natgillin/translations-raw huggingface dataset:
Steps 3 to 6 should not be more than 30 minutes.
Koraki od 3 do 6 ne smejo trajati več kot 30 minut.
PFS and OS results in the PP population are summarised in Figures 3 and 4.
Rezultati PFS in OS v populaciji PP so povzeti v sliki 3 in 4.
• allergic reactions to other medicines, such as penicillin
• alergijske reakcije na druga zdravila, kot je penicilin;
The following information is intended for healthcare professionals only: Administration precautions
Naslednje informacije so namenjene samo zdravstvenemu osebju: Previdnostni ukrepi pri dajanju zdravila
These reactions are more common on the first infusion and may be improved by slowing the rate of infusion.
Te reakcije so pogostejše pri prvi infuziji in se lahko izboljšajo z upočasnitvijo hitrosti infundiranja.
• low body temperature
• nizka telesna temperatura;
Patients 65 years and older
Bolnice, stare 65 let in več
The expiry date refers to the last day of that month.
Rok uporabnosti zdravila se nanaša na zadnji dan navedenega meseca.
The average time to onset was 53 days from the first dose.
Povprečni čas do pojavitve je bil 53 dni od prvega odmerka.
You will be observed closely during treatment:
Med zdravljenjem vas bodo skrbno spremljali:
Continue to swirl the vial until the powder is completely dissolved.
Z vialo še naprej krožite, dokler se prašek v celoti ne raztopi.
• multi-organ failure which can lead to death
• odpoved več organov, ki lahko povzroči smrt;
In both groups, the majority of the serious adverse events were haematological toxicities.
V obeh skupinah so večino resnih neželenih dogodkov predstavljale hematološke toksičnosti.
Further it has been shown that the rate of paclitaxel elimination increased with increasing body size.
Nadalje se je pokazalo, da se je stopnja izločanja paklitaksela povečala s povečanjem telesne velikosti.
• epileptic fit lasting longer than five minutes or more than one fit within five minutes
• epileptični napad, ki traja več kot pet minut, ali več kot en napad v petih minutah;
Talk to your doctor or nurse, if you are not sure if any of the above applies to you.
Pogovorite se z zdravnikom ali medicinsko sestro, če niste prepričani, ali kaj od zgoraj navedenega velja za vas.
6.2 Incompatibilities
6.2 Inkompatibilnost
Probability of survival
Verjetnost preživetja
Range (mmol/L)
Razpon (mmol/l)
Apealea is not recommended for children and adolescents under 18 years, because it has not been studied in this age group.
Zdravilo Apealea ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker ga v tej starostni skupini niso proučevali.
Steps c and to f should not be more than 30 minutes.
Koraki od c do f ne smejo trajati več kot 30 minut.
Thus, the distribution phase is essentially complete at 2 hours after the end of infusion.
To pomeni, da se porazdelitvena faza zaključi dve uri po zaključku infuzije.
Ask your doctor or nurse about hair loss and what can be done to avoid it.
Pozanimajte se pri zdravniku ali medicinski sestri glede izgube las ter kaj lahko naredite, da to preprečite.
The dose is based on your body surface area (worked out from your height and weight) and blood test results.
Odmerek je odvisen od vaše telesne površine (ta se izračuna glede na višino in telesno maso) in rezultatov preiskav krvi.
In view of this, and of the potential for frailty and co-morbidities, elderly patients should be carefully monitored.
Ob upoštevanju tega in možnosti slabotnosti in soobolevnosti je treba starejše bolnice skrbno spremljati.
Your doctor may wish to delay further treatment with Apealea or reduce the dose.
Zdravnik bo morda želel odložiti nadaljnje zdravljenje z zdravilom Apealea ali vam zmanjšati odmerek.
After reconstitution
Po rekonstituciji
Additional subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the PP and the ITT population.
Dodatne analize podskupine so bile izvedene za raziskovanje učinkovitosti glede na recidiv (prvi in drugi) v populacijah PP in ITT.
Paclitaxel should not be used during pregnancy unless the clinical condition requires this treatment.
Paklitaksel se ne sme uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva takšno zdravljenje.
• are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na paklitaksel ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
There was no marked difference in overall tolerability between the 65-74 age group and younger patients.
Ni opazne razlike v celokupnem prenašanju med starostno skupino 65-74 let in mlajšimi bolnicami.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če zdravilo ni porabljeno takoj, je za čas shranjevanja in pogoje med uporabo odgovoren uporabnik.
Total plasma levels of paclitaxel were similar after infusion of the two formulations.
Skupne ravni paklitaksela v plazmi so bile po infundiranju obeh formulacij podobne.
For appropriate use of carboplatin, the prescriber is advised to consult the prescribing information for carboplatin as well.
Za zagotovitev ustrezne uporabe karboplatina se priporoča, da zdravnik, ki predpisuje zdravilo, pregleda tudi informacije o predpisovanju karboplatina.
• cognitive disorder (difficulty thinking or processing thoughts, difficulty remembering)
• kognitivne motnje (oteženo razmišljanje ali predelava misli, otežen priklic spomina);
This is equivalent to 80% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 80 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
• toxicity to the nervous system
• toksičnost za živčni sistem;
The recommended dose of carboplatin is AUC = 5-6 mg/mL×min.
Priporočeni odmerek karboplatina je AUC = 5-6 mg/ml × min.
Patients were stratified based on relapse (first or second) and CA125 values.
Bolnice so bile stratificirane glede na recidiv (prvi ali drugi) in vrednosti CA125.
Patients should be advised not to drive or use machines if they feel tired or dizzy.
Bolnicam je treba odsvetovati vožnjo ali upravljanje strojev, če se počutijo utrujene ali omotične.
Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Rezultat stabilizacije je zaviranje normalne dinamične reorganizacije mreže mikrotubulov, ki je bistvena za vitalne celične funkcije med interfazo in mitozo.
In the event of an overdose, the patient should be closely monitored.
Pri prevelikem odmerjanju je treba bolnico skrbno spremljati.
non-inferiority margin (1.2)
Meja neinferiornosti (1,2)
The solution should be administered by an intravenous infusion over approximately one hour (120−140 drops/min).
Raztopina se daje z intravensko infuzijo približno eno uro (120−140 kapljic/min).
Paclitaxel affects or stops growth of rapidly dividing cells, such as tumour cells.
Paklitaksel zavira ali zaustavi rast celic, ki se hitro delijo, kot so tumorske celice.
Stop breast-feeding while being treated, as paclitaxel passes into breast milk and may harm the child.
Med zdravljenjem prenehajte dojiti, saj paklitaksel prehaja v materino mleko in lahko škodi dojenčku.
In some of the cases, the patients had previously been exposed to cardiotoxic medicinal products such as doxorubicin or had underlying cardiac history.
V nekaterih primerih so bile bolnice predhodno izpostavljene kardiotoksičnim zdravilom, kot je doksorubicin, ali so imele v anamnezi osnovno srčno bolezen.
Inject the required amount of reconstituted Apealea into an empty, sterile ethylene-vinyl acetate (EVA) bag.
Injicirajte potrebno količino rekonstituiranega zdravila Apealea v prazno, sterilno vrečko iz etilen-vinil acetata (EVA).
Chromosomal aberrations have also been detected in in vivo studies in mice and monkeys.
Kromosomske aberacije so odkrili tudi v študijah in vivo pri miših in opicah.
Patients who had pre-existing neuropathy of grade ≥ 2 or serious medical risk factors involving any of the major organ systems were not allowed to enter the study.
Bolnice, ki so imele predhodno prisotno nevropatijo stopnje ≥ 2 ali resne zdravstvene dejavnike tveganja, ki vključujejo enega izmed glavnih organskih sistemov, niso smele sodelovati v študiji.
non-inferiority margin (1.185)
Meja neinferiornosti (1,185)
Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation.
Nadalje je bilo dokazano, da lahko periferne nevropatije vztrajajo tudi več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.
Limited data are available on use in patients ≥ 75 years.
Glede uporabe pri bolnicah ≥ 75 let je na voljo le malo podatkov.
The median number of cycles with paclitaxel/carboplatin treatment for patients receiving GCSF was 6 in both groups.
Mediano število ciklov zdravljenja s paklitakselom/karboplatinom za bolnice, ki so prejemale GCSF je bilo v obeh skupinah 6.
Contact your doctor immediately, if during treatment you develop:
Takoj se posvetujte z zdravnikom, če se med zdravljenjem pojavijo:
• blood poisoning
• zastrupitev krvi;
Alopecia is a very common adverse reaction and occurs early in treatment.
Alopecija je zelo pogost neželeni učinek in se pojavi zgodaj med zdravljenjem.
There were no differences in Eastern Cooperative Oncology Group (ECOG) performance score between the two study groups at any time during or after treatment (mainly score 0 or 1).
V stanju zmogljivosti po lestvici ameriškega združenja ECOG (Eastern Cooperative Oncology Group) ni bilo razlik med obema študijskima skupinama, ne kadar koli med zdravljenjem ne po njem (rezultat večinoma 0 ali 1).
Delayed reactions related to paclitaxel occurring during or after infusion of carboplatin cannot be excluded.
Zapoznelih reakcij, povezanih s paklitakselom, ki se pojavijo med infundiranjem karboplatina ali po njem, ni mogoče izključiti.
• painful severe swelling of deep skin layers, mainly in the face
• boleče močne otekline globokih slojev kože, predvsem na obrazu;
b Can persist beyond 6 months of paclitaxel discontinuation.c c As reported in the post-marketing surveillance of paclitaxel.
b Lahko traja še več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.c c Kot so poročali v okviru nadzora po dajanju zdravil, ki vsebujejo paklitaksela na trg.
It can have a marked impact on the patients' self-image and quality of life and patients should be counselled about the likelihood of this adverse effect and on what measures might be available to mitigate it, for example the use of cold caps.
Lahko ima pomemben vpliv na bolničino samopodobo in kakovost življenja, zato je treba bolnice seznaniti z verjetnostjo tega neželenega učinka in ukrepi, s katerimi ga je mogoče zmanjšati, na primer z uporabo hladilnih kap.
Since renal elimination is a minor pathway for paclitaxel, increased plasma levels are not expected in this patient group.
Ker predstavlja ledvično izločanje manjši delež izločanja paklitaksela, v tej skupini bolnic ni pričakovati povečanih ravni v plazmi.
PFS as the primary endpoint was evaluated by blinded assessment of computerised tomography images using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0.
PFS kot primarniizid so ocenjevali s slepim ocenjevanjem računalniških tomografskih slik z uporabo meril za ocenjevanje odziva pri trdih tumorjih (Response Evaluation Criteria in Solid Tumours - RECIST) 1.0.
Proportions of patients who received premedication prior to infusion of paclitaxel or carboplatin or overall (safety population)
Deleži bolnic, ki so prejele premedikacijo pred infundiranjem paklitaksela ali karboplatina ali na splošno (varnostna populacija)
Repeat dose toxicity studies have shown non-reversible, toxic effects on male reproductive organs.
Študije toksičnosti ponavljajočih odmerkov so pokazale ireverzibilne, toksične učinke na moške reproduktivne organe.
Administration sets containing a 15 µm polyamide fluid filter should be used.
Uporabiti je treba sisteme, ki vsebujejo 15-µm poliamidni filter za tekočino.
Pack size: 1 vial.
Velikost pakiranja: 1 viala.
Once opened, Apealea is recommended to be used immediately.
Po odprtju zdravila Apealea je priporočljivo, da ga takoj porabite.
Thus, the results in the subgroup of patients with first relapse are consistent with the results in the overall population and in addition, there was an indication of PFS benefit for Apealea.
Rezultati v podskupini bolnic s prvim recidivom so torej skladni z rezultati celotne populacije, poleg tega je bila ugotovljena korist zdravila Apealea za PFS.
The solution should be clear and greenish-yellow without visible particles or precipitates.
Raztopina mora biti bistra in zelenkasto rumena, brez vidnih delcev ali oborine.
There are very limited data on the use of paclitaxel in pregnant women.
Podatkov o uporabi paklitaksela pri nosečnicah je zelo malo.
Paclitaxel is distributed equally between plasma and blood as described in published in vitro data.
Paklitaksel je enakovredno porazdeljen med plazmo in krvjo, kot navajajo objavljeni podatki in vitro.
− low blood pressure
− nizek krvni tlak;
The solution should be injected during approximately one minute towards the inner wall of the vial and not directly onto the powder as this will result in foaming.
Injiciranje raztopine naj traja približno eno minuto, usmerite jo v notranjo steno viale in ne neposredno na prašek, saj se sicer začne peniti.
If neuropathy is observed, follow dose reduction recommendations in Table 1.
Če opazite nevropatijo, upoštevajte priporočila za zmanjšanje odmerka iz preglednice 1.
As a result of the combined treatment, it is not possible to determine whether this observation is due to Apealea or to other factors, and delayed reactions related to paclitaxel cannot be excluded.
Zaradi kombiniranega zdravljenja ni mogoče dokazati, ali je to zaradi zdravila Apealea ali drugih dejavnikov, poleg tega ni mogoče izključiti zapoznelih reakcij, povezanih s paklitakselom.
• primary peritoneal cancer - a cancer of the cells lining the space between the wall of the belly and the internal organs
• primarni peritonealni rak - rak celic, ki obdajajo prostor med trebušno steno in notranjimi organi;
• blood vessel disorders, such as:
• okvare krvnih žil, kot so:
Patients with low neutrophil count should be made aware of the increased risk of infections.
Bolnice z nizkim številom nevtrofilcev je treba opozoriti na povečano tveganje okužb.
Withhold treatment until symptoms resolve to grade ≤ 1
Odložite zdravljenje, dokler se simptomi ne izboljšajo do stopnje ≤ 1
Thus, only about 1% of the paclitaxel in the body is located in plasma during the elimination phase.
To pomeni, da je v fazi izločanja v plazmi le približno 1 % paklitaksela v telesu.
Standard dose:
Standardni odmerek:
These patients should be vigilantly monitored by physicians for the occurrence of cardiac events.
Zdravniki morajo te bolnice skrbno spremljati glede pojavitve srčnih dogodkov.
A non-inferiority analysis was conducted for PFS in the per-protocol (PP) population with pre-specified non-inferiority margin.
Analizo neinferiornosti so izvedli za PFS v populaciji po protokolu (PP) z vnaprej določeno mejno vrednostjo neinferiornosti.
Number at risk
Število ogroženih
If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Če raztopina pride v stik s kožo, jo takoj in temeljito umijte z milom in vodo.
This amounted to a 14% decline in an 86-year-old patient compared to one aged 56.
To pomeni 14-odstotno zmanjšanje pri 86-letnem bolniku v primerjavi s
Women of childbearing potential must use effective contraception during treatment and for six months afterwards.
Ženske v rodni dobi morajo med zdravljenjem in šest mesecev po njem uporabljati učinkovito kontracepcijo.
Dose reductions or/and delays should be considered as a result of any clinically significant adverse reaction as presented in Table 1.
O zmanjšanju odmerkov in/ali odlogu zdravljenja je treba razmisliti zaradi morebitnih klinično pomembnih neželenih učinkov, ki so predstavljeni v preglednici 1.
Of the 391 patients with ovarian cancer in the randomised study who received Apealea in combination with carboplatin, 13% were between 65 and 74 years old.
Izmed 391 bolnic z rakom jajčnikov v randomizirani študiji, ki so prejemale zdravilo Apealea v kombinaciji s karboplatinom, jih je bilo 13 % starih med 65 in 74 let.
Patients should be observed closely during treatment, particularly those patients who previously suffered hypersensitivity reactions with any taxane formulation.
Med zdravljenjem je treba bolnice skrbno spremljati, zlasti tiste, pri katerih se je že pojavila preobčutljivostna reakcija pri katerem koli zdravilu s taksanom.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2-8 °C).
The tissue distribution is extensive, with a volume of distribution on the terminal elimination phase of about 155 L/m2 corresponding to about 280 L for an average patient with a body surface area of 1.8 m2.
Porazdelitev po tkivih je obsežna, pri čemer je prostornina porazdelitve v končni fazi izločanja približno 155 l/m2, kar ustreza približno 280 l za povprečno bolnico s površino telesa 1,8 m2.
With regard to age, the population model indicated an approximate 5% decline in paclitaxel elimination rate for each 10-year increase in age compared to the median age of 56 years of the study.
Glede na starost je model skupin bolnikov pokazal približno 5-odstotno zmanjšanje stopnje izločanja paklitaksela za vsako povečanje starosti za 10 let v primerjavi z mediano starostjo v študiji, tj. 56 let.
• abnormally high levels of nitrogen-containing compounds in the blood
• nenormalno visoke ravni spojin, ki vsebujejo dušik, v krvi.
Apealea dose for subsequent courses (mg/m2)b
Odmerek zdravila Apealea pri nadaljnjih ciklih (mg/m2)b
Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Huda preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
Protect from direct and/or bright light throughout the preparation process.
Med postopkom priprave poskrbite za zaščito pred neposredno in/ali močno svetlobo.
Apealea is used to treat the following cancers in adults, in combination with another medicine called carboplatin:
Zdravilo Apealea se uporablja za zdravljenje naslednjih oblik raka pri odraslih v kombinaciji z drugim zdravilom, imenovanim karboplatin:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
What Apealea is and what it is used for What you need to know before you are given Apealea How Apealea is given
Kaj je zdravilo Apealea in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Apealea Kako se daje zdravilo Apealea
Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD01 Mechanism of action
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, taksani, oznaka ATC: L01CD01 Mehanizem delovanja
Other side effects and their frequencies include:
Drugi neželeni učinki in njihove pogostnosti:
• lack of white and red blood cells, and blood platelets
• pomanjkanje belih in rdečih krvničk ter krvnih ploščic;
Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Poročali so o diseminirani intravaskularni koagulaciji (DIC), pogosto povezani s sepso ali odpovedjo več organov.
The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles (see sections 4.4 and 5.2).
Zmanjšani odmerek se lahko poveča do odmerka za bolnice z normalnim delovanjem jeter, če bolnica prenaša zdravljenje najmanj dva cikla (glejte poglavji 4.4 in 5.2).
To keep the generation of foam to a minimum, do not shake the vial.
Da bi bilo penjenje minimalno, viale ne stresajte.
The proportions of patients treated at first or second relapse were then equal in both treatment groups (76% were treated at first relapse and 24% at second relapse).
Delež bolnic, ki so jih zdravili ob prvem ali drugem recidivu, je bil nato v obeh skupinah zdravljenja enak (76 % jih je bilo zdravljenih ob prvem in 24 % ob drugem recidivu).
When Apealea (paclitaxel micellar) is administered intravenously, its pharmacokinetic profile suggests that the formulation immediately releases paclitaxel into the blood.
Pri intravenskem dajanju zdravila Apealea (micelarnega paklitaksela) njegov farmakokinetični profil kaže, da formulacija nemudoma sprosti paklitaksel v kri.
Apealea in children and adolescents aged 0−17 years has not been established.
Varnost in učinkovitost zdravila Apealea pri otrocih ter mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
Post-hoc subgroup analysis by relapse
Post-hoc analiza podskupine glede na recidiv
Infusion site reactions, such as pain, phlebitis, and erythema, were seen in 12% of patients (see section 4.4).
Reakcije na mestu infundiranja, kot so bolečina, flebitis in eritem, so opazili pri 12 % bolnic (glejte poglavje 4.4).
Palmar-plantar erythrodysesthesia syndromec
sindrom palmarno-plantarne eritrodisestezijec
Apealea should be reconstituted using either one of the three suitable solutions for reconstitution and according to the following steps:
Zdravilo Apealea je treba rekonstituirati z eno od treh raztopin, primernih za rekonstitucijo, in po sledečih navodilih:
The mean age was 56 years of age in both treatment groups (range 26-81).
Povprečna starost v obeh zdravljenih skupinah je bila 56 let (razpon od 26 do 81 let).
Almost all patients treated with Apealea had neutropenia of some grade, 79% of the patients had grade 3 or 4.
Skoraj vse bolnice, ki so prejemale zdravilo Apealea, so imele določeno stopnjo nevtropenije; pri 79 % bolnic je bila stopnje 3 ali 4.
The (reconstituted) product can only withstand short-term handling in absence of light protection.
Z (rekonstituiranim) zdravilom je mogoče brez zaščite pred svetlobo ravnati le kratkoročno.
Apealea is supplied as a sterile powder for reconstitution before use.
Zdravilo Apealea je dobavljeno kot sterilen prašek za rekonstitucijo pred uporabo.
* Can persist beyond 6 months of paclitaxel discontinuation.
* Lahko traja še več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.
Severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angioedema or generalised urticaria require immediate discontinuation of paclitaxel and initiation of symptomatic treatment.
Pri hudih reakcijah, kot so hipotenzija, ki zahteva zdravljenje, dispneja, pri kateri so potrebni bronhodilatatorji, angioedem ali generalizirana urtikarija, je treba takoj prenehati dajanje paklitaksela in začeti simptomatsko zdravljenje.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5.3).
Binding of paclitaxel to both albumin and α1-acid glycoprotein has been reported, but other binding proteins such as lipoproteins might be important.
Poročali so o vezavi paklitaksela na albumin in α1-kisli glikoprotein, vendar utegnejo biti pomembne tudi druge vezavne beljakovine, kot so lipoproteini.
n Events
n Dogodki
• difficulty producing voice sounds
• težava pri tvorbi glasov;
• blue tinged lips or skin
• pomodrele ustnice ali koža;
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C in lactated and acetated Ringer's solution and for 4 hours at 2 °C to 8 °C in sodium chloride 9 mg/mL (0.9%) solution when protected from light.
Kemična in fizikalna stabilnost med uporabo je bila dokazana za 24 ur pri 2-8 °C v Ringerjevi raztopini laktata ali acetata in za 4 ure pri 2-8 °C v raztopini natrijevega klorida 9 mg/ml (0,9 %), če je zdravilo zaščiteno pred svetlobo.
In studies with Apealea, 45% of patients reported alopecia during therapy.
Pri študijah z zdravilom Apealea je 45 % bolnic poročalo o alopeciji med zdravljenjem.