FrancophonIA/ELRC3.0 huggingface dataset:
English: In psoriasis, Otezla has been investigated in 2 main studies involving a total of 1,257 patients with moderate to severe plaque psoriasis, in which treatment with Otezla was compared with placebo (a dummy treatment).
Slovenian: Kar zadeva zdravljenje psoriaze, so zdravilo Otezla preučevali v dveh glavnih študijah, v kateri je bilo vključenih skupno 1 257 bolnikov z zmerno do hudo psoriazo v plakih in v katerih so to zdravilo primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The most common side effects with Otezla (which may affect more than 1 in 10 people) are effects on the digestive system such as diarrhoea and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Otezla (ki lahko prizadenejo več kot 1 osebo od 10) so učinki na prebavni sistem, kot sta driska in navzeja (slabost).
English: Other information about Otezla
Slovenian: Druge informacije o zdravilu Otezla
English: For the full list of all side effects and restrictions with Otezla, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri zdravilu Otezla glejte navodilo za uporabo.
English: For practical information about using Otezla, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Otezla naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The CHMP considered that benefit had been shown in psoriasis and psoriatic arthritis.
Slovenian: CHMP je menil, da je zdravilo izkazalo koristi pri zdravljenju psoriaze in psoriatičnega artritisa.
English: Otezla contains the active substance apremilast.
Slovenian: Zdravilo Otezla vsebuje zdravilno učinkovino apremilast.
English: How does Otezla work?
Slovenian: Kako zdravilo Otezla deluje?
English: Treatment should be started as soon as possible after diagnosis of pre-term labour.
Slovenian: Zdravljenje je treba začeti čim prej po diagnozi prezgodnjega poroda.
English: The full EPAR for Atosiban SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Atosiban SUN je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Slovenian: • redne kontrakcije maternice, ki trajajo vsaj 30 sekund, s pogostnostjo najmanj štiri v 30 minutah,
English: This means that Atosiban SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Tractocile.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Tractocile.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Atosiban SUN on 31 July 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Atosiban SUN, veljavno po vsej Evropski uniji, odobrila dne 31. julija 2013.
English: This is a summary of the European public assessment report (EPAR) for Atosiban SUN.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Atosiban SUN.
English: What measures are being taken to ensure the safe and effective use of Atosiban SUN?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Atosiban SUN?
English: If contractions come back, treatment with Atosiban SUN can be repeated up to three more times during the pregnancy.
Slovenian: Če se kontrakcije maternice spet pojavijo, se lahko zdravljenje z zdravilom Atosiban SUN v času nosečnosti ponovi največ trikrat.
English: The CHMP concluded that, in accordance with EU requirements, Atosiban SUN has been shown to have comparable quality and to be comparable to Tractocile.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Atosiban Sun primerljivo raven kakovosti kot zdravilo Tractocile ter da mu je podobno.
English: The company provided data from the published literature on atosiban.
Slovenian: Družba je predstavila podatke o atosibanu iz objavljene literature.
English: A risk management plan has been developed to ensure that Atosiban SUN is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Atosiban SUN je bil pripravljen načrt obvladovanja tveganj.
English: It is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Slovenian: v veno (6,75 mg), ki ji sledi visokoodmerna triurna infuzija (18 mg na uro), in nato infuzija z manjšim odmerkom (6 mg na uro), ki traja do 45 ur.
English: The Committee recommended that Atosiban SUN be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Atosiban Sun odobri dovoljenje za promet.
English: By blocking the action of oxytocin, Atosiban SUN prevents contractions and causes the womb to relax, helping to delay birth.
Slovenian: Z zaviranjem delovanja oksitocina zdravilo Atosiban SUN prepreči kontrakcije in povzroči, da se maternica sprosti, kar pomaga k odložitvi poroda.
English: Because Atosiban SUN is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Atosiban SUN generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: It is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth preterm (prematurely).
Slovenian: Zdravilo Atosiban SUN se uporablja za odložitev poroda pri odraslih ženskah, ki so noseče 24 do 33 tednov, če izkazujejo znake, da bi utegnilo priti do prezgodnjega nastopa poroda.
English: Treatment with Atosiban SUN should be carried out by a doctor who has experience in the treatment of pre-term labour.
Slovenian: Zdravljenje z zdravilom Atosiban SUN mora izvajati zdravnik z izkušnjami z zdravljenjem prezgodnjega poroda.
English: The active substance in Atosiban SUN, atosiban, is an antagonist of the natural hormone oxytocin.
Slovenian: Zdravilna učinkovina zdravila Atosiban SUN, atosiban, je antagonist naravnega hormona oksitocina.
English: What are the benefits and risks of Atosiban SUN?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Atosiban SUN?
English: What is Atosiban SUN and what is it used for?
Slovenian: Kaj je zdravilo Atosiban SUN in za kaj se uporablja?
English: Other information about Atosiban SUN
Slovenian: Druge informacije o zdravilu Atosiban SUN
English: For more information about treatment with Atosiban SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Atosiban SUN preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atosiban SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Atosiban SUN vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Atosiban SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Atosiban SUN naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Therefore, the CHMP's view was that, as for Tractocile, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Tractocile, odtehtajo znana tveganja.
English: Atosiban SUN is available as a solution for injection and as a concentrate that is made up into a solution for infusion
Slovenian: Zdravilo Atosiban Sun je na voljo v obliki raztopine za injiciranje in kot koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: Atosiban SUN is a medicine that contains the active substance atosiban.
Slovenian: Atosiban Sun je zdravilo, ki vsebuje zdravilno učinkovino atosiban.
English: How does Atosiban SUN work?
Slovenian: Kako zdravilo Atosiban SUN deluje?
English: It is not intended to provide practical advice on how to use Atosiban SUN.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Atosiban SUN approved?
Slovenian: Zakaj je bilo zdravilo Atosiban SUN odobreno?
English: Atosiban SUN is a ‘generic medicine'.
Slovenian: Zdravilo Atosiban SUN je „generično zdravilo“.
English: Atosiban SUN can only be obtained with a prescription.
Slovenian: Izdaja zdravila Atosiban SUN je le na recept.
English: No additional studies were needed as Atosiban SUN is a generic medicine that is given by infusion or injection and contains the same active substance as the reference medicine, Tractocile.
Slovenian: Ker je zdravilo Atosiban SUN generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Tractocile, niso bile potrebne nobene dodatne študije.
English: How has Atosiban SUN been studied?
Slovenian: Kako je bilo zdravilo Atosiban SUN raziskano?
English: How is Atosiban SUN used?
Slovenian: Kako se zdravilo Atosiban SUN uporablja?
English: The full EPAR for Stronghold Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Stronghold Plus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Stronghold Plus on 9 February 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Stronghold Plus, veljavno po vsej Evropski uniji, izdala 9. februarja 2017.
English: The medicine must be kept in its packaging until use, in order to prevent access by children.
Slovenian: Zdravilo je treba do uporabe hraniti v embalaži, da bi preprečili dostop otrokom.
English: Stronghold Plus selamectin / sarolaner
Slovenian: Stronghold Plus selamektin/sarolaner
English: This is a summary of the European public assessment report (EPAR) for Stronghold Plus.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Stronghold Plus.
English: In order to be exposed to selamectin and sarolaner, fleas and ticks must commence feeding on the cat's blood.
Slovenian: Da bi bili izpostavljeni selamektinu in saloranerju, se morajo bolhe in klopi začeti hraniti s krvjo mačke.
English: Selamectin and sarolaner are antiparasitic medicines.
Slovenian: Selamektin in sarolaner sta antiparazitni zdravili.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Stronghold Plus's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Stronghold Plus večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: It is not intended to provide practical advice on how to use Stronghold Plus.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Stronghold Plus with caution.
Slovenian: Ljudje z občutljivo kožo ali tisti, ki so preobčutljivi za (alergični na) selamektin ali sarolaner, morajo z zdravilom Stronghold Plus ravnati previdno.
English: On the day of treatment, treated cats must not be allowed to sleep in the same bed as their owner, especially children.
Slovenian: Na dan nanosa zdravila zdravljene živali ne smejo spati v isti postelji z lastniki, zlasti ne z otroki.
English: Because ticks must start feeding on the cat in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.
Slovenian: Ker se morajo klopi začeti hraniti s krvjo mačke, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so ti paraziti lahko okuženi.
English: Stronghold Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Slovenian: Zdravilo Stronghold Plus se lahko uporablja le, ko obstaja potreba po zdravljenju klopov ter ene ali več vrst zgoraj navedenih parazitov.
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Slovenian: Selamektin aktivira posebne beljakovine, imenovane kloridni kanalčki, na površini živčnih in mišičnih celic zajedavcev, kar nabitim kloridnim delcem omogoča, da vstopijo v živčne celice in ohromijo njihovo običajno električno dejavnost.
English: Other information about Stronghold Plus
Slovenian: Druge informacije o zdravilu Stronghold Plus
English: Children must not be allowed to play with treated cats for 4 hours after treatment.
Slovenian: Otroci se z zdravljenimi mačkami ne smejo igrati štiri ure po nanosu zdravila.
English: Stronghold Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).
Slovenian: Zdravilo Stronghold Plus se ne sme uporabljati pri mačkah, ki trpijo zaradi drugih bolezni ali pri mačkah, ki so oslabljene ali podhranjene (glede na starost).
English: Stronghold Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that live inside the body.
Slovenian: Stronghold Plus je zdravilo, ki se uporablja za zdravljenje mešanih infestacij s klopi in drugimi paraziti, ki jih je mogoče najti na koži ali dlaki mačk, kot so bolhe, ušesne garje in uši ter/ali črvi, ki živijo v telesu.
English: The effectiveness of Stronghold Plus was investigated in a field study in cats naturally infested with fleas.
Slovenian: Učinkovitost zdravila Stronghold Plus so raziskovali v terenski študiji pri mačkah, ki so bile naravno okužene z bolhami.
English: Stronghold Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Slovenian: Zdravilo Stronghold Plus povzroča pogin bolh in nekaterih vrst klopov v 24 urah ter nadaljnjih pet tednov učinkuje proti bolham in štiri do pet tednov proti klopom (odvisno od vrste).
English: Sarolaner blocks the normal movement of charged chloride particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Slovenian: Zavira normalno prehajanje nabitih kloridnih delcev v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gama-aminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata sporočila med živci (živčna prenašalca).
English: What is Stronghold Plus and what is it used for?
Slovenian: Kaj je zdravilo Stronghold Plus in za kaj se uporablja?
English: What are the risks associated with Stronghold Plus?
Slovenian: Kakšna tveganja so povezana z zdravilom Stronghold Plus?
English: What benefits of Stronghold Plus have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Stronghold Plus izkazalo v študijah?
English: Stronghold Plus is harmful after swallowing.
Slovenian: Zdravilo Stronghold Plus je škodljivo ob zaužitju.
English: Why is Stronghold Plus approved?
Slovenian: Zakaj je bilo zdravilo Stronghold Plus odobreno?
English: The most common side effects with Stronghold Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling saliva.
Slovenian: Najpogostejši neželeni učinki zdravila Stronghold Plus (ki lahko prizadenejo največ 1 od 100 mačk) so blaga do zmerna alopecija (izpadanje dlake) na mestu nanosa, eritem (pordelost kože) in slinjenje.
English: Stronghold Plus contains two active substances, selamectin and sarolaner.
Slovenian: Zdravilo Stronghold Plus vsebuje dve zdravilni učinkovini, selamektin in sarolaner.
English: Cats were treated with Stronghold Plus monthly for 3 months or another medicine, containing fipronil.
Slovenian: Mačke so bile mesečno zdravljene z zdravilom Stronghold Plus v obdobju treh mesecev, ali z drugim zdravilom, ki je vsebovalo fipronil.
English: A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.
Slovenian: Laboratorijska študija z mačkami, okuženimi z ušmi, je pokazala, da selamektin odpravi uši v obdobju 42 dni po zdravljenju v primerjavi z mačkami, zdravljenimi s placebom.
English: Stronghold Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Slovenian: Zdravilo Stronghold Plus je močno vnetljivo in ga je treba hraniti na varni razdalji od vročine, isker, odprtega plamena ali drugih virov vžiga.
English: Selamectin is effective against fleas, ear mites, biting lice, heartworms, roundworms and hookworms.
Slovenian: Selamektin učinkuje proti bolham, ušesnim garjam, ušem, srčni glistavosti, valjastim in kavljastim črvom.
English: Stronghold Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Slovenian: Zdravilo Stronghold Plus je bilo enako učinkovito kot drugo zdravilo in je zmanjšalo število klopov za več kot 90 %.
English: The contents of the pipette are squeezed onto the skin after parting the fur at the base of the cat's neck in front of the shoulder blades.
Slovenian: Vsebino merilne kapalke iztisnemo na kožo, potem ko razmaknemo dlako v predelu zatilja mačke oziroma v sprednjem delu lopatic.
English: Cats were treated with Stronghold Plus monthly for 3 months or another antiparasitic medicine, containing imidacloprid and moxidectin.
Slovenian: Mačke so bile mesečno zdravljene z zdravilom Stronghold Plus v obdobju treh mesecev, ali z drugim antiparazitnim zdravilom, ki je vsebovalo imidakloprid in moksidektin.
English: Two laboratory studies were conducted in cats with intestinal worms which showed Stronghold Plus to have more than 94% efficacy.
Slovenian: Izvedeni sta bili dve laboratorijski študiji z mačkami z intestinalnimi črvi, ki sta pokazali, da ima zdravilo Stronghold Plus več kot 94-odstotno učinkovitost.
English: Two laboratory studies with cats artificially infested with ear mites showed Stronghold Plus to reduce ear mites by more than 90% 30 days after a single treatment.
Slovenian: Dve laboratorijski študiji z mačkami, umetno okuženimi z ušesnimi garjami, sta pokazali, da zdravilo Stronghold Plus zmanjšuje ušesne garje za več kot 90 % v 30 dneh po enem samem zdravljenju.
English: • to treat adult roundworms and adult hookworms in the gut
Slovenian: • za zdravljenje infestacij z odraslimi valjastimi črvi in odraslimi intestinalnimi kavljastimi črvi,
English: Hands should be washed after use and any product in contact with the skin should be washed off immediately with soap and water.
Slovenian: Po uporabi zdravila je treba umiti roke in nemudoma z milom in vodo sprati kožo, ki pride v stik z zdravilom.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Stronghold Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: How is Stronghold Plus used?
Slovenian: Kako se zdravilo Stronghold Plus uporablja?
English: Stronghold Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Slovenian: Zdravilo Stronghold Plus je bilo enako učinkovito kot drugo zdravilo in je zmanjšalo število bolh za več kot 95 %.
English: A laboratory study with cats artificially infected with heartworm showed Stronghold Plus to be effective for the prevention of heartworm disease.
Slovenian: Laboratorijska študija z mačkami, ki so bile umetno okužene s srčno glisto, je pokazala, da zdravilo Stronghold Plus učinkovito preprečuje obolenje srčne glistavosti
English: • to prevent heartworm disease
Slovenian: • za preprečevanje obolenja srčne glistavosti.
English: For more information about treatment with Stronghold Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Stronghold Plus naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For practical information about using Stronghold Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Stronghold Plus naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Stronghold Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Slovenian: Zdravilo Stronghold Plus je na voljo v obliki raztopine za kožni nanos v treh jakostih.
English: How does Stronghold Plus work?
Slovenian: Kako zdravilo Stronghold Plus deluje?
English: The full EPAR for Azomyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Azomyr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr on 15 January 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Azomyr, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2001.
English: This is a summary of the European public assessment report (EPAR) for Azomyr.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azomyr.
English: For more information about treatment with Azomyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Azomyr preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: What benefit has Azomyr shown during the studies?
Slovenian: Kakšne koristi je zdravilo Azomyr izkazalo med študijami?
English: In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment).
Slovenian: V vseh študijah so učinkovitost zdravila Azomyr primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: 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 Azomyr.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Azomyr, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Other information about Azomyr
Slovenian: Druge informacije o zdravilu Azomyr: