FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance is mepolizumab.
Slovenian: Učinkovina je mepolizumab.
English: Make sure the security seals are not broken
Slovenian: Preverite, da varnostni pečat ni pretrgan
English: • The yellow indicator will move down through the inspection window as you receive your dose.
Slovenian: • Medtem ko boste prejemali odmerek, se bo rumeni indikator pomikal navzdol skozi okence za ogled.
English: A caregiver can also inject Nucala into the upper arm.
Slovenian: Negovalec lahko zdravilo Nucala injicira tudi v nadlaket.
English: Check the security seals are not broken.
Slovenian: Preverite, da varnostni pečat ni pretrgan.
English: Administer the 0.4mL injection (equivalent to 40 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Slovenian: Injicirajte 0,4 mL raztopine (to ustreza 40 mg mepolizumaba) subkutano v nadlaket, stegno ali trebuh.
English: Patients had a blood eosinophil count of ≥150/µL at baseline or a blood eosinophil count of ≥300/µL in the 12 months prior to screening.
Slovenian: Bolniki so imeli število eozinofilcev v krvi ≥ 150/µl izhodiščno ali ≥ 300/µl v 12 mesecih pred presejanjem.
English: The pre-filled syringe is not intended for use in children below 12 years of age.
Slovenian: Napolnjena injekcijska brizga ni namenjena za uporabo pri otrocih, mlajših od 12 let.
English: Powder for solution for injection 1 vial
Slovenian: Prašek za raztopino za injiciranje 1 viala
English: The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Slovenian: Priporočeni odmerek mepolizumaba je 40 mg subkutano enkrat na 4 tedne.
English: Thirty-seven adolescents (aged 12-17) were enrolled in four placebo-controlled studies (25 mepolizumab treated intravenously or subcutaneously) of 24 to 52 weeks duration.
Slovenian: Štiri s placebom kontrolirane 24 do 52 tednov trajajoče študije so zajele 37 mladostnikov (starih od 12 do 17 let) (25 zdravljenih z mepolizumabom intravensko ali subkutano).
English: Patients were administered mepolizumab or placebo treatment once every 4 weeks over the treatment period.
Slovenian: Med obdobjem zdravljenja so dobivali ali mepolizumab ali placebo enkrat na 4 tedne.
English: Do not use the pen if the yellow needle guard doesn't slide up as described.
Slovenian: Če rumeni ščitnik igle ne zdrsne navzgor, kot je opisano, peresnika ne uporabite.
English: • Remove the clear needle cap from the pen by firmly pulling it straight off.
Slovenian: • Odstranite pokrovček igle s peresnika tako, da ga odločno potegnete naravnost dol.
English: Mepolizumab 75 mg IV/100 mg SC N=538
Slovenian: mepolizumab 75 mg i.v./100 mg s.c.
English: Complete your injection
Slovenian: Dokončajte injiciranje
English: Nucala contains sodium
Slovenian: Zdravilo Nucala vsebuje natrij
English: In patients with severe refractory eosinophilic asthma (adults/adolescents), following a dose of 100 mg administered subcutaneously every 4 weeks for 32 weeks, blood eosinophils were reduced from a geometric mean count at baseline of 290 to 40 cells/µL at week 32 (n=182), a reduction of 84% compared to placebo.
Slovenian: Pri bolnikih s težko trdovratno eozinofilno astmo (odraslih /mladostnikih) se je po subkutani uporabi 100 mg na 4 tedne v obdobju 32 tednov geometrična sredina števila eozinofilcev v krvi zmanjšala z 290 celic/µl izhodiščno na 40 celic/µl 32. teden (n = 182); to je 84-odstotno zmanjšanje v primerjavi s placebom.
English: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala.
Slovenian: Po dajanju zdravila Nucala so se pojavile akutne in pozne sistemske reakcije, med njimi tudi preobčutljivostne reakcije (npr. anafilaksija, urtikarija, angioedem, izpuščaj, bronhospazem, hipotenzija).
English: 44 cells/µL (n=10) following 100 mg (for a weight ≥ 40 kg), a reduction from baseline of 85% and 87%,
Slovenian: 331 na 44 celic/µl (n = 10) po 100 mg zdravila (za telesno maso ≥ 40 kg); to pomeni pri prvih zmanjšanje za 85 % in pri drugih za 87 %.
English: Slowly push down
Slovenian: Počasi potisnite bat dol
English: Inject yourself in thighs or abdomen
Slovenian: Injicirajte v stegno ali trebuh
English: Instructions for using the pre-filled syringe are given on the other side of this leaflet.
Slovenian: Navodila za uporabo napolnjene injekcijske brizge so navedena na hrbtni strani tega navodila.
English: After removal, do not put the needle cap back onto the pen, as it may accidentally start the injection.
Slovenian: Po odstranitvi pokrovčka igle ne nameščajte več nazaj na peresnik, ker lahko s tem nehote
English: • Do not use the syringe if it appears damaged.
Slovenian: • Brizge ne uporabite, če je poškodovana.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja ekcem pogosti
English: What you need to know before you use Nucala Do not use Nucala:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nucala Ne uporabljajte zdravila Nucala
English: You should also receive training on how to use the pre-filled syringe.
Slovenian: Opraviti morate tudi usposabljanje za uporabo napolnjene injekcijske brizge.
English: • Keep in the carton to protect from light.
Slovenian: • Shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: n
Slovenian: V
English: • Holding the middle of the syringe, carefully take it out of the tray.
Slovenian: • Primite brizgo na sredini in jo previdno vzemite iz embalaže.
English: • Do not share your Nucala pre-filled syringe with another person.
Slovenian: • Ne souporabljajte napolnjene injekcijske brizge zdravila Nucala z nikomer drugim.
English: Paediatric pharmacokinetics were broadly consistent with adults and adolescents after accounting for bodyweight and bioavailability.
Slovenian: Farmakokinetika pri pediatričnih bolnikih se je ob upoštevanju telesne mase in biološke uporabnosti na splošno skladala s farmakokinetiko, ugotovljeno pri odraslih in mladostnikih.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih pri opicah ne kažejo posebnega tveganja za človeka.
English: Do not inject if the solution looks cloudy or discoloured, or has particles.
Slovenian: Zdravila ne injicirajte, če je raztopina motna, spremenjene barve ali vsebuje delce.
English: If you think you have injected too much Nucala, contact your doctor for advice.
Slovenian: 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.
English: Following reconstitution, Nucala should be visually inspected for particulate matter and clarity prior to use.
Slovenian: Po rekonstituciji je treba zdravilo Nucala pred pripravo pregledati, da ne vsebuje delcev in da je bistro.
English: 1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Slovenian: 1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) v napolnjenem injekcijskem peresniku.
English: Nucala is provided as a lyophilised, white powder in a single-use vial for subcutaneous injection only.
Slovenian: Zdravilo Nucala je na voljo kot liofiliziran bel prašek v viali za enkratno uporabo, samo za subkutano injiciranje.
English: The pre-filled pen is not intended for use in children below 12 years of age.
Slovenian: Napolnjen injekcijski peresnik ni namenjen za uporabo pri otrocih, mlajših od 12 let.
English: Asthma-related adverse symptoms or exacerbations may occur during treatment.
Slovenian: Med zdravljenjem se lahko pojavijo z astmo povezani simptomi ali poslabšanja.
English: White finger grip
Slovenian: Bel oprijem za prste
English: Before administration, the solution should be inspected visually.
Slovenian: Pred uporabo je treba raztopino pregledati.
English: As mepolizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Slovenian: 5.3 Predklinični podatki o varnosti Ker je mepolizumab monoklonsko protitelo, študij genotoksičnosti in kancerogenosti niso izvedli.
English: Patients with preexisting helminth infections should be treated before starting therapy.
Slovenian: Bolnike, ki že imajo okužbo s helminti, je treba zdraviti pred uvedbo zdravila Nucala.
English: Time out of refrigeration should not exceed a maximum of 7 days when protected from light and stored below 30°C.
Slovenian: Čas izven hladilnika ne sme presegati 7 dni, če je zdravilo zaščiteno pred svetlobo in shranjeno pri sobni temperaturi (do 30 °C).
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX09.
Slovenian: Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni.
English: Do not put the needle cap back onto the syringe.
Slovenian: Ne nameščajte pokrovčka igle nazaj na injekcijsko brizgo.
English: 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.
Slovenian: 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).
English: Adults and adolescents aged 12 years and older The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Slovenian: Odrasli in mladostniki, stari 12 let ali več Priporočeni odmerek mepolizumaba je 100 mg subkutano enkrat na 4 tedne.
English: The Nucala pre-filled pen or pre-filled syringe should be used for subcutaneous injection only.
Slovenian: Napolnjeni injekcijski peresnik oziroma napolnjeno injekcijsko brizgo zdravila Nucala se sme uporabljati le za subkutano injiciranje.
English: Powder for solution for injection Multipack: 3 (3 packs of 1) vials
Slovenian: Prašek za raztopino za injiciranje Večkratno pakiranje: 3 viale (3 pakiranja po 1)
English: 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.
Slovenian: 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.
English: • Do not put the needle cap back onto the syringe.
Slovenian: • Ne nameščajte pokrovčka igle nazaj na injekcijsko brizgo.
English: • pharyngitis (sore throat) • nasal congestion (stuffy nose)
Slovenian: • vnetje žrela (faringitis), • zamašenost nosu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: NALEPKA NA VIALI IME ZDRAVILA IN POT(I) UPORABE
English: Nucala 100 mg injection mepolizumab SC
Slovenian: Nucala 100 mg injekcija mepolizumab s.c.
English: Inject 6.
Slovenian: Shranjevanje zdravila Nucala 6.
English: • If necessary, the pre-filled syringe may be kept at room temperature, up to 30°C, for no more than
Slovenian: • Če je treba, je mogoče napolnjen injekcijski peresnik shranjevati na sobni temperaturi do 30 °C,
English: 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.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Nucala,
English: Follow these instructions on how to use the pre-filled syringe.
Slovenian: Upoštevajte ta navodila za uporabo napolnjene injekcijske brizge.
English: Alternatively, another person can inject in your upper arm
Slovenian: Druga oseba lahko injicira tudi v nadlaket
English: Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start Nucala treatment.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če astma po začetku zdravljenja z zdravilom Nucala ostane neurejena ali se vam poslabša.
English: Children aged 6 to 11 years old The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Slovenian: Otroci, stari od 6 do 11 let Priporočeni odmerek mepolizumaba je 40 mg subkutano enkrat na 4 tedne.
English: - Check that the inspection window is filled with the yellow indicator.
Slovenian: • Če ne slišite drugega "klika": - Preverite, ali je okence za ogled napolnjeno z rumenim indikatorjem.
English: Administer the 1 mL injection (equivalent to 100 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Slovenian: Injicirajte 1 ml raztopine (to ustreza 100 mg mepolizumaba) subkutano v nadlaket, stegno ali trebuh.
English: • Holding the middle of the pen, carefully take it out of the tray.
Slovenian: • Primite peresnik na sredini in ga previdno vzemite iz embalaže.
English: • Do not share your Nucala pre-filled pen with another person.
Slovenian: • Ne souporabljajte napolnjenega injekcijskega peresnika zdravila Nucala z nikomer drugim.
English: 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.
Slovenian: 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.
English: Following a single subcutaneous administration in the abdomen, thigh or arm of healthy subjects, mepolizumab absolute bioavailability was 64%, 71% and 75%, respectively.
Slovenian: Pri zdravih preiskovancih je bila absolutna biološka uporabnost po enkratnem subkutanem injiciranju v trebuh 64 %, v stegno 71 % in v roko 75 %.
English: Sodium phosphate dibasic heptahydrate Citric acid monohydrate Polysorbate 80
Slovenian: Natrijev hidrogenfosfat heptahidrat Citronska kislina, monohidrat Polisorbat 80
English: Failure to follow these instructions may affect proper function of the pre-filled syringe.
Slovenian: Če teh navodil ne upoštevate, se lahko zgodi, da napolnjena injekcijska brizga ne bo delovala pravilno.
English: Instructions for using the pre-filled pen are given on the other side of this leaflet.
Slovenian: Navodila za uporabo napolnjenega injekcijskega peresnika so navedena na hrbtni strani tega navodila.
English: It may be injected into the upper arm, thigh, or abdomen.
Slovenian: Injicira se ga lahko v nadlaket, stegno ali trebuh.
English: 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.
Slovenian: Prekinitev ali prenehanje zdravljenja z zdravilom Nucala lahko povzroči, da se vam znova pojavijo simptomi in napadi astme.
English: The pre-filled syringe should be used only once and then discarded.
Slovenian: Napolnjen injekcijski peresnik uporabite le enkrat in ga nato zavrzite.
English: If you may have had a similar reaction to any injection or medicine: Tell your doctor before you or your child are given Nucala.
Slovenian: Če ste morda kdaj imeli podobno reakcijo na kakšno injekcijo ali zdravilo, morate to povedati zdravniku, preden dobite zdravilo Nucala.
English: 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.
Slovenian: Izčrpna navodila za subkutano injiciranje zdravila Nucala v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi so navedena v navodilu za uporabo zdravila.
English: Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably using a 2
Slovenian: Vsebino viale rekonstituirajte z 1,2 ml sterilne vode za injekcije; po možnosti uporabite 2- ali 3-ml brizgo in iglo dimenzije 21G (gauge).
English: Lower respiratory tract infection Urinary tract infection Pharyngitis
Slovenian: Infekcijske in parazitske bolezni okužba spodnjih dihal okužba sečil faringitis pogosti
English: 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.
Slovenian: 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.
English: Don't suddenly stop taking your preventer medicines for your asthma once you have started Nucala.
Slovenian: Po začetku zdravljenja z zdravilom Nucala ne prenehajte nenadoma uporabljati preventivnih zdravil za astmo.
English: No formal studies have been conducted to investigate the effect of renal impairment on the pharmacokinetics of mepolizumab.
Slovenian: Formalnih študij o vplivu okvare ledvic na farmakokinetiko mepolizumaba niso izvedli.
English: If a dose of Nucala is missed
Slovenian: Če ste pozabili uporabiti odmerek zdravila Nucala
English: Instructions for administration of 40 mg dose 1.
Slovenian: Navodila za dajanje 40 mg odmerka:
English: 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.
Slovenian: povprečna starost 50 let), ki so se zdravili s PKS (5-35 mg na dan) ter visokim odmerkom IKS in dodatnim vzdrževalnim zdravilom.
English: Elderly patients No dose adjustment is required for elderly patients (see section 5.2).
Slovenian: Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Abrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended.
Slovenian: Ni priporočljivo, da bolnik po uvedbi zdravila Nucala nenadno preneha uporabljati kortikosteroide.
English: Remove the needle cap
Slovenian: Odstranite pokrovček igle
English: Sodium phosphate dibasic heptahydrate Polysorbate 80
Slovenian: Natrijev hidrogenfosfat heptahidrat Polisorbat 80
English: Nucala is a lyophilised white powder supplied in a clear, colourless glass vial with a rubber stopper.
Slovenian: Zdravilo Nucala je liofiliziran bel prašek v prozorni viali iz brezbarvnega stekla z gumijastim zamaškom.
English: 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.
Slovenian: Zvišana raven vnetnih citokinov (npr. IL-6) preko interakcije s kognatnimi receptorji na jetrnih celicah zavre tvorbo encimov CYP450 in prenašalcev zdravil.
English: Thirty -six paediatric patients (aged 611) received mepolizumab subcutaneously in an open-label study for 12 weeks.
Slovenian: pediatričnih bolnikov (starih od 6 do 11 let), ki so 12 tednov prejemali mepolizumab subkutano.
English: Eczema
Slovenian: ZDRAVILA
English: Severe refractory eosinophilic asthma
Slovenian: Težka trdovratna eozinofilna astma
English: Inspection window
Slovenian: Okence za ogled
English: 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).
Slovenian: 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).
English: Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Slovenian: Zdravilo Nucala vsebuje učinkovino mepolizumab, ki je monoklonsko protitelo, vrsta beljakovine,
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80.
Slovenian: Druge sestavine zdravila so saharoza, natrijev hidrogenfosfat heptahidrat in polisorbat 80.
English: For self-administration the recommended injection sites are the abdomen or thigh.
Slovenian: Priporočeni mesti za samoinjiciranje sta trebuh ali stegno.
English: 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.
Slovenian: 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.
English: The liquid should be clear to opalescent, colourless to pale yellow to pale brown.
Slovenian: Raztopina mora biti bistra do opalescentna in brezbarvna do bledo rumena ali rjava.
English: The pack should be discarded if left out of the refrigerator for more than 7 days.
Slovenian: Pakiranje, ki ostane izven hladilnika več kot 7 dni, je treba zavreči.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (INDIVIDUAL PACKS INCLUDING BLUE BOX)
Slovenian: ŠKATLA (POSAMEZNA PAKIRANJA, VKLJUČNO Z MODRIM OKENCEM)
English: 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.
Slovenian: 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.
English: The other ingredients are sucrose, sodium phosphate dibasic heptahydrate, citric acid monohydrate, polysorbate 80, EDTA disodium dihydrate, water for injections.
Slovenian: Druge sestavine zdravila so saharoza, natrijev hidrogenfosfat heptahidrat, monohidrat citronske kisline, polisorbat 80, dinatrijev edetat dihidrat, voda za injekcije.
English: Do not use the syringe if the security seal on the carton is broken.
Slovenian: Če je varnostni pečat na škatli pretrgan, brizge ne uporabite.
English: • Keep your used syringes and needle caps out of the reach of children.
Slovenian: • Uporabljene brizge in pokrovčke igel shranjujte nedosegljive otrokom.
English: No dose adjustment is required for elderly patients (see section 5.2).
Slovenian: Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: The recommended dose for adults and adolescents aged 12 years and older is 100 mg. You will have 1 injection every four weeks.
Slovenian: Priporočeni odmerek za odrasle in mladostnike, stare 12 let ali več, je 100 mg.
English: Label
Slovenian: Nalepka
English: Instructions for administration of 100 mg dose 1.
Slovenian: Navodila za dajanje 100 mg odmerka:
English: • Dispose of the used syringe and needle cap according to local requirements.
Slovenian: • Uporabljeno brizgo in pokrovček igle zavrzite v skladu z lokalnimi predpisi.
English: • Remove the tray from the carton.
Slovenian: • Vzemite embalažo iz škatle.
English: Nucala is available in a pack containing 1 pre-filled syringe or in multipacks comprised of 3 x 1 pre-filled syringes.
Slovenian: 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.