natgillin/translations-raw huggingface dataset:
It can also be considered for use in patients who have been treated for ITP who have a spleen and cannot have surgery.
Zdravilo se lahko uporabi tudi pri bolnikih, ki so se zdravili zaradi imunske trombocitopenične purpure in še imajo vranico, vendar niso primerni za operativni poseg.
The spleen is an organ that is involved in the destruction of platelets.
Vranica je organ, ki sodeluje pri uničevanju trombocitov.
Because the number of patients with ITP is low, the disease is considered ‘ rare’, and Nplate was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 27 May 2005.
Ker je število bolnikov z imunsko trombocitopenično purpuro majhno, velja ta bolezen za redko, zato je bilo zdravilo Nplate dne 27. maja 2005 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Nplate is given once a week as an injection under the skin.
Zdravilo Nplate se daje enkrat tedensko kot injekcija pod kožo.
The starting dose depends on the patient’ s weight, and is then adjusted every week to maintain platelet counts at target levels.
Začetni odmerek je odvisen od mase bolnika, nato pa se ga prilagodi vsak teden za ohranjanje števila trombocitov na ciljni ravni.
Treatment can be interrupted if platelet counts become too high.
Če postane število trombocitov preveliko, se lahko zdravljenje prekine.
Treatment with Nplate should be stopped after four weeks of treatment with the maximum dose of Nplate if the platelet count does not reach levels that are high enough to reduce the risk of bleeding.
Zdravljenje z zdravilom Nplate je treba prekiniti po štirih tednih zdravljenja z največjim odmerkom zdravila Nplate, če število trombocitov ne doseže ravni, ki je dovolj visoka za zmanjšanje tveganja krvavitev.
Nplate should be used with caution in patients who have problems with their liver or kidneys because it has not been formally studied in this group.
Zdravilo Nplate je treba uporabljati previdno pri bolnikih, ki imajo jetrne ali ledvične težave, ker uradne študije za to skupino niso izvedli.
Reproduction is authorised provided the source is acknowledged. attach to and stimulate the same receptors as thrombopoietin.
Kako zdravilo Nplate deluje?
By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, increasing blood platelet counts.
Zdravilna učinkovina v zdravilu Nplate, romiplostim, je zdravilo, ki spodbuja nastajanje trombocitov.
Romiplostim is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce romiplostim.
Romiplostim se proizvaja z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori romiplostim.
The effects of Nplate were first tested in experimental models before being studied in humans.
Učinki zdravila Nplate so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The second study involved 62 patients who still had their spleens and who had been treated for ITP in the past.
V drugo študijo je bilo vključenih 62 bolnikov, ki so še vedno imeli vranico in so se v preteklosti zdravili zaradi imunske trombocitopenične purpure.
This was classified as the patient ’ s platelet counts being above 50 million per millilitre for at least six of the last eight weeks of the 24-week treatment period, without the need for any other medicines for ITP.
Določeno je bilo kot število trombocitov bolnika, ki je vsaj šest do osem zadnjih tednov 24- tedenskega obdobja zdravljenja presegalo število 50 milijonov na mililiter, ne da bi pri tem potrebovali druga zdravila za imunsko trombocitopenično purpuro.
Platelet counts below 30 million per millilitre are considered to put ITP patients at risk of bleeding, while normal counts are between 150 and 400 million per millilitre.
Število trombocitov bolnika, ki je manjše od 30 milijonov na mililiter, se šteje kot nevarnost krvavitve za bolnike z imunsko trombocitopenično purpuro, normalno število trombocitov pa se giblje od 150 do 400 milijonov na mililiter.
In the study of patients whose spleen had been removed, 38% of the patients had a lasting response to treatment with Nplate (16 out of 42), compared with none of the 21 patients receiving placebo.
Pri študiji bolnikov z odstranjeno vranico je 38% bolnikov doseglo trajen odziv na zdravilo Nplate (16 bolnikov od 42) v primerjavi z nobenim od 21 bolnikov, ki so prejemali placebo.
In the study of patients with a spleen, 61% of the patients had a lasting response to treatment with Nplate (25 out of 41), compared with 5% of the patients receiving placebo (1 out of 21).
Pri študiji bolnikov, ki so imeli vranico, je 61% bolnikov doseglo trajen odziv na zdravilo Nplate (25 bolnikov od 41) v primerjavi s 5% bolnikov, ki so prejemali placebo (1 bolnik od 21).
The most common side effect with Nplate (seen in more than 1 patient in 10) is headache.
Najpogostejši neželeni učinek zdravila Nplate (opažen pri več kot 1 bolniku izmed 10) je glavobol.
For the full list of all side effects reported with Nplate, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nplate, glejte navodilo za uporabo.
Nplate should not be used in people who may be hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Zdravila Nplate ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) romiplostim, katero koli drugo sestavino zdravila ali beljakovine, ki jih tvori bakterija Escherichia coli.
The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Nplate had been shown in patients whose spleens had been removed, as well as in patients who still had their spleens.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bila učinkovitost zdravila Nplate dokazana pri bolnikih, ki so jim odstranili vranico, pa tudi pri bolnikih, ki so vranico še imeli.
However, because removal of the spleen is a potential cure for ITP, the Committee concluded that Nplate should only be used in these patients with a spleen if they are not able to undergo surgery.
Ker pa je odstranitev vranice eno od zdravljenj za imunsko trombocitopenično purpuro, je Odbor sklenil, da je treba zdravilo Nplate uporabljati pri bolnikih z vranico samo, če niso primerni za operativni poseg.
Therefore, the CHMP decided that Nplate’ s benefits are greater than its risks for adult chronic immune (idiopathic) thrombocytopenic purpura splenectomised patients who are refractory to other treatments, and that it may be considered as second-line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Zato je CHMP zaključil, da so koristi zdravila Nplate pri zdravljenju odraslih s kronično imunsko (idiopatično) trombocitopenično purpuro pri splenektomiranih bolnikih, ki so odporni na druga zdravila, večje od z njim povezanih tveganj, in da se zdravilo lahko uporablja kot zdravilo drugega izbora pri odraslih nesplenektomiranih bolnikih, pri katerih je operacija kontraindicirana.
The Committee recommended that Nplate be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Nplate odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Nplate?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Nplate?
The company that makes Nplate will provide educational packs for doctors in each Member State.
Družba, ki proizvaja zdravilo Nplate, bo priskrbela izobraževalne komplete za zdravnike v posameznih državah članicah.
The packs will include information on the safety and effectiveness of Nplate.
Kompleti bodo vsebovali informacije o varnosti in učinkovitosti zdravila Nplate.
They will also remind doctors how to use the medicine and to discuss the benefits and risks of Nplate with patients.
Zdravniki bodo prejeli tudi
Doctors will also receive a ‘ dosing calculator’ to help them calculate the volumes of Nplate that need to be injected.
2/ 3 „ kalkulator odmerka “, s pomočjo katerega bodo lahko izračunali količino zdravila Nplate, ki jo je treba vbrizgati.
These volumes can sometimes be very small.
Ta količina je lahko včasih zelo majhna.
Other information about Nplate:
Druge informacije o zdravilu Nplate:
The European Commission granted a marketing authorisation valid throughout the European Union for Nplate to Amgen Europe B. V. on 04 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Nplate, veljavno po vsej Evropski uniji, odobrila družbi Amgen Europe B. V. dne 04. februarja 2009.
The summary of opinion of the Committee for Orphan Medicinal Products for Nplate is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Nplate je na voljo tukaj.
The full EPAR for Nplate can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nplate je na voljo tukaj.
EU/ 1/ 08/ 497/ 001
Številka EU EU/ 1/ 08/ 497/ 001
Nplate
Izmišljeno ime Nplate
250 µg
Jakost 250 µg
Powder for solution for injection
Farmacevtska oblika Prašek za raztopino za injiciranje
Subcutaneous use
Pot uporabe Za subkutano uporabo
vial (glass)
Ovojnina (steklena) viala
1 vial
Velikost pakiranja 1viala
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 µg of romiplostim (500 µg/ ml).
Po pripravi uporabna količina 0, 5 ml raztopine vsebuje 250 µg romiplostima (500 µg/ ml).
An additional overfill is included in each vial to ensure that 250 µg of romiplostim can be delivered.
Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 µg romiplostima.
Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Romiplostim je pridobljen s tehnologijo rekombinantne DNA pri Escherichia coli (E. coli).
This powder is white.
Prašek je bel.
Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e. g. corticosteroids, immunoglobulins).
Nplate je indiciran za zdravljenje kronične imunske (idiopatične) trombocitopenične purpure (ITP) pri odraslih splenektomiranih bolnikih, ki se niso ustrezno odzvali na druga zdravila (npr. kortikosteroide, imunoglobuline).
Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Nplate pride v poštev kot zdravilo drugega izbora pri odraslih nesplenektomiranih bolnikih, pri katerih je operacija kontraindicirana.
Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Zdravljenje mora ves čas potekati pod nadzorstvom zdravnika, izkušenega v zdravljenju hematoloških bolezni.
Nplate should be administered once weekly as a subcutaneous injection.
Nplate je treba dajati enkrat na teden v subkutani injekciji.
The initial dose of romiplostim is 1 µg/ kg based on actual body weight.
Začetni odmerek romiplostima je 1 µg/ kg glede na dejansko telesno maso.
Initial or subsequent once weekly dose:
Začetni in nadaljnji odmerek enkrat na teden
Weight* in kg x Dose in µg/ kg = Individual patient dose in µg
Telesna masa * v kg x odmerek v µg/ kg = odmerek v µg za posameznega bolnika
Dose in µg x 1 ml 500 µg = Amount to inject in ml
Odmerek v µg x 1 ml 500 µg = količina za injiciranje v ml
Example:
2 Primer:
75 kg patient is initiated at 1 µg/ kg of romiplostim.
Zdravljenje 75- kg bolnika se začne z 1 µg/ kg romiplostima.
The individual patient dose = 75 kg x 1 µg = 75 µg The corresponding amount of Nplate solution to inject = 75 µg x 1 ml = 0.15 ml 500 µg
Odmerek za bolnika = 75 kg x 1 µg = 75 µg Ustrezna količina raztopine Nplate za injiciranje = 75 µg x 1 ml = 0, 15 ml 500 µg
2 *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
* Za izračun odmerka romiplostima morate vedno uporabiti dejansko telesno maso na začetku zdravljenja.
Future dose adjustments are based on changes in platelet counts only and made in 1 µg increments (see Table below).
Nadaljnje prilagoditve odmerka morajo temeljiti zgolj na spremembi števila trombocitov in jih je treba izvajati v korakih po 1 µg (glejte tabelo spodaj).
A subject’ s actual body weight at initiation of therapy should be used to calculate dose.
Za izračun odmerka morate uporabiti bolnikovo dejansko telesno maso na začetku zdravljenja.
The once weekly dose of romiplostim should be increased by increments of 1 μ g/ kg until the patient achieves a platelet count ≥ 50 x 109/ l.
Odmerek romiplostima enkrat na teden je treba povečevati po 1 µg/ kg, dokler bolnik ne doseže števila trombocitov ≥ 50 x 109/ l.
Platelet counts should be assessed weekly until a stable platelet count (≥ 50 x 109/ l for at least 4 weeks without dose adjustment) has been achieved.
Število trombocitov je treba kontrolirati vsak teden, dokler ni doseženo stabilno število trombocitov (≥ 50 x 109/ l vsaj 4 tedne brez prilagoditve odmerka).
Do not exceed a maximum once weekly dose of 10 μ g/ kg.
Ne presezite največjega odmerka 10 µg/ kg enkrat na teden.
Platelet count Action (x 109/ l )< 50 Increase once weekly dose by 1 μg/kg > 200 for two Decrease once weekly dose by 1 μg/kg consecutive weeks Do not administer, continue to assess the platelet count weekly > 400 After the platelet count has fallen to < 200 x 109/l, resume dosing with once weekly dose reduced by 1 μg/kg
Število Ukrepanje trombocitov (x 109/ l) < 50 Odmerek enkrat na teden povečajte za 1 µg/ kg. > 200 dva tedna Odmerek enkrat na teden zmanjšajte za 1 µg/ kg. zapored Ne uporabite zdravila, nadaljujte kontrole števila trombocitov vsak teden. > 400 Potem ko število trombocitov upade na < 200 x 109/ l, znova začnite uporabljati zdravilo enkrat na teden v odmerku, zmanjšanem za 1 µg/ kg.
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).
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).
A syringe with graduations of 0.01 ml should be used.
Uporabiti je treba brizgo z 0, 01- ml graduacijo.
For instructions on reconstitution of Nplate, see section 6.6.
Za navodila o pripravi zdravila Nplate glejte poglavje 6. 6.
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 μ g/ kg.
Zdravljenje z romiplostimom je treba prekiniti, če se število trombocitov po štirih tednih zdravljenja z romiplostimom v največjem tedenskem odmerku 10 µg/ kg ne poveča dovolj, da bi preprečilo klinično pomembne krvavitve.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician.
Bolnike morate redno klinično spremljati; lečeči zdravnik se mora o nadaljevanju zdravljenja odločiti za vsakega bolnika posamezno.
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).
Elderly patients (≥ 65 years)
3 Starejši bolniki (≥ 65 let)
No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
V celoti se varnost in učinkovitost nista razlikovali med bolniki, starimi < 65 in ≥ 65 let (glejte poglavje 5. 1).
3 Children and adolescents (< 18 years)
Otroci in mladostniki (< 18 let)
Nplate is not recommended for use in children below age 18 due to insufficient data on safety or efficacy.
Zdravila Nplate zaradi nezadostnih podatkov o varnosti in učinkovitosti ni priporočljivo uporabljati pri otrocih, mlajših od 18 let.
No dose advice in this population can be provided.
Za odmerjanje v tej populaciji ni mogoče dati navodil.
No formal clinical studies have been conducted in these patient populations.
Pri bolnikih te starostne skupine niso opravili uradnih kliničnih študij.
Nplate should be used with caution in these populations.
Nplate morate zato pri njih uporabljati previdno.
Hypersensitivity to the active substance, to any of the excipients or to E. coli derived proteins.
Preobčutljivost na zdravilno učinkovino, katerokoli pomožno snov ali beljakovine pridobljene iz E. coli.
The following special warnings and precautions have been actually observed or are potential class effects based on the pharmacological mechanism of action of thrombopoietin (TPO) receptor stimulators.
Naslednja opozorila in previdnostne ukrepe so dejansko zabeležili ali pa so možni skupinski učinki glede na farmakološke mehanizme delovanja stimulatorjev receptorjev trombopoetina (TPO).
There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Prenehanje zdravljenja z romiplostimom ob uporabi antikoagulantov ali antiagregacijskih sredstev povečuje tveganje krvavitev.
Additional medical management may include cessation of anticoagulant and/ or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Dodatni možni zdravstveni ukrepi so prenehanje antikoagulantnega in/ ali antiagregacijskega zdravljenja, odprava antikoagulacije ali trombocitna podpora.
Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Ta povzroči povečanje števila megakariocitov v kostnem mozgu, kar lahko vodi do sproščanja citokinov.
See Section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
Za informacije o zvišanju retikulina, ugotovljenem v kliničnih preskušanjih romiplostima, glejte poglavje 4. 8.
Thrombotic/ thromboembolic complications
4 Trombotični/ trombembolični zapleti
Platelet counts above the normal range present a theoretical risk for thrombotic/ thromboembolic complications.
Zvišano število trombocitov pomeni teoretično tveganje za trombotične/ trombembolične zaplete.
The incidence of thrombotic/ thromboembolic events observed in clinical trials was similar between romiplostim and placebo, and an association between these events and elevated platelet counts was not observed.
V kliničnih preskušanjih je bila incidenca trombotičnih/ trombemboličnih dogodkov med uporabo romiplostima in placeba podobna in niso opazili, da bi bili ti dogodki povezani z večjim številom trombocitov.
Dose adjustment guidelines should be followed (see section 4.2).
Upoštevati je treba smernice za prilagajanje odmerka (glejte poglavje 4. 2).
4 Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS)
Napredovanje obstoječih hematopoetskih malignomov ali mielodisplastičnega sindroma (MDS)
TPO receptor stimulators are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation, and platelet production.
Stimulatorji receptorjev TPO so rastni faktorji, ki povzročijo ekspanzijo in diferenciacijo trombopoetskih matičnih celic ter nastajanje trombocitov.
The TPO receptor is predominantly expressed on the surface of cells of the myeloid lineage.
Receptorji TPO so izraženi predvsem na površini celic mieloične vrste.
For TPO receptor stimulators there is a theoretical concern that they may stimulate the progression of existing haematopoietic malignancies or MDS.
Stimulatorji receptorjev TPO bi teoretično lahko spodbudili napredovanje obstoječih hematopoetskih malignomov ali MDS.
Romiplostim should not be used for the treatment of thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP outside of clinical trials.
Romiplostima se razen v okviru kliničnih preskušanj ne sme uporabljati za zdravljenje trombocitopenije, ki je posledica MDS, ali trombocitopenije kakršnegakoli drugega vzroka razen ITP.
The risk-benefit profile for romiplostim has not been established in MDS or other non-ITP patient populations.
Ocena koristi in tveganja romiplostima ni podana za bolnike z MDS in druge populacije bolnikov, ki nimajo ITP.
In a single-arm, open-label clinical study of treatment with romiplostim in patients with MDS, there were reported cases of progression to acute myeloid leukaemia (AML), however this is an expected clinical outcome of MDS and the relationship to romiplostim treatment is unclear.
V odprti klinični študiji z enim krakom zdravljenja z romiplostimom pri bolnikih z MDS so zabeležili primere napredovanja v akutno mieloično levkemijo (AML), vendar je to pričakovan klinični izid MDS, in povezanost z uporabo romiplostima ni jasna.
In addition, cases of transient blast cell increases were observed in this study.
Poleg tega so v tej študiji zabeležili primere prehodnega porasta blastnih celic.
The transient blast cell increases were reversible upon discontinuation of romiplostim.
Prehodni porast blastnih celic je bil po prenehanju uporabe romiplostima reverzibilen.
Therefore this observation is inconsistent with progression to AML.
Zato se to opažanje ne sklada z napredovanjem v AML.
It is not possible to distinguish leukaemic blasts from normal blasts.
Levkemičnih blastov ni mogoče razlikovati od normalnih blastov.
A loss of response or failure to maintain a platelet response with romiplostim treatment within the recommended dosing range should prompt a search for causative factors, including immunogenicity (see section 4.8) and increased bone marrow reticulin (see above).
V primeru neodzivnosti ali neuspešnega vzdrževanja odziva trombocitov pri zdravljenju z romiplostimom v priporočenem razponu odmerkov je treba takoj iskati vzročne dejavnike, vključno z imunogenostjo (glejte poglavje 4. 8) in zvišanjem retikulina v kostnem mozgu (glejte zgoraj).
Alterations in red (decrease) and white (increase) blood cell parameters have been observed in non- clinical toxicology studies (rat and monkey) but not in ITP patients.
V nekliničnih toksikoloških študijah (na podganah in opicah) so opažali spremembe vrednosti rdečih (znižanje) in belih (zvišanje) krvnih celic; pri bolnikih z ITP tega niso ugotovili.
The potential interactions of romiplostim with co- administered drugs due to binding to plasma proteins remain unknown.
Možna medsebojna delovanja romiplostima med sočasno uporabo drugih zdravil zaradi vezave na plazemske beljakovine ostajajo neznana.
Medicinal products used in the treatment of ITP in combination with romiplostim in clinical studies included corticosteroids, danazol, and/ or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Med zdravili, ki so jih v kliničnih študijah uporabljali za zdravljenje ITP v kombinaciji z romiplostimom, so bili kortikosteroidi, danazol in/ ali azatioprin, intravenski imunoglobulin (IVIG) in anti- D imunoglobulin.
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).
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).
Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1).
V kombinaciji z romiplostimom (glejte poglavje 5. 1) je mogoče uporabo kortikosteroidov, danazola in azatioprina zmanjšati ali prekiniti.
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).
For romiplostim no clinical data on exposed pregnancies are available.
Kliničnih podatkov o izpostavljenosti romiplostimu med nosečnostjo ni.