FrancophonIA/ELRC3.0 huggingface dataset:
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Za ugodniju primjenu injekcije, ostavite napunjenu štrcaljku da stoji 30 minuta dok ne postigne sobnu temperaturu ili je držite u rukama nekoliko minuta.
English: • a pre-filled syringe of Pelgraz;
Croatian: • napunjenu štrcaljku lijeka Pelgraz;
English: For a more comfortable injection, let the pre-filled injector stand for 30 minutes to reach room temperature or hold the pre-filled injector gently in your hand for a few minutes.
Croatian: Za ugodniju primjenu injekcije, ostavite napunjeni injektor da stoji 30 minuta dok ne postigne sobnu temperaturu ili ga držite u rukama nekoliko minuta.
English: In view of the possible risk of microbial contamination, Pelgraz in pre-filled injector are for single use only.
Croatian: Zbog potencijalnog rizika od mikrobiološke kontaminacije, napunjeni injektor s lijekom Pelgraz namijenjen je isključivo jednokratnoj uporabi.
English: If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Croatian: Ako se tijekom primjene pegfilgrastima u bolesnika razvio Stevens Johnsonov sindrom, ni u jednom trenutku se ne smije ponovno započeti tog bolesnika liječiti pegfilgrastimom.
English: • Dispose of the used Pelgraz pre-filled injector: Place injector in an approved sharps container.
Croatian: • Zbrinjavanje iskorištenog injektora Pelgraz: stavite injektor u odobreni spremnik za odlaganje oštrih predmeta.
English: Pelgraz contains the active substance pegfilgrastim.
Croatian: Pelgraz sadrži djelatnu tvar pegfilgrastim.
English: If you forget to inject Pelgraz
Croatian: Ako ste zaboravili primijeniti lijek Pelgraz
English: Leukocytosis1
Croatian: Leukocitoza1
English: Do not recap.
Croatian: Nemojte ponovno stavljati poklopac.
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 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: Thrombocytopeni a1
Croatian: Trombocitopenij a1
English: In order to improve traceability of granulocyte-colony stimulating factors, the medicine name (Pelgraz) and batch number of the administered syringe should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost lijekova koji sadrže faktore stimulacije granulocitnih kolonija, naziv lijeka (Pelgraz) i broj serije primijenjene štrcaljke mora se jasno evidentirati u bolesnikovoj medicinskoj dokumentaciji.
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 mcg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Croatian: (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: Pelgraz is available in packs containing 1 pre-filled syringe, with prefixed needle safety guard in individual blister pack and one alcohol swab.
Croatian: Pelgraz je dostupan u pakiranjima koja sadrže 1 napunjenu štrcaljku, s fiksiranim sigurnosnim štitnikom za iglu u pojediničnim blister pakiranjima i jedan jastučić natopljen alkoholom.
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 (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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: If exposure has been greater than 24 hours or frozen more than once, then Pelgraz should NOT be used.
Croatian: U slučaju izlaganja lijeka temperaturama zamrzavanja u razdoblju dužem od 24 sata ili višekratnog zamrzavanja, Pelgraz se NE smije koristiti.
English: Pelgraz contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodiumfree'.
Croatian: Pelgraz sadrži manje od 1 mmol (23 mg) natrija po dozi od 6 mg, tj. zanemarive količine natrija.
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: In order to improve traceability of granulocyte-colony stimulating factors, the medicine name (Pelgraz) and batch number of the administered pre-filled injector should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost lijekova koji sadrže faktore stimulacije granulocitnih kolonija, naziv lijeka (Pelgraz) i broj serije primijenjenog napunjenog injektora mora se jasno evidentirati u bolesnikovoj medicinskoj dokumentaciji.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Pre-filled syringe (type I glass) with a permanently attached stainless steel injection needle, with a needle safety guard.
Croatian: Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka (staklo tipa I) s fiksno pričvršćenom iglom za injekciju od nehrđajućeg čelika, sa sigurnosnim štitnikom za iglu.
English: • bleeding from the lung (pulmonary haemorrhage)
Croatian: • krvarenje iz pluća (plućno krvarenje).
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici štrcaljke iza oznake „Rok valjanosti“/„EXP“.
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 6 mg, tj. zanemarive količine natrija.
English: What you need to know before you use Pelgraz Do not use Pelgraz
Croatian: Što morate znati prije nego počnete primjenjivati lijek Pelgraz
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 %),
English: The pre-filled syringe is externally equipped with the device for selfadministration (pre-filled injector).
Croatian: S vanjske strane napunjene štrcaljke nalazi se uređaj za samostalnu primjenu (napunjeni injektor).
English: If you use more Pelgraz than you should contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više Pelgraza nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Solution for injection 1 pre-filled syringe + 1 alcohol swab
Croatian: Otopina za injekciju 1 napunjena štrcaljka + 1 jastučić natopljen alkoholom
English: Pelgraz is a clear colourless solution for injection in a pre-filled injector with an injection needle.
Croatian: Pelgraz je bistra bezbojna otopina za injekciju u napunjenom injektoru s iglom za injekciju.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count).
Croatian: Simptomi koji su se javljali su vrućica, bol u trbuhu, malaksalost, bol u leđima i povišeni upalni markeri (npr. C-reaktivni protein i broj bijelih krvnih stanica).
English: • alcohol swab.
Croatian: • jastučić natopljen alkoholom.
English: Check the expiry date on the pre-filled syringe label (EXP).
Croatian: 3. Provjerite rok valjanosti na naljepnici napunjene štrcaljke (EXP).
English: Sickle cell crisis2; Splenomegaly2;
Croatian: Kriza srpastih stanica2,
English: Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled injector label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici napunjenog injektora iza oznake „Rok valjanosti“/„EXP“.
English: For all questions about storage, ask your doctor, nurse or pharmacist.
Croatian: Za sva pitanja o čuvanju lijeka obratite se liječniku, medicinskoj sestri ili ljekarniku.
English: Dispose of the syringe as instructed by your doctor, pharmacist or nurse.
Croatian: Štrcaljku zbrinite prema uputama liječnika, ljekarnika ili medicinske sestre.
English: Pelgraz is available in a pack containing 1 pre-filled injector in a monocarton and one alcohol swab.
Croatian: Pelgraz je dostupan kao jednostruko pakiranje koje sadrži 1 napunjeni injektor u jednoj kutiji i s jednim jastučićem natopljenim alkoholom.
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Croatian: (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza)
English: Pelgraz is a clear colourless solution for injection in a pre-filled syringe with an injection needle.
Croatian: Pelgraz je bistra bezbojna otopina za injekciju u napunjenoj štrcaljki s iglom za injekciju.
English: • have sickle cell anaemia.
Croatian: • bolujete od anemije srpastih stanica.
English: One 6 mg dose (a single pre-filled syringe or pre-filled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Croatian: Doziranje Jednokratna doza lijeka Pelgraz od 6 mg (jedna napunjena štrcaljka ili napunjeni injektor) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: • Clean injection site: use an alcohol swab to wipe site clean.
Croatian: • Očistite mjesto za primjenu injekcije: jastučićem ili maramicom natopljenom alkoholom prebrišite mjesto.
English: The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled injector 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 6 mg primijenjena jednom potkožnom injekcijom (injekcija pod kožu) pomoću napunjenog injektora, koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet
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 6 mg primijenjena jednom potkožnom injekcijom (injekcija pod kožu) pomoću napunjene štrcaljke, koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
English: • Gather an alcohol swab and a sharps container
Croatian: • Uzmite jastučić natopljen alkoholom i spremnik za odlaganje oštrih predmeta
English: How to use Pelgraz
Croatian: Kako primjenjivati lijek Pelgraz
English: Read the package leaflet for further information.
Croatian: Za dodatne informacije pročitajte uputu o lijeku.
English: Pack size of one pre-filled injector with one alcohol swab, in a blistered packaging.
Croatian: Veličina pakiranja: jedan napunjeni injektor s jastučićem natopljenim alkoholom, u blister pakiranju.
English: Pack size of one pre-filled syringe with one alcohol swab, in a blistered packaging.
Croatian: Veličina pakiranja: jedna napunjena štrcaljka s jastučićem natopljenim alkoholom, u blister pakiranju.
English: Elevations in lactate dehydrogenase and alkaline phosphatase1;
Croatian: Povišena razina laktat-dehidrogenaze i alkalne fosfataze1; Prolazno povišenje vrijednosti testova jetrene funkcije za ALT ili AST1
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (PRE-FILLED INJECTOR)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (NAPUNJENI INJEKTOR)
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
English: Pelgraz is for subcutaneous use.The injections should be given subcutaneously into the thigh, abdomen or upper arm.
Croatian: Injekcije je potrebno primijeniti supkutanim putem u bedro, abdomen ili nadlakticu.
English: • Remove bottom cap: Twist and pull bottom cap to remove.
Croatian: • Skinite poklopac na dnu injektora: odvrnite i povucite poklopac na dnu injektora kako biste ga skinuli.
English: Solution for injection 1 pre-filled injector + 1 alcohol swab
Croatian: 1 napunjeni injektor + 1 jastučić natopljen alkoholom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED INJECTOR)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (NAPUNJENI INJEKTOR)
English: Allow the pre-filled injector to reach room temperature before injecting.
Croatian: Prije injiciranja pričekajte da napunjeni injektor dosegne sobnu temperaturu.
English: Musculoskelet al and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva
English: • 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: • imate alergijsku reakciju koja uključuje slabost, pad krvnog tlaka, otežano disanje, oticanje lica
English: Find a comfortable, well-lit place and put everything you need where you can reach them (the pre-filled syringe and alcohol swab).
Croatian: Pronađite udobno, dobro osvijetljeno mjesto i stavite sve što trebate tako da Vam je pri ruci
English: How to store Pelgraz
Croatian: Kako čuvati lijek Pelgraz
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED SYRINGE)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (NAPUNJENA ŠTRCALJKA)
English: • get left upper abdominal pain or pain at the tip of your shoulder.
Croatian: Pogledajte dio 4. • osjetite bol u gornjem lijevom dijelu trbuha ili u vrhu ramena.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Croatian: Pedijatrijska populacija Farmakokinetika pegfilgrastima ispitivana je u 37 pedijatrijskih bolesnika sa sarkomom koji su primali
English: Check for any changes in colour, cloudiness or large particles.
Croatian: Provjerite da nije promijenila boju, da nije zamućena te da nisu prisutne krupne čestice.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Pelgraz 6 mg solution for injection in pre-filled injector
Croatian: Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki Pelgraz 6 mg otopina za injekciju u napunjenom injektoru
English: Do not try to inject yourself unless you have received special training from your doctor or nurse.
Croatian: Ako niste prošli obuku od strane liječnika ili medicinske sestre, nemojte samostalno pokušavati injicirati lijek.
English: Pelgraz 6 mg solution for injection in pre-filled syringe Before use, Pelgraz solution should be inspected visually for particulate matter.
Croatian: Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki Prije uporabe, potrebno je provjeriti sadrži li otopina Pelgraza vidljive čestice.
English: - The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Croatian: - Pomoćne tvari su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije (vidjeti dio 2).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (PRE-FILLED SYRINGE)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (NAPUNJENA ŠTRCALJKA)
English: Injecting Pelgraz yourself
Croatian: Samostalno davanje lijeka Pelgraz
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelgraz.
Croatian: Ako primjenjujete lijek Pelgraz, morate prekinuti s dojenjem, osim ako Vaš liječnik ne savjetuje drugačije.
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: 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: How do I inject Pelgraz myself?
Croatian: Kako samostalno primijeniti injekciju lijeka Pelgraz?
English: Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Croatian: Jedan napunjeni injektor sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
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
English: Keep the pre-filled injector in the carton in order to protect from light.
Croatian: Napunjeni injektor čuvati u kutiji radi zaštite od svjetlosti.
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo AML compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
Croatian: AML-om liječenih kemoterapijom uspoređivan je pegfilgrastim (pojedinačna doza od 6 mg) s filgrastimom, primjenjivanima tijekom indukcijske kemoterapije.
English: Gastrointestin al disorders
Croatian: Tablični prikaz nuspojava
English: Keep the pre-filled injector in the outer carton in order to protect from light.
Croatian: Napunjeni injektor čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Allow the pre -filled syringe to reach room temperature before injecting.
Croatian: Prije injiciranja pričekajte da napunjena štrcaljka dosegne sobnu temperaturu.
English: Each pre-filled syringe injector contains 0.6 mL of solution for injection.
Croatian: Jedan napunjeni injektor sadrži 0,6 ml otopine za injekciju.
English: Each pre-filled syringe contains 0.6 mL of solution for injection.
Croatian: Jedna napunjena štrcaljka sadrži 0,6 ml otopine za injekciju.
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
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
English: In a second study (n = 310), which used a weightadjusted dose (100 mcg/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: 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 injector contains 6 mg of pegfilgrastim in 0.6 mL of solution.
Croatian: Jedan napunjeni injektor sadrži 6 mg pegfilgrastima u 0,6 ml otopine.
English: Pelgraz 6 mg solution for injection in pre-filled injector
Croatian: Pelgraz 6 mg otopina za injekciju u napunjenom injektoru
English: Adult Respiratory Distress
Croatian: Plućne nuspojave
English: Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim
Croatian: Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim
Croatian: Pelgraz 6 mg otopina za injekciju u napunjenom injektoru pegfilgrastim
English: Acute myeloid leukaemia (AML)
Croatian: Median Serum Pegfilgrastim Conc. (ng/ml)
English: Each pre-filled syringe contains 0.6 mL of solution.
Croatian: Jedna napunjena štrcaljka sadrži 0,6 ml otopine.
English: The needle safety guard will cover the needle when releasing the plunger.
Croatian: Kada otpustite klip, sigurnosni štitnik za iglu će prekriti iglu.
English: Each pre-filled injector contains 0.6 mL of solution.
Croatian: Jedan napunjeni injektor sadrži 0,6 ml otopine.
English: Keep the pre-filled syringe in the carton in order to protect from light.
Croatian: Napunjenu štrcaljku čuvati u kutiji radi zaštite od svjetlosti.
English: Package leaflet: Information for the user Pelgraz 6 mg solution for injection in pre-filled syringe pegfilgrastim This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Pelgraz 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal (see section 4.4).
Croatian: koji mogu imati smrtni ishod (vidjeti dio 4.4).
English: Package leaflet: Information for the user Pelgraz 6 mg solution for injection in pre-filled injector pegfilgrastim This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Pelgraz 6 mg otopina za injekciju u napunjenom injektoru pegfilgrastim
English: 4 cycles).
Croatian: oticanje lica).
English: Not better?
Croatian: Nije bolje?
English: Check for a response, to see if the person is conscious.
Croatian: Provjerite reakciju da vidite je li osoba pri svijesti.
English: • Difficulty in sleeping.
Croatian: • probleme sa spavanjem.
English: This leaflet was last revised in.
Croatian: Ova uputa zadnji put je revidirana u.
English: Can you feel breath on the cheek?
Croatian: Osjećate li dah na obrazu?
English: Be aware - even if they wake up, they may become unconscious again, and stop breathing.
Croatian: Pazite - čak i ako se probudi, ponovno se može onesvijestiti i prestati disati.
English: Always tell your friends and family that you carry Nyxoid with you.
Croatian: Uvijek recite prijateljima i obitelji da sa sobom nosite Nyxoid.