natgillin/translations-raw huggingface dataset:
The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Varnosti in učinkovitosti zdravila Neulasta za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]).
Neželena učinka, o katerih so najpogosteje poročali, sta bila bolečina v kosteh (zelo pogosto [≥ 1/10]) in mišičnoskeletna bolečina (pogosto [≥ 1/100 do < 1/10]).
Instructions for use:
Navodilo za uporabo:
No adverse events directly attributable to this degree of leukocytosis have been reported.
Ne poročajo o neželenih učinkih, ki bi jih bilo možno neposredno pripisati tej stopnji levkocitoze.
This may be a sign of a problem with your spleen (splenomegaly).
To je lahko znak, da imate težave z vranico (splenomegalija).
Other warnings
Ostala opozorila
• what action to take in a suspected case of failed delivery or incomplete delivery of the dose and if symptoms of serious infection that may indicate a missed dose present.
• kako ukrepati pri domnevnem primeru odpovedi injiciranja ali nepopolnega injiciranja odmerka in če so prisotni simptomi resne okužbe, ki lahko kažejo na izpuščeni odmerek.
This means the dose is complete.
To pomeni, da je dajanje odmerka dokončano.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s pegfilgrastimom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Activity
Dejavnosti
Do not use the pre-filled syringe if:
Napolnjene injekcijske brizge ne uporabite, če:
Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Podobno kot pri filgrastimu nevtrofilci, ki nastanejo pri odgovoru na pegfilgrastim, kažejo normalno ali zvečano delovanje, kot kažejo testi kemotaktične in fagocitne funkcije.
For further information on use with the on-body injector, please read the instructions for use at the end of this leaflet.
Za dodatne informacije o uporabi zdravila z injektorjem preberite navodila za uporabo na koncu tega navodila.
For more information, see section 5.1.
Za podrobnosti glejte poglavje 5.1.
In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev (G-CSF) je treba v bolnikovi dokumentaciji jasno zabeležiti zaščiteno ime uporabljenega zdravila.
Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.
Možnih interakcij z drugimi hemopoetičnimi rastnimi faktorji in citokini v kliničnih preskušanjih niso posebej raziskovali.
Dispose of it in a sharps disposal container as instructed by your healthcare provider or in accordance with local requirements.
Zavrzite ga v vsebnik za ostre odpadke, kot vam je naročil zdravnik oziroma v skladu z lokalnimi zahtevami.
• general aches and pains in the joints and muscles.
• splošne bolečine ter bolečine v sklepih in mišicah.
Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki injekcijske brizge poleg oznake »EXP«.
Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Bolnike, ki se jim pojavijo simptomi sindroma kapilarne prepustnosti, je treba natančno kontrolirati in deležni morajo biti standardnega simptomatskega zdravljenja, ki lahko vključuje potrebo po intenzivni negi (glejte poglavje 4.8).
Check to see if the status light is SOLID GREEN or has switched off.
Preverite, da boste videli, ali je lučka stanja STALNO ZELENA oz. ali se je izključila.
Detailed information on this medicinal product is available on the website of the European Medicines Agency 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/
Where should I give my injection?
Kam naj si dam injekcijo?
Only use each syringe for one injection.
Vsako napolnjeno injekcijsko brizgo uporabite le za eno injiciranje.
• Do not put the cap back on used needles.
• Ne nameščajte pokrovčka nazaj na uporabljene igle.
If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Če se je pri bolniku ob uporabi pegfilgrastima pojavil SJS, se pri tem bolniku nikoli več ne sme ponovno uvesti zdravljenja s pegfilgrastimom.
The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.
Mehanizem vaskulitisa pri bolnikih, ki prejemajo pegfilgrastim, ni znan.
Check the expiry date on the pre-filled syringe label (EXP).
Preverite datum izteka roka uporabnosti zdravila na nalepki napolnjene injekcijske brizge (EXP).
It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Pomembno je, da nemudoma pokličete svojega zdravnika, če se pojavi bolečina v zgornjem levem delu trebuha ali v predelu leve rame, saj je lahko povezana s težavami z vašo vranico.
This is known as a subcutaneous injection.
Temu pravimo subkutano injiciranje.
The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Podatki v spodnji preglednici opisujejo neželene učinke, zabeležene v kliničnih preskušanjih in med spontanim poročanjem.
• The grey needle cap is missing or not securely attached.
• sivi pokrovček igle manjka ali ni trdno nameščen.
Medicines should be disposed of in accordance with local requirements.
Zdravila morate zavreči v skladu z lokalnimi predpisi.
This means that the delivery is complete.
To pomeni, da je dajanje zdravila dokončano.
Sweet's syndrome (acute febrile dermatosis)1,2
Sweetov sindrom (akutna febrilna dermatoza) kožni vaskulitis1,2
Name and address of the manufacturers of the biological active substance
Ime in naslov izdelovalcev biološke učinkovine
• When dose delivery is complete, a long beep will sound and the status light will be solid green.
• Ko bo injiciranje dokončano, bo slišen dolg pisk in lučka stanja bo stalno zelena.
• when to expect dose delivery to begin
• kdaj pričakovati začetek injiciranja odmerka
This may affect your medicine.
Vsi ti lahko neugodno vplivajo na vaše zdravilo.
• Do not expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: - Diagnostic imaging (e.g. CT scan, MRI, ultrasound, x-ray).
• Injektorja ne izpostavljajte naslednjim okoliščinam, saj se zaradi njih lahko pokvari, vi pa se lahko poškodujete: - Diagnostičnim slikanjem (npr. računalniški tomografiji, magnetnoresonančnemu slikanju, pregledom z ultrazvokom, rentgenskemu slikanju).
The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Neželeni učinki so bili podobni tistim pri preiskovancih, ki so prejemali nižje odmerke pegfilgrastima.
The manually administered injections should be given into the thigh, abdomen or upper arm.
Ročno dane injekcije se morajo dati v stegno, trebuh ali zgornji del roke.
9/L after the expected nadir, this medicine should be discontinued immediately.
9/l, je treba nemudoma prenehati z zdravljenjem s tem zdravilom.
It contains important advice on how to monitor your device for medication errors including under dose leading to lack of effect, and when to seek immediate medical attention.
Kartica vsebuje pomembna navodila o tem, kako pripomoček nadzirati glede napak pri uporabi zdravila, vključno z nezadostnim odmerjanjem, ki povzroči izostanek učinka, ter kdaj je treba nemudoma poiskati zdravniško pomoč.
• Neulasta is given as an injection into the tissue just under the skin (subcutaneous injection).
• Zdravilo Neulasta se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
For patients who have reactions to acrylic adhesives, use of this product may result in an allergic reaction.
Bolnikom, ki imajo reakcije na akrilna lepila, lahko uporaba tega pripomočka povzroči alergijsko reakcijo.
Your doctor may decide that it would be more convenient for you to inject Neulasta yourself.
Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Neulasta injicirate sami.
If you have a cough, fever and difficulty breathing please tell your doctor.
Če kašljate, imate vročino in težko dihate, o tem obvestite svojega zdravnika.
Do not use Neulasta
Ne uporabljajte zdravila Neulasta
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Če se ne odzivate več na zdravljenje s pegfilgrastimom ali z njim ni mogoče vzdrževati odziva, bo zdravnik preučil razloge za to, vključno s tem ali so se vam pojavila protitelesa, ki nevtralizirajo delovanje pegfilgrastima.
• if you have sickle cell anaemia.
• če imate srpastocelično anemijo.
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- do 9-krat višji od priporočenega odmerka za človeka (na podlagi telesne površine) (glejte poglavje 5.3).
This may affect the on-body injector's performance.
To namreč lahko vpliva na delovanje injektorja.
B Open the tray, peeling away the cover.
B Odprite podlogo, tako da z nje odlepite pokrivno folijo.
If you develop or are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your doctor.
Če se vam bodo pojavili ali je verjetno, da se vam bodo pojavili krvni raki, ne smete uporabljati zdravila Neulasta, razen če vam to naroči zdravnik.
• The used syringe should be disposed of in accordance with local requirements.
• Uporabljene injekcijske brizge zavrzite v skladu z lokalnimi zahtevami.
• Avoid activities and places that may interfere with monitoring during the dosing of Neulasta.
• Izogibajte se dejavnostim in mestom, ki lahko motijo vaš nadzor injektorja med injiciranjem zdravila Neulasta.
If this happens, you may not receive your dose of Neulasta.
V takšnem primeru se lahko zgodi, da ne dobite svojega odmerka zdravila Neulasta.
Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.
Zdravila Neulasta smete uporabiti, če je bilo pomotoma zamrznjeno eno samo obdobje, krajše od 24 ur.
Do not remove the on-body injector at this time.
V tem času ne odstranite injektorja.
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Na splošno so primeri glomerulonefritisa minili po zmanjšanju odmerka ali prenehanju uporabe filgrastima ali pegfilgrastima.
• The on-body injector has a self-adhesive backing to attach it to the skin, do not use additional materials to hold it in place as this could dislodge the cannula leading to a missed or incomplete dose of Neulasta.
• Injektor ima samolepilno površino, s katero je prilepljen na kožo; ne uporabljajte dodatnih materialov, da bi ga držali na mestu, ker lahko s tem premaknete kanilo, posledica pa je izpuščen ali nepopoln odmerek zdravila Neulasta.
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Varnost in učinkovitost uporabe pegfilgrastima pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Navzeo in glavobole so zelo pogosto opazili pri bolnikih, ki so dobivali kemoterapijo.
Your doctor will check your blood and urine regularly as Neulasta can harm the tiny filters inside your kidneys (glomerulonephritis).
Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Neulasta lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
Healthcare providers only The trade name of the administered product should be clearly recorded in the patient file.
Samo za zdravstveno osebje Zaščiteno ime uporabljenega zdravila je treba jasno zabeležiti v bolnikovi dokumentaciji.
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Zdravilo se ne sme mešati z drugimi zdravili, predvsem pa ne z raztopinami natrijevega klorida.
• serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• resne alergijske reakcije, vključno z anafilaksijo (slabost, padec krvnega tlaka, težave z dihanjem, otekanje obraza).
The safety and efficacy of pegfilgrastim 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 pegfilgrastima nista raziskani pri bolnikih z mielodisplastičnim sindromom, s kronično mielogeno levkemijo in s sekundarno AML, zato ga pri takšnih bolnikih ne smete uporabljati.
Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Dokazali so, da imata pegfilgrastim in filgrastim enak način delovanja, v 24 urah povzročita izrazito zvišanje števila nevtrofilcev v periferni krvi, medtem ko je zvišanje monocitov in/ali limfocitov manjše.
The on-body injector is working properly.
Injektor deluje pravilno.
Do not use the pre-filled syringe if it has been dropped on a hard surface.
Ne uporabite napolnjene injekcijske brizge, če je ta pred tem padla na trdo površino.
In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to 7 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.
Turn the plunger to move the label into a position where you can remove the syringe label.
Obrnite bat tako, da nalepko premaknete na mesto, s katerega jo boste lahko odstranili.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
• damage to the tiny filters inside your kidneys (glomerulonephritis).
• okvara drobnih filtrov v ledvicah (glomerulonefritis).
• Do not expose the on-body injector to direct sunlight.
• Injektorja ne izpostavljajte neposredni sončni svetlobi.
In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Pokazali so, da v živalskih modelih sočasna uporaba zdravila Neulasta in 5-fluorouracila (5-FU) ali drugih antimetabolitov okrepi mielosupresijo.
In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
V takih primerih je treba pegfilgrastim po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje (glejte poglavje 4.8).
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Pojav pljučnih znakov, kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov, in poslabšanje pljučne funkcije skupaj z zvečanim številom nevtrofilcev utegnejo biti preliminarni znaki sindroma akutne dihalne stiske (ARDS - 'Acute Respiratory Distress Syndrome').
It must be a clear and colourless liquid.
Biti mora bistra in brezbarvna tekočina.
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy.
Varnosti in učinkovitosti pegfilgrastima niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
• It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
• Pomembno je, da si injekcij ne poskušate dajati sami, dokler vas tega ne nauči zdravnik ali zdravstveni delavec.
• 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.
• 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.
There is a small cannula which sits just under your skin.
Tik pod kožo imate drobno kanilo.
Step 4: Finish A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
4. korak: Zaključek A Zavrzite uporabljeno injekcijsko brizgo in drugo opremo v vsebnik za ostre odpadke.
4.7 Effects on ability to drive and use machines
Vpliv na sposobnost upravljanja vozil in strojev
• if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia).
• če ste seznanjeni z morebitnimi spremembami števila krvnih celic (npr. s povečanjem števila belih krvničk ali anemijo) ali z zmanjšanim številom krvnih ploščic v krvi, kar zmanjša sposobnost strjevanja krvi (trombocitopenija).
Approximately 27 hours after the on-body injector is applied to the patient's skin, Neulasta will be delivered over approximately 45 minutes.
Približno 27 ur po namestitvi injektorja na bolnikovo kožo, bo injektor v teku približno 45 minut injiciral zdravilo Neulasta.
The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Izločanje pegfilgrastima iz telesa je glede na odmerek nelinearno; serumski očistek pegfilgrastima se z naraščajočim odmerkom zmanjšuje.
If someone else is injecting you, they can also use the back of your arms.
Če vam daje injekcijo kdo drug, vam jo lahko da tudi v zadnji del nadlakta.
The healthcare professional must ensure the patient receives appropriate training about the on-body injector and understands that if they suspect a device failure or malfunction the patient must immediately inform a healthcare professional as they may need a replacement dose.
Zdravstveni delavec mora poskrbeti, da je bolnik deležen ustreznega usposabljanja o injektorju ter da ve, da se mora v primeru suma na odpoved injektorja ali njegovo nepravilno delovanje nemudoma posvetovati z zdravstvenim delavcem, saj bo morda potreben nadomesten odmerek.
Push the plunger all the way down as far as it will go to inject all the liquid.
Potisnite bat povsem do konca, dokler gre, da boste injicirali vso tekočino.
• Belly, except for a 5 cm (2-inch) area right around your belly button.
• trebuh (razen v predelu 5 cm okrog popka).
The least-squares geometric mean ratios (90% CIs) (on-body injector to manual injection) were 0.97 (0.83, 1.14) for Cmax and 1.00 (0.84, 1.20) for AUC0-inf within the pre-specified bioequivalence limit of 0.80 to 1.25, and established bioequivalence between the two delivery methods of a single 6 mg dose of pegfilgrastim.
Geometrični sredini razmerij po metodi najmanjših kvadratov (90 % IZ) (injektor glede na ročno injiciranje) sta bili 0,97 (0,83; 1,14) za Cmax in 1,00 (0,84; 1,20) za AUC0-inf ter znotraj vnaprej določenih bioekvivalenčnih mej od 0,80 do 1,25; to potrjuje bioekvivalentnost obeh načinov uporabe enkratnega 6-mg odmerka pegfilgrastima.
In the event of a partial or missed dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered.
V primeru delnega ali izpuščenega odmerka obstaja večje tveganje za učinke, kot so nevtropenija, febrilna nevtropenija in/ali okužbe, kakor bi bilo, če bi bil odmerek pravilno injiciran.
After injecting the liquid, remove the needle and let go of your skin.
Ko tekočino injicirate, izvlecite iglo in spustite kožo.
Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Posebna previdnost je potrebna med uporabo posameznih kemoterapevtikov ali njihovih kombinacij, za katere je znano, da povzročajo hudo trombocitopenijo.
Neulasta has no or negligible effect on the ability to drive or use machines.
Zdravilo Neulasta nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Ko boste bat sprostili, bo varnostni ščitnik injekcijske brizge varno pokril injekcijsko iglo.
This may result in a missed or incomplete dose of Neulasta.
To lahko povzroči izpustitev odmerka ali nepopoln odmerek zdravila Neulasta.
• During this time, the on-body injector will flash a fast green light.
• Med tem časom bo lučka na injektorju hitro zeleno utripala.
Medication error as a result of device failure
Napaka pri uporabi zdravila kot posledica odpovedi pripomočka
Do not try to do this yourself, as you may accidently move it and dislodge the cannula from your skin leading to a missed or incomplete dose of Neulasta.
Ne poskušajte tega narediti sami, ker lahko injektor po nesreči premaknete, tako da gre kanila iz kože, posledica pa je izpuščen ali nepopoln odmerek zdravila Neulasta.
If you are injecting yourself and have forgotten your dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.
Če ste si pozabili injicirati zdravilo Neulasta Če si zdravilo injicirate sami in ste pozabili uporabiti odmerek zdravila Neulasta, se morate posvetovati z zdravnikom, da se bosta dogovorila, kdaj si morate injicirati naslednji odmerek.
EU/1/02/227/001 - 1 pack blistered syringe EU/1/02/227/002 - 1 pack unblistered syringe EU/1/02/227/004 - 1 pack blistered syringe with needle guard EU/1/02/227/005 - 1 pack blistered syringe with blistered on-body injector
EU/1/02/227/001 - pakiranje po 1 v pretisnem omotu EU/1/02/227/002 - pakiranje po 1 brez pretisnega omota EU/1/02/227/004 - pakiranje po 1 v pretisnem omotu s ščitnikom igle EU/1/02/227/005 - pakiranje po 1 v pretisnem omotu z injektorjem, ki se pritrdi na telo, v pretisnem omotu
The adhesive pad is water-resistant but you are advised to avoid submerging the on-body injector in water.
Lepljiva blazinica je vodoodporna, vendar svetujemo, da injektorja ne potapljate v vodo.
It may harm them,
Opazno vlažno (napojeno) lepilo
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˝.