natgillin/translations-raw huggingface dataset:
If you think you have injected too much Nucala, contact your doctor for advice. 
Če ste uporabili večji odmerek zdravila Nucala, kot bi smeli Če menite, da ste si injicirali preveč zdravila Nucala, se za nasvet obrnite na svojega zdravnika.
Following reconstitution, Nucala should be visually inspected for particulate matter and clarity prior to use. 
Po rekonstituciji je treba zdravilo Nucala pred pripravo pregledati, da ne vsebuje delcev in da je bistro.
1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen. 
1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) v napolnjenem injekcijskem peresniku.
Nucala is provided as a lyophilised, white powder in a single-use vial for subcutaneous injection only. 
Zdravilo Nucala je na voljo kot liofiliziran bel prašek v viali za enkratno uporabo, samo za subkutano injiciranje.
The pre-filled pen is not intended for use in children below 12 years of age. 
Napolnjen injekcijski peresnik ni namenjen za uporabo pri otrocih, mlajših od 12 let.
Asthma-related adverse symptoms or exacerbations may occur during treatment. 
Med zdravljenjem se lahko pojavijo z astmo povezani simptomi ali poslabšanja.
White finger grip 
Bel oprijem za prste
Before administration, the solution should be inspected visually. 
Pred uporabo je treba raztopino pregledati.
As mepolizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted. 
5.3 Predklinični podatki o varnosti Ker je mepolizumab monoklonsko protitelo, študij genotoksičnosti in kancerogenosti niso izvedli.
Patients with preexisting helminth infections should be treated before starting therapy. 
Bolnike, ki že imajo okužbo s helminti, je treba zdraviti pred uvedbo zdravila Nucala.
Time out of refrigeration should not exceed a maximum of 7 days when protected from light and stored below 30°C. 
Čas izven hladilnika ne sme presegati 7 dni, če je zdravilo zaščiteno pred svetlobo in shranjeno pri sobni temperaturi (do 30 °C).
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX09. 
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni.
Do not put the needle cap back onto the syringe. 
Ne nameščajte pokrovčka igle nazaj na injekcijsko brizgo.
This magnitude of blood eosinophils reduction was maintained 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. 
Ta velikost znižanja eozinofilcev v krvi se je ohranila 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).
Adults and adolescents aged 12 years and older The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks. 
Odrasli in mladostniki, stari 12 let ali več Priporočeni odmerek mepolizumaba je 100 mg subkutano enkrat na 4 tedne.
The Nucala pre-filled pen or pre-filled syringe should be used for subcutaneous injection only. 
Napolnjeni injekcijski peresnik oziroma napolnjeno injekcijsko brizgo zdravila Nucala se sme uporabljati le za subkutano injiciranje.
Powder for solution for injection Multipack: 3 (3 packs of 1) vials 
Prašek za raztopino za injiciranje Večkratno pakiranje: 3 viale (3 pakiranja po 1)
Single doses of up to 1,500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities. 
V kliničnem preskušanju pri bolnikih z eozinofilno boleznijo so uporabljali enkratne odmerke do 1.500 mg intravensko, ne da bi se pojavili znaki z odmerkom povezanih toksičnih reakcij.
• Do not put the needle cap back onto the syringe. 
• Ne nameščajte pokrovčka igle nazaj na injekcijsko brizgo.
• pharyngitis (sore throat) • nasal congestion (stuffy nose) 
• vnetje žrela (faringitis), • zamašenost nosu.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
NALEPKA NA VIALI IME ZDRAVILA IN POT(I) UPORABE
Inject 6. 
Shranjevanje zdravila Nucala 6.
• If necessary, the pre-filled syringe may be kept at room temperature, up to 30°C, for no more than 
• Če je treba, je mogoče napolnjen injekcijski peresnik shranjevati na sobni temperaturi do 30 °C,
A decision must be made whether to discontinue breast-feeding or to discontinue Nucala therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Nucala,
Follow these instructions on how to use the pre-filled syringe. 
Upoštevajte ta navodila za uporabo napolnjene injekcijske brizge.
Alternatively, another person can inject in your upper arm 
Druga oseba lahko injicira tudi v nadlaket
Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start Nucala treatment. 
Obvestite zdravnika ali medicinsko sestro, če astma po začetku zdravljenja z zdravilom Nucala ostane neurejena ali se vam poslabša.
Children aged 6 to 11 years old The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks. 
Otroci, stari od 6 do 11 let Priporočeni odmerek mepolizumaba je 40 mg subkutano enkrat na 4 tedne.
- 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.
Label 
Nalepka
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).