FrancophonIA/ELRC3.0 huggingface dataset:
English: ProMeris Duo is available in five different sizes for various weights of dog.
Slovenian: Zdravilo ProMeris Duo je na voljo v petih različnih velikostih za različno težke pse.
English: ProMeris Duo should not enter surface water, as this may be harmful for fish and other aquatic organisms.
Slovenian: Zdravilo ProMeris Duo ne sme zaiti v površinske vode, ker je to lahko nevarno za ribe ali druge vodne organizme.
English: The effectiveness was measured looking at the clinical signs and the number of Demodex mites in skin scrapings taken every four weeks, for several weeks following monthly administration of the treatment.
Slovenian: Učinkovitost so merili s proučevanjem kliničnih znakov in števila garjavcev Demodex v vzorcih kože, ki so bili odvzeti vsake štiri tedne, nekaj tednov po mesečnem zdravljenju.
English: What benefit has ProMeris Duo shown during the studies?
Slovenian: Kakšne koristi je zdravilo ProMeris Duo izkazalo med študijami?
English: The medicine killed most fleas within 24 hours, most ticks within 48 hours and most lice within a week of treatment.
Slovenian: Zdravilo je uničilo večino bolh v 24 urah, večino klopov v 48 urah in večino uši teden po nanosu.
English: What is the risk associated with ProMeris Duo?
Slovenian: Kakšna tveganja so povezana z zdravilom ProMeris Duo?
English: Do not smoke, eat or drink when applying ProMeris Duo.
Slovenian: Med dajanjem zdravila ProMeris Duo ne kadite, pijte ali jejte.
English: As for other products in this group, ProMeris Duo should not be used in sick dogs, dogs that have just recovered from an illness or dogs that are suffering from heat stress.
Slovenian: Kot to velja za ostala zdravila iz te skupine zdravil, se zdravilo ProMeris Duo ne sme uporabljati pri bolnih živalih, psih, ki so pravkar okrevali, ali psih, ki so bili izpostavljeni vročinskemu stresu.
English: If a dog licks the application area, the dog might salivate considerably for a short period.
Slovenian: Če pes poliže mesto nanosa, se lahko pojavi kratko obdobje prekomernega slinjenja.
English: This means that it will kill parasites that live on or in the skin or in the fur of animals, such as fleas, ticks, lice and Demodex mites (mites that cause demodicosis or ‘mange').
Slovenian: To pomeni, da uničuje zajedavce, ki živijo na koži, v njej ali v dlaki živali, kot so denimo bolhe, klopi, uši in garjavci Demodex (iz rodu pršic, ki povzročajo demodikozo, kožno bolezen).
English: In very rare cases, temporary local hair loss may occur.
Slovenian: Zelo redko dlaka na tem mestu začasno izpade.
English: The effectiveness of ProMeris Duo against flea, lice and tick infestations and Demodex mites has been studied in a number of studies, including one study in dogs infested with fleas or ticks carried out at veterinary practices in Germany and France.
Slovenian: Učinkovitost zdravila ProMeris Duo proti bolham, ušem, klopom in garjavcem Demodex so raziskali v številnih študijah, tudi v študijo na psih z bolhami ali klopi, ki so jo izvedli v nemških in francoskih veterinarskih ambulantah.
English: Dogs were treated with ProMeris Duo or the combination of imidacloprid and moxidectin (another medicine authorised in the EU for this indication).
Slovenian: Psi so bili zdravljeni z zdravilom ProMeris Duo ali s kombinacijo imidaklopridina in moksidektina (drugega zdravila, ki je bilo v EU odobreno za to indikacijo).
English: A further study compared the effectiveness of ProMeris Duo with that of fipronil (another medicine for the treatment of lice).
Slovenian: V nadaljnji študiji so primerjali učinkovitost zdravila ProMeris Duo z učinkovitostjo fipronila (drugega zdravila za zatiranje uši).
English: Why has ProMeris Duo been approved?
Slovenian: Zakaj je bilo zdravilo ProMeris Duo odobreno?
English: The effectiveness of ProMeris Duo lasted for at least six weeks against fleas and for four weeks against ticks.
Slovenian: Učinek zdravila ProMeris Duo je trajal najmanj šest tednov pri zatiranju bolh in štiri tedne pri zatiranju klopov.
English: Dogs of various breeds, ages and weights were treated with ProMeris Duo or with other medicines authorised in the European Union (EU) for flea and tick infestation.
Slovenian: Psi različnih pasem, starosti in telesnih mas so bili zdravljeni z zdravilom ProMeris Duo ali drugimi zdravili, odobrenimi v Evropski uniji (EU) za zatiranje bolh in klopov.
English: The effectiveness was measured looking at the number of live ticks or number of fleas on the dogs up to two months after application.
Slovenian: Učinkovitost so merili s štetjem živih klopov ali bolh na psih do dveh mesecev po uporabi zdravila.
English: In rare cases, temporary irritation may occur at the site of application.
Slovenian: Redko se na mestu nanosa pojavi začasna razdraženost.
English: Avoid touching the skin with the pipette's contents.
Slovenian: Pazite, da vsebina kapalke ne pride v stik s kožo.
English: ProMeris Duo is used in dogs over eight weeks of age to treat and to prevent tick and flea infestations, and to treat demodicosis (caused by Demodex mites) and lice infestations.
Slovenian: Zdravilo ProMeris Duo se uporablja pri psih, starejših od osem tednov, za zatiranje klopov in bolh in preprečevanje njihovega pojava ter za zdravljenje demodikoze (ki jo povzročajo garjavci Demodex) in ušivosti.
English: Both active substances in ProMeris Duo, metaflumizone and amitraz, interfere with the neural activity of the parasites and consequently lead to their death.
Slovenian: Zdravilni učinkovini v zdravilu ProMeris Duo, metaflumizon in amitraz, ovirata živčne funkcije zajedavcev, kar povzroča njihovo uničenje.
English: ProMeris Duo is a clear, yellow-to-amber solution that contains metaflumizone and amitraz as active substances.
Slovenian: Zdravilo ProMeris Duo je bistra, rumenojantarna raztopina, ki vsebuje zdravilni učinkovini metaflumizon in amitraz.
English: The effectiveness was measured by looking at the number of lice on the dogs after treatment.
Slovenian: Učinkovitost je bila merjena s štetjem uši na psih po zdravljenju.
English: There may also be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Slovenian: Na mestu nanosa se lahko pojavijo spremembe dlake (masten videz, vozlanje in zlepljenje dlake).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris Duo exceed the risks for the treatment and prevention of flea and tick infestations, and the treatment of demodicosis and lice infestation in dogs.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila ProMeris Duo za zatiranje bolh in klopov in preprečevanje njihovega pojava pri psih ter za zdravljenje demodikoze in ušivosti večje od z njim povezanih tveganj.
English: The results of the studies showed that ProMeris Duo is effective in the treatment and prevention of flea and tick infestations, and in the treatment of demodicosis and lice infestation in dogs.
Slovenian: Rezultati študij so pokazali, da je zdravilo ProMeris Duo učinkovito pri zatiranju bolh in klopov in preprečevanju njihovega pojava pri psih ter pri zdravljenju demodikoze in ušivosti pri psih.
English: What is ProMeris Duo used for?
Slovenian: Za kaj se zdravilo ProMeris Duo uporablja?
English: The contents of the pipette are squeezed onto the skin after parting the fur at the back of the head.
Slovenian: Psu razmaknemo dlako na zadnji strani glave, da se prikaže koža, na katero stisnemo vsebino merilne kapalke.
English: What is ProMeris Duo?
Slovenian: Kaj je zdravilo ProMeris Duo?
English: How has ProMeris Duo been studied?
Slovenian: Kako je bilo zdravilo ProMeris Duo raziskano?
English: Wash the skin and rinse eyes with water, if accidental exposure occurs.
Slovenian: Če zdravilo po nesreči pride v stik s kožo ali z očmi, jih dobro sperite z vodo.
English: How does ProMeris Duo work?
Slovenian: Kako zdravilo ProMeris Duo deluje?
English: This summary was last updated in 05-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2009.
English: The recommended dose is one tablet once a day.
Slovenian: Priporočeni odmerek je ena tableta enkrat dnevno.
English: Ref.: EMEA/280173/2009 EMEA/H/C/1016
Slovenian: : EMEA/485921/2009 EMEA/H/C/1016
English: It is available as brown tablets (250 mg).
Slovenian: Na voljo je v obliki rjavih tablet (250 mg).
English: The main measure of effectiveness was survival (how long the patients lived).
Slovenian: Glavno merilo učinkovitosti je bilo preživetje (kako dolgo je bolnik živel).
English: Iressa gefitinib EPAR summary for the public
Slovenian: Iressa gefitinib Povzetek EPAR za javnost
English: The main measure of effectiveness was how long the patients lived without the disease getting worse.
Slovenian: Glavno merilo učinkovitosti je bilo, kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala.
English: Other information about Iressa:
Slovenian: Druge informacije o zdravilu Iressa:
English: The effects of Iressa were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Iressa so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iressa to AstraZeneca AB on 24 June 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Iressa, veljavno po vsej Evropski uniji, odobrila družbi AstraZeneca AB dne 24. junija 2009.
English: The Committee recommended that Iressa be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Iressa odobri dovoljenje za promet.
English: Treatment with Iressa should be started and supervised by a doctor who has experience with anticancer treatments.
Slovenian: Zdravljenje z zdravilom Iressa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: It must not be used in mothers who are breastfeeding.
Slovenian: Zdravila ne smejo uporabljati doječe matere.
English: What benefit has Iressa shown during the studies?
Slovenian: Kakšne koristi je zdravilo Iressa izkazalo med študijami?
English: The most common side effects with Iressa (seen in more than 1 patient in 10) are loss of appetite, diarrhoea, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), increased level of alanine aminotransferase (a liver enzyme) in the blood, skin reactions such as pustular rash, and asthenia (weakness).
Slovenian: Najpogostejši neželeni učinki zdravila Iressa (opaženi pri več kot 1 bolniku izmed 10) so izguba apetita, driska, bruhanje, navzea (slabost), stomatitis (vnetje ustne sluznice), povišane koncentracije alanin aminotransferaze (jetrnega encima) v krvi, kožne reakcije, kot je pustulozen izpuščaj, in astenija (šibkost).
English: Among patients with the EGFR mutation, those who took Iressa lived for an average of nine and a half months without the disease getting worse, compared with about six months for those who took the combination therapy.
Slovenian: Bolniki z mutacijo receptorja za epidermalni rastni dejavnik, ki so jemali zdravilo Iressa, so v povprečju živeli devet in pol mesecev brez poslabšanja stanja bolezni, v primerjavi s šestimi meseci pri tistih, ki so jemali kombinacijsko terapijo.
English: This means that it blocks specific enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira določene encime, ki jim pravimo tirozin kinaze.
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Slovenian: Uporablja se pri bolnikih, katerih rakave celice imajo mutacijo v genih, ki vsebujejo zapis za beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR).
English: Iressa should not be used in people who may be hypersensitive (allergic) to gefitinib or any of the other ingredients.
Slovenian: Zdravila Iressa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) gefitinib ali katerokoli drugo sestavino zdravila.
English: What is the risk associated with Iressa?
Slovenian: Kakšna tveganja so povezana z zdravilom Iressa?
English: The active substance in Iressa, gefitinib, is a protein tyrosine kinase inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Iressa, gefitinib, je zaviralec protein tirozin kinaze.
English: In the first main study, Iressa was more effective at preventing the cancer from worsening than the combination.
Slovenian: V prvi glavni študiji je bilo zdravilo Iressa pri preprečevanju poslabšanja rakavega obolenja učinkovitejše od kombinacije dveh zdravil.
English: For the full list of all side effects reported with Iressa, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Iressa, glejte navodilo za uporabo.
English: Iressa is a medicine that contains the active substance gefitinib.
Slovenian: Iressa je zdravilo, ki vsebuje zdravilno učinkovino gefitinib.
English: Why has Iressa been approved?
Slovenian: Zakaj je bilo zdravilo Iressa odobreno?
English: Iressa is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Slovenian: Zdravilo Iressa se uporablja za zdravljenje odraslih z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom (pri katerem se celice raka širijo iz izvornega mesta v druge dele telesa).
English: The tablet can be dispersed in water for patients who have difficulty swallowing.
Slovenian: Bolniki, ki imajo težave s požiranjem, lahko tableto raztopijo v vodi.
English: In the second main study, patient survival among all patients who took Iressa was similar to those who took docetaxel.
Slovenian: V drugi glavni študiji je bilo preživetje v obeh skupinah bolnikov, ki so jemali zdravilo Iressa, podobno tistemu pri bolnikih, ki so jemali docetaksel.
English: EGFR is involved in the growth and spread of cancer cells.
Slovenian: Receptor za epidermalni rastni dejavnik sodeluje pri rasti in širjenju rakavih celic.
English: In a second main study involving 1,466 patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with docetaxel (another anticancer medicine).
Slovenian: V drugi glavni študiji, ki je vključevala 1 466 bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, so zdravilo Iressa primerjali z zdravilom docetaksel (drugim zdravilom proti raku).
English: In one main study involving 1,217 adult patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with a combination of carboplatin and paclitaxel (other anticancer medicines).
Slovenian: V eni glavni študiji, ki je vključevala 1 217 odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, so zdravilo Iressa primerjali s kombinacijo karboplatina in paklitaksela (drugima zdraviloma proti raku).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Iressa's benefits are greater than its risks for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Iressa pri zdravljenju odraslih z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom z aktivacijsko mutacijo receptorja za epidermalni rastni dejavnik, večje od z njim povezanih tveganj.
English: These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Slovenian: Ker se ti encimi se nahajajo na površini rakavih celic, se tudi receptor za epidermalni rastni dejavnik nahaja na površini celic nedrobnoceličnega pljučnega raka.
English: The full EPAR for Iressa can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Iressa je na voljo tukaj.
English: There is also a risk of interstitial lung disease in patients taking Iressa.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Iressa, obstaja tudi tveganje za intersticijsko pljučno bolezen.
English: By blocking EGFR, Iressa helps to slow down the growth and spread of the cancer.
Slovenian: Zdravilo Iressa z zaviranjem receptorja za epidermalni rastni dejavnik pomaga upočasniti rast in širjenje raka.
English: Both studies included patients with and without the EGFR mutation.
Slovenian: Obe študiji sta vključevali bolnike z mutacijo receptorja za epidermalni rastni dejavnik in tiste brez mutacije.
English: What is Iressa used for?
Slovenian: Za kaj se zdravilo Iressa uporablja?
English: How does Iressa work?
Slovenian: Kako zdravilo Iressa deluje?
English: Iressa works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Slovenian: Zdravilo Iressa deluje samo na celice nedrobnoceličnega pljučnega raka, ki imajo mutacijo receptorja za epidermalni rastni dejavnik.
English: What is Iressa?
Slovenian: Kaj je zdravilo Iressa?
English: How has Iressa been studied?
Slovenian: Kako je bilo zdravilo Iressa raziskano?
English: How is Iressa used?
Slovenian: Kako se zdravilo Iressa uporablja?
English: 1 August 2017 EMA/443893/2017
Slovenian: 1. avgust 2017 EMA/443893/2017
English: Most cases of allergic reactions occurred in patients under 12 years of age.
Slovenian: Alergijske reakcije so se večinoma pojavile pri bolnikih, mlajših od 12 let.
English: • If you have any questions or concerns, speak with your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom ali farmacevtom.
English: The above recommendations are based on analyses of spontaneous reports of suspected adverse effects and a review of published literature.
Slovenian: Zgornja priporočila temeljijo na analizah spontanih poročil o domnevnih neželenih učinkih in pregledu objavljene literature.
English: On 31 July 2017 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Slovenian: Skupina CMDh je 31. julija 2017 soglasno sprejela svoje stališče, zato bodo morale države članice, v katerih so zdravila odobrena, v skladu z dogovorjeno časovnico neposredno izvajati ukrepe, ki jih je priporočil odbor PRAC.
English: The review of injectable medicines for acute allergic reaction that contain lactose from cows' milk was initiated on 1 December 2016 at the request of Croatia, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil v obliki injekcije za akutne alergijske reakcije, ki vsebujejo laktozo iz kravjega mleka, se je začel 1. decembra 2016 na zahtevo Hrvaške, v skladu s členom 31 Direktive 2001/83/ES.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in podal več priporočil.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position.
Slovenian: Priporočila odbora PRAC so bila poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela stališče.
English: This may lead to additional doses being given which will further worsen the patient's condition.
Slovenian: To bi lahko privedlo do tega, da bi bolnik prejel dodatne odmerke, kar bi njegovo stanje še poslabšalo.
English: This is of particular concern in patients already being treated for an allergic reaction as they are more prone to developing new allergic reactions.
Slovenian: To je zlasti zaskrbljujoče pri bolnikih, ki se že zdravijo zaradi alergijske reakcije, saj so dovzetnejši za pojav novih alergijskih reakcij.
English: 1 The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) is a medicines regulatory body representing the European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.
Slovenian: 1 Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn in Norveško.
English: Current formulations containing lactose will be replaced with lactose-free formulations
Slovenian: Trenutne formulacije, ki vsebujejo laktozo, bodo nadomestile formulacije brez laktoze
English: • Companies have been asked to take steps by 2019 to replace current formulations containing lactose with lactose-free formulations.
Slovenian: • Družbe so bile zaprošene, da do leta 2019 izvedejo ukrepe za zamenjavo trenutnih formulacij, ki vsebujejo laktozo, s formulacijami brez laktoze.
English: Methylprednisolone-containing medicines have been authorised by national procedures for use by injection into a vein or muscle and have been available for many years in the EU under a variety of brand names including Solu-Medrol.
Slovenian: Zdravila, ki vsebujejo metilprednizolon, so bila po nacionalnih postopkih odobrena za injiciranje v veno ali mišico in so že mnogo let na voljo v EU pod različnimi tržnimi imeni, vključno z imenom Solu-Medrol.
English: Corticosteroids are anti-inflammatory medicines used to control the immune system (the body's natural defences) when it is overactive, as in allergic conditions.
Slovenian: Kortikosteroidi so protivnetna zdravila, ki se uporabljajo za nadzor imunskega sistema (naravne obrambe telesa), kadar je preveč dejaven, npr. pri alergijskih boleznih.
English: In this case it may be difficult to determine whether the patient's symptoms are due to a new allergic reaction caused by methylprednisolone products containing lactose or due to a worsening of the original condition.
Slovenian: V tem primeru bi lahko bilo težko ugotoviti, ali so se simptomi pri bolniku pojavili zaradi nove alergijske reakcije, ki so jo povzročila zdravila z metilprednizolonom, ki vsebujejo laktozo, ali zaradi poslabšanja prvotne bolezni.
English: Considering that methylprednisolone is used for the treatment of severe allergic reactions in an emergency setting where details of the patients' allergies may not always be known, the CMDh confirmed that the most effective way of minimising any risks is to remove cow's milk proteins from the preparation.
Slovenian: Ob upoštevanju, da se metilprednizolon uporablja za zdravljenje hudih alergijskih reakcij v nujnih primerih, kadar podatki o alergijah pri bolniku niso vedno znani, je skupina CMDh potrdila, da je najučinkovitejši način zmanjšanja tveganja odstranitev beljakovin kravjega mleka iz pripravka.
English: In some of the reported cases the adverse reaction was misinterpreted as a lack of therapeutic effect, leading to re-administration of methylprednisolone and subsequent worsening of the patient's clinical condition.
Slovenian: V nekaterih primerih, o katerih so poročali, so neželeni učinek zmotno razložili kot odsotnost terapevtskega učinka, kar je privedlo do ponovnega dajanja metilprednizolona in nadaljnjega poslabšanja kliničnega stanja bolnika.
English: CMDh further confirmed that patients being treated with methylprednisolone for an allergic reaction should have their treatment stopped if their symptoms worsen or they develop new symptoms.
Slovenian: Skupina CMDh je poleg tega potrdila, da je treba zdravljenje bolnikov, pri katerih z metilprednizolonom zdravijo alergijsko reakcijo, prekiniti, če se njihovi simptomi poslabšajo ali se razvijejo novi simptomi.
English: In addition, the vial and packaging of these medicines will be clearly marked with a warning against use in patients with cow's milk allergy.
Slovenian: Poleg tega bo na viali in embalaži teh zdravil jasno označeno opozorilo o prepovedi uporabe pri bolnikih z alergijo na kravje mleko.