natgillin/translations-raw huggingface dataset:
Studies in animals have shown reproductive toxicity, such as transplacental passage and increased foetal platelet counts in rats (see section 5.3).
5 Študije na živalih so pokazale reproduktivne toksične učinke, npr. prehajanje skozi placento in večje število trombocitov pri plodovih podgan (glejte poglavje 5. 3).
Romiplostim should not be used during pregnancy unless clearly necessary.
Romiplostima se med nosečnostjo ne sme uporabljati, če ni nedvomno potreben.
There are no data on excretion of romiplostim in human milk.
Podatkov o izločanju romiplostima v človeško mleko ni.
However, excretion is likely and a risk to the suckling child cannot be excluded.
Toda izločanje je verjetno in tveganja za dojenčka ni mogoče izključiti.
5 A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with romiplostim should be made taking into account the benefit of breast-feeding to the child and the benefit of romiplostim therapy to the woman.
Pri odločitvi za nadaljevanje/ prekinitev dojenja oz. za nadaljevanje/ prekinitev terapije z romiplostimom je treba upoštevati korist dojenja za otroka in korist zdravljenja z romiplostimom za mater.
However, patients should be informed that in clinical trials mild to moderate, transient bouts of dizziness were experienced by some patients, which may affect the ability to drive or use machines.
Vendar je bolnikom treba povedati, da so se nekaterim bolnikom v kliničnih preskušanjih pojavili prehodni napadi omotice, ki lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical studies, the overall subject incidence of all adverse events for romiplostim-treated subjects was 91.5% (248/ 271).
Na podlagi analize vseh odraslih bolnikov z ITP, ki so prejemali romiplostim v 4 kontroliranih in 5 nekontroliranih kliničnih študijah, je bila celotna incidenca vseh neželenih učinkov pri preiskovancih, zdravljenih z romiplostimom, 91, 5% (248/ 271).
The adverse events listed in the table below are those deemed treatment related by investigators and which occur at a > 1% incidence (n = 271).
V spodnji preglednici so našteti tisti neželeni učinki, ki so bili po mnenju raziskovalcev povezani z zdravljenjem in so se pojavili z incidenco > 1% (n = 271).
Very common (≥ 1/ 10) and Common (≥ 1/ 100 to < 1/ 10).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/ 10) in pogosti (≥ 1/ 100 do < 1/ 10).
MedDRA system organ class Blood and lymphatic system disorders Psychiatric disorders
Organski sistem po MedDRA Bolezni krvi in limfatičnega sistema Psihiatrične motnje
Common Bone marrow disorder* Thrombocytopenia* Insomnia
Pogosti motnja kostnega mozga * trombocitopenija * nespečnost
Dizziness Paraesthesia Migraine
omotica parestezije migrena
Vascular disorders Respiratory, thoracic and mediastinal disorders
Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Flushing Pulmonary embolism*
zardevanje pljučna embolija *
Nausea Diarrhoea Abdominal pain Dyspepsia Constipation
slabost driska bolečine v trebuhu dispepsija zaprtje
Pruritis Ecchymosis Rash
srbenje ekhimoze izpuščaj
Arthralgia Myalgia Pain in extremity Muscle spasm Back pain Bone pain
artralgija mialgija bolečina v okončini spazem mišic bolečine v hrbtu bolečine v kosteh
6 MedDRA system organ class General disorders and administration site conditions
6
Common Fatigue Injection site bruising Injection site pain Oedema peripheral Influenza like illness Pain Asthenia Pyrexia Chills Injection site haematoma Injection site swelling
Pogosti utrujenost podplutba na mestu injiciranja bolečina na mestu injiciranja periferni edemi gripi podobna bolezen bolečine astenija pireksija mrzlica hematom na mestu injiciranja oteklost na mestu injiciranja
Injury, poisoning and procedural complications * see section 4.4
Poškodbe, zastrupitve in postopkovni zapleti * glejte poglavje 4. 4
In addition the events listed below have been deemed to be related to romiplostim treatment.
Poleg tega je bilo tudi za spodaj naštete učinke ocenjeno, da so povezani z zdravljenjem z romiplostimom.
Thrombocytosis
Trombocitoza
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical studies, 3 events of thrombocytosis were reported, n = 271.
Na podlagi analize vseh odraslih bolnikov z ITP, ki so prejemali romiplostim v 4 kontroliranih in 5 nekontroliranih kliničnih študijah, so bili opisani 3 primeri trombocitoze, n = 271.
No clinical sequelae were reported in association with the elevated platelet counts in any of the 3 subjects.
Pri nobenem od teh 3 preiskovancev niso zabeležili kliničnih posledic zvišanega števila trombocitov.
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical studies, 4 events of thrombocytopenia after cessation of treatment were reported, n = 271 (see section 4.4).
Na podlagi analize vseh odraslih bolnikov z ITP, ki so prejemali romiplostim v 4 kontroliranih in 5 nekontroliranih kliničnih študijah, so bili opisani 4 primeri trombocitopenije po prenehanju zdravljenja, n = 271 (glejte poglavje 4. 4).
In clinical studies, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
V kliničnih študijah so zaradi odlaganja retikulina v kostnem mozgu zdravljenje z romiplostimom prekinili pri 4 od 271 bolnikov.
In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
Pri 6 nadaljnih bolnikih so retikulin ugotovili z biopsijo kostnega mozga (glejte poglavje 4. 4).
In clinical studies, antibodies to romiplostim were examined.
Protitelesa, ki so nevtralizirala delovanje romiplostima, so se pojavila pri 1 od 271 ITP bolnikov, ki so prejemali romiplostim v kliničnem programu ITP.
Of the 271 adult ITP patients receiving romiplostim in the ITP clinical programme one patient developed antibodies capable of neutralising the activity of romiplostim but these antibodies did not cross react with endogenous TPO.
Vendar ta protitelesa niso navzkrižno reagirala z endogenim TPO.
Approximately 4 months later, the patient tested negative for neutralising antibodies to romiplostim.
Približno 4 mesece pozneje je bil izvid nevtralizirajočih protiteles proti romiplostimu pri tem bolniku negativen.
If formation of neutralising antibodies is suspected, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet) for antibody testing.
Navodila za uporabo).
In early clinical studies, the maximum dose of romiplostim was 30 µg/ kg.
V zgodnjih kliničnih študijah je bil največji odmerek romiplostima 30 µg/ kg.
This was later reduced to 10 µg/ kg due to lack of additional clinical benefit of doses above this level.
Odmerek so pozneje zmanjšali na 10 µg/ kg, ker večji odmerki niso prinesli dodatnih kliničnih koristi.
No adverse effects were seen in rats given a single dose of 1000 μ g/ kg or in monkeys after repeated administration of romiplostim at 500 µg/ kg (100 or 50 times the maximum clinical dose of 10 µg/ kg, respectively).
Pri podganah, ki so dobile posamičen odmerek 1000 µg/ kg, in opicah po večkratni uporabi 500 µg/ kg romiplostima (prvo je 100- kratni, drugo pa 50- kratni največji klinični odmerek 10 µg/ kg) niso ugotovili neželenih učinkov.
7 In the event of overdose, platelet counts may increase above the normal range.
7 Po prevelikem odmerjanju se lahko število trombocitov poveča nad normalne vrednosti.
Platelet counts should be monitored and appropriate treatment should be given (see section 4.2).
Število trombocitov morate redno spremljati in uvesti ustrezno terapijo (glejte poglavje 4. 2).
Pharmacotherapeutic group:
Farmakoterapevtska skupina: antihemoragiki.
Antihemorrhagics, ATC code:
Oznaka ATC:
Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the thrombopoietin (TPO) receptor (also known as cMpl) to increase platelet production.
Romiplostim je Fc- peptidna fuzijska beljakovina (peptidno telo), ki signalizira in aktivira znotrajcelične transkripcijske poti preko receptorjev trombopoetina (TPO) (te receptorje imenujemo tudi cMpI), in tako poveča nastajanje trombocitov.
The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains.
Vsaka enoverižna podenota je na C- terminalnem delu kovalentno vezana na peptidno verigo, ki ima 2 vezavna odseka za TPO.
In pre-clinical and clinical studies no anti-romiplostim antibodies cross reacted with endogenous TPO.
V predkliničnih in kliničnih študijah nobeno protitelo proti romiplostimu ni navzkrižno reagiralo z endogenim TPO.
In clinical studies, treatment with romiplostim resulted in dose-dependent increases in platelet count.
V kliničnih študijah je zdravljenje z romiplostimom povzročilo od odmerka odvisno povečanje števila trombocitov.
After a single subcutaneous dose of 1 to 10 µg/ 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.
The platelet counts of ITP patients who received 6 weekly doses of 1 or 3 µg/ kg of romiplostim were within the range of 50 to 450 x 109/ l for most patients.
Pri večini bolnikov z ITP, ki so prejeli 6 tedenskih odmerkov 1 ali 3 µg/ kg romiplostima, je bilo število trombocitov 50 do 450 x 109/ l.
Of the 271 patients who received romiplostim in ITP clinical studies, 55 (20%) were age 65 and over, and 27 (10%) were 75 and over.
Od 271 bolnikov, ki so romiplostim prejemali v kliničnih študijah ITP, je bilo 55 (20%) starejših od 65 let in 27 (10%) starejših od 75 let.
Prior treatments included corticosteroids (90% of all patients), immunoglobulins (76%), rituximab (29%), cytotoxic therapies (21%), danazol (11%), and azathioprine (5%).
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%).
Patients had a median platelet count of 19 x 109/ l at study entry.
Ob vključitvi v študijo so imeli bolniki mediano vrednost števila trombocitov 19 x 109/ l.
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%).
Patients had a median platelet count of 14 x 109/ l at study entry.
Ob vključitvi v študijo so imeli bolniki mediano vrednost števila trombocitov 14 x 109/ l.
Patients (≥ 18 years) were randomised in a 2:1 ratio to receive a starting dose of romiplostim 1 µg/ kg or placebo.
Bolnike (stare ≥ 18 let) so v razmerju 2: 1 randomizirali na skupino, ki je prejemala začetni odmerek 1 µg/ kg romiplostima in skupino, ki je prejemala placebo.
Doses were adjusted to maintain (50 to 200 x 109/ l) platelet counts.
Odmerki so bili prilagojeni za vzdrževanje števila trombocitov (od 50 do 200 x 109/ l).
In both studies, efficacy was determined by an increase in the proportion of patients who achieved a durable
V obeh študijah so učinkovitost
8 platelet response.
8 ugotavljali s povečanjem deleža bolnikov, ki so dosegli trajen odziv trombocitov.
The median average weekly dose for splenectomised patients was 3 µg/ kg and for non-splenectomised patients was 2 µg/ kg.
Mediani povprečni tedenski odmerek pri splenektomiranih bolnikih je bil 3 µg/ kg in pri nesplenektomiranih 2 µg/ kg.
A significantly higher proportion of patients receiving romiplostim achieved a durable platelet response compared to patients receiving placebo in both studies.
V obeh študijah je trajen odziv trombocitov dosegel znatno večji delež bolnikov, ki so prejemali Nplate, kot tistih, ki so prejemali placebo.
Following the first 4-weeks of study romiplostim maintained platelet counts ≥ 50 x 109/ l in between 50% to 70% of patients during the 6 month treatment period in the placebo-controlled studies.
V študijah, kontroliranih s placebom, je romiplostim po prvih 4 tednih študije med 6- mesečnim zdravljenjem ohranil število trombocitov ≥ 50 x 109/ l pri 50% do 70% bolnikov.
In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment.
V skupini s placebom je med 6- mesečno uporabo doseglo odziv števila trombocitov od 0 do 7% bolnikov.
non-splenectomised patients
Nesplenektomirani bolniki
splenectomised patients
Splenektomirani bolniki
studies 1 & 2
študiji 1 in 2
(%) patients with
(%) bolnikov s
Placebo romiplostim Placebo romiplostim (n = 21) (n = 42) (n = 21) (n = 83)
romiplostim placebo (n = 42) (n = 21)
Placebo (n = 42)
placebo (n = 42)
durable platelet responsea
trajnim odzivom trombocitova
1 (5%) 16 (38%) 0 (0%) 41 (50%)
(0%,
1 (2%)
(38%,
(24%, 54%)
24%)
(0%, 16%)
16%)
(38%, 61%)
61%)
(0%, 13%)
13%)
(%) patients with overall platelet responseb
(%) bolnikov s celotnim odzivom trombocitovb
(3%, 36%)
(3%,
(63%, 90%)
(63%,
(0%, 16%)
(0%,
(73%, 91%)
(73%,
(2%, 20%)
(2%,
Mean no. weeks with platelet responsec
Povprečno št. tednov z odzivom trombocitovc
(SD) p-value
(std. odklon) vrednost p
< 0.0001
3, 5 < 0, 0001
7.8
0, 5
< 0.0001
7, 8 < 0, 0001
(%) patients requiring rescue therapiesd
(%) bolnikov, ki so potrebovali
8(20%)
8
13 (62%)
13
11 (26%)
11
12 (57%)
12
19 (23%)
19
25 (60%)
25
(38%, 82%)
(38%,
(14%, 42%)
(14%,
(34%, 78%)
(34%,
(14%, 33%) (43%, 74%)
(14%,
p-value
(43%,
0.001
82%)
0.0175
42%)
< 0.0001
78%)
Study 1
33%)
Study 2
74%)
studies 1 & 2
vrednost p
(%) patients with durable
0, 001
romiplostim (n = 41)
0, 0175
Placebo (n = 42)
< 0, 0001
platelet response with stable dosee
(%) bolnikov s trajnim odzivom trombocitov s stabilnim odmerkome
(0%, 16%) (18%, 47%) (0%, 16%) (30%, 52%)
(0%,
(0%, 8%)
(0%,
a
vrednost p a
p-value
0, 0001
0.0001
16%)
0.0046
47%) 16%) 0, 0046
< 0.0001
52%) < 0, 0001
Durable platelet response was defined as weekly platelet count ≥ 50 x 109/ l for 6 or more times for study weeks 18-25 in the absence of rescue therapies any time during the treatment period. b Overall platelet response is defined as achieving durable or transient platelet responses.
Trajni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 109/ l, ugotovljeno 6 - ali večkrat od 18. do 25. tedna študije brez uporabe rešilnih zdravil kadarkoli med zdravljenjem. b Celotni odziv trombocitov je opredeljen kot doseganje trajnega ali prehodnega odziva trombocitov.
Transient platelet response was defined as weekly platelet count ≥ 50 x 109/ l for 4 or more times during study weeks 2-25 but without durable platelet response.
Prehodni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 109/ l, ugotovljeno 4 - ali večkrat od 2. do 25. tedna, a brez trajnega odziva.
Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products. c Number of weeks with platelet response is defined as number of weeks with platelet counts ≥ 50 x 109/ l during study weeks 2-25.
Bolnik lahko nima tedenskega odziva v 8 tednih po prejetju kakršnekoli rešilne terapije. c Število tednov z odzivom trombocitov je opredeljeno kot število tednov s številom trombocitov ≥ 50 x 109/ l od 2. do 25. tedna študije.
Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products. d Rescue therapies defined as any therapy administered to raise platelet counts.
9 kakršnekoli rešilne terapije. d Za rešilno terapijo velja vsaka terapija, uvedena z namenom povečanja števila trombocitov.
Rescue therapies allowed in the study were IVIG, platelet transfusions, anti-D immunoglobulin, and corticosteroids. e Stable dose defined as dose maintained within ± 1 µg/ kg during the last 8 weeks of treatment.
V študiji dovoljena rešilna zdravila so bila IVIG, transfuzije trombocitov, anti- D imunoglobulin in kortikosteroidi. e Stabilni odmerek je opredeljen kot odmerek, ki je bil v zadnjih 8 tednih zdravljenja znotraj ± 1 µg/ kg.
In both placebo-controlled, double-blind studies, patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the study (corticosteroids, danazol and/ or azathioprine).
V obeh s placebom kontroliranih, dvojno slepih študijah so lahko bolniki, ki so že prejemali zdravila za ITP po stalni odmerni shemi, ta zdravila ves čas študije jemali še naprej (kortikosteroidi, danazol in/ ali azatioprin).
Seventy-three percent of non-splenectomised patients receiving romiplostim were able to reduce the dose by more than 25% or discontinue concurrent ITP medical therapies by the end of the study compared to 50% of placebo treated patients (see section 4.5).
Triinsedemdeset odstotkov nesplenektomiranih bolnikov, ki so prejemali romiplostim, je lahko do konca študije zmanjšalo odmerek sočasnih zdravil za ITP za več kot 25% ali je lahko ta zdravila celo opustilo; med bolniki, ki so prejemali placebo, je bilo takšnih 50% (glejte poglavje 4. 5).
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.
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.
In the two placebo-controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/ placebo] = 0.59; 95% CI = (0.15, 2.31)).
V dveh s placebom kontroliranih študijah je pri 9 bolnikih prišlo do krvavitve, ki je bila ocenjena za resno (5 [6, 0%] romiplostim, 4 [9, 8%] placebo, razmerje obetov [romiplostim/ placebo] = 0, 59, 95% IZ = (0, 15, 2, 31)).
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)).
Krvavitve ≥ 2. stopnje je imelo 15% bolnikov, ki so dobivali romiplostim, in 34% bolnikov, ki so dobivali placebo (razmerje obetov [romiplostim/ placebo] = 0, 35, 95% IZ = (0, 14, 0, 85)).
After subcutaneous administration of 3 to 15 μ g/ kg romiplostim, maximum romiplostim serum levels in ITP patients were obtained after 7-50 hours (median 14 hours).
Po subkutani uporabi od 3 do 15 µg/ kg romiplostima je bila največja koncentracija romiplostima v serumu pri bolnikih z ITP dosežena po 7 do 50 urah (mediano po 14 urah).
The volume of distribution of romiplostim following intravenous administration of romiplostim decreased nonlinearly from 122, 78.8, to 48.2 ml/ kg for intravenous doses of 0.3, 1.0 and 10 μ g/ kg, respectively in healthy subjects.
Volumen porazdelitve po intravenski uporabi romiplostima se je pri zdravih preiskovancih nelinearno zmanjševal od 122 ml/ kg po odmerku 0, 3 µg/ kg preko 78, 8 ml/ kg po odmerku 1, 0 µg/ kg do 48, 2 ml/ kg po odmerku 10 µg/ kg.
Elimination
10 Odstranjevanje
Elimination half-life of romiplostim in ITP patients ranged from 1 to 34 days (median, 3.5 days).
Eliminacijski razpolovni čas romiplostima pri bolnikih z ITP je bil od 1 do 34 dni (mediana 3, 5 dni).
In another ITP clinical study, no accumulation in serum concentrations was observed after 6 weekly doses of romiplostim (3 μ g/ kg).
V drugi klinični študiji ITP po 6 tedenskih odmerkih romiplostima (3 µg/ kg) niso opazili kopičenja koncentracije v serumu.
In these studies, myelofibrosis was not observed in animals after a 4-week post- treatment recovery period, indicating reversibility.
V teh študijah po koncu 4- tedenskega okrevanja po zdravljenju pri živalih niso ugotovili mielofibroze, kar nakazuje reverzibilnost.
In 1-month rat and monkey toxicology studies, a mild decrease in red blood cell count, haematocrit and haemoglobin was observed.
V 1- mesečnih toksikoloških študijah pri podganah in opicah so opazili blago znižanje števila eritrocitov, hematokrita in hemoglobina.
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.
Although high doses were tested in the animal studies, due to differences between the laboratory species and humans with regard to the sensitivity for
V študijah na živalih so sicer preizkusili velike odmerke, vendar zaradi razlik med laboratorijskimi vrstami in človekom, kar zadeva občutljivost na farmakodinamične učinke romiplostima in učinek nevtralizirajočih protiteles, meje varnosti ni mogoče zanesljivo oceniti.
Carcinogenesis:
Kancerogenost:
Reproductive toxicology:
Reproduktivna toksičnost:
In embryo-foetal development studies in mice and rats, reductions in maternal body weight were found only in mice.
V študijah embrio- fetalnega razvoja pri miših in podganah so samo pri miših ugotovili zmanjšanje telesne mase samic- mater.
In mice there was evidence of increased post- implantation loss.
Pri miših so ugotavljali večje poimplantacijske izgube plodov.
6.1 List of excipients
Manitol (E421) Saharoza
Mannitol (E421) Sucrose L-histidine Hydrochloric acid (for pH adjustment) Polysorbate 20
11 L- histidin Klorovodikova kislina (za prilagoditev pH) Polisorbat 20
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smete mešati skupaj z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and for 24 hours at 2°C – 8°C, when protected from light and kept in the original vial.
Če je zdravilo zaščiteno pred svetlobo in je v originalni viali, sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 25 °C in za 24 ur pri temperaturi od 2 °C do 8 °C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 25°C or 24 hours in a refrigerator (2°C – 8°C), protected from light.
Čas običajno ne sme presegati 24 ur pri 25 °C ali 24 ur v hladilniku (2 °C do 8 °C), zaščiteno pred svetlobo.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Za pogoje shranjevanja pripravljenega (rekonstituiranega) zdravila glejte poglavje 6. 3.
5 ml vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene).
5- ml viala (iz prozornega stekla tipa I) z zamaškom (iz klorobutilne gume), zaporo (iz aluminija) in snemno zaporko (iz polipropilena).
Carton containing 1 or 4 vials of 250 µg of romiplostim.
Škatla, ki vsebuje 1 ali 4 viale z 250 µg romiplostima.
12 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Nplate is a sterile but unpreserved product and is intended for single use only.
Nplate je sterilno zdravilo, vendar ne vsebuje konzervansov in je namenjeno samo za enkratno uporabo.
Nplate should be reconstituted in accordance with good aseptic practice.
Nplate morate pripraviti (rekonstituirati) skladno z dobro aseptično prakso.