FrancophonIA/ELRC3.0 huggingface dataset:
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 (AML) (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 (AML) (vidjeti dio 5.1).
English: The healthcare professional must ensure the patient receives appropriate training about the on-body injector and understands that if they suspect a device failure or malfunction the patient must immediately inform a healthcare professional as they may need a replacement dose.
Croatian: Zdravstveni radnika mora osigurati da bolesnik prođe prikladnu obuku o primjeni on-body injektora i da razumije da mora hitno obavijestiti zdravstvenog radnika ako posumnja na neispravnost ili kvar uređaja jer će možda trebati dobiti nadomjesnu dozu.
English: In rat studies, it was shown that pegfilgrastim may cross the placenta.
Croatian: Ispitivanja provedena u štakora pokazala su da pegfilgrastim može proći kroz posteljicu.
English: Your healthcare provider will fill the on-body injector with Neulasta and then apply it directly to your skin using an adhesive pad.
Croatian: Vaš zdravstveni radnik će napuniti on-body injektor lijekom Neulasta i zatim ga postaviti izravno na Vašu kožu pomoću ljepljive podloge.
English: Leukocytosis
Croatian: Leukocitoza
English: Important: Do not grasp the on-body injector itself to try to pull it off of your body.
Croatian: Važno: Ne povlačite samo kućište on-body injektora kako biste ga pokušali skinuti s tijela.
English: The aim of this patient alert card is to help prevent medication errors including underdose resulting in lack of efficacy with the on-body injector device.
Croatian: Cilj korištenja kartice s upozorenjima za bolesnika je pomoći u sprječavanju medikacijskih pogrešaka kao što su primjena preniske doze koja će dovesti do smanjene djelotvornosti kod primjene on-body injektora.
English: If the status light is solid green or it has switched off, it is ok.
Croatian: Ako je svijetlo neprekidno zeleno ili ako se ugasilo, ispravno je.
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: • 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 dan navedenog mjeseca.
English: If the needle is exposed, contact your healthcare provider immediately.
Croatian: Ako je igla izložena, odmah obavijestite svog zdravstvenog radnika.
English: • When dose delivery is complete, a long beep will sound and the status light will be solid green.
Croatian: • Kada doziranje završi, oglasit će se dugi zvučni signal, a statusna lampica će svijetliti neprekidnim zelenim svjetlom.
English: The syringe for use with the on-body injector must either be used within 36 hours after it has reached room temperature (not above 30°C) or disposed of.
Croatian: Injekcija za uporabu s on-body injektorom mora se upotrijebiti u roku od 36 sati nakon što dosegne sobnu temperaturu (ne višu od 30 °C) ili je treba baciti.
English: • Do not put the cap back on used needles.
Croatian: • Ne vraćajte kapicu na upotrijebljenu iglu.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su navedene prema ozbiljnosti od najozbiljnijih prema manje ozbiljnima.
English: If the status light is flashing green, it is ok.
Croatian: Ako lampica svijetli treptajućim zelenim svjetlom, ispravno je.
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: It is important to push down through the “snap” to deliver your full dose.
Croatian: Važno je gurati do kraja uz škljocanje kako bi se primijenila cijela doza.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Croatian: Neklinički podaci dobiveni konvencionalnim ispitivanjima toksičnosti ponovljenih doza pokazuju očekivane farmakološke učinke, uključujući povećanje broja leukocita, mijeloičnu hiperplaziju u koštanoj srži, ekstramedularnu hematopoezu i povećanje slezene.
English: This may affect the on-body injector's performance.
Croatian: Ovo može utjecati na rad on-body injektora.
English: See also section 2.
Croatian: Vidjeti i dio 2.
English: Package leaflet: Information for the user
Croatian: Uputa o lijeku: Informacije za bolesnika
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (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 pegfilgrastimom (manje često [≥ 1/1000 do < 1/100]).
English: Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Croatian: Proizvođač Amgen NV Telecomlaan 5-7 1831 Diegem Belgija
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: Da bi injiciranje bilo ugodnije, ostavite napunjenu štrcaljku oko 30 minuta da dosegne sobnu temperaturu ili je pažljivo držite u ruci nekoliko minuta.
English: The adhesive pad is water-resistant but you are advised to avoid submerging the on-body injector in water.
Croatian: Ljepljiva podloga otporna je na vodu, no preporučuje se izbjegavati uranjanje on-body injektora za tijelo u vodu.
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 medicinsku pomoć.
English: The manually administered injections should be given into the thigh, abdomen or upper arm.
Croatian: Injekcije je potrebno ručno primijeniti u bedro, abdomen ili nadlakticu.
English: Glomerulonephritis
Croatian: Glomerulonefritis
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: Guide to parts for on-body injector for Neulasta Green flashing status light
Croatian: Priručnik o dijelovima on-body injektora za lijek Neulasta Zeleno treptajuće svjetlo statusne lampice
English: Failure to keep the on-body injector at least this recommended distance may interfere with its operation and can lead to a missed or incomplete dose of Neulasta.
Croatian: Držanje on-body injektora na udaljenosti manjoj od preporučene može utjecati na njegov rad i dovesti do propuštene ili nepotpune doze lijeka Neulasta.
English: These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
Croatian: Ovo mogu biti znakovi stanja koje se zove „sindrom povećane propusnosti kapilara" koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela.
English: Hold the syringe barrel and gently take the cap from the needle without twisting.
Croatian: Držite tijelo štrcaljke i pažljivo skinite zaštitnu kapicu s igle bez okretanja.
English: Uncommon (≥ 1/1,000 to
Croatian: Manje često (≥ 1/1000 do
English: • If the on-body injector at any time comes away from your skin before your full dose delivery, do not reapply it.
Croatian: • Ako se on-body injektor u bilo kojem trenutku odvoji od kože prije nego što primite cijelu dozu, ne stavljajte ga ponovno.
English: On-body injector placement Important: Contact your healthcare provider immediately if you have severe pain or skin discomfort around your on-body injector.
Croatian: Postavljanje on-body injektora Važno: Odmah obavijestite svog zdravstvenog radnika ako osjetite jaku bol ili nelagodu kože u području oko on-bodyinjektora.
English: The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Croatian: Sigurnost i djelotvornost Neulaste nisu ispitivani u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
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, a karakteriziraju ga hipotenzija, hipoalbuminemija, edemi i hemokoncentracija.
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: 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: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Croatian: Nakon jednokratne supkutane doze pegfilgrastima vršna se koncentracija pegfilgrastima u serumu postiže 16 do 120 sati nakon doziranja, a koncentracija pegfilgrastima u serumu održava se tijekom razdoblja neutropenije nakon mijelosupresivne kemoterapije.
English: It contains important advice on how to monitor your device for medication errors including under dose leading to lack of effect, and when to seek immediate medical attention.
Croatian: Vaš uređaj vezano uz medikacijske pogreške, uključujući primjenu premale doze koja vodi do izostanka učinka lijeka, i savjete o tome kada potražiti hitnu medicinsku pomoć.
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 (Rok valjanosti/EXP).
English: There are no or limited amount of data from the use of pegfilgrastim in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni pegfilgrastima u trudnica ograničeni.
English: You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
Croatian: Lijek Neulasta možete izvaditi iz hladnjaka i čuvati je na sobnoj temperaturi (ne višoj od 30 °C), ali ne dulje od 3 dana.
English: Do not use the pre-filled syringe if:
Croatian: Ne upotrebljavajte napunjenu štrcaljku:
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Croatian: Pegfilgrastim je bjelančevina dobivena biotehnološkim postupkom u bakteriji E.coli.
English: This may be a sign of a problem with your spleen (splenomegaly).
Croatian: To može biti znak problema sa slezenom (povećanje slezene);
English: The usual dose is one 6 mg subcutaneous injection (injection under your skin) 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), koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
English: Thrombocytopenia1 Leukocytosis
Croatian: Trombocitopenija1 Leukocitoza1
English: The on-body injector is worn for 27 hours after placement and is programmed to make sure you do not receive Neulasta any sooner than 24 hours after your chemotherapy.
Croatian: On-body injektor nosi se 27 sati nakon primjene i programiran je kako bi spriječio da lijek primite prije nego prođe 24 sata od primanja kemoterapije.
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Croatian: Pripada grupi bjelančevina naziva citokini i vrlo je sličan prirodnoj bjelančevini (faktor stimulacije rasta kolonije granulocita) koju stvara
English: G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Croatian: G-CSF može potaknuti rast mijeloidnih stanica, uključujući zloćudne stanice, in vitro, a slični učinci mogu se primijetiti i na nekim nemijeloičnim stanicama in vitro.
English: • During this time, the on-body injector will flash a fast green light.
Croatian: • Tijekom tog razdoblja, on-body injektor će svijetliti brzo treptajućim zelenim svjetlom.
English: • The medicine is cloudy or there are particles in it.
Croatian: • Ukoliko lijek izgleda mutan ili su u njemu vidljive čestice.
English: What if there is blood at my application site after the on-body injector has been removed?
Croatian: Što ako ima krvi na mjestu primjene lijeka nakon skidanja on-body injektora?
English: The on-body injector will flash a fast green light.
Croatian: On-body injektor će svijetliti brzo treptajućim zelenim svjetlom.
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 mijelodisplastičkih sindroma).
English: It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist.
Croatian: Važno je da ne pokušavate sami sebi dati injekciju ako niste prošli obuku kod svojeg liječnika, medicinske sestre ili ljekarnika.
English: Push all the way down through the snap.
Croatian: Gurajte sve do kraja uz škljocanje.
English: MedDRA system organ class
Croatian: Klasifikacija organskih sustava prema MedDRA-i
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Croatian: Eliminacija pegfilgrastima je nelinearna s obzirom na dozu; povećanjem doze smanjuje se klirens pegfilgrastima u serumu.
English: Common (≥ 1/100 to < 1/10)
Croatian: Često (≥ 1/100 do
English: • After your on-body injector removal, place the on-body injector in a sharps disposal container whether the needle is exposed or not.
Croatian: • Nakon što ste skinuli on-body injektor, odložite ga u spremnik za odlaganje oštrih predmeta bez obzira na to je li igla izložena ili ne.
English: • increased spleen size.
Croatian: • povećanje slezene.
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Croatian: Bol u kostima Mišićno-koštana bol (mijalgija, artralgija, bol u udovima, bol u leđima, mišićno-koštana bol, bol u vratu)
English: Insert the needle into the skin.
Croatian: UVEDITE iglu u kožu.
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 Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
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,
English: In such circumstances pegfilgrastim 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 pegfilgrastima treba prekinuti i primijeniti odgovarajuće liječenje (vidjeti dio 4.8).
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: Solution for injection in a pack size of one single use pre-filled syringe (0.64 mL) and one on-body injector (Onpro kit).
Croatian: Otopina za injekciju u veličini pakiranja od jedne napunjene štrcaljke za jednokratnu primjenu (0,64 ml) i jednog on-body injektora (Onpro pribor).
English: A Record the end status of your on-body injector.
Croatian: Zabilježite završni status svog on-body injektora.
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: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·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 a phase I (n = 253) randomised, single dose, parallel-group study conducted in healthy subjects the exposure (mean serum concentration-time profiles) of pegfilgrastim delivered by manual injection and by the on-body injector were comparable.
Croatian: U fazi I (n = 253) randomiziranog ispitivanja jednokratne doze s usporednim skupinama provedenog u zdravih ispitanika, izloženost (srednja vrijednost profila koncentracija-vrijeme u serumu) pegfilgrastimu primijenjenom ručnom injekcijom i on-body injektorom bili su usporedivi.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy.
Croatian: Nisu provedena ispitivanja sigurnosti i djelotvornosti pegfilgrastima u bolesnika koji primaju visokodoznu kemoterapiju.
English: What to do if the on-body injector adhesive becomes noticeably wet (saturated) with fluid, or you see dripping.
Croatian: Što učiniti ako ljepljiva podloga on-body injektora postane vidno mokra (natopljena tekućinom) ili ako iz on-body injektora kaplje.
English: For the next 45 minutes, monitor your on-body injector frequently for leaks during dose delivery.
Croatian: Sljedećih 45 minuta učestalo provjeravajte Vaš on-body injektor za curenje tekućine tijekom primjene doze.
English: Do not leave the pre-filled syringe exposed to direct sunlight.
Croatian: Ne izlažite napunjenu štrcaljku izravnoj sunčevoj svjetlosti.
English: Neulasta is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Croatian: Neulasta je bistra, bezbojna otopina za injekciju u napunjenoj štrcaljki (6 mg/0,6 ml).
English: Neulasta 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: Neulasta 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: In clinical trials, Neulasta has been safely administered 14 days before chemotherapy.
Croatian: Neulasta sigurno primjenjivala 14 dana prije kemoterapije.
English: • Be careful not to bump or knock the on-body injector off your body.
Croatian: • Pazite da ne udarite ili udarcem skinete on-body injektor s Vaše kože.
English: • bleeding from the lung (pulmonary haemorrhage).
Croatian: • krvarenje iz pluća (plućna hemoragija).
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: 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: For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Croatian: Za ugodniju primjenu, ostavite napunjenu štrcaljku na sobnoj temperature oko 30 minuta prije injiciranja.
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 učinci mogu se vidjeti i kod nekih nemijeloičnih stanica in vitro.
English: Ask your pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte svog ljekarnika kako zbrinuti lijekove koje više ne trebate.
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 smanjeni broj krvnih pločica koji može uzrokovati poremećaje u zgrušavanju (trombocitopenija).
English: “SNAP”
Croatian: “ŠKLJOC”
English: Pulmonary haemorrhage
Croatian: Plućna hemoragija
English: • rash, itchy red raised bumps (contact dermatitis/local skin reactions) have been seen with the on-body injector.
Croatian: • osip, izdignuta područja kože koja svrbe (kontaktni dermatitis / lokalne kožne reakcije) opaženi su kod uporabe on-body injektora.
English: B Properly dispose of the on-body injector.
Croatian: B Propisno odložite on-body injektor.