natgillin/translations-raw huggingface dataset:
Strontium ranelate, the active substance in Protelos/Osseor, is expected to stimulate formation of new cartilage and reduce bone breakdown.
Zdravilna učinkovina v zdravilu Protelos/Osseor, stroncijev ranelat, naj bi spodbujala nastajanje novega hrustanca in zmanjšala razgradnjo kosti.
This causes pain and
To povzroči, da je sklep pri premikanju boleč in okorel.
What was Protelos/Osseor expected to be used for?
Za kaj naj bi se zdravilo Protelos/Osseor uporabljalo?
How is Protelos/Osseor expected to work?
Kako naj bi zdravilo Protelos/Osseor delovalo?
Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection
Zypadhera 210 mg prašek in vehikel za raztopino za injiciranje s podaljšanim sproščanjem
Invented Strength Pharmaceutical Form Route of Administration
Jakost Farmacevtska oblika
Packaging name
(Izmišljeno) ime
5 million cells/ml Suspension for injection
5 milijonov celic/ml suspenzija za injiciranje intralezijska uporaba viala (steklena) 6 ml
Pharmaceutica l Form
Farmacevtska oblika
Intralesional use vial (glass)
Pot uporabe Stična ovojnina Vsebina
The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil on 20 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Gardasil, veljavno po vsej Evropski uniji, izdala 20. septembra 2006.
The women were followed up for around three years after the third dose of the vaccine.
Ženske so spremljali približno tri leta po prejemu tretjega odmerka cepiva.
These virus-like particles are not capable of causing infection.
Ti virusom podobni delci ne morejo povzročiti okužbe.
The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za spodbujanje boljšega odziva.
Other information about Gardasil:
Druge informacije o zdravilu Gardasil:
What measures are being taken to ensure the safe and effective use of Gardasil?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gardasil?
There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Obstaja več kot 100 tipov papilomavirusov, od katerih nekatere povezujejo z rakom na spolovilih.
The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Cepivo se daje v obliki injekcije v mišico, po možnosti v ramo ali stegno.
Gardasil is given according to official recommendations.
Zdravilo Gardasil se daje v skladu z uradnimi priporočili.
For the full list of all restrictions, see the package leaflet.
Za celoten seznam vseh omejitev glejte navodilo za uporabo.
Human papillomaviruses are viruses that cause warts and abnormal tissue growth.
Humani papilomavirusi so virusi, ki povzročajo bradavice in nenormalno rast tkiva.
This document is a summary of the European public assessment report (EPAR) for Gardasil.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Gardasil.
A risk management plan has been developed to ensure that Gardasil is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Gardasil je bil pripravljen načrt obvladovanja tveganj.
It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18).
Gre za suspenzijo za injiciranje, ki vsebuje prečiščene beljakovine za štiri tipe humanega papilomavirusa (tipe 6, 11, 16 in 18).
When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Ko oseba prejme cepivo, začne imunski sistem tvoriti protitelesa proti beljakovinam L1.
There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.
V študiji ni bilo nobenega primera raka zadnjika, a se domneva, da lahko zaščita pred predrakavimi lezijami na zadnjiku pomeni tudi zaščito pred nastankom raka.
The CHMP decided that Gardasil's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Gardasil večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Patients who show signs of an allergy after a dose of Gardasil should not receive further doses of the vaccine.
Osebe, ki po odmerku zdravila Gardasil kažejo znake alergije, ne smejo prejeti nadaljnjih odmerkov cepiva.
Gardasil is a vaccine.
Zdravilo Gardasil je cepivo.
What benefit has Gardasil shown during the studies?
Kakšne koristi je zdravilo Gardasil izkazalo med študijami?
Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Gardasil cepivo proti humanim papilomavirusom [tipom 6, 11, 16, 18] (rekombinantno, adsorbirano)
With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients).
Kar zadeva predrakave lezije na zadnjiku, je bilo pet primerov v skupini (z okoli 200 bolniki), ki je prejela cepivo, v primerjavi s 24 primeri v skupini, ki je prejela placebo (v kateri je bilo prav tako okoli 200 bolnikov).
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 Gardasil.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Gardasil is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Cepivo Gardasil se uporablja pri dečkih in deklicah, starejših od devet let, za zaščito pred naslednjimi vrstami obolenj, ki jih povzročajo posamezni tipi humanega papilomavirusa (HPV):
The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.
Pokazale so tudi, da cepivo spodbuja proizvajanje zadostnih količin protiteles proti humanemu papilomavirusu pri deklicah in dečkih, starih od devet do 15 let.
After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Po cepljenju je imunski sistem ob morebitni ponovni izpostavitvi dejanskim virusom zmožen hitreje tvoriti protitelesa.
What is the risk associated with Gardasil?
Kakšna tveganja so povezana z zdravilom Gardasil?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Gardasil in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Podoben učinek zdravila Gardasil so opazili v analizi, ki je vključevala tudi lezije na materničnem vratu, povzročene zaradi okužbe z drugima dvema tipoma HPV (tipoma 6 in 11).
In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
V študijah so bili najpogostejši neželeni učinki zdravila Gardasil (opaženi pri več kot 1 osebi od 10) glavobol in reakcije na mestu injiciranja (rdečina, bolečina in oteklina).
It is available in vials or prefilled syringes.
Na voljo je v vialah ali napolnjenih injekcijskih brizgah.
There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Med prvim in drugim odmerkom mora biti najmanj enomesečni presledek, med drugim in tretjim odmerkom pa morajo preteči najmanj trije meseci; osebe morajo vse odmerke prejeti v obdobju enega leta.
• genital warts.
• bradavicami na spolovilih.
All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Vsi papilomavirusi imajo plašč ali kapsido iz beljakovin, imenovanih beljakovine L1.
Why has Gardasil been approved?
Zakaj je bilo zdravilo Gardasil odobreno?
In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo.
V študiji, v katero so bili vključeni dečki in moški, so se v treh primerih od okoli 1 400 bolnikov, ki so bili cepljeni, pojavile lezije na spolovilih v primerjavi z 32 primeri med 1 400 bolniki, ki so prejeli placebo.
The study testing Gardasil given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Študija, v kateri je bilo zdravilo Gardasil dano v dveh odmerkih deklicam, starim od devet do trinajst let, je pokazala, da sta bila dva odmerka, ki so ju prejele v razmiku šestih mesecev, prav tako učinkovita kot cepljenje v treh odmerkih: pri vseh osebah je nastalo zadostno število protiteles proti humanemu papilomavirusu v enem mesecu po injiciranju zadnjega odmerka.
The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Študije so pokazale tudi, da je zdravilo Gardasil zagotovilo zaščito pred lezijami na materničnem vratu, povezanimi z drugimi tipi humanega papilomavirusa (med drugim tudi s tipom 31), ki povzročajo raka.
The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18 one month after the last dose.
Glavno merilo učinkovitosti je bil razvoj zaščitnih ravni protiteles proti tipom 6, 11, 16 in 18 humanega papilomavirusa en mesec po injiciranju zadnjega odmerka.
For the full list of all side effects reported with Gardasil, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Gardasil, glejte navodilo za uporabo.
The studies looked at how many women developed genital lesions or warts that were due to HPV infection.
V študijah so proučevali, pri koliko ženskah se razvijejo bradavice ali lezije na spolovilih, povezane z okužbo s humanim papilomavirusom.
Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Zdravilo Gardasil vsebuje prečiščene beljakovine L1 za tipe 6, 11, 16 in 18 humanih papilomavirusov, ki jih proizvajajo z metodo, znano kot tehnologija rekombinantne DNK, pri kateri je v kvasovke vstavljen gen (DNK), kar jim omogoča tvorjenje beljakovin L1.Beljakovine tvorijo virusu podobne delce (strukture, ki so podobne humanemu papilomavirusu, tako da jih telo zlahka prepozna).
The full EPAR for Gardasil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Gardasil je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.Za več informacij o zdravljenju z zdravilom Gardasil preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Another study in around 800 girls and women compared the effect of two doses of Gardasil in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
V drugi študiji, v katero je bilo vključenih okoli 800 deklic in žensk, so primerjali učinek dveh odmerkov zdravila Gardasil pri deklicah, starih od devet do trinajst let, in učinek treh odmerkov pri deklicah in mlajših ženskah, starih od 16 do 24 let.
• precancerous lesions (growths) in the cervix, vulva or vagina and anus;
• predrakavimi lezijami (nenormalno rastjo celic) na materničnem vratu, ženskih zunanjih ali notranjih spolovilih in zadnjiku);
HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers.
Tipa 16 in 18 humanega papilomavirusa sta povzročitelja približno 70 % vseh primerov raka materničnega vratu in 80 % raka zadnjika.
It is recommended that individuals who receive the first dose of Gardasil should complete the dosing regimen with Gardasil.
Priporočeno je, da osebe, ki prejmejo prvi odmerek, prejmejo vse tri odmerke zdravila Gardasil.
Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
V treh študijah so proučevali sposobnost zdravila Gardasil, danega v treh odmerkih, za preprečevanje okužbe s tipi 6, 11, 16 in 18 humanega papilomavirusa ter bradavic na spolovilih, ki jih povzročijo ti tipi humanega papilomavirusa, pri skoraj 4 000 ženskah, starih od 24 do 45 let, in nastanek protiteles proti omenjenim tipom virusa pri okoli 1 700 deklicah in dečkih, starih od devet do 15 let.
Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
V glavni študiji, v katero je bilo vključenih okoli 4 000 dečkov in moških, starejših od 16 let, so nazadnje cepivo primerjali s placebom, da bi preizkusili učinek cepiva pri preprečevanju nastanka bradavic na spolovilih, predrakavih lezij na zadnjiku in raka zadnjika.
If the second dose is given earlier than six months after the first dose, a third dose should always be given.
Če se drugi odmerek da pred pretekom šestih mesecev po prvem odmerku,
In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Za razliko od tega so med skoraj 8 000 ženskami iz skupine, ki je prejemala placebo, zabeležili 189 primerov lezij na zunanjih spolovilih.
For people aged nine to thirteen years, Gardasil can be given as two doses six months apart.
Zdravilo Gardasil se lahko daje osebam, starim od devet do trinajst let, v dveh odmerkih s šestmesečnim razmikom.
In addition, these studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women.
Poleg tega so te študije potrdile, da zdravilo Gardasil ščiti ženske, stare od 24 do 45 let, pred lezijami in okužbo s humanim papilomavirusom.
In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Zdravilo Gardasil, ki so ga dajali v treh odmerkih, so s placebom primerjali v štirih glavnih študijah, v katerih je sodelovalo skoraj 21 000 žensk, starih od 16 do 26 let.
In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
V štirih študijah, v katere je bilo vključenih 21 000 žensk, je bilo dokazano, da so se v skupini žensk, ki predhodno niso bile okužene s tipi 6, 11, 16 ali 18 humanega papilomavirusa, pri eni bolnici od več kot 8 000 žensk, cepljenih z zdravilom Gardasil, pojavile predrakave lezije na materničnem vratu, ki bi lahko bile povezane s tipom 16 ali 18 humanega papilomavirusa.
HPV types 6 and 11 cause approximately 90% of genital warts.
Tipa 16 in 11 humanega papilomavirusa sta povzročitelja približno 90 % bradavic na spolovilih.
How has Gardasil been studied?
Kako je bilo zdravilo Gardasil raziskano?
What is Gardasil used for?
Za kaj se zdravilo Gardasil uporablja?
What is Gardasil?
Kaj je zdravilo Gardasil?
In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
V treh študijah, v katerih so proučevali bradavice na spolovilih, so se bradavice na spolovilih pojavile pri dveh bolnicah od skoraj 8 000 žensk v skupini, ki je prejemala zdravilo Gardasil, primerov predrakavih lezij na zunanjem ali notranjem spolovilu pa ni bilo.
How does Gardasil work?
Kako zdravilo Gardasil deluje?
Vaccination should be postponed in patients who are ill with a high fever.
Pri osebah, ki so bolne in imajo povišano telesno temperaturo, je treba cepljenje odložiti.
For people aged fourteen or above, Gardasil is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second.
Zdravilo Gardasil se osebam, starejšim od štirinajst let, običajno daje v treh odmerkih, pri čemer drugi odmerek sledi dva meseca po prvem, tretji pa štiri mesece po drugem.Enake tri odmerke lahko prejmejo tudi osebe, stare od devet do trinajst let.
• cervical and anal cancers;
• rakom materničnega vratu ali zadnjika;
How is Gardasil used?
Kako se zdravilo Gardasil uporablja?
In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Nasprotno pa so se lezije, ki jih je povzročila okužba s tema dvema tipoma humanega papilomavirusa, pojavile pri 85 bolnicah od več kot 8 000 žensk, ki so bile cepljene s placebom.
Filgrastim has been available in other medicines in the EU for a number of years.
Filgrastim je v Evropski uniji kot sestavina v drugih zdravilih na voljo že več let.
Further information on Pegfilgrastim Mundipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
Nadaljnje informacije za zdravilo Pegfilgrastim Mundipharma so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
The most common side effect with Pegfilgrastim Mundipharma (which may affect more than 1 in 10 people) is pain in the bones.
Najpogostejši neželeni učinek zdravila Pegfilgrastim Mundipharma (ki se lahko pojavi pri več kot 1od 10 bolnikov) je bolečina v kosteh.
This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection).
Zdravilo se daje zlasti za skrajševanje trajanja nevtropenije in preprečevanje febrilne nevtropenije (nevtropenije, ki jo spremlja povišana telesna temperatura zaradi okužbe).
Side effects reported with Pegfilgrastim Mundipharma are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Pegfilgrastim Mundipharma, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Pegfilgrastim Mundipharma is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy.
Zdravilo Pegfilgrastim Mundipharma se daje v obliki enkratnega 6-miligramskega odmerka, ki se injicira pod kožo vsaj 24 ur po koncu vsakega cikla kemoterapije.
What measures are being taken to ensure the safe and effective use of Pegfilgrastim Mundipharma?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pegfilgrastim Mundipharma?
For more information about using Pegfilgrastim Mundipharma, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Pegfilgrastim Mundipharma glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pegfilgrastim Mundipharma 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 Pegfilgrastim Mundipharma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Pegfilgrastim Mundipharma and why it is authorised in the EU
Pregled zdravila Pegfilgrastim Mundipharma in zakaj je odobreno v EU
Pegfilgrastim Mundipharma can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Predpisovanje in izdaja zdravila Pegfilgrastim Mundipharma je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
As for all medicines, data on the use of Pegfilgrastim Mundipharma are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pegfilgrastim Mundipharma stalno spremljajo.
All these data were considered sufficient to conclude that Pegfilgrastim Mundipharma will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Pegfilgrastim Mundipharma pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
The safety of Pegfilgrastim Mundipharma has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Varnost zdravila Pegfilgrastim Mundipharma je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
The active substance in Pegfilgrastim Mundipharma, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Učinkovina v zdravilu Pegfilgrastim Mundipharma, pegfilgrastim, je ena od oblik filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
Because Pegfilgrastim Mundipharma is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pegfilgrastim Mundipharma.
Zdravilo Pegfilgrastim Mundipharma je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Pegfilgrastim Mundipharma ni treba ponavljati.
Pegfilgrastim Mundipharma is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Zdravilo Pegfilgrastim Mundipharma ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
Why is Pegfilgrastim Mundipharma authorised in the EU?
Zakaj je bilo zdravilo Pegfilgrastim Mundipharma odobreno v EU?
What benefits of Pegfilgrastim Mundipharma have been shown in studies?
Kakšne koristi zdravila Pegfilgrastim Mundipharma so se pokazale v študijah?
The reference medicine for Pegfilgrastim Mundipharma is Neulasta.
Referenčno zdravilo za zdravilo Pegfilgrastim Mundipharma je zdravilo Neulasta.