natgillin/translations-raw huggingface dataset:
The CHMP noted that no values were used below the estimated LOQ of 5 ng/ml and that the last value above the LOQ was used for the estimation of AUCinf. 
CHMP je ugotovil, da predlagatelj ni uporabil nobene vrednosti pod ocenjenim LOQ 5 ng/ml in da je za oceno AUCinf uporabil zadnjo vrednost nad LOQ.
Slovak Republic 
Slovaška republika
The analytical centre gives only numerical results when the concentration is not BLQ, so is not possible to perform any calculations with these results. 
Ko koncentracija ni bila pod mejo kvantifikacije, je analitični center podajal le številske rezultate, zato s temi rezultati ni možno opraviti izračunov.
Due to these outstanding concerns and the lack of documentation, the CHMP was unable to consider Prokanazol as being bioequivalent to the reference product and considered that more data was needed before an opinion could be provided. 
CHMP zaradi nerešenih zadržkov in pomanjkljive dokumentacije ni mogel šteti zdravila Prokanazol za biološko enakovrednega referenčnemu zdravilu, ter je menil, da je za mnenje potrebnih več podatkov.
the CHMP has recommended the refusal of the granting of the Marketing Authorisations in the Concerned Member States and the suspension of the Marketing Authorisation in the Reference Member State, where the product is currently authorised, for Prokanazol and associated names (see Annex I). 
CHMP je za zdravilo Prokanazol in z njim povezana imena (glejte Dodatek I) priporočil zavrnitev odobritve dovoljenj za promet z zdravilom v zadevnih državah članicah ter umik dovoljenja za promet z zdravilom v referenčni državi članici, kjer je zdravilo trenutno odobreno.
The pharmacokinetic analysis applied, following the recommendations from the regulatory agencies, was non-compartmental amodelistic. 
Uporabljena pa je bila nekompartmentalizirana amodelistična farmakokinetična analiza skladno s priporočili regulativnih agencij.
EU/EEA 
Država članica EU/EGP
Form 
Jakost
Route of administration 
Pot uporabe zdravila
This overview was last updated in 10-2019. 
Povzetek je bil nazadnje posodobljen 10-2019.
Treatment should last for at least 3 weeks and continue until the patient no longer has symptoms. 
Zdravljenje mora trajati vsaj tri tedne in se nadaljevati, dokler simptomi pri bolniku ne izzvenijo.
What measures are being taken to ensure the safe and effective use of Defitelio? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Defitelio?
Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary. 
Agencija bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
Defitelio is used in adults and in children from one month of age. 
Zdravilo Defitelio se lahko uporablja pri odraslih in otrocih, starejših od enega meseca.
Further information on Defitelio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Defitelio so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Medicines Agency decided that Defitelio's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Defitelio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Severe VOD has a high mortality rate of 75% or higher. 
Stopnja umrljivosti zaradi hude venookluzivne bolezni je visoka in znaša 75 % ali več.
Defitelio received a marketing authorisation valid throughout the European Union on 18 October 2013. 
Za zdravilo Defitelio je bilo 18. oktobra 2013 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
As for all medicines, data on the use of Defitelio are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Defitelio stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Defitelio 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 Defitelio upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Defitelio lowered the mortality rate to 62% at 100 days after transplantation, and 24% of patients had no symptoms of severe VOD after 100 days. 
Zdravilo Defitelio je po 100 dneh po presaditvi zmanjšalo stopnjo umrljivosti na 62 %, 24 % bolnikov pa po 100 dneh ni imelo nobenih simptomov hude venookluzivne bolezni.
Benefits of Defitelio were also seen in data from a United States patient registry (information about patients collected in a standard way), where patients with severe VOD after blood stem cell transplantation who received Defitelio plus standard care had better outcomes than those given standard care alone, including a higher 100-day survival rate (39% versus 31%) and a higher proportion of patients whose VOD resolved (51% versus 29%). 
Koristi zdravila Defitelio so bile opažene tudi pri podatkih iz registra bolnikov v ZDA (informacije o bolnikih, zbrane na standarden način), na podlagi katerih so imeli bolniki s hudo venookluzivno boleznijo, ki so po presaditvi krvotvornih matičnih celic prejemali zdravilo Defitelio v kombinaciji s standardnim zdravljenjem, boljše izide kot tisti, ki so prejemali samo standardno zdravljenje, vključno z višjo stopnjo preživetja po 100 dneh (39 % v primerjavi z 31 %) in višjim odstotkom bolnikov, pri katerih so simptomi venookluzivne bolezni izginili (51 % v primerjavi z 29 %).
Why is Defitelio authorised in the EU? 
Zakaj je zdravilo Defitelio odobreno v EU?
Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival. 
Čeprav ni bilo mogoče izvesti študije, v kateri bi zdravilo Defitelio neposredno primerjali s placebom (zdravilom brez učinkovine), je podjetje priskrbelo dovolj podatkov, da je dokazalo, da so imeli bolniki, ki so se zdravili z zdravilom, večje možnosti preživetja.
An overview of Defitelio and why it is authorised in the EU 
Pregled zdravila Defitelio in zakaj je odobreno v EU
The side effects seen, such as bleeding, were considered manageable and it was not possible to determine with certainty whether they were caused by Defitelio. 
Neželeni učinki, kot je krvavitev, so se šteli za obvladljive, poleg tega pa ni bilo mogoče z gotovostjo trditi, da jih je povzročilo zdravilo Defitelio.
What benefits of Defitelio have been shown in studies? 
Kakšne koristi zdravila Defitelio so se pokazale v študijah?
What is Defitelio and what is it used for? 
Kaj je zdravilo Defitelio in za kaj se uporablja?
VOD is rare, and Defitelio was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 July 2004. 
Venookluzivna bolezen je redka, zato je bilo zdravilo Defitelio 29. julija 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What are the risks associated with Defitelio? 
Kakšna tveganja so povezana z zdravilom Defitelio?
For more information about using Defitelio, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Defitelio glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Defitelio are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Defitelio, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Defitelio has been authorised under ‘exceptional circumstances'. 
Zdravilo Defitelio je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
Defitelio must not be used together with other medicines that break down blood clots. 
Zdravilo Defitelio se ne sme uporabljati skupaj z drugimi zdravili za razgrajevanje krvnih strdkov.
The most common side effects with Defitelio are hypotension (low blood pressure) and bleeding. 
Najpogostejša neželena učinka zdravila Defitelio sta hipotenzija (nizek krvni tlak) in krvavitev.
In one main study involving 102 patients with severe VOD following blood stem cell transplantation, Defitelio was compared with past records of patients who had received standard supportive care. 
V eni glavni študiji, v katero sta bila vključena 102 bolnika s hudo venookluzivno boleznijo, ki je bila posledica presaditve krvotvornih matičnih celic, so zdravilo Defitelio primerjali z zdravniškimi izvidi bolnikov iz preteklosti, ki so prejeli standardno podporno zdravljenje.
This is because it has not been possible to obtain complete information about Defitelio due to the rarity of the disease. 
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Since Defitelio has been authorised under exceptional circumstances, the company that markets the medicine is required to provide results of an ongoing study on safety of the medicine when used for prevention of VOD in adults and children undergoing hematopoietic stem cell transplantation. 
Ker je zdravilo Defitelio pridobilo dovoljenje za promet v izjemnih okoliščinah, mora podjetje, ki ga trži, predložiti rezultate potekajoče študije o varnosti zdravila, kadar se to uporablja za preprečevanje venookluzivne bolezni pri odraslih in otrocih, ki so prestali presaditev krvotvornih matičnih celic.
Myeloablative chemotherapy is used to clear the patient's bone marrow of cells before receiving healthy stem cells. 
Mieloablativna kemoterapija se uporablja zato, da se iz kostnega mozga bolnika izločijo celice, preden ta prejme zdrave matične celice.
The company will also analyse data on transplant outcomes in VOD patients who have and have not been treated with Defitelio. 
Podjetje bo tudi analiziralo podatke o izidih presaditev pri bolnikih z venookluzivno boleznijo, ki so bili zdravljeni z zdravilom Defitelio, in pri tistih, ki s tem zdravilom niso bili zdravljeni.
Other information about Defitelio 
Druge informacije o zdravilu Defitelio
Defitelio had been shown to improve survival in patients with severe VOD. 
Zdravilo Defitelio je dokazano izboljšalo stopnjo preživetja pri bolnikih s hudo venookluzivno boleznijo.
The active substance in Defitelio, defibrotide, works by increasing the breakdown of clots in the blood. 
Učinkovina v zdravilu Defitelio, defibrotid, deluje tako, da pospešuje razgrajevanje strdkov v krvi.
Defitelio can only be obtained with a prescription and it must be prescribed and given by a doctor experienced in the management of complications of blood stem cell transplantation. 
Predpisovanje in izdaja zdravila Defitelio je le na recept, zdravljenje pa mora predpisati in izvajati zdravnik, ki ima izkušnje z zdravljenjem zapletov pri presaditvi krvotvornih matičnih celic.
The medicines used for this treatment can damage the lining of the blood vessels in the liver, leading to the formation of clots and obstruction of the vessels seen in VOD. 
Zdravila, ki se uporabijo pri tem zdravljenju, lahko poškodujejo notranje plasti krvnih žil v jetrih, to pa lahko povzroči nastanek strdkov in zaporo žil, ki se pojavita pri venookluzivni bolezni.
VOD is usually a complication resulting from a treatment known as ‘myeloablative chemotherapy' given before blood stem cell transplantation. 
Venookluzivna bolezen je običajno zaplet, ki je posledica zdravljenja, imenovanega „mieloablativna kemoterapija“, ki se bolniku daje pred presaditvijo krvotvornih matičnih celic.
What information is still awaited for Defitelio? 
Katere informacije o zdravilu Defitelio še pričakujemo?
How does Defitelio work? 
Kako zdravilo Defitelio deluje?
Defitelio is a medicine used to treat severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem cell transplantation. 
Defitelio je zdravilo, ki se uporablja za zdravljenje hude venookluzivne bolezni (VOB) pri bolnikih, ki so prestali presaditev hematopoetskih (krvotvornih) matičnih celic.
For the full list of side effects of Defitelio, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Defitelio, glejte navodilo za uporabo.
How is Defitelio used? 
Kako se zdravilo Defitelio uporablja?
Defitelio contains the active substance defibrotide. 
Vsebuje učinkovino defibrotid.
In addition, defibrotide may protect the cells that line blood vessels. 
Poleg tega utegne ščititi celice, ki tvorijo notranjo plast stene krvnih žil.
The dose depends on the patient's bodyweight. 
Daje se z dvourno (kapalno) infuzijo v veno štirikrat na dan. Odmerek je odvisen od bolnikove telesne mase.
VOD is a condition in which the veins in the liver become blocked and stop the liver working properly. 
Huda venookluzivna bolezen je bolezen, pri kateri se vene v jetrih zamašijo, to pa povzroči jetrno okvaro.
This summary was last updated in 02-2008. 
Povzetek je bil nazadnje posodobljen 02-2008.
This helps to protect against the diseases that these bacteria and viruses cause. 
To pomaga pri zaščiti pred boleznimi, ki jih te bakterije in virusi povzročajo.
for PROCOMVAX on 7 May 1999. 
dne 7. maja 1999.
In both groups, the infants were vaccinated at two, four, and 12 to 15 months of age. 
V obeh skupinah so bili dojenčki cepljeni pri dveh, štirih ter 12 do 15 mesecih starosti.
This document is a summary of the European Public Assessment Report (EPAR). 
Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
PROCOMVAX has been studied in one main study involving 882 infants. 
Zdravilo PROCOMVAX so preučevali v eni glavni klinični študiji, v katero je bilo vključenih 882 dojenčkov.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
However, the company provided further information from other studies to show that three doses of PROCOMVAX produced adequate levels of protection. 
Vendar pa je podjetje priskrbelo dodatne informacije iz drugih študij, s katerimi so pokazali, da trije odmerki zdravila PROCOMVAX zagotovijo ustrezno stopnjo
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR). 
Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROCOMVAX 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PROCOMVAX
The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S.N.C. 
Evropska komisija je dovoljenje za promet z zdravilom PROCOMVAX, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD S.N.C.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznimi.
Vaccination with PROCOMVAX should be postponed in infants with moderate or severe sudden fever until they have recovered. 
Cepljenje s cepivom PROCOMVAX je treba pri dojenčkih z zmernim ali hudim nenadnim povišanjem telesne temperature odložiti, dokler ne okrevajo.
Their breathing should be monitored for up to three days after vaccination. 
Njihovo dihanje je potrebno nadzorovati do tri
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them. 
Ko dojenček prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot „tujke“ in proti njim razvije protitelesa.
The active substances are ‘adsorbed', meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response. 
Zdravilni učinkovini sta „adsorbirani“, kar pomeni, da sta vezani na površino aluminijeve spojine, cepivo pa vsebuje „adjuvans“ (spojino, ki vsebuje aluminij), ki spodbudi boljši odziv.
Other information about PROCOMVAX: 
Druge informacije o zdravilu PROCOMVAX:
Other common side effects are fever, anorexia (loss of appetite), vomiting, diarrhoea, irritability, somnolence (sleepiness), crying (including unusual highpitched crying and prolonged crying) and otitis media (infection of the middle ear). 
Drugi pogosti neželeni učinki so povišana telesna temperatura, anoreksija (izguba teka), bruhanje, driska, razdražljivost, zaspanost, jok (vključno z jokom z nenavadno visokim glasom in dolgotrajnim jokom) in otitis media (vnetje srednjega ušesa).
Infants who show signs of hypersensitivity (allergic reaction) after an injection should not receive further injections of the vaccine. 
Dojenčki, pri katerih se po injiciranju pojavijo simptomi, ki nakazujejo na preobčutljivost (alergijsko reakcijo), ne smejo več dobiti nadaljnjih injekcij tega cepiva.
PROCOMVAX is a vaccine, which is available as a suspension for injection. 
Zdravilo PROCOMVAX je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
PROCOMVAX is a vaccine. 
Zdravilo PROCOMVAX je cepivo.
The most common side effects seen with PROCOMVAX are reactions at the injection site, including pain, soreness, erythema (redness) and swelling. 
Najpogostejši neželeni učinki, opaženi pri uporabi zdravila PROCOMVAX, so reakcije na mestu injiciranja, vključno z bolečino, občutljivostjo, eritemi (rdečino) in otekanjem.
• a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of 
• iz Hib prečiščene beljakovine, vezane na nosilec (beljakovino, prečiščeno iz zunanje ovojnice
PROCOMVAX should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients. 
Zdravilo PROCOMVAX se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) katero izmed zdravilnih učinkovin ali katero koli drugo sestavino zdravila.
The study compared the effects of PROCOMVAX with those of separate vaccines containing the same active substances. 
V študiji so primerjali učinke zdravila PROCOMVAX z učinki ločenih cepiv, ki sta vsebovali isti zdravilni učinkovini.
It contains proteins from Haemophilus influenzae type b (‘Hib', a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances. 
Kot zdravilno učinkovino vsebuje beljakovine Haemophilus influenzae tipa b („Hib“ je bakterija, ki lahko povzroči meningitis) in dele virusa hepatitisa B.
The vaccine must only be given by injection into a muscle. 
Cepivo se sme dajati le z injiciranjem
What benefit has PROCOMVAX shown during the studies? 
Kakšne koristi je zdravilo PROCOMVAX izkazalo med raziskavami?
The vaccination schedule is three doses of PROCOMVAX, ideally at two, four, and 12 to 15 months of age. 
Shema cepljenja predvideva tri odmerke zdravila PROCOMVAX, ki bi jih naj otrok idealno prejel pri starosti dveh, štirih ter 12 do 15 mesecev.
The main measure of effectiveness whether protective levels of antibodies to Hib and hepatitis B virus had developed at one and two months after vaccination. 
Glavni pokazatelj učinkovitosti je bil, ali se je razvila zaščitna koncentracija protiteles proti Hib ter virusu hepatitisa B en oziroma dva meseca po cepljenju.
In the main study, the responses both to PROCOMVAX and to the separate vaccines were low in terms of levels of antibodies against Hib. 
V glavni študiji sta bila odziva tako na zdravilo PROCOMVAX kot na ločeni cepivi z vidika koncentracije protiteles proti Hib šibka.
The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX's benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila PROCOMVAX pri cepljenju proti invazivni bolezni, ki jo povzroča Hib, ter proti okužbi, ki jo povzročajo vsi znani podtipi virusa hepatitisa B, pri otrocih, starih od 6 tednov do 15 mesecev, večje od z njim povezanih tveganj.
For the full list of all side effects reported with PROCOMVAX, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PROCOMVAX, glejte Navodilo za uporabo.
Why has PROCOMVAX been approved? 
Zakaj je bilo zdravilo PROCOMVAX odobreno?
The Committee recommended that PROCOMVAX be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo PROCOMVAX odobri dovoljenje
PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘invasive' disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus. 
Zdravilo PROCOMVAX se uporablja za cepljenje dojenčkov, starih od šest tednov do 15 mesecev, proti invazivni bolezni, ki jo povzroča Hib (npr. bakterijski meningitis), in proti okužbi z virusom
PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years. 
Zdravilo PROCOMVAX je kombinacija komponent, ki so v raznih cepivih v Evropski uniji (EU) na voljo že vrsto let.Kako je bilo zdravilo PROCOMVAX raziskano?
What is the risk associated with PROCOMVAX? 
Kakšna tveganja so povezana z zdravilom PROCOMVAX?
Children who receive one dose of a hepatitis B vaccine at or shortly after birth can be given PROCOMVAX. 
Otroci, ki ob rojstvu ali kmalu zatem prejmejo odmerek cepiva proti hepatitisu B, lahko dobijo zdravilo PROCOMVAX.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses. 
Posledično bo imunski sistem ob ponovni izpostavitvi bakterijam ali virusom sposoben hitreje tvoriti protitelesa.
The results of further studies were used to support the use of PROCOMVAX, both in infants who had and who had not received hepatitis B vaccination in the past. 
Rezultati nadaljnjih študij so bili uporabljeni v podporo uporabi zdravila PROCOMVAX, in sicer tako pri dojenčkih, ki so bili predhodno cepljeni proti hepatitisu B, kot tudi pri tistih, ki tega celjenja predhodno niso prejeli.
As for all vaccines, if PROCOMVAX is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing). 
Kot pri vseh cepivih, obstaja tudi pri zdravilu PROCOMVAX, če se uporablja pri nedonošenčkih, tveganje za pojav apneje (krajših prekinitev dihanja).
The full EPAR for PROCOMVAX can be found here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo PROCOMVAX je na voljo tukaj.
The additional studies showed that protection against hepatitis B from PROCOMVAX was adequate in infants who had and who had not received hepatitis B vaccination in the past. 
Dodatne študije so pokazale, da je zaščita, ki jo proti hepatitisu B nudi zdravilo PROCOMVAX, ustrezna tako pri dojenčkih, ki so bili predhodno cepljeni proti hepatitisu B, kot tudi pri tistih, ki tega
The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus. 
Z glavno študijo so pokazali tudi, da zdravilo PROCOMVAX zagotavlja ustrezno stopnjo zaščite proti virusu hepatitisa B. Ta zaključek so potrdili tudi rezultati sedmih dodatnih študij, ki jih je predložilo
What is PROCOMVAX used for? 
Za kaj se zdravilo PROCOMVAX uporablja?
PROCOMVAX contains small amounts of: 
Zdravilo PROCOMVAX vsebuje