natgillin/translations-raw huggingface dataset:
- Check that the inspection window is filled with the yellow indicator.
• Če ne slišite drugega "klika": - Preverite, ali je okence za ogled napolnjeno z rumenim indikatorjem.
Administer the 1 mL injection (equivalent to 100 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Injicirajte 1 ml raztopine (to ustreza 100 mg mepolizumaba) subkutano v nadlaket, stegno ali trebuh.
• Holding the middle of the pen, carefully take it out of the tray.
• Primite peresnik na sredini in ga previdno vzemite iz embalaže.
• Do not share your Nucala pre-filled pen with another person.
• Ne souporabljajte napolnjenega injekcijskega peresnika zdravila Nucala z nikomer drugim.
Nucala 100 mg solution for injection in pre-filled pen and Nucala 100 mg solution for injection in pre-filled syringe are not indicated for administration to this population.
Zdravilo Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku in zdravilo Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi nista indicirani za uporabo v tej populaciji.
Following a single subcutaneous administration in the abdomen, thigh or arm of healthy subjects, mepolizumab absolute bioavailability was 64%, 71% and 75%, respectively.
Pri zdravih preiskovancih je bila absolutna biološka uporabnost po enkratnem subkutanem injiciranju v trebuh 64 %, v stegno 71 % in v roko 75 %.
Sodium phosphate dibasic heptahydrate Citric acid monohydrate Polysorbate 80
Natrijev hidrogenfosfat heptahidrat Citronska kislina, monohidrat Polisorbat 80
Failure to follow these instructions may affect proper function of the pre-filled syringe.
Če teh navodil ne upoštevate, se lahko zgodi, da napolnjena injekcijska brizga ne bo delovala pravilno.
Instructions for using the pre-filled pen are given on the other side of this leaflet.
Navodila za uporabo napolnjenega injekcijskega peresnika so navedena na hrbtni strani tega navodila.
It may be injected into the upper arm, thigh, or abdomen.
Injicira se ga lahko v nadlaket, stegno ali trebuh.
Do not stop injections of Nucala unless your doctor advises you to. Interrupting or stopping the treatment with Nucala may cause your asthma symptoms and attacks to come back.
Prekinitev ali prenehanje zdravljenja z zdravilom Nucala lahko povzroči, da se vam znova pojavijo simptomi in napadi astme.
The pre-filled syringe should be used only once and then discarded.
Napolnjen injekcijski peresnik uporabite le enkrat in ga nato zavrzite.
If you may have had a similar reaction to any injection or medicine: Tell your doctor before you or your child are given Nucala.
Če ste morda kdaj imeli podobno reakcijo na kakšno injekcijo ali zdravilo, morate to povedati zdravniku, preden dobite zdravilo Nucala.
Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen or pre-filled syringe are provided in the instructions for use in the package leaflet.
Izčrpna navodila za subkutano injiciranje zdravila Nucala v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi so navedena v navodilu za uporabo zdravila.
Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably using a 2
Vsebino viale rekonstituirajte z 1,2 ml sterilne vode za injekcije; po možnosti uporabite 2- ali 3-ml brizgo in iglo dimenzije 21G (gauge).
Lower respiratory tract infection Urinary tract infection Pharyngitis
Infekcijske in parazitske bolezni okužba spodnjih dihal okužba sečil faringitis pogosti
No impairment of fertility was observed in a fertility and general reproduction toxicity study in mice performed with an analogous antibody that inhibits IL-5 in mice.
Plodnost V študiji toksičnosti za plodnost in splošno reproduktivno sposobnost pri miših, pri katerih so uporabili analogno protitelo, ki pri njih zavira IL-5, niso ugotovili okrnjene plodnosti.
Don't suddenly stop taking your preventer medicines for your asthma once you have started Nucala.
Po začetku zdravljenja z zdravilom Nucala ne prenehajte nenadoma uporabljati preventivnih zdravil za astmo.
No formal studies have been conducted to investigate the effect of renal impairment on the pharmacokinetics of mepolizumab.
Formalnih študij o vplivu okvare ledvic na farmakokinetiko mepolizumaba niso izvedli.
If a dose of Nucala is missed
Če ste pozabili uporabiti odmerek zdravila Nucala
Instructions for administration of 40 mg dose 1.
Navodila za dajanje 40 mg odmerka:
For the oral corticosteroid-sparing study MEA115575, a total of 135 patients were enrolled (55% were female; mean age of 50 years) who were being treated daily with OCS (5-35 mg per day), and high-dose ICS plus an additional maintenance medicine.
povprečna starost 50 let), ki so se zdravili s PKS (5-35 mg na dan) ter visokim odmerkom IKS in dodatnim vzdrževalnim zdravilom.
Elderly patients No dose adjustment is required for elderly patients (see section 5.2).
Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
Abrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended.
Ni priporočljivo, da bolnik po uvedbi zdravila Nucala nenadno preneha uporabljati kortikosteroide.
Remove the needle cap
Odstranite pokrovček igle
Sodium phosphate dibasic heptahydrate Polysorbate 80
Natrijev hidrogenfosfat heptahidrat Polisorbat 80
Nucala is a lyophilised white powder supplied in a clear, colourless glass vial with a rubber stopper.
Zdravilo Nucala je liofiliziran bel prašek v prozorni viali iz brezbarvnega stekla z gumijastim zamaškom.
Increased levels of pro-inflammatory cytokines (e.g. IL-6), via interaction with their cognate receptors on hepatocytes, have been shown to suppress the formation of CYP450 enzymes and drug transporters, however, elevation of systemic pro-inflammatory markers in severe refractory eosinophilic asthma is minimal and there is no evidence of IL-5 receptor alpha expression on hepatocytes.
Zvišana raven vnetnih citokinov (npr. IL-6) preko interakcije s kognatnimi receptorji na jetrnih celicah zavre tvorbo encimov CYP450 in prenašalcev zdravil.
Thirty -six paediatric patients (aged 611) received mepolizumab subcutaneously in an open-label study for 12 weeks.
pediatričnih bolnikov (starih od 6 do 11 let), ki so 12 tednov prejemali mepolizumab subkutano.
Eczema
ZDRAVILA
Severe refractory eosinophilic asthma
Težka trdovratna eozinofilna astma
Inspection window
Okence za ogled
In MEA112997, a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of 52 weeks duration in 616 patients with severe refractory eosinophilic asthma, mepolizumab significantly reduced clinically significant asthma exacerbations (defined as worsening of asthma requiring use of oral/systemic corticosteroids and/or hospitalisation and/or emergency department visits) when administered in doses of 75 mg, 250 mg or 750 mg intravenously compared to placebo (see Table 1).
tej študiji je mepolizumab v odmerkih 75 mg, 250 mg ali 750 mg intravensko v primerjavi s placebom pomembno zmanjšal klinično pomembna poslabšanja astme (opredeljena kot poslabšanje, ki je zahtevalo uporabo peroralnih/sistemskih kortikosteroidov in/ali sprejem v bolnišnico in/ali obisk v ambulanti za nujno pomoč) (glejte preglednico 1).
Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Zdravilo Nucala vsebuje učinkovino mepolizumab, ki je monoklonsko protitelo, vrsta beljakovine,
The other ingredients are sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80.
Druge sestavine zdravila so saharoza, natrijev hidrogenfosfat heptahidrat in polisorbat 80.
For self-administration the recommended injection sites are the abdomen or thigh.
Priporočeni mesti za samoinjiciranje sta trebuh ali stegno.
The immunogenicity profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Profil imunogenosti mepolizumaba pri bolnikih s težko trdovratno eozinofilno astmo (n = 998), ki so v odprtih podaljšanih študijah prejemali zdravljenje mediano 2,8 leta (razpon: od 4 tedne do 4,5 leta), je bil podoben, kot so ga opažali v s placebom kontroliranih študijah.
The liquid should be clear to opalescent, colourless to pale yellow to pale brown.
Raztopina mora biti bistra do opalescentna in brezbarvna do bledo rumena ali rjava.
The pack should be discarded if left out of the refrigerator for more than 7 days.
Pakiranje, ki ostane izven hladilnika več kot 7 dni, je treba zavreči.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (INDIVIDUAL PACKS INCLUDING BLUE BOX)
ŠKATLA (POSAMEZNA PAKIRANJA, VKLJUČNO Z MODRIM OKENCEM)
If necessary, the Nucala pre-filled pen and pre-filled syringe can be removed from the refrigerator and kept in the unopened pack for up to 7 days at room temperature (up to 30°C), when protected from light.
Če je treba, je mogoče napolnjeni injekcijski peresnik ali napolnjeno injekcijsko brizgo zdravila Nucala vzeti iz hladilnika in v neodprtem pakiranju hraniti do 7 dni pri sobni temperaturi (do 30 °C), če je zaščiteno pred svetlobo.
The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Druge sestavine zdravila so saharoza, natrijev hidrogenfosfat heptahidrat, monohidrat citronske kisline, polisorbat 80, dinatrijev edetat dihidrat, voda za injekcije.
Do not use the syringe if the security seal on the carton is broken.
Če je varnostni pečat na škatli pretrgan, brizge ne uporabite.
• Keep your used syringes and needle caps out of the reach of children.
• Uporabljene brizge in pokrovčke igel shranjujte nedosegljive otrokom.
No dose adjustment is required for elderly patients (see section 5.2).
Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
The recommended dose for adults and adolescents aged 12 years and older is 100 mg. You will have 1 injection every four weeks.
Priporočeni odmerek za odrasle in mladostnike, stare 12 let ali več, je 100 mg.
Instructions for administration of 100 mg dose 1.
Navodila za dajanje 100 mg odmerka:
• Dispose of the used syringe and needle cap according to local requirements.
• Uporabljeno brizgo in pokrovček igle zavrzite v skladu z lokalnimi predpisi.
• Remove the tray from the carton.
• Vzemite embalažo iz škatle.
Nucala is available in a pack containing 1 pre-filled syringe or in multipacks comprised of 3 x 1 pre-filled syringes.
Zdravilo Nucala je na voljo v pakiranju, ki vsebuje 1 napolnjeno injekcijsko brizgo, in v skupnem pakiranju, ki vsebuje 3 x 1 napolnjeno injekcijsko brizgo.
Renal and hepatic impairment No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Okvara ledvic ali jeter Bolnikom z okvaro ledvic ali jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
Primary endpoint Percent reduction in OCS from baseline (weeks 20-24)
Odstotno zmanjšanje PKS od izhodišča (20.
• Do not shake the syringe.
• Brizge ne stresajte.
The solution should be clear to opalescent, and colourless to pale yellow or pale brown, free of visible particles.
Raztopina mora biti bistra do opalescentna in brezbarvna do bledorumena ali svetlorjava, brez vidnih delcev.
• Dispose of the used pen and needle cap according to local requirements.
• Uporabljeni peresnik in pokrovček igle zavrzite v skladu z lokalnimi predpisi.
Each vial contains 100 mg mepolizumab.
Ena viala vsebuje 100 mg mepolizumaba.
• Do not rub your injection site.
• Mesta injiciranja ne drgnite.
Step-by-step instructions for use
Podrobna navodila za uporabo
No children had detectable anti-mepolizumab antibodies during the long-term phase of the study.
V dolgotrajni fazi študije ni imel noben otrok zaznanih protiteles proti mepolizumabu.
Placebo
s placebom)
The powder for solution for injection presentation is appropriate for administration to this population.
Za uporabo v tej populaciji je primerna oblika praška za raztopino za injiciranje.
Patients continued to receive their existing asthma medicine during the study with the exception of their OCS dose which was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained.
PKS, ki so jim ga med obdobjem zmanjševanja PKS (4. do 20. teden) zmanjšali vsake 4 tedne, če je bila astma še vedno urejena.
Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet.
Izčrpna navodila za subkutano injiciranje zdravila Nucala v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi so navedena na koncu navodila za uporabo zdravila.
Solution for injection (injection) A clear to opalescent, colourless to pale yellow to pale brown solution
Raztopina za injiciranje (injekcija) Bistra do opalescentna, brezbarvna do bledo rumena ali bledo rjava raztopina.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu pogosti
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (MULTIPACK ONLY WITHOUT BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (LE ZA VEČKRATNO PAKIRANJE, BREZ MODREGA OKENCA)
Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled syringe.
Zdravilo Nucala je na voljo kot 1 ml bistre do opalescentne, brezbarvne do bledo rumene ali bledo rjave raztopine v napolnjeni injekcijski brizgi za enkratno uporabo.
Check with your doctor if you think this applies to you.
Če menite, da to velja za vas, se posvetujte z zdravnikom.
You should also receive training on how to use the pre-filled pen.
Opraviti morate tudi usposabljanje za uporabo napolnjenega injekcijskega peresnika.
The Nucala pre-filled syringe can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30°C), when protected from light.
Napolnjeni injekcijski peresnik zdravila Nucala je mogoče vzeti iz hladilnika in ga hraniti v njegovi neodprti škatli do 7 dni pri sobni temperaturi (do 30 °C), če je zaščiten pred svetlobo.
Also contains: sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Pomožne snovi: saharoza, natrijev hidrogenfosfat heptahidrat, citronska kislina, monohidrat, polisorbat 80, dinatrijev edetat dihidrat in voda za injekcije.
Exacerbation rate per year Mepolizumab vs. placebo Rate ratio (95% CI)
Delež poslabšanj na leto Mepolizumab v primerjavi s placebom Razmerje deležev (95 % IZ)
Solution for injection in pre-filled syringe.
Raztopina za injiciranje v napolnjeni injekcijski brizgi
Exacerbation rate per year Percent reduction Rate ratio (95% CI) p-value
Delež poslabšanj na leto Odstotno zmanjšanje Razmerje deležev (95 % IZ) Vrednost p
Nucala is available in a pack containing 1 pre-filled pen, or in a multipack comprised of 3 x 1 pre-filled pen.
Zdravilo Nucala je na voljo v pakiranju, ki vsebuje 1 napolnjen injekcijski peresnik, in v skupnem pakiranju, ki vsebuje 3 x 1 napolnjen injekcijski peresnik.
The safety profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Varnostne značilnosti mepoluzimaba pri bolnikih s težko trdovratno eozinofilno astmo (n=998) , ki so v odprtih podaljšanih študijah prejemali zdravljenje mediano 2,8 leta (razpon: od 4 tedne do 4,5 leta), so bile podobne tistim, ki so jih opažali v s placebom kontroliranih študijah.
Table 3: Combined analysis of the rate of clinically significant exacerbations by baseline blood eosinophil count in patients with severe refractory eosinophilic asthma
Preglednica 3: Kombinirana analiza deleža klinično pomembnih poslabšanj pri bolnikih s težko trdovratno eozinofilno astmo glede na izhodiščno število eozinofilcev v krvi mepolizumab 75 mg i.v./100 mg s.c.
Do not rub your injection site.
Mesta injiciranja ne drgnite.
Multipack: 3 pre-filled syringes (3 packs of 1 pre-filled syringe).
Večkratno pakiranje: 3 napolnjeni injekcijski peresniki (3 pakiranja po 1 napolnjen injekcijski peresnik)
PARTICULARS TO APPEAR ON OUTER PACKAGING MULTIPACK CARTON (3 PACKS OF 1 VIAL - WITH BLUE BOX)
ŠKATLA Z VEČKRATNIM PAKIRANJEM (3 PAKIRANJA Z 1 VIALO - Z MODRIM OKENCEM)
A total of 896 adults and 19 adolescent subjects with severe refractory eosinophilic asthma received either a subcutaneous or an intravenous dose of mepolizumab during three placebo-controlled clinical studies of 24 to 52 weeks duration.
19 mladostnikov s težko trdovratno eozinofilno astmo prejemalo mepolizumab subkutano ali intravensko.
Nucala 100 mg solution for injection in pre-filled pen Nucala 100 mg solution for injection in pre-filled syringe
Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
The long-term efficacy profile of Nucala in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies MEA115666, MEA115661 and 201312 was generally consistent with the 3 placebo-controlled studies.
ki so v odprtih podaljšanih študijah MEA115666, MEA115661 in 201312 prejemali zdravljenje mediano 2,8 leta (razpon: od 4 tedne do 4,5 leta), se je na splošno skladal s tistim v 3 s placebom kontroliranih študijah.
Nucala is supplied as a 1 mL clear to opalescent, colourless to pale yellow to pale brown solution in a single use pre-filled pen.
Zdravilo Nucala je na voljo kot 1 ml bistre do opalescentne, brezbarvne do bledo rumene ali bledo rjave raztopine v napolnjenem injekcijskem peresniku za enkratno uporabo.
• Risk Management Plan (RMP)
• Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe,
1 pre-filled syringe.
1 napolnjena injekcijska brizga.
Nucala 100 mg solution for injection in pre-filled syringe Each 1 ml pre-filled syringe contains 100 mg of mepolizumab.
Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 1 ml napolnjena injekcijska brizga vsebuje 100 mg mepolizumaba.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora zamašenost nosu pogosti
No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Bolnikom z okvaro ledvic ali jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
Seek medical attention immediately if you think you (or your child) may be having a reaction.
Če sumite, da imate (vi ali vaš otrok) takšno reakcijo, nemudoma poiščite zdravniško pomoč.
Solution for injection in pre-filled pen Multipack: 3 pre-filled pens (3 packs of 1 pre-filled pen).
Raztopina za injiciranje v napolnjeni injekcijski brizgi Večkratno pakiranje: 3 napolnjene injekcijske brizge (3 pakiranja po 1 napolnjeno injekcijsko brizgo)
Anti-mepolizumab antibodies did not discernibly impact the pharmacokinetics and pharmacodynamics of mepolizumab in the majority of patients and there was no evidence of a correlation between antibody titres and change in blood eosinophil level.
Protitelesa proti mepolizumabu pri večini bolnikov niso opazno vplivala na farmakokinetiko in farmakodinamiko mepolizumaba.
Headache
Zamašek
MEA115588 was a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study which evaluated the efficacy and safety of mepolizumab as add-on therapy in 576 patients with severe refractory eosinophilic asthma defined as peripheral blood eosinophils greater than or equal to 150 cells/μL at initiation of treatment or greater than or equal to 300 cells/μL within the past 12 months.
Študija MEA115588 je bila randomizirana, dvojno slepa, s placebom kontrolirana multicentrična študija vzporednih skupin za oceno učinkovitosti in varnosti mepolizumaba kot dodatnega zdravljenja pri
• If someone else gives you the injection, they can also use your upper arm. Do not inject where your skin is bruised, tender, red or hard.
• Če vam zdravilo injicira nekdo drug, lahko uporabi tudi vaš nadlaket.
Mepolizumab crosses the placental barrier in monkeys.
Pri opicah mepolizumab prehaja skozi placento.
Nucala 100 mg powder for solution for injection
Nucala 100 mg prašek za raztopino za injiciranje
Excipients: Sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80
Pomožne snovi: saharoza, natrijev hidrogenfosfat heptahidrat in polisorbat 80.
Once reconstituted, Nucala will contain a concentration of 100 mg/mL mepolizumab.
Po rekonstituciji bo koncentracija mepolizumaba v zdravilu Nucala 100 mg/ml.
• Peel back the film cover from the tray.
• Odlepite prekrivno folijo z embalaže.
Nucala 100 mg powder for solution for injection mepolizumab
Nucala 100 mg prašek za raztopino za injiciranje mepolizumab
Multipack comprising 3 (3 packs of 1) pre-filled syringe
Večkratno pakiranje s 3 (3 pakiranja po 1) napolnjenimi injekcijskimi peresniki
Pull off the needle cap
Potegnite pokrovček igle
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
Asthma exacerabations
Poslabšanja astme
The recommended dose for adults and adolescents is 100 mg. You will be given 1 injection every four weeks.
Priporočeni odmerek za odrasle in mladostnike je 100 mg.
Package leaflet: Information for the user Nucala 100 mg powder for solution for injection mepolizumab This medicine is subject to additional monitoring.
Navodilo za uporabo Nucala 100 mg prašek za raztopino za injiciranje mepolizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING INTERMEDIATE CARTON - PRE-FILLED SYRINGE MULTIPACK (WITHOUT BLUE BOX)
VMESNA ŠKATLA - VEČKRATNO PAKIRANJE NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA)
If you are not sure what to do, ask your doctor, pharmacist or nurse.
Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Some people get asthma-related side effects, or their asthma may become worse, during treatment with Nucala.
Nekaterim bolnikom se lahko med zdravljenjem z zdravilom Nucala pojavijo z astmo povezani neželeni učinki ali se jim astma poslabša.
Stopper
minut
Safely, throw the pre-filled syringe away if it has been kept out of the refrigerator for more than 7 days.
Če je bila napolnjena injekcijska brizga shranjena izven hladilnika več kot 7 dni, jo varno zavrzite.
Do not let the needle touch any surface.
Pazite, da se z iglo ničesar ne dotaknete.
How to store Nucala
Shranjevanje zdravila Nucala
• Nucala pre-filled syringe
• napolnjeno injekcijsko brizgo zdravila Nucala
Needle guard
Ščitnik igle
Dispose of the remaining solution.
Preostanek raztopine zavrzite.
The pack should be discarded if not administered within 8 hours.
Če zdravilo ni uporabljeno v 8 urah, je pakiranje treba zavreči.
After reconstitution, each ml of solution contains 100 mg mepolizumab.
Po rekonstituciji vsebuje 1 ml raztopine 100 mg mepolizumaba.
Rate ratio (95% CI) p-value
Razmerje obetov (95 % IZ) Vrednost p
Step by step instructions for using the pre-filled syringe
Navodila za uporabo napolnjene injekcijske brizge korak za korakom
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - FOR PRE-FILLED SYRINGE MULTIPACK (WITH BLUE BOX)
NALEPKA ZA NAPOLNJEN INJEKCIJSKI PERESNIK ZA VEČKRATNO PAKIRANJE (Z MODRIM OKENCEM)
Package leaflet: Information for the user Nucala 100 mg solution for injection in pre-filled syringe mepolizumab This medicine is subject to additional monitoring.
Navodilo za uporabo Nucala 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku mepolizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Nucala 100 mg solution for injection in pre-filled syringe
Zdravilo Nucala 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Median % reduction in daily OCS dose from baseline (95% CI) Median difference (95% CI) p-value
Mediani % zmanjšanja dnevnega odmerka PKS od izhodišča (95 % IZ)