FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Pelmeg for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Pelmeg za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: Pelmeg may be used if it is accidentally frozen for two periods of less than 72 hours each.
Slovenian: Zdravilo Pelmeg je mogoče uporabiti, če je bilo nehote zamrznjeno za največ dve obdobji, od katerih nobeno ni trajalo dlje kot 72 ur.
English: OTHER Mundipharma
Slovenian: DRUGI PODATKI Mundipharma
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Zdravila za spodbujanje imunske odzivnosti, Kolonije spodbujajoči faktorji; oznaka ATC: L03AA13
English: Do not administer Pelmeg to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Slovenian: Zdravila Pelmeg ne dajajte bolnikom z anamnezo preobčutljivosti na pegfilgrastim ali filgrastim.
English: Pelmeg is a biosimilar medicinal product.
Slovenian: Zdravilo Pelmeg je podobno biološko zdravilo.
English: In such circumstances Pelmeg should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Slovenian: V takih primerih je treba zdravilo Pelmeg po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje (glejte poglavje 4.8).
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Slovenian: Pegfilgrastim je kovalenten konjugat rekombinantnega humanega G-CSF (r-metHuG-CSF) z eno samo molekulo 20 kd polietilenglikola
English: Your doctor will check your blood and urine regularly as Pelmeg can harm the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Pelmeg lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Slovenian:  resne alergijske reakcije, vključno z anafilaksijo (slabotnost, padec krvnega tlaka, težave z dihanjem, otekanje obraza).
English: 0.6 mL of solution.
Slovenian: 0,6 ml raztopine.
English: INFORMATION IN BRAILLE Pelmeg
Slovenian: PODATKI V BRAILLOVI PISAVI Pelmeg
English: The safety and efficacy of Pelmeg have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Slovenian: Varnost in učinkovitost zdravila Pelmeg nista raziskani pri bolnikih z mielodisplastičnim sindromom, kronično mielogeno levkemijo in sekundarno AML, zato ga pri takšnih bolnikih ne smete uporabljati.
English: The trade name and the batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Samo za zdravstveno osebje Tržno ime in številko serije uporabljenega zdravila je treba jasno dokumentirati v bolnikovo kartoteko.
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).
Slovenian:  če ste seznanjeni z morebitnimi spremembami števila krvnih celic (npr. s povečanjem števila belih krvničk ali anemijo) ali z zmanjšanim številom krvnih ploščic v krvi, kar zmanjša sposobnost strjevanja krvi (trombocitopenija).
English: What Pelmeg looks like and contents of the pack Pelmeg is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Slovenian: Izgled zdravila Pelmeg in vsebina pakiranja Zdravilo Pelmeg je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
English: On the basis of the scientific conclusions for pegfilgrastim the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pegfilgrastim is unchanged subject to the proposed changes to the product information.
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za pegfilgrastim odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) pegfilgrastim, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Manufacturer PharmaKorell GmbH Marie-Curie-Strasse 8 D-79539 Lörrach Germany
Slovenian: Izdelovalec PharmaKorell GmbH Marie-Curie-Strasse 8 D-79539 Lörrach
English: In order to improve the traceability of biologic medicinal products, the tradename and the batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil morata biti v bolnikovi kartoteki jasno dokumentirana ime in številka serije prejetega zdravila.
English: • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Slovenian:  krvavitev iz pljuč (pljučna krvavitev)  Stevens-Johnsonov sindrom, ki se lahko pojavi kot rdečkaste lise v obliki tarče ali krožne lise na trupu, pogosto z mehurčki na sredini, luščenje kože, razjede v ustih, grlu, nosu, genitalijah in očeh, pred tem pa se lahko pojavijo vročina in gripi podobni simptomi.
English: Pelmeg is used in adult patients to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Slovenian: Zdravilo Pelmeg se uporablja pri odraslih bolnikih za skrajšanje trajanja nevtropenije (zmanjšano število belih krvničk) in zmanjševanje pojavljanja febrilne nevtropenije (zmanjšano število belih krvničk z zvišano telesno temperaturo), ki ju lahko povzroča uporaba citotoksične kemoterapije (zdravila, ki uničujejo hitro rastoče celice).
English: Open the tray, peeling away the cover.
Slovenian: Odprite podlogo, tako da z nje odlepite pokrivno folijo.
English: The safety and efficacy of Pelmeg have not been investigated in patients receiving high dose chemotherapy.
Slovenian: Varnosti in učinkovitosti zdravila Pelmeg niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
English: If you become pregnant during Pelmeg treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom Pelmeg zanosite, o tem obvestite zdravnika.
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Pelmeg should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Slovenian: Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba zdravilo Pelmeg dati vsaj 24 ur po aplikaciji citotoksične kemoterapije.
English: How to use Pelmeg
Slovenian: Kako uporabljati zdravilo Pelmeg
English: Permanently discontinue Pelmeg in patients with clinically significant hypersensitivity.
Slovenian: Dokončno prenehajte z zdravljenjem z zdravilom Pelmeg pri bolnikih s klinično signifikantno preobčutljivostjo.
English: Pelmeg is injected subcutaneously.
Slovenian: Zdravilo Pelmeg se injicira subkutano.
English: Pelmeg is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Pelmeg ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: You may take Pelmeg out of the refrigerator and keep it at room temperature (not above 30° C) for no longer than 4 days.
Slovenian: Zdravilo Pelmeg smete vzeti iz hladilnika in ga hraniti pri sobni temperaturi (pod 30 °C) največ 4 dni dolgo.
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)
Slovenian:  če ste nedavno imeli hudo okužbo pljuč (pljučnico), tekočino v pljučih (pljučni edem), vnetje pljuč (intersticijsko pljučno bolezen) ali nenormalen izvid rentgenskega slikanja pljuč (pljučne infiltrate).
English: • Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
Slovenian:  Sweetov sindrom (izbočene, boleče spremembe slivove barve na okončinah in včasih tudi na obrazu in vratu z zvišano telesno temperaturo), vendar tu lahko vplivajo tudi drugi dejavniki.
English: • if you have sickle cell anaemia.
Slovenian:  če imate srpastocelično anemijo.
English: Solution for injection 1 pre-filled syringe with automatic needle guard (0.6 mL).
Slovenian: raztopina za injiciranje 1 napolnjena injekcijska brizga z avtomatskim ščitnikom igle (0,6 ml)
English: Pelmeg contains the active substance pegfilgrastim.
Slovenian: Zdravilo Pelmeg vsebuje učinkovino pegfilgrastim.
English: Important: read the package leaflet before handling pre-filled syringe
Slovenian: Pomembno: Pred ravnanjem z napolnjeno injekcijsko brizgo preberite priloženo navodilo.
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]).
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije preobčutljivostne vrste, vključno z izpuščajem na koži, urtikarijo, angioedemom, dispnejo, eritemom, zardevanjem in hipotenzijo (občasni [≥ 1/1.000 do < 1/100]).
English: Stop using Pelmeg if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se vam pojavijo ti simptomi, prenehajte uporabljati zdravilo Pelmeg in se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: Concomitant use of Pelmeg with any chemotherapy agent has not been evaluated in patients.
Slovenian: Sočasne uporabe zdravila Pelmeg s katerim koli kemoterapevtskim zdravilom pri bolnikih niso ovrednotili.
English: This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Slovenian: To zdravilo vsebuje 30 mg sorbitola v eni napolnjeni injekcijski brizgi, kar je enako 50 mg/ml.
English: For subcutaneous use.
Slovenian: za enkratno uporabo za subkutano uporabo
English: Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 %, 95 % CI of −19 %, 5 %).
Slovenian: V celotni študiji je bila pogostost febrilne nevtropenije pri bolnikih, zdravljenih s pegfilgrastimom, 13 %, pri bolnikih, zdravljenih s filgrastimom, pa 20 % (razlika 7 %, 95 % IZ je -19 %, 5 %).
English: What you need to know before you use Pelmeg
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Pelmeg Ne uporabljajte zdravila Pelmeg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pelmeg 6 mg pegfilgrastim
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pelmeg 6 mg pegfilgrastim s.c.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Pelmeg Vsebina pakiranja in dodatne informacije
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).
Slovenian: V eni študiji (n = 157), v kateri so uporabili stalni odmerek 6 mg pegfilgrastima, je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,8 dni, v skupini s filgrastimom pa 1,6 dni (razlika 0,23 dneva, 95 % IZ je -0,15, 0,63).
English: For further instructions on how to inject yourself with Pelmeg, please read the section at the end of this leaflet.
Slovenian: Nadaljnja navodila za samoinjiciranje zdravila Pelmeg si preberite v poglavju na koncu tega navodila za uporabo.
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
Slovenian:  če se vam pojavi alergijska reakcija, vključno s šibkostjo, padcem krvnega tlaka, težavami z dihanjem, otekanjem obraza (anafilaksa), pordelostjo in navali vročine, izpuščajem na koži in predeli kože, ki srbijo.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelmeg.
Slovenian: Ob uporabi zdravila Pelmeg so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).
English: Instructions for use Guide to parts
Slovenian: Navodilo za uporabo: Sestavni deli
English: Inspect the medicine and pre-filled syringe.
Slovenian: C Preglejte zdravilo in napolnjeno injekcijsko brizgo.
English: • think you may be pregnant; or
Slovenian: Pomembno je, da poveste zdravniku, če:  ste noseči,  mislite, da bi lahko bili noseči, ali  načrtujete zanositev.
English: Pelmeg has no or negligible effect on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pelmeg nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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).
Slovenian: 4.1 Terapevtske indikacije Skrajšanje trajanja nevtropenije in incidence febrilne nevtropenije pri odraslih bolnikih, zdravljenih s citotoksično kemoterapijo za maligne bolezni (z izjemo kronične mieloidne levkemije in mielodisplastičnih sindromov).
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v
English: In a second study (n = 310), which used a weight-adjusted 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
Slovenian: V drugi študiji (n = 310), v kateri so uporabljali za telesno maso popravljen odmerek (100 μg/kg), je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,7 dni, v skupini s filgrastimom pa 1,8 dni (razlika 0,03 dneva, 95 % IZ je -0,36, 0,30).
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 × 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.
Slovenian: ki so dobili 100 μg/kg pegfilgrastima po 1. ciklusu kemoterapije z vinkristinom, doksorubicinom in ciklofosfamidom (VAdriaC/IE), so pri mlajših otrocih, starih od 0 do 5 let, ugotovili dolgotrajnejšo hudo nevtropenijo (nevtrofilci < 0,5 x 109) (8,9 dni) kot pri starejših otrocih, starih od 6 do 11 let (6 dni) in 12 do 21 let (3,7 dni) in pri odraslih.
English: • spleen rupture.
Slovenian:  ruptura vranice.
English: • The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections.
Slovenian:  Pomožne snovi so natrijev acetat, sorbitol (E 420), polisorbat 20 in voda za injekcije.
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Slovenian: • Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu).
English: Pelmeg has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Pelmeg nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Syringe label
Slovenian: Nalepka brizge
English: Splenomegaly2; Splenic rupture2
Slovenian: srpastocelična kriza2, splenomegalija2, ruptura vranice2
English: One 6 mg dose (a single pre-filled syringe) of Pelmeg is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Slovenian: Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) zdravila Pelmeg, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
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.
Slovenian: Pri mlajših otrocih, starih od 0 do 5 let, so ugotovili večjo pogostnost resnih neželenih reakcij (92 %) kot pri starejših otrocih, starih od 6 do 11 (80 %) in 12 do 21 let
English: • if you experience a cough, fever and difficulty breathing.
Slovenian:  če začnete kašljati, se vam zviša telesna temperatura in začnete težko dihati.
English: Pre-filled syringe (Type I glass), with a bromobutyl rubber stopper and a stainless steel needle with an automatic needle guard.
Slovenian: 6.5 Vrsta ovojnine in vsebina Napolnjena injekcijska brizga (iz stekla tipa I) z zaporko iz bromobutilne gume in iglo iz nerjavnega jekla z avtomatskim ščitnikom igle.
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).
Slovenian: večja (47,9 ± 22,5 μg h/ml) kot med otroci, starimi od 6 do 11 (22,0 ± 13,1 μg h/ml) in od 12 do 21 let (29,3 ± 23,2 μg h/ml) (glejte poglavje 5.1).
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):  bolečine v kosteh.
English: Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Slovenian:  če se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov:
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 %).
Slovenian: Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9 %, pri bolnikih, zdravljenih s filgrastimom, pa 18 % (razlika 9 %, 95 % IZ je
English: Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Slovenian: pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza), hemoptiza pljučna krvavitev
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.
Slovenian: (podkožna injekcija) z uporabo napolnjene injekcijske brizge, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
English: • if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction.
Slovenian: otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk a risk to the newborns/infants cannot be excluded.
Slovenian: Dojenje Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
English: Transient elevations in
Slovenian:  povečana vranica.
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.
Slovenian: G-CSF lahko pospešuje rast mieloidnih celic, z malignimi celicami vred, in vitro,
English: • if you get left upper abdominal pain or pain at the tip of your shoulder.
Slovenian:  če začutite bolečino levo zgoraj v trebuhu ali v predelu lopatice.
English: Step 2: Get ready A Wash your hands thoroughly.
Slovenian: 2. korak: Pripravite se
English: Pelmeg 6 mg solution for injection in pre-filled syringe pegfilgrastim
Slovenian: Pelmeg 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
English: • The active substance is pegfilgrastim.
Slovenian:  Učinkovina je pegfilgrastim.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Solution for injection Clear, colourless solution for injection.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje bistra, brezbarvna raztopina za injiciranje
English: If you use more Pelmeg than you should contact your doctor, pharmacist or nurse.
Slovenian: Če ste uporabili večji odmerek zdravila Pelmeg, kot bi smeli Če uporabite več zdravila Pelmeg, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Pulmonary hemorrhage
Slovenian: Srpastocelična anemija
English: The number of cases is small, but because of the seriousness of the ADR, the PRAC recommends that the Product Information should be updated accordingly.
Slovenian: Število primerov je majhno, vendar zaradi resnosti
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).
Slovenian: kot med prejemnicami placeba (1 % v primerjavi s 14 %, p < 0,001, ter 2 % v primerjavi z 10 %, p < 0,001).
English: Syringe label Syringe barrel
Slovenian: OVOJNINAH NALEPKA BRIZGE
English: Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common) have occurred on initial or subsequent treatment with pegfilgrastim.
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasni) in tudi bolečino na mestu injiciranja
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi natrijev acetat* sorbitol (E 420) polisorbat 20 voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: Talk to your doctor, pharmacist or nurse before using Pelmeg:
Slovenian: Pred začetkom uporabe zdravila Pelmeg se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelmeg.
Slovenian: Če uporabljate zdravilo Pelmeg, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
English: (ng/ml)
Slovenian: (PEG).
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).
Slovenian: (70 %) in 12 do 21 let (33 %) ter pri odraslih (glejte poglavji 4.8 in 5.2).
English: Stop using Pelmeg and seek medical attention immediately if you notice any of the symptoms described in section 4.
Slovenian: Če opazite katerega od simptomov, opisanih v poglavju 4, prenehajte uporabljati zdravilo Pelmeg in nemudoma poiščite zdravniško pomoč.