natgillin/translations-raw huggingface dataset:
10 pre-filled syringes without needle
10 napolnjenih injekcijskih brizg brez igle
Route of Administration
Pot Uporabe
can be given to the following groups of patients:
se lahko daje naslednjim skupinam bolnikov:
is one 75 mg tablet once a day, taken with or without food.
je ena 75-miligramska tableta enkrat na dan, vzeta s hrano ali brez nje.
can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
be given marketing authorisation.
odobri dovoljenje za promet.
It is available as pink, round tablets (75 mg).
Na voljo je v obliki rožnatih, okroglih tablet (75 mg).
The European Commission granted a marketing authorisation valid throughout the EU for Zopya on 21 September 2009.
Evropska komisija je dovoljenje za promet z zdravilom Zopya, veljavno po vsej Evropski uniji, odobrila dne 21. septembra 2009.
can be started between seven days and six months after the stroke;
se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
Previously known as Zopya.
Zdravilo prej znano pod imenom Zopya.
is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost arterij).
is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Krka d.d.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel Krka d.d., na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
• patients with peripheral arterial disease (problems with blood flow in the arteries).
• bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v krvnih žilah).
is a medicine that contains the active substance clopidogrel.
je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
can be started between a few days and 35 days after the attack;
Zdravilo Clopidogrel Krka d.d se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka d.d.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel Krka d.d.
For more information about treatment with Clopidogrel Krka d.d., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Krka d.d.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Krka d.d.
What are the benefits and risks of Clopidogrel Krka d.d.
Kakšne so koristi in tveganja, povezani z zdravilom Clopidogrel Krka d.d.
been approved?
odobreno?
The active substance in Clopidogrel Krka d.d., clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel Krka d.d., klopidogrel, je zaviralec agregacije trombocitov.
has been shown to have comparable quality and to be bioequivalent to Plavix.
primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
The Committee recommended that Clopidogrel Krka d.d.
Odbor je priporočil, da se za zdravilo Clopidogrel Krka d.d.
The name of the medicine was changed to Clopidogrel Krka d.d.
Ime zdravila je bilo 18. maja 2011 spremenjeno v Clopidogrel Krka d.d.
Other information about Clopidogrel Krka d.d.
Druge informacije o zdravilu Clopidogrel Krka d.d.
The standard dose of Clopidogrel Krka d.d.
Običajni odmerek zdravila Clopidogrel Krka d.d.
How does Clopidogrel Krka d.d.
Kako se zdravilo Clopidogrel Krka d.d.
Why has Clopidogrel Krka d.d.
Zakaj je bilo zdravilo Clopidogrel Krka d.d.
What is Clopidogrel Krka d.d.
Kaj je zdravilo Clopidogrel Krka d.d.
How is Clopidogrel Krka d.d.
Kako je bilo zdravilo Clopidogrel Krka d.d.
These effects have been seen frequently, and are sometimes severe.
Te učinke so opažali pogosto in so včasih hudi.
The frequencies are provided according to the following convention:
Pogostnosti so opredeljene po naslednji konvenciji:
These results, though not mature, constituted the protocol defined final analysis.
Ti rezultati, ki sicer še niso bili zreli, pa so sestavljali s protokolom opredeljeno končno analizo.
Three cases were poorly documented and were excluded from the assessment.
Trije primeri niso bili zadostno dokumentirani, zato so bili izločeni iz ocene.
* Measured at the end of a 30-minute infusion
* izmerjeno na koncu 30-minutne infuzije
Wait an additional week
Počakajte še en teden
These effects may occur early on in treatment.
Ti učinki se lahko pojavijo zgodaj med zdravljenjem.
20 months.
20 mesecev
Lagoas Park, Edifício 9
Lagoas Park, Edificio 9
The following information is intended for medical or healthcare professionals only (see section 3):
Naslednje informacije so namenjene samo zdravstvenemu osebju (glejte poglavje 3):
Reduce next dose by 25%.
Zmanjšajte naslednji odmerek za 25%.
Myelosuppression was mostly mild or moderate and manageable.
Mielosupresija je bila večinoma blaga ali zmerna in obvladljiva.
Patients and doctors must be aware of this higher incidence and take action as appropriate.
Bolniki in zdravniki se morajo tega zavedati in ustrezno ukrepati.
The overall incidence of PPE reported was 44.0%-46.1%.
Splošna incidenca PPE je bila 44,0 do 46,1%.
The application of ice over the site of extravasation for approximately 30 minutes may be helpful in alleviating the local reaction.
Približno 30-minutno polaganje ledu na mesto ekstravazacije lahko pomaga ublažiti lokalno reakcijo.
If you are allergic to peanut or soya, do not use this medicine.
Če ste alergični na arašide ali sojo, ne uporabljajte tega zdravila.
Day 4 dosing of both medicinal products may be delayed up to 48 hours as medically necessary.
Dajanje obeh zdravil na 4. dan se lahko odloži do 48 ur, če je to medicinsko potrebno.
Very rare
redki zelo redki
The dose is repeated every 2 to 3 weeks for 2-3 months, then as often as necessary to maintain an improvement in your condition.
Odmerek je treba ponavljati na vsaka 2 do 3 tedne skupaj 2 do 3 mesece, potem pa tako pogosto, kot je treba, da se ohrani izboljšanje vašega stanja.
Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).
Odvisno od odmerka in indikacije lahko infuzija traja od 30 minut do več kot eno uro (npr. 90 minut).
If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.
Če niste prepričani, kakšna zdravila ste prejemali ali katere bolezni ste imeli, se o tem pogovorite s svojim zdravnikom.
< 1/10,000 including isolated reports
< 1/10.000, vključno s posameznimi primeri
Continue treatment as needed to maintain a therapeutic response.
Zdravljenje nadaljujte, kolikor dolgo je potrebno za ohranitev terapevtskega odziva.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
3) and extensive mucocutaneous or visceral disease.
3) in razširjeno mukokutano ali visceralno boleznijo.
However, the response was not life-threatening and the dogs recovered quickly upon discontinuation of treatment.
Vendar odziv ni bil smrtno nevaren in psi so si po prekinitvi zdravljenja hitro opomogli.
It is because of the potential changes in your blood cells that you will have regular blood tests.
Prav zaradi možnosti, da pride do spremembe števila krvnih celic v vaši krvi, boste imeli redne krvne preiskave.
The average duration of the most common severe (grade 3/4) events for both groups was 30 days or less.
Povprečno trajanje najpogostejših hudih neželenih učinkov (3. do 4. stopnja) pri obeh skupinah je bilo 30 dni ali manj.
After dilution:
Po razredčenju:
not previously reported in clinical trials
ki še niso bili poročani v kliničnih preskušanjih
Paediatric population The experience in children is limited.
Izkušnje pri otrocih so omejene.
PPE infrequently resulted in permanent treatment discontinuation (3.7%-7.0%).
PPE je redko povzročila dokončno ukinitev zdravila (3,7 do 7,0%).
Among the seven cases reviewed, the causality was stated as probable in 4 cases and possible in 1 case.
Med sedmimi pregledanimi primeri, je bila pri 4 primerih ugotovljena verjetna vzročna povezanost in pri 1 primeru možna vzročna povezanost.
From a microbiological point of view, the product should be used immediately.
Z mikrobiološkega stališča pa je treba zdravilo uporabiti takoj.
5% of the total dose should be infused slowly over the first 15 minutes.
5% celotnega odmerka infundirajte počasi v prvih 15 minutah.
The exact mechanism of the antitumour activity of doxorubicin is not known.
Natančen mehanizem protitumorskega delovanja doksorubicina ni znan.
These effects were mostly mild, with severe (grade 3) cases reported in 17%-19.5%.
Ti učinki so bili večinoma blagi, o hujših primerih (3. stopnje) pa so poročali v 17 do 19,5% primerov.
Pegylated placebo liposomes are neither mutagenic nor genotoxic.
Pegilirani placebo liposomi niso ne mutageni ne genotoksični.
In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely.
V hujših primerih lahko ti učinki motijo določene vsakodnevne dejavnosti in lahko trajajo kar 4 tedne ali celo dlje, preden popolnoma minejo.
A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
S protokolom določena vmesna analiza (na osnovi 249 TTP dogodkov) je vodila do predčasne prekinitve študije kar zadeva ugotavljanje učinkovitosti.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Nosečnost in dojenje Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.
Grade 3 PPE was reported in 5% of patients.
O PPE 3. stopnje so poročali pri 5% bolnikov,
The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Stopnja toksičnosti, navedena v teh preglednicah, temelji na merilih NCI-CTC (National Cancer Institute Common Toxicity Criteria).
In all patients, infusion-associated reactions occurred primarily during the first infusion.
Pri vseh bolnikih so se infuzijske reakcije pojavile predvsem med prvo infuzijo.
The final analysis for overall survival (OS) performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Končna analiza celokupnega preživetja (OS) po medianem spremljanju bolnikov 8,6 let ni pokazala pomembne razlike v OS med obema skupinama zdravljenja.
The risk of low blood counts and infections was similarly low in breast cancer studies.
Tveganje za premajhno število krvnih celic in pojav okužb je bilo podobno majhno tudi v raziskavah raka dojk.
Fertility The effect of doxorubicin hydrochloride on human fertility has not been evaluated (see section 5.3).
Plodnost Učinka doksorubicinijevega klorida na plodnost pri človeku niso ocenjevali (glejte poglavje 5.3).
In this case, the dose interval may be extended by 1-2 weeks or the dose reduced (see section 4.2).
V tem primeru lahko razmik med odmerki podaljšate za 1 do 2 tedna ali pa zmanjšate odmerek zdravila (glejte poglavje 4.2).
 1/100 and < 1/10
 1/100 in < 1/10
Caution must be observed in patients who have received other anthracyclines.
Previdnost je potrebna tudi pri bolnikih, ki so prejemali druge antracikline.
Other symptoms of Kaposi's sarcoma, such as swelling around the tumour, may also improve or disappear.
Tudi drugi simptomi Kaposijevega sarkoma, npr. otekanje okrog tumorja, se lahko izboljšajo ali izginejo.
No grade 4 PPE was reported.
primerov s PPE 4. stopnje pa ni bilo.
In very rare cases, seizures (convulsions) have occurred.
V zelo redkih primerih so se pojavili epileptični napadi (konvulzije).
Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Zdravstveni strokovnjaki priporočajo, naj s HIV okužene ženske v nobenem primeru ne dojijo, da se prepreči prenos HIV.
Date of first authorisation: 21 June 1996 Date of lastest renewal: 19 May 2006
Datum zadnjega podaljšanja : 19. maj 2006
60 mg/m2/every 3 weeks) met the protocol-defined criteria for cardiac toxicity during treatment and/or follow-up.
60 mg/m2 na vsake 3 tedne) izpolnjevalo kriterije kardiotoksičnosti po protokolu, med zdravljenjem in/ali med spremljanjem po zdravljenju.
Patients who suffer from these effects must avoid driving and operating machinery.
Bolniki, pri katerih se pojavita ta dva neželena učinka, naj ne vozijo in ne upravljajo s stroji.
It is not known whether Caelyx is excreted in human milk.
Ni znano, ali se zdravilo Caelyx izloča v mleko pri ljudeh.
Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.
Kongestivno srčno popuščanje zaradi kardiomiopatije se lahko pojavi nenadoma in brez predhodnih EKG sprememb, lahko tudi več tednov po koncu zdravljenja.
Therefore, Caelyx should not be used during pregnancy unless clearly necessary.
Zdravila Caelyx ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
- From a microbiological point of view, the product should be used immediately.
- Z mikrobiološkega stališča velja, da je treba zdravilo uporabiti takoj.
Grade 4 (requires parenteral or enteral support)
Stopnja 4 (potrebno parenteralno ali enteralno hranjenje)
Doses of bortezomib should be at least 72 hours apart.
Med zaporednimi odmerki bortezomiba mora preteči najmanj 72 ur.
Do not use with in-line filters.
Ne uporabljajte linij s filtri.
Temporarily stopping the infusion usually resolves these symptoms without further therapy.
Začasna prekinitev infundiranja običajno odpravi te simptome, ne da bi bilo potrebno dodatno zdravljenje.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih sprejetih posodobitvah RMP.
For all patients
Za vse bolnike
Treatment discontinuation of one or both agents due to adverse events was seen in 38% of patients.
Zdravljenje z enim ali obema zdraviloma so zaradi pojava neželenih učinkov ukinili pri 38% bolnikov.
In patients experiencing this event, it is generally seen after two or three cycles of treatment.
Ta učinek se pri bolnikih običajno pojavi po dveh ali treh krogih zdravljenja.
Caelyx should not be used in children and adolescents, because it is not known how the medicine will affect them.
Zdravila Caelyx se ne sme uporabljati pri otrocih in mladostnikih, ker vpliv zdravila pri tej populaciji ni znan.
Population based analysis demonstrates that age across the range tested (21-75 years) does not significantly alter the pharmacokinetics of Caelyx.
Populacijska analiza kaže, da starost v preskušanem razponu (21 do 75 let) bistveno ne spremeni farmakokinetike zdravila Caelyx.
Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out.
Presledki naj ne bodo krajši od 10 dni, ker ni mogoče izključiti kopičenja zdravila in posledične povečane toksičnosti.
If the bilirubin is > 3.0 mg/dl, the first dose is reduced by 50%.
Če je koncentracija bilirubina > 3,0 mg/dl, prvi odmerek zmanjšajte za 50%.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Če se ne uporabi takoj, čas in pogoje shranjevanja pred uporabo z lastno odgovornostjo določi uporabnik na lastno odgovornost, vendar ne sme presegati 24 ur pri temperaturi 2 °C do 8 °C.
If Caelyx comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water.
Če pride zdravilo Caelyx v stik s kožo ali sluznico, jo takoj in temeljito umijte z milom in vodo.
Other less frequently (< 5%) observed undesirable effects included hypersensitivity reactions including anaphylactic reactions.
Med drugimi, redkejšimi (< 5%) neželenimi učinki so bile preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami.
The infusion may be given through a peripheral vein.
Infuzija lahko teče v periferno veno.
Treatment of patients for two-to-three months is recommended to achieve a therapeutic response.
Za doseganje terapevtskega odziva je priporočljivo bolnike zdraviti dva do tri mesece.
When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Pri samostojni uporabi zdravila Caelyx je verjetnost, da se bodo pojavili nekateri od teh učinkov, manjša, drugi pa se sploh ne pojavljajo.
Improvement usually occurs in one - two weeks, and in some cases, may take up to 4 weeks or longer for complete resolution.
Izboljšanje običajno nastopi v enem do dveh tednih, v nekaterih primerih pa lahko traja tudi do 4 tedne ali celo dlje, da izpuščaj popolnoma mine.
Section 4 of the package leaflet should be updated accordingly with the term “patches of skin thickening”.
Ustrezno je treba posodobiti tudi poglavje 4 Navodila za uporabo in vključiti izraz “zadebelitev delov kože”.
The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.
Odmerek je treba ponoviti na vsake 4 tedne, če bolezen ne napreduje in če dobro prenašate zdravljenje.
Decrease dose by 25%; return to 4 week interval
Zmanjšajte odmerek za 25%; vrnite se na 4-tedenski presledek
Growth factor support was required infrequently (< 5%) and transfusion support was required in approximately 15% of patients (see section 4.2).
Redko je bila potrebna podpora z rastnim faktorjem (< 5%), transfuzijo pa je potrebovalo približno 15% bolnic (glejte poglavje 4.2).
75,000 - 150,000 Resume treatment with no dose reduction.
75.000 - 150.000 Nadaljujte zdravljenje, ne da bi zmanjšali odmerek.
If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i.e., if reduced by 25% for the first dose, increase to full dose for cycle 2; if reduced by 50% for the first dose, increase to 75% of full dose for cycle 2.
Če bolnik prenese prvi odmerek brez povečanja koncentracije serumskega bilirubina ali jetrnih encimov, lahko odmerek za 2. krog povečate na naslednjo odmerno raven, tj. če je bil prvi odmerek zmanjšan za 25%, ga v 2. krogu povečajte na polni odmerek; če je bil prvi odmerek zmanjšan za 50%, ga v 2. krogu povečajte na 75% polnega odmerka.
On the basis of the scientific conclusions for doxorubicin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing doxorubicin is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za doksorubicin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) doksorubicin nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
Zdravila Caelyx ne smete dajati intramuskularno ali subkutano (glejte poglavje 6.6).
Grade 4 (diffuse or local process causing infectious complications, or a bedridden state or hospitalisation)
Stopnja 4 (difuzni ali lokalni procesi, ki povzročajo infekcijske zaplete; priklenjenost na posteljo ali bolnišnično zdravljenje)
These methods must be applied routinely before the initiation of Caelyx therapy and repeated periodically during treatment.
Takšen pregled je treba opraviti rutinsko še pred začetkom terapije z zdravilom Caelyx in ga med zdravljenjem redno ponavljati.
Other side effects Between infusions, the following may occur:
Drugi neželeni učinki Med posameznimi infuzijami se lahko pojavijo:
A similar, but less severe response was also noted in dogs treated with Caelyx and standard doxorubicin.
Podoben, a manj močan odziv je bil zabeležen tudi pri psih, zdravljenih z zdravilom Caelyx in standardnim doksorubicinom.
No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min.
Podatki o farmakokinetiki zdravila pri bolnikih z očistkom kreatinina pod 30 ml/min niso na voljo.
However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Zmanjšanje kompleksa QRS pa velja za izrazitejši znak toksičnega učinka na srce.
Very rarely, convulsions also have been observed in relation to infusion reactions (see section 4.8).
Zelo redko se lahko v povezavi z infuzijskimi reakcijami pojavijo tudi konvulzije (glejte poglavje 4.8).
What Caelyx is and what it is used for
Kaj je zdravilo Caelyx in za kaj ga uporabljamo
Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
Poleg tega je le 1 bolnik (ki je dobil kumulativni odmerek antraciklina 944 mg/m2) prekinil zdravljenje v raziskavi zaradi kliničnih simptomov kongestivnega srčnega popuščanja.
For further instructions on preparation and special precautions for handling see section 6.6.
Za navodila o pripravi in posebnih previdnostnih ukrepih za ravnanje z zdravilom glejte poglavje 6.6.
Only 13 of these 88 patients (15%) had at least one clinically significant change in their LVEF, defined as an LVEF value less than 45% or a decrease of at least 20 points from baseline.
Le 13 od teh 88 bolnikov (15%) je imelo vsaj eno klinično pomembno spremembo LVEF, kar je bilo opredeljeno kot LVEF manjši od 45% ali zmanjšanje LVEF za vsaj 20 točk glede na vrednost na začetku raziskave.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Kemična in fizikalna stabilnost zdravila med uporabo je dokazana za čas 24 ur pri temperaturi od 2 °C do 8 °C.
Pegylated liposomes are small enough (average diameter of approximately 100 nm) to pass intact (extravasate) through defective blood vessels supplying tumours.
Pegilirani liposomi so dovolj majhni (povprečni premer je približno 100 nm), da nespremenjeni preidejo (ekstravazirajo) skozi okvarjene žile, ki oskrbujejo tumorje s krvjo.