natgillin/translations-raw huggingface dataset:
B. While holding the pre-filled pen in place, (1) press and (2) release the green button on top.
B. Ko držite napolnjeni injekcijski peresnik tako pritisnjen na kožo, (1) pritisnite in (2) spustite zeleni gumb na vrhu.
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
The recommended sites for injection using the pre-filled pen are the top of the thigh and the back of the arm if given by a nurse or carer (see picture 1).
Priporočeni mesti za injiciranje z napolnjenim injekcijskim peresnikom sta zgornji del stegen in zadnji del nadlakta, če vam daje injekcijo medicinska sestra ali negovalec (glejte sliko 1).
Neupopeg is for use in adults aged 18 and over.
Neupopeg je namenjena uporabi pri odraslih, starih 18 ali več let.
A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A IZDELOVALEC BIOLOŠKO AKTIVNE SUBSTANCE IN IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN ZA SPROŠČANJE SERIJE
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
A. IZDELOVALEC BIOLOŠKO AKTIVNE SUBSTANCE IN IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN
Like all medicines, Neupopeg can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi Neupopeg neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Pack size of one.
Pakiranje po ena.
The needle safety cover will move down over the needle and lock into place.
Varnostni pokrovček igle se bo pomaknil navzdol preko igle in se bo zaskočil.
The safety and efficacy of Neupopeg have not been investigated in patients receiving high dose chemotherapy.
Varnosti in učinkovitosti Neupopega niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40% incidence of febrile neutropenia.
Poročajo, da je ta odmerna shema v odsotnosti podpore s strani rastnega faktorja povzročila nevtropenijo 4. stopnje, ki je povprečno trajala 5 do 7 dni, in 30-40-% incidenco febrilne nevtropenije.
Your doctor has decided it would be best for you to inject Neupopeg yourself.
Vaš zdravnik se je odločil, da bi bilo za vas najboljše, če si Neupopeg injicirate sami.
Maintain firm skin pinch for entire procedure (see picture 5).
Kožno gubo trdno držite skozi celoten postopek (glejte sliko 5).
Important information about some of the ingredients of Neupopeg Neupopeg contains sorbitol (a type of sugar).
Pomembne informacije o nekaterih sestavinah zdravila Neupopeg Neupopeg vsebuje sorbitol (vrsto sladkorja).
In such circumstances Neupopeg should be discontinued at the discretion of the physician and the appropriate treatment given.
V takem primeru je treba Neupopeg po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje.
Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see Figure 1).
V skladu z avtoregulacijskim mehanizmom očistka se serumska koncentracija pegfilgrastima ob nastopu okrevanja nevtrofilcev hitro zniža (glejte sliko 1).
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were common (≥ 1/100 to < 1/10); reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were very common (≥ 1/10) in patients receiving Neupopeg following cytotoxic chemotherapy.
Reverzibilno, blago do zmerno zvišanje sečne kisline in alkalne fosfataze brez pridruženih kliničnih učinkov se je pojavilo pogosto (≥ 1/100 do < 1/10); reverzibilno, blago do zmerno zvišanje laktatne dehidrogenaze brez pridruženih kliničnih učinkov se je pojavilo zelo pogosto (≥ 1/10) pri bolnikih, ki so dobivali Neupopeg po citotoksični kemoterapiji.
Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back.
Pogosti neželeni učinki (verjetno je, da se bodo pojavili pri manj kot 1 od 10 bolnikov) vključujejo bolečino in pordelost na mestu injiciranja, glavobole in splošne bolečine ter bolečine v sklepih, mišicah, prsih, okončinah, vratu ali hrbtu.
The mechanism of vasculitis in patients receiving Neupopeg is unknown.
Mehanizem vaskulitisa pri bolnikih, ki prejemajo Neupopeg, še ni pojasnjen.
Your doctor may decide that it would be more convenient for you to inject Neupopeg yourself.
Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si Neupopeg injicirate sami.
Treatment with Neupopeg alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Zdravljenje s samo Neupopegom ne prepreči trombocitopenije in anemije, ker se hkrati vzdržuje mielosupresivna kemoterapija s polnimi odmerki po predpisani shemi.
Instructions for injecting with the Neupopeg pre-filled syringe This section contains information on how to give yourself an injection of Neupopeg.
Navodila za injiciranje Neupopega z uporabo napolnjene injekcijske brizge To poglavje vsebuje informacije o tem, kako si sami injicirate zdravilo Neupopeg.
Before use (with grey needle shield)
Pred uporabo (s sivim pokrovčkom igle)
Neupopeg has not been tested in pregnant women.
Neupopega pri nosečnicah niso preskusili.
• 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 ščitnik igle nameščali nazaj na • Zaradi varnostnega pokrovčka ni priporočljivo, da bi sivi ščitnik igle nameščali nazaj na
Neupopeg may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Neupopeg sme biti izpostavljena sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
Neupopeg 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).
Neupopeg 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).
Read the package leaflet before use.
Pred uporabo preberite priloženo navodilu.
The objective of the skin pinch technique is to create a firm site for the injection
Namen tega, da naredite kožno gubo, je zagotoviti čvrsto mesto za injiciranje.
How do you, or the person injecting you, use Neupopeg pre-filled syringe?
Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo Neupopega?
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 myelodysplastic syndromes).
Skrajšanje trajanja nevtropenije in incidence febrilne nevtropenije pri bolnikih, zdravljenih s citotoksično kemoterapijo za maligne bolezni (z izjemo kronične mieloidne levkemije in mielodisplastičnih sindromov).
Equipment: To give yourself a subcutaneous injection you will need:
Za subkutano samoinjiciranje boste potrebovali:
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Neupopeg should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba Neupopeg dati približno 24 ur po aplikaciji citotoksične kemoterapije.
To perform a successful injection a firm injection area is required.
Za uspešno injiciranje je potrebna čvrsta površina kože za injiciranje.
• The pre-filled pen has a safety cover that will protect you from needle sticks or loss of medicine by accidental bumping or touching.
• Napolnjeni injekcijski peresnik ima varnostni pokrovček, ki preprečuje, da bi se po nesreči zbodli z iglo ali da bi zaradi naključnega sunka ali dotika prišlo do izgube zdravila.
Neupopeg may be used if it is accidentally frozen for a single period of less than 24 hours.
Neupopeg smete uporabiti, če je bil pomotoma zamrznjena eno samo obdobje, krajše od 24 ur.
In a open label, single dose study (n=31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Različne stopnje okvare ledvic (vključno s končno odpovedjo ledvic) v odprti študiji posamičnega odmerka (n = 31) niso vplivale na farmakokinetiko pegfilgrastima.
Each pen may only be used once.
Vsak injekcijski peresnik se sme uporabiti le enkrat.
Isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section
Pri bolnikih s srpasto anemijo so v posameznih primerih poročali o srpastocelični krizi (glejte poglavje
Other commonly reported undesirable effects include pain, injection site pain; chest pain (non-cardiac); headache; arthralgia; myalgia; back, limb, musculo-skeletal and neck pain.
Med drugimi pogosto opisanimi neželenimi učinki so bolečine, bolečine na mestu injiciranja, bolečine v prsih (ki ne izvirajo od srca), glavobol, artralgija, mialgija, bolečine v hrbtu, udih, vratu in osteomuskularne bolečine.
Marketing Authorisation Holder:
Navodilo je bilo odobreno:
There is no clinical experience with breast-feeding women, therefore Neupopeg should not be administered to women who are breast-feeding.
Z doječimi materami ni kliničnih izkušenj, zato pri ženskah, ki dojijo, Neupopega ne smete uporabljati.
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 na 3 tedne, 4 cikluse).
Renal impairment: no dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Okvara ledvic: pri bolnikih z okvaro ledvic odmerka ni treba spreminjati; to velja tudi za bolnike s končno odpovedjo ledvic.
Rare (≥ 1/10,000 to < 1/1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Opisani so redki (≥ 1/10.000 do < 1/1.000) neželeni učinki na pljučih, vključno z intersticijsko pljučnico, pljučnim edemom, pljučnimi infiltrati in pljučno fibrozo.
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-% interval zaupanja -16,8 %, -1,1 %).
A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain.
Zelo pogost neželen učinek (verjetno je, da se bo pojavil pri več kot 1 od 10 bolnikov) so bolečine v kosteh.
If there are particles in it, you must not use it. 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 manj neprijetno, pustite napolnjeno injekcijsko brizgo stati 30 minut zunaj hladilnika, da bo dosegla sobno temperaturo, ali jo nekaj minut previdno držite v roki.
Concomitant use of Neupopeg with any chemotherapy agent has not been evaluated in patients.
Sočasne uporabe Neupopega s katerimkoli kemoterapevtskim sredstvom pri bolnikih niso ovrednotili.
Hold down.
Ne zamrzujte!
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Na diagnozo rupture vranice moramo misliti pri dajalcih in/ali bolnikih, ki poročajo o bolečini v zgornjem levem delu trebuha ali v predelu leve lopatice.
An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.
Občasen neželen učinek (verjetno je, da se bo pojavil pri manj kot 1 od 100 bolnikov) je slabost.
Rare (≥ 1/10,000 to < 1/1,000) cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Redko (≥ 1/10.000 do < 1/1.000) so poročali o primerih Sweetovega sindroma, čeprav imajo lahko tu vpliv tudi osnovne hematološke maligne bolezni.
• if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neupopeg.
• če ste preobčutljivi za (alergični na) pegfilgrastim, filgrastim, beljakovine, ki izvirajo iz E. coli, Bodite posebno pozorni pri uporabi Neupopega
How to inject into the abdomen
Kako injicirati v trebuh
4.9 Overdose There is no experience with overdose of Neupopeg in humans.
4.9 Preveliko odmerjanje S prevelikim odmerjanjem Neupopega pri ljudeh ni izkušenj.
Check the appearance of Neupopeg.
Preverite videz Neupopega.
At start, keep thumb clear of green button
Sprva ne pritiskajte na zeleni gumb
In randomised clinical studies in patients with malignancy receiving Neupopeg after cytotoxic chemotherapy, most adverse events were caused by the underlying malignancy or cytotoxic chemotherapy.
V randomiziranih kliničnih študijah pri bolnikih z maligno boleznijo, ki so po citotoksični kemoterapiji dobivali Neupopeg, sta večino neželenih učinkov povzročili osnovna maligna bolezen ali citotoksična kemoterapija.
PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (SureClick).
Raztopina za injiciranje (injekcijo) v napolnjenem injekcijskem peresniku (SureClick).
The syringe inside the pen is made from Type I glass with a rubber stopper, and with a stainless steel needle; it contains 0.6 ml of solution for injection.
Injekcijska brizga v injekcijskem peresniku je izdelana iz stekla tipa I z batnim zamaškom in nerjavno iglo: vsebuje 0,6 ml raztopine za injiciranje.
What Neupopeg looks like and contents of the pack
Izgled Neupopeg in vsebina pakiranja
If you use more Neupopeg than you should contact your doctor, nurse or pharmacist.
Če uporabite več Neupopega, kot bi smeli, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom.
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at low subcutaneous doses.
Pri potomcih brejih podgan, ki so jim subkutano dali pegfilgrastim, niso opazili neželenih učinkov, pri kuncih pa so pokazali, da pegfilgrastim v majhnih subkutanih odmerkih povzroča toksičnost za zarodek in plod (izgubo zarodka).
Neupopeg contains sorbitol.
Neupopeg vsebuje sorbitol.
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist.
Pomembno je, da si injekcije ne poskušate dati sami, če vas nista zdravnik ali medicinska sestra tega posebej naučila.
• if you experience a cough, fever and difficulty breathing;
• če začnete kašljati, se vam zviša telesna temperatura in začnete s težavo dihati;
How do you, or the person injecting you, use Neupopeg pre-filled pen (SureClick)?
Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeni injekcijski peresnik Neupopeg (SureClick)?
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease.
Pri bolnikih s srpasto anemijo je bila uporaba pegfilgrastima povezana s srpastocelično krizo.
The most frequently reported and very common study-drug related undesirable effect was bone pain Bone pain was generally of mild-to-moderate severity, transient and could be controlled in most patients with standard analgesics.
Bolečina v kosteh je bila na splošno blage do zmerne stopnje, prehodna in jo je bilo pri večini bolnikov mogoče obvladati s standardnimi analgetiki.
Do not remove the grey needle shield from the pre-filled pen until you are ready to inject.
Ne snemite sivega pokrovčka z injekcijskega peresnika, dokler niste pripravljeni na injiciranje.
For further instructions on how to inject yourself with Neupopeg, please read the section at the end of this leaflet.
Nadaljnja navodila za samoinjiciranje Neupopega si preberite v poglavju na koncu tega navodila za uporabo.
Over the entire study, the rate of febrile neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients (difference 7%, 95% CI of -19%, 5%).
V celotni študiji je bila pogostost febrilne nevtropenije pri bolnikih, zdravljenih s pegfilgrastimom, 13 %, pri bolnikih, zdravljenih s filgrastimom, pa 20 % (razlika 7 %, 95-% interval zaupanja -19 %, 5 %).
Rare (≥ 1/10,000 to < 1/1,000) cases of thrombocytopenia and leukocytosis have been reported.
Poročali so o redkih (≥ 1/10.000 do < 1/1.000) primerih trombocitopenije in levkocitoze.
You may take Neupopeg out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
Neupopeg smete vzeti iz hladilnika in ga hraniti pri sobni temperaturi (pod 30 ºC) največ 3 dni dolgo.
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 17 %, p < 0,001).
• if you get left upper abdominal pain or pain at the tip of your shoulder.
• če začutite bolečino levo zgoraj v trebuhu ali v predelu leve lopatice;
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 shem odmerjanja.
How do I prepare my Neupopeg injection?
Kako si pripravim injekcijo Neupopega?
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neupopeg.
Če je Neupopeg pomotoma izpostavljena temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4).
Pomožne snovi z znanim delovanjem: sorbitol E420, natrijev acetat (glejte poglavje 4.4).
Only use a single Neupopeg pre-filled pen for each injection.
Vsak napolnjeni injekcijski peresnik Neupopega uporabite samo za eno injiciranje.
• a pre-filled syringe of Neupopeg; and
• napolnjeni injekcijski peresnik Neupopega;
Check the expiry date on the pre-filled pen label (EXP:).
Preverite datum izteka roka uporabnosti zdravila na nalepki napolnjenega injekcijskega peresnika (Uporabno do:).
• The used pre-filled pen should be disposed of in accordance with local requirements.
• Uporabljene injekcijske peresnike zavrzite v skladu z lokalnimi zahtevami.
Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea, hypotension, injection site reactions, erythaema and flushing, occurring on initial or subsequent treatment have been reported with Neupopeg.
Med začetnim ali nadaljnjim zdravljenjem z Neupopegom so bile opisane alergijske reakcije, vključno z anafilaksijo, izpuščajem na koži, urtikarijo, angioedemom, dispnejo, hipotenzijo, reakcijami na mestu injiciranja, eritemom in zardevanjem.
*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 z polietilenglikolom (PEG).
The effect of Neupopeg on the ability to drive or use machines is not known.
Učinek Neupopega na sposobnost upravljanja vozil in strojev ni znan.
• plan to become pregnant.
• načrtujete zanositev.
Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (pod 30 ºC), jo morate bodisi v 3 dneh porabiti ali pa zavreči.
0.6 ml of solution for injection in a pre-filled syringe (Type I glass), with a rubber stopper, and with a stainless steel needle.
0,6 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (iz stekla tipa I) z batnim zamaškom in nerjavno iglo.
Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients)) of spleen rupture have been reported after the use of Neupopeg.
Poročali so o povečani vranici in zelo redko (verjetno je, da se bodo pojavile pri manj kot 1 od 10.000 bolnikov) o primerih rupture vranice po uporabi Neupopega.
In one study (n=157), which used a 6mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
V eni študiji (n=157), v kateri so uporabili stalni odmerek 6 mg pegfilgrastima, je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,8 dni, v skupini s filgrastimom pa 1,6 dni (razlika 0,23 dneva, 95-odstotni interval zaupanja -0,15, 0,63).
What Neupopeg is and what it is used for Before you use Neupopeg How to use Neupopeg Possible side effects
Kaj je Neupopeg in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili Neupopeg
The pre-filled pen has a safety cover that will protect you from needle 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 prišlo do izgube zdravila.
Very rare (< 1/10,000) elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Zelo redko (< 1/10.000) so se bolnikom, ki so po citotoksični kemoterapiji dobili pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov ALT (alanin-aminotransferaze) ali AST (aspartataminotransferaze).
It is a clear, colourless liquid.
Neupopeg je bistra, brezbarvna tekočina.
Do not use Neupopeg after the expiry date which is stated on the box and on the syringe label (EXP).
Neupopega ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in na nalepki injekcijske brizge poleg oznake »Uporabno do«.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suh naravni kavčuk (derivat lateksa) (glejte poglavje 4.4).
Press the pre-filled pen firmly enough against the skin so that the safety cover is fully retracted (see picture 6).
Pomembno pri koraku A postopka injiciranja Napolnjeni injekcijski peresnik pritisnite na kožo dovolj močno, da se varnostni pokrovček popolnoma umakne (glejte sliko 6).
Neupopeg is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba Neulaste ni priporočljiva pri otrocih, mlajših od 18 let.