natgillin/translations-raw huggingface dataset:
After the second “click” (or count of 15) lift pre-filled pen from the injection site.
Ko boste zaslišali drugi “ klik ” (ali prešteli do 15), dvignite napolnjeni injekcijski peresnik z mesta injiciranja.
If you experience difficulties choose a more firm injection site
Če se pojavijo težave, izberite čvrstejše mesto za injiciranje.
Only use a single Neulasta pre-filled pen for each injection.
Vsak napolnjeni injekcijski peresnik Neulaste uporabite samo za eno injiciranje.
Choose a site at least 5 cm away from the belly button (navel) (see picture 4).
Izberite primerno mesto, ki je vsaj 5 cm oddaljeno od popka (glejte 5. sliko 4).
5.
Kožno gubo trdno držite skozi celoten postopek (glejte sliko 5).
Press the pre-filled pen firmly enough against the skin so that the safety cover is fully retracted (see picture 6).
Pomembne informacije za korak A v postopku injiciranja Napolnjeni injekcijski peresnik pritisnite na kožo dovolj močno, da se varnostni pokrovček popolnoma umakne (glejte sliko 6).
The pre-filled pen has a safety cover that will protect you from needle Safety cover sticks or loss of drug by accidental bumping or touching.
Napolnjeni injekcijski peresnik ima pokrovček, ki preprečuje, da bi se po nesreči zbodli z iglo ali da bi zaradi naključnega sunka ali dotika
Safety cover out
Varnostni
fully retracted
Varnostni pokrovček
47 At start, keep thumb clear of green button
prišlo do izgube zdravila.
A.
umaknjen
Hold down.
Napolnjeni injekcijski peresnik prislonite pravokotno na sredino kožne gube (pod kotom 90 stopinj), nato ga čvrsto pritisnite na kožo in zadržite.
2 release
2. spustite
1 press
1. pritisnite B.
Maintaining firm skin pinch, (1) press and (2) release the green button on top.
Ko trdno držite kožno gubo, (1) pritisnite in (2) spustite zeleni gumb na vrhu.
You will hear a “click”.
Pri tem boste zaslišali “ klik ”.
After the second “click” (or a count of 15) lift the pre-filled pen from the injection site.
Ko boste zaslišali drugi “ klik ” (ali prešteli do 15), dvignite napolnjeni injekcijski peresnik z mesta injiciranja.
• Due to the protective safety cover it is not recommended to put the grey needle shield back on the used pre-filled pen.
• Zaradi varnostnega pokrovčka ni priporočljivo, da bi sivi pokrovček igle nameščali nazaj na uporabljen injekcijski peresnik.
Neulasta 6 mg solution for injection in a pre -filled syringe pegfilgrastim
Neulasta 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
• if you have an allergy to latex.
50 • če ste alergični na lateks.
49 Using other medicines
Uporaba drugih zdravil
50 If you forget to inject Neulasta
51 Če ste si pozabili injicirati Neulasto
You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
52 Neulasto smete vzeti iz hladilnika in jo hraniti pri sobni temperaturi (pod 30 ºC) največ 3 dni dolgo.
51 Do not freeze.
Ne zamrzujte.
Neulasta is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Neulasta je raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/ 0, 6 ml).
The syringes are provided either with or without an automatic needle guard or blister wrapping.
Na voljo so napolnjene injekcijske brizge z avtomatičnim ščitnikom igle ali brez v pretisnem omotu.
53 This leaflet was last approved in.
54 Navodilo je bilo odobreno:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
INSTRUCTIONS FOR INJECTING WITH THE NEULASTA PRE-FILLED SYRINGE
NAVODILA ZA INJICIRANJE Z NAPOLNJENO INJEKCIJSKO BRIZGO NEULASTA
This section contains information on how you, or the person injecting you, use the Neulasta pre-filled syringe.
To poglavje obsega informacije o tem, kako naj vi sami ali oseba, ki vam injicira zdravilo Neulasta, uporabite napolnjeno injekcijsko brizgo.
To reduce the risk of accidental needle sticks to users, each pre-filled syringe is equipped with a needle guard that is automatically activated to cover the needle after complete delivery of the pre-filled syringe content.
Da bi bilo tveganje naključnih vbodov z iglo za uporabnike čim manjše, so napolnjene injekcijske brizge opremljene s ščitnikom igle, ki se avtomatično aktivira in prekrije iglo, ko je celotna vsebina brizge injicirana.
DO NOT attempt to unlock the pre-filled syringe prior to injection.
NE POSKUŠAJTE sprostiti napolnjene injekcijske brizge pred injiciranjem.
DO NOT use the pre-filled syringe if the needle cover has been removed, or the needle guard has been activated (covering the needle).
NE UPORABITE napolnjene injekcijske brizge, če je bil pokrovček igle odstranjen ali je bil ščitnik igle aktiviran (in prekriva iglo).
How do I use the Neulasta pre-filled syringe?
Kako naj uporabim napolnjeno injekcijsko brizgo Neulasta?
Your doctor has prescribed an Neulasta pre-filled syringe for injection into the tissue just under the skin.
Zdravnik vam je predpisal napolnjeno injekcijsko brizgo Neulasta za injiciranje tik pod kožo.
Your doctor, nurse, or pharmacist will tell you how much Neulasta you need and how frequently it should be injected.
Zdravnik, medicinska sestra ali farmacevt vam bo povedal, koliko zdravila Neulasta potrebujete in kako pogosto si ga morate injicirati.
• a new Neulasta pre-filled syringe; and
• novo napolnjeno injekcijsko brizgo zdravila Neulasta in
What should I do before I give myself a subcutaneous injection of Neulasta?
Kaj moram narediti, preden si podkožno injiciram zdravilo Neulasta?
Do not pick up the pre-filled syringe by the plunger or needle cover.
Ne prijemajte napolnjene injekcijske brizge za bat ali pokrovček igle.
Leave the pre-filled syringe at room temperature for approximately 30 minutes.
Približno 30 minut jo pustite na sobni temperaturi.
Do not warm Neulasta in any other way (for example, in a microwave or in hot water).
Ne ogrevajte zdravila Neulasta kako drugače (npr. v mikrovalovni pečici ali vroči vodi).
Do not leave the syringe exposed to direct sunlight.
Ne puščajte brizge neposredno izpostavljene sončni svetlobi.
Do not remove the cover from the pre-filled syringe until you are ready to inject.
Ne odstranite ovojnine z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
Do not use it if the date has passed the last day of the month shown.
Ne uporabite je, če je že pretekel zadnji dan navedenega meseca.
It must be a clear and colourless liquid.
Biti mora bistra, brezbarvna ali rahlo biserna tekočina.
If someone else is injecting for you, they can also use the back of your arms.
Če vam zdravilo injicira kdo drug, vam ga lahko da tudi v zadnjo stran nadlaktov.
Change the injection site if you notice the area is red or sore.
Če je predel pordel ali boli, zamenjajte mesto injiciranja.
Disinfect your skin by using an alcohol wipe.
Kožo razkužite z alkoholnim lističem
To avoid bending the needle, gently pull the cover from the needle straight off without twisting as shown.
Da ne boste zvili igle, previdno snemite pokrovček igle povsem naravnost, ne da bi ga upogibali, tako kot je prikazano.
Do not touch the needle or push the plunger.
Ne dotikajte se igle in ne pritiskajte bata.
Pinch (without squeezing) the skin between your thumb and forefinger.
Kožo primite med palec in kazalec, ne da bi jo stiskali.
If you see blood in the syringe, pull the needle out and re-insert it in another place after disinfecting the skin.
Če v brizgi opazite kri, izvlecite iglo in jo zabodite drugam; pred tem morate kožo na tistem drugem mestu razkužiti.
Push the plunger with a slow constant pressure, always keeping your skin pinched.
Kožo ves čas držite ter počasi in stalno potiskajte bat.
The needle guard will not activate unless you empty the pre-filled syringe.
Ščitnik igle se ne aktivira, dokler ni napolnjena injekcijska brizga prazna.
While the plunger is still pressed all the way down, remove the needle from the skin, then release the plunger and allow the syringe to move up until the entire needle is covered by the needle guard.
Potem bat izpustite in pustite, da se brizga pomakne navzgor, dokler ni igla v celoti prekrita s ščitnikom igle.
If the needle guard is not activated, an incomplete injection may have occurred.
Če se ščitnik igle ne aktivira, morda niste injicirali vsega zdravila.
Call your health care provider if you think you have not received the full dose.
Če se vam zdi, da niste dobili celotnega odmerka, se obrnite na svojega zdravnika.
DO NOT put the needle cover back on the needle.
Pokrovčka igle NE NAMEŠČAJTE nazaj na iglo.
If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Če opazite kapljico krvi, jo previdno popivnajte s koščkom vate ali papirnatim robčkom.
Only use each pre-filled syringe for one injection.
Vsako napolnjeno injekcijsko brizgo uporabite le za eno injiciranje.
Remember:
Ne pozabite:
If you have any problems, please ask your doctor or nurse for help and advice.
Če imate kakršnekoli težave, se za pomoč in nasvet obrnite na zdravnika ali medicinsko sestro.
• You do not need to put the needle cover back on used syringes. • Keep used syringes out of the reach and sight of children. • The used syringe should be disposed of in accordance with local requirements.
• Pokrovčka igle vam ni treba namestiti nazaj na uporabljeno brizgo. • Uporabljene injekcijske brizge shranjujte nedosegljive otrokom. • Uporabljeno brizgo zavrzite v skladu z lokalnimi predpisi.
It explains how
Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
is the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
or If you need more information about your medical condition or your treatment, read the Package
et Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodilo za
th Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
o želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je
au of the EPAR).
pr prav tako del EPAR).
Neupopeg is a solution for injection that contains the active ingredient pegfilgrastim.
za Kaj je zdravilo Neupopeg? a Zdravilo Neupopeg je raztopina za injiciranje, ki vsebuje zdravilno učinkovino pegfilgrastim.
It is available in ng a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim. lo
Na voljo nj je kot napolnjena injekcijska brizga in napolnjeno injekcijsko pero (Sure Click), ki vsak vsebuje 6 mg lje pegfilgrastima. vo
What is Neupopeg used for?
Za kaj se zdravilo Neupopeg uporablja? do
Chemotherapy (cancer treatment) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low white blood cell counts) and the development of infections.
Kemoterapija (zdravljenje raka), ki je citotoksična (torej taka, ki ubija celice) ā
Neupopeg is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with ct
ubija tudi bele krvničke, kar lahko povzroči nevtropenijo (zmanjšano število belih krvničk) ter razvoj ve
fever). du
vnetij.
Neupopeg can be used for many types of cancer, except for chronic myeloid leukaemia (a cancer of the white blood cells).
Zdravilo Neupopeg se lahko uporablja pri mnogih vrstah raka, razen pri kronični mieloidni levkemiji m
It also cannot be used in patients with myelodysplastic syndromes, a disease in which too many white blood cells are produced, and which can develop into leukaemia. ro
Zdravila prav tako ne smejo prejemati osebe z mielodisplastičnim sindromom, boleznijo, pri kateri nastaja preveč belih krvničk in ki se lahko razvije v levkemijo. ni
The medicine can only be obtained with a prescription. lp
Zdravilo se dobi samo na recept. lo vi
How is Neupopeg used? a
Kako se zdravilo Neupopeg uporablja?
Neupopeg treatment should be initiated and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
zdravljenjem raka ali boleznimi krvi.
Neupopeg is given as a single 6 mg injection under the skin in
Zdravilo Neupopeg se daje kot enkratna 6 mg injekcija pod kožo Zd
around 24 hours after the end of each cycle of chemotherapy.
približno 24 ur ob koncu vsakega cikla kemoterapije.
have been trained appropriately.
Bolniki si lahko zdravilo vbrizgajo sami, če so bili ustrezno usposobljeni.
Neupopeg is not recommended for use in children, due to a lack of information on its safety and effectiveness in this group. ed
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, zdravilo Neupopeg ni priporočeno za otroke.
M
Kako zdravilo Neupopeg deluje?
The active substance in Neupopeg, pegfilgrastim, is an immunostimulant that belongs to the group ‘ colony stimulating factors’.
Zdravilna učinkovina v zdravilu Neupopeg, pegfilgrastim, je imunostimulant, ki spada v skupino „ kolonije spodbujajočih faktorjev “.
The filgrastim in Neupopeg is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Filgrastim v zdravilu Neupopeg se proizvaja po metodi, imenovani „ tehnologija rekombinantne DNK “: encim proizvede bakterija, ki je prejela gen (DNK) s pomočjo katerega postane sposobna tvoriti filgrastim.
ed Neupopeg was as effective as filgrastim in reducing the duration of severe neutropenia.
Zdravilo Neupopeg je bilo pri skrajšanju trajanja hude nevtropenije enako učinkovito kot filgrastim.
is What is the risk associated with Neupopeg?
Kakšna tveganja so povezana z zdravilom Neupopeg?
or Most of the side effects seen in patients taking Neupopeg in studies are due to their underlying disease or chemotherapy.
et Večino neželenih učinkov, opaženih pri bolnikih, ki so jemali zdravilo Neupopeg, je treba pripisati
The most common side effects with Neupopeg (seen in more than 1 in 10 patients)
Najpogostejši neželeni učinki pri jemanju zdravila Neupopeg (opaženi pri več kot enem izmed 10 bolnikov) so bolečine v kosteh in povišane ravni laktat -
For
Za celoten seznam neželenih učinkov, o
au the full list of all side effects reported with Neupopeg, see the Package Leaflet.
pr katerih so poročali pri uporabi zdravila Neupopeg, glejte Navodilo za uporabo.
Neupopeg should not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.
za Zdravila Neupopeg ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pegfilgrastim ali katero koli drugo sestavino zdravila.
Why has Neupopeg been approved? er ng The Committee for Medicinal Products for Human Use (CHMP) decided that Neupopeg’ s benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile lo neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Neupopeg lje
The Committee recommended that Neupopeg be given marketing authorisation. no
Odbor je priporočil, da se za zdravilo Neupopeg odobri dovoljenje za promet. do
Other information about Neupopeg:
Druge informacije o zdravilu Neupopeg: ā
The European Commission granted a marketing authorisation valid throughout the EU for Neupopeg ct
Evropska komisija je dovoljenje za promet z zdravilom Neupopeg, veljavno po vsej Evropski uniji, ve
to Dompé Biotec S. p. A. on 22 August 2002.
odobrila družbi Amgen Europe B. V. dne 22. avgusta 2002.
The marketing authorisation was renewed on 22 August 2007. du
Dovoljenje za promet je bilo podaljšano 22. avgusta 2007. a m
The full EPAR for Neupopeg can be found here. ro lp
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Neupopeg je na voljo tukaj. ni lo
This summary was last updated in 02-2008. a in ic ed M
Povzetek je bil nazadnje posodobljen 02- 2008. vi ra Zd
Invented
Zaščiteno
d Package size
Velikost pakiranja
ris
et
pre-filled
(steklena) napolnjena
EU/ 1/ 02/ 228/ 002
ro EU/ 1/ 02/ 228/ 002
u without blister EU/ 1/ 02/ 228/ 003
p v nepretisni ovojnini EU/ 1/ 02/ 228/ 003
1 pre-filled pen
1 napolnjeni injekcijski
use
injekcijski peresnik
(glass)
peresnik
r (SureClick)
z (SureClick)
e ng lo t no c du ro lp
a nj je ol v do ā ve a im n ilo v ra d Z
ed is or th au ANNEX Ier ng SUMMARY OF PRODUCT CHARACTERISTICS lo o tn uc od pr al in ic ed M 1.
et m o pr za a nj DODATEK I lje POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA vo do ā ve a m ni lo vi ra Zd
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/ ml if the PEG moiety is included
et ** Če je vključen še delež PEG, je koncentracija 20 mg/ ml.
The potency of this product should not be compared to the potency of another pegylated or non- pegylated protein of the same therapeutic class.
m Učinkovitosti tega sredstva ne gre primerjati z učinkovitostjo drugih pegiliranih ali nepegiliranih proteinov iz iste terapevtske skupine.
ed Excipients:
o pr Pomožne snovi:
is or Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4).
za Pomožne snovi z znanim delovanjem: sorbitol E420, natrijev acetat (glejte poglavje 4. 4).
th For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
au 3.
a nj 3.
Solution for injection. lo
FARMACEVTSKA OBLIKA lje Raztopina za injiciranje (injekcija) vo
Clear, colourless solution for injection. o tn uc
Bistra, brezbarvna raztopina za injiciranje. do ā
CLINICAL PARTICULARS od
KLINIČNI PODATKI ve
4.1 Therapeutic indications pr
4. 1 Terapevtske indikacije a
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and al
Skrajšanje trajanja nevtropenije in incidence febrilne nevtropenije pri bolnikih, zdravljenih s m
myelodysplastic syndromes). in ic
citotoksično kemoterapijo za maligne bolezni (z izjemo kronične mieloidne levkemije in mielodisplastičnih sindromov). ni
4.2 Posology and method of administration ed
4. 2 Odmerjanje in način uporabe lo
Neupopeg therapy should be initiated and supervised by physicians experienced in oncology and/ or M
Zdravljenje z Neupopegom morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ ali vi
haematology.
hematologiji. ra
One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Neupopega, ki je dan v obliki subkutane injekcije približno 24 ur po citotoksični kemoterapiji.
4.4 Special warnings and precautions for use
2 4. 4 Posebna opozorila in previdnostni ukrepi
The safety and efficacy of Neupopeg 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.
Varnost in učinkovitost zdravila Neupopeg nista raziskani pri bolnikih z mielodisplastičnim sindromom, kronično mielogeno levkemijo in s sekundarno akutno mieloično levkemijo (AML), zato
ed The safety and efficacy of Neupopeg administration in de novo AML patients aged < 55 years with cytogenetics t(15; 17) have not been established.
m Varnost in učinkovitost Neupopega pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko
is or The safety and efficacy of Neupopeg have not been investigated in patients receiving high dose
pr Varnosti in učinkovitosti Neupopega niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih
th chemotherapy.
za odmerkih.
au Rare (≥ 1/ 10,000 to < 1/ 1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Po uporabi G- CSF so opisani redki primeri (≥ 1/ 10. 000 do < 1/ 1. 000) neželenih učinkov na pljučih,
Patients with a recent history of pulmonary infiltrates or er pneumonia may be at higher risk. ng
Bolj ogroženi utegnejo biti bolniki z nedavno anamnezo pljučnih
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological lo
nj infiltratov ali pljučnice. lje Pojav pljučnih znakov, kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi vo
In such o
znaki pljučnih infiltratov, in poslabšanje pljučne funkcije skupaj z zvečanim številom nevtrofilcev utegnejo biti preliminarni znaki sindroma dihalne stiske odraslih (ARDS - 'Adult Respiratory Distress Syndrome').
circumstances Neupopeg should be discontinued at the discretion of the physician and the appropriate tn
V takem primeru je treba Neupopeg po presoji zdravnika prenehati dajati in poskrbeti za do
treatment given. uc
ustrezno zdravljenje. ā
Common (≥ 1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare od
Po uporabi pegfilgrastima so poročali o pogostih (≥ 1/ 100 do < 1/ 10), a v splošnem asimptomatskih ve
(< 1/ 10,000) cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim.
primerih splenomegalije, zelo redko (< 1/ 10. 000) pa o primerih rupture vranice, vključno z nekaterimi smrtnimi primeri.
Therefore, spleen size should be carefully monitored (e. g. clinical pr
Zato moramo skrbno spremljati velikost vranice (denimo, s kliničnim pregledom, ultrazvokom).
A diagnosis of splenic rupture should be considered in patients reporting left al
Na diagnozo rupture vranice moramo misliti pri dajalcih in/ ali bolnikih, ki poročajo o a
upper abdominal pain or shoulder tip pain. in
bolečini v zgornjem levem delu trebuha ali v predelu leve lopatice. m
Treatment with Neupopeg alone does not preclude thrombocytopenia and anaemia because full dose ic
Zdravljenje s samo Neupopegom ne prepreči trombocitopenije in anemije, ker se hkrati vzdržuje ni
myelosuppressive chemotherapy is maintained on the prescribed schedule.
mielosupresivna kemoterapija s polnimi odmerki po predpisani shemi.
M
Priporočajo redno spremljanje števila trombocitov in hematokrita. lo
Neupopeg should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Neupopega ne smete uporabljati za zvečevanje odmerka citotoksične kemoterapije preko uveljavljenih vi
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease.
Zato Zd
Therefore, physicians should exercise caution when administering Neupopeg in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of Neupopeg with splenic enlargement and vaso-occlusive crisis.
morajo biti zdravniki previdni, kadar dajejo Neupopeg bolnikom s srpasto anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo Neupopega z zvečanjem vranice in vazookluzivno krizo.
White blood cell counts of 100 x 109/ l or greater have been observed in less than 1% of patients receiving Neupopeg.
Pri manj kot 1% bolnikov, ki dobivajo Neupopeg, so opazili število belih krvničk, ki je enako 100 x 109/ l ali višje.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
3 Pokrovček igle pri napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroča alergične reakcije.
Neupopeg contains less than 1 mmol (23 mg) sodium per 6 mg dose, i. e. essentially ‘ sodium-free’.
Neupopeg vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni ˝brez natrija˝.
4.5 Interaction with other medicinal products and other forms of interaction
et 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij