natgillin/translations-raw huggingface dataset:
• generally feeling unwell (malaise); chest pain; irritability; swelling of the face (face oedema); feeling hot; increased body temperature; feeling jittery;
• splošno slabo počutje, bolečine v prsih, razdražljivost, oteklost obraza (edem obraza), občutek vročine, zvišana telesna temperatura, občutek živčnosti,
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.
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.
Hydrochloric acid (for pH adjustment) Polysorbate 20
L-histidin klorovodikova kislina (za uravnavanje pH) polisorbat 20
B. Maintain pressure on plunger.
B. Bat držite pritisnjen.
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).
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).
Both subjects tested negative for neutralising antibodies to romiplostim at 4 months after the end of dosing.
Oba bolnika sta imela 4 mesece po koncu uporabe zdravila negativen izvid za nevtralizirajoča protitelesa proti romiplostimu.
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).
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).
In clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
V kliničnih preskušanjih so zaradi odlaganja retikulina v kostnem mozgu zdravljenje z romiplostimom prekinili pri 4 od 271 bolnikov.
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).
Romiplostim je beljakovina, ki jo uporabljamo za zdravljenje premajhnega števila trombocitov pri bolnikih z imunsko (idiopatično) trombocitopenično purpuro (ki jo s kratico označujemo ITP).
The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
Po prenehanju zdravljenja je verjeten ponoven pojav trombocitopenije (glejte poglavje 4.4).
Keeping the vial on the bench, push the vial adapter down onto the centre of the vial until it is firmly in place.
Viala naj stoji na podlagi; v tem položaju potisnite nastavek za vialo navzdol na sredino viale, dokler ni trdno na mestu.
• Peel off paper backing slowly from vial adapter while keeping vial adapter in the plastic package.
• Z nastavka za vialo počasi odlepite prekrivni papir, nastavek za vialo pa naj medtem še ostane v plastičnem pakiranju.
• Do not inject into areas with scars or stretch marks.
• Ne injicirajte v predele, kjer so brazgotine ali strije.
Deep vein thrombosis Hypotension Peripheral embolism Peripheral ischaemia Phlebitis
Žilne bolezni vročinski oblivi globoka venska tromboza hipotenzija periferna embolija periferna ishemija flebitis povrhnji tromboflebitis tromboza eritromelalgija
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).
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).
After reconstitution of the powder, Nplate solution for injection is administered subcutaneously.
Po pripravi praška je treba raztopino za injiciranje Nplate dati subkutano.
• Attach safety needle to filled syringe.
• Namestite varnostno iglo na napolnjeno brizgo.
Do not shake the vial
Viale ne stresajte
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.
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.
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.
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.
Add this volume of preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection to the reconstituted vial
Dodajte navedeno količino sterilne raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez dodanih konzervansov k rekonstituirani viali
If your doctor has allowed you to self-inject and you use more Nplate than you should, then inform your doctor immediately.
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.
• heart attack (myocardial infarction); increased heart rate;
• srčni infarkt (miokardni infarkt), hitrejši srčni utrip,
Single-dose vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene).
Enoodmerna viala (iz prozornega stekla tipa 1) z zamaškom (iz klorobutilne gume), zaporo (iz aluminija) in snemno zaporko (iz polipropilena).
• 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;
• 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,
Prior treatments included corticosteroids (98% of all patients), immunoglobulins (97%), rituximab (71%), danazol (37%), cytotoxic therapies (68%), and azathioprine (24%).
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 %).
• tingling or numbness of the hands or feet (paraesthesia);
• mravljinčenje ali omrtvelost rok ali nog (parestezije),
Clinical trials in adult ITP patients examined antibodies to romiplostim.
Klinična preskušanja pri odraslih bolnikih z ITP so ugotavljala protitelesa proti romiplostimu.
Note: This may take up to 2 minutes for the powder to completely dissolve.
Opomba: Da se prašek povsem raztopi, lahko traja do 2 minuti.
• upper respiratory tract infection.
• okužba zgornjih dihal.
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.
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.
If your doctor has allowed you to self-inject and you use less Nplate than you should, then inform your doctor immediately.
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.
Choose and prepare an injection site
7. korak: Izbira in priprava mesta za injiciranje
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.
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.
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).
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).
Nplate single-use vial
Nplate viala za enkratno uporabo
Using: Pre-filled sterile water syringe and plunger rod.
Uporabite: Napolnjeno brizgo s sterilno vodo in držalo bata.
A vial of powder, either 250 micrograms OR 500 micrograms x1
1 x vialo praška, 250 mikrogramsko ALI 500 mikrogramsko
Mean no. weeks with platelet response c
Povprečno št. tednov z odzivom trombocitov c
• muscle tightness; muscular weakness; shoulder pain; muscle twitching;
• napetost mišic, šibkost mišic, bolečine v rami, trzanje mišic,
In the longer duration chronic monkey study, there was no effect on the erythroid and leukocytic lineages when romiplostim was administered for 6 months where the administration of romiplostim was decreased from thrice weekly to once weekly.
V dolgotrajnejši kronični študiji pri opicah so romiplostim uporabljali 6 mesecev, pri čemer so dajanje zmanjšali iz trikrat na teden na enkrat na teden; med to 6-mesečno študijo niso ugotovili vpliva na eritroidno in levkocitno vrsto.
Nplate is a white powder for solution for injection supplied in a 5 mL single-dose glass vial.
Zdravilo Nplate je bel prašek za raztopino za injiciranje v 5 ml enoodmerni stekleni viali.
Powder and solvent for solution for injection (powder for injection).
prašek in vehikel za raztopino za injiciranje (prašek za injekcijo) Prašek je bel.
• higher than normal platelet counts (thrombocytosis);
• število trombocitov, večje od normalnega (trombocitoza),
Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
Romiplostim je treba previdno uporabljati pri bolnikih z znanimi dejavniki tveganja za tromboembolije, vključno (vendar ne samo) s podedovanimi (npr. faktorjem V Leiden) ali pridobljenimi dejavniki tveganja (npr. pomanjkanjem ATIII, antifosfolipidnim sindromom), višjo starostjo, dolgotrajno imobilizacijo, malignomi, uporabo kontraceptivov in hormonskega nadomestnega zdravljenja, operacijo/poškodbo, debelostjo in kajenjem.
Bleeding events that were grade 2 or higher were reported by 15% of patients treated with romiplostim and 34% of patients treated with placebo (Odds Ratio; [romiplostim/placebo] = 0.35; 95% CI = (0.14, 0.85)).
O krvavitvah stopnje 2 ali več so poročali pri 15 % bolnikov, zdravljenih z romiplostimom, in 34 % bolnikov, zdravljenih s placebom (razmerje obetov [romiplostim/placebo] = 0,35; 95 % IZ = (0,14, 0,85)).
WATER FOR INJECTIONS LABEL
NALEPKA ZA VODO ZA INJEKCIJE
Across the study, the overall subject incidence of platelet response (1 or more platelet count ≥ 50 x 10
V preskušanju je celokupna incidenca odgovora trombocitov (število trombocitov ≥ 50 x 10
Individual patient dose (mcg) = 10 kg x 1 mcg/kg = 10 mcg
Odmerek za posameznega bolnika (µg) = 10 kg x 1 µg/kg = 10 µg
All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 109/L.
Vse klinično pomembne (≥ 3. stopnje) krvavitve so se pojavile pri številu trombocitov < 30 x 109/l.
For instructions on reconstitution and administration of the medicinal product, see section 6.6.
Za navodila o pripravi in uporabi zdravila glejte poglavje 6.6.
Dissolving Nplate by injecting water into vial
4. korak: Raztapljanje zdravila Nplate z injiciranjem vode v vialo
Remove the empty pre-filled syringe from the vial adapter.
Odstranite prazno napolnjeno injekcijsko brizgo z nastavka za vialo.
The resulting concentration is 500 mcg/mL.
Koncentracija je tako 500 µg/ml.
• problems with your nervous system including involuntary muscle contractions (clonus); distorted sense of taste (dysgeusia); decrease in sense of taste (hypogeusia); decreased feeling of sensitivity, especially in the skin (hypoaesthesia); alteration in the nerve functions in the arms and legs (neuropathy peripheral); blood clot in the transverse sinus (transverse sinus thrombosis);
• težave z živčevjem, vključno z nehotenim krčenjem mišic (klonus), moteno okušanje (dizgevzija), zmanjšano okušanje (hipogevzija), zmanjšana občutljivost, zlasti na koži (hipoestezija), spremenjeno delovanje živcev v rokah in nogah (periferna nevropatija), krvni strdek v transverzalnem sinusu (tromboza tranzverzalnega sinusa),
* see section 4.4 ** Hypersensitivity reactions including cases of rash, urticaria, and angioedema
** Preobčutljivostne reakcije vključno s primeri izpuščaja, urtikarije in angioedema.
1 pre-filled syringe containing 0.72 mL of water for injections for reconstitution.
1 napolnjeno injekcijsko brizgo, ki vsebuje 0,72 ml vode za injekcije za pripravo.
All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 10
Vse klinično pomembne krvavitve (stopnja 3 ali več) so se zgodile pri številu trombocitov < 30 x 10
All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 10
Vse krvavitve stopnje 2 ali več so se zgodile pri številu trombocitov < 50 x 10
If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Če imate vprašanja o injiciranju zdravila, se za pomoč obrnite na vašega zdravnika, medicinsko sestro ali farmacevta.
• Do not delay injecting Nplate.
• Zdravilo Nplate injicirajte brez odlašanja.
The primary endpoint was the incidence of durable response, defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10
Trajen odziv na zdravljenje je bil definiran kot vsaj 6 doseženih vrednosti števila trombocitov ≥ 50 x 10
Across the entire adult ITP clinical programme an inverse relationship between bleeding events and platelet counts was observed.
V celotnem kliničnem programu ITP odraslih je bilo opaziti obratno sorazmerno povezavo med krvavitvami in številom trombocitov.
The 125 mcg vial cap is beige, the 250 mcg vial cap is red and the 500 mcg vial cap is blue.
Zaporka viale s 125 µg je bež barve, zaporka viale z 250 µg je rdeče barve in zaporka viale s 500 µg je modre barve.
• problems with the circulation including blood clot in the vein in the liver (portal vein thrombosis); deep vein thrombosis; low blood pressure (hypotension); increased blood pressure; blocking of a blood vessel or (peripheral embolism); reduced blood flow in the hands, ankles or feet (peripheral ischaemia); swelling and clotting in a vein, which may be extremely tender when touched (phlebitis or thrombophlebitis superficial); blood clot (thrombosis);
• težave s krvnim obtokom, vključno s krvnim strdkom v jetrni veni (tromboza portalne vene), globoka venska tromboza, nizek krvni tlak (hipotenzija), zvišan krvni tlak, zamašitev krvne žile (periferna embolija), zmanjšan pretok krvi v dlaneh, gležnjih ali stopalih (periferna ishemija), oteklost in strjevanje v veni, lahko z izredno občutljivostjo na dotik (flebitis ali povrhnji tromboflebitis), krvni strdek (tromboza),
Alterations in red (decrease) and white (increase) blood cell parameters have been observed in non-clinical toxicology studies (rat and monkey) as well as in ITP patients.
V nekliničnih toksikoloških študijah (na podganah in opicah) so opažali spremembe vrednosti rdečih (znižanje) in belih (zvišanje) krvnih celic.
Weight* in kg x Dose in mcg/kg = Individual patient dose in mcg
Telesna masa* v kg x odmerek v µg/kg = odmerek v µg za posameznega bolnika
• Immediately discard syringe with covered needle into a sharps container.
• Brizgo s pokrito iglo takoj zavrzite v vsebnik za ostre odpadke.
If the calculated individual patient dose is less than 23 mcg, dilution with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate dosing (see section 6.6).
Če je izračunan odmerek za posameznega bolnika manjši od 23 µg, je potrebno zdravilo razredčiti s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez konzervansov, zato da se zagotovi natančno odmerjanje (glejte poglavje 6.6).
All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 109/L.
Vse krvavitve ≥ 2. stopnje so se pojavile pri številu trombocitov < 50 x 109/l.
1 pre-filled syringe containing 1.2 mL of water for injections for reconstitution.
1 napolnjeno injekcijsko brizgo, ki vsebuje1,2 ml vode za injekcije za pripravo.
This medicine 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 obdobje 30 dni pri sobni temperaturi (do 25 °C).
A total of 22 subjects (52%) had durable platelet response in the romiplostim arm compared with 2 subjects (10%) in the placebo arm: ≥ 1 to < 6 years 38% versus 25%; ≥ 6 to < 12 years 56% versus 11%; ≥ 12 to < 18 years 56% versus 0.
V skupini, ki je prejemala romiplostim, je skupno 22 bolnikov (52 %) doseglo trajen odziv trombocitov v primerjavi z 2 bolnikoma (10 %) v skupini, ki je prejemala placebo: ≥ 1 leto do < 6 let: 38 % bolnikov, ki so prejemali romiplostim, in 25 % bolnikov, ki so prejemali placebo; ≥ 6 let do < 12 let: 56 % bolnikov, ki so prejemali romiplostim, in 11 % bolnikov, ki so prejemali placebo; ≥ 12 let do < 18 let: 56 % bolnikov, ki so prejemali romiplostim, in 0 bolnikov, ki so prejemali placebo.
Nplate 500 micrograms powder and solvent for solution for injection: Pre-filled syringe (type 1 clear glass with bromobutyl rubber plunger) containing 1.2 mL of water for injections for reconstitution.
Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje: Napolnjena injekcijska brizga (prozorno steklo tipa 1 z batom iz bromobutilne gume) vsebuje 1,2 ml vode za injekcije za pripravo.
In clinical trials, treatment with romiplostim resulted in dose-dependent increases in platelet count.
V kliničnih preskušanjih je zdravljenje z romiplostimom povzročilo od odmerka odvisno povečanje števila trombocitov.
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 34.0 months
V skupini vseh bolnikov je znašala mediana (Q1, Q3) števila mesecev z odgovorom trombocitov 30,0 mesecev (13,0 mesecev, 43,0 mesecev) in mediana (Q1, Q3) časa vključenosti v preskušanje je znašala 34,0 mesecev (24,0 mesecev, 46,0 mesecev).
Deliverable product and volume
Uporabno zdravilo in količina
A total of 17 subjects (53.1%) had durable platelet response in the romiplostim arm compared with 1 subject (6.3%) in the placebo arm: ≥ 1 to < 6 years 28.6% versus 25%; ≥ 6 to < 12 years 63.6% versus 0%; ≥ 12 to < 18 years 57.1% versus 0%.
V skupini, ki je prejemala romiplostim, je skupno 17 bolnikov (53,1 %) je doseglo trajen odziv trombocitov v primerjavi z 1 bolnikom (6,3 %) v skupini, ki je prejemala placebo: ≥ 1 leto do < 6 let: 28,6 % bolnikov, ki so prejemali romiplostim, in 25 % bolnikov, ki so prejemali placebo; ≥ 6 let do < 12 let: 63,6 % bolnikov, ki so prejemali romiplostim in 0 % bolnikov, ki so prejemali placebo; ≥ 12 let do < 18 let: 57,1 % bolnikov, ki so prejemali romiplostim, in 0 % bolnikov, ki so prejemali placebo.
Transient platelet response was defined as weekly platelet count ≥ 50 x 10
Trajni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 10
You may have excess Nplate left over after administering your prescribed dose.
Morda vam bo po injiciranju predpisanega odmerka ostalo še nekaj zdravila Nplate.
Keep the dissolved Nplate Vial.
Obdržite vialo z raztopljenim zdravilom Nplate.
• cough;
• kašelj,
• sore throat and discomfort when swallowing (pharyngitis);
• boleče grlo in nelagodje ob požiranju (faringitis),
If the calculated individual patient dose is less than 23 mcg (see section 4.2), 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 (glejte poglavje 4.2), 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 natančne količine (glejte tabelo spodaj).
Individual patient dose (mcg) = weight (kg) x dose in mcg/kg
Odmerek za posameznega bolnika (µg) = telesna masa (kg) x odmerek v µg/kg
Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended.
Zato je pred zdravljenjem z romiplostimom in med njim priporočljivo opraviti pregled razmaza periferne krvi na morfološke nepravilnosti celic in določitev celotne krvne slike.
If you stop using Nplate, your low blood platelet count (thrombocytopenia) is likely to reoccur.
Če nehate uporabljati zdravilo Nplate, se bo verjetno znova pojavilo premajhno število trombocitov (trombocitopenija).
If you have not been trained, please contact your healthcare professional.
Če vas tega še niso naučili, se posvetujte s svojim zdravnikom.
Water for injections should be injected into the vial.
V vialo morate injicirati vodo za injekcije.
It may harm them,
• vnetje očesa (konjuktivitis),
Each vial of Nplate 250 micrograms powder for solution for injection contains a total of 375 micrograms of romiplostim.
Ena viala zdravila Nplate 250 mikrogramov prašek za raztopino za injiciranje vsebuje celokupno 375 mikrogramov romiplostima.
1 sterile vial adapter.
1 sterilen nastavek za vialo.
Ensure the correct amount of solution for the patient dose is in the administration syringe by injecting any excess solution back into the vial.
Poskrbite, da je v brizgi za injiciranje prava količina raztopine za bolnikov odmerek: to naredite tako, da injicirate odvečno raztopino nazaj v vialo.
• diarrhoea;
• migrena,
Nplate is used to treat patients aged 1 year 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.
Zdravilo Nplate uporabljamo za zdravljenje bolnikov (starih 1 leto 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.
• Do ensure that all water is injected from the syringe into the vial before dissolving.
• Pred raztapljanjem se prepričajte, da ste iz brizge v vialo injicirali vso vodo.