natgillin/translations-raw huggingface dataset:
This is a summary of the European public assessment report (EPAR) for Xalkori.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xalkori.
For the previously untreated patients, 6 out of 7 responded to treatment.
Med predhodno nezdravljenimi bolniki se jih je šest od sedmih odzvalo na zdravljenje.
This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments, in those patients who had been given them.
To se zdi ugoden odziv glede na stopnjo odziva na prejšnja zdravljenja, ki je bila od 20 do 30 % med bolniki, ki so ta zdravljenja prejemali.
This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.
To pomeni, da rakave celice vsebujejo spremembe, ki vplivajo na gen, odgovoren za beljakovino ROS1.
Therefore the Agency decided that Xalkori's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključila, da so koristi zdravila Xalkori večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
A study in 53 ROS1-positive patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely or partially to treatment.
Študija, v katero je bilo vključenih 53 ROS1-pozitivnih bolnikov, pri katerih je bolezen napredovala, je pokazala, da se je približno 70 % (37 od 53) bolnikov, ki so jemali zdravilo Xalkori, popolnoma ali deloma odzvalo na zdravljenje.
Other information about Xalkori
Druge informacije o zdravilu Xalkori
The most common side effects with Xalkori (seen in more than 1 in 4 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage) and tiredness.
Najpogostejši neželeni učinki zdravila Xalkori (opaženi pri več kot 1 bolniku od 4) so motnje vida, navzeja (slabost), driska, bruhanje, edem (oteklina), povišanje jetrnih encimov v krvi, zmanjšanje teka, zaprtje, omotica, nevropatija (bolečine zaradi okvare živcev) in utrujenost.
For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments.
Pri bolnikih z ROS1-pozitivnim nedrobnoceličnim pljučnim rakom, za katere trenutno ni na voljo posebnega zdravljenja, je agencija ugotovila visoko stopnjo odziva, zlasti med bolniki, ki so predhodno prejemali druga zdravila za zdravljenje raka.
ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells.
ALK in ROS1 spadata v skupino beljakovin, imenovanih receptorji tirozinske kinaze (RTK), ki sodelujejo pri rasti celic.
The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart).
Najresnejši neželeni učinki so poškodbe jeter, pnevmonitis (vnetje pljuč), nevtropenija (nizko število nevtrofilcev, vrste belih krvničk) in podaljšan interval QT (težava z električno dejavnostjo srca).
What benefits of Xalkori have been shown in studies?
Kakšne koristi je zdravilo Xalkori izkazalo v študijah?
What is Xalkori and what is it used for?
Kaj je zdravilo Xalkori in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xalkori upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC.
Deluje predvsem tako, da zavira aktivnost ALK ali ROS1, tudi ob prisotnosti genske spremembe, in s tem zmanjšuje rast in širitev raka pri ALK-pozitivnem ali ROS 1-pozitivnem nedrobnoceličnem pljučnem raku.
• It is used if the NSCLC is ‘ALK-positive', which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
• Uporablja se, če je nedrobnocelični pljučni rak ALK-pozitiven, kar pomeni, da rakave celice vsebujejo določene spremembe, ki vplivajo na gen, odgovoren za beljakovino, imenovano anaplastična limfomska kinaza (ALK).
For more information about treatment with Xalkori, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xalkori preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Xalkori?
Kakšna tveganja so povezana z zdravilom Xalkori?
Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines.
Zdravljenje z zdravilom Xalkori lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The presence of the genetic changes affecting ALK (‘ALK-positive' status) or ROS1 (‘ROS1-positive' status) has to be confirmed before starting treatment with Xalkori.
Prisotnost genskih sprememb, ki vplivajo na anaplastično limfomsko kinazo (ALK-pozitivni status) ali ROS1 (ROS1-pozitivni status), je treba pred zdravljenjem z zdravilom Xalkori potrditi.
The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a pack containing the medicine's summary of product characteristics and a patient alert card to be given to patients.
Družba, ki trži zdravilo Xalkori, bo zagotovila, da bodo zdravniki, ki naj bi zdravilo predpisovali, prejeli izobraževalno gradivo s povzetkom glavnih značilnosti zdravila in opozorilno kartico za bolnike, ki se izroči bolniku.
It is not intended to provide practical advice on how to use Xalkori.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced:
Xalkori je zdravilo, ki se uporablja za zdravljenje odraslih z vrsto pljučnega raka, imenovano nedrobnocelični pljučni rak (NSCLC), pri katerih je bolezen napredovala.
In patients either ‘ALK-positive' or ‘ROS1-positive', the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.
Pri bolnikih, ki so ALK-pozitivni ali ROS1-pozitivni, sta ALK in ROS1 beljakovini nenormalno aktivni in lahko spodbudita rast rakavih celic ter nastanek novih krvnih žil, ki te celice oskrbujejo.
Why is Xalkori approved?
Zakaj je bilo zdravilo Xalkori odobreno?
Xalkori is available as capsules (200 mg and 250 mg).The recommended dose is 250 mg twice per day.
Zdravilo Xalkori je na voljo v kapsulah (200 in 250 mg).
For the full list of all side effects reported with Xalkori, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xalkori, glejte navodilo za uporabo.
For practical information about using Xalkori, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Xalkori naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The European Medicines Agency concluded that treatment with Xalkori increases the time patients with ALK-positive NSCLC live without the disease getting worse, irrespective of whether they are previously treated.
Evropska agencija za zdravila je zaključila, da zdravljenje z zdravilom Xalkori pri bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom podaljša čas življenja brez poslabšanja bolezni, ne glede na to, ali so bili predhodno zdravljeni.
• It is also used when the NSCLC is ‘ROS1-positive'.
• Uporablja se tudi, kadar je nedrobnocelični pljučni rak ROS1-pozitiven.
In another study in 343 patients who had not received previous treatment for their NSCLC before, patients treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy.
V drugi študiji, v katero je bilo vključenih 343 bolnikov, ki pred tem še niso bili zdravljeni zaradi nedrobnoceličnega pljučnega raka, so tisti, ki so bili zdravljeni z zdravilom Xalkori, v povprečju živeli skoraj enajst mesecev brez poslabšanja bolezni, medtem ko so bolniki, ki so bili predhodno zdravljeni z zdravili, ki so vsebovala pemetreksed, brez poslabšanja bolezni živeli sedem mesecev.
Doses may need to be adjusted in patients with severely reduced kidney function.
Pri bolnikih s hudo okvaro delovanja ledvic je odmerke morda treba prilagoditi.
A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.
Študija, v katero je bilo vključenih 347 predhodno zdravljenih ALK-pozitivnih bolnikov, je pokazala, da so tisti, ki so jemali zdravilo Xalkori, v povprečju živeli osem mesecev brez poslabšanja bolezni, medtem ko so bolniki, ki so bili predhodno zdravljeni s pemetreksedom ali docetakselom, brez poslabšanja bolezni živeli tri mesece.
How is Xalkori used?
Kako se zdravilo Xalkori uporablja?
ROS1-positive NSCLC
ROS1-pozitiven nedrobnocelični pljučni rak
The active substance in Xalkori, crizotinib, is an RTK inhibitor.
Zdravilna učinkovina v zdravilu Xalkori, krizotinib, je zaviralec receptorjev tirozinske kinaze.
How does Xalkori work?
Kako zdravilo Xalkori deluje?
ALK-positive NSCLC
ALK-pozitiven nedrobnocelični pljučni rak
Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Če se pri bolniku pojavijo določeni resni neželeni učinki, bo morda treba zdravljenje začasno ali trajno prekiniti.
Xalkori contains the active substance crizotinib.
Zdravilo Xalkori vsebuje zdravilno učinkovino krizotinib.
The European Commission granted a marketing authorisation valid throughout the European Union for Vepacel on 17 February 2012.
Evropska komisija je dovoljenje za promet z zdravilom Vepacel, veljavno po vsej Evropski uniji, odobrila 17. februarja 2012.
What measures are being taken to ensure the safe and effective use of Vepacel?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vepacel?
The vaccine is given according to official recommendations.
Cepivo se lahko daje samo v skladu z uradnimi priporočili.
The full EPAR for Vepacel 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 Vepacel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Vepacel
Druge informacije o zdravilu Vepacel
If vaccination is necessary, facilities to resuscitate patients need to be immediately available.
Če je cepljenje vseeno potrebno, je treba zagotoviti opremo za oživljanje, ki mora biti takoj na voljo.
This is a summary of the European public assessment report (EPAR) for Vepacel.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vepacel.
Two main studies provided data on vaccination with Vepacel in adults.
V dveh glavnih študijah so pridobili podatke o cepljenju z zdravilom Vepacel pri odraslih.
What is the risk associated with Vepacel?
Kakšna tveganja so povezana z zdravilom Vepacel?
What benefit has Vepacel shown during the studies?
Kakšne koristi je zdravilo Vepacel izkazalo med študijami?
Vepacel contains a flu strain called A/Vietnam/1203/2004 (H5N1).
Zdravilo Vepacel vsebuje sev gripe, imenovan A/Vietnam/1203/2004 (H5N1).
Vepacel must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine or to any of the substances found at trace (very low) levels in the vaccine such as formaldehyde, benzonase, sucrose, trypsin or vero cell protein.
Zdravilo Vepacel se ne sme dajati osebam, ki so imele anafilaktično (hudo alergijsko) reakcijo na katero koli sestavino cepiva ali na katero koli izmed snovi, prisotno v cepivu v sledeh (v zelo nizkih koncentracijah), npr. formaldehid, benzonaza, saharoza, tripsin ali beljakovine celic vero.
Vepacel is a ‘prepandemic' vaccine.
Zdravilo Vepacel je „prepandemsko“ cepivo.
A risk management plan has been developed to ensure that Vepacel is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Vepacel je bil pripravljen načrt obvladovanja tveganj.
Both studies looked separately at people aged above and below 60 years old.
V obeh študijah so ločeno proučevali osebe, mlajše od 60 let in starejše od 60 let.
For more information about treatment with Vepacel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vepacel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Moreover, protective levels of antibodies were seen in 71.6% of patients with a weakened immune system and 77.5% of patients with a long-term illness.
Poleg tega so bile zaščitne ravni protiteles opažene pri 71,6 % bolnikov z oslabljenim imunskim sistemom in 77,5 % bolnikov s kronično boleznijo.
The vaccine is given by injection into the shoulder or thigh in two single doses, at least three weeks apart.
Cepivo se daje z injiciranjem v rame ali stegno z dvema posamičnima odmerkoma, med katerima mora biti vsaj tritedenski premor.
No major safety issues were seen during the studies and the side effects seen were generally mild and similar to those seen with other flu vaccines.
Med študijami niso bili izpostavljeni nobeni večji varnostni pomisleki, opaženi neželeni učinki pa so bili večinoma blagi in podobni tistim, ki se opažajo pri drugih cepivih proti gripi.
The CHMP decided that the benefits of Vepacel are greater than its risks and recommended that it be granted a marketing authorisation.
CHMP je zaključil, da so koristi cepiva Vepacel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 Vepacel.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Vepacel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects with Vepacel (seen in more than 1 person in 10) in adults are headache, fatigue (tiredness) and pain at the site of injection.
Najpogostejši neželeni učinki cepiva Vepacel (opaženi pri več kot 1 osebi od 10) pri odraslih so glavobol, utrujenost in bolečina na mestu injiciranja.
Vaccination with Vepacel in adults produced an antibody response that met these criteria.
Cepljenje z zdravilom Vepacel pri odraslih je izzvalo odziv protiteles, ki izpolnjuje ta merila.
The first main study involved 561 healthy adults, while the second study involved around 3,600 adults including those at higher risk of flu (such as people with a long-term illness or a weakened immune system).
V prvo glavno študijo je bilo vključenih 561 zdravih odraslih ljudi, medtem ko je v drugi študiji sodelovalo okoli 3 600 odraslih, vključno s tistimi, pri katerih obstaja velika nevarnost, da se okužijo z gripo (kot so na primer osebe s kroničnimi boleznimi ali oslabelim imunskim sistemom).
According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
V skladu z merili, ki jih je določil CHMP, je prepandemično cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % odraslih oseb.
The use of Vepacel was later extended to children from 6 months of age since the vaccine was shown to produce a good antibody response also in this population, with a safety profile similar to that seen in adults.
Uporaba cepiva Vepacel je bila kasneje razširjena na uporabo pri otrocih od 6 meseca starosti dalje, saj je bilo ugotovljeno, da cepivo tudi pri tej populaciji zagotavlja dober odziv protiteles s podobnim varnostnim profilom, kot je bil opažen pri odraslih osebah.
The Committee noted that Vepacel produced a good antibody response in healthy adults and an acceptable response in healthy adults aged 60 and over and in patients with a weakened immune system or long-term illness.
Menil je, da je cepivo Vepacel izzvalo dober odziv, kar zadeva tvorjenje protiteles pri zdravih odraslih osebah, ter sprejemljiv odziv pri zdravih osebah, starih 60 let ali več, in bolnikih z oslabljenim imunskim sistemom ali kronično boleznijo.
This may help to provide protection in the event of a pandemic caused by a new strain of the H5N1 virus.
To bi lahko pripomoglo k zagotovitvi zaščite v primeru pandemije, ki bi jo povzročil nov sev virusa H5N1.
All of the studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against H5N1.
V vseh študijah so proučevali sposobnost cepiva, da sproži nastajanje protiteles („imunogenost“) proti virusu H5N1.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vepacel, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu z njim so bile v povzetek glavnih značilnosti zdravila Vepacel in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The viruses used in Vepacel are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Virusi, uporabljeni pri cepivu Vepacel, so vzgojeni v celicah sesalcev (celicah vero) in ne v kokošjih jajcih.
Why has Vepacel been approved?
Zakaj je bilo zdravilo Vepacel odobreno?
The study in children showed that vaccination with Vepacel brought about similar levels of antibodies to those seen in adults: at 21 days after the second injection, 85.4% of children aged 9 to 17 years, 72.9% of children aged 3 to 8 years and 68.8% of children aged 6 to 35 months had levels of antibodies that would protect them against H5N1.
Študija, izvedena pri otrocih, je pokazala, da cepljenje s cepivom Vepacel vzpostavi podobne ravni protiteles kot pri odraslih: na 21. dan po drugem injiciranju, je bila pri 85,4 % otrok, starih od 9 do 17 let, 72,9 % otrok, starih od 3 do 8 let, in 68,8 % otrok, starih od 6 do 35 mesecev, vzpostavljena raven protiteles, ki bi jih lahko zaščitila proti virusu H5N1.
The booster vaccination (one year after the 2-dose vaccination with Vepacel) also produced a strong antibody response against the strains used in the booster and in Vepacel.
Tudi poživitveno cepljenje (leto dni po cepljenju z drugim odmerkom cepiva Vepacel) je izzvalo močan odziv protiteles zoper seve, uporabljene v poživitvenem cepivu in cepivu Vepacel.
Health experts are concerned that a future flu pandemic could be caused by a strain of the H5N1 virus.
Zdravstvene strokovnjake skrbi, da bi lahko naslednjo pandemijo gripe povzročil sev virusa H5N1.
This vaccine contains a strain of the H5N1 virus.
To cepivo vsebuje sev virusa H5N1.
Vepacel is a vaccine for use in adults and children from 6 months of age to protect against flu caused by the H5N1 (“bird flu”) subtype of the influenza A virus.
Zdravilo Vepacel je cepivo, ki se uporablja za cepljenje odraslih in otrok, starejših od 6 mesecev, za zaščito proti gripi, ki jo povzroča podtip H5N1 virusa gripe A („ptičja gripa“).
In both studies, participants were given two doses of Vepacel followed by a booster dose (given after six months, one year or two years) of a vaccine containing different strengths of the same H5N1 flu strain as in Vepacel or a different H5N1 flu strain.
V obeh študijah so preiskovanci prejeli dva odmerka cepiva Vepacel, ki jima je sledil poživitveni odmerek (po šestih mesecih, enem letu ali dveh letih) cepiva, ki je vsebovalo druge jakosti istega seva virusa H5N1 kot v cepivu Vepacel ali drug sev virusa H5N1.
Vepacel has also been studied in a main study involving 657 healthy children aged 6 months to 17 years, who were given two doses of Vepacel, three weeks apart.
Cepivo Vepacel so prav tako proučevali v glavni študiji, ki je zajela 657 zdravih otrok, starih od 6 mesecev do 17 let, katerim so dali dva odmerka cepiva Vepacel s tritedenskim razmikom med obema odmerkoma.
Vepacel is a vaccine.
Zdravilo Vepacel je cepivo.
Influenza vaccine (whole virion, inactivated)
Povzetek EPAR za javnost cepivo proti gripi (s celimi virioni, inaktivirano)
For the full list of all side effects reported with Vepacel, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vepacel, glejte navodilo za uporabo.
In the first main study, at 21 days after the second injection, 72.5% of adults under 60 and 74.1% of adults aged 60 and over had levels of antibodies that would protect them against H5N1.
V prvi glavni študiji je imelo 21 dni po drugem injiciranju 72,5 % odraslih oseb, mlajših od 60 let, in 74,1 % odraslih oseb, starih 60 let ali več, tako raven protiteles, ki bi jih lahko zaščitila pred virusom H5N1.
What is Vepacel used for?
Za kaj se zdravilo Vepacel uporablja?
In the second main study, 85.8% of healthy adults under 60 and 80.2% of healthy adults aged 60 and over had protective levels of antibodies.
V drugi glavni študiji se je zaščitna raven protiteles vzpostavila pri 85,8 % zdravih odraslih oseb, mlajših od 60 let, in 80,2 % zdravih odraslih oseb, starih 60 let ali več.
In both studies, patients who received Vepacel and a booster with a different H5N1 flu strain produced antibodies that could react with several strains of H5N1 virus.
V obeh študijah so se pri bolnikih, ki so bili cepljeni s cepivom Vepacel in so prejeli poživitveni odmerek drugega seva virusa H5N1, pojavila protitelesa, ki bi lahko reagirala z več sevi virusa H5N1.
The Committee also noted that Vepacel produced a reasonable antibody response against other H5N1 strains that could potentially cause a flu pandemic.
Prav tako je ugotovil, da je cepivo Vepacel izzvalo soliden odziv protiteles proti sevom virusa H5N1, ki bi lahko morda povzročili pandemijo gripe.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni
How is Vepacel used?
Kako se zdravilo Vepacel uporablja?
The vaccine has been developed so that it can be used before or during a flu pandemic to provide protection against the H5N1 virus.
Cepivo je bilo razvito za zagotavljanje zaščite pred virusom H5N1, tako da ga je mogoče uporabiti pred pandemijo gripe ali med njo.
What is Vepacel?
Kaj je zdravilo Vepacel?
Some children also received a booster dose of a vaccine containing a different H5N1 flu strain after one year.
Nekateri od teh otrok so po enem letu prejeli še poživitveni odmerek cepiva, ki je vseboval drug sev virusa H5N1.
How has Vepacel been studied?
Kako je bilo zdravilo Vepacel raziskano?
How does Vepacel work?
Kako zdravilo Vepacel deluje?
During the previous inspection (January 2014) a number of major deficiencies were already identified.
Med predhodnim inšpekcijskim pregledom (januarja 2014) je bilo že ugotovljenih več bistvenih pomanjkljivosti.