natgillin/translations-raw huggingface dataset:
How is Zunrisa expected to work?
Kako naj bi zdravilo Zunrisa delovalo?
By blocking the receptors, casopitant was expected to prevent nausea and vomiting which often happens during chemotherapy or as a complication of surgery.
Kasopitant naj bi z blokiranjem teh receptorjev preprečil slabost in bruhanje, ki sta pogosta med kemoterapijo ali kot zaplet po operativnih posegih.
Zunrisa was also expected to be used with other medicines to prevent nausea and vomiting in patients undergoing surgery.
Zdravilo Zunrisa naj bi se uporabljalo z drugimi zdravili za preprečevanje slabosti in bruhanja pri bolnikih po operativnih posegih.
The referral procedure started on 19 September 2005.
Napotitveni postopek se je pričel 19. septembra 2005.
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The final opinion was converted into a Decision by the European Commission on 4 July 2006.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 4. julija 2006.
International Non-Proprietary Name (INN): salmeterol / fluticasone
Mednarodno nelastniško ime (INN): salmeterol / flutikazon
The Rapporteur and Co-Rapporteur appointed were Dr D Lyons and Dr G Calvo Rojas, respectively.
Poročevalec je bil dr. D. Lyons, soporočevalec pa dr. G. Calvo Rojas.
In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Finland, France, Germany, Italy, Ireland, Luxembourg, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
V postopku medsebojnega priznavanja je bila Švedska referenčna država članica, medtem ko so bile Avstrija, Belgija, Finska, Francija, Nemčija, Italija, Irska, Luksemburg, Portugalska, Španija in Združeno kraljestvo zadevne države članice.
*Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
*Opomba: informacije, podane v tem dokumentu in v dodatkih, odražajo zgolj mnenje CHMP z dne 27. aprila 2006.
VIANI DISKUS and associated names (See Annex I)
VIANI DISKUS in z njim povezana imena (glejte Dodatek I)
PERSUANT TO ARTICLE 6(13) OF COMMISSSION REGULATION (EC) No 1084/2003 FOR
PREDLOŽENO V SKLADU S ČLENOM 6(13) UREDBE KOMISIJE (ES) št. 1084/2003, ZA
In several EU Member States Viani Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
V številnih državah članicah EU je bilo zdravilo Viani Diskus in z njim povezana imena odobreno s postopkom medsebojnega priznavanja (MRP).
On 12 August 2005 the Marketing Authorisation Holders presented to the EMEA a referral under article 6(13) of Commission Regulation (EC) No 1084/2003.
Dne 12. avgusta 2005 so imetniki dovoljenja za promet z zdravilom zadevo napotili na agencijo EMEA v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003.
Supplementary information was provided by the Marketing Authorisation Holders on 3 February 2006 and written explanations were given on 30 March 2006.
Imetniki dovoljenja za promet z zdravilom so 3. februarja 2006 predložili dodatne informacije, 30. marca 2006 pa še pisna pojasnila.
SUMMARY INFORMATION ON REFERRAL OPINION
POVZETEK INFORMACIJ O MNENJU V ZVEZI Z NAPOTITVIJO,
Viani Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Zdravilo Viani Diskus in z njim povezana imena (glejte Dodatek I), ki vsebuje salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β-agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), je indicirano za običajno zdravljenje astme, kadar je uporaba kombiniranega zdravila (dolgo delujočega beta-2-agonista in inhalacijskega kortikosteroida) ustrezna: pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in »po potrebi« z inhalacijskim kratko delujočim beta-2-agonistom ni mogoče doseči zadostnega nadzora bolezni, ali pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta-2agonistom vzpostaviti zadosten nadzor bolezni.
Based on evaluation of the available data and the Rapporteur's assessment reports, the CHMP adopted an opinion on 27 April 2006 recommending the variation to the terms of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package leaflet .
Na podlagi ocene razpoložljivih podatkov in ocenjevalnih poročil poročevalca je CHMP dne 27. aprila 2006 sprejel mnenje, v katerem priporoča variacijo pogojev dovoljenj za promet z zdravilom ter spremembo Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo.
On the basis of the grounds for referral, the point considered by the CHMP was whether it is appropriate to introduce initial maintenance therapy with the fixed dose combination of salmeterol and fluticasone propionate in all patients with chronic persistent asthma.
V skladu z razlogi za napotitev je CHMP obravnaval vprašanje, ali je primerno uvesti začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov salmeterola in flutikazon propionata pri vseh bolnikih s kronično perzistentno astmo.
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics, Labelling and Package Leaflet in the Annex III.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, Dodatek III pa vsebuje spremenjeni Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo.
The Marketing Authorisation Holders submitted a type II variation subject to the MRP in July 2004 to extend the indication to include initial maintenance therapy with the fixed dose combination in patients with chronic persistent asthma.
Imetniki dovoljenja za promet z zdravilom so predložili vlogo za variacijo tipa II, ki je bila obravnavana v postopku medsebojnega priznavanja julija 2004, z namenom razširiti indikacijo, tako da bo vključevala začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov pri bolnikih s kronično perzistentno astmo.
The RMS and CMSs rejected the type II variation based on the grounds that the overall risk/benefit was unfavourable for the initial maintenance therapy indication.
Referenčna država članica in zadevne države članice so zavrnile variacijo tipa II, ker je bilo splošno razmerje med tveganji in koristmi zdravila neugodno za indikacijo začetnega vzdrževalnega zdravljenja.
Further information on Nucala can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/nucala.
Nadaljnje informacije za zdravilo Nucala so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/nucala.
What measures are being taken to ensure the safe and effective use of Nucala?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nucala?
The recommended dose is 100 mg in patients aged 12 years and above, and 40 mg in patients aged 6 to 11 years.
Priporočeni odmerek je 100 mg pri bolnikih, starejših od 12 let, in 40 mg pri bolnikih, starih od 6 do 11 let.
This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.
S tem pomaga ublažiti vnetje, kar zmanjša število napadov astme in izboljša simptome.
Nucala received a marketing authorisation valid throughout the EU on 2 December 2015.
Za zdravilo Nucala je bilo 2. decembra 2015 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Nucala'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 Nucala večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In addition, a reduction in corticosteroid dose was considered clinically relevant, given the potential complications of long-term corticosteroid treatment.
Poleg tega je bilo zmanjšanje odmerka kortikosteroidov ocenjeno za klinično pomembno glede na morebitne zaplete pri dolgotrajnem zdravljenju s kortikosteroidi.
Over half (37 of 69) of the patients given Nucala were able to reduce their daily corticosteroid dose by more than 50% to a dose of 5 mg or less, and 10 of them were able to stop corticosteroids altogether, compared with about a third of those given placebo (22 of 66, of whom 5 were able to stop corticosteroids).
Več kot polovica (37 od 69) bolnikov, ki so prejemali zdravilo Nucala, je lahko zmanjšala dnevni odmerek kortikosteroidov za več kot 50 % na odmerek 5 mg ali manj, od katerih jih je deset lahko prenehalo uporabljati kortikosteroide, v primerjavi s tretjino bolnikov, ki so prejemali placebo (22 od 66, od katerih jih je pet lahko prenehalo uporabljati kortikosteroide).
As for all medicines, data on the use of Nucala are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nucala stalno spremljajo.
Other information about Nucala
Druge informacije o zdravilu Nucala
Side effects reported with Nucala are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Nucala, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effect with Nucala (which may affect more than 1 in 10 people) is headache.
Najpogostejši neželeni učinek zdravila Nucala (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je glavobol.
What benefits of Nucala have been shown in studies?
Kakšne koristi zdravila Nucala so se pokazale v študijah?
Why is Nucala authorised in the EU?
Zakaj je bilo zdravilo Nucala odobreno v EU?
An overview of Nucala and why it is authorised in the EU
Pregled zdravila Nucala in zakaj je odobreno v EU
The reduction in eosinophil levels in the blood achieved in children was also comparable with that seen with standard doses in adults.
Zmanjšanje ravni eozinofilcev v krvi, ki je bilo doseženo pri otrocih, je bilo prav tako primerljivo s tistim, ki so ga opazili pri standardnih odmerkih pri odraslih.
The Agency concluded that the data available indicate that Nucala acts in a similar way in adults and children and the results in adults therefore also apply to children with eosinophilic asthma.
Agencija je zaključila, da razpoložljivi podatki kažejo, da zdravilo Nucala pri odraslih in otrocih deluje podobno ter da rezultati, ki veljajo za zdravilo Nucala pri odraslih, veljajo tudi za otroke z eozinofilno astmo.
The main measure of effectiveness in these studies was the number of severe attacks (exacerbations) of asthma that occurred during treatment, which was reduced by about half in patients given Nucala.
Glavno merilo učinkovitosti v teh študijah je bilo število hudih napadov (poslabšanj) astme med zdravljenjem, ki se je pri bolnikih, ki so prejemali zdravilo Nucala, zmanjšalo za polovico.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nucala have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nucala upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
It is used with other medicines in patients whose asthma is severe and not well controlled with previous treatments.
Skupaj z drugimi zdravili se uporablja pri bolnikih s težko astmo, ki s predhodnimi zdravili ni bila dobro nadzorovana.
For more information about using Nucala, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Nucala glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is Nucala and what is it used for?
Kaj je zdravilo Nucala in za kaj se uporablja?
The second study involved 576 adults and adolescents given Nucala every 4 weeks for 28 weeks.
V drugo študijo je bilo vključenih 576 odraslih in mladostnikov, ki so 28 tednov prejemali zdravilo Nucala enkrat na štiri tedne.
In children, eosinophilic asthma is rare and the data available are therefore limited.
Pri otrocih je eozinofilna astma redka, zato ni na voljo veliko podatkov.
The active substance in Nucala, mepolizumab, is a type of protein called a monoclonal antibody, which attaches to a specific substance in the body.
Učinkovina v zdravilu Nucala, mepolizumab, je vrsta beljakovine, imenovana monoklonsko protitelo, ki se veže na določeno snov v telesu.
What are the risks associated with Nucala?
Kakšna tveganja so povezana z zdravilom Nucala?
Mepolizumab attaches to a substance called interleukin-5 which encourages the production and survival of eosinophils.
Mepolizumab se pripoji na snov, imenovano interlevkin-5, ki spodbuja tvorbo in preživetje eozinofilcev.
An additional study was carried out in children aged 6 years to 11 years which showed that a dose of 40 mg Nucala given under the skin produced comparable levels of active substance in the body to those seen with standard doses in adults.
Opravili so tudi dodatno študijo pri otrocih, starih od 6 do 11 let, ki je pokazala, da je 40-miligramski odmerek zdravila Nucala pri injiciranju v podkožje dosegel primerljive ravni učinkovine v telesu s tistimi, ki so jih opazili pri standardnih odmerkih pri odraslih.
In eosinophilic asthma, symptoms are associated with having too many eosinophils (a type of white blood cell) in the blood and in phlegm in the lungs.
Simptomi pri eozinofilni astmi so povezani s prevelikim številom eozinofilcev (določene vrste belih krvnih celic) v krvi in pljučni sluzi.
By attaching to interleukin-5, mepolizumab blocks its action and thereby reduces the numbers of eosinophils.
Mepolizumab s pripojitvijo na interlevkin-5 zavre njegovo delovanje in tako zmanjša število eozinofilcev.
In adults the reduction seen in severe asthma attacks and consequent need for hospital treatment was considered important and outweighed the low risk of side effects.
Zmanjšanje napadov težke astme in posledično manjšo potrebo po bolnišničnem zdravljenju pri odraslih bolnikih so ocenili za pomembno in je odtehtalo majhno tveganje za neželene učinke.
The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection.
Koristi zdravila Nucala pri težki eozinofilni astmi, ki ni bila dobro nadzorovana s prejšnjimi zdravili, so se pokazale v treh glavnih študijah, v katerih so zdravilo primerjali z injiciranjem placeba (zdravila brez učinkovine).
The patient and carer can use Nucala prefilled pen or syringe themselves once they have been trained, whereas the vial is only for use by a healthcare professional.
Bolnik in njegov skrbnik lahko napolnjeni peresnik ali injekcijsko brizgo zdravila Nucala uporabljata samostojno, potem ko sta opravila ustrezno usposabljanje, medtem ko lahko vialo uporabljajo le zdravstveni delavci.
Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called eosinophilic asthma.
Zdravilo Nucala je zdravilo za astmo, ki se uporablja za zdravljenje bolnikov, starih šest let ali več, s posebno vrsto astme, imenovano eozinofilna astma.
The medicine is given by injection under the skin of the upper arm, thigh or abdomen (belly) once every 4 weeks.
Zdravilo se daje z injiciranjem v podkožje nadlakti, stegna ali trebuha vsake štiri tedne.
The first study involved 616 adults and adolescents given Nucala every 4 weeks for a year, in addition to their regular asthma medicines.
V prvo študijo je bilo vključenih 616 odraslih in mladostnikov, ki so poleg svojih običajnih zdravil za astmo eno leto prejemali zdravilo Nucala enkrat na štiri tedne.
For the full list of side effects and restrictions with Nucala, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nucala glejte navodilo za uporabo.
Nucala is available as a solution in a prefilled pen or syringe or as a powder that comes in a vial and is made up into an injection.
Zdravilo Nucala je na voljo v obliki raztopine v napolnjenem peresniku ali injekcijski brizgi ali praška v viali za pripravo raztopine za injiciranje.
How does Nucala work?
Kako zdravilo Nucala deluje?
Nucala can only be obtained with a prescription and should be prescribed by a doctor experienced in identifying and treating severe eosinophilic asthma.
Predpisovanje in izdaja zdravila Nucala je le na recept, predpiše pa ga lahko le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem težke eozinofilne astme.
How is Nucala used?
Kako se zdravilo Nucala uporablja?
The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids (potent anti-inflammatory medicines such as prednisone and prednisolone), and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo.
V tretjo študijo je bilo vključenih 135 bolnikov z dovolj težko eozinofilno astmo, da je bilo potrebno redno peroralno zdravljenje s kortikosteroidi (močnimi protivnetnimi zdravili, kot sta prednizon in prednizolon).
Reactions at the site of injection and back pain are common, affecting up to 1 patient in 10.
Pogosti neželeni učinki, ki se lahko pojavijo pri največ 1 od 10 bolnikov, so reakcije na mestu injiciranja in bolečine v hrbtu.
Nucala contains the active substance mepolizumab.
Vsebuje učinkovino mepolizumab.
This summary was last updated in September 2007.
Ta povzetek je bil nazadnje posodobljen 09-2007.
In very rare cases depression may develop.
V zelo redkih primerih se lahko razvije depresija.
Horses from four months of age should receive a second injection after four weeks.
Konji, starejši od štirih tednov, morajo prejeti drugo injekcijo po štirih tednih.
All horses should be revaccinated every three months to maintain immunity.
Za vzdrževanje imunosti je treba vse konje ponovno cepiti vsake tri mesece.
The effectiveness of Equilis StrepE has been studied in safety studies and one main field study.
Učinkovitost zdravila Equilis StrepE so preučevali v študijah varnosti zdravila in v eni večji terenski študiji.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUILIS StrepE EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) EQUILIS StrepE Povzetek EPAR za javnost
Other information about Equilis StrepE:
Druge informacije o zdravilu Equilis StrepE:
The vaccine is given as a 0.2-ml injection into the inside of the upper lip.
Cepivo se daje z 0,2 ml injekcijo v notranjo stran zgornje ustnice.
The horses had not had any disease including strangles in the past and had never been vaccinated.
Konji niso v preteklosti imeli nobene bolezni, niti smolike, in niso bili nikoli cepljeni.
An increase in body temperature of up to 2°C may occur on the day of vaccination.
Na dan cepljenja se lahko telesna temperatura poveča za največ 2 °C.
No adjuvant or preservative is included.
Ne vsebuje adjuvansov ali sredstev za konzerviranje.
The highly contagious and common disease caused by this bacterium is commonly called ‘strangles'.
Visoko nalezljiva in pogosta bolezen, ki jo povzroča ta bakterija, je običajno znana pod imenom „smolika“.
Equilis StrepE is a vaccine.
Zdravilo Equilis StrepE je cepivo.
This is the first vaccine to be licensed for horses in the EU against strangles.
To je prvo cepivo za konje, ki je v Evropski uniji odobreno proti smoliki.
In case of accidental self-injection, which can cause inflammation with severe pain and swelling, seek medical advice immediately and show the Package Leaflet or the label to the doctor, even if only a small amount has been injected.
V primeru nenamernega samoinjiciranja, ki lahko povzroči vnetje s hudo bolečino in oteklino, nemudoma poiščite medicinsko pomoč in pokažite zdravniku Navodilo za uporabo ali nalepko, tudi če je bila injicirana zelo majhna količina.
In rare cases, loss of appetite, fever and shivering may be observed.
V redkih primerih se lahko pojavijo izguba apetita, vročina in tresavica.
After injection, swelling will develop at the injection site within four hours and the injection site may become warm or painful.
V štirih urah po injekciji se bo na mestu injiciranja pojavila oteklina, mesto injiciranja pa lahko postane toplo ali boleče.
This is a highly contagious disease and a common bacterial infection in horses.
Gre za visoko nalezljivo in pogosto bakterijsko okužbo pri konjih.
When a horse is given the vaccine, the immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Ko konj prejme cepivo, imunski sistem prepozna bakterije kot „tujke“ in proti njim razvije protitelesa.
The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse's body and is less likely to cause disease.
Sevu bakterije, ki ga vsebuje zdravilo Equilis StrepE, so bili odstranjeni nekateri geni, zato v telesu konja slabše raste in obstaja manjša verjetnost, da bi povzročil bolezen.
The vaccine is provided together with the solvent, applicator and a syringe with needle.
Cepivu so priloženi vehikel, aplikator in brizga z iglo.
The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B.V. on 7 May 2004.
Evropska komisija je dovoljenje za promet z zdravilom Equilis StrepE, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection.
Zdravilo Equilis StrepE je na voljo kot liofilizat (peleta, posušena v zmrznjenem stanju) za pripravo suspenzije za injiciranje.
Equilis StrepE is only for use in healthy horses that are at risk of S. equi infection due to contact with horses from areas where the bacterium is known to be present.
Zdravilo Equilis StrepE je namenjeno samo za uporabo pri zdravih konjih, pri katerih obstaja tveganje za okužbo s S. equi zaradi stika s konji z območij, na katerih je bakterija prisotna.
as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable.
mesecev, saj so bile reakcije na mestu injiciranja in reakcije telesa, ugotovljene po enkratnem in večkratnem cepljenju ter cepljenju s prevelikim odmerkom, ocenjene kot sprejemljive.
In strangles, the lymph nodes in the head can become large enough to block the airway, causing the horse to have difficulty breathing.
Pri smoliki se lahko bezgavke v glavi tako povečajo, da blokirajo dihalno pot, konj pa ima zaradi tega težave z dihanjem.
The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Študije so pokazale, da je zdravilo Equilis StrepE učinkovito pri aktivni imunizaciji konj, starejših od 4 mesecev, proti Streptococcus equi za zmanjšanje kliničnih znakov in nastanka abscesov na bezgavkah.
The results of the safety trials demonstrate that Equilis StrepE is safe for horses from four months of age onwards,
Rezultati študij varnosti zdravila so pokazali, da je Equilis StrepE varen za uporabo pri konjih, starejših od štirih
Equilis StrepE contains small amounts of a type of bacterium called S. equi.
Zdravilo Equilis StrepE vsebuje majhne količine bakterije vrste S. equi.
Only healthy horses which are at risk of infection should be vaccinated.
Cepivo je namenjeno samo zdravim konjem, pri katerih obstaja tveganje za pojav okužbe.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the bacteria.
Ko bo imunski sistem naslednjič izpostavljen bakterijam, bo lahko hitreje izdelal protitelesa.