natgillin/translations-raw huggingface dataset:
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3). 
Pegfilgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic pri kumulativnih tedenskih odmerkih, ki so približno 6-krat do 9-krat višji od priporočenega odmerka za človeka (na podlagi telesne površine) (glejte poglavje 5.3).
Pegfilgrastim Mundipharma is for use in adults aged 18 and over. 
Zdravilo Pegfilgrastim Mundipharma je namenjeno uporabi pri odraslih, starih 18 ali več let.
• Pegfilgrastim Mundipharma is given as an injection into the tissue just under the skin (subcutaneous injection). 
• Zdravilo Pegfilgrastim Mundipharma se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule. 
Pegfilgrastim je kovalenten konjugat rekombinantnega humanega G-CSF (r-metHuG-CSF) z eno samo molekulo 20 kd polietilenglikola (PEG).
Belly, except for a 5 cm (2-inch) area right around your belly button. 
trebuh (razen v predelu 5 cm okrog popka).
In such circumstances Pegfilgrastim Mundipharma should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8). 
V takih primerih je treba zdravilo Pegfilgrastim Mundipharma po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje (glejte poglavje 4.8).
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. 
Na splošno so primeri glomerulonefritisa izzveneli po zmanjšanju odmerka ali prenehanju uporabe filgrastima ali pegfilgrastima.
Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow. 
Faktor, ki stimulira humane granulocitne kolonije (G-CSF), je glikoprotein, ki uravnava nastajanje nevtrofilcev in njihovo sproščanje iz kostnega mozga.
Pulmonary hemorrhage 
hemoptiza pljučna krvavitev
Pegfilgrastim Mundipharma has no or negligible effect on the ability to drive or use machines. 
Zdravilo Pegfilgrastim Mundipharma nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
It is important to push down through the “snap” to deliver your full dose. 
Pomembno je, da potisnete vse do “tleska“, saj le tako injicirate celotni odmerek.
Before you use a Pegfilgrastim Mundipharma pre-filled syringe with automatic needle guard, read this important information: 
Pred uporabo zdravila Pegfilgrastim Mundipharma v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
Your doctor will check your blood and urine regularly as Pegfilgrastim Mundipharma can harm the tiny filters inside your kidneys (glomerulonephritis). 
Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Pegfilgrastim Mundipharma lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4). 
Občasno so ti primeri povzročili respiratorno insuficienco ali sindrom akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome), ki sta lahko smrtna (glejte poglavje 4.4).
The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. 
Farmakokinetiko pegfilgrastima so raziskali pri 37 pediatričnih bolnikih s sarkomom, ki so po dokončanju kemoterapije z VAdriaC/IE dobili 100 μg/kg pegfilgrastima.
Pegfilgrastim Mundipharma may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours. 
Zdravilo Pegfilgrastim Mundipharma sme biti izpostavljeno sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 96 ur.
Pegfilgrastim Mundipharma may be used if it is accidentally frozen for two periods of less than 72 hours each. 
Zdravilo Pegfilgrastim Mundipharma je mogoče uporabiti, če je bilo nehote zamrznjeno za največ dve obdobji, od katerih nobeno ni trajalo dlje kot 72 ur.
The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count). 
Simptomi, ki so se pojavili, vključujejo zvišano telesno temperaturo, bolečine v trebuhu, slabo počutje, bolečine v hrbtu in zvišane vrednosti vnetnih označevalcev (npr. C-reaktivnega proteina in števila belih krvnih celic).
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. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih so razkrili pričakovane farmakološke učinke, ki so zajemali zvišanje števila levkocitov, mieloidno hiperplazijo v kostnem mozgu, ekstramedularno hematopoezo in zvečanje vranice.
Figure 1: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection 
Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - Absolute Neutrophil Count) pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6-miligramski injekciji
This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg/mL. 
To zdravilo vsebuje 30 mg sorbitola v eni napolnjeni injekcijski brizgi, kar je enako 50 mg/ml.
The safety and efficacy of Pegfilgrastim Mundipharma administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established. 
Varnost in učinkovitost uporabe zdravila Pegfilgrastim Mundipharma pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
Splenomegaly and splenic ruptura 
Splenomegalija in ruptura vranice
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. 
Običajni odmerek je ena 6-miligramska subkutana injekcija (podkožna injekcija) z uporabo napolnjene injekcijske brizge, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
Each pre-filled syringe contains 30 mg sorbitol (E420). 
Ena napolnjena injekcijska brizga vsebuje 30 mg sorbitola (E 420).
Rare side effects (may affect up to 1 in 1,000 people) - Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2. 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
Pegfilgrastim Mundipharma 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). 
Zdravilo Pegfilgrastim Mundipharma 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).
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 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1). 
Razen v najmlajši starostni skupini (od 0 do 5 let) je bila povprečna AUC pri pediatričnih bolnikih podobna kot pri odraslih bolnikih z visoko tveganim stadijem II-IV raka dojke, ki so dobili 100 μg/kg pegfilgrastima po dokončanju doksorubicina/docetaksela (glejte poglavji 4.8 in 5.1).
6.6 Special precautions for disposal and other handling Before administration, Pegfilgrastim Mundipharma solution should be inspected visually for particulate matter. 
6.6 Posebni varnostni ukrepi za odstranjevanje Pred uporabo morate raztopino zdravila Pegfilgrastim Mundipharma pregledati glede vidnih delcev.
- 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. 
- 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.
Uncommon side effects (may affect up to 1 in 100 people): - allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch. 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - reakcije alergijske vrste, vključno s pordelostjo in zardevanjem, izpuščajem na koži in dvignjenimi predeli kože, ki srbijo.
- 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. 
- 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.
Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. 
Omejeno število zdravih prostovoljcev in bolnikov z nedrobnoceličnim pljučnim rakom je prejelo subkutane posamične odmerke 300 μg/kg brez resnih neželenih reakcij.
The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. 
Simptomi lahko vključujejo zvišano telesno temperaturo, bolečine v trebuhu, slabo počutje, bolečine v hrbtu in zvišane vrednosti vnetnih označevalcev.
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m2 every 3 weeks for 4 cycles). 
V dvojno slepi, s placebom kontrolirani študiji pri bolnicah z rakom na dojki so ocenili učinek pegfilgrastima na incidenco febrilne nevtropenije po uporabi takšne sheme kemoterapije, ki je povezana z 10-20 % deležem febrilne nevtropenije (docetaksel 100 mg/m2 vsake 3 tedne za 4 cikluse).
Do not shake Pegfilgrastim Mundipharma vigorously as this may affect its activity. 
Zdravila Pegfilgrastim Mundipharma ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
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. 
To so lahko simptomi občasne motnje (pojavi se lahko pri do 1 od 100 oseb), imenovane “sindrom kapilarne prepustnosti”, ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu, in zahteva nujno zdravniško pomoč.
Do not administer Pegfilgrastim Mundipharma to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. 
Zdravila Pegfilgrastim Mundipharma ne dajajte bolnikom z anamnezo preobčutljivosti na pegfilgrastim ali filgrastim.
Very common side effects (may affect more than 1 in 10 people): - bone pain. 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - bolečine v kosteh.
Do not recycle pre-filled syringes or throw them into household waste. 
Napolnjenih injekcijskih brizg ne smete reciklirati ali jih odvreči med gospodinjske odpadke.
The safety and efficacy of Pegfilgrastim Mundipharma 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. 
Varnost in učinkovitost zdravila Pegfilgrastim Mundipharma nista raziskani pri bolnikih z mielodisplastičnim sindromom, kronično mielogeno levkemijo in sekundarno AML, zato ga pri takšnih bolnikih ne smete uporabljati.
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. 
Granulocitne kolonije spodbujajoči faktor lahko spodbudi rast mieloidnih celic in vitro; podobni učinki bi se lahko pojavili pri nekaterih nemieloidnih celicah in vitro.
The safety and efficacy of Pegfilgrastim Mundipharma for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. 
Druga opozorila Varnosti in učinkovitosti zdravila Pegfilgrastim Mundipharma za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
Pegfilgrastim Mundipharma has not been tested in pregnant women. 
Zdravila Pegfilgrastim Mundipharma pri nosečnicah niso preskusili.
- are planning to have a baby. 
- ste noseči,
Important: read the package leaflet before handling pre-filled syringe 
Pomembno: Pred ravnanjem z napolnjeno injekcijsko brizgo preberite priloženo navodilo!
România Egis Pharmaceuticals PLC România Tel: +40 
Egis Pharmaceuticals PLC România Tel: +40 21 412 00 17
The safety and efficacy of Pegfilgrastim Mundipharma have not been investigated in patients receiving high dose chemotherapy. 
Varnosti in učinkovitosti zdravila Pegfilgrastim Mundipharma niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni "brez natrija".
Sodium acetate* Sorbitol (E 420) 
sorbitol (E 420)
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below. 
Občasno (≥ 1/1.000 do < 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo po uporabi granulocitne kolonije spodbujajočega faktorja, 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.
Do not remove the needle cap from the pre-filled syringe until you are ready to inject. 
Ne odstranite pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
Pre-filled syringe (Type I glass), with a bromobutyl rubber stopper and a stainless steel needle with an automatic needle guard. 
Napolnjena injekcijska brizga (iz stekla tipa I) z zaporko iz bromobutilne gume in iglo iz nerjavnega jekla z avtomatskim ščitnikom igle.
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). 
*Pegfilgrastim izdelujejo s tehnologijo rekombinantne DNA v celicah Escherichia coli, ki ji sledi konjugacija s polietilenglikolom (PEG).
Pack size of one pre-filled syringe in a blistered packaging. 
Pakiranje z eno napolnjeno injekcijsko brizgo v pretisnem omotu.
Solution for injection 1 pre-filled syringe with automatic needle guard (0.6 mL). 
1 napolnjena injekcijska brizga z avtomatskim ščitnikom igle (0,6 ml)
Excipients: sodium acetate, sorbitol (E 420), polysorbate 20, and water for injections. 
Pomožne snovi: natrijev acetat, sorbitol (E 420), polisorbat 20 in voda za injekcije.
No dose change is recommended in patients with renal impairment, including those with end stage renal disease. 
Pri bolnikih z okvaro ledvic se spreminjanje odmerka ne priporoča; to velja tudi za bolnike s končno odpovedjo ledvic.
The syringe is provided with an automatic needle guard. 
Na voljo je napolnjena injekcijska brizga z avtomatičnim ščitnikom igle.
Each pack contains 1 pre-filled glass syringe with an attached stainless steel needle and needle cap. 
Ena škatla vsebuje 1 napolnjeno stekleno injekcijsko brizgo s pričvrščeno iglo iz nerjavnega jekla in pokrovčkom igle.
- 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. 
- če 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.
Sweet's syndrome (acute febrile dermatosis)1,2; 
(akutna febrilna dermatoza)1,2; kožni vaskulitis1,2
For further instructions on how to inject yourself with Pegfilgrastim Mundipharma, please read the section at the end of this leaflet. 
Nadaljnja navodila za samoinjiciranje zdravila Pegfilgrastim Mundipharma si preberite v poglavju na koncu tega navodila za uporabo.
What Pegfilgrastim Mundipharma is and what it is used for 
Kaj je zdravilo Pegfilgrastim Mundipharma in za kaj ga uporabljamo
What Pegfilgrastim Mundipharma looks like and contents of the pack Pegfilgrastim Mundipharma is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL). 
Zdravilo Pegfilgrastim Mundipharma je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
- The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections. 
- Pomožne snovi so natrijev acetat, sorbitol (E 420), polisorbat 20 in voda za injekcije.
Pegfilgrastim Mundipharma therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. 
4.2 Odmerjanje in način uporabe Zdravljenje z zdravilom Pegfilgrastim Mundipharma morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
If you become pregnant during Pegfilgrastim Mundipharma treatment, please inform your doctor. 
Če med zdravljenjem z zdravilom Pegfilgrastim Mundipharma zanosite, o tem obvestite zdravnika.
Permanently discontinue Pegfilgrastim Mundipharma in patients with clinically significant hypersensitivity. 
Dokončno prenehajte z zdravljenjem z zdravilom Pegfilgrastim Mundipharma pri bolnikih s klinično signifikantno preobčutljivostjo.
Pegfilgrastim Mundipharma is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Zdravila Pegfilgrastim Mundipharma ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001). 
Incidenca febrilne nevtropenije je bila nižja pri bolnicah, ki so dobivale pegfilgrastim, kot pri tistih, ki so dobivale placebo (1 % v primerjavi s
Concomitant use of Pegfilgrastim Mundipharma with any chemotherapy agent has not been evaluated in patients. 
Sočasne uporabe zdravila Pegfilgrastim Mundipharma s katerim koli kemoterapevtskim zdravilom pri bolnikih niso ovrednotili.
B Open the tray, peeling away the cover. 
Odprite podlogo, tako da z nje odlepite pokrivno folijo.
There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk a risk to the newborns/infants cannot be excluded. 
Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4). 
Bolnikom, ki prejemajo pegfilgrastim, se lahko pojavijo resne alergijske reakcije, vključno z anafilaksijo (občasni) (glejte poglavje 4.4).
- 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 - if you experience a cough, fever and difficulty breathing. 
- 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.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 
Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
Pegfilgrastim Mundipharma is a biosimilar medicinal product. 
Zdravilo Pegfilgrastim Mundipharma je podobno biološko zdravilo.
Nausea1 
AST1
Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included). 
potrebno za injiciranje: alkoholne zložence, kosem vate ali zloženec gaze, obliž in vsebnik za ostre odpadke (ni priloženo).
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). 
Pri bolnikih z de novo akutno mieloidno levkemijo (AML) omejeni klinični podatki kažejo primerljiv učinek pegfilgrastima in filgrastima na čas do okrevanja po hudi nevtropeniji (glejte poglavje 5.1).
Other medicines and Pegfilgrastim Mundipharma 
Druga zdravila in zdravilo Pegfilgrastim Mundipharma
The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6. 
Za navodila glede ravnanja z zdravilom pred dajanjem glejte poglavje 6.6.
(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). 
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).
Pegfilgrastim Mundipharma is injected subcutaneously. 
Zdravilo Pegfilgrastim Mundipharma se injicira subkutano.
Solution for injection Clear, colourless solution for injection. 
raztopina za injiciranje bistra, brezbarvna raztopina za injiciranje
One 6 mg dose (a single pre-filled syringe) of Pegfilgrastim Mundipharma is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. 
Za vsak cikel kemoterapije priporočajo en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) zdravila Pegfilgrastim Mundipharma, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
If you forget to inject Pegfilgrastim Mundipharma If you have forgotten a dose of Pegfilgrastim Mundipharma, you should contact your doctor to discuss when you should inject the next dose. 
Če ste si pozabili injicirati zdravilo Pegfilgrastim Mundipharma Če ste pozabili odmerek zdravila Pegfilgrastim Mundipharma, se posvetujte z zdravnikom glede tega,
Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8). 
Po uporabi pegfilgrastima so poročali o v splošnem asimptomatskih primerih splenomegalije in o primerih rupture vranice, vključno z nekaterimi smrtnimi primeri (glejte poglavje 4.8).
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pegfilgrastim Mundipharma. 
Ob uporabi zdravila Pegfilgrastim Mundipharma so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).