natgillin/translations-raw huggingface dataset:
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;
The active substance in Doxorubicin SUN and Caelyx, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Zdravilna učinkovina v zdravilu Doxorubicin SUN in Caelyx, doksorubicin, je citotoksično zdravilo iz skupine „antraciklinov“.
Doxorubicin SUN is concentrate to be made up into a solution for infusion (drip into a vein).
Zdravilo Doxorubicin SUN je koncentrat, ki se pripravi v raztopino za infundiranje (kapalna infuzija v veno).
What was Doxorubicin SUN expected to be used for?
Za kaj naj bi se zdravilo Doxorubicin SUN uporabljalo?
How was Doxorubicin SUN expected to work?
Kako naj bi zdravilo Doxorubicin SUN delovalo?
18 August 2011
dnevu“.
Information on the reference medicine can also be found on the Agency's website.
Informacije o referenčnem zdravilu so prav tako na voljo na spletni strani agencije.
Further information on Pazenir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pazenir.
Nadaljnje informacije o zdravilu Pazenir so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/pazenir.
The medicine is given once a day on days 1, 8 and 15 of each cycle.
Daje se enkrat na dan na 1., 8. in 15. dan vsakega cikla.
What measures are being taken to ensure the safe and effective use of Pazenir?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pazenir?
The recommended dose depends on the patient's height and weight.
Priporočeni odmerek je odvisen od bolnikove telesne mase in višine.
‘Metastatic' means that the cancer has spread to other parts of the body;
„Metastatski“ pomeni, da se je rak razširil na druge dele telesa;
Pazenir received a marketing authorisation valid throughout the EU on 6 May 2019.
Za zdravilo Pazenir je bilo 6. maja 2019 izdano dovoljenje za promet, veljavno po vsej EU.
It should not be interchanged with other medicines containing paclitaxel.
Ne sme se nadomeščati z drugimi zdravili, ki vsebujejo paklitaksel.
As for every medicine, the company provided studies on the quality of Pazenir.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Pazenir.
Paclitaxel has been available as a cancer medicine since 1993.
Paklitaksel je kot zdravilo za zdravljenje raka na voljo od leta 1993.
For more information on generic medicines, see the question-and-answer document here.
Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
What are the benefits and risks of Pazenir?
Kakšne so koristi in tveganja, povezani z zdravilom Pazenir?
Why is Pazenir authorised in the EU?
Zakaj je bilo zdravilo Pazenir odobreno v EU?
An overview of Pazenir and why it is authorised in the EU
Pregled zdravila Pazenir in zakaj je odobreno v EU
By keeping this structure intact, the cells cannot divide and they eventually die.
Z ohranjanjem celičnega skeleta se celice ne morejo deliti in sčasoma odmrejo.
Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Paklitaksel zavira fazo delitve celic, med katero se notranji „skelet“ celice razgradi, kar ji omogoča delitev.
What is Pazenir and what is it used for?
Kaj je zdravilo Pazenir in za kaj se uporablja?
The European Medicines Agency concluded that, in accordance with EU requirements, Pazenir has been shown to be comparable to Abraxane.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pazenir primerljivo z zdravilom Abraxane.
Pazenir is used to treat the following cancers in adults:
Zdravilo Pazenir se uporablja za zdravljenje naslednjih vrst raka pri odraslih:
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Abraxane, and do not need to be repeated for Pazenir.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Abraxane, zato jih ni treba ponoviti za zdravilo Pazenir.
As for all medicines, data on the use of Pazenir are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pazenir stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pazenir have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pazenir upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Pazenir, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Pazenir glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Pazenir
Druge informacije o zdravilu Pazenir
Pazenir also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Zdravilo Pazenir učinkuje tudi na nerakave celice, kot so krvne ali živčne celice, kar lahko povzroči neželene učinke.
Immediately after giving Pazenir, gemcitabine should be given.
Takoj po dajanju zdravila Pazenir mora bolnik prejeti tudi gemcitabin.
Side effects reported with Pazenir are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Pazenir, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Because Pazenir is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pazenir generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
To olajša pripravo raztopine s paksitakselom, ki se lahko infundira v veno.
In non-small cell lung cancer, treatment is carried out in 3-week cycles with Pazenir given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Pazenir.
Pri nedrobnoceličnem pljučnem raku se zdravljenje izvaja v tritedenskih ciklih, in sicer se zdravilo Pazenir daje na 1., 8. in 15. dan vsakega cikla, karboplatin pa na 1. dan cikla takoj po infundiranju zdravila Pazenir.
This means that Pazenir contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Abraxane.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Abraxane.
• metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable.
• metastatskega raka dojk, kadar je prvotno zdravljenje postalo neučinkovito, standardno zdravljenje, ki vključuje antracikline (drugo vrsto zdravil za zdravljenje raka), pa ni primerno.
This is because Pazenir is given by infusion into a vein and the nanoparticles it contains rapidly separate into its constituent parts in the same way as Abraxane's.
Razlog za to je, da se zdravilo Pazenir daje z infundiranjem v veno in nanodelci, ki jih vsebuje, hitro razpadejo na sestavne dele na enak način kot pri zdravilu Abraxane.