natgillin/translations-raw huggingface dataset:
These dose units are specific to NeuroBloc only and are not relevant to preparations of Botulinum Toxin Type A. The unit dose recommendations for Botulinum Toxin Type A are significantly lower than those for NeuroBloc and administration of Botulinum Toxin Type A at the unit dose recommended for NeuroBloc may result in systemic toxicity and life-threatening clinical sequelae. 
Te enote za odmerek so specifične le za zdravilo NeuroBloc, ne pa tudi za pripravke botulinskega toksina vrste A. Priporočeni odmerki botulinskega toksina vrste A so bistveno nižji od odmerkov zdravila NeuroBloc.
In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles. 
Tako kot pri botulinskem toksinu vrste A lahko bolniki v nekaterih oddaljenih mišicah občutijo elektrofiziološke trzljaje, ki niso povezani s klinično slabotnostjo ali drugimi elektrofiziološkimi bolezenskimi spremembami.
Adverse reactions related to spread of toxin distant from the site of administration have been reported: exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases (see section 4.4). 
Poročali so o neželenih učinkih, povezanih s širjenjem toksina distalno od mesta dajanja: zelo izrazita mišična šibkost, disfagija, dispnea, v nekaterih primerih aspiracijska pljučnica s smrtnim izidom (glejte poglavje 4.4).
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties 
FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti
The potency of Neurobloc is 5000 U/ml. 
Jakost zdravila Neurobloc je 5.000 E/ml.
NeuroBloc is provided in vials for single use only. 
Zdravilo NeuroBloc je na voljo samo v vialah za enkratno uporabo.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le na poseben recept in s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid and water for injections. 
Dinatrijev sukcinat, natrijev klorid, raztopina humanega serumskega albumina, klorovodikova kislina in voda za injekcije
NeuroBloc should only be administered by a physician who is familiar with and experience in the treatment of cervical dystonia and in the use of botulinum toxins. 
Zdravilo NeuroBloc sme dajati le zdravnik, ki ima izkušnje z zdravljenjem cervikalne distonije in uporabo botulinskih toksinov.
Pregnancy, breast-feeding and fertility you will not normally be given NeuroBloc if you are pregnant or breast-feeding. 
Na splošno vam ne bi smeli dati zdravila NeuroBloc, če ste noseči ali če dojite.
EXP After dilution, use immediately 
Uporabno do Uporabite takoj po razredčenju.
Post marketing experience 
Izkušnje po uvedbi zdravila na trg
NeuroBloc is not to be used in children aged less than18 years. 
Pri otrocih, mlajših od 18 let, se zdravilo NeuroBloc ne sme uporabljati.
To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and the solution used immediately. 
Da boste lahko celotni odmerek razdelili na več injekcij, lahko zdravilo NeuroBloc razredčite z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje in nato raztopino porabite takoj.
The active substance is Botulinum Toxin Type B. One millilitre (ml) contains 5000 U. 
Zdravilna učinkovina je botulinski toksin vrste B. En mililiter (ml) vsebuje 5.000 E.
Respiratory thoracic and mediastinal disorders dysphonia 
Bolezni dihal, prsnega koša in mediastinalnega prostora disfonija
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
If you are not sure talk to your doctor or pharmacist. 
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
NeuroBloc 5000 U/ml Solution for Injection Botulinum Toxin Type B 
NeuroBloc 5.000 E/ml raztopina za injiciranje botulinski toksin vrste B
Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4). 
Poročajo o neželenih učnikih, povezanih s širjenjem toksina proč od mesta injiciranja (pretirana oslabelost mišic, disfagija, dispneja, in v nekaterih primerih usodna aspiracijska pljučnica) (glejte poglavje 4.4)
NeuroBloc will be injected into your neck or shoulder muscles, depending on which ones are causing the problem your doctor may inject part of the dose into different places in your muscles 
Zdravilo NeuroBloc vam bodo injicirali v vratne ali ramenske mišice, odvisno od tega, katere vam povzročajo težave.
To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2 of Summary of Product Characteristics). 
Da boste lahko celotni odmerek razdelili na več injekcij, lahko zdravilo NeuroBloc razredčite z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila).
To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2). 
Da boste lahko celotni odmerek razdelili na več injekcij, lahko zdravilo NeuroBloc razredčite z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje (glejte poglavje 4.2).
NeuroBloc is recommended for intramuscular administration only. 
Zdravilo NeuroBloc je namenjeno le za intramuskularno uporabo.
NeuroBloc 5000 U/ml solution for injection. 
NeuroBloc 5.000 E/ml raztopina za injiciranje
In the first study, type A resistant patients (A-non responders) were randomised to receive placebo or 10,000 U of NeuroBloc and in the second, type A toxin responsive patients (A-responders) were randomised to receive placebo, 5000 U or 10,000 U of toxin. 
V prvi študiji so bili bolniki, rezistentni na toksin vrste A (A-nedovzetni), naključno razporejeni v skupine, ki so prejemale placebo ali 10.000 E zdravila NeuroBloc.
How NeuroBloc is given 
Kako se zdravilo NeuroBloc daje
A serious condition called “botulism” which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body. 
Če vam v telo injicirajo preveč zdravilne učinkovine (botulinskega toksina), se lahko pojavi resno stanje, ki se imenuje “botulizem”, ki povzroči ohromitev mišic in odpoved dihanja.
Single dose intramuscular toxicology studies have been performed in cynomolgus monkeys. 
Na opicah vrste Macaca fascicularis so opravili intramuskularne toksikološke raziskave enkratnih odmerkov.
Any unused solution, all vials of expired NeuroBloc and equipment used in the administration of the medicinal product should be carefully discarded as Medical Biohazardous Waste in accordance with local requirements. 
Morebitno neporabljeno raztopino, vse viale zdravila NeuroBloc s pretečenim rokom uporabnosti in pripomočke, ki ste jih uporabili pri dajanju zdravila, morate skrbno zavreči kot biološko nevarne medicinske odpadke v skladu z lokalnimi predpisi.
Aspiration pneumonia caused by food particles or vomit entering into the lungs, and respiratory disease, have been reported after treatment with botulinum toxins (Type A and Type B). 
Po zdravljenju z botulinskimi toksini (vrsta A in vrsta B) so poročali o aspiracijski pljučnici, ki jo povzročajo delci hrane ali izbruhka, ki vstopijo v pljuča, in o bolezni dihal.
You may have muscle weakness or eye problems such as blurred vision or eyelid drooping after being given NeuroBloc. 
Potem ko vam dajo zdravilo NeuroBloc, se lahko pojavi mišična šibkost ali težave z očmi, na primer zamegljen vid ali povešenost očesnih vek.
This is because it is not known how NeuroBloc affects patients who are pregnant and it is not known if NeuroBloc passes into a nursing mother's breast milk if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
There have been spontaneous reports of dysphagia, aspiration pneumonia and/or potentially fatal respiratory disease, after treatment with Botulinum Toxin Type A/B. 
Po zdravljenju z botulinskim toksinom vrste A/B obstajajo spontana poročila o disfagiji, aspiracijski pljučnici in/ali potencialno usodnih obolenjih dihal.
Renal and hepatic impairment 
Okvarjeno delovanje ledvic in jeter
Eye disorders blurred vision 
Očesne bolezni zamegljen vid
Do not use after the expiration date stamped on the vial. 
Zdravila NeuroBloc ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 0.5 ml vial 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 0,5 ml viala
Contents of the pack and other information 
Shranjevanje zdravila NeuroBloc Vsebina pakiranja in dodatne informacije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1.0 ml vial 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 1,0 ml viala
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2.0 ml vial 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 2,0 ml viala
Physician Global 
Splošna ocena zdravnika
As with many biological/biotechnology proteins used as therapeutic agents, repeated administration of NeuroBloc may be associated with development of antibodies to Botulinum Toxin Type B in some patients. 
Podobno kot pri številnih bioloških/biotehnoloških beljakovinah, ki se uporabljajo kot zdravilne učinkovine, je ponavljajoča se uporaba zdravila NeuroBloc pri nekaterih bolnikih lahko povezana z razvojem protiteles proti botulinskemu toksinu vrste B. Podatki o imunogenosti iz treh dolgoročnih kliničnih študij kažejo, da se pri približno eni tretjini bolnikov razvijejo protitelesa, kot je bilo ugotovljeno s testom nevtralizacije pri miših/zaščite miši, odvisno od trajanja izpostavljenosti (glejte poglavje 5.1).
Each ml contains 5000 U Botulinum Toxin Type B. 
En ml vsebuje 5.000 E botulinskega toksina vrste B.
Gastrointestinal disorders dysphagia dyspepsia 
Bolezni prebavil disfagija dispepsija
Skin allergies such as rash with or without paleness, redness, patches, severe itching; and skin eruptions such as welts or hives have also been reported after receiving NeuroBloc. 
Po prejemanju zdravila NeuroBloc so poročali tudi o kožnih alergijah, na primer izpuščaju z bledico ali brez nje, rdečici, lisah, močnem srbenju in kožnih izpuščajih, na primer marogah ali koprivnici.
Musculoskeletal connective tissue and bone disorders myasthenia 
Bolezni mišično-skeletnega sistema in vezivnega tkiva miastenija
Human serum albumin Hydrochloric acid (for pH adjustment) Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi dinatrijev sukcinat natrijev klorid humani serumski albumin klorovodikova kislina (za uravnavanje pH) voda za injekcije
Each 0.5 ml vial contains 2500 U Botulinum Toxin Type B. 
Ena viala po 0,5 ml vsebuje 2.500 E botulinskega toksina vrste B.
Having more injections of NeuroBloc the effects of NeuroBloc will usually last about 12 to 16 weeks your doctor will decide if you need another injection and how much to give you 
Učinki zdravila NeuroBloc navadno trajajo okrog 12 do 16 tednov.
This may occur when higher doses of up to 15,000 units are given if you have difficulty breathing or you are worried by any symptoms you develop away from the place of the injection, talk to your doctor immediately. 
Če imate težave z dihanjem ali ste zaskrbljeni zaradi kakšnih simptomov, ki se pojavijo v zvezi s širjenjem botulinskega toksina v druge telesne dele z mesta, kamor je bila dana injekcija, se nemudoma pogovorite s svojim zdravnikom.
Each 1.0 ml vial contains 5000 U Botulinum Toxin Type B. 
Ena viala po 1,0 ml vsebuje 5.000 E botulinskega toksina vrste B.
Each 2.0 ml vial contains 10,000 U Botulinum Toxin Type B. 
Ena viala po 2,0 ml vsebuje 10.000 E botulinskega toksina vrste B.
How to store NeuroBloc 
Shranjevanje zdravila NeuroBloc
If there are any visible signs of deterioration, the medicine should not be used, but discarded any unused solution should be discarded due to the special nature of NeuroBloc, the doctor will ensure that all used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements 
Zaradi posebne narave zdravila NeuroBloc bo zdravnik poskrbel, da se bodo vse uporabljene viale, igle in brizge obravnavale kot biološko nevarni medicinski odpadki v skladu z lokalnimi predpisi.
How much will be given your doctor will decide how much NeuroBloc to give you the usual dose is 10,000 units, however, it can be higher or lower if you have had NeuroBloc injections before, your doctor will take into account how well it worked the other times 
Če ste že prej dobivali injekcije zdravila NeuroBloc, bo vaš zdravnik upošteval, kako dobro je zdravilo delovalo pri predhodni uporabi.
Each ml contains 5000 U Botulinum Toxin Type B. One vial of 1 ml contains 5000 U of Botulinum Toxin Type B. 
En ml vsebuje 5.000 E botulinskega toksina vrste B. Ena viala po 1 ml vsebuje 5.000 E botulinskega toksina vrste B.
Each ml contains 5000 U Botulinum Toxin Type B. One vial of 0.5 ml contains 2500 U of Botulinum Toxin Type B. 
En ml vsebuje 5.000 E botulinskega toksina vrste B. Ena viala po 0,5 ml vsebuje 2.500 E botulinskega toksina vrste B.
Do not freeze keep the vial in the outer carton in order to protect from light within its shelf-life, NeuroBloc may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25oC. 
Do preteka roka uporabnosti smete vzeti zdravilo iz hladilnika za eno samo obdobje, ki ne sme biti daljše od 3 mesecev, pri temperaturi, ki ne presega 25 °C.
Each ml contains 5000 U of Botulinum Toxin Type B. One vial of 2 ml contains 10,000 U of Botulinum Toxin Type B. 
En ml vsebuje 5.000 E botulinskega toksina vrste B. Ena viala po 2 ml vsebuje 10.000 E botulinskega toksina vrste B.
Assessments 
Odmerjanje
You must not be given NeuroBloc if any of the above applies to you. 
Če kaj od zgoraj navedenega velja za vas, ne smete prejeti zdravila NeuroBloc.
How to store NeuroBloc keep this medicine out of the sight and reach of children do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP store in a refrigerator (2°C-8°C). 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli in na viali poleg oznake Uporabno do oziroma EXP.
At the end of this period, the product should not be put back in the refrigerator and should be disposed of the date at which the medicine was taken out from the refrigerator will be put on the outer carton if the medicine is diluted, the doctor will use it immediately before using the medicine the doctor will check that the solution is clear and colourless/light yellow. 
Preden bo zdravnik zdravilo uporabil, se bo prepričal, da je raztopina bistra in brezbarvna/svetlorumena.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 1.0 ml vial 
OZNAKA VIALE 1,0 ml viala
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 2.0 ml vial 
OZNAKA VIALE 2,0 ml viala
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 0.5 ml vial 
OZNAKA VIALE 0,5 ml
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM • Redno posodobljena poročila o varnosti zdravila (PSUR)
The application was withdrawn after ‘day 181'. 
Vlogo so umaknili po „181.
‘Metastatic' means the cancer has spread to other parts of the body. 
„Metastatski“ pomeni, da se je rak razširil na druge dele telesa.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'. 
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“.
The company also presented the results of animal studies showing the distribution of the two medicines in different body tissues such as the heart, skin, kidney and spleen, since this could not be studied in humans. 
Družba je predstavila tudi rezultate študij na živalih, ki so pokazali porazdelitev obeh zdravil v različnih telesnih tkivih, kot so srce, koža, ledvice in vranica, saj tega ni bilo možno proučevati na ljudeh.
It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects. 
Prav tako zmanjša učinke zdravila na nerakava tkiva in celice, zato je manj verjetno, da povzroča določene neželene učinke.
• metastatic breast cancer in patients at risk of heart problems. 
• metastatskega raka dojke pri bolnikih s tveganjem za težave s srcem.
It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins. 
Deluje tako, da vpliva na DNK v celicah ter jim preprečuje ustvarjati nove kopije DNK in proizvajati beljakovine.
This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions. 
To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues. 
Potem ko je CHMP ocenil odgovore družbe na zadnja vprašanja, so nekatera vprašanja še vedno ostala nerešena.
The active substance has an effect in the body when it is released (freed) from the liposome. 
Zdravilna učinkovina učinkuje na telo, ko se sprosti (izloči) iz liposoma.
It contains the active substance doxorubicin (2 mg/ml). 
Vsebuje zdravilno učinkovino doksorubicin (2 mg/ml).
Because Doxorubicin SUN was assessed as a hybrid generic medicine, the company presented the results of studies carried out to investigate whether it is similar to the reference medicine. 
Ker je bilo zdravilo Doxorubicin SUN ocenjeno kot hibridno generično zdravilo, je družba predstavila rezultate študij, ki so bile izvedene za proučevanje, ali je podobno referenčnemu zdravilu.
• advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working; 
• napredovalega raka jajčnikov pri ženskah, pri katerih predhodno zdravljenje, ki je vključevalo zdravilo proti raku na osnovi platine, ne deluje več;
• multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant. 
• multiplega mieloma (rak celic v kostnem mozgu) pri bolnikih z napredovalo boleznijo, ki so se v preteklosti že vsaj enkrat zdravili z drugim zdravilom in je bila pri njih že opravljena presaditev kostnega mozga ali zanjo niso primerni.
On 20 Jul 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Doxorubicin SUN, intended for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma. 
je dne 20. julija 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Doxorubicin SUN, namenjenim zdravljenju metastatskega raka dojke, napredovalega raka jajčnikov in napredovalega multiplega mieloma.
This means that it is similar to a ‘reference medicine' already authorised in the European Union containing the same active substance, called Caelyx. 
To pomeni, da je podobno „referenčnemu zdravilu“, in sicer zdravilu Caelyx, ki je v Evropski uniji že odobreno in vsebuje enako zdravilno učinkovino.
Doxorubicin SUN was originally also expected to be used to treat AIDS-related Kaposi's sarcoma (a cancer of the blood vessels) but this indication was withdrawn during the evaluation process. 
Prvotno naj bi se zdravilo Doxorubicin SUN uporabljalo tudi za zdravljenje z aidsom povezanega Kaposijevega sarkoma (rak krvnih žil), vendar so to indikacijo med postopkom ocenjevanja umaknili.
Doxorubicin SUN was expected to be used to treat the following types of cancer in adults: 
Zdravilo Doxorubicin SUN naj bi se uporabljalo za zdravljenje naslednjih vrst raka pri odraslih:
Doxorubicin accumulates in areas of the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated. 
Doksorubicin se kopiči v delih telesa, kjer imajo žile nenormalno obliko, npr. v tumorjih, kjer se njegovo delovanje skoncentrira.
This means that cancer cells cannot divide and eventually die. 
To pomeni, da se rakaste celice ne morejo razmnoževati in sčasoma odmrejo.
Doxorubicin SUN was assessed as a ‘hybrid generic medicine'. 
Zdravilo Doxorubicin SUN je bilo ocenjeno kot „hibridno generično zdravilo“.
This reduces the rate at which the active substance is broken down, allowing it to circulate in the blood for longer. 
To upočasni hitrost razgrajevanja zdravilne učinkovine in podaljša čas njenega kroženja v krvi.
Based on the data submitted, the CHMP was of the opinion that the studies did not provide enough evidence to show that Doxorubicin SUN was similar to the reference medicine. 
Na podlagi predloženih podatkov je CHMP menil, da študije niso zagotovile zadostnih dokazov, da je zdravilo Doxorubicin SUN podobno referenčnemu zdravilu.
Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Doxorubicin SUN could not have been approved. 
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Doxorubicin ni mogoče odobriti.
Doxorubicin SUN was to be used in combination with bortezomib (another anticancer medicine). 
Zdravilo Doxorubicin SUN naj bi se uporabljalo skupaj z bortezomibom (drugo zdravilo proti raku).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Doxorubicin SUN. 
Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Doxorubicin SUN.
These included studies in patients with ovarian cancer and multiple myeloma to investigate the concentrations of doxorubicin in the blood produced by Doxorubicin SUN compared with Caelyx. 
V dokumentacijo so bile vključene študije, v katerih so sodelovali bolniki z rakom jajčnikov in multiplim mielomom ter v katerih so proučevali koncentracije doksorubicina v krvi, ki ga tvori zdravilo Doxorubicin SUN v primerjavi z zdravilom Caelyx.
Doxorubicin SUN was expected to work in the same way as the reference medicine, Caelyx. 
Zdravilo Doxorubicin SUN naj bi delovalo na enak način kot referenčno zdravilo Caelyx.
This included the total amount of doxorubicin and the amounts of liposome-encapsulated doxorubicin, free doxorubicin and doxorubicinol (the main metabolite of doxorubicin). 
To je vključevalo celotno količino doksorubicina in količine doksorubicina, enkapsuliranega v liposome, prostega doksorubicina in doksorubicinola (glavni presnovek doksorubicina).
What is Doxorubicin SUN? 
Kaj je zdravilo Doxorubicin SUN?
In Caelyx and Doxorubicin SUN, doxorubicin is contained (encapsulated) in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol). 
V zdravilu Caelyx in Doxorubicin SUN je doksorubicin (enkapsuliran) v „pegiliranih liposomih“ (majhnih maščobnih kroglicah, ki so prevlečene s snovjo, imenovano polietilen glikol).
Doxorubicin SUN was expected to be used on its own for this disease; 
Zdravilo Doxorubicin SUN naj bi se pri zdravljenju te bolezni uporabljalo samostojno;