natgillin/translations-raw huggingface dataset:
Statistically significant increases from treatment baseline in absolute FVC volume were seen at most visits for all treatment groups combined and for each of the prior TKT024 treatment groups.
Statistično pomembna povečanja od izhodiščnih vrednosti absolutne prostornine FVK pri zdravljenju so opazili pri večini obiskov v vseh skupinah, vključno s tistimi, ki so se predhodno zdravile v študiji TKT024.
Related reactions in the placebo group were similar in nature and severity to those in the treated group.
V skupini, ki je prejemala placebo, sta bili narava in pogostnost učinkov podobni kot v skupini, ki je prejemala zdravilo.
One patient was unclassified / unclassifiable.
Enega bolnika ni bilo mogoče razvrstiti v nobeno skupino.
Patients with complete deletion/large rearrangement genotype have a higher probability of developing infusion related adverse events (see section 4.4).
Pri bolnikih z genotipom s popolno delecijo/obsežno preureditvijo je večja verjetnost za pojav neželenih učinkov, povezanih z infuzijo (glejte poglavje 4.4).
Very common side effects (may affect more than 1 in 10 people) are:
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) so:
A higher volume of distribution at steady state (Vss) was observed in the lowest weight groups.
V skupinah z najmanjšo telesno maso so opazili večji volumen porazdelitve v stanju dinamičnega ravnovesja (Vss).
Store in a refrigerator Do not freeze
Shranjujte v hladilniku.
Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution.
Vsaka viala zdravila Elaprase je namenjena le enkratni uporabi in vsebuje 6 mg idursulfaze v 3 ml raztopine.
Elaprase should not be infused with other medicinal products in the infusion tubing.
Zdravilo Elaprase se ne sme infundirati z drugimi zdravili skozi isto cevko.
Idursulfase is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme.
Idursulfaza je prečiščena oblika lizosomskega encima iduronat-2-sulfataze, izdelanega v humani celični liniji, ki omogoča humani profil glikozilacije, ki je analogen naravnemu encimu.
There is no experience with overdoses of Elaprase.
Izkušenj s prevelikim odmerjanjem zdravila Elaprase ni.
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Mean cardiac LVMI remained stable over 36 months of idursulfase treatment within each TKT024 treatment group.
Srednji indeks leve ventrikularne mase (LVMI) je ostal stabilen v 36 mesecih zdravljenja z idursulfazo v vseh skupinah TKT024, ki so jih zdravili.
Elaprase contains an active substance called idursulfase which works by acting as a replacement for the enzyme that is at a low level, thereby breaking down this carbohydrate in affected cells.
Zdravilo Elaprase vsebuje učinkovino, imenovano idursulfaza, ki nadomesti encim, ki ga primanjkuje, in razgrajuje ta ogljikov hidrat v prizadetih celicah.
Patients with the complete deletion/large rearrangement genotype Paediatric patients with the complete deletion/large rearrangement genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to exposure to idursulfase.
Bolniki z genotipom s popolno delecijo/obsežno preureditvijo Pri pediatričnih bolnikih z genotipom s popolno delecijo/obsežno preureditvijo je velika verjetnost, da bodo kot odziv na izpostavljenost idursulfazi razvili protitelesa, vključno z nevtralizirajočimi protitelesi.
Hunter syndrome is an X-linked disease caused by insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Hunterjev sindrom je bolezen, povezana s kromosomom X, ki jo povzročajo nezadostne količine lizosomskega encima iduronat-2-sulfataze.
What Elaprase looks like and contents of the pack
Izgled zdravila Elaprase in vsebina pakiranja
At their final visit 21/31 patients in the TKT024 Weekly group, 24/32 in the TKT024 EOW group and 18/31 patients in the TKT024 placebo group had final normalised urine GAG levels that were below the upper limit of normal.
Pri zadnjem obisku je imelo 21/31 bolnikov v skupini TKT024 enkrat na teden, 24/32 bolnikov v skupini TKT024 vsak drugi teden in 18/31 bolnikov v skupini TKT024 s placebom končne normalizirane ravni GAG v urinu, ki so bile pod zgornjo mejo.
These events did not recur with subsequent infusions using a slower infusion rate and administration of pre-infusion medicinal products, usually low-dose steroids, antihistamine, and beta-agonist nebulisation.
Do teh dogodkov ni prišlo pri poznejših infundiranjih, pri katerih so zmanjšali hitrost infundiranja in uporabili predinfuzijska zdravila, ponavadi majhne odmerke steroidov, antihistaminike in nebulizator z beta-agonisti.
There have been post-marketing reports of anaphylactoid/anaphylactic reactions (see section 4.4).
Na voljo so poročila iz obdobja trženja o anafilaktoidnih/anafilaktičnih reakcijah (glejte poglavje 4.4).
Among patients who were originally randomised to weekly idursulfase in TKT024, mean maximum improvement in distance walked during six minutes occurred at Month 20 and mean percent predicted FVC peaked at Month 16.
Pri bolnikih, ki so bili v študiji TKT024 naključno razporejeni v izvirno skupino z idursulfazo enkrat na teden, se je srednje največje izboljšanje v razdalji, prehojeni v šestih minutah, pojavilo v 20. mesecu, srednji odstotek predvidene FVK pa je bil največji v 16. mesecu.
Fertility No effects on male fertility were seen in reproductive studies in male rats.
Plodnost V študijah vpliva na sposobnost razmnoževanja pri samcih podgan niso opazili vpliva na plodnost.
At most time points tested, patients who were from the original TKT024 weekly treatment group improved their walking distance to a greater extent that patients in the other 2 treatment groups.
Pri večini testiranih točk se je pri bolnikih, ki so bili v izvirni skupini TKT024, ki se je zdravila enkrat na teden, prehojena razdalja bolj podaljšala kot pri bolnikih v drugih dveh skupinah.
During the 53-week study, 67.9% (19 of 28) of patients had at least one blood sample that tested positive for anti-idursulfase antibodies, and 57.1% (16 of 28) tested positive for antibodies on at least three consecutive study visits.
V 53-tedenski študiji je imelo 67,9 % (19 od 28) bolnikov vsaj en vzorec krvi s pozitivnim rezultatom testa protiteles proti idursulfazi in 57,1 % (16 od 28) bolnikov pozitivne teste protiteles ob vsaj treh zaporednih študijskih obiskih.
Among all patients, statistically significant mean increases from treatment baseline (TKT024 baseline for TKT024 idursulfase patients and Week 53 baseline for TKT024 placebo patients) were seen in the distance walked 6MWT at the majority of time points tested, with significant mean and percent increases ranging from 13.7m to 41.5m (maximum at Month 20) and from 6.4% to 13.3% (maximum at Month 24) respectively.
Pri vseh bolnikih se je statistično pomembno srednje povečanje od izhodiščne vrednosti pri zdravljenju (izhodiščna vrednost TKT024 za bolnike z idursulfazo TKT024 in izhodiščna vrednost v 53. tednu za bolnike s placebom TKT024) v razdalji, prehojeni v šestih minutah, pokazalo pri večini testiranih točk, pri čemer so bila srednja in odstotna povečanja od 13,7 m do 41,5 m (največ v 20. mesecu) oziroma od 6,4 % do 13,3 % (največ v 24. mesecu).
Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Raztopina ostane kemično in fizično stabilna osem ur, če jo hranimo pri temperaturi do 25 °C.
Of the 25 patients with abnormally large livers at baseline in the weekly treatment group, 80% (20 patients) had reductions in liver volume to within the normal range by the end of the study.
Med 25 bolniki z nenormalno povečanimi jetri na začetku študije se je v skupini, ki je prejemala tedensko zdravljenje, pri 80 % (20 bolnikih) prostornina jeter do konca študije zmanjšala do obsega normalne prostornine.
The other ingredients are Polysorbate 20, sodium chloride, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, monohydrate and water for injections.
Druge sestavine zdravila so polisorbat 20, natrijev klorid, natrijev dihidrogenfosfat heptahidrat, natrijev hidrogenfosfat monohidrat in voda za injekcije.
In the placebo treatment group 128 infusion-related reactions were reported in 21 out of 32 patients following administration of a total of 1612 infusions.
V skupini, ki je prejemala placebo, so pri 21 od 32 bolnikov poročali o 128 učinkih, povezanih z infundiranjem, po infundiranju skupno 1612 infuzij.
Idursulfase is secreted as a 525 amino acid glycoprotein and contains 8 N-linked glycosylation sites that are occupied by complex, hybrid, and high-mannose type oligosaccharide chains.
Idursulfaza se izloča kot glikoprotein, sestavljen iz 525 aminokislin in vsebuje osem z N povezanih mest glikozilacije, na katerih so kompleksne hibridne oligosaharidne verige z veliko manoze.
There are no data or limited amount of data from the use of idursulfase in pregnant women.
Podatkov o uporabi idursulfaze pri nosečnicah ni oziroma so omejeni.
Patients treated with idursulfase may develop infusion-related reactions (see section 4.8).
Pri bolnikih, ki prejemajo idursulfazo, se lahko pojavijo učinki, povezani z infundiranjem (glejte poglavje 4.8).
If an anaphylactoid/anaphylactic reaction occurs the infusion should be immediately suspended and appropriate treatment and observation initiated.
Če pride do anafilaktoidne/anafilaktične reakcije, je treba infundiranje takoj ustaviti in bolnika začeti ustrezno zdraviti ter opazovati.
Idursulfase is taken up by selective receptor-mediated mechanisms involving binding to mannose 6phosphate receptors.
Prevzem idursulfaze poteka prek mehanizmov, ki jih uravnavajo selektivni receptorji, pri katerih se zdravilo veže na receptorje za manozo-6-fosfat.
% Change in liver volume
% spremembe prostornine jeter
The complete deletion/ large rearrangement genotype was most commonly associated with development of high titre of antibodies and neutralising antibodies to idursulfase and was most likely to display a muted response to the medicinal product.
Genotip s popolno delecijo/obsežno preureditvijo je bil najpogosteje povezan z razvojem visokega titra protiteles in nevtralizirajočih protiteles proti idursulfazi in v tej skupini je bil zmanjšan odziv na zdravilo najverjetnejši.
Instructions for use, handling and disposal
Navodila za pripravo in ravnanje z zdravilom in odlaganje
No formal medicinal product interaction studies have been conducted with idursulfase.
Formalnih študij medsebojnega delovanja idursulfaze z drugimi zdravili niso izvedli.
• Rapid heartbeat, irregular heartbeat, bluish skin
• hiter srčni utrip, nereden srčni utrip, modrikasta koža
Animal studies have shown excretion of idursulfase in breast milk.
Študije na živalih so pokazale, da se idursulfaza izloča v mleko.
In the post-hoc immunogenicity analysis of data from TKT024/024EXT studies, 51% (32/63) patients treated with 0.5mg/kg weekly idursulfase had at least 1 blood sample that tested positive for antiidursulfase antibodies, and 37 % (23/63) tested positive for antibodies on at least 3 consecutive study visits.
V post hoc analizi imunogenosti na podlagi podatkov iz študij TKT024/024EXT je imelo 51 % (32/63) bolnikov, zdravljenih z 0,5 mg/kg idursulfaze na teden, vsaj 1 krvni vzorec, ki je bil pozitiven za protitelesa proti idursulfazi, 37 % (23/63) pa je bilo pozitivnih za protitelesa pri vsaj 3 zaporednih obiskih v študiji.
The mean and percent changes from treatment baseline were greatest in the group of patients from the TKT024 study who had received the weekly dosing, across all time points.
Srednje in odstotne spremembe od izhodiščnih vrednosti pri zdravljenju so bile na vseh časovnih točkah največje v skupini bolnikov iz študije TKT024, ki so odmerek prejemali enkrat na teden.
If you have missed an Elaprase infusion, please contact your doctor.
Če ste izpustili infuzijo zdravila Elaprase, se obrnite na zdravnika.
Patients who developed a high titre of antibodies displayed less response to idursulfase as assessed by urine output of glycosaminoglycans and by liver and spleen size.
Bolniki, ki so razvili visok titer protiteles, so pokazali slabši odziv na idursulfazo, kar so ocenili po izločanju glikozaminoglikanov z urinom ter po velikosti jeter in vranice.
Infusion-related reactions were treated or ameliorated by slowing the infusion rate, interrupting the infusion, or by administration of medicinal products, such as antihistamines, antipyretics, low-dose corticosteroids (prednisone and methylprednisolone), or beta-agonist nebulisation.
Učinke, povezane z infundiranjem, so zdravili ali ublažili z zmanjšanjem hitrosti infundiranja, prekinjanjem infundiranja, z uporabo zdravil, kot so antihistaminiki, antipiretiki, majhni odmerki kortikosteroidov (prednizon in metilprednizolon) ali uporabo nebulizatorja z beta-agonisti.
All patients with the complete deletion/large rearrangement genotype developed antibodies, and the majority of them (7/8) also tested positive for neutralizing antibodies on at least 3 consecutive occasions.
Vsi bolniki z genotipom s popolno delecijo/obsežno preureditvijo so razvili protitelesa in pri večini od njih (7/8) so bili testi za nevtralizirajoča protitelesa vsaj trikrat zaporedoma pozitivni.
Approximately half of the patients in the weekly treatment group (15 of 32; 47%) had left ventricular hypertrophy at baseline, defined as LVM index 103 g/m2.
V skupini, ki je prejemala tedensko zdravljenje, je imela na začetku študije približno polovica bolnikov (15 od 32; 47 %) hipertrofijo levega prekata, opredeljeno kot indeks LVM  103 g/m2.
Concentrate for solution for infusion 3 ml
Koncentrat za raztopino za infundiranje 3 ml
The recommended dose is an infusion of 0.5 mg (half a milligram) for every kg you weigh
Priporočeni odmerek je infundiranje 0,5 mg (pol miligrama) na kilogram telesne mase.
A total of 11 of 31 (36%) patients in the weekly treatment group versus 5 of 31 (16%) patients in the placebo group had an increase in FEV1 of at least 0.2 l at or before the end of the study, indicating a dose-related improvement in airway obstruction.
V skupini, ki je zdravljenje prejemala enkrat tedensko, so pri skupno 11 od 31 (36 %) bolnikov, v skupini, ki je prejemala placebo, pa pri skupno 5 od 31 (16%) na koncu študije ali pred njim opazili povečanje vrednosti FEV1 za najmanj 0,2 l, kar kaže na od odmerka odvisno izboljšanje obstrukcije dihalnih poti.
Fifty-four percent of patients tested positive for neutralizing antibodies at least once and half of the patients tested positive for neutralizing antibodies on at least three consecutive study visits.
Štiriinpetdeset odstotkov bolnikov je bilo vsaj enkrat pozitivnih na nevtralizirajoča protitelesa in pol bolnikov je bilo pozitivnih na nevtralizirajoča protitelesa ob vsaj treh zaporednih študijskih obiskih.
The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing (redness).
Najpogostejši simptomi so srbenje, izpuščaj, koprivnica, zvišana telesna temperatura, glavobol, zvišan krvni tlak in vročinski oblivi (rdečica).
Changes in urinary GAG levels were the earliest signs of clinical improvement with idursulfase treatment and the greatest decreases in urinary GAG were seen within the first 4 months of treatment in all treatment groups; changes from Month 4 to 36 were small.
Največje zmanjšanje vrednosti GAG v urinu so opazili v prvih štirih mesecih zdravljenja v vseh skupinah, ki so jih zdravili; spremembe od četrtega do 36. meseca so bile majhne.
Patients with this genotype have a higher probability of developing infusion-related adverse events and tend to show a muted response as assessed by decrease in urinary output of glycosaminoglycans, liver size and spleen volume compared to patients with the missense genotype.
Bolniki s tem genotipom imajo večjo verjetnost, da razvijejo z infundiranjem povezane neželene učinke in so nagnjeni k zmanjšani odzivnosti, kar so ocenili po zmanjšanem izločanju glikozaminoglikanov z urinom, velikosti jeter in volumnu vranice v primerjavi z bolniki z genotipom z »missense« (drugačnosmiselno) mutacijo.
Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue.
Glikozaminoglikan se značilno kopiči v vranici, jetrih, pljučih, srcu in vezivnem tkivu.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
You may be given additional medicines such as antihistamines and corticosteroids to treat or help prevent allergic-type reactions.
Za preprečevanje alergijskih reakcij boste morda prejeli dodatna zdravila, kot so antihistaminiki in kortikosteroidi.
Once diluted, the solution should be mixed gently, but not shaken.
Raztopino po redčenju nežno premešajte, vendar je ne stresajte.
Care must be taken to ensure the sterility of the prepared solutions since Elaprase does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Zdravilo Elaprase ne vsebuje nikakršnih konzervansov ali bakteriostatičnih sredstev, zato morate paziti, da je pripravljena raztopina sterilna; uporabiti morate aseptično tehniko.
Each vial contains 3 ml of concentrate for solution for infusion.
Ena viala vsebuje 3 ml koncentrata za raztopino za infundiranje.
It was not possible, however, to accurately predict individual clinical outcome based on antibody response or genotype.
Vendar pa na podlagi odziva s protitelesi ali genotipa ni bilo mogoče natančno napovedati kliničnih rezultatov za posamezne bolnike.
Study HGT-ELA-038
Študija HGT-ELA-038
Twenty-one percent (13/63) tested positive for neutralizing antibodies at least once and 13 % (8/63) tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Enaindvajset odstotkov bolnikov (13/63) je bilo vsaj enkrat pozitivnih za nevtralizirajoča protitelesa, 13 % (8/63) pa jih je bilo za nevtralizirajoča protitelesa pozitivnih pri vsaj 3 zaporednih obiskih v študiji.
≥ 40 and < 50 (n=5)
≥ 40 in < 50 (n=5)
Patients who tested antibody-positive displayed less reduction in urinary output of glycosaminoglycans than antibody-negative patients.
Pri bolnikih, ki so bili pozitivni za protitelesa, se je pojavilo manjše zmanjšanje izločanja glikozaminoglikanov z urinom kot pri bolnikih, negativnih za protitelesa.
Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) CL (mL/min/kg) Mean ± SD Vss (mL/kg)
AUC0-∞ (min*μg/ml) CL (ml/min/kg) Srednja vrednost ± SD
Patients using supplemental oxygen should have this treatment readily available during infusion in the event of an infusion-related reaction.
Pri bolnikih, ki prejemajo nadomestni kisik, mora biti zaradi možnosti razvoja učinkov, povezanih z infundiranjem, tako zdravljenje na voljo ves čas infundiranja.
Patients experiencing severe or refractory anaphylactoid/anaphylactic reactions may require prolonged clinical monitoring.
Bolnike s hudimi ali refraktarnimi anafilaktoidnimi/anafilaktičnimi reakcijami bo morda treba opazovati dalj časa.
Table 4.
Tabela 4.
Talk to your doctor or nurse before using this medicine.
Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom ali medicinsko sestro.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
- The solution in the vials should not be used if it is discoloured or if particulate matter is present.
- Ne uporabljajte, če je raztopina v vialah spremenila barvo ali če so v njej prisotni delci.
Mean treatment difference compared with placebo (SE)
Srednja vrednost razlike med zdravljenjem in placebom (SN)
How to use Elaprase
Kako uporabljati zdravilo Elaprase
≥ 20 and < 30 (n=18)
≥ 20 in < 30 (n=18)
Infusion-related reactions
Učinki, povezani z infundiranjem
Pharmacokinetic parameters measured during the first infusion at week 1 of studies TKT024 (0.5 mg/kg weekly arm) and HGT-ELA-038 are displayed in table 3 and table 4 below as a function of age and body weight, respectively.
Farmakokinetični parametri, izmerjeni med prvo infuzijo v 1. tednu študije TKT024 (krak z odmerkom 0,5 mg/kg tedensko) in študije HGT-ELA-038, v odvisnosti od starosti in telesne mase, so prikazani v tabelah 3 in 4.
Elaprase contains sodium
Zdravilo Elaprase vsebuje natrij
≥ 30 and < 40 (n=9)
≥ 30 in < 40 (n=9)
Treatment of Hunter syndrome patients with intravenous idursulfase provides exogenous enzyme for uptake into cellular lysosomes.
Pri zdravljenju bolnikov s Hunterjevim sindromom z idursulfazo lahko celični lizosomi privzamejo eksogeni encim.
Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well.
Pri bolnikih, ki so prejeli več mesecev zdravljenja na kliniki in dobro prenašajo infundiranje, je infundiranje mogoče tudi na domu.
Anaphylactoid/anaphylactic reactions
Anafilaktoidne/anafilaktične reakcije
• Dizziness, tremor
• zasoplost, sopenje
Cyanosis, arrhythmia, tachycardia
Srčne bolezni cianoza, aritmija, tahikardija
For single use only Read the package leaflet before use Intravenous use
Pred uporabo preberite priloženo navodilo!
The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Učinkovina je idursulfaza, ki ima obliko humanega encima iduronat-2-sulfataze.
All patients with the frameshift/splice site mutation genotype developed antibodies and 4/6 also tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Tudi vsi bolniki z mutacijo »frameshift« (premik bralnega okvira) oz. »splice site« (mutacija, ki spremeni mesto cepitve) so razvili protitelesa in pri 4 od 6 teh bolnikov so bili testi za nevtralizirajoča protitelesa pozitivni ob vsaj treh zaporednih študijskih obiskih.
Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Idursulfaza se presnavlja v celičnih lizosomih, zato ni pričakovati interakcij povezanih s citokrom P450.
abdominal pain, nausea, and chest pain.
glavobol, bruhanje, bolečine v trebuhu, navzea in bolečina v prsih.
During clinical trials, the most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, and flushing.
Med kliničnimi preskušanji so bili najpogostejši učinki, povezani z infundiranjem, kožne reakcije (izpuščaj, pruritus, urtikarija), pireksija, glavobol, hipertenzija in vročinski obliv.
5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.
5-mililitrska viala (steklo vrste I) z zamaškom (butilna guma, obložena s fluorovo smolo), enodelno tesnilo in modra zaporka „flip-off“.
No patient discontinued treatment due to an infusion reaction during clinical studies.
Zaradi učinkov, povezanih z infundiranjem, med kliničnimi preskušanji niso prekinili zdravljenja pri nobenem bolniku.
Of the 9 patients in the weekly treatment group with abnormally large spleens at baseline, 3 had spleen volumes that normalized by the end of the study.
Med 9 bolniki z nenormalno povečano vranico na začetku študije v skupini, ki je zdravljenje prejemala tedensko, se je do konca študije velikost vranice povrnila na normalno prostornino pri treh bolnikih.
• Hives, rash, itching, redness of the skin
• koprivnica, izpuščaj, srbenje, rdečica kože
Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Water for injections
polisorbat 20 natrijev klorid natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat voda za injekcije
Common side effects (may affect up to 1 in 10 people) are:
Pogosti neželeni učinki (pojavijo se pri največ 1 od 10 bolnikov) so:
After dilution this medicine is given through a vein (drip feed).
Zdravilo se po redčenju daje v veno (z infuzijo).