natgillin/translations-raw huggingface dataset:
The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Prvo cepivo je treba dati muckam, starim vsaj osem tednov, drugo injekcijo pa tri do štiri tedne pozneje.
The vaccine is given as two doses injected under the skin.
Cepivo se injicira pod kožo v dveh odmerkih.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi katere je oblikoval priporočila glede uporabe zdravila.
Information on the prescription status of this product may be found on the label/outer package.
Podatki o predpisovanju tega zdravila so navedeni na nalepki/zunanji ovojnini.
It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.
Hkrati pa lahko prepreči smrt zaradi panlevkopenije in FeLV, ki ostane v krvi.
When exposed to any of these viruses or bacteria later in life, the cat will either not become infected or have a much less serious infection.
Pri izpostavljenosti kateremu koli od teh virusov pozneje v življenju se mačka ne bo okužila ali pa bo okužba blažja.
There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.
Na mestu injiciranja se lahko pojavi lokalna reakcija z rahlo bolečino ob dotiku, srbečico ali edemom (oteklino), ki izgine v tednu ali dveh.
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Pri mačkah se občasno pojavijo začasna apatija (izguba interesa za okolico) in anoreksija (izguba apetita) ter hipertermija (zvišana telesna temperatura), ki traja dan ali dva.
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom in bakterijam iz cepiva, razen sestavine FeLV, katere učinkovitost pri preprečevanju okužbe je bila že dokazana v drugih študijah.
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Zvišanja ravni protiteles proti C. felis zaradi visoke ravni protiteles pri mačkah ob začetku študije ni bilo mogoče zaznati.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV on 23 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Purevax RCPCh FeLV, veljavno po vsej Evropski uniji, izdala 23. februarja 2005.
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Razmerje med koristmi in tveganji je na voljo v modulu znanstvene razprave tega evropskega javnega poročila o oceni zdravila (EPAR).
They included young and adult cats of various breeds, but not young kittens.
V študije so vključili mlade in odrasle mačke različnih pasem, vendar ne muck.
The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Poksvirusi kanarčkov se ne širijo in ne razmnožujejo v mački, vendar tvorijo beljakovine genov FeLV.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis and feline leukaemia, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Mačko je treba ponovno cepiti za vse sestavine cepiva eno lepo po prvem cepljenju, nato na vsako leto proti klamidiozi in mačji levkemiji, in na vsaka tri leta proti rinotraheitisu, kalicivirozi in panlevkopeniji.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses, the FeLV proteins, and the weakened bacteria as ‘foreign' and makes antibodies against them.
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse, beljakovine virusa FeLV in oslabljene bakterije kot „tujke“ ter proti njim razvije protitelesa.
In the field, the studies of Purevax RCPCh FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and the booster vaccination.
V študijah zdravila Purevax RCPCh FeLV na terenu so preučevali osnovno shemo cepljenja (dve injekciji od tri do štiri tedne narazen) in obnovitveno cepljenje.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh FeLV exceed the risks for the approved indications and recommended that Purevax RCPCh FeLV be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCPCh FeLV večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
To protect against feline leukaemia, the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Za zaščito pred mačjo levkemijo cepivo vsebuje dva gena FeLV, imenovana env in gag, ki sta bila s „tehnologijo rekombinantne DNK“ vstavljena v drug vektorski (prenašalni) virus, imenovan poksvirus kanarčkov.
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
• inaktivirane (uničene) antigene proti kalicivirozi (seva FCV 431 in G1),
If self-injection does occur in these people, the doctor should be told that self-injection with a live chlamydial vaccine has occurred.
V primeru samoinjiciranja pri taki osebi zdravniku povejte, da je prišlo do samoinjiciranja z živim cepivom, ki vsebuje klamidijo.
• attenuated feline panleucopenia virus (PLI IV),
• atenuirani virus panlevkopenije mačk (PLI IV);
In case of accidental self-injection medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
• attenuated Chlamydophila felis (905 strain),
• atenuirano bakterijo Chlamydophila felis (sev 905);
In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RCPCh FeLV ščiti pred zgoraj navedenimi boleznimi.
• feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
• mačji levkemiji (bolezni, ki prizadene imunski sistem in jo povzroča retrovirus, virus mačje levkemije).
• attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
• atenuirani (oslabljeni) herpesvirus rinotraheitisa mačk (sev FHV F2),
The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus.
Učinkovitost zdravila Purevax RCPCh FeLV so proučevali v več preskušanjih v laboratorijskih pogojih, v katerih so mačke cepili in okužili s herpesvirusom, kalicivirusom, bakterijo C. felis, parvovirusom ali virusom levkemije.
Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Zdravilo Purevax RCPCh FeLV je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) in vehikla za pripravo suspenzije za injiciranje.
Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against:
Zdravilo Purevax RCPCh FeLV se uporablja za cepljenje mačk, starih osem tednov ali več, proti:
For a full list of the side-effects reported with Purevax RCPCh FeLV, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCPCh FeLV, glejte navodilo za uporabo.
Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Zdravilo Purevax RCPCh FeLV vsebuje majhne količine oslabljenih ali uničenih virusov, ki povzročajo rinotraheitis, kalicivirozo, klamidiozo in panlevkopenijo.
• feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
• panlevkopeniji mačk (resni bolezni, ki povzroča krvavo drisko in jo povzroča parvovirus);
Purevax RCPCh FeLV is a vaccine.
Zdravilo Purevax RCPCh FeLV je cepivo.
Purevax RCPCh FeLV should not be used in pregnant cats.
Zdravilo Purevax RCPCh FeLV se ne sme uporabljati pri brejih mačkah.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
V študiji obnovitvenega cepljenja so ravni protiteles proti herpesvirusu rinotraheitisa, okužbi s kalicivirusom, panlevkopeniji mačk in bakteriji C. felis ostale stabilne na visoki vrednosti ali pa so se rahlo zvišale.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria.
Ob ponovni izpostavitvi virusom ali bakterijam v prihodnosti bo imunski sistem hitreje izdelal protitelesa.
Purevax RCPCh FeLV is a veterinary vaccine that contains:
Zdravilo RCPCh FeLV je veterinarsko cepivo, ki vsebuje:
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
V terenski študiji osnovnega cepljenja so se zvišale ravni protiteles proti okužbi s herpesvirusom rinotraheitisa, okužbi s kalicivirusom in virusom panlevkopenije mačk.
What benefit has Purevax RCPCh FeLV shown during the studies?
Kakšne koristi je zdravilo Purevax RCPCh FeLV izkazalo v študijah?
• feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
• kalicivirozi mačk (gripi podobni bolezni z vnetjem ust, ki jo povzroča kalicivirus);
• feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
• klamidiozi mačk (gripi podobni bolezni, ki jo povzroča bakterija C. felis);
• feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
• rekombinantni poksvirus kanarčkov (vCP97), ki vsebuje antigen virusa mačje levkemije (FeLV).
What is the risk associated with Purevax RCPCh FeLV?
Kakšna tveganja so povezana z zdravilom Purevax RCPCh FeLV?
Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Cepivo proti virusnemu rinotraheitisu mačk, klamidiozi mačk, panlevkopeniji mačk (živo oslabljeno), mačji levkemiji in kalicivirozi mačk (inaktivirano)
Why has Purevax RCPCh FeLV been approved?
Zakaj je bilo zdravilo Purevax RCPCh FeLV odobreno?
• feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
• virusnemu rinotraheitisu mačk (gripi podobni bolezni, ki jo povzroča herpesvirus);
Other information about Purevax RCPCh FeLV:
Druge informacije o zdravilu Purevax RCPCh FeLV
How has Purevax RCPCh FeLV been studied?
Kako je bilo zdravilo Purevax RCPCh FeLV raziskano?
What is Purevax RCPCh FeLV?
Kaj je zdravilo Purevax RCPCh FeLV?
How does Purevax RCPCh FeLV work?
Kako zdravilo Purevax RCPCh FeLV deluje?
What is Purevax RCPCh FeLV used for?
Za kaj se zdravilo Purevax RCPCh FeLV uporablja?
This summary was last updated in 09-2013.
Povzetek je bil nazadnje posodobljen 09-2013.
The contents of the capsules must not be inhaled using any other device.
Vsebina kapsul se ne sme inhalirati z nobenim drugim pripomočkom.
Side effects seen in studies were generally benign and were considered manageable.
Neželeni učinki, opaženi v študijah, so bili navadno blagi in obvladljivi.
However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend its use for reducing exacerbations.
Vendar je odbor CHMP menil, da so njegovi učinki na zmanjšanje deleža poslabšanj preslabi, da bi ga priporočil za to indikacijo.
The full EPAR for Xoterna Breezhaler 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 Xoterna Breezhaler je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Uporablja se kot vzdrževalno (redno) zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB) .
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xoterna Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Xoterna Breezhaler večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The European Commission granted a marketing authorisation valid throughout the European Union for Xoterna Breezhaler on 19 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Xoterna Breezhaler, veljavno po vsej Evropski uniji, odobrila 19. septembra 2013.
This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xoterna Breezhaler.
When inhaled, indacaterol reaches the receptors in the airways and activates them.
Ob inhalaciji indakaterol doseže receptorje v dihalnih poteh in jih aktivira.
Xoterna Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Zdravilo Xoterna Breezhaler so proučevali v dveh glavnih študijah, v kateri je bilo skupaj vključeno 2 667 bolnikov s KOPB.
The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Kombinirano delovanje teh dveh zdravilnih učinkovin pomaga vzdrževati prehodnost dihal in bolniku olajša dihanje.
The most common side effects with Xoterna Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Najpogostejši neželeni učinki zdravila Xoterna Breezhaler (ki prizadenejo več kot 1 osebo od 10) so okužbe zgornjih dihal (prehladi).
Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Xoterna Breezhaler je zdravilo, ki vsebuje dve zdravilni učinkovini, indakaterol (85 mikrogramov) in glikopironij (43 mikrogramov).
It is taken at the same time each day using the Xoterno Breezhaler device.
Jemlje se vsak dan ob istem času z uporabo inhalatorja Xoterno Breezhaler.
The recommended dose is one inhalation once a day of the powder content of a single capsule.
Priporočeni odmerek je en vpih praška, ki ga vsebuje ena kapsula, enkrat na dan.
Glycopyrronium is a muscarinic receptor antagonist.
Glikopirinij je antagonist muskarinskih receptorjev.
In both studies, the main measure of effectiveness was how Xoterna Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
V obeh študijah je bilo glavno merilo učinkovitosti bolnikovo izboljšanje forsiranega ekspiracijskega volumna (FEV1 - največje količine zraka, ki jo oseba lahko izdihne v eni sekundi) po 26 tednih zdravljenja.
It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Deluje tako, da se veže na beta2 adrenergične receptorje v mišicah mnogih organov, vključno s pljučnimi dihalnimi potmi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xoterna Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Xoterna Breezhaler vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What measures are being taken to ensure the safe and effective use of Xoterna Breezhaler?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xoterna Breezhaler?
It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles.
Deluje tako, da zavira receptorje, imenovane muskarinski receptorji, ki nadzorujejo krčenje mišic.
Indacaterol is a long-acting beta-2 agonist.
Indakaterol je dolgodelujoči agonist beta-2 adrenergičnih receptorjev.
In patients with severely reduced kidney function Xoterna Breezhaler should only be used after a careful benefit-risk assessment.
Pri bolnikih s hudo poslabšanim ledvičnim delovanjem se sme zdravilo Xoterna Breezhaler uporabiti samo po skrbni oceni razmerja med tveganji in koristmi.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Kronična obstruktivna pljučna bolezen je dolgotrajna bolezen, pri kateri so dihalne poti in pljučni mešički poškodovani ali blokirani, kar povzroča težko vdihavanje in izdihavanje zraka.
The reduction in the rate of exacerbations was 10 to 12% higher with Xoterna Breezhaler than with tiotropium and glycopyrronium.
Zmanjšanje deleža poslabšanj je bilo za od 10 do 12 % večje pri zdravilu Xoterna Breezhaler kot pri tiotropiju in glikopironiju.
For more information about treatment with Xoterna Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xoterna Breezhaler preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that Xoterna Breezhaler is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Xoterna Breezhaler je bil pripravljen načrt obvladovanja tveganj.
The effects of Xoterna Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Ko se je zdravilo Xoterna Breezhaler uporabljalo za lajšanje simptomov KOPB, so bili njegovi učinki klinično pomembni.
For practical information about using Xoterna Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Xoterna Breezhaler naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Xoterna Breezhaler is available as capsules containing a powder for inhalation can only be obtained with a prescription.
Zdravilo Xoterna Breezhaler je na voljo v obliki kapsul, ki vsebujejo prašek za inhaliranje, in se izdaja le na recept.
In the second study the average increase in FEV1 was 140 ml more with Xoterna Breezhaler than with treatment with fluticasone and salmeterol.
V drugi študiji je bila povprečna vrednost FEV1 za 140 ml večja pri zdravilu Xoterna Breezhaler v primerjavi s flutikazonom in salmeterolom.
Other information about Xoterna Breezhaler
Druge informacije o zdravilu Xoterna Breezhaler
A third study studied the effects of Xoterna Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
V tretji študiji so proučevali učinke zdravila Xoterna Breezhaler na delež poslabšanj (izbruhov), ki so se pri bolnikih pojavili v 64 tednih zdravljenja, v primerjavi z zdravljenjem z glikopironijem ali tiotropijem (drugima oblikama zdravljenja KOPB).
Xoterna Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml than glycopyrronium alone.
Zdravilo Xoterna Breezhaler je prav tako povečalo vrednost FEV1 za dodatnih 70 ml v primerjavi s samostojnim indakaterolom in 90 ml v primerjavi s samostojnim glikopironijem.
The active substances in Xoterna Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Zdravilni učinkovini v zdravilu Xoterna Breezhaler, indakaterol in glikopironij, različno razširita dihalne poti in izboljšata dihanje pri KOPB.
The first study showed that treatment with Xoterna Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Prva študija je pokazala, da je bilo zdravljenje z zdravilom Xoterna Breezhaler učinkovitejše od placeba, saj je bila povprečna vrednost FEV1 za 200 ml večja kot pri placebu.
Regarding its safety, Xoterna Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Varnost zdravila Xoterna Breezhaler je primerljiva z indakaterolom in glikopironijem, če se uporabljata kot ločeni zdravili.
For the full list of all side effects reported with Xoterna Breezhaler, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xoterna Breezhaler, glejte navodilo za uporabo.
What is Xoterna Breezhaler and what is it used for?
Kaj je zdravilo Xoterna Breezhaler in za kaj se uporablja?
Muscarinic receptor antagonists and long-acting beta-2-adrenergic agonists are commonly combined in the management of COPD.
Kombinacija antagonistov muskarinskih receptorjev in dolgodelujočih agonistov beta-2 adrenergičnih receptorjev se pogosto uporablja za urejanje KOPB.
What benefits of Xoterna Breezhaler have been shown in studies?
Kakšne koristi je zdravilo Xoterna Breezhaler izkazalo v študijah?
While one study compared the effects of Xoterna Breezhaler with those of placebo (a dummy treatment), or indacaterol or glycopyrronium alone, the other study compared Xoterna Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
V eni študiji so primerjali učinke zdravila Xoterna Breezhaler z učinki placeba (zdravila brez zdravilne učinkovine) ali samostojnega indakaterola ali glikopironija, v drugi pa zdravilo Xoterna Breezhaler s kombinacijo flutikazona in salmeterola, tj. standardno obliko zdravljenja KOPB.
What are the risks associated with Xoterna Breezhaler?
Kakšna tveganja so povezana z zdravilom Xoterna Breezhaler?
Why is Xoterna Breezhaler approved?
Zakaj je bilo zdravilo Xoterna Breezhaler odobreno?
When glycopyrronium is inhaled, it causes the muscles of the airways to relax.
Ob inhalaciji glikopironij sprosti mišice v dihalih.
This causes the muscles of the airways to relax.
To sprosti mišice v dihalih.
How is Xoterna Breezhaler used?
Kako se zdravilo Xoterna Breezhaler uporablja?
How does Xoterna Breezhaler work?
Kako zdravilo Xoterna Breezhaler deluje?
Indacaterol / glycopyrronium
Xoterna Breezhaler indakaterol/glikopironij
Further information on Vyxeos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Vyxeos so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Vyxeos?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vyxeos?
Other information about Vyxeos
Druge informacije o zdravilu Vyxeos
As for all medicines, data on the use of Vyxeos are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vyxeos stalno spremljajo.
The European Medicines Agency decided that Vyxeos'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 Vyxeos večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
An overview of Vyxeos and why it is authorised in the EU
Pregled zdravila Vyxeos in zakaj je odobreno v EU