natgillin/translations-raw huggingface dataset:
The PRAC adopted a recommendation on 17 March 2016 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC. 
Odbor PRAC je 17. marca 2016 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015). 
Vendar so IKS pomembna terapevtska možnost za določene skupine bolnikov, kakor navajajo nekatere smernice za zdravljenje (poročilo GOLD, 2015).
Episodes of acute worsening of these symptoms (exacerbations) often occur. 
Pogoste so epizode akutnega poslabšanja teh simptomov (izbruhi).
All these products are restricted to ‘prescription only' status. 
Izdaja vseh teh zdravil je „le na recept“.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation. 
Potem ko je odbor CHMP pregledal priporočilo odbora PRAC, se je strinjal s končnimi zaključki in podlago za priporočilo.
Since the results of the TORCH study were published in 2007, a number of large meta-analyses of pooled data have been conducted. 
Od objave rezultatov študije TORCH leta 2007 je bilo opravljenih več velikih metaanaliz združenih podatkov.
Grounds for PRAC recommendation 
Podlaga za priporočilo odbora PRAC
On 27 April 2015 the European Commission therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of ICS containing medicinal products indicated in the treatment of COPD and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Zato je Evropska komisija 27. aprila 2015 na podlagi farmakovigilančnih podatkov sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni vpliv navedenih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo IKS, indiciranih za zdravljenje KOPB, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
The therapeutic effect of inhaled corticosteroids is considered to be the result of suppression of airway inflammation, but the airway effects of ICS in COPD are complex and the mechanism of action is not completely understood (Finney et al., 2014, Jen et al., 2012). 
Velja, da je terapevtski učinek inhalacijskih kortikosteroidov posledica zavrtja vnetja dihalnih poti, vendar so učinki IKS na dihalne poti pri KOPB kompleksni, mehanizem delovanja pa ni popolnoma jasen (Finney idr., 2014, Jen idr., 2012).
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease (COPD); 
• Odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo inhalacijske kortikosteroide (IKS), indicirane za zdravljenje kronične obstruktivne pljučne bolezni (KOPB);
ICS-containing products authorised across the EU for the treatment of COPD includes the active substances beclomethasone, fluticasone propionate, fluticasone furoate, budesonide and flunisolide. 
Zdravila, ki vsebujejo IKS, odobrena v EU za zdravljenje KOPB, vključujejo zdravilne učinkovine beklometazon, flutikazon propionat, flutikazon furoat, budezonid in flunizolid.
Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015]. 
K celokupni resnosti pri posameznem bolniku prispevajo izbruhi in sočasne bolezni [Svetovna pobuda za kronično obstruktivno pljučno bolezen (GOLD), 2015].
A signal of increased risk of pneumonia in COPD patients with ICS-containing treatments was first identified in the TORCH study (Calverley et al., 2007) a large clinical study of three years treatment duration comparing the fluticasone propionate/salmeterol combination with its component parts and placebo in COPD patients. 
Signal povečanega tveganja za pljučnico pri bolnikih s KOPB pri zdravilih, ki vsebujejo IKS, je bil prvič ugotovljen v študiji TORCH (Calverley idr., 2007), veliki klinični študiji triletnega zdravljenja, v kateri so primerjali kombinacijo flutikazon propionat/salmeterol z njenimi sestavnimi deli in placebom pri bolnikih s KOPB.
It is considered mechanistically plausible that a higher dose of corticosteroid could cause a greater degree of immunosuppression in the lung and lead to a higher risk of pneumonia, but this has not been demonstrated conclusively across all studies. 
Velja, da je mehanično verjetno, da večji odmerek kortikosteroida lahko povzroči večjo stopnjo imunosupresije v pljučih ter vodi do večjega tveganja za pljučnico, vendar to ni bilo nesporno dokazano v vseh študijah.
No clinical trials directly examined the risk of pneumonia with ICSs head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available, mainly between budesonide and fluticasone. 
V nobenem kliničnem preskušanju niso z neposredno primerjavo proučevali tveganja za pljučnico pri IKS; na voljo so samo posredne primerjave iz metaanaliz/sistematičnih pregledov ali opazovalnih študij, v glavnem med budezonidom in flutikazonom.
Overall the evidence from observational studies was in agreement with the randomised clinical trials (RCT) findings and it was therefore considered that the evidence continues to support the conclusion that treatment with ICS increases the risk of pneumonia in COPD patients. 
Skupno so bili dokazi iz opazovalnih študij skladni z izsledki randomiziranih kliničnih preskušanj (RKP), zato je obveljalo, da dokazi še naprej podpirajo zaključek, da zdravljenje z IKS povečuje tveganje za pljučnico pri bolnikih s KOPB.
Chronic obstructive pulmonary disease (COPD) is characterised by persistent, usually progressive, airflow limitation associated with an enhanced inflammatory response in the airways and the lungs. 
Za kronično obstruktivno pljučno bolezen (KOPB) je značilna trajna, običajno napredujoča zapora dihalnih poti, povezana s povečanim vnetnim odzivom v dihalnih poteh in pljučih.
Inhaled corticosteroid (ICS) medicinal products are widely used in the treatment of COPD, as a monocomponent or in combination with a long-acting beta2 adrenergic agonist (LABA). 
Inhalacijski kortikosteroidi (IKS) se pogosto uporabljajo pri zdravljenju KOPB v monoterapiji ali v kombinaciji z dolgodelujočimi agonisti adrenergičnih receptorjev beta2 (DDBA).
Results from older meta-analyses and from observational studies were also variable, with some suggesting an increased risk of pneumonia with fluticasone compared to budesonide and others finding no difference. 
Tudi rezultati iz starejših metaanaliz in opazovalnih študij niso bili enotni, nekateri so kazali na povečano tveganje za pljučnico s flutikazonom v primerjavi z budezonidom, pri drugih pa razlike ni bilo.
Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class. 
Ocene na podlagi predloženih podatkov kažejo, da je bilo razredu IKS izpostavljenih desetine milijonov bolnikov.
Overall, due to the variability in the clinical data and multiple uncertainties with study methodologies, there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among inhaled corticosteroid products. 
Zaradi variabilnosti kliničnih podatkov in več negotovosti, povezanimi s študijskimi metodologijami, ni nespornih kliničnih dokazov za razlike znotraj razreda glede velikosti tveganja med inhalacijskimi kortikosteroidnimi zdravili.
Although a number of common criticisms can be levelled at the studies included in these meta-analyses, including difficulties with the accurate identification of pneumonia (particularly pre-TORCH studies), variations in participant populations and comparators, differential withdrawal rates, and trials not specifically powered to detect pneumonia, a consistent association between ICS use and increased risk of pneumonia in COPD patients was seen across the meta-analyses. 
Čeprav je mogoče študijam, vključenim v metaanalize, očitati več stvari, vključno s težavami z natančno identifikacijo pljučnice (zlasti študijam, opravljenim pred študijo TORCH), z variacijami v populacijah udeležencev in primerjalnih zdravilih, z diferencialnimi odstotki umika ter s preskušanji, ki niso imela specifične moči za zaznavanje pljučnice, so v metaanalizah opazili skladno povezavo med uporabo IKS in povečanim tveganjem za pljučnico pri bolnikih s KOPB.
• The PRAC considered that some evidence of an increased risk of pneumonia with increasing steroid dose exists, although this has not been demonstrated conclusively across all studies; 
• menil je, da obstaja nekaj dokazov o povečanem tveganju za pljučnico s povečevanjem odmerka steroida, čeprav tega niso nesporno dokazali v vseh študijah;
Symptoms of COPD include dyspnoea, chronic cough and chronic sputum production. 
Simptomi KOPB vključujejo dispnejo, kronični kašelj in kronično nastajanje izmečka.
Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients. 
Zaradi maloštevilnih podatkov o morebitnih učinkih drugih razredov zdravil, ki se predpisujejo za KOPB, ni mogoče izpeljati zaključkov o vplivu sočasnih zdravil na tveganje za pljučnico pri bolnikih s KOPB.
Since then other products containing ICS have been subject to review and it was considered that data on the risk of pneumonia with these products in the COPD population should be reviewed all together, so that the risk of pneumonia in this patient population could be further characterised. 
Od takrat so pregledali tudi druga zdravila, ki vsebujejo IKS, in zaključili, da je treba pregledati vse podatke o tveganju za pljučnico pri teh zdravilih v populaciji s KOPB, tako da bi lahko nadalje opredelili tveganje za pljučnico v tej populaciji bolnikov.
Some evidence suggests an increased risk of pneumonia with increasing steroid dose. 
Nekateri dokazi kažejo, da je tveganje za pljučnico pri večjem odmerku steroida večje.
Further, it was recognised that there are difficulties associated with the differential diagnosis of pneumonia or an exacerbation of COPD. 
Ugotovili so tudi, da so pri diferencialni diagnostiki pljučnice oziroma izbruha KOPB težave.
• The PRAC reviewed the data submitted by the marketing authorisation holders in relation to the increased risk of pneumonia in patients with COPD in association with ICS-containing medicinal products; 
• odbor PRAC je pregledal podatke, ki so jih predložili imetniki dovoljenj za promet z zdravilom, povezane s povečanim tveganjem za pljučnico pri bolnikih s KOPB v povezavi z zdravili, ki vsebujejo IKS;
• The PRAC concluded that the evidence provided supports a causal association between the use of ICS-containing products and an increased risk of pneumonia in COPD patients; 
• odbor PRAC je zaključil, da dokazi podpirajo vzročno povezavo med uporabo zdravil, ki vsebujejo IKS, in povečanim tveganjem za pljučnico pri bolnikih s KOPB;
It was acknowledged that any risk of pneumonia with ICS should be considered in context, as pneumonia is an intrinsic comorbidity to COPD with certain predisposing factors making some COPD patients more susceptible to this risk than others. 
Potrdili so, da je treba vsako tveganje za pljučnico pri IKS obravnavati v kontekstu, saj je pljučnica pri določenih dejavnikih nagnjenosti, zaradi katerih so nekateri bolnikih s KOPB bolj dovzetni za to tveganje kot drugi, pri KOPB intrinzična sočasna bolezen.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for ICS-containing medicinal products indicated in the treatment of COPD. 
Odbor je zato priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo IKS, indiciranih za zdravljenje KOPB.
The PRAC therefore concluded that pneumonia (in COPD patients) should be added as a common adverse drug reaction in the product information of all ICS-containing products and that for products with an existing Risk Management Plan, “increased risk of pneumonia in COPD patients” should be considered an Important Identified Risk. 
Odbor PRAC je zato zaključil, da je treba v informacije o zdravilu za vsa zdravila, ki vsebujejo IKS, dodati pljučnico (pri bolnikih s KOPB) kot pogost neželeni učinek in da pri zdravilih z obstoječim načrtom za obvladovanje tveganj „povečano tveganje za pljučnico pri bolnikih s KOPB“ velja za pomembno ugotovljeno tveganje.
In view of the above, the Committee considers that the benefit-risk balance of ICS-containing medicinal products remains favourable in the treatment of COPD subject to the agreed amendments to the product information. 
Glede na zgoraj navedeno je odbor menil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo IKS, še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
Finally, the PRAC considered the ICS dose-response effect or the influence of LABA and other concomitant medications on the risk of pneumonia in COPD patients. 
Odbor PRAC je tudi proučil povezavo med odmerkom IKS in odzivom oziroma vpliv DDBA in drugih sočasnih zdravil na tveganje za pljučnico pri bolnikih s KOPB.
• The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD. 
• stališče odbora PRAC je bilo, da je treba v informacije o zdravilu za vsa zdravila, ki vsebujejo IKS, indicirana za zdravljenje KOPB, vključiti povečano tveganje za pljučnico ter dodati opozorilo za zdravstvene delavce in bolnike, naj bodo pozorni na morebiten pojav pljučnice pri bolnikih s KOPB in naj pri tem upoštevajo prekrivanje simptomov pljučnice s simptomi izbruha KOPB.
To mitigate the risk of pneumonia, the PRAC considered that a warning should be included in the product information for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD. 
Odbor PRAC je presodil, da je treba za zmanjšanje tveganja za pljučnico v informacije o zdravilu za zdravstvene delavce in bolnike dodati opozorilo, naj bodo pozorni na morebiten pojav pljučnice pri bolnikih s KOPB in naj pri tem upoštevajo prekrivanje simptomov pljučnice s simptomi izbruha KOPB.
• The PRAC also concluded that there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS-containing products; 
• zaključil je tudi, da znotraj razreda zdravil, ki vsebujejo IKS, ni nespornih kliničnih dokazov za razlike v velikosti tveganja;
In conclusion, the PRAC considered that the benefit-risk balance of ICS-containing products remained favourable, provided the proposed changes to the product information are implemented. 
Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo IKS, še naprej ugodno, pod pogojem, da se informacije o zdravilu in načrt za obvladovanje tveganj spremenijo, kot je predlagano.
It can also prevent death due to panleucopenia. 
Hkrati pa lahko prepreči smrt zaradi panlevkopenije.
The cat should be revaccinated for all components one year after the first vaccination course, then every three years. 
Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju in nato vsaka tri leta.
The vaccine helps to reduce the symptoms of the diseases. 
Cepivo pripomore k zmanjšanju simptomov bolezni.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP on 23 February 2005. 
Evropska komisija je dovoljenje za promet z zdravilom Purevax RCP, veljavno po vsej Evropski uniji, izdala dne 23. februarja 2005.
It also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination. 
Prispeva tudi k zmanjšanju izločanja virusov pri okužbi s kalicivirusi eno leto po cepljenju.
When exposed to any of these viruses 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.
The antibodies will help to protect against the diseases caused by these viruses. 
Ta mu bodo pomagala pri zaščiti pred boleznimi, ki jih povzročajo ti virusi.
The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine. 
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom iz cepiva.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako se braniti pred boleznimi.
The studies included young and adult cats of various breeds, but not young kittens. 
V študije so vključili mlade in odrasle mačke različnih pasem, ne pa mladh muck.
The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later. 
Prvo injekcijo je treba dati muckam, starim vsaj osem tednov, drugo pa tri do štiri tedne pozneje.
If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age. 
Če ima mucka visoke ravni protiteles, ki jih je prejela od matere v maternici in z mlekom, je treba s cepljenjem počakati do starosti 12 tednov.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP exceed the risks for the approved indications and recommended that Purevax RCP be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCP večje od z njim povezanih tveganj pri odobrenih indikacijah, in priporočil, da se zanj izda dovoljenje za promet.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign' and makes antibodies against them. 
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse kot „tujke“ in proti njim razvije protitelesa.
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. 
Občasno se lahko pri mačkah pojavijo začasna apatija (pomanjkanje zanimanja za okolico) in anoreksija (izguba teka) ter hipertermija (povišana telesna temperatura), ki traja dan ali dva.
In laboratory conditions Purevax RCP was demonstrated to provide protection against the diseases listed above. 
V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RCP zagotavlja zaščito proti zgoraj navedenim boleznim.
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 nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
• attenuated feline panleucopenia virus (PLI IV). 
• atenuirani virus panlevkopenije mačk (PLI IV).
In the field, the studies of Purevax RCP looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection). 
V terenskih študijah zdravila Purevax RCP so preučevali osnovno shemo cepljenja (dve injekciji v tri- do štiritedenskem razmiku) in obnovitveno cepljenje (samo ena injekcija).
Purevax RCP is a vaccine. 
Zdravilo Purevax RCP je cepivo.
Purevax RCP should not be used in pregnant cats. 
Zdravilo Purevax RCP se ne sme uporabljati pri brejih mačkah.
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains), 
• inaktivirane (uničene) antigene kalicivirusa (sev FCV 431 in G1);
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. 
Ob ponovni izpostavitvi virusom v prihodnosti bo imunski sistem hitreje izdelal protitelesa.
Purevax RCP is used to vaccinate cats from the age of 8 weeks against: 
Zdravilo Purevax RCP se uporablja za cepljenje mačk, starih osem tednov ali več, proti:
Other information about Purevax RCP: 
Druge informacije o zdravilu Purevax RCP:
The effectiveness of Purevax RCP has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or parvovirus. 
Učinkovitost zdravila Purevax RCP so proučili v več preskušanjih v laboratorijskih pogojih, kjer so mačke cepili in okužili z virulentnim herpesvirusom, kalicivirusom ali parvovirusom.
For a full list of the side-effects reported with Purevax RCP, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCP, glejte navodilo za uporabo.
• 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 RCP contains small amounts of weakened or killed viruses that cause feline rhinotracheitis, calicivirosis and panleucopenia. 
Zdravilo Purevax RCP vsebuje majhne količine oslabljenih ali uničenih virusov, ki povzročajo rinotraheitis, kalicivirozo in panlevkopenijo mačk.
• attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain), 
• atenuirani (oslabljeni) herpesvirus rinotraheitisa mačk (sev FHV F2);
Purevax RCP is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection. 
Zdravilo Purevax RCP je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) in vehikla za pripravo suspenzije za injiciranje.
What benefit has Purevax RCP shown during the studies? 
Kakšne koristi je zdravilo Purevax RCP izkazalo v študijah?
Purevax RCP is a veterinary vaccine that contains: 
Zdravilo Purevax RCP je cepivo za uporabo v veterinarski medicini, ki vsebuje:
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and feline panleucopenia remained stable at a high level or increased slightly. 
V študiji obnovitvenega cepljenja je bilo ugotovljeno, da so ravni protiteles proti herpesvirusu rinotraheitisa mačk, okužbam s kalicivirusi in panlevkopeniji mačk ostale stabilne na visoki ravni ali pa so se nekoliko zvišale.
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 je bilo ugotovljeno povečanje protiteles proti herpesvirusu rinotraheitisa mačk, okužbam s kalicivirusom in virusom panlevkopenije mačk.
What is the risk associated with Purevax RCP? 
Kakšna tveganja so povezana z zdravilom Purevax RCP?
Why has Purevax RCP been approved? 
Zakaj je bilo zdravilo Purevax RCP odobreno?
Feline viral rhinotracheitis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine 
Cepivo proti virusnemu rinotraheitisu mačk, (živo oslabljeno) cepivo proti mačji panlevkopeniji in (inaktivirano) cepivo proti kalicivirozi mačk
What is Purevax RCP used for? 
Za kaj se zdravilo Purevax RCP uporablja?
What is Purevax RCP? 
Kaj je zdravilo Purevax RCP?
How has Purevax RCP been studied? 
Kako je bilo zdravilo Purevax RCP raziskano?
How does Purevax RCP work? 
Kako zdravilo Purevax RCP deluje?
This summary was last updated in 12-2014. 
Povzetek je bil nazadnje posodobljen 12-2014.