FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Tysabri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tysabri preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Treatment with Tysabri should be started and continuously supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner.
Slovenian: Zdravljenje z zdravilom Tysabri mora uvesti in stalno nadzorovati zdravnik, ki ima izkušnje z zdravljenjem nevroloških bolezni in ki ima na voljo napravo za magnetnoresonančno slikanje (MRI).
English: Why is Tysabri approved?
Slovenian: Zakaj je bilo zdravilo Tysabri odobreno?
English: It is not intended to provide practical advice on how to use Tysabri.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For practical information about using Tysabri, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Tysabri naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Tysabri, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tysabri, glejte navodilo za uporabo.
English: Studies have shown that Tysabri is effective in treating relapsing-remitting MS.
Slovenian: Študije so pokazale, da je zdravilo Tysabri učinkovito pri zdravljenju recidivno-remitentne multiple skleroze.
English: Tysabri can increase the risk of infections, including the brain infection PML.
Slovenian: Zdravilo Tysabri lahko poveča tveganje za okužbe, vključno z okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML).
English: It contains the active substance natalizumab.
Slovenian: Vsebuje zdravilno učinkovino natalizumab.
English: By attaching to integrin, natalizumab is thought to stop white blood cells from going from the blood to the brain tissue, thereby reducing inflammation and nerve damage caused by MS.
Slovenian: Domneva se, da natalizumab z vezavo na integrin belim krvnim celicam prepreči prehod iz krvi v možgane in s tem zmanjša vnetje in okvaro živcev, ki ju povzroča multipla skleroza.
English: The risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than two years.
Slovenian: Čim dlje bolnik prejema zdravilo Tysabri, tem večje je tveganje za PML, zlasti pri bolnikih, ki se zdravijo več kot dve leti.
English: Tysabri is used in the type of MS known as ‘relapsing-remitting' MS, when the patient has attacks (relapses) in between periods with no symptoms (remissions).
Slovenian: Zdravilo Tysabri se uporablja pri vrsti multiple skleroze, znani kot recidivno-remitentna multipla skleroza, pri kateri ima bolnik napade (recidive), ki jim sledijo obdobja brez simptomov (remisije).
English: How does Tysabri work?
Slovenian: Kako zdravilo Tysabri deluje?
English: How is Tysabri used?
Slovenian: Kako se zdravilo Tysabri uporablja?
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojni organi držav članic lahko v nadaljevanju posodobijo informacije o zdravilu v povezavi z referenčno državo članico, kot je ustrezno, v skladu s postopki iz poglavja 4 naslova III Direktive 2001/83/ES.
English: The wording should be added to or replace existing text as appropriate for each product.
Slovenian: Besedilo je treba dodati ali obstoječe besedilo zamenjati, kot je ustrezno za vsako zdravilo.
English: • Section 4.8 Undesirable effects
Slovenian: • Poglavje 4.8, Neželeni učinki
English: • Section 4.4 Special warnings and precautions for use Pneumonia in patients with COPD
Slovenian: • Poglavje 4.4, Posebna opozorila in previdnostni ukrepi Pljučnica pri bolnikih z KOPB
English: • increased cough or increased breathing difficulties
Slovenian: • močnejši kašelj ali več težav z dihanjem.
English: If the current SmPC or package leaflet includes corresponding information in any other sections, it should be deleted in order to avoid repeated or contradictory information.
Slovenian: Če trenutni povzetek glavnih značilnosti zdravila vključuje ustrezne informacije v katerem koli drugem poglavju, je slednje treba izbrisati, da bi preprečili ponavljanje ali nasprotujoče si informacije.
English: Annex III Amendments to relevant sections of the product information
Slovenian: Priloga III Spremembe relevantnih delov informacij o zdravilu
English: • Section 4: Possible side effects
Slovenian: • Poglavje 4: Možni neželeni učinki
English: • increased mucus production, change in mucus colour
Slovenian: • obilnejše nastajanje sluzi, spremenjeno barvo sluzi,
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Slovenian: Te spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so izid postopka arbitraže.
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while taking <active substance> they could be symptoms of a lung infection:
Slovenian: Pljučnica (okužba pljuč) pri bolnikih s KOPB (pogost neželen učinek) Svojemu zdravniku morate povedati, če imate med jemanjem <zdravilna učinkovina> kar koli od naštetega, ker so to lahko simptomi okužbe pljuč:
English: Tabulated list of adverse reactions “Pneumonia (in COPD patients)” to be listed as “Common” adverse drug reaction in the “Infections and infestations” SOC.
Slovenian: Seznam neželenih učinkov v preglednici "Pljučnica (pri bolnikih s KOPB)" mora biti navedena kot "pogost" neželen učinek pri organskem sistemu "Infekcijske in parazitske bolezni".
English: The following information should be implemented in the product information of inhaled corticosteroids with a COPD indication.
Slovenian: Za inhalacijske kortikosteroide, ki imajo kot indikacijo KOPB, je treba v informacije o zdravilu vključiti naslednje informacije.
English: • fever or chills
Slovenian: • zvišano telesno temperaturo ali mrzlico,
English: 1 pre-filled pen
Slovenian: 1 napolnjen injekcijski peresnik
English: Immediate Packaging
Slovenian: Stična ovojnina Vsebina Velikost pakiranja
English: 31 July 2015
Slovenian: 31. julija 2015
English: December 2016 CMDh meeting
Slovenian: Zasedanje skupine CMDh decembra 2016
English: 29 March 2017
Slovenian: 29. marec 2017
English: 28 January 2017
Slovenian: 28. januar 2017
English: Annex III Timetable for the implementation of this position
Slovenian: Priloga III Časovnica za uveljavitev tega stališča
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint survey drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0005), complies with their obligation to conduct a database drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products.
Slovenian: Končno poročilo študije skupne zbirke podatkov o uporabi zdravila, ki so jo predložili imetniki dovoljenj za promet, skupaj s končnim poročilom skupne študije o uporabi zdravila, ki so jo predložili imetniki dovoljenj za promet v ločenem postopku (EMEA/H/N/PSR/J/0005), je v skladu z obveznostjo izvajanja študije zbirke podatkov o uporabi zdravila za ugotavljanje značilnosti predpisovalnih praks zdravila v okviru običajne in klinične uporabe pri reprezentativnih skupinah predpisovalcev in za ocenitev glavnih razlogov za predpisovanje, naloženih v okviru postopka člena 107i EMA/H/A-107i/1357 za zdravila, ki vsebujejo ciproteron/etinilestradiol.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Slovenian: Skupina CMDh je sprejela stališče, da je potrebna sprememba dovoljenja (dovoljenj) za promet z zdravili, ki jih zadeva končno poročilo PASS.
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0005), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Slovenian: Zato na podlagi razpoložljivih podatkov glede končnega poročila študije skupne zbirke podatkov o uporabi zdravila, skupaj s končnim poročilom študije skupne zbirke podatkov o uporabi zdravila, predložene v okviru ločenega postopka (EMEA/H/N/PSR/J/0005), odbor PRAC meni, da so potrebne spremembe pogojev dovoljenj za promet z zdravili.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov rezultatov študije za zdravila, ki vsebujejo ciproteron/etinilestradiol in jih zadeva končno poročilo PASS, skupina CMDh meni, da je razmerje med koristjo in tveganjem zgoraj navedenih zdravil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Slovenian: Priloga I Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the scientific conclusions are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) za končno poročilo o naloženi neintervencijski študiji o varnosti v obdobju trženja (PASS) za zdravila, ki vsebujejo ciproteron/etinilestradiol in jih zadeva končno poročilo PASS, so bili sprejeti naslednji znanstveni zaključki:
English: Grounds for the variation to the terms of the Marketing Authorisation(s)
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance cyproterone/ethinylestradiol concerned by the non-interventional imposed PASS final report The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Slovenian: Imetniki dovoljenj za promet bodo izbrisali naslednji(-e) pogoj(-e) (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo je prečrtano)
English: This summary was last updated in: 04-2013.
Slovenian: Povzetek je bil nazadnje posodobljen dne 04-2013.
English: It is available as triangular chewable tablets, in five different strengths (6, 20, 30, 75 and 95 mg).
Slovenian: Na voljo je v obliki trikotnih žvečljivih tablet v petih različnih jakostih (6, 20, 30, 75 in 95 mg).
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Slovenian: Če želite več informacij, ki temeljijo na priporočilih CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR)..
English: Wash hands after handling the medicine.
Slovenian: Po uporabi zdravila si umijte roke.
English: It is used when continuous treatment for more than one month is needed.
Slovenian: Uporablja se , kadar je potrebno neprekinjeno zdravljenje, daljše od enega meseca.
English: It works by blocking an enzyme called cyclo oxygenase 2 (COX 2).
Slovenian: Deluje tako, da zavira encim, imenovan ciklo-oksigenaza-2 (COX-2).
English: Trocoxil is given at a dose of 2 mg per kilogram body weight, immediately before or with the dog's main meal.
Slovenian: Zdravilo Trocoxil se daje v odmerku 2 mg na kilogram telesne mase, neposredno pred ali skupaj z glavnim obrokom psa.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Trocoxil on 09/09/2008.
Slovenian: Evropska Komisija je dovoljenje za promet z zdravilom Trocoxil, veljavno po vsej Evropski uniji, odobrila dne 9. september 2008.
English: Compliance to treatment was better with Trocoxil, possibly because it is given once a month rather than every day.
Slovenian: Upoštevanje načina zdravljenja je bilo pri zdravljenju z zdravilom Trocoxil večje, verjetno zato, ker se zdravilo daje le enkrat mesečno in ne vsak dan.
English: Other information about Trocoxil:
Slovenian: Druge informacije o zdravilu Trocoxil :
English: Dogs of both sexes and various breeds were included in the study.
Slovenian: V študijo so bili vključeni psi obeh spolov in različnih pasem.
English: Trocoxil has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“clinical studies”).
Slovenian: Zdravilo Trocoxil je bilo raziskano na laboratorijskih živalih in psih, ki so bili zdravljeni v različnih veterinarskih ambulantah in klinikah po Evropi („klinične študije“).
English: The dose and duration of treatment (maximum 6.5 months) will depend on the weight and type of animal and condition to be treated.
Slovenian: Odmerjanje in trajanje zdravljenja (največ 6,5 meseca) je odvisno od telesne mase in vrste živali ter bolezenskega stanja, ki zahteva zdravljenje.
English: There should be a gap of two weeks between the first and second doses, after which it is given once a month.
Slovenian: Med prvim in drugim odmerkom zdravila morata preteči vsaj dva tedna, nato pa se zdravilo daje enkrat na mesec.
English: The medicine was compared with carprofen (another NSAID) for up to 6.5 months and long term effects of treatment were also studied.
Slovenian: Zdravilo so 6,5 meseca primerjali s karprofenom (drugim nesteroidnim protivnetnim zdravilom), preučevali pa so se tudi dolgoročni učinki zdravljenja.
English: The product was shown to be comparable to the reference product (carprofen).
Slovenian: Rezultati so pokazali, da je zdravilo primerljivo z referenčnim zdravilom (karprofen).
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Slovenian: Ta encim sodeluje pri proizvodnji snovi, imenovanih prostaglandini, ki sodelujejo pri bolečinah in vnetjih.
English: Do not eat, drink, or smoke when handling Trocoxil.
Slovenian: Med rokovanjem z zdravilom Trocoxil ne jejte, pijte ali kadite.
English: People with a known allergy to NSAIDs should avoid contact with Trocoxil.
Slovenian: Osebe s potrjeno alergijo na nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom Trocoxil.
English: What benefit has Trocoxil shown during the studies?
Slovenian: Kakšne koristi je zdravilo Trocoxil izkazalo med študijami?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trocoxil exceed the risks for the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated, and recommended that Trocoxil be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Trocoxil pri zdravljenju bolečin in vnetij, povezanih z degenerativnim obolenjem sklepov pri psih, kadar je indicirano neprekinjeno zdravljenje, daljše od enega meseca, večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Trocoxil odobri dovoljenje za promet.
English: To avoid accidental ingestion, give the tablet to the dog immediately after it is removed from the blister packaging.
Slovenian: Da se izognete možnosti nenamernega zaužitja, dajte tableto psu takoj, ko jo odstranite iz pretisnega omota.
English: If a dog experiences these side effects, treatment should be stopped and general supportive therapy should be given as appropriate for NSAID overdose.
Slovenian: Če se pri psu pojavijo ti neželeni učinki, je treba zdravljenje prekiniti in pričeti splošno podporno zdravljenje, kot je primerno pri prevelikem odmerjanju nesteroidnih protivnetnih zdravil.
English: Ingestion of Trocoxil may be harmful for children.
Slovenian: Zaužitje zdravila Trocoxil lahko škoduje otrokom.
English: The side effects of Trocoxil are similar to those seen with other medicines in this product class (NSAIDs) and include loss of appetite, soft faeces/diarrhoea, vomiting, apathy (lack of interest in surroundings) and signs of kidney problems.
Slovenian: Neželeni učinki zdravila Trocoxil so podobni neželenim učinkom, opaženim pri zdravljenju z drugimi zdravili iz te skupine zdravil (nesteroidnih protivnetnih zdravil), in vključujejo izgubo teka, mehko blato/drisko, bruhanje, apatijo (pomanjkanje zanimanja za okolico) in znake težav z ledvicami.
English: It must not be used with glucocorticosteroids or other NSAIDs.
Slovenian: Ne sme se uporabljati skupaj z glukokortikosteroidi ali drugimi nesteroidnimi protivnetnimi zdravili.
English: Trocoxil is used for the treatment of pain and inflammation associated with degenerative joint disease (disease involving damage to the joints, such as osteoarthritis) in dogs at least one year of age.
Slovenian: Zdravilo Trocoxil se uporablja za zdravljenje bolečine in vnetij, povezanih z degenerativnim obolenjem sklepov (boleznijo, ki vključuje poškodbe sklepov, kot je osteoartritis) pri psih, starih vsaj eno leto.
English: Administration of the product in accordance with the recommended monthly dosing schedule for a period of up to 6.5 months resulted in an improvement in lameness and quality of life in dogs with established osteoarthritis, as assessed by the dogs' owners.
Slovenian: Uporaba zdravila v skladu s priporočenim načrtom mesečnega odmerjanja za obdobje do 6,5 meseca je po ocenah lastnikov psov pokazala izboljšanje hromosti in kakovosti življenja pri psih, obolelih z osteoartritisom.
English: It must also not be used in dogs that are hypersensitive (allergic) to mavacoxib, any of the other ingredients in the tablet or sulphonamides.
Slovenian: Prav tako se ne sme uporabljati pri psih, ki so preobčutljivi za (alergični na) mavakoksib ali katero koli drugo sestavino zdravila ali sulfonamide.
English: The results showed an improvement in lameness score in dogs with established osteoarthritis.
Slovenian: Rezultati so pokazali izboljšanje rezultatov hromosti pri psih, obolelih z osteoartritisom.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Trocoxil chewable tablets for dogs were studied in one main study in dogs with osteoarthritis.
Slovenian: Žvečljive tablete Trocoxil so bile raziskane v eni glavni študiji, ki je vključevala pse z osteoartritisom.
English: The active substance in Trocoxil, mavacoxib, belongs to a class of medicines called non steroidal antiinflammatory drugs (NSAIDs).
Slovenian: Zdravilna učinkovina v zdravilu Trocoxil, mavakoksib, spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
English: It must not be used in dogs with kidney or liver problems, or inadequate blood flow to the heart muscle, or in dogs that are pregnant, breeding or lactating.
Slovenian: Ne sme se uporabljati pri psih z motnjami v delovanju ledvic ali jeter ali neustreznim pretokom krvi v srčno mišico ali pri brejih psih, tistih, ki so namenjeni za razplod ali so v obdobju laktacije.
English: Why has Trocoxil been approved?
Slovenian: Zakaj je bilo zdravilo Trocoxil odobreno?
English: Trocoxil tablets for dogs improved pain relief and inflammation.
Slovenian: Tablete Trocoxil za pse so izboljšale lajšanje bolečine in vnetja.
English: By blocking the production of prostaglandins, Trocoxil reduces the pain and inflammation caused by damage to the joints.
Slovenian: Zdravilo Trocoxil z zaviranjem proizvodnje prostaglandinov zmanjšuje bolečino in vnetje, ki ju povzročajo poškodbe sklepov.
English: Trocoxil contains the active substance mavacoxib, which belongs to a class of medicines with anti inflammatory action.
Slovenian: Zdravilo Trocoxil vsebuje zdravilno učinkovino mavakoksib, ki spada v skupino zdravil s protivnetnim delovanjem.
English: For details, please see the Package Leaflet.
Slovenian: Za podrobnejše informacije glejte navodilo za uporabo.
English: Mavacoxib
Slovenian: Mavakoksib
English: What is Trocoxil used for?
Slovenian: Za kaj se zdravilo Trocoxil uporablja?
English: How has Trocoxil been studied?
Slovenian: Kako je bilo zdravilo Trocoxil raziskano?
English: What is Trocoxil?
Slovenian: Kaj je zdravilo Trocoxil?
English: How does Trocoxil work?
Slovenian: Kako zdravilo Trocoxil deluje?
English: It must not be used in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems.
Slovenian: Zdravilo Trocoxil se ne sme uporabljati pri psih, starih manj kot eno leto ali lažjih od 5 kg. Ne sme se uporabljati pri psih z motnjami v delovanju želodca ali črevesja, vključno z ulkusi in krvavitvami, ali pri psih, pri katerih se pojavljajo težave s krvavitvami.
English: What is the risk associated with Trocoxil?
Slovenian: Kakšni so neželeni učinki zdravila Trocoxil?
English: Content (concentration) Pack size
Slovenian: Pot uporabe Stična ovojnina Vsebina (koncentracija) Velikost pakiranja
English: Route of administration
Slovenian: Jakost
English: _ _ 1 25 mg rilpivirine (as hydrochloride) / 200 mg emtricitabine / 245 mg tenofovir disoproxil (as fumarate)
Slovenian: _ _ 1 25 mg rilpivirin (v obliki klorida) / 200 mg emtricitabin / 245 mg tenofovirdizoproksilat (v obliki fumarata)
English: (Invented) name
Slovenian: Številka EU Izmišljeno ime
English: 3 x 30 tablets
Slovenian: Filmsko obložena tableta Peroralna uporaba Plastenka (HDPE) 3 x 30 tablet
English: 30 tablets
Slovenian: Filmsko obložena tableta Peroralna uporaba Plastenka (HDPE) 30 tablet
English: 20 January 2011
Slovenian: 20. januar 2011
English: Two of the studies lasted 12 weeks, and two lasted 52 weeks.
Slovenian: Dve študiji sta trajali 12 tednov, dve pa 52 tednov.
English: What consequences does this withdrawal have for patients in clinical trials?
Slovenian: Kakšne so posledice tega umika za bolnike, ki sodelujejo v kliničnih preskušanjih?
English: The application was withdrawn before ‘day 120'.
Slovenian: Družba je vlogo umaknila pred 120. dnem postopka.
English: The company informed the CHMP that its current clinical trials will continue.
Slovenian: Družba je CHMP obvestila, da bo s kliničnimi študijami, ki jih trenutno izvaja, nadaljevala.
English: Briakinumab was designed to attach to a part of two ‘cytokines' (messenger molecules) in the immune system called interleukin-12 and interleukin-23.
Slovenian: Briakinumab se veže na del dveh „citokinov“ (sporočilnih molekul) v imunskem sistemu, imenovanih interlevkin-12 in interlevkin-23.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made the application?
Slovenian: Ker je CHMP ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.