natgillin/translations-raw huggingface dataset:
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.
It is available as tablets (30 mg).
Na voljo je v obliki tablet (30 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for ellaOne on 15 May 2009.
Evropska komisija je dovoljenje za promet z zdravilom ellaOne, veljavno po vsej Evropski uniji, izdala 15. maja 2009.
EllaOne can be taken at any time during the menstrual cycle.
Zdravilo ellaOne se lahko zaužije kadar koli med menstrualnim ciklom.
The main measure of effectiveness was the number of women who did not become pregnant.
Glavno merilo učinkovitosti je bilo število žensk, ki niso zanosile.
This number was calculated from published pregnancy rates.
Število so izračunali na podlagi objavljenih stopenj nosečnosti.
What measures are being taken to ensure the safe and effective use of ellaOne?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila ellaOne?
The full EPAR for ellaOne 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 ellaOne je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
If the woman vomits within three hours of taking the medicine she should take another tablet.
Če ženska v treh urah po zaužitju tablete bruha, mora vzeti še eno tableto.
Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant.
Zanosilo je 2,1 % (26 od 1 241) žensk, ki so v glavni študiji sodelovale do konca.
This is less than the 5.5% of women who would have been expected to become pregnant if they had not taken any contraceptive.
To je manj kot 5,5 % žensk, ki bi verjetno zanosile, če ne bi vzele kontracepcijskega sredstva.
For the full list of all side effects and restrictions, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev glejte navodilo za uporabo.
EllaOne therefore prevented about three-fifths of the pregnancies.
Zdravilo ellaOne je preprečilo približno tri petine nosečnosti.
The CHMP decided that ellaOne's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila ellaOne večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
This document is a summary of the European public assessment report (EPAR) for ellaOne.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ellaOne.
If ovulation has already occurred, ellaOne is no longer effective.
Če je do ovulacije že prišlo, zdravilo ellaOne ni več učinkovito.
Other information about ellaOne:
Druge informacije o zdravilu ellaOne:
This means that it attaches to the receptors that progesterone normally attaches to, preventing the hormone from having its effect.
To pomeni, da se veže na receptorje, na katere se navadno veže progesteron, kar hormonu prepreči delovanje.
EPAR summary for the public ellaOne ulipristal acetate
Povzetek EPAR za javnost ellaOne ulipristalacetat
What benefit has ellaOne shown during the studies?
Kakšne koristi je zdravilo ellaOne izkazalo med študijami?
For more information about treatment with ellaOne, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom ellaOne preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception).
V dodatni študiji so zdravilo ellaOne primerjali z levonorgestrelom (drugim zdravilom, uporabljenim kot nujna kontracepcija).
This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive.
To število so primerjali s številom žensk, ki bi verjetno zanosile, če ne bi vzele kontracepcijskega sredstva.
If a woman's menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before ellaOne is taken.
Če menstruacija kasni ali če so opazni simptomi nosečnosti, je treba možnost nosečnosti izključiti, preden se vzame zdravilo ellaOne.
The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains).
Najpogostejši neželeni učinki zdravila ellaOne so glavobol, navzeja (slabost), bolečine v trebuhu in dismenoreja (menstrualne bolečine).
A risk management plan has been developed to ensure that ellaOne is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila ellaOne je bil pripravljen načrt obvladovanja tveganj.
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 ellaOne.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with ellaOne?
Kakšna tveganja so povezana z zdravilom ellaOne?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ellaOne, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure.
V eni glavni študiji je zdravilo ellaOne prejelo 1 533 žensk (povprečne starosti 24 let), ki so potrebovale nujno kontracepcijo od dva do pet dni po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
The medicine can be obtained without a prescription.
Izdaja zdravila je le na recept.
For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb.
Da ženska zanosi, mora imeti ovulacijo (sprostitev jajčec), ki ji sledi oploditev jajčeca (združitev s spermijem) in njegova vgnezditev v maternico.
EllaOne is a medicine that contains the active substance ulipristal acetate.
EllaOne je zdravilo, ki vsebuje zdravilno učinkovino ulipristalacetat.
Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation.
Z delovanjem na receptorje progesterona zdravilo ellaOne prepreči nosečnost tako, da prepreči ali odloži ovulacijo.
The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.
Spolni hormon progesteron sodeluje pri časovnem uravnavanju ovulacije in pripravi maternice na sprejem oplojenega jajčeca.
The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator.
Zdravilna učinkovina zdravila ellaOne, ulipristalacetat, deluje kot modulator progesteronskih receptorjev.
The additional study, which included women who took the medicine within two days of unprotected sex or contraceptive failure, supported the effectiveness of ellaOne.
Dodatna študija, v kateri so ženske vzele zdravilo v dveh dneh po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji, je potrdila učinkovitost zdravila ellaOne.
Why has ellaOne been approved?
Zakaj je bilo zdravilo ellaOne odobreno?
EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after unprotected sex or contraceptive failure.
Zdravilo ellaOne v obliki ene tablete je treba zaužiti peroralno čim prej, vendar najkasneje 120 ur po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.