FrancophonIA/ELRC3.0 huggingface dataset:
English: Following subcutaneous administration to healthy subjects or patients with asthma, mepolizumab was absorbed slowly with a median time to reach maximum plasma concentration (Tmax) ranging from 4 to 8 days.
Slovenian: Po subkutani uporabi pri zdravih preiskovancih ali bolnikih z astmo se je mepolizumab absorbiral počasi; mediani čas do največje koncentracije v plazmi (tmax) je bil od 4 do 8 dni.
English: The pre-filled pen or pre-filled syringe must be administered within 8 hours once the pack is opened.
Slovenian: Napolnjeni injekcijski peresnik ali napolnjeno injekcijsko brizgo je treba uporabiti v 8 urah po odprtju pakiranja.
English: • Slowly push down on the plunger to inject your full dose.
Slovenian: • Počasi potisnite bat dol, da boste injicirali celoten odmerek.
English: Your doctor or nurse will decide if you or your caregiver can inject Nucala.
Slovenian: Zdravnik ali medicinska sestra bosta presodila, ali lahko zdravilo Nucala injicirate vi ali vaš negovalec.
English: The posology of Nucala in children and adolescents aged between 6 to 17 years old with severe refractory eosinophilic asthma has been determined by limited efficacy, pharmacokinetic and pharmacodynamic studies and supported by modelling and simulation data (see sections 5.1 and 5.2).
Slovenian: Odmerjanje zdravila Nucala pri otrocih in mladostnikih, starih od 6 do 17 let, s težko trdovratno eozinofilno astmo so določili z omejenimi študijami učinkovitosti, farmakokinetike in farmakodinamike ter potrdili z modeliranjem in simulacijskimi podatki (glejte poglavji 5.1 in 5.2).
English: • You can inject Nucala into your thighs or abdomen.
Slovenian: • Zdravilo Nucala si lahko injicirate v stegno ali trebuh.
English: Do not remove the needle cap during this step.
Slovenian: Ne odstranite pokrovčka igle med tem korakom.
English: Allergic and injection site reactions
Slovenian: Alergijske reakcije in reakcije na mestu injiciranja
English: Following a single intravenous administration to patients with asthma, the mean systemic clearance (CL) ranged from 1.9 to 3.3 mL/day/kg, with a mean terminal half-life of approximately 20 days.
Slovenian: Po enkratni intravenski uporabi pri bolnikih z astmo je bil povprečni sistemski očistek od 1,9 do 3,3 ml/dan/kg, povprečni terminalni razpolovni čas pa približno 20 dni.
English: Table 2: Results of primary and secondary endpoints at week 32 in the intent to treat population (MEA115588)
Slovenian: Preglednica 2: Rezultati primarnih in sekundarnih opazovanih dogodkov 32. teden v populaciji znamenom-zdravljenja (MEA115588)
English: Patients received mepolizumab 100 mg administered subcutaneously, mepolizumab 75 mg administered intravenously or placebo treatment once every 4 weeks over 32 weeks.
Slovenian: Bolniki so prejemali 100 mg mepolizumaba subkutano, 75 mg mepolizumaba intravensko ali placebo enkrat na 4 tedne v obdobju 32 tednov.
English: Of these 34 subjects: 12 received placebo, 9 received mepolizumab 75 mg intravenously, and 13 received 100 mg subcutaneously.
Slovenian: Od teh 34 preiskovancev jih je 12 dobivalo placebo, 9 jih je dobivalo 75 mg mepolizumaba intravensko in 13 preiskovancev 100 mg subkutano.
English: Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs.
Slovenian: Nekateri bolniki s težko astmo imajo v krvi in pljučih preveč eozinofilcev (eozinofilci so vrsta belih krvnih celic).
English: Dispose of the used syringe
Slovenian: Zavrzite uporabljeno brizgo
English: Nucala has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Nucala nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), which targets human interleukin-5 (IL-5) with high affinity and specificity.
Slovenian: Mepolizumab je humanizirano monoklonsko protitelo (IgG1, kapa), ki je z veliko afiniteto in specifičnostjo usmerjeno na človeški interlevkin-5 (IL-5).
English: Do not touch your injection site again until you have finished your injection.
Slovenian: Ne dotikajte se več mesta injiciranja, dokler injiciranja ne dokončate.
English: Additional maintenance treatments included long-acting beta2 -adrenergic agonists (LABA), leukotriene modifiers, long-acting muscarinic antagonists (LAMA), theophylline, and oral corticosteroids (OCS).
Slovenian: Med dodatnimi vzdrževalnimi zdravili so bili dolgodelujoči agonisti adrenergičnih receptorjev beta2 (LABA), levkotrienski modifikatorji, dolgodelujoči antagonisti muskarinskih receptorjev (LAMA) in peroralni kortikosteroidi (PKS).
English: The table below presents the adverse reactions from the two placebo-controlled studies in patients receiving mepolizumab 100 mg subcutaneously (n=263).
Slovenian: Spodnja preglednica prikazuje neželene učinke v dveh s placebom kontroliranih študijah pri bolnikih, ki so prejemali 100 mg mepolizumaba subkutano (n=263).
English: Mepolizumab, the active substance in Nucala, blocks a protein called interleukin-5.
Slovenian: Mepolizumab, učinkovina v zdravilu Nucala, zavre beljakovino, imenovano interlevkin-5.
English: Oral corticosteroid reduction study MEA115575 (SIRIUS)
Slovenian: Študija zmanjšanja peroralnih kortikosteroidov MEA115575 (SIRIUS)
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Slovenian: Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom, če astma po uvedbi zdravljenja ostaja neurejena ali se poslabša.
English: 1 ml solution in a Type 1 glass syringe with a fixed needle (stainless steel) and passive safety needle guard.
Slovenian: 1 ml raztopine v brizgi iz stekla tipa 1 s fiksno iglo (iz nerjavečega jekla) in pasivnim varnostnim ščitnikom igle.
English: If the solution is cloudy, discoloured or contains particles, the solution should not be used.
Slovenian: Če je raztopina motna, spremenjene barve ali vsebuje delce, se je ne sme uporabiti.
English: Investigation of a 40 mg subcutaneous dosing regimen administered every 4 weeks in children 6 to 11 years old over a 15-70 kg broad weight range by PK modelling and simulation predicts that the exposure of this dosing regimen would remain on average within 38% of adults at 100 mg.
Slovenian: Raziskava odmerne sheme 40 mg subkutano na 4 tedne pri otrocih, starih od 6 do 11 let in z razponom telesne mase od 15 do 70 kg, s farmakokinetičnim modeliranjem in simulacijo kaže, da bi bila izpostavljenost ob uporabi te odmerne sheme v povprečju 38 % tiste, ki je ugotovljena pri odraslih med uporabo 100 mg.
English: The stream of sterile water should be directed vertically, onto the centre of the lyophilised cake.
Slovenian: Tok sterilne vode usmerite navpično, na sredino liofiliziranega praška.
English: Do not expel any air bubbles from the syringe.
Slovenian: Ne iztiskajte zračnih mehurčkov iz injekcijske brizge.
English: Do not warm the syringe in a microwave, hot water, or direct sunlight.
Slovenian: Peresnika ne segrevajte v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
English: It is used to treat severe asthma in adults, adolescents and children aged 6 years and older.
Slovenian: Uporablja se za zdravljenje težke astme pri odraslih, mladostnikih in otrocih, starih 6 let ali več.
English: Reduction in the daily OCS dose to ≤5mg/day
Slovenian: Zmanjšanje dnevnega odmerka PKS na ≤ 5 mg/dan
English: What Nucala is and what it is used for
Slovenian: Kaj je zdravilo Nucala in za kaj ga uporabljamo
English: Security seals
Slovenian: Varnostni pečat
English: Since mepolizumab is degraded by widely distributed proteolytic enzymes, not restricted to hepatic tissue, changes in hepatic function are unlikely to have any effect on the elimination of mepolizumab.
Slovenian: Mepolizumab se razgradi s široko porazdeljenimi proteolitičnimi encimi, ki niso omejeni na jetrno tkivo, zato ni verjetno, da bi spremembe delovanja jeter vplivale na odstranjevanje mepolizumaba.
English: Do not use the syringe if left out of the carton for more than 8 hours.
Slovenian: Peresnika ne uporabite, če je bil več kot 8 ur izven škatle.
English: mg (for a weight < 40kg) or 100 mg (for a weight ≥ 40 kg) was 1.32 and 1.97 times of that observed in adults at 100 mg.
Slovenian: Po subkutanem odmerku 40 mg (za telesno maso < 40 kg) ali 100 mg (za telesno maso ≥ 40 kg) je bila izpostavljenost 1,32-krat oz. 1,97-krat tolikšna kot s 100 mg pri odraslih.
English: What Nucala looks like and contents of the pack
Slovenian: Izgled zdravila Nucala in vsebina pakiranja
English: Do not remove the needle cap at this stage.
Slovenian: V tej fazi ne odstranite pokrovčka igle.
English: Nucala may weaken your resistance to infections caused by parasites.
Slovenian: Zdravilo Nucala lahko poslabša odpornost proti okužbam, ki jih povzročajo paraziti (zajedalci).
English: In MEA115588 and in the double-blind placebo-controlled study 200862, there were 34 adolescents (12 to 17 years old).
Slovenian: MEA115588 in dvojno slepa, s placebom kontrolirana študija 200862 sta zajeli 34 mladostnikov (starih od 12 do 17 let).
English: IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils.
Slovenian: IL-5 je glavni citokin, odgovoren za rast in diferenciacijo,
English: 150 to <300 cells/µL
Slovenian: 150 do < 300 celic/µl n
English: If a dose of Nucala is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Slovenian: Če ste izpustili odmerek zdravila Nucala Čim prej pokličite zdravnika ali bolnišnico, da boste dobili nov datum obiska.
English: What you need to know before you use Nucala 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nucala 3.
English: Choose your injection site
Slovenian: Izberite mesto injiciranja
English: Just prior to administration, remove 1 mL of reconstituted Nucala.
Slovenian: Tik pred uporabo izvlecite 1 ml rekonstituiranega zdravila Nucala.
English: • Use your free hand to pinch the skin around your injection site.
Slovenian: • S prosto roko stisnite kožo okrog mesta injiciranja.
English: 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.
Slovenian: 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.
English: Intravenous mepolizumab pharmacokinetics was evaluated by population pharmacokinetic analysis in a paediatric study conducted in subjects aged 2-17 years old with eosinophilic esophagitis.
Slovenian: Farmakokinetiko intravensko uporabljenega mepolizumaba so ocenili s populacijsko farmakokinetično analizo v pediatrični študiji bolnikov z eozinofilnim ezofagitisom, starih od 2 do 17 let.
English: Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation.
Slovenian: Rekonstituirane raztopine med postopkom ne smete stresati, ker to lahko povzroči penjenje ali precipitacijo zdravila.
English: 300 to <500 cells/µL
Slovenian: 300 do < 500 celic/µl n
English: 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.
Slovenian: 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.
English: Just prior to administration, remove 0.4mL of reconstituted Nucala.
Slovenian: Tik pred uporabo izvlecite 0,4 ml rekonstituiranega zdravila Nucala.
English: Each vial contains 100 mg mepolizumab (100 mg/ml after reconstitution)
Slovenian: Ena viala vsebuje 100 mg mepolizumaba (100 mg/ml po rekonstituciji).
English: Following subcutaneous dosing in patients with asthma, mepolizumab exhibited approximately doseproportional pharmacokinetics over a dose range of 12.5 mg to 250 mg.
Slovenian: Pri bolnikih z astmo je imel subkutano uporabljeni mepolizumab v odmerkih od 12,5 mg do 250 mg približno odmerku sorazmerno farmakokinetiko.
English: Do not use Nucala after the expiry date which is stated on the label and carton after EXP.
Slovenian: 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.
English: Tell your doctor before you are given Nucala.
Slovenian: morate to povedati zdravniku, preden dobite zdravilo Nucala.
English: 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.
Slovenian: Za subkutano injiciranje po možnosti uporabite 1-ml polipropilensko brizgo z iglo za enkratno uporabo dimenzij 21G (gauge) do 27G (gauge) x 13 mm.
English: However, mepolizumab was excreted into the milk of cynomolgous monkeys at concentrations of less than 0.5% of those detected in plasma.
Slovenian: 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.
English: ITT Population Mepolizumab 100 mg (subcutaneous) N= 69
Slovenian: Populacija ZNZ mepolizumab 100 mg (subkutano) N = 69
English: • 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.
Slovenian: • Poglejte skozi okence za ogled in preverite, da je tekočina bistra (ni motna in je brez delcev) in brezbarvna do rumenkasta do rjavkasta.
English: • urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back)
Slovenian: • okužba sečil (kri v urinu, boleče in pogosto uriniranje, zvišana telesna temperatura, bolečina v spodnjem delu hrbta),
English: Mepolizumab pharmacokinetics in adolescent subjects with severe refractory eosinophilic asthma included in the phase 3 studies were consistent with adults (see section 4.2).
Slovenian: 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).
English: Do not warm the pen in a microwave, hot water, or direct sunlight.
Slovenian: Brizge ne segrevajte v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
English: The rate of exacerbations in the placebo arm increased with increasing baseline blood eosinophil count.
Slovenian: Delež poslabšanj se je v skupini s placebom povečeval z naraščanjem izhodiščnega števila eozinofilcev v krvi.
English: Stopping treatment with Nucala
Slovenian: Prenehanje zdravljenja z zdravilom Nucala
English: 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.
Slovenian: 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.
English: If your asthma symptoms get worse while receiving injections of Nucala Call your doctor.
Slovenian: Če se vam simptomi astme med prejemanjem injekcij zdravila Nucala poslabšajo se posvetujte z zdravnikom.
English: Nucala is available in a pack containing 1 vial, or in multipacks with 3 individual vials.
Slovenian: Zdravilo Nucala je na voljo v pakiranju, ki vsebuje 1 vialo, ali v večkratnem pakiranju, v katerem so 3 posamezne viale.
English: • Check the expiry date on the label of the syringe.
Slovenian: • Preverite datum izteka roka uporabnosti na nalepki brizge.
English: 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.
Slovenian: 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.
English: If you (or your child) may have had a similar reaction to any injection or medicine: Tell your doctor before you are given Nucala.
Slovenian: Če ste morda (vi ali vaš otrok) kdaj imeli podobno reakcijo na kakšno injekcijo ali zdravilo, morate to povedati zdravniku, preden dobite zdravilo Nucala.
English: Check the expiry date
Slovenian: Preverite datum izteka roka uporabnosti
English: 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.
Slovenian: 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.
English: • Keep refrigerated before use.
Slovenian: • Pred uporabo hranite v hladilniku.
English: Clean your injection site
Slovenian: Očistite mesto injiciranja
English: Automatic needle guard
Slovenian: Avtomatski ščitnik igle
English: Table 1: Frequency of clinically significant exacerbations at week 52 in the intent to treat population
Slovenian: Preglednica 1: Pogostnost klinično pomembnih poslabšanj po 52 tednih v populaciji z-namenom zdravljenja mepolizumab intravensko placebo
English: There is no specific treatment for an overdose with mepolizumab.
Slovenian: Za preveliko odmerjanje mepolizumaba ni specifičnega zdravljenja.
English: Nucala is for subcutaneous injection only and should be administered by a healthcare professional.
Slovenian: Zdravilo Nucala je namenjeno samo za subkutano injiciranje in ga mora dati zdravstveni delavec.
English: Exacerbation rate/year Percent reduction
Slovenian: Delež poslabšanj na leto Odstotno zmanjšanje
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, No 90 43056 San Polo di Torrile, Parma Italy
Slovenian: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, 90 43056 San Polo di Torrile, Parma Italija
English: Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Slovenian: Mepolizumab je humanizirano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
English: Start your injection
Slovenian: Začnite injiciranje
English: Table 3 shows the results of a combined analysis of the two exacerbation studies (MEA112997 and MEA115588) by baseline blood eosinophil count.
Slovenian: Preglednica 3 prikazuje rezultate kombinirane analize dveh študij poslabšanj (MEA112997 in MEA115588)
English: Following subcutaneous administration of mepolizumab the mean terminal half-life (t1/2) ranged from 16 to 22 days.
Slovenian: Povprečni terminalni razpolovni čas (t1/2) je bil po subkutani uporabi mepolizumaba od 16 do 22 dni.
English: GlaxoSmithKline Trading Services Ltd, Currabinny, Co. Cork, Ireland.
Slovenian: GlaxoSmithKline Trading Services Ltd., Currabinny, Co. Cork, Irska
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Nucala is given by injection just under the skin (subcutaneous injection).
Slovenian: Zdravilo Nucala se daje z injekcijo tik pod kožo (subkutano injiciranje).
English: Press a cotton wool ball or gauze on the area for a few moments if necessary.
Slovenian: Če je treba, na ta predel za nekaj trenutkov pritisnite kosem vate ali zloženec gaze.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Following a single intravenous administration to patients with asthma, mepolizumab distributes into a mean volume of distribution of 55 to 85 mL/kg.
Slovenian: Pri bolnikih z astmo se mepolizumab po enkratni intravenski uporabi porazdeli v povprečni volumen porazdelitve od 55 do 85 ml/kg.
English: • Do not use the syringe if dropped onto a hard surface.
Slovenian: • Brizge ne uporabite, če je padla na trdo površino.
English: • chest infection - symptoms of which may include cough and fever (high temperature)
Slovenian: • okužba v prsnem košu - med njenimi simptomi so lahko kašelj in zvišana telesna temperatura
English: The possible side effects of Nucala are unlikely to affect your ability to drive or use machines.
Slovenian: Ni verjetno, da bi možni neželeni učinki zdravila Nucala neugodno vplivali na vašo sposobnost upravljanja vozil in strojev.
English: nucala syringe
Slovenian: nucala brizga
English: How to use Nucala
Slovenian: Kako uporabljati zdravilo Nucala
English: 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.
Slovenian: 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.
English: Each vial of Nucala should be used for a single patient, and any remainder of the vial should be discarded.
Slovenian: Vsako vialo zdravila Nucala je treba uporabiti le za enega samega bolnika.
English: In 2 placebo-controlled studies the incidence of local injection site reactions with mepolizumab 100 mg subcutaneous and placebo was 8% and 3%, respectively.
Slovenian: 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 %.
English: Peel off the plastic cover
Slovenian: Odlepite prekrivno plastično folijo
English: Powder for solution for injection.
Slovenian: Prašek za raztopino za injiciranje.
English: EU/1/15/1043/003 1 pre-filled pen EU/1/15/1043/004 3 (3 x 1) pre-filled pens (multipack)
Slovenian: 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)
English: • Place the syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.
Slovenian: • Položite peresnik na čisto, ravno površino, na sobno temperaturo, tako da ni izpostavljen neposredni sončni svetlobi in ni dosegljiv otrokom.
English: Hypersensitivity and administration-related reactions
Slovenian: Preobčutljivostne reakcije in reakcije, povezane z dajanjem zdravila
English: • Check the expiry date on the label of the pen.
Slovenian: • Preverite datum izteka roka uporabnosti na nalepki peresnika.
English: • injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given)
Slovenian: • reakcija na mestu injiciranja (bolečina, pordelost, oteklost, srbenje in pekoč občutek v predelu kože,