system and breast disorders 
Vpliv na sposobnost razmnoževanja
Headache 
Krvavitve
Nplate is not recommended for use if you are breast-feeding. 
Če dojite, uporaba zdravila Nplate ni priporočljiva.
After reconstitution, a deliverable volume of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL). 
Po pripravi vsebuje uporabna količina 0,25 ml raztopine 125 mikrogramov romiplostima (500 mikrogramov/ml).
Set up materials for an injection 
1. korak: Priprava materiala za injiciranje
An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered. 
Vsaka viala vsebuje presežek, ki zagotavlja, da je mogoče iz nje dobiti 125 µg romiplostima.
After reconstitution, a deliverable volume of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL). 
Po pripravi vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ml).
500 mcg 
Za komplet 500 μg
Following the first 4-weeks of study romiplostim maintained platelet counts ≥ 50 x 10 
V študijah, kontroliranih s placebom, je romiplostim po prvih 4 tednih študije med 6-mesečnim zdravljenjem ohranil število trombocitov ≥ 50 x 109/l pri 50 % do 70 % bolnikov.
Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20. 
Prašek: manitol (E421), saharoza, L-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
Powder: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20. 
Prašek: manitol (E421), saharoza, l-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
Nplate 125 µg powder for injection romiplostim 
Nplate 125 µg prašek za injiciranje romiplostim s.c.
After reconstitution, a deliverable volume of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL). 
Po pripravi vsebuje uporabna količina 0,5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ml).
Upper abdominal pain*** 
Bolezni prebavil bolečina v zgornjem delu trebuha***
Nplate 500 micrograms powder and solvent for solution for injection romiplostim 
Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje romiplostim
Attach vial adapter to Nplate vial by peeling off paper backing from vial adapter, keeping the vial adapter in its packaging. 
Namestite nastavek za vialo na vialo zdravila Nplate tako, da odstranite papirnato prelepko z nastavka za vialo.
Nplate 250 micrograms powder and solvent for solution for injection 
Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje
Nplate 250 micrograms powder and solvent for solution for injection romiplostim 
Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje romiplostim
There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents. 
Prenehanje zdravljenja z romiplostimom ob uporabi antikoagulantov ali antiagregacijskih zdravil povečuje tveganje za krvavitve.
Nplate 250 µg powder for injection romiplostim 
Nplate 250 µg prašek za injiciranje romiplostim s.c.
Nplate 500 µg powder for injection romiplostim 
Nplate 500 µg prašek za injiciranje romiplostim s.c.
9/L at study entry. 
9/l od 2. do 25. tedna študije.
Lacrimation increased Papilloedema Visual disturbances 
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica
Nplate 500 micrograms powder and solvent for solution for injection 
Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje:
Plunger rod for pre-filled sterile water syringe x1 Pre-filled sterile water syringe x1 
1 vialo praška za raztopino za injiciranje 1 napolnjeno injekcijsko brizgo, ki vsebuje 1,2 ml vehikla 1 držalo bata za napolnjeno injekcijsko brizgo 1 sterilen nastavek za vialo
• contusion; 
• zaprtje,