FrancophonIA/ELRC3.0 huggingface dataset:
English: In another ITP clinical trial, no accumulation in serum concentrations was observed after 6 weekly doses of romiplostim (3 mcg/kg).
Slovenian: V drugem kliničnem preskušanju ITP po 6 tedenskih odmerkih romiplostima (3 µg/kg) niso opazili kopičenja koncentracije v serumu.
English: 75 kg patient is initiated at 1 mcg/kg of romiplostim.
Slovenian: Zdravljenje 75 kg bolnika se začne z 1 µg/kg romiplostima.
English: 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).
Slovenian: 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).
English: Thrombocytopenia after cessation of treatment
Slovenian: Trombocitopenija po prenehanju zdravljenja
English: 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).
Slovenian: 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).
English: Carton containing 1 or 4 vials of either 125 micrograms (beige cap), 250 micrograms (red cap) or 500 micrograms of romiplostim (blue cap).
Slovenian: 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).
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: The resulting concentration is 125 mcg/mL.
Slovenian: Koncentracija je tako 125 µg/ml.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: • Remove clear needle shield by holding syringe in one hand and carefully pulling shield straight off with the other hand.
Slovenian: • Odstranite prozorni ščitnik igle tako, da držite brizgo v eni roki in z drugo roko previdno potegnete ščitnik naravnost z nje.
English: • Note: It may take up to 2 minutes for the powder to completely dissolve.
Slovenian: • Opomba: Da se prašek povsem raztopi, lahko traja do 2 minuti.
English: • hair loss (alopecia); sensitivity to light (photosensitivity reaction); acne; allergic reaction in the skin upon contact with allergen (dermatitis contact); skin manifestation with rash and blisters (eczema); dry skin; redness of the skin (erythema); severe flaking or peeling rash (exfoliative rash); abnormal hair growth; thickening and itching of the skin due to repeated scratching (prurigo); bleeding beneath the surface of the skin or bruising under the skin (purpura); bumpy skin rash (rash papular); itchy skin rash (rash pruritic); generalised itchy rash (urticaria); bump on the skin (skin nodule); abnormal smell to the skin (skin odour abnormal);
Slovenian: • izpadanje las (alopecija), občutljivost za svetlobo (fotosenzibilnostna reakcija), akne, alergijska reakcija na koži po stiku z alergenom (kontaktni dermatitis), kožne spremembe z izpuščajem in mehurji (ekcem), suha koža, pordelost kože (eritem), hudo luščenje ali izpuščaj z lupljenjem kože (eksfoliativen izpuščaj), nenormalna rast dlak, zadebelitev in srbenje kože zaradi ponavljajočega se praskanja (prurigo), krvavitev pod kožno površino ali podkožne podplutbe (purpura), kožni izpuščaj z bunčicami (papularen izpuščaj), srbeč kožni izpuščaj (pruritičen izpuščaj), generaliziran izpuščaj na koži (urtikarija), bunčica na koži (kožni vozlič), nenormalen vonj kože,
English: Actual body weight at initiation of treatment should always be used when calculating initial dose.
Slovenian: Za izračun začetnega odmerka morate vedno uporabiti dejansko telesno maso na začetku zdravljenja.
English: • Do ensure that the plunger remains in the syringe.
Slovenian: • Poskrbite, da bat ostane v brizgi.
English: Three recommended injection sites for Nplate include: Front of the middle thighs
Slovenian: Med tremi priporočenimi mesti za injiciranje zdravila Nplate so: sprednji del srednjega dela stegen trebuh (razen predela 5 centimetrov tik okrog popka)
English: *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
Slovenian: *Za izračun odmerka romiplostima morate vedno uporabiti dejansko telesno maso na začetku zdravljenja.
English: • Holding the syringe in the palm of your hand with the tip facing up, remove the safety needle from the package.
Slovenian: • Držite brizgo v dlani roke in s konico obrnjeno navzgor ter vzemite varnostno iglo iz pakiranja.
English: No. (%) patients with overall platelet response b
Slovenian: vrednost p Št. (%) bolnikov s celotnim odzivom trombocitov b
English: 10 kg patient is initiated at 1 mcg/kg of romiplostim.
Slovenian: Zdravljenje 10 kg bolnika se začne z 1 µg/kg romiplostima.
English: Overdose may result in an excessive increase in platelet counts associated with thrombotic/thromboembolic complications.
Slovenian: Preveliko odmerjanje lahko povzroči prekomerno povečanje števila trombocitov in s tem povezane trombotične/tromboembolične zaplete.
English: Romiplostim must not be used for the treatment of thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP outside of clinical trials.
Slovenian: Romiplostima se zunaj kliničnih preskušanj ne sme uporabljati za zdravljenje trombocitopenije, ki je posledica MDS, ali trombocitopenije kakršnegakoli drugega vzroka razen ITP.
English: The mean duration of exposure to romiplostim in this study population was 50 weeks.
Slovenian: Ta skupina bolnikov je bila romiplostimu izpostavljena povprečno 50 tednov.
English: The initial dose of romiplostim is 1 mcg/kg based on actual body weight.
Slovenian: Začetni odmerek romiplostima je 1 µg/kg glede na dejansko telesno maso.
English: Your dose may be adjusted further in order to maintain long-term control of your platelet count.
Slovenian: Odmerek bo morda treba še prilagoditi, da bo število vaših trombocitov dolgoročno ostalo na primerni ravni.
English: Medication errors including overdose and underdose have been reported in patients receiving Nplate, dose calculation and dose adjustment guidelines should be followed.
Slovenian: 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.
English: The MAH shall agree the details of the following educational tools with the National Competent Authorities and must implement such programme nationally.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet bo podrobnosti sledečih izobraževalnih orodij uskladil s pristojnimi nacionalnimi organi.
English: = 500 mcg in 1.00 mL
Slovenian: = 500 µg v 1,00 ml
English: In clinical trials, mild to moderate, transient bouts of dizziness were experienced by some patients.
Slovenian: V kliničnih preskušanjih so se nekaterim bolnikom pojavili blagi do zmerni prehodni napadi omotice.
English: • problems with the nose and throat including: cough; runny nose (rhinorrhoea); dry throat; shortness of breath or difficulty breathing (dyspnoea); nasal congestion; painful breathing (painful respiration)
Slovenian: • težave z nosom in žrelom, med njimi: kašelj, izcedek iz nosu (rinoreja), suho žrelo, kratka sapa ali težko dihanje (dispneja), zamašenost nosu, bolečine pri dihanju (boleča respiracija),
English: • dizziness;
Slovenian: • izpuščaj,
English: Home Administration Training (HAT) pack
Slovenian: Paket za usposabljanje za samoinjiciranje doma
English: 5 mL single-dose vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene).
Slovenian: 5 ml enoodmerna viala (iz prozornega stekla tipa 1) z zamaškom (iz klorobutilne gume), zaporo (iz aluminija) in snemno zaporko (iz polipropilena).
English: Nplate is a white powder for solution for injection supplied in a single-dose glass vial.
Slovenian: Zdravilo Nplate je bel prašek za raztopino za injiciranje v enoodmerni stekleni viali.
English: The starting dose of romiplostim 1 mcg/kg and doses were adjusted to maintain (50 to 200 x 10
Slovenian: Začetni odmerek romiplostima je znašal 1 µg/kg, odmerki pa so se prilagajali tako, da se je vzdrževalo število trombocitov (od 50 do 200 x 10
English: C. Turn vial assembly and syringe upside down, so the vial is directly above the syringe.
Slovenian: C. Obrnite sestavljeno enoto z vialo in brizgo na glavo, tako da je viala neposredno nad brizgo.
English: Platelet counts should be monitored when combining romiplostim with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2).
Slovenian: Med kombinirano uporabo romiplostima in drugih zdravil za zdravljenje ITP je treba kontrolno spremljati število trombocitov, da njihovo število ne bi odstopalo od priporočenega razpona (glejte poglavje 4.2).
English: Prior treatments included corticosteroids (90% of all patients), immunoglobulins (76%), rituximab (29%), cytotoxic therapies (21%), danazol (11%), and azathioprine (5%).
Slovenian: Pred vključitvijo v študijo so bolniki zaradi ITP opravili mediano 3 (razpon: od 1 do 7) zdravljenja, ki so vključevala kortikosteroide (90 % vseh bolnikov), imunoglobuline (76 %), rituksimab (29 %), citotoksična zdravila (21 %), danazol (11 %) in azatioprin (5 %).
English: In adult clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
Slovenian: V kliničnih preskušanjih odraslih bolnikov so zaradi odlaganja retikulina v kostnem mozgu zdravljenje z romiplostimom prekinili pri 4 od 271 bolnikov.
English: Sodium chloride solutions or bacteriostatic water should not be used when reconstituting the medicinal product.
Slovenian: Za pripravo zdravila ne smete uporabiti raztopine natrijevega klorida ali bakteriostatične vode.
English: Volume to administer (mL) = Individual patient dose (mcg) / 125 mcg/mL (Round volume to the nearest hundredth mL)
Slovenian: Količina za aplikacijo (ml) = odmerek za posameznega bolnika (µg) / 125 µg/ml (zaokrožite volumen na stotinko ml)
English: Mannitol (E421)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) saharoza
English: Volume to administer:
Slovenian: Količina za apliciranje:
English: Using: Pre-filled sterile water syringe and vial with vial adapter attached.
Slovenian: Uporabite: Napolnjeno brizgo s sterilno vodo in vialo z nameščenim nastavkom za vialo.
English: After the first 4 weeks of self-administration, the patient should again be supervised while reconstituting and administering Nplate.
Slovenian: Po prvih 4 tednih, odkar si bolnik zdravilo Nplate injicira sam, morate bolnika ponovno nadzorovati, ko si pripravlja in si sam injicira zdravilo Nplate.
English: The overall subject incidence rate of splenectomy was 8.9% (14 of 157 subjects) in the romiplostim group compared with 36.4% (28 of 77 subjects) in the SOC group, with an odds ratio (romiplostim vs SOC) of 0.17 (95% CI: 0.08, 0.35).
Slovenian: Skupna stopnja incidence splenektomije pri bolnikih je bila v skupini z romiplostimom 8,9 % (14 od 157 bolnikov) in v skupini s standardno oskrbo 36,4 % (28 od 77 bolnikov), z razmerjem obetov (romiplostim v primerjavi s standardno oskrbo) 0,17 (95 % IZ: 0,08, 0,35).
English: Volume to administer (mL) = Individual patient dose (mcg) / 500 mcg/mL (Round volume to the nearest hundredth mL)
Slovenian: Količina za aplikacijo (ml) = odmerek za posameznega bolnika (µg) / 500 µg/ml (zaokrožite volumen na stotinko ml)
English: • generally feeling unwell (malaise); chest pain; irritability; swelling of the face (face oedema); feeling hot; increased body temperature; feeling jittery;
Slovenian: • splošno slabo počutje, bolečine v prsih, razdražljivost, oteklost obraza (edem obraza), občutek vročine, zvišana telesna temperatura, občutek živčnosti,
English: Nplate is used to treat adult patients (aged 18 years and over) who may or may not have had their spleen removed for chronic ITP and who have been previously treated with corticosteroids or immunoglobulins, where these treatments don't work.
Slovenian: Zdravilo Nplate uporabljamo za zdravljenje odraslih bolnikov (starih 18 let in več), ki so jim ali pa jim niso zaradi kronične ITP odstranili vranico in so pred tem dobivali kortikosteroide ali imunoglobuline, ki pri njih niso učinkoviti.
English: Hydrochloric acid (for pH adjustment) Polysorbate 20
Slovenian: L-histidin klorovodikova kislina (za uravnavanje pH) polisorbat 20
English: B. Maintain pressure on plunger.
Slovenian: B. Bat držite pritisnjen.
English: Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Slovenian: Zdravilo Nplate je indicirano za zdravljenje kronične imunske (idiopatične) trombocitopenične purpure (ITP) pri odraslih bolnikih, ki se niso ustrezno odzvali na druga zdravila (npr. kortikosteroide, imunoglobuline) (glejte poglavji 4.2 in 5.1).
English: Both subjects tested negative for neutralising antibodies to romiplostim at 4 months after the end of dosing.
Slovenian: Oba bolnika sta imela 4 mesece po koncu uporabe zdravila negativen izvid za nevtralizirajoča protitelesa proti romiplostimu.
English: The overall subject incidence of treatment failure was 11.5% (18 of 157 subjects) in the romiplostim group compared with 29.9% (23 of 77 subjects) in the SOC group, with an odds ratio (romiplostim vs SOC) of 0.31 (95% CI: 0.15, 0.61).
Slovenian: Skupna incidenca neuspeha zdravljenja pri bolnikih je bila v skupini z romiplostimom 11,5 % (18 od 157 bolnikov) in v skupini s standardno oskrbo 29,9 % (23 od 77 bolnikov), z razmerjem obetov (romiplostim v primerjavi s standardno oskrbo) 0,31 (95 % IZ: 0,15, 0,61).
English: In clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
Slovenian: V kliničnih preskušanjih so zaradi odlaganja retikulina v kostnem mozgu zdravljenje z romiplostimom prekinili pri 4 od 271 bolnikov.
English: Nplate's active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP).
Slovenian: Romiplostim je beljakovina, ki jo uporabljamo za zdravljenje premajhnega števila trombocitov pri bolnikih z imunsko (idiopatično) trombocitopenično purpuro (ki jo s kratico označujemo ITP).
English: The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
Slovenian: Po prenehanju zdravljenja je verjeten ponoven pojav trombocitopenije (glejte poglavje 4.4).
English: Keeping the vial on the bench, push the vial adapter down onto the centre of the vial until it is firmly in place.
Slovenian: Viala naj stoji na podlagi; v tem položaju potisnite nastavek za vialo navzdol na sredino viale, dokler ni trdno na mestu.
English: • Peel off paper backing slowly from vial adapter while keeping vial adapter in the plastic package.
Slovenian: • Z nastavka za vialo počasi odlepite prekrivni papir, nastavek za vialo pa naj medtem še ostane v plastičnem pakiranju.
English: • Do not inject into areas with scars or stretch marks.
Slovenian: • Ne injicirajte v predele, kjer so brazgotine ali strije.
English: Deep vein thrombosis Hypotension Peripheral embolism Peripheral ischaemia Phlebitis
Slovenian: Žilne bolezni vročinski oblivi globoka venska tromboza hipotenzija periferna embolija periferna ishemija flebitis povrhnji tromboflebitis tromboza eritromelalgija
English: Nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Slovenian: Zdravilo Nplate je indicirano za zdravljenje kronične imunske (idiopatične) trombocitopenične purpure (ITP) pri bolnikih, starih eno leto ali starejših od enega leta, ki se niso ustrezno odzvali na druga zdravila (npr. kortikosteroide, imunoglobuline) (glejte poglavji 4.2 in 5.1).
English: After reconstitution of the powder, Nplate solution for injection is administered subcutaneously.
Slovenian: Po pripravi praška je treba raztopino za injiciranje Nplate dati subkutano.
English: • Attach safety needle to filled syringe.
Slovenian: • Namestite varnostno iglo na napolnjeno brizgo.
English: Do not shake the vial
Slovenian: Viale ne stresajte
English: After a single subcutaneous dose of 1 to 10 mcg/kg romiplostim in ITP patients, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2 to 3 week period and the response was variable among patients.
Slovenian: Pri bolnikih z ITP se je število trombocitov po posamičnem subkutanem odmerku od 1 do 10 µg/kg romiplostima v 2 do 3 tednih povečalo za 1,3- do 14,9-krat v primerjavi z izhodiščem, odziv pa se je med bolniki razlikoval.
English: 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 compared to lower risk MDS.
Slovenian: 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, kot pri bolnikih z manj tveganim MDS.
English: Add this volume of preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection to the reconstituted vial
Slovenian: Dodajte navedeno količino sterilne raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez dodanih konzervansov k rekonstituirani viali
English: If your doctor has allowed you to self-inject and you use more Nplate than you should, then inform your doctor immediately.
Slovenian: Če vam je zdravnik dovolil, da si zdravilo injicirate sami in uporabite večji odmerek zdravila Nplate, kot bi smeli, morate o tem takoj obvestiti svojega zdravnika.
English: • heart attack (myocardial infarction); increased heart rate;
Slovenian: • srčni infarkt (miokardni infarkt), hitrejši srčni utrip,
English: Single-dose vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene).
Slovenian: Enoodmerna viala (iz prozornega stekla tipa 1) z zamaškom (iz klorobutilne gume), zaporo (iz aluminija) in snemno zaporko (iz polipropilena).
English: • problems with the eyes including: bleeding in the eye (conjunctival haemorrhage); difficulty focussing or blurred vision (accommodation disorder, papilloedema or eye disorder); blindness; itchy eye (eye pruritus); increased tears (lacrimation increased); or visual disturbances;
Slovenian: • težave z očmi, med njimi: očesna krvavitev (veznična krvavitev), težave z izostritvijo vida ali zamegljen vid (akomodacijska motnja, papiledem ali očesna motnja), slepota, srbenje očesa (očesni pruritus), močnejše solzenje (zvečana lakrimacija) ali motnje vida,
English: Prior treatments included corticosteroids (98% of all patients), immunoglobulins (97%), rituximab (71%), danazol (37%), cytotoxic therapies (68%), and azathioprine (24%).
Slovenian: Poleg splenektomije so bolniki pred vključitvijo v študijo zaradi ITP opravili mediano 6 (razpon: od 3 do 10) zdravljenj, ki so vključevala kortikosteroide (98 % vseh bolnikov), imunoglobuline (97 %), rituksimab (71 %), danazol (37 %), citotoksična zdravila (68 %) in azatioprin (24 %).
English: • tingling or numbness of the hands or feet (paraesthesia);
Slovenian: • mravljinčenje ali omrtvelost rok ali nog (parestezije),
English: Clinical trials in adult ITP patients examined antibodies to romiplostim.
Slovenian: Klinična preskušanja pri odraslih bolnikih z ITP so ugotavljala protitelesa proti romiplostimu.
English: Note: This may take up to 2 minutes for the powder to completely dissolve.
Slovenian: Opomba: Da se prašek povsem raztopi, lahko traja do 2 minuti.
English: • upper respiratory tract infection.
Slovenian: • okužba zgornjih dihal.
English: The mean (SD) number of composite bleeding episodes was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.5 (0, 4.5) in the placebo arm.
Slovenian: Povprečno (SD - standardni odklon) število skupne pojavnosti krvavitev je bilo 1,9 (4,2) v skupini, ki je prejemala romiplostim, in 4,0 (6,9) v skupini, ki je prejemala placebo, z mediano (Q1, Q3) števila krvavitev 0,0 (0, 2) v skupini, ki je prejemala romiplostim, in 0,5 (0, 4,5) v skupini, ki je prejemala placebo.
English: If your doctor has allowed you to self-inject and you use less Nplate than you should, then inform your doctor immediately.
Slovenian: Če vam je zdravnik dovolil, da si zdravilo injicirate sami in uporabite manjši odmerek zdravila Nplate, kot bi morali, morate o tem takoj obvestiti svojega zdravnika.
English: Choose and prepare an injection site
Slovenian: 7. korak: Izbira in priprava mesta za injiciranje
English: Nplate 250 micrograms powder and solvent for solution for injection: Pre-filled syringe (type 1 clear glass with bromobutyl rubber plunger) containing 0.72 mL of water for injections for reconstitution.
Slovenian: Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje: Napolnjena injekcijska brizga (prozorno steklo tipa 1 z batom iz bromobutilne gume) vsebuje 0,72 ml vode za injekcije za pripravo.
English: Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).
Slovenian: V primeru zmanjševanja ali prekinitve drugih zdravil za ITP je treba redno spremljati število trombocitov, da se ne bi zmanjšalo pod priporočeno vrednost (glejte poglavje 4.2).
English: Nplate single-use vial
Slovenian: Nplate viala za enkratno uporabo
English: Using: Pre-filled sterile water syringe and plunger rod.
Slovenian: Uporabite: Napolnjeno brizgo s sterilno vodo in držalo bata.