FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Slovenian: V kliničnih preskušanjih so pegfilgrastim varno dajali 14 dni pred kemoterapijo.
English: - general aches and pains in the joints and muscles.
Slovenian: - splošne bolečine ter bolečine v sklepih in mišicah.
English: Do not shake Fulphila vigorously as this may affect its activity.
Slovenian: Zdravila Fulphila ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
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: If you develop or are likely to develop cancers of the blood, you should not use Fulphila, 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 Fulphila, razen če vam to naroči zdravnik.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Fulphila; and - alcohol wipes or similar.
Slovenian: Oprema, ki jo boste potrebovali Za subkutano samoinjiciranje boste potrebovali: - napolnjeno injekcijsko brizgo zdravila Fulphila; in - alkoholne krpice ali podobno.
English: 0.6 mL of solution.
Slovenian: 0,6 ml
English: Important: handle syringe as pictured
Slovenian: Pomembno: z injekcijsko brizgo ravnajte, kot je prikazano na sliki
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Slovenian: Upoštevati je treba aditivni učinek sočasnega jemanja zdravil, ki vsebujejo sorbitol (ali fruktozo) in sorbitola (ali fruktoze), ki ga vnesemo s hrano.
English: What should I do before I give myself a subcutaneous injection of Fulphila?
Slovenian: Kaj moram narediti, preden si dam subkutano injekcijo zdravila Fulphila?
English: Important Before you use a Fulphila pre-filled syringe with automatic needle guard, read this important information:
Slovenian: Pred uporabo zdravila Fulphila v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
English: The safety and efficacy of pegfilgrastim in children has not yet been established.
Slovenian: Varnost in učinkovitost pegfilgrastima pri otrocih še nista bili dokazani.
English: Clean your skin by using an alcohol wipe.
Slovenian: 1 Očistite si kožo z alkoholno krpico.
English: Grounds for the variation to the terms of the marketing authorisation(s) 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: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom 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: Fulphila left at room temperature for more than 72 hours should be discarded.
Slovenian: Zdravilo Fulphila, ki je bilo na sobni temperaturi več kot 72 ur, je treba zavreči.
English: If leukocyte counts exceed 50 x 109/l after the expected nadir, this medicinal product should be discontinued immediately.
Slovenian: Če število levkocitov po pričakovanem najmanjšem številu preseže 50 × 109l, je treba nemudoma prenehati z zdravljenjem s tem zdravilom.
English: Do not use this medicine after the expiry date which is stated on the carton, on the blister and on the syringe label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, na pretisnem omotu in na nalepki injekcijske brizge poleg oznake ”EXP”.
English: StevensJohnson syndrome
Slovenian: StevensJohnsonov sindrom
English: What Fulphila is and what it is used for
Slovenian: Kaj je zdravilo Fulphila in za kaj ga uporabljamo
English: Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Fulphila lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
English:  Do not use the pre-filled syringe if:
Slovenian: X Napolnjene injekcijske brizge ne uporabite, če:
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 večji od priporočenega odmerka za človeka (na podlagi telesne površine) (glejte poglavje 5.3).
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Slovenian: Sweetov sindrom (akutna febrilna dermatoza)1,2; kožni vaskulitis1,2
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 manjše odmerke pegfilgrastima.
English: If you forget to inject Fulphila
Slovenian: Če ste si pozabili injicirati zdravilo Fulphila
English: Each pre-filled syringe contains 30 mg sorbitol (E420).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 mg sorbitola (E420).
English: C Pinch your injection site to create a firm surface.
Slovenian: C Na mestu injiciranja kožo stisnite v kožno gubo, da boste ustvarili trdno površino.
English: - if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia).
Slovenian: - če ste seznanjeni z morebitnimi spremembami števila krvnih celic (npr. s povečanjem števila belih krvničk ali anemijo) ali z zmanjšanim številom krvnih ploščic v krvi, kar zmanjša sposobnost strjevanja krvi (trombocitopenija).
English: 6.6 Special precautions for disposal and other handling Before administration, Fulphila solution should be inspected visually for particulate matter.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Pred uporabo morate raztopino zdravila Fulphila pregledati glede vidnih delcev.
English: Check the appearance of Fulphila.
Slovenian: Preverite videz zdravila Fulphila.
English: - if you have sickle cell anaemia.
Slovenian: - če imate srpastocelično anemijo.
English:  Do not touch the cleaned area of the skin.
Slovenian: X Ne dotikajte se očiščenega predela kože.
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Slovenian: Pojav pljučnih znakov, kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov, in poslabšanje pljučne funkcije skupaj z zvečanim številom nevtrofilcev utegnejo biti preliminarni znaki sindroma akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome).
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnosti in učinkovitosti pegfilgrastima za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (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 akutno mieloično levkemijo (AML), zato ga pri takšnih bolnikih ne smete uporabljati.
English: Push all the way down through the snap.
Slovenian: Potisnite do konca navzdol vse do tleska.
English: Elevations in lactate dehydrogenase and alkaline phosphatase1; Transient elevations in LFT's for ALT or AST1
Slovenian: Preiskave zvišanje laktatdehidrogenaze in alkalne fosfataze1, prehodno zvišanje jetrnih funkcijskih testov za ALT ali AST1
English: Fulphila may be used if it is accidentally frozen for a single period of less than 24 hours.
Slovenian: Zdravilo Fulphila smete uporabiti, če je bilo pomotoma zamrznjeno eno samo obdobje, krajše od 24 ur.
English: How do you, or the person injecting you, use Fulphila pre-filled syringe?
Slovenian: Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo zdravila Fulphila?
English: - Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Slovenian: - Stevens-Johnsonov sindrom, ki se lahko pojavi kot rdečkaste lise v obliki tarče ali krožne lise na trupu, pogosto z mehurčki na sredini, luščenje kože, razjede v ustih, grlu, nosu, genitalijah in očeh, pred tem pa se lahko pojavijo vročina in gripi podobni simptomi.
English: - sickle cell crises in patients with sickle cell anaemia.
Slovenian: - srpastocelična kriza pri bolnikih s srpastocelično anemijo.
English: Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see figure 1).
Slovenian: V skladu z avtoregulacijskim mehanizmom očistka se serumska koncentracija pegfilgrastima ob nastopu okrevanja nevtrofilcev hitro zmanjša (glejte sliko 1).
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Slovenian: Občasno so ti primeri povzročili respiratorno insuficienco ali sindrom akutne dihalne stiske (ARDS), ki sta lahko smrtna (glejte poglavje 4.4).
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede ravnanja z zdravilom pred dajanjem injekcije glejte poglavje 6.6. 4.3 Kontraindikacije
English: - damage to the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: - okvara drobnih filtrov v ledvicah (glomerulonefritis).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Fulphila: - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Fulphila se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če se vam pojavi alergijska reakcija, vključno s šibkostjo, padcem krvnega tlaka, težavami z dihanjem, otekanjem obraza (anafilaksa), pordelostjo in navali vročine, izpuščajem na koži in predeli kože, ki srbijo.
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Slovenian: Po enem samem subkutanem odmerku pegfilgrastima se največja serumska koncentracija pegfilgrastima pojavi 16 do 120 ur po odmerku, serumske koncentracije pegfilgrastima se vzdržujejo v obdobju nevtropenije po mielosupresivni kemoterapiji.
English: Other medicines and Fulphila
Slovenian: Druga zdravila in zdravilo Fulphila
English: Fulphila is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Slovenian: Zdravilo Fulphila se uporablja za skrajšanje trajanja nevtropenije (zmanjšano število belih krvničk) in zmanjševanje pojavljanja febrilne nevtropenije (zmanjšano število belih krvničk z zvišano telesno temperaturo), ki ju lahko povzroča uporaba citotoksične kemoterapije (zdravila, ki uničujejo hitro rastoče celice).
English: Fulphila is a biosimilar medicinal product.
Slovenian: Zdravilo Fulphila je podobno biološko zdravilo.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Slovenian: Ti primeri so se na splošno pojavili pri bolnikih z napredovalimi malignimi boleznimi, sepso, uporabo več zdravil za kemoterapijo ali zdravljenih z aferezo (glejte poglavje 4.4).
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Slovenian: Poročajo, da je ta odmerna shema v odsotnosti podpore s strani rastnega faktorja povzročila nevtropenijo 4. stopnje, ki je povprečno trajala 5 do 7 dni, in 30-40 % incidenco febrilne nevtropenije.
English: - if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).
Slovenian: - če ste nedavno imeli hudo okužbo pljuč (pljučnico), tekočino v pljučih (pljučni edem), vnetje pljuč (intersticijsko pljučno bolezen) ali nenormalen izvid rentgenskega slikanja pljuč (pljučne infiltrate).
English: - redness at the site of injection.
Slovenian: - pordelost na mestu injiciranja.
English: - bleeding from the lung (pulmonary haemorrhage).
Slovenian: - krvavitev iz pljuč (pljučna hemoragija).
English: Profile of median pegfilgrastim serum concentration and Absolute Neutrophil Count (ANC) in chemotherapy treated patients after a single 6 mg injection
Slovenian: Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - Absolute Neutrophil Count) pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6-miligramski injekciji mediana serumske konc.
English:  Do not use the pre-filled syringe if it has been dropped on a hard surface.
Slovenian: X Ne uporabite napolnjene injekcijske brizge, če je ta pred tem padla na trdo površino.
English: If you become pregnant during Fulphila treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom Fulphila zanosite, o tem obvestite zdravnika.
English:  Do not leave the pre-filled syringe exposed to direct sunlight.
Slovenian: X Napolnjene injekcijske brizge ne puščajte izpostavljene neposredni sončni svetlobi.
English: - if you have any of the following or combination of the following side effects:
Slovenian: - se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov:
English: Driving and using machines Fulphila has no or negligible effect on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Fulphila nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Uncommon side effects (may affect up to 1 in 100 people) - allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - reakcije alergijske vrste, vključno s pordelostjo in zardevanjem, izpuščajem na koži in dvignjenimi predeli kože, ki srbijo.
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Slovenian: Tega zdravila ne smete uporabljati za zvečevanje odmerka citotoksične kemoterapije preko uveljavljenih shem odmerjanja.
English: Rare side effects (may affect up to 1 in 1,000 people) - inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov) - vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
English: - Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
Slovenian: - Sweetov sindrom (izbočene, boleče spremembe slivove barve na okončinah in včasih tudi na obrazu in vratu s povišano telesno temperaturo), vendar tu lahko vplivajo tudi drugi dejavniki.
English: Only use each syringe for one injection.
Slovenian: Ne pozabite Vsako napolnjeno injekcijsko brizgo uporabite le za eno injiciranje.
English: You may take Fulphila out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
Slovenian: Zdravilo Fulphila smete vzeti iz hladilnika in ga hraniti pri sobni temperaturi (pod 30 °C) največ 3 dni dolgo.
English: Fulphila may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Slovenian: Zdravilo Fulphila sme biti izpostavljeno sobni temperaturi (do 30 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
English: INFORMATION IN BRAILLE Fulphila
Slovenian: PODATKI V BRAILLOVI PISAVI fulphila
English: These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
Slovenian: To so lahko simptomi motnje, imenovane “sindrom kapilarne prepustnosti”, ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu.
English: The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Slovenian: Priporočeni odmerek je ena 6-miligramska subkutana injekcija (podkožna injekcija) z napolnjeno injekcijsko brizgo, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
English: Do not use any Fulphila that is left in the syringe.
Slovenian: Ne uporabljajte preostanka zdravila Fulphila, ki ostane v brizgi.
English: Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Slovenian: A. Vzemite podlogo z napolnjeno injekcijsko brizgo iz pakiranja in pripravite opremo, potrebno za injiciranje: alkoholne zložence, kosem vate ali zloženec gaze, obliž in vsebnik za ostre odpadke (ni priloženo).
English: Very common side effects (may affect more than 1 in 10 people) - bone pain.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - bolečine v kosteh.
English: - spleen rupture.
Slovenian: - ruptura vranice.
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m² every 3 weeks for 4 cycles).
Slovenian: V dvojno slepi, s placebom kontrolirani študiji pri bolnicah z rakom na dojki so ocenili učinek pegfilgrastima na incidenco febrilne nevtropenije po uporabi takšne sheme kemoterapije, ki je povezana z 10-20 % deležem febrilne nevtropenije (docetaksel 100 mg/m² vsake 3 tedne za 4 cikluse).
English: The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of -16.8 %,-1.1 %).
Slovenian: Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9 %, pri bolnikih, zdravljenih s filgrastimom, pa 18 % (razlika 9 %, 95 % IZ je -16,8 %, -1,1 %).
English: It is important to push down through the “snap” to deliver your full dose.
Slovenian: Pomembno je, da potisnete vse do “tleska”, saj le tako injicirate celotni odmerek.
English: It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Slovenian: Pomembno je, da si injekcije ne poskušate dati sami, če vas tega ne nauči zdravnik, medicinska sestra ali farmacevt.
English:  Do not recycle pre-filled syringes or throw them into household waste.
Slovenian: X Napolnjenih injekcijskih brizg ne smete reciklirati ali jih zavreči med gospodinjske odpadke.
English: Fulphila is injected subcutaneously.
Slovenian: Zdravilo Fulphila se injicira subkutano.
English: India
Slovenian: Indija
English: These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Slovenian: To so lahko simptomi občasne motnje (pojavi se lahko pri do 1 od 100 oseb), imenovane “sindrom kapilarne prepustnosti”, ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu, ki zahteva nujno zdravniško pomoč.
English: - if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, these could be signs of a severe allergic reaction.
Slovenian: - če se vam pojavijo nenadni znaki alergije, kot so izpuščaj, srbečica ali koprivnica na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Slovenian: Reverzibilno, blago do zmerno zvišanje sečne kisline in alkalne fosfataze brez pridruženih kliničnih učinkov se je pojavilo občasno; reverzibilno, blago do zmerno zvišanje laktatne dehidrogenaze brez pridruženih kliničnih učinkov se je pojavilo občasno pri bolnikih, ki so dobivali pegfilgrastim po citotoksični kemoterapiji.
English: Important: read the package leaflet before handling the pre-filled syringe.
Slovenian: Pomembno: Pred rokovanjem z napolnjeno injekcijsko brizgo preberite priloženo navodilo.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Slovenian: * Pegfilgrastim izdelujejo s tehnologijo rekombinantne DNA v celicah Escherichia coli, kateri sledi konjugacija s polietilenglikolom (PEG).
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculo-skeletal pain, neck pain)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v kosteh mišično-skeletna bolečina (mialgija, artralgija, bolečina v okončini, bolečina v hrbtu, mišično-skeletna bolečina, bolečina v vratu)
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni “brez natrija”.
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Slovenian: Pri potomcih brejih podgan, ki so jim subkutano dali pegfilgrastim, niso opazili neželenih učinkov, pri kuncih pa so pokazali, da pegfilgrastim v kumulativnih odmerkih, ki so približno 4-krat večji od priporočenega odmerka za človeka, povzroča toksičnost za zarodek/plod (izgubo zarodka), česar pa niso videli, ko so breje kunčje samice izpostavili priporočenemu odmerku za človeka.