natgillin/translations-raw huggingface dataset:
Pelgraz is a biosimilar medicinal product.
Zdravilo Pelgraz je podobno biološko zdravilo.
Other medicines and Pelgraz
Druga zdravila in zdravilo Pelgraz
What you need to know before you use Pelgraz Do not use Pelgraz
Kaj morate vedeti, preden boste uporabili zdravilo Pelgraz Ne uporabljajte zdravila Pelgraz
The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4).
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (glejte poglavje 4.4).
Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours.
Zdravilo Pelgraz sme biti izpostavljeno sobni temperaturi (ne nad 25 °C ± 2 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
If you become pregnant during Pelgraz treatment, please inform your doctor.
Če med zdravljenjem z zdravilom Pelgraz zanosite, o tem obvestite zdravnika.
In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of filgrastim or pegfilgrastim.
V večini primerov je bil aortitis diagnosticiran s slikanjem CT in je izzvenel po prenehanju dajanja filgrastima ali pegfilgrastima.
The safety and efficacy of Pelgraz in children and adolescents has not yet been established.
Varnost in učinkovitost zdravila Pelgraz pri otrocih in mladostnikih še nista bili dokazani.
These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
To so lahko simptomi motnje, imenovane "sindrom kapilarne prepustnosti", ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu.
Pelgraz is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Zdravilo Pelgraz 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).
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček igle pri napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), kar lahko povzroča alergijske reakcije.
• 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).
• 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).
Like all medicines, Pelgraz can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Pelgraz neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
It is quite normal to have a number of courses of treatment with Pelgraz.
Povsem običajno je, da zdravljenje z zdravilom Pelgraz poteka v več ciklih.
The safety and efficacy of Pelgraz in children has not yet been established.
Varnost in učinkovitost zdravila Pelgraz pri otrocih še nista bili dokazani.
It is better to change the injection site every time to avoid the risk of soreness at any one site.
Priporočljivo je, da vsakič injicirate na drugem mestu, saj se s tem izognete bolečini na posameznih mestih injiciranja.
The safety and efficacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Mobilizacija matičnih krvotvornih celic Varnosti in učinkovitosti zdravila Pelgraz za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
Pelgraz does not contain any preservative.
Zdravilo Pelgraz ne vsebuje konzervansov.
• have sickle cell anaemia.
• imate srpastocelično anemijo.
If you stop using Pelgraz
Če ste prenehali uporabljati zdravilo Pelgraz
Take the pre-filled injector out of the refrigerator.
Vzemite napolnjen injektor iz hladilnika.
Find a comfortable, well-lit place and put everything you need where you can reach them (the pre-filled injector and alcohol swab).
Poiščite udoben, dobro osvetljen prostor in pripravite vso opremo, ki jo boste potrebovali, tako da bo ta pri roki (napolnjen injektor in alkoholni zloženec).
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
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).
After injecting the liquid, while keeping the syringe at the same angle and maintaining pressure on the plunger, remove the needle and then let go of your skin.
Po injiciranju tekočine ne popuščajte pritiska na batu in iglo ohranite pod istim kotom, nato pa iglo izvlecite in spustite kožo.
Read the package leaflet for further information.
Za nadaljnje informacije preberite navodilo za uporabo.
The pre-filled syringe is externally equipped with the device for selfadministration (pre-filled injector).
Napolnjena injekcijska brizga je zunanje opremljena s pripomočkom za samoinjiciranje (napolnjen injektor).
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 največ 1 od 100 bolnikov), imenovane "sindrom kapilarne prepustnosti", ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu, ki zahteva nujno zdravniško pomoč.
Disposing of used syringes
Odstranjevanje rabljenih injekcijskih brizg
Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Sindrom kapilarne prepustnosti Po uporabi granulocitne kolonije spodbujajočega faktorja so poročali o sindromu kapilarne prepustnosti, za katerega so značilni hipotenzija, hipoalbuminemija, edemi in hemokoncentracija.
*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, kateri sledi konjugacija s polietilenglikolom (PEG).
While maintaining pressure on the plunger, the syringe should be removed from the injection site.
Med ohranjanjem pritiska na batu je treba brizgo izvleči iz mesta injiciranja.
Do not recap.
Ne zamrzujte.
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˝.
Take the pre-filled syringe out of the refrigerator.
Vzemite napolnjeno injekcijsko brizgo iz hladilnika.
Read the package leaflet before use.
za subkutano uporabo Pred uporabo preberite priloženo navodilo!
How do I prepare my Pelgraz injection?
Kako si pripravim injekcijo zdravila Pelgraz?
(acute febrile dermatosis)1,2
Sweetov sindrom (akutna febrilna dermatoza)1,2; kožni vaskulitis1,2
Find a comfortable, well-lit place and put everything you need where you can reach them (the pre-filled syringe and alcohol swab).
Poiščite udoben, dobro osvetljen, čist prostor in pripravite vso opremo, ki jo boste potrebovali, tako da bo ta pri roki (napolnjena injekcijska brizga in alkoholni zloženec).
Hold the syringe and gently take the cover from the needle without twisting.
Primite injekcijsko brizgo ter nežno in brez sukanja potegnite pokrovček z igle.
Check the expiry date on the pre-filled injector label (EXP).
Preverite datum izteka roka uporabnosti zdravila na nalepki napolnjenega injektorja (EXP).
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo AML (see section 5.1).
Pri bolnikih z de novo AML omejeni klinični podatki kažejo primerljiv učinek pegfilgrastima in filgrastima na čas do okrevanja po hudi nevtropeniji (glejte poglavje 5.1).
• a pre-filled injector of Pelgraz;
• napolnjen injektor zdravila Pelgraz;
• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
How to use Pelgraz
Kako uporabljati zdravilo Pelgraz
Dispose of the syringe as instructed by your doctor, pharmacist or nurse.
Injekcijsko brizgo odstranite v skladu z navodili zdravnika, farmacevta ali medicinske sestre.
In order to improve traceability of granulocyte-colony stimulating factors, the medicine name (Pelgraz) and batch number of the administered syringe should be clearly recorded in the patient file.
Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev je treba v bolnikovi dokumentaciji jasno zabeležiti ime zdravila (Pelgraz) in številko serije uporabljene injekcijske brizge.
In view of the possible risk of microbial contamination, Pelgraz syringes are for single use only.
Zaradi možnosti onesnaženja z mikrobi so injekcijske brizge zdravila Pelgraz namenjene le enkratni uporabi.
Pre-filled syringe with needle safety guard b.
Napolnjena injekcijska brizga s ščitnikom za iglo b.
Do not inject if you drop the pre-filled injector after removing cap.
Ne injicirajte, če vam je napolnjen injektor po odstranitvi zamaška padel iz rok.
If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
SJS, se pri tem bolniku nikoli več ne sme ponovno uvesti zdravljenja s pegfilgrastimom.
Uncommon (≥ 1/1,000 to
(≥ 1/1.000 do
What Pelgraz looks like and contents of the pack
Izgled zdravila Pelgraz in vsebina pakiranja
Pelgraz contains sorbitol (E420) and sodium acetate
Zdravilo Pelgraz vsebuje sorbitol (E420) in natrijev acetat
Solution for injection 1 pre-filled injector + 1 alcohol swab
Raztopina za injiciranje 1 napolnjen injektor + 1 alkoholni zloženec
Using the pre filled syringe with a needle safety guard The needle safety guard covers the needle after injection to prevent needle stick injury.
Uporaba napolnjene injekcijske brizge s ščitnikom igle Ščitnik igle po injiciranju prekrije iglo, s čimer se preprečijo poškodbe zaradi vboda z iglo.
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Da bo injiciranje bolj prijetno, pustite napolnjeno injekcijsko brizgo stati 30 minut zunaj hladilnika, da bo dosegla sobno temperaturo, ali jo nekaj minut previdno držite v roki.
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled injector label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki napolnjenega injektorja poleg oznake »EXP«.
• 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.
• 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.
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/
Pelgraz contains the active substance pegfilgrastim.
Zdravilo Pelgraz vsebuje učinkovino pegfilgrastim.
In order to improve traceability of granulocyte-colony stimulating factors, the medicine name (Pelgraz) and batch number of the administered pre-filled injector should be clearly recorded in the patient file.
Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev je treba v bolnikovi dokumentaciji jasno zabeležiti ime zdravila (Pelgraz) in številko serije uporabljenega napolnjenega injektorja.
• get left upper abdominal pain or pain at the tip of your shoulder.
• začutite bolečino levo zgoraj v trebuhu ali v predelu lopatice.
For a more comfortable injection, let the pre-filled injector stand for 30 minutes to reach room temperature or hold the pre-filled injector gently in your hand for a few minutes.
Da bo injiciranje bolj prijetno, pustite napolnjen injektor stati 30 minut zunaj hladilnika, da bo dosegel sobno temperaturo, ali ga nekaj minut previdno držite v roki.
The plunger should be slowly and evenly depressed until the entire dose has been given and the plunger cannot be depressed any further.
Bat je treba počasi in enakomerno potiskati, dokler ni dan celoten odmerek in dokler bat ni pritisnjen do konca.
Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
bolečina v okončini, bolečina v hrbtu, mišičnoskeletna bolečina, bolečina v vratu)
If you use more Pelgraz than you should contact your doctor, pharmacist or nurse.
Če ste uporabili večji odmerek zdravila Pelgraz, kot bi smeli Če uporabite več zdravila Pelgraz, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Pelgraz contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodiumfree'.
Zdravilo Pelgraz vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni
The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Simptomi lahko vključujejo povišano telesno temperaturo, bolečine v trebuhu, splošno slabo počutje, bolečine v hrbtu in povišane vrednosti vnetnih označevalcev (npr. Creaktivnega proteina in števila belih krvničk).
In view of the possible risk of microbial contamination, Pelgraz in pre-filled injector are for single use only.
Zaradi možnosti onesnaženja z mikrobi so napolnjeni injektorji zdravila Pelgraz namenjeni le enkratni uporabi.
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/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 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.
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.
The needle safety guard covers the needle after injection to prevent needle stick injury.
Ščitnik igle po injiciranju prekrije iglo, s čimer se preprečijo poškodbe zaradi vboda z iglo.
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pelgraz.
Če je zdravilo Pelgraz pomotoma izpostavljeno temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
• 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.
• 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.
Pelgraz is available in packs containing 1 pre-filled syringe, with prefixed needle safety guard in individual blister pack and one alcohol swab.
Zdravilo Pelgraz je na voljo v pakiranju s po 1 napolnjeno injekcijsko brizgo z nameščenim ščitnikom za iglo v posameznem pretisnem omotu in enim alkoholnim zložencem.
Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
• experience a cough, fever and difficulty breathing.
• začnete kašljati, se vam zviša telesna temperatura in začnete težko dihati.
One 6 mg dose (a single pre-filled syringe or pre-filled injector) of Pelgraz 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 ali en napolnjen injektor) zdravila Pelgraz, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
Solution for injection 1 pre-filled syringe + 1 alcohol swab
Raztopina za injiciranje 1 napolnjena injekcijska brizga + 1 alkoholni zloženec
The needle safety guard will cover the needle when releasing the plunger.
Ščitnik za iglo bo iglo pokril ob sprostitvi pritiska na bat.
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz .
Ob uporabi zdravila Pelgraz so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).
Pelgraz is a clear colourless solution for injection in a pre-filled injector with an injection needle.
Zdravilo Pelgraz je bistra, brezbarvna raztopina za injiciranje v napolnjenem injektorju z injekcijsko iglo.
• Lift straight up: The yellow band indicates that the needle guard is locked.
Rumen krog označuje, da je ščitnik za iglo zaklenjen.
Allow the pre-filled injector to reach room temperature before injecting.
Pred injiciranjem pustite napolnjen injektor, da doseže sobno temperaturo.
Pulmonary adverse reactions
Neželene reakcije na pljučih
Keep hands away from needle guard after cap is removed.
Po odstranitvi zamaška roke umaknite od ščitnika za iglo.
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%).
Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9 %, pri bolnikih, zdravljenih s filgrastimom, pa 18 % (razlika 9 %, 95 % IZ je
Contents of the pack and other information
Shranjevanje zdravila Pelgraz Vsebina pakiranja in dodatne informacije
Aortitis has been reported after filgrastim or pegfilgrastim administration in healthy subjects and in cancer patients.
Pri zdravih posameznikih in bolnikih z rakom so po dajanju filgrastima ali pegfilgrastima poročali o aortitisu.
• Gather an alcohol swab and a sharps container
• Pripravite alkoholni zloženec in zbiralnik za ostre predmete.
Pelgraz is a clear colourless solution for injection in a pre-filled syringe with an injection needle.
Zdravilo Pelgraz je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi z injekcijsko iglo.
The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count).
Simptomi, ki so se pojavili, so vključevali povišano telesno temperaturo, bolečine v trebuhu, splošno slabo počutje, bolečine v hrbtu in povišane vrednosti vnetnih označevalcev (npr. Creaktivnega proteina in števila belih krvničk).
Pelgraz is available in a pack containing 1 pre-filled injector in a monocarton and one alcohol swab.
Zdravilo Pelgraz je na voljo v pakiranju s po 1 napolnjenim injektorjem v škatli in enim alkoholnim zložencem.
For all questions about storage, ask your doctor, nurse or pharmacist.
Če imate kakršna koli vprašanja glede shranjevanja, se obrnite na zdravnika, medicinsko sestro ali farmacevta.
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.
Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike krvne žile, ki prenaša kri od srca po telesu).
Using the pre-filled syringe with needle safety guard
Uporaba napolnjene injekcijske brizge s ščitnikom igle
Pack size of one pre-filled injector with one alcohol swab, in a blistered packaging.
Pakiranje z enim napolnjenim injektorjem in enim alkoholnim zložencem v pretisnem omotu.
Talk to your doctor, pharmacist or nurse before using Pelgraz if you:
Pred začetkom uporabe zdravila Pelgraz se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
• a pre-filled syringe of Pelgraz;
• napolnjeno injekcijsko brizgo zdravila Pelgraz;
There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Dojenje Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
da subkutano dajanje pegfilgrastima ne vpliva na sposobnost razmnoževanja, plodnost, obdobje estrusa, dneve med parjenjem in koitusom ter intrauterino preživetje.
Capillary leak syndrome1
Žilne bolezni sindrom kapilarne prepustnosti1
The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1).
(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).
How do I inject Pelgraz myself?
Kako si injiciram zdravilo Pelgraz?
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon
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 (občasno [≥ 1/1.000 do < 1/100]).
Sickle cell crisis2; Splenomegaly2;
srpastocelična kriza2, splenomegalija2, ruptura vranice2
Glomerulonephrit is2
Bolezni sečil glomerulonefritis2
Check with your doctor or pharmacist for proper disposal instructions.
Glede ustreznih navodil za odstranjevanje se posvetujte z zdravnikom ali farmacevtom.
A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo AML compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
faze pri bolnikih, ki so dobivali kemoterapijo zaradi de novo AML, je primerjala pegfilgrastim (enkraten odmerek 6 mg) s filgrastimom ob aplikaciji med indukcijsko kemoterapijo.
Pelgraz 6 mg solution for injection in pre-filled syringe Pre-filled syringe (type I glass) with a permanently attached stainless steel injection needle, with a needle safety guard.
Pelgraz 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga (iz stekla tipa I) s trajno pritrjeno nerjavečo jekleno injekcijsko iglo in ščitnikom igle.