natgillin/translations-raw huggingface dataset:
Keeping the vial on the bench, attach the pre-filled syringe of water for injections to vial adapter: hold the outer edge of the vial adapter with one hand and twist the syringe tip clockwise onto the adapter with the other hand until you feel a slight resistance.
Viala naj stoji na podlagi; v tem položaju namestite napolnjeno injekcijsko brizgo z vodo za injekcije na nastavek za vialo: z eno roko držite zunanji rob nastavka za vialo in z drugo roko zasučite konico brizge v smeri urnega kazalca v nastavek, dokler ne začutite rahlega upora.
Immediately discard syringe and needle into an approved Sharps Container.
Brizgo in iglo takoj zavrzite v ustrezen vsebnik za ostre odpadke.
Protein urine present
Bolezni sečil beljakovine v urinu
• Do dispose of the used needle and syringe in a puncture-resistant container.
• Zavrzite uporabljeno iglo in brizgo v vsebnik, odporen proti prebadanju.
= 250 mcg in 0.50 mL
= 250 µg v 0,50 ml
RECONSTITUTION PACK OUTER CARTON WITH BLUE BOX
ZUNANJA OVOJNINA KOMPLETA ZA PRIPRAVO Z MODRIM OKENCEM
1 sterile 1 mL Luer lock syringe.
1 sterilno 1 ml brizgo z nastavkom Luer.
Apply strong force while twisting to attach the safety needle onto syringe.
Med sukanjem močno pritisnite, da boste varnostno iglo namestili na brizgo.
No. (%) patients with durable platelet response a
Št. (%) bolnikov s trajnim odzivom trombocitov a
Each vial of Nplate 500 micrograms powder for solution for injection contains a total of 625 micrograms of romiplostim.
Ena viala zdravila Nplate 500 mikrogramov prašek za raztopino za injiciranje vsebuje celokupno 625 mikrogramov romiplostima.
Powder for solution for injection (powder for injection).
prašek za raztopino za injiciranje (prašek za injekcijo) Prašek je bel.
Treatment with romiplostim resulted in statistically significantly greater incidence of platelet response compared with placebo (p = 0.0008).
V skupini, ki je prejemala zdravljenje z romiplostimom, je bilo statistično značilno višja incidenca odziva trombocitov v primerjavi s skupino, ki je prejemala placebo (p = 0,0008).
It is not known if this may progress to a more severe form called “fibrosis.” Signs of bone marrow changes may show up as abnormalities in your blood tests.
Ni znano, ali lahko napreduje v hujšo obliko, ki jo imenujemo "fibroza".
In the Phase 3 paediatric study, the mean (SD) number of composite bleeding episodes (see section 5.1) was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm.
V preskušanju faze 3 pediatričnih bolnikov je bilo povprečje števila sestavljenih krvavitev (glejte poglavje 5.1) v skupini, ki je prejemala romiplostim, 1,9 (4,2) in v skupini, ki je prejemala placebo,
Each vial of Nplate 125 micrograms powder for solution for injection contains a total of 230 micrograms of romiplostim.
Ena viala zdravila Nplate 125 mikrogramov prašek za raztopino za injiciranje vsebuje celokupno 230 mikrogramov romiplostima.
Patients had a median platelet count of 19 x 10
Ob vključitvi v študijo so imeli bolniki mediano vrednost števila trombocitov 19 x 10
What Nplate contains
Kaj vsebuje zdravilo Nplate
• bone marrow failure; disorder of the bone marrow that causes scarring (myelofibrosis); enlarged spleen (splenomegaly); bleeding of the vagina (vaginal haemorrhage), bleeding in the rectum (rectal haemorrhage); bleeding mouth (mouth haemorrhage); injection site bleeding (injection site haemorrhage);
• odpoved kostnega mozga, bolezen kostnega mozga, ki povzroči brazgotinjenje (mielofibroza), povečana vranica (splenomegalija), krvavitev iz nožnice (vaginalna krvavitev), krvavitev iz danke (rektalna krvavitev), krvavitev v ustih, krvavitev na mestu injiciranja,
• itching of the skin (pruritis);
• srbenje kože (pruritus),
Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection
Nplate 125 mikrogramov prašek za raztopino za injiciranje Nplate 250 mikrogramov prašek za raztopino za injiciranje Nplate 500 mikrogramov prašek za raztopino za injiciranje
Across the entire ITP clinical programme an inverse relationship between bleeding events and platelet counts was observed.
V celotnem kliničnem programu ITP so opažali obratno sorazmerje med pojavom krvavitev in številom trombocitov.
Dose adjustment guidance based on platelet count
Tabela 2: Navodilo za prilagajanje odmerkov na osnovi števila trombocitov
Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1).
V kombinaciji z romiplostimom (glejte poglavje 5.1) je mogoče uporabo kortikosteroidov, danazola in azatioprina zmanjšati ali prekiniti.
• upper respiratory tract infection;
• okužba zgornjih dihal,
Patients had a median platelet count of 14 x 10
Ob vključitvi v študijo so imeli bolniki mediano vrednost števila trombocitov 14 x 10
• Lift off plastic vial adapter packaging, leaving vial adapter on vial.
• Dvignite plastično ovojnino z nastavka za vialo, tako da ostane nastavek za vialo na viali.
If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts.
Če se število trombocitov preveč poveča, prekinite uporabo zdravila Nplate in kontrolirajte število trombocitov.
After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC and for 24 hours at 2ºC - 8ºC, when protected from light and kept in the original vial.
Po pripravi: Če je zdravilo zaščiteno pred svetlobo in je v originalni viali, sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 25 °C in za 24 ur pri temperaturi od 2 °C do 8 °C.
Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC.
Med 77 bolniki, ki so bili randomizirani v skupino s standardno oskrbo, dva bolnika nista prejela standardne oskrbe.
Patients with hepatic Impairment
Bolniki z okvaro jeter
In a randomised placebo-controlled trial in MDS subjects, treatment with romiplostim was prematurely stopped due to a numerical excess of disease progression to AML and an increase in circulating blasts greater than 10% in patients receiving romiplostim.
V randomiziranem, s placebom kontroliranem preskušanju pri bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim številčni presežek napredovanje bolezni v AML in povečanje števila blastnih celic v obtoku za več kot 10 %.
Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Izdelovalec Amgen NV Arianelaan 5 1200 Brussel Belgija
In the subset of subjects with ITP > 12 months of duration, the mean (SD) number of composite bleeding episodes was 2.1 (4.7) for the romiplostim arm and 4.2 (7.5) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.0 (0, 4) in the placebo arm. Because the statistical testing for the incidence of rescue medication use was not significant, no statistical test was done for the number of composite bleeding episodes endpoint.
V podskupini bolnikov, ki so imeli ITP > 12 mesecev, je bilo povprečno (SD) število skupne pojavnosti krvavitev 2,1 (4,7) v skupini, ki je prejemala romiplostim, in 4,2 (7,5) v skupini, ki je prejemala placebo, z mediano (Q1, Q3) števila krvavitev 0,0 (0, 2) v skupini, ki je prejemala romiplostim, in 0,0 (0, 4) v skupini, ki je prejemala placebo.
9/L for 4 or more times during study weeks 2-25 but without durable platelet response.
9/l, ugotovljeno 6- ali večkrat od 18. do 25. tedna študije brez uporabe rešilnih zdravil kadarkoli med zdravljenjem.
Action Increase once weekly dose by 1 mcg/kg
Odmerek enkrat na teden povečajte za 1 µg/kg.
A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with chronic ITP and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
Pozitivno razmerje koristi in tveganja za romiplostim je vzpostavljeno samo za zdravljenje trombocitopenije, povezane s kronično ITP.
Both studies enrolled paediatric subjects (≥ 1 year to < 18 years of age) with thrombocytopenia (defined by a mean of 2 platelet counts ≤ 30 x 109/L with neither count > 35 x 109/L in both studies) with ITP, regardless of splenectomy status.
V obe preskušanji so bili vključeni pediatrični bolniki (stari ≥ 1 leto do < 18 let) s trombocitopenijo (definirano kot povprečje dveh vrednosti števila trombocitov ≤ 30 x 10
If the calculated individual patient dose is less than 23 mcg, an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate volume (see table below).
Če je izračunan odmerek za posameznega bolnika nižji od 23 µg, je potreben dodaten korak redčenja do 125 µg/ml s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez dodanih konzervansov za zagotovitev točnega volumna (glejte tabelo spodaj).
Sterile water for injections only should be used when reconstituting the medicinal product.
Za pripravo zdravila smete uporabiti le sterilno vodo za injekcije.
• Do make sure that all air bubbles are removed before injection.
• Pred injiciranjem preverite, da so vsi zračni mehurčki odstranjeni.
In adult clinical studies of treatment with romiplostim in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to AML were reported.
V kliničnih preskušanjih zdravljenja odraslih bolnikov z romiplostimom pri bolnikih z MDS so opazili primere prehodnega povečanja števila blastnih celic in poročali tudi o primerih napredovanja bolezni iz MDS v AML.
Vial containing 125 micrograms of romiplostim.
Ena viala vsebuje 125 mikrogramov romiplostima.
Overall, a significant greater proportion of subjects in the romiplostim arm achieved the primary endpoint compared with subjects in the placebo arm (p = 0.0018).
Celokupno je v skupini bolnikov, ki so prejemali romiplostim, značilno večji delež bolnikov dosegel primarni opazovani dogodek v primerjavi z bolniki, ki so prejemali placebo (p = 0,0018).
In clinical studies of treatment with romiplostim in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to AML were reported.
V kliničnih preskušanjih zdravljenja z romiplostimom pri bolnikih z MDS so opazili primere prehodnega povečanja števila blastnih celic in poročali tudi o primerih napredovanja bolezni iz MDS v AML.
Study S3 (131) was an open-label randomised 52 week trial in adult 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 odraslih bolnikih, ki so prejemali zdravljenje z romiplostimom ali s standardno zdravstveno oskrbo.
Vaginal haemorrhage
ZUNANJA OVOJNINA
Dose calculator
Kalkulator odmerka
No adverse effects were seen in rats given a single dose of 1,000 mcg/kg or in monkeys after repeated administration of romiplostim at 500 mcg/kg (100 or 50 times the maximum clinical dose of 10 mcg/kg, respectively).
Pri podganah, ki so dobile posamičen odmerek 1.000 µg/kg, in opicah po večkratni uporabi 500 µg/kg romiplostima (prvo je 100-kratni, drugo pa 50-kratni največji klinični odmerek 10 µg/kg) niso ugotovili neželenih učinkov.
Cases of thromboembolic events (TEEs), including portal vein thrombosis, have been reported in patients with chronic liver disease receiving romiplostim.
Pri bolnikih s kronično boleznijo jeter, ki so prejemali romiplostim, so bili opisani primeri tromboemboličnih dogodkov, vključno s trombozo portalne vene.
Similar reduction of the subject prevalence of rescue medication over the course of the study was seen in the subset of subjects with ITP > 12 months of duration: from 25.4% (weeks 1 to 12) to ≤ 13.1% (weeks 13 to 216), then 0% after week 216 until the end of the study.
Podobno zmanjševanje prevalence uporabe rešilnega zdravila v času študije je bilo opaženo v podskupini bolnikov, ki so imeli ITP > 12 mesecev: od 25,4 % (1. do 12. teden) do ≤ 13,1 % (13. do 216. teden) in nato 0 % od tedna 216 do konca preskušanja.
You should speak with your doctor before driving or using machines, as some side effects (e.g. temporary bouts of dizziness) may impair your ability to do so safely.
Nekateri neželeni učinki (npr. prehodni pojavi omotice) namreč lahko poslabšajo vašo sposobnost za varno izvajanje teh dejavnosti.
Turn assembled syringe-vial unit upside down, so the vial of reconstituted product is above the syringe.
Obrnite sestavljeno enoto brizga-viala na glavo, tako da je viala s pripravljenim zdravilom nad brizgo.
From a microbiological point of view, the diluted medicinal product should be used immediately.
Z mikrobiološkega stališča je razredčeno zdravilo treba uporabiti takoj.
Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim.
Po prenehanju zdravljenja z romiplostimom je verjeten ponoven pojav trombocitopenije.
A significantly higher proportion of patients receiving romiplostim achieved a durable platelet response compared to patients receiving placebo in both studies.
V obeh študijah je trajen odziv trombocitov dosegel znatno večji delež bolnikov, ki so prejemali zdravilo Nplate, kot tistih, ki so prejemali placebo.
Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Zvišanje retikulina v kostnem mozgu velja za posledico stimulacije receptorjev TPO.
Monitoring of these parameters should be considered in patients treated with romiplostim.
Bolnikom, ki dobivajo romiplostim, je priporočljivo kontrolirati te vrednosti.
• bruising (contusion);
• podplutbe (kontuzija),
• problems with the digestive system including: vomiting; bad breath (breath odour); difficulty swallowing (dysphagia); indigestion or heartburn (gastro-oesophageal reflux disease); blood in the stools (haematochezia); stomach discomfort; mouth ulcers or mouth blistering (stomatitis); discoloured teeth (tooth discolouration);
• težave s prebavili, med njimi: bruhanje, zadah iz ust, težave s požiranjem (disfagija), prebavne motnje ali zgaga (gastroezofagealna refluksna bolezen), kri v blatu (hematohezija), nelagodje v želodcu, razjede v ustih ali mehurji v ustih (stomatitis), obarvanje zob,
Hypoaesthesia Hypogeusia Neuropathy peripheral Transverse sinus thrombosis
Bolezni živčevja glavobol omotica migrena parestezije klonus dizgevzija hipoestezija hipogevzija periferna nevropatija tromboza tranzverzalnega sinusa
Attach plunger rod to the pre-filled syringe of water for injections by twisting the plunger rod clockwise onto the syringe plunger, until you feel a slight resistance.
Namestite držalo bata na napolnjeno injekcijsko brizgo z vodo za injekcije, in sicer tako, da držalo v smeri urnega kazalca privijate na bat brizge, dokler ne začutite rahlega upora.
Self-administration of Nplate is not allowed for paediatric patients.
Pediatrični bolniki si zdravila Nplate ne smejo aplicirati sami.
Rectal haemorrhage Breath odour Dysphagia Gastro-oesophageal reflux disease Haematochezia Mouth haemorrhage Stomach discomfort Stomatitis
navzea driska bolečine v trebuhu zaprtost dispepsija bruhanje rektalna krvavitev halitoza disfagija gastroezofagealna refluksna bolezen hematohezija krvavitev v ustih nelagodje v želodcu stomatitis obarvanje zob
• 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.