natgillin/translations-raw huggingface dataset:
• Use your free hand to pinch the skin around your injection site.
• S prosto roko stisnite kožo okrog mesta injiciranja.
In children aged 6 to 11 years old with severe refractory eosinophilic asthma following either 40 mg subcutaneously (for a weight < 40kg) or 100 mg subcutaneously (for a weight ≥ 40 kg), 2/35 (6%) had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab during the initial short phase of the study.
Med otroki, starimi od 6 do 11 let, s težko trdovratno eozinofilno astmo sta imela po odmerku 40 mg subkutano (za telesno maso < 40 kg) ali 100 mg subkutano (za telesno maso ≥ 40 kg) zaznavna protitelesa proti mepolizumabu 2/35 (6 %) bolnikov, potem ko sta prejela vsaj en odmerek mepolizumaba med uvodno kratko fazo študije.
Intravenous mepolizumab pharmacokinetics was evaluated by population pharmacokinetic analysis in a paediatric study conducted in subjects aged 2-17 years old with eosinophilic esophagitis.
Farmakokinetiko intravensko uporabljenega mepolizumaba so ocenili s populacijsko farmakokinetično analizo v pediatrični študiji bolnikov z eozinofilnim ezofagitisom, starih od 2 do 17 let.
Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation.
Rekonstituirane raztopine med postopkom ne smete stresati, ker to lahko povzroči penjenje ali precipitacijo zdravila.
300 to <500 cells/µL
300 do < 500 celic/µl n
The efficacy of mepolizumab in the treatment of a targeted group of patients with severe refractory eosinophilic asthma was evaluated in 3 randomised, double-blind, parallel-group clinical studies of between 24-52 weeks duration, in patients aged 12 years and older.
Učinkovitost mepolizumaba za zdravljenje ciljne skupine bolnikov s težko trdovratno eozinofilno astmo so ocenili v 3 randomiziranih, dvojno slepih kliničnih študijah vzporednih skupin pri bolnikih, starih 12 let ali več.
Just prior to administration, remove 0.4mL of reconstituted Nucala.
Tik pred uporabo izvlecite 0,4 ml rekonstituiranega zdravila Nucala.
Each vial contains 100 mg mepolizumab (100 mg/ml after reconstitution)
Ena viala vsebuje 100 mg mepolizumaba (100 mg/ml po rekonstituciji).
Following subcutaneous dosing in patients with asthma, mepolizumab exhibited approximately doseproportional pharmacokinetics over a dose range of 12.5 mg to 250 mg.
Pri bolnikih z astmo je imel subkutano uporabljeni mepolizumab v odmerkih od 12,5 mg do 250 mg približno odmerku sorazmerno farmakokinetiko.
Do not use Nucala after the expiry date which is stated on the label and carton after EXP.
Zdravila Nucala ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Tell your doctor before you are given Nucala.
morate to povedati zdravniku, preden dobite zdravilo Nucala.
For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
Za subkutano injiciranje po možnosti uporabite 1-ml polipropilensko brizgo z iglo za enkratno uporabo dimenzij 21G (gauge) do 27G (gauge) x 13 mm.
However, mepolizumab was excreted into the milk of cynomolgous monkeys at concentrations of less than 0.5% of those detected in plasma.
Podatkov o izločanju mepolizumaba v materino mleko pri človeku ni. Se je pa mepolizumab izločal v mleku opic cynomolgus, in sicer v koncentraciji, ki je bila manj kot 0,5 % koncentracije v plazmi.
ITT Population Mepolizumab 100 mg (subcutaneous) N= 69
Populacija ZNZ mepolizumab 100 mg (subkutano) N = 69
• Look in the inspection window to check that the liquid is clear (free from cloudiness or particles) and colourless to pale yellow to pale brown.
• Poglejte skozi okence za ogled in preverite, da je tekočina bistra (ni motna in je brez delcev) in brezbarvna do rumenkasta do rjavkasta.
• urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back)
• okužba sečil (kri v urinu, boleče in pogosto uriniranje, zvišana telesna temperatura, bolečina v spodnjem delu hrbta),
Mepolizumab pharmacokinetics in adolescent subjects with severe refractory eosinophilic asthma included in the phase 3 studies were consistent with adults (see section 4.2).
Farmakokinetika mepolizumaba pri mladostnikih s težko trdovratno eozinofilno astmo, vključenih v študije 3. faze, se je skladala s tisto pri odraslih (glejte poglavje 4.2).
Do not warm the pen in a microwave, hot water, or direct sunlight.
Brizge ne segrevajte v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
The rate of exacerbations in the placebo arm increased with increasing baseline blood eosinophil count.
Delež poslabšanj se je v skupini s placebom povečeval z naraščanjem izhodiščnega števila eozinofilcev v krvi.
Stopping treatment with Nucala
Prenehanje zdravljenja z zdravilom Nucala
After removing the pre-filled pen or pre-filled syringe from the refrigerator, allow the pen or syringe to reach room temperature for at least 30 minutes before injecting Nucala.
Potem, ko vzamete napolnjeni injekcijski peresnik ali napolnjeno injekcijsko brizgo iz hladilnika, morate pred injiciranjem zdravila Nucala peresnik ali brizgo pustiti vsaj 30 minut, da doseže sobno temperaturo.
If your asthma symptoms get worse while receiving injections of Nucala Call your doctor.
Če se vam simptomi astme med prejemanjem injekcij zdravila Nucala poslabšajo se posvetujte z zdravnikom.
Nucala is available in a pack containing 1 vial, or in multipacks with 3 individual vials.
Zdravilo Nucala je na voljo v pakiranju, ki vsebuje 1 vialo, ali v večkratnem pakiranju, v katerem so 3 posamezne viale.
• Check the expiry date on the label of the syringe.
• Preverite datum izteka roka uporabnosti na nalepki brizge.
In clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain.
V kliničnih študijah pri bolnikih s težko trdovratno eozinofilno astmo so bili najpogosteje zabeleženi neželeni učinki med zdravljenjem glavobol, reakcije na mestu injiciranja in bolečine v hrbtu.
If you (or your child) may have had a similar reaction to any injection or medicine: Tell your doctor before you are given Nucala.
Če ste morda (vi ali vaš otrok) kdaj imeli podobno reakcijo na kakšno injekcijo ali zdravilo, morate to povedati zdravniku, preden dobite zdravilo Nucala.
Check the expiry date
Preverite datum izteka roka uporabnosti
Paediatric pharmacokinetics following subcutaneous administration in subjects 6 to 11 years old with severe refractory eosinophilic asthma was investigated in an open label, uncontrolled study of 12-weeks duration.
Farmakokinetiko po subkutani uporabi pri pediatričnih bolnikih, starih od 6 do 11 let, s težko trdovratno eozinofilno astmo so raziskali v odprti, nekontrolirani 12-tedenski študiji.
• Keep refrigerated before use.
• Pred uporabo hranite v hladilniku.
Clean your injection site
Očistite mesto injiciranja
Automatic needle guard
Avtomatski ščitnik igle
Table 1: Frequency of clinically significant exacerbations at week 52 in the intent to treat population
Preglednica 1: Pogostnost klinično pomembnih poslabšanj po 52 tednih v populaciji z-namenom zdravljenja mepolizumab intravensko placebo
There is no specific treatment for an overdose with mepolizumab.
Za preveliko odmerjanje mepolizumaba ni specifičnega zdravljenja.
Nucala is for subcutaneous injection only and should be administered by a healthcare professional.
Zdravilo Nucala je namenjeno samo za subkutano injiciranje in ga mora dati zdravstveni delavec.
Exacerbation rate/year Percent reduction
Delež poslabšanj na leto Odstotno zmanjšanje
GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, No 90 43056 San Polo di Torrile, Parma Italy
GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, 90 43056 San Polo di Torrile, Parma Italija
Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Mepolizumab je humanizirano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
Start your injection
Začnite injiciranje
Table 3 shows the results of a combined analysis of the two exacerbation studies (MEA112997 and MEA115588) by baseline blood eosinophil count.
Preglednica 3 prikazuje rezultate kombinirane analize dveh študij poslabšanj (MEA112997 in MEA115588)
Following subcutaneous administration of mepolizumab the mean terminal half-life (t1/2) ranged from 16 to 22 days.
Povprečni terminalni razpolovni čas (t1/2) je bil po subkutani uporabi mepolizumaba od 16 do 22 dni.
GlaxoSmithKline Trading Services Ltd, Currabinny, Co. Cork, Ireland.
GlaxoSmithKline Trading Services Ltd., Currabinny, Co. Cork, Irska
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serij
Nucala is given by injection just under the skin (subcutaneous injection).
Zdravilo Nucala se daje z injekcijo tik pod kožo (subkutano injiciranje).
Press a cotton wool ball or gauze on the area for a few moments if necessary.
Če je treba, na ta predel za nekaj trenutkov pritisnite kosem vate ali zloženec gaze.
Clear, colourless 10 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a plastic flip-cap containing 100 mg powder for solution for injection.
10-ml viala iz prozornega, brezbarvnega stekla tipa I z zamaškom iz brombutilne gume in s sivo aluminijevo prekrivno zaporo s plastično snemno zaporko; viala vsebuje 100 mg praška za raztopino za injiciranje.
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (see section 5.1).
Zdravilo Nucala je indicirano kot dodatno zdravilo za težko trdovratno eozinofilno astmo pri odraslih, mladostnikih in otrocih, starih 6 let in starejših (glejte poglavje 5.1).
Following a single intravenous administration to patients with asthma, mepolizumab distributes into a mean volume of distribution of 55 to 85 mL/kg.
Pri bolnikih z astmo se mepolizumab po enkratni intravenski uporabi porazdeli v povprečni volumen porazdelitve od 55 do 85 ml/kg.
• Do not use the syringe if dropped onto a hard surface.
• Brizge ne uporabite, če je padla na trdo površino.
• chest infection - symptoms of which may include cough and fever (high temperature)
• okužba v prsnem košu - med njenimi simptomi so lahko kašelj in zvišana telesna temperatura
The possible side effects of Nucala are unlikely to affect your ability to drive or use machines.
Ni verjetno, da bi možni neželeni učinki zdravila Nucala neugodno vplivali na vašo sposobnost upravljanja vozil in strojev.
nucala syringe
nucala brizga
How to use Nucala
Kako uporabljati zdravilo Nucala
In the placebo-controlled trials, 15/260 (6%) of adults and adolescents treated with 100 mg dose subcutaneously had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab.
V preskušanjih, kontroliranih s placebom, je zaznavna protitelesa proti mepolizumabu imelo 15 od 260 (6 %) odraslih in mladostnikov, zdravljenih z odmerkom 100 mg subkutano, potem ko so dobili vsaj en odmerek mepolizumaba.
Each vial of Nucala should be used for a single patient, and any remainder of the vial should be discarded.
Vsako vialo zdravila Nucala je treba uporabiti le za enega samega bolnika.
In 2 placebo-controlled studies the incidence of local injection site reactions with mepolizumab 100 mg subcutaneous and placebo was 8% and 3%, respectively.
Lokalne reakcije na mestu injiciranja V dveh s placebom kontroliranih študijah je bila pojavnost lokalnih reakcij na mestu injiciranja med subkutano uporabo 100 mg mepolizumaba 8 % in med uporabo placeba 3 %.
Peel off the plastic cover
Odlepite prekrivno plastično folijo
Powder for solution for injection.
Prašek za raztopino za injiciranje.
EU/1/15/1043/003 1 pre-filled pen EU/1/15/1043/004 3 (3 x 1) pre-filled pens (multipack)
EU/1/15/1043/003 1 napolnjen injekcijski peresnik EU/1/15/1043/004 3 (3 x 1) napolnjeni injekcijski peresniki (večkratno pakiranje) EU/1/15/1043/005 1 napolnjena injekcijska brizga EU/1/15/1043/006 3 (3 x 1) napolnjena injekcijska brizga (večkratno pakiranje)
• Place the syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.
• Položite peresnik na čisto, ravno površino, na sobno temperaturo, tako da ni izpostavljen neposredni sončni svetlobi in ni dosegljiv otrokom.
Hypersensitivity and administration-related reactions
Preobčutljivostne reakcije in reakcije, povezane z dajanjem zdravila
• Check the expiry date on the label of the pen.
• Preverite datum izteka roka uporabnosti na nalepki peresnika.
• injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given)
• reakcija na mestu injiciranja (bolečina, pordelost, oteklost, srbenje in pekoč občutek v predelu kože,
The active substance is mepolizumab.
Učinkovina je mepolizumab.
Make sure the security seals are not broken
Preverite, da varnostni pečat ni pretrgan
• The yellow indicator will move down through the inspection window as you receive your dose.
• Medtem ko boste prejemali odmerek, se bo rumeni indikator pomikal navzdol skozi okence za ogled.
A caregiver can also inject Nucala into the upper arm.
Negovalec lahko zdravilo Nucala injicira tudi v nadlaket.
Check the security seals are not broken.
Preverite, da varnostni pečat ni pretrgan.
Administer the 0.4mL injection (equivalent to 40 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
Injicirajte 0,4 mL raztopine (to ustreza 40 mg mepolizumaba) subkutano v nadlaket, stegno ali trebuh.
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.
Bolniki so imeli število eozinofilcev v krvi ≥ 150/µl izhodiščno ali ≥ 300/µl v 12 mesecih pred presejanjem.
The pre-filled syringe is not intended for use in children below 12 years of age.
Napolnjena injekcijska brizga ni namenjena za uporabo pri otrocih, mlajših od 12 let.
Powder for solution for injection 1 vial
Prašek za raztopino za injiciranje 1 viala
The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.
Priporočeni odmerek mepolizumaba je 40 mg subkutano enkrat na 4 tedne.
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.
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).
Patients were administered mepolizumab or placebo treatment once every 4 weeks over the treatment period.
Med obdobjem zdravljenja so dobivali ali mepolizumab ali placebo enkrat na 4 tedne.
Do not use the pen if the yellow needle guard doesn't slide up as described.
Če rumeni ščitnik igle ne zdrsne navzgor, kot je opisano, peresnika ne uporabite.
• Remove the clear needle cap from the pen by firmly pulling it straight off.
• Odstranite pokrovček igle s peresnika tako, da ga odločno potegnete naravnost dol.
Mepolizumab 75 mg IV/100 mg SC N=538
mepolizumab 75 mg i.v./100 mg s.c.
Complete your injection
Dokončajte injiciranje
Nucala contains sodium
Zdravilo Nucala vsebuje natrij
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.
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.
Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala.
Po dajanju zdravila Nucala so se pojavile akutne in pozne sistemske reakcije, med njimi tudi preobčutljivostne reakcije (npr. anafilaksija, urtikarija, angioedem, izpuščaj, bronhospazem, hipotenzija).
44 cells/µL (n=10) following 100 mg (for a weight ≥ 40 kg), a reduction from baseline of 85% and 87%,
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 %.
Slowly push down
Počasi potisnite bat dol
Inject yourself in thighs or abdomen
Injicirajte v stegno ali trebuh
Instructions for using the pre-filled syringe are given on the other side of this leaflet.
Navodila za uporabo napolnjene injekcijske brizge so navedena na hrbtni strani tega navodila.
After removal, do not put the needle cap back onto the pen, as it may accidentally start the injection.
Po odstranitvi pokrovčka igle ne nameščajte več nazaj na peresnik, ker lahko s tem nehote
• Do not use the syringe if it appears damaged.
• Brizge ne uporabite, če je poškodovana.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja ekcem pogosti
What you need to know before you use Nucala Do not use Nucala:
Kaj morate vedeti, preden boste uporabili zdravilo Nucala Ne uporabljajte zdravila Nucala
You should also receive training on how to use the pre-filled syringe.
Opraviti morate tudi usposabljanje za uporabo napolnjene injekcijske brizge.
• Keep in the carton to protect from light.
• Shranjujte v škatli za zagotovitev zaščite pred svetlobo.
n
V
• Holding the middle of the syringe, carefully take it out of the tray.
• Primite brizgo na sredini in jo previdno vzemite iz embalaže.
• Do not share your Nucala pre-filled syringe with another person.
• Ne souporabljajte napolnjene injekcijske brizge zdravila Nucala z nikomer drugim.
Paediatric pharmacokinetics were broadly consistent with adults and adolescents after accounting for bodyweight and bioavailability.
Farmakokinetika pri pediatričnih bolnikih se je ob upoštevanju telesne mase in biološke uporabnosti na splošno skladala s farmakokinetiko, ugotovljeno pri odraslih in mladostnikih.
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih pri opicah ne kažejo posebnega tveganja za človeka.
Do not inject if the solution looks cloudy or discoloured, or has particles.
Zdravila ne injicirajte, če je raztopina motna, spremenjene barve ali vsebuje delce.
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.