FrancophonIA/ELRC3.0 huggingface dataset:
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 štakora kojima je supkutano primijenjen pegfilgrastim nisu primijećene nuspojave, ali se pokazalo da je pegfilgrastim u zečeva 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 pookazalo kod primjene doza koje odgovaraju preporučenoj dozi za ljude.
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Croatian: Sindrom povećane propusnosti kapilara prijavljen je nakon primjene faktora stimulacije rasta granulocita, a karakteriziraju ga hipotenzija, hipoalbuminemija, edemi i hemokoncentracija.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN (ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Croatian: Farmakokinetika pegfilgrastima ispitivana je u 37 pedijatrijskih bolesnika sa sarkomom koji su primali 100 μg/kg pegfilgrastima nakon završetka kemoterapije po protokolu VAdriaC/IE.
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1).
Croatian: Ograničeni klinički podaci upućuju na usporediv učinak pegfilgrastima i filgrastima na vrijeme potrebno za oporavak od teške neutropenije u bolesnika s de novo akutnom mijeloičnom leukemijom (vidjeti dio 5.1).
English: The safety and efficacy of Ristempa 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.
Croatian: Sigurnost i djelotvornost Ristempe nije ispitivana u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnom akutnom mijeloičnom leukemijom (AML), stoga se lijek ne smije primjenjivati u tih bolesnika.
English: EU/1/15/996/001 1 pack blistered syringe EU/1/15/996/002 1 pack unblistered syringe EU/1/15/996/003 1 pack blistered syringe with needle guard
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/996/001 pakiranje od 1 štrcaljke u blisteru EU/1/15/996/002 pakiranje od 1 štrcaljke bez blistera EU/1/15/996/003 pakiranje od 1 štrcaljke u blisteru sa štitnikom za iglu
English: Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (Day 2) after chemotherapy in each cycle.
Croatian: Randomizirano je 928 bolesnica tako da primaju ili pojedinačnu dozu pegfilgrastima ili placebo približno 24 sata (2. dan) nakon svakog kemoterapijskog ciklusa.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with Ristempa (uncommon [≥ 1/1,000 to < 1/100]).
Croatian: Reakcije preosjetljivosti, uključujući osip na koži, urtikariju, angioedem, dispneju, eritem, navale crvenila i hipotenziju, javljale su se tijekom prvog ili sljedećeg liječenja s Ristempom (manje često [≥ 1/1000 do < 1/100]).
English: Ristempa contains sorbitol.
Croatian: Ristempa sadrži sorbitol.
English: Ristempa contains sorbitol (E420) and sodium acetate
Croatian: Ristempa sadrži sorbitol (E420) i natrijev acetat
English: Pack size of one pre-filled syringe, in either a blistered or non-blistered packaging.
Croatian: Veličina pakiranja od jedne napunjene štrcaljke koja može biti ili u blisteru ili u pakiranju bez blistera.
English: This may be a sign of a problem with your spleen (splenomegaly)
Croatian: To može biti znak problema sa slezenom (povećanje slezene);
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: 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: Injection site reactions, including injection site erythaema (uncommon (≥ 1/1000 to < 1/100)) as well as injection site pain (common events ≥ 1/100 to < 1/10) have occurred on initial or subsequent treatment with Ristempa.
Croatian: Reakcije na mjestu injiciranja, uključujući eritem na mjestu injiciranja (manje često (≥ 1/1000 do < 1/100)) kao i bol na mjestu injiciranja (često ≥ 1/100 do < 1/10) javljale su se prilikom prvog ili sljedećeg liječenja Ristempom.
English: This section contains information on how to give yourself an injection of Ristempa.
Croatian: Ovo poglavlje sadrži upute o samoprimjeni injekcije Ristempe.
English: The youngest age group (0-5 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: 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), 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: Reference Guide - Read all instructions found in the carton before use
Croatian: Vodič za primjenu lijeka - Prije uporabe pročitajte cijele upute u kutiji.
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%).
Croatian: Ukupna stopa febrilne neutropenije u bolesnika liječenih pegfilgrastimom iznosila je 9%, a 18% u bolesnika liječenih filgrastimom (razlika 9%, 95% CI od -16,8%, -1,1%).
English: Common (≥ 1/100 to < 1/10)
Croatian: Manje često (≥ 1/1000 do < 1/100)
English: Permanently discontinue Ristempa in patients with clinically significant hypersensitivity.
Croatian: Liječenje Ristempom se mora trajno prekinuti u bolesnika koji razviju klinički značajnu preosjetljivost.
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 10
Croatian: U fazi II (n = 37) multicentričnog, randomiziranog, otvorenog ispitivanja pedijatrijskih bolesnika sa sarkomom koji su primali 100 μg/kg pegfilgrastima nakon 1. ciklusa kemoterapije vinkristinom, doksorubicinom i ciklofosfamidom (VAdriaC/IE) uočeno je dulje trajanje teške neutropenije (neutrofili < 0,5 x 10
English: Uncommon (≥ 1/1,000 to
Croatian: Često (≥ 1/100 do
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Ristempa should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Croatian: Zbog moguće osjetljivosti brzo dijelećih mijeolidnih stanica na citotoksičnu kemoterapiju, Ristempu treba primijeniti najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: • alcohol wipes or similar.
Croatian: • napunjenu štrcaljku Ristempe i • vatu natopljenu alkoholom ili slično.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section
Croatian: Manje često su ovi slučajevi rezultirali respiratornim zatajenjem ili akutnim respiratornim distres sindromom (ARDS), koji mogu imati smrtni ishod (vidjeti dio 4.4).
English: Ristempa 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: Ristempa 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: • 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
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: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: The safety and efficacy of Ristempa have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Croatian: Sigurnost i djelotvornost Ristempe nisu ispitivani u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
English: Treatment with Ristempa alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Croatian: Liječenje Ristempom u monoterapiji ne isključuje razvoj trombocitopenije niti anemije uslijed liječenja punom dozom mijelosupresivne kemoterapije prema propisanom rasporedu.
English: Uncommon (≥1/1,000 to < 1/100) pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Croatian: Prijavljene su manje česte (≥ 1/1000 i < 1/100) plućne nuspojave, posebice intersticijska upala pluća, nakon primjene faktora stimulacije rasta granulocita (G-CSF).
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, 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: Marketing Authorisation Holder and Manufacturer: Amgen Europe B.V.
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač: Amgen Europe B.V.
English: You may take Ristempa out of the refrigerator and keep it at room temperature (not above 30C) for no longer than 3 days.
Croatian: Ristempu možete izvaditi iz hladnjaka i čuvati je na sobnoj temperaturi (ne višoj od 30 C), ali ne dulje od 3 dana.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30C) it must either be used within 3 days or disposed of.
Croatian: Kada štrcaljku jednom izvadite iz hladnjaka te ona dosegne sobnu temperaturu (ne višu od 30 C), mora se upotrijebiti u roku od 3 dana ili zbrinuti.
English: BLISTER PACK WITH SYRINGE
Croatian: BLISTER PAKIRANJE SA ŠTRCALJKOM
English: Carefully pull grey needle cap straight out and away from your body.
Croatian: Pažljivo ravno povucite sivu kapicu s igle i dalje od Vašeg tijela.
English: See section 4.
Croatian: Pogledajte dio 4;
English: • 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 smanjeni broj krvnih pločica koji može uzrokovati poremećaje u zgrušavanju (trombocitopenija).
English: Healthcare professionals only The trade name of the administered product should be clearly recorded in the patient file.
Croatian: Samo za zdravstvene djelatnike Zaštićeno ime primijenjenog lijeka mora se jasno navesti u bolesnikovoj medicinskoj dokumentaciji.
English: The syringes are provided with an automatic needle guard.
Croatian: Štrcaljke se isporučuju s automatskim sigurnosnim sustavom za
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: Women who become pregnant during Ristempa treatment are encouraged to enrol in Amgen's Pregnancy Surveillance Programme.
Croatian: Žene koje zatrudne za vrijeme liječenja lijekom Ristempa potiču se da se upišu u Amgenov Program praćenja trudnoće.
English: The safety and efficacy of Ristempa have not been investigated in patients receiving high dose chemotherapy.
Croatian: Nisu provedena ispitivanja sigurnosti i djelotvornosti Ristempe u bolesnika koji primaju visokodoznu kemoterapiju.
English: • The expiry date printed on the label has passed the last day of the month shown.
Croatian: • Ukoliko je rok valjanosti otisnut na naljepnici istekao, odnosno ako je prošao posljednji
English: • experience a cough, fever and difficulty breathing.
Croatian: • ako počnete kašljati, imate vrućicu ili otežano disanje.
English: There is insufficient information on the excretion of Ristempa / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Croatian: Nema dovoljno podataka o izlučivanju Ristempe/metabolita u majčino mlijeko u ljudi.
English: A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Croatian: Odložite iskorištenu napunjenu štrcaljku i ostali pribor u spremnik za odlaganje oštrih
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: Instructions for injecting with the Ristempa pre-filled syringe
Croatian: Upute za injiciranje Ristempe napunjenom štrcaljkom
English: Do not administer Ristempa to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Croatian: Ristempa se ne smije primjenjivati kod bolesnika s preosjetljivosti na pegfilgrastim ili filgrastim u anamnezi.
English: In a second study (n = 310), which used a weightadjusted dose (100 μg /kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
Croatian: U drugom ispitivanju (n=310), u kojemu je primjenjivana doza prilagođena tjelesnoj težini (100 μg/kg), srednje trajanje neutropenije 4. stupnja u skupini liječenoj pegfilgrastimom iznosilo je 1,7 dana, u usporedbi s 1,8 dana u skupini liječenoj filgrastimom (razlika 0,03 dana, 95% CI -0,36, 0,30).
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 yrs (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 od 0-5 godina (75%) u usporedbi sa starijom djecom u dobi od 6-11 i 12-21 godine (70% odnosno 33%) odnosno odraslima (vidjeti dio 4.8 i 5.2).
English: The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section
Croatian: Pokrov igle napunjene štrcaljke sadrži suhu prirodnu gumu (derivat lateksa) (vidjeti dio 4.4).
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,
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: One 6 mg dose (a single pre-filled syringe) of Ristempa is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Croatian: Jednokratna doza Ristempe od 6 mg (jedna napunjena štrcaljka) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: Solution for injection in a single use pre-filled syringe with automatic needle guard (0.6 ml).
Croatian: Otopina za injekciju u napunjenoj štrcaljki za jednokratnu upotrebu s automatskim štitnikom za iglu (0,6 ml).
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving Ristempa (uncommon) (see section 4.4).
Croatian: U bolesnika koji primaju Ristempu mogu se javiti ozbiljne alergijske reakcije, uključujući anafilaksiju (manje često) (vidjeti dio 4.4).
English: Marketing Authorisation Holder: Amgen Europe B.V.
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka: Amgen Europe B.V.
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Croatian: Akutni respiratorni distres sindrom Plućne nuspojave (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza)
English: In one study (n = 157), which used a 6mg 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 (difference 0.23 days, 95% CI -0.15, 0.63).
Croatian: U jednom ispitivanju (n = 157), u kojemu je primjenjivana fiksna doza pegfilgrastima od 6 mg, srednje vrijeme trajanja neutropenije 4. stupnja u skupini koja je primala pegfilgrastim iznosilo 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: Do not attempt to remove the peelable label on the pre-filled syringe barrel before
Croatian: Ne pokušavajte odlijepiti odvojivu naljepnicu sa spremnika napunjene štrcaljke prije primjene
English: Concomitant use of Ristempa with any chemotherapy agent has not been evaluated in patients.
Croatian: Istodobna primjena Ristempe i kemoterapije nije procijenjena u bolesnika.
English: Median Serum Pegfilgrastim Conc.
Croatian: Median Serum Pegfilgrastim Conc. (ng/ml)
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with Ristempa.
Croatian: Kod bolesnika liječenih Ristempom prijavljena je preosjetljivost, uključujući anafilaktičke reakcije, koja se može javiti kod prvog ili sljedećeg liječenja.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free'
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija na 6 mg doze, tj. sadrži zanemarive količine natrija.
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 Ristempa 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 Ristempu nakon citotoksične kemoterapije.
English: Uncommon but generally asymptomatic cases of splenomegaly and uncommon 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 manje česti, ali obično asimptomatski slučajevi splenomegalije i manje česti slučajevi rupture slezene, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: Ristempa 6 mg Pegfilgrastim SC
Croatian: Ristempa 6 mg pegfilgrastim s.c.
English: The needle cap on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions
Croatian: Kapica igle na napunjenoj štrcaljki sadrži derivat lateksa i može prouzročiti teške alergijske reakcije.
English: Solution for injection in a single use pre-filled syringe (0.6 ml).
Croatian: Otopina za injekciju u napunjenoj štrcaljki za jednokratnu upotrebu (0,6 ml).
English: • 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: 9/l) have been reported (see section 4.4).
Croatian: 9/l) (vidjeti dio
English: Contact details are provided in section 6 of the Package leaflet.
Croatian: Podaci o kontaktu dostupni su u dijelu 6 Upute o lijeku.
English: For subcutaneous use.
Croatian: Za potkožnu primjenu.
English: Your platelet count may become low which might result in bruising.
Croatian: Broj trombocita može pasti što može dovesti do
English: Grab the pre-filled syringe safety guard to remove the
Croatian: Uhvatite napunjenu štcaljku za sigurnosni štitnik kako biste je izvadili iz podloge.
English: If you use more Ristempa than you should contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više Ristempe nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: How do I prepare my Ristempa injection?
Croatian: Kako se priprema injekcija Ristempe?
English: Gastrointestinal disorders Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva