natgillin/translations-raw huggingface dataset:
• After injecting, use your thumb (or tip of your finger) to activate the pink safety cover by pushing the cover forward using the same hand until you hear and/or feel it click and lock into place over the needle.
• Po injiciranju s palcem (ali konico kakšnega drugega prsta) aktivirajte rožnati varnostni pokrovček tako, da ga z isto roko potisnete naprej, dokler ne zaslišite in/ali začutite, da je kliknil in se je zaskočil nad iglo.
Keep the Nplate self injection kit refrigerated at 2ºC to 8ºC.
Komplet za samoinjiciranje zdravila Nplate shranjujte v hladilniku pri temperaturi od 2 do 8 °C.
• inflammation of the sinuses (sinusitis);
• vnetje sinusov (sinusitis),
The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML.
Najbolj resni neželeni učinki, ki se lahko pojavijo med zdravljenjem z zdravilom Nplate, vključujejo: ponoven pojav trombocitopenije in krvavenje po prenehanju zdravljenja, zvišanje retikulina v kostnem mozgu, trombotične/tromboembolične zaplete, napake pri uporabi zdravila in napredovanja bolezni iz MDS v AML.
It is unknown whether romiplostim/metabolites are excreted in human milk.
Ni znano, ali se romiplostim/presnovki izločajo v materino mleko.
• In adults, future dose adjustments are based on changes in platelet counts only.
• Pri odraslih bolnikih nadaljnje prilagoditve odmerka temeljijo samo na spremembi števila trombocitov.
The median (Q1, Q3) average weekly dose was 4.82 mcg/kg (1.88 mcg/kg, 8.79 mcg/kg).
Mediana (Q1, Q3) povprečnega tedenskega odmerka je bila 4,82 µg/kg (1,88 µg/kg, 8,79 µg/kg).
Patients had been diagnosed with ITP for approximately 2 years at the time of study entry.
Ob vključitvi v študijo so imeli ITP diagnosticirano približno 2 leti.
The risk of blood clotting may also be increased if you: have liver problems; are elderly (≥ 65 years); are bedridden; have cancer; are taking the contraceptive pill or hormone replacement therapy; have recently had surgery or suffered an injury; are obese (overweight); are a smoker.
Vaše tveganje krvnih strdkov je lahko večje tudi: če imate težave z jetri, če ste starejša oseba (≥ 65 let), če ste priklenjeni na posteljo, če imate raka, če jemljete kontracepcijske tablete ali hormonsko nadomestno zdravljenje, če ste pred kratkim imeli operacijo ali kakšno poškodbo, če ste debeli (čezmerno težki), če kadite.
Pull back on the pink safety cover toward the syringe and away from the needle.
Potegnite rožnati varnostni pokrovček k brizgi in proč od igle.
Among the 75 subjects who received at least one dose of SOC, the total median exposure to SOC was 51 weeks and ranged from 0.4 to 52 weeks.
Med 75 bolniki, ki so prejeli vsaj en odmerek standardne oskrbe, je bila celotna mediana izpostavljenosti standardni oskrbi 51 tednov in je segala od 0,4 do 52 tednov.
• Do not use components that have evidence of tampering or damage.
• Ne uporabite posameznih naštetih elementov, na katerih so vidni znaki poseganja vanje ali okvare.
• Do not force the water into the vial.
• Ne potiskajte vode v vialo s silo.
Volume of sterile water for injection
Količina sterilne vode za injekcije
Injecting Nplate yourself
Če si sami injicirate zdravilo Nplate
Results from pivotal placebo-controlled studies
Rezultati ključnih s placebom kontroliranih študij
If you have very high blood platelet counts this may increase the risk of blood clotting.
Če imate zelo veliko trombocitov v krvi, lahko to poveča tveganje za nastanek krvnih strdkov.
Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg.
Zdravljenje z romiplostimom je treba prekiniti, če se število trombocitov po štirih tednih zdravljenja z največjim tedenskim odmerkom romiplostima 10 µg/kg ne poveča dovolj, da bi preprečilo klinično pomembne krvavitve.
• blood clot in a lung artery (pulmonary embolism);
• krvni strdek v pljučni arteriji (pljučna embolija),
Therefore if your doctor suspects that you have been given more Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Če torej zdravnik sumi, da ste dobili večji odmerek zdravila Nplate, kot bi smeli, je priporočljivo, da vas kontrolira glede znakov in simptomov neželenih učinkov in da ste takoj deležni ustreznega zdravljenja.
The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes.
Farmakokinetika romiplostima vključuje tarčno posredovano odstranjevanje, ki domnevno poteka preko receptorjev TPO na trombocitih in drugih celicah trombopoetske vrste, npr. na megakariocitih.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z romiplostimom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
• Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.
• Predpisani odmerek injicirajte pod kožo po navodilu, ki ste ga dobili od vašega zdravnika, medicinske sestre ali farmacevta.
Romiplostim has no amino acid sequence homology to endogenous TPO.
Aminokislinsko zaporedje romiplostima ni homologno endogenemu TPO.
9/L) and treatment interruption (400 x 10 9/L) may be considered according to medical judgement.
9/l) in prekinitev zdravljenja (400 x 10
Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production.
Romiplostim je Fc-peptidna fuzijska beljakovina (peptidno telo), ki signalizira in aktivira znotrajcelične transkripcijske poti preko receptorjev TPO (te receptorje imenujemo tudi cMpl), in tako poveča nastajanje trombocitov.
Reconstitute lyophilised product as described in section 6.6.
Pripravite liofilizirano zdravilo kot je opisano v poglavju 6.6.
Therefore if your doctor suspects that you have been given less Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Če torej zdravnik sumi, da ste dobili manjši odmerek zdravila Nplate, kot bi morali, je priporočljivo, da vas kontrolira glede znakov in simptomov neželenih učinkov in da ste takoj deležni ustreznega zdravljenja.
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 24 hours at 25ºC or 24 hours in a refrigerator (2ºC - 8ºC), protected from light.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme biti daljši od 24 ur pri 25 °C ali 24 ur v hladilniku (2 °C do 8 °C), zaščiteno pred svetlobo.
Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Romiplostim je pridobljen v Escherichia coli (E. coli) s tehnologijo rekombinantne DNA.
Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim.
Bolnike morate natančno spremljati, da bi ugotovili zmanjšanje števila trombocitov, in jih ustrezno voditi, da bi preprečili krvavitve po prenehanju zdravljenja z romiplostimom.
A maximum once weekly dose of 10 mcg/kg should not be exceeded.
Največjega odmerka 10 µg/kg enkrat na teden ne smete preseči.
Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts.
Študije na živalih so pokazale, da romiplostim prehaja skozi placento in poveča število trombocitov pri plodovih.
Your doctor will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate.
Zdravnik bo presodil, ali je treba zaradi nepravilnosti vaših izvidov krvi opraviti preiskave kostnega mozga in ali morate nehati uporabljati zdravilo Nplate.
The once weekly dose of romiplostim should be increased by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 x 10
Odmerek romiplostima enkrat na teden je treba povečevati po 1 µg/kg, dokler bolnik ne doseže števila trombocitov ≥ 50 x 10
• raised white blood cell count (leucocytosis);
• povečano število belih krvnih celic (levkocitoza),
Immediately prepare new syringe for injection.
Takoj pripravite novo brizgo za injiciranje.
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5% (248/271).
Na podlagi analize vseh odraslih bolnikov z ITP, ki so prejemali romiplostim v 4 kontroliranih in 5 nekontroliranih kliničnih preskušanjih, je bila celotna incidenca vseh neželenih učinkov pri bolnikih, zdravljenih z romiplostimom, 91,5 % (248/271).
Draw air into syringe to the 1 mL mark
Potegnite v brizgo zrak do oznake 1 ml
- The active substance is romiplostim.
- Zdravilna učinkovina je romiplostim.
The maximum deliverable volume for the 250 microgram vial is 0.5 mL and for the 500 microgram vial is 1 mL.
Največja uporabna količina iz 250 mikrogramske viale je 0,5 ml in iz 500 mikrogramske viale 1 ml.
What Nplate looks like and contents of the pack
Izgled zdravila Nplate in vsebina pakiranja
Across all subjects, the median (Q1, Q3) percentage of months with platelet response was 93.33% (67.57%, 100.00%) and was similar across age groups.
V skupini vseh bolnikov je znašala mediana (Q1, Q3) odstotka mesecev z odgovorom trombocitov 93,33 % (67,57 %, 100,00 %) in je bila podobna med starostnimi skupinami.
Common: may affect up to 1 in 10 people (may show up in blood or urine tests)
Pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov (lahko se pokažejo na preiskavah krvi ali urina)
Dilution is required to ensure accurate dosing.
Za natančno odmerjanje je potrebno redčenje.
This non-linear decrease in volume of distribution is in line with the (megakaryocyte and platelet) target-mediated binding of romiplostim, which may be saturated at the higher doses applied.
To nelinearno zmanjšanje volumna porazdelitve se sklada s tarčno posredovano vezavo romiplostima (na megakariocitih in trombocitih), ki je lahko pri večjih odmerkih zasičena.
Nplate is not recommended for use if you are pregnant unless indicated by your doctor.
Uporaba zdravila Nplate ni priporočljiva, če ste noseči, razen če zdravnik ugotovi, da to zdravilo res potrebujete.
If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inform your doctor immediately.
Če vam je zdravnik dovolil, da si zdravilo injicirate sami in ste si pozabili dati injekcijo, morate o tem takoj obvestiti svojega zdravnika.
Additionally, in the phase 3 pivotal studies, romiplostim did not affect the red blood cell and white blood cells lineages relative to placebo treated subjects.
Poleg tega romiplostim v ključnih študijah 3. faze pri preiskovancih v primerjavi s placebom ni vplival na rdečo in belo celično vrsto.
If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered.
Če pri bolniku pride do zmanjšanja učinkovitosti in nenormalnosti v razmazu krvi, morate uporabo romiplostima prekiniti, opraviti klinični pregled in razmisliti o biopsiji kostnega mozga z ustreznim barvanjem na retikulin.
Of those 62 subjects, 48 subjects had ITP > 12 months of duration (32 subjects received romiplostim and 16 subjects received placebo).
Od teh 62 bolnikov je 48 bolnikov imelo ITP > 12 mesecev (32 bolnikov je prejelo romiplostim in 16 bolnikov je prejelo placebo).
Platelet count (x 10
Število trombocitov (x 10
Romiplostim was administered to 157 subjects by subcutaneous (SC) injection once weekly starting at a dose of 3 mcg/kg, and adjusted throughout the study within a range of 1-10 mcg/kg in order to maintain platelet counts between 50 and 200 x 10
157 bolnikom v subkutani (s.c.) injekciji enkrat na teden, uvodoma v odmerku 3 µg/kg in s prilagajanjem med celotno študijo v razponu 1-10 µg/kg, tako da so število trombocitov vzdrževali med 50 in 200 x 10
If you use less Nplate than you should
Če ste uporabili manjši odmerek zdravila Nplate, kot bi morali
Of the 66 subjects enrolled in the study, 63 subjects had ITP > 12 months of duration.
Od 66 vključenih bolnikov je imelo 63 bolnikov ITP > 12 mesecev.
All (100%) splenectomised patients who were receiving romiplostim were able to reduce the dose by more than 25% or discontinue the concurrent ITP medical therapies by the end of the treatment period compared to 17% of placebo treated patients.
Vsi (100 %) splenektomirani bolniki, ki so prejemali romiplostim, so lahko do konca obdobja zdravljenja zmanjšali odmerek sočasnih zdravil za ITP za več kot 25 % ali so lahko ta zdravila celo opustili; med bolniki, ki so prejemali placebo, je bilo takšnih 17 %.
• Do not touch vial stopper or spike of vial adapter.
• Ne dotikajte se zamaška viale ali konice nastavka za vialo.
Carton containing 1 or 4 vials of romiplostim.
Škatla vsebuje 1 ali 4 viale z romiplostimom.
Future dose adjustments are based on changes in platelet counts only and made in 1 mcg/kg increments (see table below).
Nadaljnje prilagoditve odmerka morajo temeljiti zgolj na spremembi števila trombocitov in jih je treba izvajati v korakih po 1 µg/kg (glejte preglednico spodaj).
Localised infection Nasopharyngitis
gripa lokalizirana okužba nazofaringitis
• Do make sure all air bubbles are removed from the syringe.
• Prepričajte se, da so vsi zračni mehurčki odstranjeni iz brizge.
Of these 9 subjects, 2 subjects had pre-existing binding non-neutralising antibodies to TPO.
Od teh 9 bolinkov sta 2 bolnika imela že obstoječa vezavna ne nevtralizirajoča protitelesa proti TPO.
Patients (≥ 18 years) were randomised in a 2:1 ratio to receive a starting dose of romiplostim 1 mcg/kg or placebo.
Bolnike (stare ≥ 18 let) so v razmerju 2:1 randomizirali na skupino, ki je prejemala začetni odmerek 1 µg/kg romiplostima in skupino, ki je prejemala placebo.
Post implantation loss and a slight increase in peri-natal pup mortality also occurred in animal studies (see section 5.3).
V študijah na živalih so ugotovili tudi poimplantacijske izgube in rahlo večjo perinatalno umrljivost mladičev (glejte poglavje 5.3).
• Do not shake the vial.
• Ne stresajte viale.
• Do not touch the top of vial adapter.
• Ne dotikajte se zgornjega dela nastavka za vialo.
Medication Errors
Napake pri uporabi zdravila
• Once all air bubbles are removed and syringe is filled with your correct dose, twist off syringe from vial adapter.
• Ko so vsi zračni mehurčki odstranjeni in je brizga napolnjena s pravilnim odmerkom, odvijte brizgo iz nastavka za vialo.
Do rotate the site for each injection.
Krožno menjajte mesta za vsako posamezno injiciranje.
• Draw air into syringe to 1 mL marking.
• Potegnite v brizgo zrak do oznake 1 ml.
• Do not pull the plunger out of the back of the syringe.
• Ne izvlecite bata ven iz zadnjega dela brizge.
Blood pressure increased Blood lactate dehydrogenase increased Body temperature increased Weight decreased Weight increased
Preiskave zvišan krvni tlak zvišanje laktat-dehidrogenaze v krvi zvišanje telesne temperature zmanjšanje telesne mase povečanje telesne mase
• 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