FrancophonIA/ELRC3.0 huggingface dataset:
English: Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Croatian: Sindrom povećane propusnosti kapilara, koji može biti opasan po život ukoliko se ne počne liječiti na vrijeme, prijavljen je manje često (≥ 1/1000 do < 1/100) u bolesnika s rakom liječenih kemoterapijom nakon koje su primali faktore stimulacije rasta granulocita; vidjeti dio 4.4 i dio „Opis odabranih nuspojava“ u nastavku.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body (see section 4).
Croatian: Ovo mogu biti znakovi stanja koje se zove „sindrom povećane propusnosti kapilara" koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela (pogledajte dio 4.).
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Croatian: Mišićno-koštana bol (mijalgija, artralgija, bol u udovima, bol u leđima, mišićno-koštana bol, bol u vratu)
English: Grasustek contains sorbitol (E420) and sodium
Croatian: Grasustek sadrži sorbitol (E420) i natrij
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Croatian: Sigurnost i djelotvornost pegfilgrastima u mobilizaciji krvotvornih matičnih stanica u bolesnika ili zdravih darivatelja nisu odgovarajuće ispitane.
English: 2 This adverse reaction was identified through post-marketing surveillance of pegfilgrastim but not observed in randomised, controlled clinical trials in adults.
Croatian: Ove su nuspojave uočene tijekom praćenja pegfilgrastima nakon stavljanja lijeka u promet, ali ne i u randomiziranim, kontroliranim kliničkim ispitivanjima u odraslih bolesnika.
English: Grasustek left at room temperature for more than 72 hours should be discarded.
Croatian: Ako je Grasustek ostavljen na sobnoj temperaturi dulje od 72 sata, mora se baciti.
English: Iceland
Croatian: Ísland
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene od ozbiljnijih prema manje ozbiljnima.
English: This medicinal product contains 30 mg sorbitol in each 6 mg dose which is equivalent to 50 mg/ml.
Croatian: Ovaj lijek sadrži 30 mg sorbitola u jednoj dozi od 6 mg, što odgovara 50 mg/ml.
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)
Croatian: • ako ste nedavno imali ozbiljniju infekciju pluća (upalu pluća), tekućinu u plućima (edem pluća), upalne procese u području pluća (intersticijska bolest pluća) ili neuobičajeni rentgenski nalaz pluća (plućna infiltracija),
English: This may be a sign of a problem with your spleen (splenomegaly)
Croatian: To može biti znak problema sa slezenom (povećanje slezene).
English: How to use Grasustek
Croatian: Kako primjenjivati Grasustek
English: Examine the injection site.
Croatian: Pregledajte mjesto primjene injekcije
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Izbjegavajte snažno protresanje.
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.
Croatian: Ovo mogu biti simptomi manje čestog (može se javiti u do 1 na 100 osoba) stanja koje se naziva „sindrom povećane propusnosti kapilara“ koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela i zahtijeva hitnu liječničku pomoć.
English: Concomitant use of pegfilgrastim with any chemotherapy medicinal product has not been evaluated in patients.
Croatian: Istodobna primjena pegfilgrastima sa bilo kojim kemoterapeutikom nije procijenjena u bolesnika.
English: Urinalysis monitoring is recommended.
Croatian: Preporučuje se praćenje nalaza analize urina.
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.
Croatian: U potomstvu skotnih ženki štakora kojima je supkutano primijenjen pegfilgrastim nisu primijećene nuspojave, ali se pokazalo da je pegfilgrastim u kunića uzrokovao embrionalnu/fetalnu toksičnost (gubitak embrija) pri kumulativnim dozama koje su bile oko 4 puta veće od preporučene doze za ljude, no isto se nije pokazalo kod primjene doza koje odgovaraju preporučenoj dozi za ljude.
English: − The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections (see section 2).
Croatian: - Drugi sastojci su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije (pogledajte dio 2).
English: Turn the plunger to move the label into a position where you can remove the syringe label.
Croatian: Okrenite klip kako bi naljepnica na štrcaljki došla u takav položaj da je možete odlijepiti.
English: The safety and efficacy of Grasustek have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Croatian: Sigurnost i djelotvornost Grasusteka nisu procijenjene u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
English: Pegfilgrastim should be permanently discontinued in patients with clinically significant hypersensitivity.
Croatian: Liječenje pegfilgrastimom se mora trajno prekinuti u bolesnika koji razviju klinički značajnu preosjetljivost.
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Croatian: Sindrom povećane propusnosti kapilara prijavljen je nakon primjene faktora stimulacije rasta granulocita rasta granulocita, a karakteriziraju ga hipotenzija, hipoalbuminemija, edemi i hemokoncentracija.
English: The usual 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.
Croatian: Uobičajena doza je jedna napunjena štrcaljka od 6 mg primijenjena supkutano (injekcijom pod kožu), koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
English: Excipients: Sorbitol (E420), polysorbate 20, sodium acetate, water for injections.
Croatian: Pomoćne tvari: sorbitol (E420), polisorbat 20, natrijev acetat, voda za injekcije.
English: Warning/Precaution: Check there is no loose fragment or fluid inside the pack.
Croatian: Upozorenje/mjera opreza: Provjerite da u pakiranju nema slabo pričvršćenih dijelova ili tekućine.
English: Each pack contains 1 glass pre-filled syringe with an attached stainless steel needle and needle cap.
Croatian: U svakom pakiranju nalazi se 1 napunjena staklena štrcaljka s pričvršćenom iglom od nehrđajućeg čelika i poklopcem igle.
English: Keep the syringe and sharps disposal container out of sight and reach of children.
Croatian: Štrcaljke i spremnik za odlaganje oštrih predmeta čuvajte izvan pogleda i dohvata djece.
English: Warning/Precaution: DO NOT twist the needle cover or touch the needle or plunger.
Croatian: Upozorenje/mjera opreza: NEMOJTE odvijati poklopac igle ili dirati iglu ili klip.
English: Date of first authorisation: Date of latest renewal:
Croatian: Datum posljednje obnove odobrenja:
English: Dispose of the used medicine immediately in a Sharps container or as instructed by your healthcare provider.
Croatian: Odmah nakon primjene iskorišteni lijek bacite u spremnik za odlaganje oštrih predmeta ili kako Vas je uputio zdravstveni radnik.
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Croatian: Profil medijana vrijednosti koncentracije pegfilgrastima u serumu i apsolutnog broja neutrofila (ABN) u bolesnika koji se liječe kemoterapijom nakon jedne injekcije od 6 mg
English: • If you have sickle cell anaemia.
Croatian: • ako bolujete od anemije srpastih stanica.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 1 pre-filled syringe with automatic needle guard (0.6 ml).
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s automatskim štitnikom za iglu (0,6 ml).
English: EU/1/19/1375/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1375/001
English: General The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy.
Croatian: Sigurnost i djelotvornost primjene pegfilgrastima nisu ispitivane u bolesnika koji primaju visokodoznu kemoterapiju.
English: The incidence of hospitalisations and Intra Venous anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).
Croatian: Incidencija bolničkog liječenja i intravenske primjene antiinfektivnih lijekova, povezanog s kliničkom dijagnozom febrilne neutropenije, bila je niža u skupini liječenoj pegfilgrastimom nego u skupini koja je primala placebo (1% prema 14%, p < 0,001 te 2% prema 10%, p < 0,001).
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Croatian: Ako ima krvi pritisnite mjesto primjene injekcije jastučićem od vate ili gaze.
English: What you need to know before you use Grasustek
Croatian: Što morate znati prije nego počnete primjenjivati Grasustek Nemojte primjenjivati Grasustek
English: Paediatric population The safety and efficacy of pegfilgrastim in children has not yet been established.
Croatian: Sigurnost i djelotvornost primjene pegfilgrastima u djece nisu još ustanovljene.
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).
Croatian: • ako imate saznanje o poremećenom broju krvnih stanica (npr. povećanje broja bijelih krvnih stanica ili anemiju) ili smanjenom broj krvnih pločica koji može uzrokovati poremećaje u zgrušavanju (trombocitopenija).
English: Caution: Avoid contact with the plunger and needle during the preparation of the syringe, The safety device is normally activated by pressure from the plunger on the syringe.
Croatian: Oprez: Tijekom pripreme štrcaljke izbjegavajte dirati klip i iglu jer se zaštita za iglu aktivira pritiskom klipa na štrcaljku.
English: Remove the pre-filled syringe from blister as shown.
Croatian: Izvadite napunjenu štrcaljku iz blistera na način kako je prikazano.
English: Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Croatian: Nemojte skidati sivi poklopac igle s napunjene štrcaljke dok niste spremni za injekciju.
English: Do not reuse the pre-filled syringe.
Croatian: Nemojte ponovo koristiti iskorištenu štrcaljku.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Croatian: Faktor stimulacije rasta granulocita može potaknuti rast mijeloičnih stanica in vitro, a slični se učinci mogu vidjeti i kod nekih nemijeloičnih stanica in vitro.
English: Pegfilgrastim should not be administered to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Croatian: Pegfilgrastim se ne smije primjenjivati u bolesnika s preosjetljivosti na pegfilgrastim ili filgrastim u anamnezi.
English: Rare to
Croatian: Rijetko do
English: Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 %, 95 % CI of-19 %, 5 %).
Croatian: Tijekom cijelog ispitivanja stopa febrilne neutropenije u bolesnika liječenih pegfilgrastimom iznosila je 13%, a 20% u bolesnika liječenih filgrastimom (razlika 7%, 95% CI od -19%, 5%).
English: With the exception of the youngest age group (0 5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and
Croatian: Uz iznimku najmlađe dobne skupine (0-5 godina), srednji AUC pedijatrijskih bolesnika bio je sličan onom odraslih bolesnika s visokorizičnim rakom dojke stadij II-IV, koji su primali 100 μg/kg pegfilgrastima nakon završetka terapije doksorubicinom/docetakselom (vidjeti dio 4.8 i 5.1).
English: • bleeding from the lung (pulmonary haemorrhage)
Croatian: • krvarenje iz pluća (plućna hemoragija).
English: Special populations Renal impairment No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Croatian: Ne preporučuje se promjena doze u bolesnika s oštećenjem funkcije bubrega, uključujući i one s terminalnim stadijem bolesti bubrega.
English: Special precautions for storage
Croatian: POSEBNE MJERE ČUVANJA
English: Alvogen Romania SRL 44B, Theodor Pallady Blvd. 3rd district, 032266
Croatian: Alvogen Romania SRL 44B, Theodor Pallady Blvd.
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Croatian: Zbog moguće osjetljivosti brzo dijelećih mijeloidnih stanica na citotoksičnu kemoterapiju, pegfilgrastim treba primijeniti najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
Croatian: Nemojte pokušavati skinuti prozirni sigurnosni štitnik s napunjene štrcaljke.
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17 %, p < 0.001).
Croatian: Incidencija febrilne neutropenije bila je niža u bolesnica randomiziranih u grupu koja je dobivala pegfilgrastima u usporedbi s bolesnicama koje su dobivale placebo (1% prema 17%, p < 0,001).
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).
Croatian: U placebom kontroliranom, dvostruko slijepom ispitivanju provedenom u bolesnica s karcinomom dojke, ispitivan je učinak pegfilgrastima na incidenciju pojave febrilne neutropenije nakon primjene kemoterapijskog režima povezanog s razvojem febrilne neutropenije sa stopom od 10 20% (docetaksel 100 mg/m2 svaka 3 tjedna tijekom 4 ciklusa).
English: 01-607 Warsaw, Poland Tel: + 48 22 460 92 00
Croatian: Ul Kniaźnina 4a lok 7 01-607 Warsaw, Poland Tel: + 48 22 460 92 00
English: Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common events) have occurred on initial or subsequent treatment with pegfilgrastim.
Croatian: Reakcije na mjestu injiciranja, uključujući eritem na mjestu injiciranja (manje često), kao i bol na mjestu injiciranja (često), javljale su se prilikom prvog ili sljedećeg liječenja pegfilgrastimom.
English: Talk to your doctor, pharmacist or nurse before using Grasustek:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene lijeka Grasustek:
English: Push the plunger all the way down as far as it will go to inject all of the solution.
Croatian: Gurajte klip sve do kraja kako biste injicirali cjelokupnu količinu otopine.
English: Driving and using machines Grasustek has no or negligible effect on the ability to drive or use machines.
Croatian: Grasustek ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Grasustek contains the active substance pegfilgrastim.
Croatian: Grasustek sadrži djelatnu tvar pegfilgrastim.
English: Pack size of one pre-filled syringe with automatic needle guard (0.6 ml) and supplied in a dispensing pack containing one syringe.
Croatian: Veličina pakiranja: jedna napunjena štrcaljka s automatskim štitnikom za iglu (0,6 ml) koja se isporučuje u pakiranju od jedne štrcaljke.
English: • if you have any of the following or combination of the following side effects: ­ swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Croatian: • ako imate znakove jedne od sljedećih ili kombinacije sljedećih nuspojava: ­ oticanje ili podbuhlost, što može biti povezano s rjeđom učestalošću mokrenja, otežano disanje, oticanje trbuha i osjećaj punoće, te opći osjećaj umora.
English: Step 4: Finish
Croatian: 4. korak: Završite
English: Pre-filled syringe (Type I glass), with a (butyl) rubber stopper and a stainless steel needle with automatic needle guard.
Croatian: Napunjena štrcaljka (staklo tipa I) s čepom od (butilne) gume i iglom od nehrđajućeg čelika s automatskim štitnikom za iglu.
English: Grasustek 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).
Croatian: Grasustek se primjenjuje za smanjenje trajanja neutropenije (smanjenog broja bijelih krvnih stanica) i pojave febrilne neutropenije (smanjeni broj bijelih krvnih stanica praćen vrućicom), koji se mogu javiti uslijed primjene citotoksične kemoterapije (lijekova koji uništavaju brzorastuće stanice).
English: Elevations in lactate dehydrogenase and alkaline phosphatase Transient elevations in LFTs for ALT or AST1
Croatian: Pretrage povišena razina laktat dehidrogenaze i alkalne fosfataze prolazno povišenje vrijednosti testova jetrene funkcije za ALT ili AST
English: A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Croatian: Mogućnost rupture slezene treba uzeti u obzir u bolesnika koji se žale na bol u gornjem lijevom dijelu abdomena ili vrhu ramena.
English: Do not use the pre-filled syringe if:
Croatian: Nemojte primijeniti napunjenu štrcaljku:
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Croatian: U većini slučajeva aortitis je dijagnosticiran CT
English: • Inflammation of aorta (the large blood vessel which transports blood from the heart to the body),
Croatian: • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Croatian: Jednokratna doza od 6 mg (jedna napunjena štrcaljka) pegfilgrastima preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/ml and 29.3 ± 23.2 μg·hr/ml, respectively) (see section 5.1).
Croatian: Djeca u najmlađoj dobnoj skupini (0-5 godina) imala su veću srednju ekspoziciju pegfilgrastimu (AUC) (± standardno odstupanje) (47,9 ± 22,5 μg·hr/ml) u odnosu na stariju djecu u dobi od 6-11, odnosno 12-21 godine (22,0 ± 13,1 μg·hr/ml te 29,3 ± 23,2 μg·hr/ml) (vidjeti dio 5.1).
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Croatian: U dva randomizirana, dvostruko slijepa, pivotalna ispitivanja u bolesnica s rakom dojke visokog rizika, stadij II-IV, podvrgnutih mijelosupresivnoj kemoterapiji koja se sastojala od doksorubicina i docetaksela, primjena pegfilgrastima, u pojedinačnoj dozi jednom po ciklusu, smanjila je trajanje neutropenije i učestalost pojave febrilne neutropenije slično kao dnevna primjena filgrastima (medijan od 11 dnevnih primjena).
English: USV Private Limited D-115, TTC Industrial Area, Shirvane Navi Mumbai - 400706, Maharashtra, INDIA
Croatian: USV Private Limited D-115, TTC Industrial Area, Shirvane
English: Do not recycle pre-filled syringes or throw them into household waste.
Croatian: Nemojte odlagati iskorištene štrcaljke u otpad za reciklažu ili kućni otpad.
English: On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
Croatian: Novu napunjenu štrcaljku i drugi pribor položite na čistu, dobro osvijetljenu radnu površinu.
English: • 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
Croatian: • ako imate alergijsku reakciju koja uključuje slabost, pad krvnog pritiska, otežano disanje, oticanje lica (anafilaksa), crvenilo i navale crvenila, osip na koži ili područja kože koja svrbe.
English: • If you get left upper abdominal pain or pain at the tip of your shoulder.
Croatian: • ako osjetite bol u gornjem lijevom dijelu trbuha ili u vrhu ramena.
English: Additionally, a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2).
Croatian: Dodatno je uočena i veća incidencija febrilne neutropenije u mlađe djece u dobi od 0-5 godina (75 %) u usporedbi sa starijom djecom u dobi od 6-11 i 12-21 godine (70 % odnosno 33 %) te odraslima (vidjeti dio 4.8 i 5.2).
English: Do not attempt to activate the pre-filled syringe prior to injection.
Croatian: Nemojte pokušavati aktivirati napunjenu štrcaljku prije injiciranja.
English: RAFARM A.E.B.E
Croatian: RAFARM A.E.B.E Κορίνθου 12, Ν.
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Croatian: Nema dovoljno podataka o izlučivanju pegfilgrastima/metabolita u majčino mlijeko u ljudi.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥
Croatian: Reakcije preosjetljivosti, uključujući osip na koži, urtikariju, angioedem, dispneju, eritem, navale crvenila i hipotenziju, javljale su se tijekom prvog ili sljedećeg liječenja pegfilgrastimom (manje često [≥ 1/1000 do < 1/100]).
English: Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (uncommon in sickle cell patients) (see section 4.4).
Croatian: Izolirani slučajevi krize srpastih stanica prijavljeni su u bolesnika koji imaju nasljedno obilježje srpastih stanica ili bolest srpastih stanica (manje često u bolesnika s anemijom srpastih stanica) (vidjeti dio 4.4).