FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg/mL.
Croatian: Ovaj lijek sadrži 30 mg sorbitola u jednoj napunjenoj štrcaljki, što odgovara 50 mg/ml.
English: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Croatian: Skraćenje trajanja neutropenije i smanjenje incidencije febrilne neutropenije u odraslih bolesnika koji se liječe citotoksičnom kemoterapijom zbog maligne bolesti (izuzev kronične mijeloične leukemije i mijelodisplastičnih sindroma).
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 5.1).
Croatian: Uz iznimku najmlađe dobne skupine (0 - 5 godina), srednja vrijednost AUC-a pedijatrijskih bolesnika bila je slična onoj u odraslih bolesnika s visokorizičnim rakom dojke stadij II-IV, koji su primali 100 μg/kg pegfilgrastima nakon završetka terapije doksorubicinom/docetakselom (vidjeti dijelove 4.8 i 5.1).
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 to isto nije se pokazalo kod primjene doza koje odgovaraju preporučenoj dozi za ljude.
English: Do not remove the needle cap from the pre-filled syringe until you are ready to inject.
Croatian: Ne skidajte kapicu igle s napunjene štrcaljke sve dok niste spremni injicirati lijek.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Croatian: Manje su često ovi slučajevi rezultirali respiratornim zatajenjem ili sindromom akutnog respiratornog distresa (ARDS), koji mogu imati smrtni ishod (vidjeti dio 4.4).
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Croatian: Eliminacija pegfilgrastima nelinearna je s obzirom na dozu; povećanjem doze smanjuje se klirens pegfilgrastima u serumu.
English: Pegfilgrastim Mundipharma is for use in adults aged 18 and over.
Croatian: Kako primjenjivati Pegfilgrastim Mundipharma Pegfilgrastim Mundipharma se primjenjuje u odraslih osoba u dobi od 18 i više godina.
English: - The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections.
Croatian: - Drugi sastojci su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER PACK WITH SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER-PAKIRANJE SA ŠTRCALJKOM
English: Pegfilgrastim Mundipharma is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Pegfilgrastim Mundipharma tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Figure 1: 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: 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 istjecanje krvi iz malih krvnih žila unutar tijela i zahtijeva hitnu liječničku pomoć.
English: Pegfilgrastim Mundipharma is a biosimilar medicinal product.
Croatian: Pegfilgrastim Mundipharma je biosličan lijek.
English: The safety and efficacy of Pegfilgrastim Mundipharma for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Croatian: Sigurnost i djelotvornost lijeka Pegfilgrastim Mundipharma u mobilizaciji krvotvornih matičnih stanica u bolesnika ili zdravih davatelja nisu odgovarajuće ispitane.
English: Median Absolute Neutrophil Count (cells x 10
Croatian: Medijan apsolutnog broja neutrofila (stanica x 109/l)
English: In such circumstances Pegfilgrastim Mundipharma should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Croatian: U takvim slučajevima, prema procjeni liječnika primjenu lijeka Pegfilgrastim Mundipharma treba prekinuti i primijeniti odgovarajuće liječenje (vidjeti dio 4.8).
English: Pegfilgrastim Mundipharma is used in adult patients 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: Pegfilgrastim Mundipharma primjenjuje se u odraslih bolesnika za smanjenje trajanja neutropenije (smanjeni broj bijelih krvnih stanica) i pojave febrilne neutropenije (smanjeni broj bijelih krvnih stanica praćen vrućicom), koje se mogu pojaviti uslijed primjene citotoksične kemoterapije (lijekova koji uništavaju brzorastuće stanice).
English: Pack size of one pre-filled syringe in a blistered packaging.
Croatian: Veličina pakiranja: jedna napunjena štrcaljka u blister pakiranju.
English: The incidence of hospitalisations and IV 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, povezana 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 % naspram 10 %, p < 0,001).
English: Upper part of your thigh.
Croatian: Gornji dio bedra
English: Do not put the needle cap back on used pre-filled syringes
Croatian: Ne vraćajte kapicu za iglu na iskorištenu štrcaljku.
English: Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Croatian: Liječenje pegfilgrastimom u monoterapiji ne isključuje razvoj trombocitopenije i anemije uslijed liječenja punom dozom mijelosupresivne kemoterapije prema propisanom rasporedu.
English: Injection site reactions2
Croatian: reakcije na mjestu injiciranja2
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 skupinu koja je dobivala pegfilgrastim 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 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: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Pegfilgrastim Mundipharma should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Croatian: Zbog moguće osjetljivosti brzo dijelećih mijeloidnih stanica na citotoksičnu kemoterapiju, Pegfilgrastim Mundipharma treba primijeniti najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: Do not grasp the needle cap.
Croatian: Ne hvatajte za kapicu igle.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Croatian: Obično su se javili u bolesnika s uznapredovalom malignom bolesti, sepsom, bolesnika koji su uzimali više kemoterapijskih lijekova ili bolesnika na aferezi (vidjeti dio 4.4).
English: Other medicines and Pegfilgrastim Mundipharma
Croatian: Drugi lijekovi i Pegfilgrastim Mundipharma
English: Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common) 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 sljedećih liječenja pegfilgrastimom.
English: Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja akutni respiratorni distres sindrom2; plućne nuspojave (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza); hemoptiza plućna hemoragija
English: The safety and efficacy of Pegfilgrastim Mundipharma 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.
Croatian: Sigurnost i djelotvornost lijeka Pegfilgrastim Mundipharma nisu ispitivane u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnim AML-om, stoga se lijek ne smije primjenjivati u tih bolesnika.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Croatian: U malom (n = 83), randomiziranom, dvostruko slijepom ispitivanju faze II u bolesnika s de novo akutnom mijeloičnom leukemijom liječenih kemoterapijom uspoređivan je pegfilgrastim (pojedinačna doza od 6 mg) s filgrastimom primjenjivanima tijekom indukcijske kemoterapije.
English: 6.6 Special precautions for disposal and other handling Before administration, Pegfilgrastim Mundipharma solution should be inspected visually for particulate matter.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije primjene potrebno je provjeriti sadrži li otopina lijeka Pegfilgrastim Mundipharma vidljive čestice.
English: The trade name and the batch number of the administered product should be clearly recorded in the patient file.
Croatian: Samo za zdravstvene radnike Zaštićeni naziv i broj serije primijenjenog lijeka moraju se jasno navesti u zdravstvenom kartonu bolesnika.
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 primijećena i veća incidencija febrilne neutropenije u mlađe djece u dobi 0 - 5 godina (75 %) u usporedbi sa starijom djecom u dobi 6 - 11 i 12 - 21 godine (70 % odnosno 33 %) odnosno odraslima (vidjeti dijelove 4.8 i 5.2).
English: What Pegfilgrastim Mundipharma contains - The active substance is pegfilgrastim.
Croatian: Što Pegfilgrastim Mundipharma sadrži - Djelatna tvar je pegfilgrastim.
English: Excipients: sodium acetate, sorbitol (E 420), polysorbate 20, and water for injections.
Croatian: Pomoćne tvari: natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije.
English: If you use more Pegfilgrastim Mundipharma than you should If you use more Pegfilgrastim Mundipharma than you should contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više lijeka Pegfilgrastim Mundipharma nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Pulmonary hemorrhage
Croatian: Plućne nuspojave
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 incidenciju febrilne neutropenije slično kao dnevna primjena filgrastima (medijan od 11 dnevnih primjena).
English: Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not expected to be affected by renal or hepatic impairment.
Croatian: Zbog mehanizma klirensa posredovanog neutrofilima ne očekuje se da bi oštećena funkcija jetre ili bubrega utjecala na farmakokinetiku pegfilgrastima.
English: The safety and efficacy of Pegfilgrastim Mundipharma have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Croatian: Sigurnost i djelotvornost lijeka Pegfilgrastim Mundipharma nisu ispitivane u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
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 i < 1/100]).
English: Solution for injection 1 pre-filled syringe with automatic needle guard (0.6 mL).
Croatian: 1 napunjena štrcaljka s automatskim štitnikom za iglu (0,6 ml)
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) *Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid.
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat* sorbitol (E420) polisorbat 20 voda za injekcije kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) * Natrijev acetat pripremljen je miješanjem natrijevog acetata trihidrata i octene kiseline.
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults.
Croatian: Primijećena je veća učestalost ozbiljnih nuspojava u mlađe djece, u dobi 0 - 5 godina (92 %) u odnosu na stariju djecu, u dobi 6 - 11 godina (80 %) i 12 - 21 godina (67 %), odnosno odrasle.
English: Permanently discontinue Pegfilgrastim Mundipharma in patients with clinically significant hypersensitivity.
Croatian: Liječenje lijekom Pegfilgrastim Mundipharma mora se trajno prekinuti u bolesnika koji razviju klinički značajnu preosjetljivost.
English: One 6 mg dose (a single pre-filled syringe) of Pegfilgrastim Mundipharma is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Croatian: Jednokratna doza lijeka Pegfilgrastim Mundipharma od 6 mg (jedna napunjena štrcaljka) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Croatian: Manje često prijavljene su plućne nuspojave, uključujući intersticijsku upalu pluća, plućni edem, plućne infiltrate i plućnu fibrozu.
English: Solution for injection Clear, colourless solution for injection.
Croatian: Bistra, bezbojna otopina za injekciju.
English: This may be a sign of a problem with your spleen (splenomegaly) - 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) - 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: Pogledajte dio 4. - ako osjetite bol u gornjem lijevom dijelu trbuha ili u vrhu ramena; to može biti znak problema sa slezenom (povećanje slezene) - ako ste nedavno imali ozbiljniju infekciju pluća (upalu pluća), tekućinu u plućima (edem pluća), upalne procese u području pluća (intersticijska bolest pluća) ili neuobičajeni rendgenski nalaz pluća (plućna infiltracija) - ako znate da Vam je poremećen broj krvnih stanica (npr. povećanje broja bijelih krvnih stanica ili anemija) ili smanjen broj krvnih pločica što može uzrokovati poremećaje u zgrušavanju (trombocitopenija).
English: Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva bol u kostima mišićno-koštana bol (mijalgija, artralgija, bol u udovima, bol u leđima, mišićnokoštana bol, bol u vratu)
English: Your doctor may decide that it would be more convenient for you to inject Pegfilgrastim Mundipharma yourself.
Croatian: Samostalno davanje lijeka Pegfilgrastim Mundipharma Vaš liječnik može odlučiti da će Vam biti pogodnije ako si sami injicirate Pegfilgrastim Mundipharma.
English: Do not administer Pegfilgrastim Mundipharma to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Croatian: Pegfilgrastim Mundipharma ne smije se primjenjivati kod bolesnika s preosjetljivosti na pegfilgrastim ili filgrastim u anamnezi.
English: Concomitant use of Pegfilgrastim Mundipharma with any chemotherapy agent has not been evaluated in patients.
Croatian: Istodobna primjena lijeka Pegfilgrastim Mundipharma i kemoterapije nije procijenjena u bolesnika.
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.
English: Outer area of upper arm (only if someone else is giving you the injection).
Croatian: Injekciju možete primijeniti na sljedeća mjesta: gornji dio bedra trbuh, osim u području unutar 5 cm od pupka vanjsko područje nadlaktice (samo ako Vam netko drugi daje injekciju).
English: SN:
Croatian: SN NN
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.
Croatian: Reverzibilna, blaga do umjerena povišenja razina laktat dehidrogenaze, bez povezanih kliničkih učinaka, bila su manje česta u bolesnika koji su dobivali pegfilgrastim nakon citotoksične kemoterapije.
English: The safety and efficacy of Pegfilgrastim Mundipharma have not been investigated in patients receiving high dose chemotherapy.
Croatian: Nisu provedena ispitivanja sigurnosti i djelotvornosti lijeka Pegfilgrastim Mundipharma u bolesnika koji primaju visokodoznu kemoterapiju.
English: Always use Pegfilgrastim Mundipharma exactly as your doctor has told you.
Croatian: Uvijek primijenite Pegfilgrastim Mundipharma točno onako kako
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA ŠTRCALJKOM U BLISTERU
English: Remove and save the pre-filled syringe label
Croatian: Odlijepite i sačuvajte naljepnicu sa štrcaljke.
English: • The needle cap is missing or not securely attached.
Croatian: • Ako nema kapice na igli ili ona nije dobro pričvršćena.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Croatian: Nakon primjene pegfilgrastima prijavljeni su obično asimptomatski slučajevi splenomegalije i rupture slezene, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: Tel.: + (48 22) 866 87 12 biuro@mundipharma.pl
Croatian: Mundipharma Polska Sp. z o.o. Tel.: + (48 22) 866 87 12 biuro@mundipharma.pl
English: How to store Pegfilgrastim Mundipharma
Croatian: Kako čuvati Pegfilgrastim Mundipharma
English: Nervous system Disorders
Croatian: Poremećaji živčanog sustava glavobolja1
English: Guide to parts
Croatian: Upute za primjenu Priručnik o dijelovima
English: Keep pre-filled syringes out of the sight and reach of children.
Croatian: Čuvajte napunjenu štrcaljku izvan pogleda i dohvata djece.
English: (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 vrijednost izloženosti pegfilgrastimu (AUC) (± standardno odstupanje) (47,9 ± 22,5 μg·h/ml) u odnosu na stariju djecu u dobi 6 - 11 godina, odnosno 12 - 21 godine (22,0 ± 13,1 μg·h/ml te 29,3 ± 23,2 μg·h/ml) (vidjeti dio 5.1).
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
English: Used needle safety spring
Croatian: Sigurnosna opruga iskorištene igle
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group
Croatian: U jednom ispitivanju (n = 157), u kojemu je primjenjivana fiksna doza pegfilgrastima od 6 mg, srednja vrijednost trajanja neutropenije 4. stupnja u skupini koja je primala pegfilgrastim iznosila je 1,8 dana, a 1,6 dana u skupini koja je primala filgrastim (razlika od 0,23 dana, 95 % CI - 0,15, 0,63).
English: Elevations in lactate dehydrogenase and alkaline phosphatase1; Transient elevations in LFT's for ALT or AST1 1 See section “Description of selected adverse reactions” below.
Croatian: Pretrage povišena razina laktat dehidrogenaz e i alkalne fosfataze1; prolazno povišenje vrijednosti testova jetrene funkcije za ALT ili AST1
English: Finger grips Syringe label Syringe barrel
Croatian: Hvatište za prste Naljepnica na štrcaljki
English: Pegfilgrastim Mundipharma is injected subcutaneously.
Croatian: Pegfilgrastim Mundipharma injicira se supkutano.