FrancophonIA/ELRC3.0 huggingface dataset:
English: If shaken vigorously, the solution may appear foamy and should not be used.
Slovenian: Če jo boste močno stresali, bo raztopina postala penasta in kot takšna se ne sme uporabljati.
English: A: Using your thumb, slowly and steadily push the plunger head down until it will go no further.
Slovenian: A: S palcem počasi in enakomerno porinite bat navzdol, dokler se ne ustavi.
English: 9 Pinch the skin and insert the needle.
Slovenian: 9 Priščipnite kožo in zabodite iglo.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Slovenian: Napolnjeno injekcijsko brizgo pustite, da pred injiciranjem doseže sobno temperaturo.
English: FIGURE 12 B: Insert the needle into the pinched area of the skin at a 45 to 90 degree angle (see Figure 13)
Slovenian: B: Zabodite iglo v priščipnjeno kožo pod kotom 45 do 90 stopinj (poglejte sliko 13)
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Slovenian: Pokazali so, da v živalskih modelih sočasna uporaba pegfilgrastim a in 5-fluorouracila (5-FU) ali drugih antimetabolitov okrepi mielosupresijo.
English: FIGURE 1 B: Open the carton and remove the sealed syringe tray (see Figure 2).
Slovenian: SLIKA 1 B: Odprite pakiranje in odstranite zapečaten pladenj z injekcijsko brizgo (glejte sliko 2).
English: Your doctor will check your blood and urine regularly as UDENYCA can harm the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo UDENYCA lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
English: 6 Clean the injection site.
Slovenian: 6 Očistite mesto injiciranja.
English: If you experience a loss of response or decrease in response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Slovenian: Če se ne odzivate več na zdravljenje s pegfilgrastimom ali je odziv manjši, bo zdravnik preučil razloge za to, vključno s tem ali so se vam pojavila protitelesa, ki nevtralizirajo delovanje pegfilgrastima.
English: B: While the needle is still inserted, slowly move your thumb back, allowing the plunger to rise.
Slovenian: B: Med tem, ko je igla še v koži, počasi odmaknite palec in pustite, da se bat ponovno dvigne.
English: DO NOT use if the expiry date has passed.
Slovenian: Zdravila NE UPORABITE, če je rok trajanja potekel.
English: • general aches and pains in the joints and muscles
Slovenian: • splošne bolečine ter bolečine v sklepih in mišicah.
English: UDENYCA is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila UDENYCA ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: If you have forgotten a dose of UDENYCA, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste si pozabili injicirati zdravilo UDENYCA Če ste pozabili uporabiti odmerek zdravila UDENYCA, se morate posvetovati z zdravnikom, da se bosta dogovorila, kdaj si morate injicirati naslednji odmerek.
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Slovenian: Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - 'Absolute Neutrophil Count') pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6-miligramski injekciji
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnost in učinkovitost pegfilgrstima za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
Slovenian: Bolniki s prirojeno motnjo intolerance za fruktozo ne smejo dobiti/jemati tega zdravila.
English: 1 Remove carton from refrigerator and check expiry date.
Slovenian: Odstranite škatlo iz hladilnika in preverite rok trajanja
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 72 hours or disposed of.
Slovenian: Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (pod 30 °C), jo morate bodisi v 72 urah porabiti ali pa zavreči.
English: Clean the injection site with an alcohol swab (see Figure 9).
Slovenian: Mesto injiciranja očistite z alkoholno krpico (poglejte sliko 9).
English: DO NOT touch the plunger or grasp the syringe above the finger grips.
Slovenian: NE DOTIKAJTE SE bata in NE PRIJEMLJITE injekcijske brizge višje od prstnih blazinic.
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Slovenian: Tega zdravila ne smete uporabljati za zviševanje odmerka citotoksične kemoterapije preko uveljavljenih shem odmerjanja.
English: • The syringe has an automatic needle guard that covers the needle after administering the medicine and designed to prevent needle stick injury
Slovenian: • Injekcijska brizga je opremljena z avtomatskim varovalom igle, ki jo po injiciranju zaščiti in je zasnovano tako, da bi se izognili poškodbam z iglo.
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-met-Hu-G-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Slovenian: Pegfilgrastim je kovalenten konjugat rekombinantnega človeškega G-CSF (r-met HuG-CSF) z eno samo molekulo 20kd polietilenglikola (PEG).
English: • damage to the tiny filters inside your kidneys (glomerulonephritis)
Slovenian: • okvara drobnih filtrov v ledvicah (glomerulonefritis).
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, pegfilgrastim 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 pegfilgrastim dati vsaj 24 ur po aplikaciji citotoksične kemoterapije.
English: If you become pregnant during UDENYCA treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom UDENYCA zanosite, o tem obvestite zdravnika.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Slovenian: Simptomi so zajemali vročino, bolečine v trebuhu, slabost, bolečine v hrbtu in zvišane vrednosti označevalcev vnetja (C-reaktivna beljakovina in število belih krvničk).
English: UDENYCA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo UDENYCA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Slovenian: Po uporabi G-CSF so poročali o sindromu kapilarne prepustnosti, za katerega so značilni hipotenzija, hipoalbuminemija, edemi in hemokoncentracija.
English: DO NOT use the pre-filled syringe if it has been left out at room temperature for more than 72 hours.
Slovenian: Injekcijske brizge NE SMETE UPORABITI, če je bila več kot 72 ur na sobni temperaturi.
English: • 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.
Slovenian: • se vam pojavijo nenadni znaki alergije, kot so izpuščaj, srbečica ali koprivnica na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
English: B: Remove the syringe from the sealed tray as follows: peel the cover off the tray, remove the syringe by grasping the middle of the syringe body (see Figure 6) DO NOT handle the syringe by the plunger, plunger head, or needle cap.
Slovenian: B: Odstranite injekcijsko brizgo iz zapečatenega pladnja: odlupite pokrov pladnja, odstranite injekcijsko brizgo tako, da jo primete za sredino valja (poglejte sliko 6) Injekcijske brizge NE PRIJEMAJTE za bat, glavo bata ali pokrovček igle.
English: • nausea and headaches
Slovenian: • slabost in glavoboli.
English: • bleeding from the lung (pulmonary haemorrhage)
Slovenian: • krvavenje iz pljuč (pljučna krvavitev)
English: The medicinal product is used to reduce the duration of low white blood cell count (neutropenia) and the occurrence of low white blood cell count with a fever (febrile neutropenia) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Slovenian: Zdravilo se uporablja 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: DO NOT use if the solution contains lumps, flakes, or particles.
Slovenian: Raztopine NE UPORABLJAJTE, če vsebuje koščke, kosmiče ali delce.
English: What UDENYCA looks like and contents of the pack UDENYCA is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Slovenian: Izgled zdravila UDENYCA in vsebina pakiranja Zdravilo UDENYCA je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier will be included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebovalo bo dvodimenzionalno črtno kodo z edinstveno oznako.
English: Driving and using machines UDENYCA has no or negligible effect on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo UDENYCA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: • have sickle cell anaemia.
Slovenian: • mate srpastocelično anemijo.
English: Pull the needle cap straight off (see Figure 10).
Slovenian: Pokrovček potegnite naravnost z igle (poglejte sliko 10).
English: These could be symptoms of an uncommon condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Slovenian: To so lahko simptomi občasne motnje, imenovane "sindrom kapilarne prepustnosti", ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu, ki zahteva nujno zdravniško pomoč.
English: If you use more UDENYCA than you should If you use more UDENYCA than you should contact your doctor, pharmacist or nurse.
Slovenian: Če ste uporabili večji odmerek zdravila UDENYCA, kot bi smeli Če uporabite več zdravila UDENYCA, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Slovenian: Varnost in učinkovitost pegfilgrastima nista raziskani pri bolnikih z mielodisplastičnim sindromom, s kronično mielogeno levkemijo in s sekundarno akutno mieloično levkemijo, zato ga pri takšnih bolnikih ne smete uporabljati.
English: UDENYCA may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Slovenian: Zdravilo UDENYCA sme biti izpostavljeno sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
English: • have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)
Slovenian: • 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: • Abdomen (except for a two-inch area surrounding the navel)
Slovenian: • trebuh (razen predela okrog popka v premeru 6 cm)
English: C: If you see drops of blood at the injection site, treat by pressing a cotton ball or gauze to the site as needed
Slovenian: C: Če na kraju injiciranja opazite kapljice krvi, po potrebi nanj pritisnite vato ali gazo.
English: DO NOT touch the plunger head while inserting the needle into the skin.
Slovenian: Med zabadanjem v kožo SE NE DOTIKAJTE glave bata.
English: How to use UDENYCA
Slovenian: Kako uporabljati zdravilo UDENYCA
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar pomeni, da je praktično 'brez natrija'.
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of pegfilgrastim.
Slovenian: Če je pegfilfrastim pomotoma izpostavljen temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
English: C: After fully inserting the needle, release the pinched skin and use your free hand to stabilise the bottom of the syringe.
Slovenian: C: Po tem, ko boste celo iglo potisnili v kožo, spustite priščipnjeno kožo in s prosto roko primite za spodnji del injekcijske brzge, da bi jo obdržali pri miru.
English: Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon in cancer patients undergoing chemotherapy following administration of G-CSFs; see section 4.4 and section “Description of selected adverse reactions” below.
Slovenian: Občasno so pri bolnikih z rakom, ki so prejemali kemoterapijo po uporabi G-CSF, poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in poglavje »Opis izbranih neželenih učinkov« spodaj.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Important: read the package leaflet before use/handling the pre-filled syringe.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pomembno: Pred rokovanjem z napolnjeno injekcijsko brizgo preberite priloženo navodilo.
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 -16,8 %, -1,1 %).
English: Then move your other hand into injection position with your thumb on the plunger head (see Figure 14).
Slovenian: Nato premaknite drugo roko tako, da boste lahko začeli z injiciranjem, in sicer postavite palec na glavo bata (poglejte sliko 14).
English: Human G-CSF is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Slovenian: Faktor, ki stimulira človeške granulocitne kolonije (G-CSF), je glikoprotein, ki uravnava nastajanje nevtrofilcev in njihovo sproščanje iz kostnega mozga.
English: *The active substance is a covalent conjugate of filgrastim produced in Escherichia coli cells by recombinant DNA technology with polyethylene glycol (PEG).
Slovenian: *Učinkovina je kovalentni konjugat filgrastima, ki se izdeluje s tehnologijo rekombinantne DNA v celicah Escherichia coli s polietilenglikolom (PEG).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION UDENYCA 6 mg pegfilgrastim
Slovenian: IME ZDRAVILA IN POT(I) UPORABE UDENYCA 6 mg pegfilgrastim s.c.
English: DO NOT recap the syringe.
Slovenian: Pokrova brizge NE VRAČAJTE.
English: DO NOT use the syringe if it appears used or damaged.
Slovenian: Injekcijske brizge NE UPORABLJAJTE, če je videti poškodovana.
English: Stop using UDENYCA if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se vam pojavijo ti simptomi, prenehajte uporabljati zdravilo UDENYCA in se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: • redness at the site of injection
Slovenian: • pordelost na mestu injiciranja
English: For further instructions on how to inject yourself with UDENYCA, please read the section at the end of this leaflet.
Slovenian: Nadaljnja navodila za samoinjiciranje zdravila UDENYCA si preberite v poglavju na koncu tega Navodila za uporabo.
English: A: Remove the carton from the refrigerator and check the expiry date printed on the carton.
Slovenian: A: Odstranite škatlo iz hladilnika in preverite rok trajanja, ki je odtisnjen na pakiranju (poglejte sliko 1)
English: Select and clean the injection site
Slovenian: Izberite mesto injiciranja in ga očistite
English: A: Use your free hand to gently pinch the skin around the injection site (see Figure 12).
Slovenian: A: S prosto roko nežno priščipnite kožo okoli mesta injiciranja (poglejte sliko 12).
English: • pain at the site of injection
Slovenian: • bolečina na mestu injiciranja.
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 s povišano telesno temperaturo), vendar tu lahko vplivajo tudi drugi dejavniki.
English: 2 Allow medicine to reach room temperature and gather supplies.
Slovenian: Pustite, da se zdravilo segreje na sobno temperaturo in pripravite pripomočke.
English: 7 Remove needle cap.
Slovenian: 7 Odstranite pokrov z igle.
English: Pegfilgrastim is injected subcutaneously.
Slovenian: Pegfilgrastim se injicira subkutano.
English: Pack size: Each carton contains 1 pre-filled syringe with an automatic needle guard blistered in a plastic tray.
Slovenian: Velikost pakiranja: vsako pakiranje vsebuje eno napolnjeno injekcijsko brizgo z avtomatskim ščitnikom igle ali brez njega v pretisnem plastičnem pakiranju na pladnju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim * in 0.6 ml solution for injection.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Slovenian: Občasno so ti primeri povzročili respiratorno insuficienco ali sindrom akutne dihalne stiske (ARDS), ki sta lahko smrtno nevarna (glejte poglavje
English: 0.6 ml of solution.
Slovenian: 0,6 ml raztopine.
English: Storage information Store the pre-filled syringes in the refrigerator between 2° to 8° C in its original carton.
Slovenian: • Napolnjeno injekcijsko brizgo shranjujete v originalnem pakiranju na temperaturi med 2 in 8° C.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of UDENYCA.
Slovenian: Ob uporabi zdravila UDENYCA so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).
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: V najmlajši starostni skupini (od 0 do 5 let) je bila povprečna izpostavljenost pegfilgrastimu (AUC) (± standardni odklon) 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: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF (see also section 4.8).
Slovenian: V večini primerov je bila diagnoza postavljena po CT-slikanju, težave pa so bile odpravljene s prenehanjem jemanja G-CSF (glejte poglavje 4.8).
English: Prepare the injection
Slovenian: Kako naj pripravim injekcijo?
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 yrs (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: faze pri pediatričnih bolnikih s sarkomom (n = 37), 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: UDENYCA contains sorbitol (E420) and sodium acetate UDENYCA contains sorbitol (a type of sugar).
Slovenian: Zdravilo UDENYCA vsebuje sorbitol (E420) in natrijev acetat Zdravilo UDENYCA vsebuje sorbitol (vrsta sladkorja).
English: What UDENYCA contains - The active substance is pegfilgrastim.
Slovenian: Kaj vsebuje zdravilo UDENYCA - Učinkovina je pegfilgrastim.
English: Concomitant use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients.
Slovenian: Sočasne uporabe pegfilgrastim a s katerim koli kemoterapevtskim zdravilom pri bolnikih niso ovrednotili.
English: This will retract the needle and secure it inside the syringe body.
Slovenian: Takrat se bo tudi igla izvlekla iz kože in bo varno spravljena znotraj injekcijske brizge.
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli followed by conjugation with polyethylene glycol (PEG) It belongs to a group of proteins called cytokines.
Slovenian: Pegfilgrastim je beljakovina, biotehnološko pridobljena iz bakterij E. coli, kateri sledi konjugacija s polietilenglikolom (PEG).
English: • Store the pre-filled syringe in its original carton to protect from light until you are ready to use it.
Slovenian: • Napolnjene injekcijske brizge pred uporabo hranite v originalnem pakiranju, da bi jih zaščitili pred svetlobo.
English: Pre-filled syringe, with a coated bromobutyl rubber stopper and a stainless steel needle with automatic needle guard.
Slovenian: Napolnjena injekcijska brizga z gumijastim zamaškom in nerjavečo jekleno iglo z avtomatskim ščitnikom igle.
English: FIGURE 16
Slovenian: SLIKA 16
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 -0.36, 0.30).
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: Uncommon but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Slovenian: Po uporabi pegfilgrastima so poročali oobčasnih, a splošno asimptomatskih primerih splenomegalije, in o občasnih primerih rupture vranice, vključno z nekaterimi smrtnimi primeri (glejte poglavje 4.8).
English: Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom akutne dihalne stiske2, pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza), hemoptiza pljučna krvavitev2
English: Then remove the syringe from the injection site (see Figure 16).
Slovenian: Šele takrat odmaknite injekcijsko brizgo od kože (poglejte sliko 16).
English: FIGURE 8
Slovenian: SLIKA 8