FrancophonIA/ELRC3.0 huggingface dataset:
English: • Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.
Slovenian: • Alergijske reakcije, vključno z anafilaktično reakcijo, angioedemom, izpuščajem in urtikarijo.
English: If someone else is giving you the injection, they can also use the outer area of the upper arms.
Slovenian: Če vam zdravilo injicira kdo drug, vam ga lahko da tudi v zunanjo stran nadlakta.
English: Do not use Nespo after the expiry date which is stated on the carton and on the pre-filled pen label after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjenega injekcijskega peresnika z oznako "Upor.
English: In order to correct your anaemia, your initial dose will be • 500 micrograms once every three weeks (6.75 micrograms of Nespo per kilogram of your body
Slovenian: Za odpravljanje anemije boste dobili začetni odmerek • 500 mikrogramov enkrat na tri tedne (6,75 mikrogramov Nespa na kilogram telesne mase enkrat
English: If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by genetechnology) to Nespo, they will choose whether you should receive your Nespo injection once weekly or once every two weeks.
Slovenian: Če se zdravnik odloči, da vam namesto zdravljenja z r-HuEPO (genskotehnološko pridobljenega eritropoetina) predpiše Nespo, bo tudi določil, ali morate injekcijo Nespa dobiti enkrat na teden ali enkrat na dva tedna.
English: In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
Slovenian: V prospektivni, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 314 bolnikih z rakom na pljučih, ki so dobivali kemoterapijo s platino, so ugotovili značilno zmanjšanje potreb po transfuziji
English: The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Slovenian: Kancerogenega potenciala darbepoetina alfa niso ocenili v
English: DO NOT use Nespo:
Slovenian: Ne uporabite Nespa, če
English: Non-response to therapy with Nespo should prompt a search for causative factors.
Slovenian: Če se bolnik na terapijo z Nespom ne odzove, je treba raziskati vzročne dejavnike za to.
English: Nespo should be used with caution in patients with epilepsy.
Slovenian: Pri bolnikih z epilepsijo morate Nespo uporabljati previdno.
English: As there is no clinical experience with lactating women Nespo should not be administered to women who are breast-feeding.
Slovenian: Kliničnih izkušenj z Nespom pri doječih ženskah ni, zato ga pri takšnih ženskah ne smete uporabljati.
English: • Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.
Slovenian: • Če zdravstveni delavci zdravilo uporabijo nepravilno, se lahko pojavijo smrtno nevarne težave na srcu ali ožilju.
English: The Nespo pre-filled pen is given as a single injection, either once a week, once every two weeks, or once every month.
Slovenian: Nespo v napolnjenem injekcijskem peresniku vbrizgamo kot eno injekcijo, bodisi enkrat na teden, enkrat na dva tedna ali enkrat na mesec.
English: If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.
Slovenian: Če se počutite kakorkoli slabo, se takoj posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Slovenian: Variabilnosti hemoglobina se je treba prilagoditi z uravnavanjem odmerka, pri čemer je treba upoštevati ciljno območje koncentracije hemoglobina od 100 g/l (6,2 mmol/l) do 120 g/l (7,5 mmol/l).
English: • an allergy to latex (the needle cover on the pre-filled syinge contains a derivative of latex).
Slovenian: • alergijo na lateks (pokrovček igle na napolnjenem injekcijskem peresniku vsebuje snov, pridobljeno iz lateksa).
English: • Hives (urticaria)
Slovenian: • Urtikarija (koprivnica)
English: Rotate the injection sites and inject slowly to avoid discomfort at the site of injection.
Slovenian: Mesto injiciranja krožno menjajte, zdravilo pa injicirajte počasi, da se boste izognili neprijetnemu
English: For the abdomen, it is recommended to lie down on your back, and stretch the skin at the injection site to create a firm and
Slovenian: Če boste injicirali v trebuh, je najbolje, da se uležete na hrbet in raztegnete kožo na mestu injiciranja, tako da ustvarite čvrsto in napeto površino.
English: FRONT- Nespo getting started guide:
Slovenian: SPREDNJA STRAN - Navodilo za začetek uporabe Nespoa:
English: • convulsions (fits or seizures);
Slovenian: • konvulzije (napade krčev),
English: Erythropoetin is a growth factor that primarily stimulates red blood cell production.
Slovenian: Eritropoetini so rastni dejavniki, ki spodbujajo predvsem nastajanje rdečih krvnih celic.
English: - Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached - At the request of the EMEA
Slovenian: farmakovigilančni načrt ali na dejavnosti za zmanjšanje tveganja; - v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjšanju tveganja);
English: How do you or the person injecting you, use the Nespo pre-filled syringe?
Slovenian: Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo
English: Your doctor has decided that the Nespo pre-filled pen is the best way for you, a nurse, or a carer to inject Nespo.
Slovenian: Zdravnik je uporabo napolnjenega injekcijskega peresnika Nespo ocenil kot najboljši način, da si zdravilo injicirate sami, da vam ga injicira medicinska sestra ali oseba, ki skrbi za vas.
English: Check the appearance of Nespo through the inspection window.
Slovenian: Skozi okence preverite videz Nespa.
English: If the inspection window is not yellow, you must contact your doctor, nurse or pharmacist.
Slovenian: Če okence ni rumeno, se obrnite na zdravnika, medicinsko sestro ali
English: Marketing Authorisation Holder: Dompé Biotec S.p.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom: Dompé Biotec S.p.A.
English: The active substance of Nespo is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Slovenian: Zdravilna učinkovina v zdravilu Nespa je darbepoetin alfa, pridobljen z gensko tehnologijo v ovarijskih celicah kitajskega hrčka (CHO-K1).
English: The initial weekly dose of Nespo (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 200.
Slovenian: Začetni tedenski odmerek Nespa (µg/teden) lahko določite tako, da celotni tedenski odmerek r-HuEPO (i.e./teden) delite z 200.
English: OTHER Dompé Biotec S.p.A.
Slovenian: DRUGI PODATKI Dompé Biotec S.p.A.
English: When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Slovenian: Pri zamenjavi r-HuEPO z Nespom je treba uporabiti isto pot aplikacije, hemoglobin pa kontrolirati na en do dva tedna.
English: In clinical studies, an increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Slovenian: V kliničnih študijah so ugotovili večje tveganje smrti, resnih srčnožilnih dogodkov, in tromboze na žilnem dostopu kadar so eritropoezo stimulirajoče agense (ESA) uporabljali tako, da je bil ciljni hemoglobin nad 120 g/l (7,5 mmol/l).
English: 1 single use pre-filled syringe 4 single use pre-filled syringes
Slovenian: 1 napolnjena injekcijska brizga za enkratno uporabo 4 napolnjene injekcijske brizga za enkratno uporabo
English: The initial weekly or once every other week pediatric dose of Nespo (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240.
Slovenian: Začetni pediatrični odmerek Nespa (µg/teden) enkrat na teden ali enkrat vsak drugi teden lahko določite tako, da celotni tedenski odmerek r-HuEPO (i.e./teden) delite z 240.
English: Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to provide adequate control of the symptoms of anaemia.
Slovenian: Bolnike morate natančno kontrolirati in tako zagotoviti uporabo najmanjšega odobrenega odmerka Nespa, ki je potreben za ustrezno obvladanje simptomov anemije..
English: In these patients an upper limit of 12 g/dl (7.5 mmol/l) should be aimed for, unless severe symptoms (e.g. angina) dictate otherwise.
Slovenian: Pri takšnih bolnikih naj bi bila ciljna zgornja meja 120 g/l (7,5 mmol/l), razen če hudi simptomi (npr. angina pektoris) ne narekujejo drugače.
English: In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in patients with CRF treated subcutaneously.
Slovenian: V posameznih primerih je bila v povezavi s terapijo z Nespom opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles, pretežno pri bolnikih s kronično odpovedjo ledvic, ki so zdravilo dobivali subkutano.
English: The syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles.
Slovenian: Injekcijska brizga v peresniku je iz stekla tipa 1 in ima nerjavno jekleno iglo številka 27.
English: Do not remove the grey needle cap from the pre-filled pen until you are ready to inject.
Slovenian: Ne odstranite sivega ščitnika igle z napolnjenega injekcijskega peresnika, dokler niste
English: • a new Nespo pre-filled syringe; and
Slovenian: • novo napolnjeno injekcijsko brizgo zdravila Nespo in
English: Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 patients who received r-HuEPO.
Slovenian: Podatki iz kontroliranih študij zajemajo 1357 bolnikov: 766 jih je dobivalo Nespo in 591 r-HuEPO.
English: Check window to confirm delivery of full dose
Slovenian: Poglejte okence, da boste preverili, ali je bil injiciran celotni odmerek
English: You may rotate the site for each injection to avoid soreness at any one site.
Slovenian: Mesto injiciranja lahko krožno menjate, da boste preprečili bolečine na posameznem mestu.
English: There may be a little bleeding at the injection site.
Slovenian: Mesto injiciranja lahko rahlo krvavi.
English: Check the expiry date on the pre-filled syringe label (EXP:).
Slovenian: Preverite datum izteka roka uporabnosti na nalepki napolnjene injekcijske brizge (Upor.
English: Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Nespo.
Slovenian: Klinične študije so pokazale, da lahko odrasli bolniki, ki dobivajo r-HuEPO enkrat, dvakrat ali trikrat na teden, preidejo na Nespo enkrat na teden ali enkrat na dva tednaNespo.
English: The initial every other week dose of Nespo (μg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200.
Slovenian: Začetni odmerek Nespa na dva tedna (µg vsak drugi teden) lahko določite tako, da celotni kumulativni odmerek r-HuEPO, apliciran v dveh tednih, delite z 200.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Slovenian: Če imate kakršnekoli težave, brez obotavljanja prosite za pomoč in nasvet zdravnika ali medicinsko sestro.
English: Nespo is a clear, colourless or slightly pearly liquid.
Slovenian: Nespo je bistra, brezbarvna ali rahlo biserna tekočina.
English: The best places to inject yourself arethe top of your thighs andthe abdomen.
Slovenian: Najprimernejši mesti za samoinjiciranje sta zgornji del stegen in trebuh.
English: You should have no serious problems if you take more Nespo than you need.
Slovenian: Če uporabite več Nespa, kot je potrebno, to ne bi smelo povzročiti resnih težav.
English: There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
Slovenian: V povezavi z darbepoetinom alfa so bile opisane resne alergijske reakcije, vključno z anafilaktično reakcijo, angioedemom, dispnejo, izpuščajem na koži in urtikarijo.
English: D Do wait for the injection to finish before releasing pressure.
Slovenian: D Pritiska ne popustite, dokler se injiciranje ne konča.
English: The following adverse reactions have been identified during postmarketing use of Nespo:
Slovenian: Pomarketinške izkušnje Med pomarketinško uporabo Nespa so ugotovili naslednje neželene učinke:
English: For subcutaneous use Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo.
English: The initial dose by subcutaneous or intravenous administration is 0.45 µg/kg body weight, as a single injection once weekly.
Slovenian: Začetni subkutani ali intravenski odmerek je 0,45 µg/kg telesne mase v eni injekciji enkrat na teden.
English: Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Slovenian: Pogostnosti neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih
English: PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Slovenian: Čista aplazija rdečih celic pomeni, da so v telesu nehale nastajati rdeče krvne celice; posledica je huda anemija.
English: Very Common (seen in more than 10 in 100 people)
Slovenian: Zelo pogosti (pojavijo se pri več kot 10 od 100 oseb)
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Slovenian: Preživetje bolnikov in napredovanje tumorja so raziskali v petih velikih kontroliranih študijah, ki so skupaj zajele 2833 bolnikov.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Ni ugotovljeno, da bi Nespa vplival na sposobnost vožnje in upravljanja s stroji.
English: In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/dl (7.5 mmol/l), the dosage adaptation described in section 4.2 should be closely respected, in order to minimise the potential risk of thromboembolic events.
Slovenian: Če hemoglobin pri bolnikih s čvrstimi tumorji ali limfoproliferativnimi malignomi preseže 120 g/l (7,5 mmol/l), natančno upoštevajte prilagoditev odmerka, opisano v poglavju 4.2, da boste zmanjšali morebitno tveganje za trombembolične incidente.
English: Alternatively, in patients not on dialysis, an initial dose of 0.75 μg/kg may be administered subcutaneously as a single injection once every two weeks.
Slovenian: Pri bolnikih, ki niso na dializi, je druga možnost začetni odmerek 0,75 μg/kg subkutano v eni injekciji enkrat na dva tedna.
English: Nespo also contains sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
Slovenian: Nespo vsebuje tudi natrijev hidrogenfosfat, natrijev dihidrogenfosfat, natrijev klorid, polisorbat 80 in vodo za injekcije.
English: Your doctor may decide that it is best for you or a carer to inject Nespo.
Slovenian: Zdravnik lahko presodi, da je za vas najbolje, če si Nespo injicirate sami oz. vam ga injicira oseba, ki za vas skrbi.
English: Nespo should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl (6.2 mmol/l)) in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l).
Slovenian: Bolniki z anemijo (npr. koncentracijo hemoglobina ≤ 100 g/l (6,2 mmol/l)) morajo Nespo dobiti subkutano s ciljem, da se hemoglobin zviša na ne več kot 120 g/l (7,5 mmol/l).
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Slovenian: Nekoliko izvlecite bat; tako se boste prepričali, da niste zabodli v žilo.
English: Paediatric patients with chronic renal failure
Slovenian: Pediatrični bolniki s kronično odpovedjo ledvic
English: METHOD OF ADMINISTRATION EXPIRY DATE
Slovenian: Datum izteka roka uporabnosti se nanaša
English: Solution for injection (injection) in a pre-filled syringe.
Slovenian: Raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi.
English: Treatment of symptomatic chemotherapy induced anaemia in cancer patients
Slovenian: Zdravljenje simptomatske anemije zaradi kemoterapije pri onkoloških bolnikih
English: Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary.
Slovenian: Zdravnik vam bo redno jemal kri za meritve, ki bodo pokazale, kako dobro se anemija odziva, in bo lahko odmerek prilagodil, kot bo potrebno .
English: Disposing of used syringes
Slovenian: Odlaganje rabljenih napolnjenih injekcijskih peresnikov
English: For patients ≥11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/kg body weight, as a single injection once weekly.
Slovenian: Za bolnike, stare ≥ 11 let, je začetni subkutani ali intravenski odmerek 0,45 µg /kg telesne mase v eni injekciji enkrat na teden.
English: If an elevated or rising potassium level is observed then consideration should be given to ceasing Nespo administration until the level has been corrected.
Slovenian: Če se izkaže, da je kalij zvišan ali se zvišuje, pride v poštev prenehanje uporabe Nespa, dokler se koncentracija kalija ne uredi.
English: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), ESAs are not indicated for use in this patient population.
Slovenian: • skrajšala čas do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, zdravljenih z obsevanjem, če je bila ciljna vrednost hemoglobina več kot 140 g/l (8,7 mmol/l).
English: Nespo is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children.
Slovenian: Nespo uporabljamo za zdravljenje simptomatske anemije, ki spremlja kronično odpoved ledvic pri odraslih in otrocih.
English: Serum potassium levels should be monitored regularly during Nespo therapy.
Slovenian: Med zdravljenjem z Nespom je treba redno kontrolirati koncentracijo kalija v serumu.
English: Injection site pain
Slovenian: bolečina na mestu injiciranja
English: In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Slovenian: Pri teh bolnikih k anemiji bistveno pripomoreta tako pomanjkanje eritropoetina kot slabši odziv eritroidnih matičnih celic na
English: Convulsions (fits and seizures) have been reported in patients treated with Nespo.
Slovenian: Pri bolnikih, zdravljenih z Nespom, so bile opisane konvulzije (napadi krčev).
English: Keep in the original package in order to protect from light.
Slovenian: Shranjuje v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: • if you are allergic to Nespo (darbepoetin alfa), r-HuEPO or to any of the other ingredients in Take special care with Nespo
Slovenian: • če ste preobčutljivi za (alergični na) Nespo (darbepoetin alfa), r-HuEPO ali katerokoli sestavino Bodite posebno pozorni pri uporabi zdravila Nespo Zdravniku povejte,če imate ali ste kdaj imeli:
English: Rare (seen in more than 1 in 10,000 people)
Slovenian: Redki (pojavijo se pri več kot 1 od 10.000 oseb)
English: Cancer patients
Slovenian: Onkološki bolniki
English: Dialysis patients converting from once weekly to once every other week dosing with Nespo should initially receive a dose equivalent to twice the previous once weekly dose.
Slovenian: Bolniki na dializi, ki preidejo z uporabe Nespa enkrat na teden na uporabo Nespa enkrat na dva tedna, morajo sprva dobivati odmerek, enak dvojnemu odmerku, ki so ga do tedaj dobivali enkrat na teden.
English: If you use more Nespo than you should
Slovenian: Če ste uporabili večji odmerek zdravila Nespo, kot bi smeli
English: Cyclosporin and tacrolimus may be affected by the number of red cells in your blood.
Slovenian: Število rdečih celic v krvi lahko vpliva na zdravili ciklosporin in takrolimus.
English: Nespo is available in packs of 1 or 4 vials (not all pack sizes may be marketed).
Slovenian: Nespo je na voljo v pakiranjih z 1 ali 4 vialami (na trgu morda ni vseh velikosti pakiranj).
English: Check the expiry date on the pre-filled pen label (EXP:).
Slovenian: Preverite datum izteka roka uporabnosti na nalepki napolnjenega injekcijskega peresnika (Upor.
English: Please read this leaflet carefully before you start using this medicine.
Slovenian: Pred uporabo natančno preberite navodilo.
English: In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
Slovenian: Med obdobjem vzdrževanja je mogoče Nespo še naprej uporabljati v eni injekciji na teden ali na dva tedna.
English: Nespo comes in a vial that contains either 15, 25, 40 or 60 micrograms of the active substance darbepoetin alfa.
Slovenian: Nespo je na voljo v vialah, ki vsebujejo 15, 25, 40 ali 60 mikrogramov zdravilne učinkovine
English: Common (seen in more than 1 in 100 people)
Slovenian: Pogosti (pojavijo se pri več kot 1 od 100 oseb)
English: Avoid areas with scars or stretch marks.
Slovenian: Ne injicirajte v predele z brazgotinami ali strijami.
English: Any medicinal product remaining in the pre-filled syringe should be disposed of.
Slovenian: Ostanek zdravila v napolnjeni injekcijski brizgi morate zavreči.
English: Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Slovenian: Nespo uporabljamo za zdravljenje simptomatske anemije pri odraslih bolnikih, ki imajo nemieloidnega raka in dobivajo kemoterapijo.
English: In this leaflet
Slovenian: ESA v tej populaciji
English: A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided.
Slovenian: Izogniti se je treba zvišanju koncentracije hemoglobina, večjemu od 20 g/l (1,25 mmol/l) v štirih tednih.
English: Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: natrijev hidrogenfosfat, natrijev dihidrogenfosfat, natrijev klorid, polisorbat 80, voda
English: If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), a dose reduction should be considered.
Slovenian: Če hemoglobin preseže 120 g/l (7,5 mmol/l), pride v poštev zmanjšanje odmerka.
English: The syringes are provided either with (1-& 4-pack) or without (1-pack) a blister-wrapping.
Slovenian: Brizge so opremljene v pretisnih omotih (pakiranje z 1 ali 4) ali brez njih
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins.
Slovenian: Pri bolnikih, ki niso na hemodializi, ima prednost subkutana uporaba, ker tako ni potrebno zbadanje
English: Potassium elevation has been reported in a few patients receiving Nespo, though causality has not been established.
Slovenian: Pri nekaj bolnikih, ki so dobivali Nespo, so zabeležili zvišanje kalija, vendar vzročne povezanosti niso ugotovili.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: Keep the pre-filled pen in the original package in order to protect from light.
Slovenian: Napolnjene injekcijske peresnike shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Nespo should not affect your ability to drive or use machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nespo ne bi smel vplivati na vašo sposobnost upravljanja vozil in strojev.