FrancophonIA/ELRC3.0 huggingface dataset:
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Neulasta with any other medicinal products.
Slovenian: Posebnih študij medsebojnega delovanja ali presnove niso izvedli, vendar klinična preskušanja niso pokazala medsebojnega delovanja zdravila Neulasta s kakšnimi drugimi zdravili.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Slovenian: Poiščite si udoben, dobro osvetljen, čist prostor in si pripravite vso opremo, ki jo boste potrebovali, tako da bo pri roki.
English: Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
Slovenian: Zato morajo biti zdravniki previdni, kadar predpisujejo pegfilgrastim bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
English: To give yourself a subcutaneous injection you will need:
Slovenian: Za subkutano samoinjiciranje boste potrebovali:
English: • Outer area of upper arm (only if someone else is giving you the injection).
Slovenian: • zunanji del nadlakta (le v primeru, če vam injekcijo da kdo drug).
English: What to do if the on-body injector adhesive becomes noticeably wet (saturated) with fluid, or you see dripping.
Slovenian: Kaj storiti, če postane lepilo injektorja opazno mokro (napojeno) s tekočino, ali če opazite kapljanje.
English: Step 1: Monitor your on-body injector A For the next 27 hours, occasionally check the status light for at least 10 seconds.
Slovenian: 1. korak: Nadzorujte injektor A Naslednjih 27 ur občasno preverite lučko stanja; opazujte jo vsaj 10 sekund.
English: The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Slovenian: Učinkovitosti tega zdravila se ne sme primerjati z učinkovitostjo drugih pegiliranih ali nepegiliranih proteinov iz iste terapevtske skupine.
English: - Oxygen rich environments, such as hyperbaric chambers (a transparent chamber with an increase in atmospheric pressure).
Slovenian: - S kisikom bogatemu okolju, npr. hiperbaričnim komoram (prozornim komoram z zvišanim atmosferskim tlakom).
English: Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Slovenian: Zdravniku morate nemudoma povedati, če se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov:
English: • how to recognise signs from the device (e.g. adhesion issues, fill indicator not moved, no beeping sound, status light has not flashed etc.) that there has been a failure in the delivery of the intended dose
Slovenian: • kako prepoznati znake z naprave (npr. težave z lepilom, kazalnik polnosti ni premaknjen, brez zvoka piskanja, lučka stanja ni utripala itd.), da je prišlo do odpovedi pri injiciranju predvidenega odmerka
English: • Serious allergic reactions can happen with Neulasta.
Slovenian: • Med uporabo zdravila Neulasta se lahko pojavijo resne alergijske reakcije.
English: You will need to give yourself the injection into the tissue just under the skin.
Slovenian: Injekcijo si boste morali dati v tkivo tik pod kožo.
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Slovenian: Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je minil po ukinitvi G-CSF.
English: Loss of response to pegfilgrastim
Slovenian: Izguba odziva na pegfilgrastim
English: • after the injection is complete you are concerned that you may not have received the full dose.
Slovenian: • če vas po dokončanem injiciranju skrbi, da morda niste dobili celotnega odmerka.
English: Do not shake Neulasta vigorously as this may affect its activity.
Slovenian: Zdravila Neulasta ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
English: • a pre-filled syringe of Neulasta; and
Slovenian: • napolnjeno injekcijsko brizgo zdravila Neulasta; in
English: In clinical trials, Neulasta has been safely administered 14 days before chemotherapy.
Slovenian: V kliničnih preskušanjih so zdravilo Neulasta varno dajali 14 dni pred kemoterapijo.
English: Your doctor may want to monitor you more closely.
Slovenian: Zdravnik vas bo morda moral natančneje kontrolirati.
English: Hypersensitivity to the active substance or to any of the excipients.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov.
English: • inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Slovenian: • vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
English: Check the appearance of Neulasta.
Slovenian: Preverite videz zdravila Neulasta.
English: On the basis of the scientific conclusions for pegfilgrastim the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pegfilgrastim is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za pegfilgrastim odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) pegfilgrastim, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Before you use a Neulasta pre-filled syringe with automatic needle guard, read this important information:
Slovenian: Pred uporabo zdravila Neulasta v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
English: Amgen Europe B.V. Minervum 7061
Slovenian: Amgen Europe BV Minervum 7061
English: Do not touch the needle or push the plunger.
Slovenian: Ne dotaknite se igle in ne pritiskajte na bat.
English: • how to monitor the on-body injector
Slovenian: • kako nadzirati injektor
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Slovenian: Tako kot pri drugih hematopoetičnih rastnih faktorjih so tudi pri G-CSF pokazali, da in vitro spodbuja človeške endotelijske celice.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu
English: The most common adverse reaction reported was bone pain (see section 5.1 and 5.2).
Slovenian: Najpogosteje poročan neželen učinek je bil bolečina v kosteh (glejte poglavji 5.1 in 5.2).
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Slovenian: Potenciala za medsebojno delovanje z litijem, ki tudi pospešuje sproščanje nevtrofilcev, niso posebej raziskali.
English: The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Neulasta za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]).
Slovenian: Neželena učinka, o katerih so najpogosteje poročali, sta bila bolečina v kosteh (zelo pogosto [≥ 1/10]) in mišičnoskeletna bolečina (pogosto [≥ 1/100 do < 1/10]).
English: Instructions for use:
Slovenian: Navodilo za uporabo:
English: No adverse events directly attributable to this degree of leukocytosis have been reported.
Slovenian: Ne poročajo o neželenih učinkih, ki bi jih bilo možno neposredno pripisati tej stopnji levkocitoze.
English: This may be a sign of a problem with your spleen (splenomegaly).
Slovenian: To je lahko znak, da imate težave z vranico (splenomegalija).
English: Other warnings
Slovenian: Ostala opozorila
English: • what action to take in a suspected case of failed delivery or incomplete delivery of the dose and if symptoms of serious infection that may indicate a missed dose present.
Slovenian: • kako ukrepati pri domnevnem primeru odpovedi injiciranja ali nepopolnega injiciranja odmerka in če so prisotni simptomi resne okužbe, ki lahko kažejo na izpuščeni odmerek.
English: Apply a plaster if needed.
Slovenian: Če je potrebno, namestite obliž.
English: This means the dose is complete.
Slovenian: To pomeni, da je dajanje odmerka dokončano.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim 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 med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s pegfilgrastimom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Activity
Slovenian: Dejavnosti
English: Do not use the pre-filled syringe if:
Slovenian: Napolnjene injekcijske brizge ne uporabite, če:
English: Injecting the solution with the air bubble is harmless.
Slovenian: Injiciranje raztopine z zračnim mehurčkom je neškodljivo.
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Slovenian: Podobno kot pri filgrastimu nevtrofilci, ki nastanejo pri odgovoru na pegfilgrastim, kažejo normalno ali zvečano delovanje, kot kažejo testi kemotaktične in fagocitne funkcije.
English: For further information on use with the on-body injector, please read the instructions for use at the end of this leaflet.
Slovenian: Za dodatne informacije o uporabi zdravila z injektorjem preberite navodila za uporabo na koncu tega navodila.
English: For more information, see section 5.1.
Slovenian: Za podrobnosti glejte poglavje 5.1.
English: Stevens-Johnson syndrome
Slovenian: Stevens-Johnsonov sindrom
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev (G-CSF) je treba v bolnikovi dokumentaciji jasno zabeležiti zaščiteno ime uporabljenega zdravila.
English: Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.
Slovenian: Možnih interakcij z drugimi hemopoetičnimi rastnimi faktorji in citokini v kliničnih preskušanjih niso posebej raziskovali.
English: Dispose of it in a sharps disposal container as instructed by your healthcare provider or in accordance with local requirements.
Slovenian: Zavrzite ga v vsebnik za ostre odpadke, kot vam je naročil zdravnik oziroma v skladu z lokalnimi zahtevami.
English: • general aches and pains in the joints and muscles.
Slovenian: • splošne bolečine ter bolečine v sklepih in mišicah.
English: It is important to keep the skin pinched when injecting.
Slovenian: Pomembno je, da držite kožo med injiciranjem stisnjeno.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki injekcijske brizge poleg oznake »EXP«.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Slovenian: Bolnike, ki se jim pojavijo simptomi sindroma kapilarne prepustnosti, je treba natančno kontrolirati in deležni morajo biti standardnega simptomatskega zdravljenja, ki lahko vključuje potrebo po intenzivni negi (glejte poglavje 4.8).
English: Check to see if the status light is SOLID GREEN or has switched off.
Slovenian: Preverite, da boste videli, ali je lučka stanja STALNO ZELENA oz. ali se je izključila.
English: Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Slovenian: Pegfilgrastim je dolgo trajajoča oblika filgrastima zaradi zmanjšanega ledvičnega očistka.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Where should I give my injection?
Slovenian: Kam naj si dam injekcijo?
English: Only use each syringe for one injection.
Slovenian: Vsako napolnjeno injekcijsko brizgo uporabite le za eno injiciranje.
English: • Do not put the cap back on used needles.
Slovenian: • Ne nameščajte pokrovčka nazaj na uporabljene igle.
English: If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Slovenian: Če se je pri bolniku ob uporabi pegfilgrastima pojavil SJS, se pri tem bolniku nikoli več ne sme ponovno uvesti zdravljenja s pegfilgrastimom.
English: The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.
Slovenian: Mehanizem vaskulitisa pri bolnikih, ki prejemajo pegfilgrastim, ni znan.
English: Check the expiry date on the pre-filled syringe label (EXP).
Slovenian: Preverite datum izteka roka uporabnosti zdravila na nalepki napolnjene injekcijske brizge (EXP).
English: It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Slovenian: Pomembno je, da nemudoma pokličete svojega zdravnika, če se pojavi bolečina v zgornjem levem delu trebuha ali v predelu leve rame, saj je lahko povezana s težavami z vašo vranico.
English: Rates of generation of antibodies against pegfilgrastim is generally low.
Slovenian: Stopnja nastajanja protiteles proti pegfilgrastimu je na splošno nizka.
English: This is known as a subcutaneous injection.
Slovenian: Temu pravimo subkutano injiciranje.
English: If needed, you may cover the injection site with a plaster.
Slovenian: Če je treba, lahko mesto injiciranja prekrijete z obližem.
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Slovenian: Podatki v spodnji preglednici opisujejo neželene učinke, zabeležene v kliničnih preskušanjih in med spontanim poročanjem.
English: • The grey needle cap is missing or not securely attached.
Slovenian: • sivi pokrovček igle manjka ali ni trdno nameščen.
English: Medicines should be disposed of in accordance with local requirements.
Slovenian: Zdravila morate zavreči v skladu z lokalnimi predpisi.
English: This means that the delivery is complete.
Slovenian: To pomeni, da je dajanje zdravila dokončano.
English: USA
Slovenian: ZDA
English: Neulasta left at room temperature for more than 72 hours should be discarded.
Slovenian: Zdravilo Neulasta, ki je bilo na sobni temperaturi več kot 72 ur, je treba zavreči.
English: Sweet's syndrome (acute febrile dermatosis)1,2
Slovenian: Sweetov sindrom (akutna febrilna dermatoza) kožni vaskulitis1,2
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Slovenian: Pegfilgrastim je beljakovina, biotehnološko pridobljena iz bakterij E. coli.
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov izdelovalcev biološke učinkovine
English: • When dose delivery is complete, a long beep will sound and the status light will be solid green.
Slovenian: • Ko bo injiciranje dokončano, bo slišen dolg pisk in lučka stanja bo stalno zelena.
English: • when to expect dose delivery to begin
Slovenian: • kdaj pričakovati začetek injiciranja odmerka
English: This may affect your medicine.
Slovenian: Vsi ti lahko neugodno vplivajo na vaše zdravilo.
English: • Do not expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: - Diagnostic imaging (e.g. CT scan, MRI, ultrasound, x-ray).
Slovenian: • Injektorja ne izpostavljajte naslednjim okoliščinam, saj se zaradi njih lahko pokvari, vi pa se lahko poškodujete: - Diagnostičnim slikanjem (npr. računalniški tomografiji, magnetnoresonančnemu slikanju, pregledom z ultrazvokom, rentgenskemu slikanju).
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Slovenian: Neželeni učinki so bili podobni tistim pri preiskovancih, ki so prejemali nižje odmerke pegfilgrastima.
English: The manually administered injections should be given into the thigh, abdomen or upper arm.
Slovenian: Ročno dane injekcije se morajo dati v stegno, trebuh ali zgornji del roke.
English: 9/L after the expected nadir, this medicine should be discontinued immediately.
Slovenian: 9/l, je treba nemudoma prenehati z zdravljenjem s tem zdravilom.
English: It contains important advice on how to monitor your device for medication errors including under dose leading to lack of effect, and when to seek immediate medical attention.
Slovenian: Kartica vsebuje pomembna navodila o tem, kako pripomoček nadzirati glede napak pri uporabi zdravila, vključno z nezadostnim odmerjanjem, ki povzroči izostanek učinka, ter kdaj je treba nemudoma poiskati zdravniško pomoč.
English: • Neulasta is given as an injection into the tissue just under the skin (subcutaneous injection).
Slovenian: • Zdravilo Neulasta se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
English: For patients who have reactions to acrylic adhesives, use of this product may result in an allergic reaction.
Slovenian: Bolnikom, ki imajo reakcije na akrilna lepila, lahko uporaba tega pripomočka povzroči alergijsko reakcijo.
English: Your doctor may decide that it would be more convenient for you to inject Neulasta yourself.
Slovenian: Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Neulasta injicirate sami.
English: If you have a cough, fever and difficulty breathing please tell your doctor.
Slovenian: Če kašljate, imate vročino in težko dihate, o tem obvestite svojega zdravnika.
English: Do not use Neulasta
Slovenian: Ne uporabljajte zdravila Neulasta
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Slovenian: Če se ne odzivate več na zdravljenje s pegfilgrastimom ali z njim ni mogoče vzdrževati odziva, bo zdravnik preučil razloge za to, vključno s tem ali so se vam pojavila protitelesa, ki nevtralizirajo delovanje pegfilgrastima.
English: • if you have sickle cell anaemia.
Slovenian: • če imate srpastocelično anemijo.
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Slovenian: Pegfilgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic pri kumulativnih tedenskih odmerkih, ki so približno 6- do 9-krat višji od priporočenega odmerka za človeka (na podlagi telesne površine) (glejte poglavje 5.3).
English: Uncommon (≥ 1/1,000 to
Slovenian: Občasni (≥ 1/1.000 do
English: This may affect the on-body injector's performance.
Slovenian: To namreč lahko vpliva na delovanje injektorja.
English: B Open the tray, peeling away the cover.
Slovenian: B Odprite podlogo, tako da z nje odlepite pokrivno folijo.
English: If you develop or are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your doctor.
Slovenian: Če se vam bodo pojavili ali je verjetno, da se vam bodo pojavili krvni raki, ne smete uporabljati zdravila Neulasta, razen če vam to naroči zdravnik.
English: • The used syringe should be disposed of in accordance with local requirements.
Slovenian: • Uporabljene injekcijske brizge zavrzite v skladu z lokalnimi zahtevami.
English: Before use
Slovenian: Pred uporabo
English: • Avoid activities and places that may interfere with monitoring during the dosing of Neulasta.
Slovenian: • Izogibajte se dejavnostim in mestom, ki lahko motijo vaš nadzor injektorja med injiciranjem zdravila Neulasta.
English: If this happens, you may not receive your dose of Neulasta.
Slovenian: V takšnem primeru se lahko zgodi, da ne dobite svojega odmerka zdravila Neulasta.
English: Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.
Slovenian: Zdravila Neulasta smete uporabiti, če je bilo pomotoma zamrznjeno eno samo obdobje, krajše od 24 ur.
English: Do not remove the on-body injector at this time.
Slovenian: V tem času ne odstranite injektorja.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Slovenian: Na splošno so primeri glomerulonefritisa minili po zmanjšanju odmerka ali prenehanju uporabe filgrastima ali pegfilgrastima.
English: • The on-body injector has a self-adhesive backing to attach it to the skin, do not use additional materials to hold it in place as this could dislodge the cannula leading to a missed or incomplete dose of Neulasta.
Slovenian: • Injektor ima samolepilno površino, s katero je prilepljen na kožo; ne uporabljajte dodatnih materialov, da bi ga držali na mestu, ker lahko s tem premaknete kanilo, posledica pa je izpuščen ali nepopoln odmerek zdravila Neulasta.
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Slovenian: Varnost in učinkovitost uporabe pegfilgrastima pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
English: Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Slovenian: Navzeo in glavobole so zelo pogosto opazili pri bolnikih, ki so dobivali kemoterapijo.
English: Allergies
Slovenian: Alergije
English: Your doctor will check your blood and urine regularly as Neulasta can harm the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Neulasta lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
English: Healthcare providers only The trade name of the administered product should be clearly recorded in the patient file.
Slovenian: Samo za zdravstveno osebje Zaščiteno ime uporabljenega zdravila je treba jasno zabeležiti v bolnikovi dokumentaciji.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Slovenian: Zdravilo se ne sme mešati z drugimi zdravili, predvsem pa ne z raztopinami natrijevega klorida.
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Slovenian: • resne alergijske reakcije, vključno z anafilaksijo (slabost, padec krvnega tlaka, težave z dihanjem, otekanje obraza).
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Slovenian: Varnost in učinkovitost pegfilgrastima nista raziskani pri bolnikih z mielodisplastičnim sindromom, s kronično mielogeno levkemijo in s sekundarno AML, zato ga pri takšnih bolnikih ne smete uporabljati.