FrancophonIA/ELRC3.0 huggingface dataset:
English: Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.
Croatian: Aktivna imunizacija dvodnevne prasadi za sprečavanje smrtnosti i smanjenje kliničkih znakova edemske bolesti (prouzročene bakterijom Escherichia coli koja proizvodi verotoxin 2e) i smanjenje gubitka dnevnog prirasta tijekom završnog razdoblja tova, uslijed infekcije bakterijom Escherichia coli koja proizvodi verotoxin 2e, do klanja u dobi od 164 dana.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti, na koje se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ovaj veterinarski medicinski proizvod se ne smije koristiti nakon isteka roka trajanja koji je istaknut na oznaci iza natpisa EXP (rok trajanja).
English: Whitish suspension.
Croatian: Bjelkasta suspenzija.
English: Vaccinated animals are able to neutralise the VT2e toxin.
Croatian: Cijepljene životinje mogu neutralizirati toksin
English: Aluminium hydroxide ............................................................................ 2.117 mg (aluminium) DEAE-dextran
Croatian: Aluminijev hidroksid ................................................................................. 2,117 mg (aluminij) DEAE-Dekstran
English: VEPURED suspension for injection for pigs recombinant verotoxin 2e of E. coli
Croatian: VEPURED injekcijska suspenzija za svinje Rekombinantni verotoksin 2e iz E. coli
English: The vials are closed with a bromobutyl rubber stopper and aluminium cap.
Croatian: Bočice su zatvorene čepom od brombutilne gume i aluminijskim zatvaračem.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: 10 doses (10 ml) 50 doses (50 ml)
Croatian: 10 doza (10 ml) 50 doza (50 ml)
English: The vaccine consisting of recombinant verotoxin 2e stimulates an active immunity against VT2e toxin produced by the causative agent of oedema disease in pigs.
Croatian: Cjepivo se sastoji od rekombinantnog verotoksina 2e te potiče aktivnu imunost protiv toksina VT2e kojeg proizvode uzročnici edemske bolesti svinja.
English: Very common adverse reactions: - Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment.
Croatian: - Blaga upala na mjestu injektiranja (< 5cm u promjeru) koja obično nestaje unutar tri dana nakon cijepljenja bez liječenja.
English: Shelf life after first opening the container: 10 hours.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 10 sati.
English: Aluminium hydroxide DEAE-dextran
Croatian: Aluminijev hidroksid DEAE-dekstran Simetikon
English: Sodium hydroxide Disodium phosphate dodecahydrate Potassium chloride Potassium dihydrogen phosphate Sodium chloride
Croatian: Natrijev hidroksid Dinatrijev fosfat dodekahidrat Kalijev klorid
English: VEPURED suspension for injection for pigs
Croatian: VEPURED suspenzija za injekciju za svinje
English: 10 doses (10 ml) 50 doses (50 ml) 100 doses (100 ml) 250 doses (250 ml) 10 x 10 doses (10 ml)
Croatian: 10 doza (10 ml) 50 doza (50 ml) 100 doza (100 ml) 250 doza (250 ml) 10 x 10 doza (10 ml)
English: Shelf life after first opening the immediate packaging: 10 hours.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 sati.
English: Cardboard box with vials of 10, 50, 100 or 250 doses.
Croatian: Kartonska kutija s bočicama od 10, 50, 100 ili 250 doza.
English: Polyethylene (PET) vials of 10, 50, 100 and 250 ml.
Croatian: Polietilenske (PET) bočice od 10, 50, 100 i 250 ml.
English: Name and address of the manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Laboratorios Hipra, S.A.
English: Vial of 10 or 50 doses
Croatian: Bočica od 10 ili 50 doza
English: The use is not recommended during pregnancy and lactation.
Croatian: Ne preporuča se primjena tijekom graviditeta i laktacije.
English: Vial of 100 or 250 doses.
Croatian: Bočica od 100 ili 250 doza.
English: PACKAGE LEAFLET: VEPURED suspension for injection for pigs
Croatian: UPUTA O VMP: VEPURED suspenzija za injekciju za svinje
English: 21 days after vaccination.
Croatian: Nastup imunosti: 21 dan nakon cijepljenja.
English: Pregnancy and lactation: The use is not recommended during pregnancy and lactation.
Croatian: Graviditet i laktacija: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ ODGOVORAN ZA
English: Cardboard box with vial of 10 x10 doses.
Croatian: Kartonska kutija s bočicom od 10 x10 doza.
English: Whitish suspension for injection.
Croatian: Bjelkasta suspenzija za injekciju.
English: Recombinant verotoxin 2e of E. coli ................................................................ RP* ≥ 1.50 * RP - relative potency (ELISA)
Croatian: Rekombinantni verotoksin 2e iz E. coli ........................................................... RP* ≥ 1,50 * RP, Relativna potentnost (ELISA)
English: la Selva, 135 17170 Amer (Girona) SPAIN
Croatian: Laboratorios Hipra, S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN
English: Each dose of 1 ml contains: Recombinant verotoxin 2e of E. coli ................................................................ RP ≥ 1.50.
Croatian: Jedna doza od 1 ml sadrži: Rekombinantni verotoksin 2e iz E. coli ........................................................... RP ≥ 1,50
English: Aluminium hydroxide (Al 3+) ........................................................................... 2.117 mg DEAE-dextran ...................................................................................................... 10 mg.
Croatian: ) .............................................................. 2,117 mg DEAE-dekstran ............................................................................................ 10 mg
English: Avda.
Croatian: VT2e.
English: Cardboard box with 1 vial of 100 doses (100 ml).
Croatian: Kartonska kutija s 1 bočicom od 100 doza (100 ml).
English: Cardboard box with 1 vial of 250 doses (250 ml).
Croatian: Kartonska kutija s 1 bočicom od 250 doza (250 ml).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ
English: Cardboard box with 1 PET vial of 250 doses (250 ml).
Croatian: Kartonska kutija s 1 PET bočicom od 250 doza (250 ml).
English: Cardboard box with 1 PET vial of 100 doses (100 ml).
Croatian: Kartonska kutija s 1 PET bočicom od 100 doza (100 ml).
English: Cardboard box with 1 polyethylene (PET) vial of 10 doses (10 ml).
Croatian: Kartonska kutija s 1 polietilen (PET) bočicom od 10 doza (10 ml).
English: Tel: ( +39) 030 7241821
Croatian: Hipra Italia S.r.l. Tel: ( +39) 030 7241821
English: Cardboard box with 1 PET vial of 50 doses (50 ml).
Croatian: Kartonska kutija s 1 PET bočicom od 50 doza (50 ml).
English: Cardboard box with 1 vial of 50 doses (50 ml).
Croatian: Kartonska kutija s 1 bočicom od 50 doza (50 ml).
English: Cardboard box with 10 PET vials of 10 doses (10 ml).
Croatian: Kartonska kutija s 10 PET bočica od 10 doza (10 ml).
English: Cardboard box with 10 vials of 10 doses (10 ml).
Croatian: Kartonska kutija s 10 bočica od 10 doza (10 ml).
English: Cardboard box with 1 vial of 10 doses (10 ml).
Croatian: Kartonska kutija s 1 bočicom od 10 doza (10 ml).
English: Batch
Croatian: NUSPOJAVE
English: SPECIAL WARNINGS
Croatian: KLINIČKE POJEDINOSTI
English: EU/1/99/124/001 Tractocile 6,75 mg/0,9 ml Solution for injection
Croatian: Tractocile 6,75 mg/ 0,9 ml Otopina za injekciju
English: EU/1/99/124/002 Tractocile 37,5 mg/ 5 ml
Croatian: Tractocile 37,5 mg/ 5 ml
English: Content Pack size
Croatian: Sadržaj Veličina pakiranje
English: ANNEX A
Croatian: A
English: Date of first authorisation: 21st September 2018
Croatian: Datum prvog odobrenja: 21. rujna 2018
English: Equipment that you need
Croatian: Pribor koji trebate
English: Regulations vary by region.
Croatian: Propisi se mogu razlikovati u zavisnosti od regije.
English: Do this at a speed that is comfortable for you.
Croatian: Ubrizgavajte brzinom koja je ugodna za Vas.
English: Allow to air dry.
Croatian: Pustite da se osuši na zraku.
English: Always take Pelgraz exactly as your doctor has told you.
Croatian: Uvijek primijenite lijek Pelgraz točno onako kako Vam je rekao liječnik.
English: This does not affect normal operation of the syringe.
Croatian: To ne utječe na normalno funkcioniranje štrcaljke.
English: • Wash hands with soap under warm running water.
Croatian: • Operite ruke sapunom pod toplom tekućom vodom.
English: Do not warm Pelgraz in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Ne zagrijavajte Pelgraz na bilo koji drugi način (na primjer, ne zagrijavajte ga u mikrovalnoj pećnici ili vrućoj vodi).
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Croatian: Ako ugledate krv u štrcaljki, izvucite iglu i ponovno je uvedite na drugo mjesto.
English: even if their symptoms of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: If you use more Pelgraz than you should
Croatian: Ako primijenite više Pelgraza nego što biste trebali
English: Do not shake Pelgraz vigorously as this may affect its activity.
Croatian: Ne tresite snažno Pelgraz jer to može utjecati na njegovu aktivnost.
English: Stop using Pelgraz and seek medical attention immediately if you notice any of the symptoms described in section 4.
Croatian: Prestanite s primjenom lijeka Pelgraz i odmah potražite medicinsku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
English: • Choose a clean, well-lit space to administer your medication.
Croatian: • Odaberite čisto, dobro osvijetljeno mjesto za primjenu lijeka.
English: Contents of the pack and other information What Pelgraz contains
Croatian: Sadržaj pakiranja i druge informacije Što Pelgraz sadrži
English: • have an allergy to latex.
Croatian: • ste alergični na lateks.
English: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Croatian: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF Ujedinjeno Kraljevstvo
English: See also section 4.8.
Croatian: Vidjeti također dio 4.8.
English: If you become pregnant during Pelgraz treatment, please inform your doctor.
Croatian: Ukoliko zatrudnite tijekom primjene Pelgraza, molimo obavijestite liječnika.
English: What Pelgraz is and what it is used for
Croatian: Što je Pelgraz i za što se koristi
English: • the abdomen, except for the area around the navel (see picture 3).
Croatian: • trbuh, osim područja oko pupka (vidjeti sliku 3).
English: Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 72 hours or has otherwise expired.
Croatian: Ne uzimajte lijek ako je istekao zadnji dan navedenog mjeseca, ako je lijek bio izvan hladnjaka dulje od 72 sata ili ako je na neki drugi način istekao.
English: Do not touch the needle or push the plunger.
Croatian: Nemojte dodirivati iglu niti gurati klip.
English: It is better to change the injection site every time to avoid the risk of soreness at any one site.
Croatian: Bolje je mijenjati mjesto injiciranja svaki dan da se izbjegne mogućnost pojave bolnosti na ponavljanom mjestu primjene.
English: • Inspect liquid in window.
Croatian: • Pregledajte tekućinu kroz prozorčić.
English: The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Croatian: Potentnost ovog lijeka ne smije se uspoređivati s potentnošću drugih pegiliranih ili nepegiliranih proteina iste terapijske skupine.
English: Your doctor may decide that it would be more convenient for you to inject Pelgraz yourself.
Croatian: Vaš liječnik može odlučiti da će Vam biti pogodnije ako si sami injicirate lijek Pelgraz.
English: Your doctor will tell you when to stop using Pelgraz.
Croatian: Vaš liječnik će Vam reći kada ćete prestati primjenjivati Pelgraz.
English: The instructions how to inject yourself are given below, but proper treatment of your disease requires close and constant co-operation with your doctor.
Croatian: Dodatne upute o tome kako samostalno injicirati lijek nalaze se u nastavku, ali pravilno liječenje Vaše bolesti zahtijeva blisku i stalnu suradnju s Vašim liječnikom.
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: Možda primijetite mali mjehurić zraka u napunjenoj štrcaljki.
English: Stop using Pelgraz if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite koristiti lijek Pelgraz ako razvijete ove simptome i obratite se liječniku ili odmah potražite medicinsku pomoć.
English: You should check with your doctor or pharmacist if you are unsure.
Croatian: Provjerite s liječnikom ili ljekarnikom ako niste sigurni.
English: Pelgraz is for use in adults aged 18 and over.
Croatian: Pelgraz se primjenjuje u odraslih osoba starijih od 18 godina.
English: To give yourself a subcutaneous injection you will need:
Croatian: Da biste si dali potkožnu injekciju trebat ćete sljedeće:
English: Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours.
Croatian: Pelgraz se može izložiti sobnoj temperaturi (ne višoj od 25 °C, ± 2 °C) jednokratno, tijekom razdoblja od najviše 72 sata.
English: The needle guard will not activate unless the entire dose has been given.
Croatian: Sigurnosni štitnik za iglu neće se aktivirati ako ne ubrizgate cijelu dozu.
English: Other medicines and Pelgraz
Croatian: Drugi lijekovi i Pelgraz
English: • if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na pegfilgrastim, filgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: Pelgraz has not been tested in pregnant women.
Croatian: Pelgraz nije ispitivan u trudnica.
English: Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Croatian: Uvedite iglu do kraja u kožu kako Vam je pokazala medicinska sestra ili liječnik (vidjeti sliku c.
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Croatian: Osobitu pozornost treba obratiti na razlikovanje dijagnoze blastične transformacije u kroničnoj mijeloičnoj leukemiji od AML-a.
English: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Croatian: Stevens Johnsonov sindrom, koji može biti životno ugrožavajući ili smrtonosan, rijetko je prijavljen kod liječenja pegfilgrastimom.
English: • Choose injection site (Abdomen or thigh if a patient is injecting himself/herself, with the additional option of the back of the arm if a Healthcare Provider or caregiver is assisting them)
Croatian: • Odaberite mjesto za primjenu injekcije (abdomen ili bedro ako bolesnik samostalno ubrizgava injekciju, a stražnji dio nadlaktice predstavlja dodatno mjesto ako zdravstveni djelatnik ili njegovatelj pomaže bolesniku)
English: Check the appearance of Pelgraz.
Croatian: Provjerite izgled lijeka Pelgraz.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je donijeti odluku o tome treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja pegfilgrastimom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 7).
Croatian: Zaštitni naglavak automatski će prekriti iglu i začut ćete „klik“, što potvrđuje da je sigurnosni štitnik aktiviran (vidjeti sliku 7).
English: Dispose of bottom cap immediately.
Croatian: Odmah bacite poklopac.
English: INDIA
Croatian: INDIJA
English: What Pelgraz looks like and contents of the pack
Croatian: Kako Pelgraz izgleda i sadržaj pakiranja
English: • pain in the chest that is not caused by heart disease or a heart attack.
Croatian: • bol u prsnom košu koja nije posljedica bolesti srca ili srčanog udara.
English: Before you inject Pelgraz you must do the following:
Croatian: Prije nego primijenite injekciju lijeka Pelgraz morate učiniti sljedeće:
English: Do not release the pressure on the plunger!
Croatian: Nemojte otpustiti pritisak na klip!
English: If someone else is injecting you, they can also use the back of your arms (see picture 4)
Croatian: Ako Vam netko drugi daje injekciju, ona se može primijeniti i na stražnji dio nadlaktica (vidjeti sliku
English: Like all medicines, Pelgraz can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, Pelgraz može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Pelgraz is a biosimilar medicinal product.
Croatian: Pelgraz je biosličan lijek.
English: Talk to your doctor, pharmacist or nurse before using Pelgraz if you:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene Pelgraza ako:
English: Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Croatian: Jednokratna doza od 300 µg/kg primijenjena je supkutano ograničenom broju zdravih dobrovoljaca i bolesnika s rakom pluća ne-malih stanica bez pojave ozbiljnih reakcija.
English: No adverse reactions directly attributable to this degree of leukocytosis have been reported.
Croatian: Nisu prijavljene nuspojave koje bi se mogle izravno pripisati tom stupnju leukocitoze.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Croatian: Malo povucite klip kako biste provjerili da niste pogodili krvnu žilu.
English: It is quite normal to have a number of courses of treatment with Pelgraz.
Croatian: Sasvim je uobičajeno nekoliko ciklusa liječenja Pelgrazom.
English: Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Croatian: Dezinficirajte kožu na mjestu injiciranja jastučićem natopljenim alkoholom te nakon toga uhvatite kožu između palca i kažiprsta, bez stiskanja (vidjeti sliku 5).
English: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Croatian: Manje često su prijavljeni slučajevi Sweetova sindroma, iako u nekim slučajevima ulogu u tome može imati i podležeća hematološka zloćudna bolest.
English: Check with your doctor or pharmacist for proper disposal instructions.
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom koje su odgovarajuće upute za zbrinjavanje.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adrese proizvođača biološke djelatne tvari
English: If you are injecting yourself and have forgotten your dose of Pelgraz, you should contact your doctor to discuss when you should inject the next dose.
Croatian: Ako sami injicirate lijek i zaboravili ste si dati svoju dozu Pelgraza, upitajte liječnika kada biste trebali injicirati sljedeću dozu.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: To može biti znak akutnog sindroma respiratornog distresa u odraslih (ARDS);
English: Common cases of leukocytosis (WBC > 100 x 109/L) have been reported (see section 4.4).
Croatian: Prijavljeni su česti slučajevi leukocitoze (broj leukocita > 100 x 109/l) (vidjeti dio 4.4).
English: • Injection is completed when the handle has been pushed down as far as possible, you hear a click and the orange body is no longer visible.
Croatian: • Ubrizgavanje je završeno: kada drška dođe do kraja, začut ćete škljocaj i narančasti trup više neće biti vidljiv.
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Ostali izvori informacija
English: • Place the injector straight onto your skin (about 90 degrees).
Croatian: • Prislonite injektor na kožu okomito (pod kutom od oko 90 stupnjeva).
English: • abnormal blood test results related to the liver (alanine aminotransferase and aspartate aminotransferase).
Croatian: • abnormalni rezultati krvnih pretraga povezanih s jetrom (alanin aminotransferaza i aspartat aminotransferaza).
English: Glomerulonephrit is2
Croatian: Glomerulonefrit is2
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Croatian: *Natrijev acetat nastaje titracijom ledene acetatne kiseline s natrijevim hidroksidom.
English: • Inject within 5 minutes of removing bottom cap.
Croatian: • Ubrizgajte u roku od 5 minuta nakon skidanja poklopca na dnu injektora.
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd PEG molecule.
Croatian: Pegfilgrastim je kovalentni konjugat rekombinantnog ljudskog GCSF-a (r-metHuG-CSF) s jednom molekulom PEG-a od 20 kd.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni kako da samostalno injicirate lijek ili imate pitanja, obratite se svom liječniku ili medicinskoj sestri za pomoć.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Croatian: Broj leukocita od 100 x 109/L ili više primijećen je u manje od 1 % bolesnika koji su primali pegfilgrastim.
English: This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 6 mg dose.
Croatian: Ovaj lijek sadrži 50 mg sorbitola u jednoj jedinici volumena, što odgovara 30 mg po dozi od 6 mg.
English: • Push the handle straight down: The medicine will be injected as you push.
Croatian: • Gurnite dršku ravno prema dolje: lijek se ubrizgava dok je gurate.
English: • Check expiration date on package.
Croatian: • Provjerite rok valjanosti na pakiranju.
English: Each pre-filled syringe or pre-filled injector contains 30 mg sorbitol (E420) (see section 4.4).
Croatian: Jedna napunjena štrcaljka ili napunjeni injektor sadrži 30 mg sorbitola (E420) (vidjeti dio 4.4).