FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Corbilta'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 humani medicini (CHMP) je zaključil, da so koristi zdravila Corbilta 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 Corbilta.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The full EPAR for Corbilta 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 Corbilta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Corbilta must not be used in patients with:
Slovenian: Zdravilo Corbilta se ne sme uporabljati pri bolnikih, ki imajo:
English: The strength of Corbilta that the patient should use is based on the amount of levodopa they need to control their symptoms.
Slovenian: Jakost zdravila Corbilta, ki naj jo bolnik uporablja, temelji na količini levodope, ki jo potrebuje za nadzor nad simptomi.
English: What benefits of Corbilta have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Corbilta izkazalo v študijah?
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Slovenian: Povezana so z zmanjšanjem učinka levodope, ko bolnik občuti nenadne prehode med stanjem „on“, ko se lahko premika, in stanjem „off“, ko ima težave z gibanjem.
English: A risk management plan has been developed to ensure that Corbilta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Corbilta je bil pripravljen načrt obvladovanja tveganj.
English: The maximum daily dose of Corbilta is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Slovenian: Največji dnevni odmerek zdravila Corbilta je deset tablet, razen pri tabletah, ki vsebujejo 175 mg levodope in 43,75 mg karbidope, pri katerih je največji dnevni odmerek osem tablet, ter pri tistih, ki vsebujejo 200 mg levodope in 50 mg karbidope, pri katerih je največji dnevni odmerek sedem tablet.
English: What are the risks associated with Corbilta?
Slovenian: Kakšna tveganja so povezana z zdravilom Corbilta?
English: What is Corbilta and what is it used for?
Slovenian: Kaj je zdravilo Corbilta in za kaj se uporablja?
English: Why is Corbilta approved?
Slovenian: Zakaj je bilo zdravilo Corbilta odobreno?
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Slovenian: • anamnezo nevroleptičnega malignega sindroma (nevarne bolezni živčnega sistema, ki jo običajno povzročijo antipsihotična zdravila) ali rabdomiolize (razgradnje mišičnega tkiva).
English: All of the active substances in Corbilta work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Slovenian: Vse zdravilne učinkovine v zdravilu Corbilta delujejo tako, da ponovno vzpostavijo ravni dopamina v tistih delih možganov, ki nadzirajo gibe in koordinacijo.
English: Corbilta is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Slovenian: Corbilta je zdravilo, ki vsebuje tri zdravilne učinkovine: levodopo, karbidopo in entakapon.
English: Corbilta is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Slovenian: Zdravilo Corbilta je na voljo v obliki tablet v sedmih jakostih, ki vsebujejo od 50 do 200 mg levodope in od 12,5 do 50 mg karbidope.
English: Corbilta must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Slovenian: Zdravilo Corbilta se ne sme uporabljati skupaj z drugimi zdravili, ki spadajo v skupino, imenovano „zaviralci monoaminooksidaze“ (vrsta antidepresivov).
English: It is used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Slovenian: Uporablja se za zdravljenje odraslih s Parkinsonovo boleznijo (napredujočo boleznijo možganov, ki povzroča tresenje, počasno gibanje in okorelost mišic).
English: Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs).
Slovenian: Resni neželeni učinki, o katerih so poročali veliko redkeje, vključujejo gastrointestinalno hemoragijo (krvavitve v črevesju) ter angioedem (podkožne otekline na obrazu in okončinah).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Corbilta, 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 Corbilta in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The most common side effects with Corbilta (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), aggravated Parkinsonism (worsening of Parkinson's disease), nausea (feeling sick) and harmless urine discoloration.
Slovenian: Najpogostejši neželeni učinki zdravila Corbilta (opaženi pri več kot 1 bolniku od 10) so diskinezija (nenadzorovani gibi), poslabšanje parkinsonizma (Parkinsonove bolezni), navzeja (slabost) in neškodljivo razbarvanje urina.
English: The company that makes Stalevo has agreed that its scientific data can be used for Corbilta (‘informed consent').
Slovenian: Družba, ki proizvaja zdravilo Stalevo, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Corbilta („uporaba dokumentacije s soglasjem“).
English: The company carried out ‘bioequivalence' studies to show that taking Corbilta produces the same levels of levodopa, carbidopa and entacapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Slovenian: Družba je izvedla študije „biološke enakovrednosti“, da bi dokazala, da so ravni levodope, karbidope in entakapona v krvi pri jemanju zdravila Corbilta enake kot pri jemanju ločenih tablet, ki vsebujejo entakapon ter kombinacijo levodope in karbidope.
English: For more information about treatment with Corbilta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Corbilta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Corbilta is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Slovenian: Zdravilo Corbilta se uporablja pri bolnikih, ki se zdravijo s kombinacijo levodope in zaviralca dopa dekarboksilaze (dveh standardnih zdravil za zdravljenje Parkinsonove bolezni), pri katerih pa se proti koncu obdobja med dvema odmerkoma zdravila pojavijo „fluktuacije“ (nihanja).
English: Having all three substances in the same tablet can lower the number of tablets patients have to take and help them stick to their treatment.
Slovenian: Ker ena tableta vsebuje vse tri učinkovine, je število tablet, ki jih mora bolnik zaužiti, manjše, zaradi česar se lažje drži režima zdravljenja.
English: For practical information about using Corbilta, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Corbilta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Corbilta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Corbilta, glejte navodilo za uporabo.
English: The company used some of the data from Comtess/Comtan (entacapone) to support the use of Corbilta and presented data from the published literature for the use of the combination of levodopa and carbidopa.
Slovenian: Družba je v podporo uporabi zdravila Corbilta uporabila nekatere podatke o zdravilu Comtess/Comtan (entakapon) in predložila podatke o uporabi kombinacije levodope in karbidope iz objavljene literature.
English: How is Corbilta used?
Slovenian: Kako se zdravilo Corbilta uporablja?
English: See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched to Corbilta and on how the dose is adjusted during treatment.
Slovenian: Za celotna navodila o tem, kako naj bolniki preidejo na jemanje zdravila Corbilta in kako je treba prilagajati odmerek med zdravljenjem, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: How does Corbilta work?
Slovenian: Kako zdravilo Corbilta deluje?
English: This overview was last updated in June 2019.
Slovenian: Ta povzetek je bil nazadnje posodobljen junija 2019.
English: Further information on Advocate can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/advocate.
Slovenian: Nadaljnje informacije o zdravilu Advocate so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/advocate.
English: Vomiting has also occurred rarely.
Slovenian: Redko se je pojavilo tudi bruhanje.
English: Other information about Advocate
Slovenian: Druge informacije o zdravilu Advocate
English: The European Medicines Agency decided that Advocate's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Advocate večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Advocate received a marketing authorisation valid throughout the EU on 2 April 2003.
Slovenian: Zdravilo Advocate je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 2. aprila 2003.
English: Advocate should not be used for any other animal species.
Slovenian: Zdravilo se ne sme uporabljati za nobeno drugo živalsko vrsto.
English: Dogs and cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should only be treated after special consideration by the veterinarian.
Slovenian: Psi in mačke, ki tehtajo manj kot 1 kg, ter beli dihurji, ki tehtajo manj kot 0,8 kg, se lahko zdravijo le po posebni presoji veterinarja.
English: Advocate (imidacloprid / moxidectin)
Slovenian: Advocate (imidakloprid/moksidektin)
English: Although no side effects have been confirmed in ferrets, similar side effects could occur rarely.
Slovenian: Čeprav pri belih dihurjih neželeni učinki niso bili opaženi, se lahko v redkih primerih pojavijo podobni neželeni učinki.
English: An overview of Advocate and why it is authorised in the EU
Slovenian: Pregled zdravila Advocate in zakaj je odobreno v EU
English: People with a known sensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Slovenian: Osebe z znano občutljivostjo na benzilalkohol, imidakloprid ali moksidektin naj zdravilo uporabljajo previdno.
English: Subsequently, the efficacy was confirmed in several field studies in cats and dogs, conducted in different European geographical locations.
Slovenian: Zatem je bila potrjena v več terenskih študijah z mačkami in psi, izvedenih na različnih geografskih območjih po Evropi.
English: What are the risks associated with Advocate?
Slovenian: Kakšna tveganja so povezana z zdravilom Advocate?
English: Field studies involving heartworm in dogs were conducted both in the USA and Europe.
Slovenian: Terenske študije, ki so vključevale srčne gliste pri psih, so potekale v ZDA in Evropi.
English: Advocate should not be used in kittens under 9 weeks of age or in puppies under 7 weeks of age.
Slovenian: Zdravilo Advocate se ne sme uporabljati pri mačkah, mlajših od devet tednov, ali psih, mlajših od sedem tednov.
English: When administering Advocate, the user should not smoke, eat or drink, and should wash their hands thoroughly after use.
Slovenian: Med nanašanjem zdravila Advocate naj uporabnik ne kadi, je ali pije, po uporabi pa naj si temeljito umije roke.
English: Why is Advocate authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Advocate odobreno v EU?
English: What is Advocate and what is it used for?
Slovenian: Kaj je zdravilo Advocate in za kaj se uporablja?
English: What benefits of Advocate have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Advocate izkazalo v študijah?
English: The effectiveness of the product was measured by the number of live parasites or egg counts in the faeces at various times after treatment.
Slovenian: Učinkovitost zdravila je bila izmerjena s številom živih zajedavcev ali jajčec v blatu ob različnih časih po zdravljenju.
English: If a cat or dog licks the application area, it might salivate for a short period and might show signs such as a lack of muscular coordination, shaking, abnormal breathing and/or vomiting.
Slovenian: Če mačka ali pes poliže mesto nanosa, se utegne kratek čas močno sliniti in kazati znake, kot so pomanjkljiva mišična koordinacija, tresenje, nenormalno dihanje in/ali bruhanje.
English: It is very important that the cat products should only be used for cats, and the dog products for dogs.
Slovenian: Zelo pomembno je, da se zdravilo za mačke uporablja le za mačke, zdravilo za pse pa le za pse.
English: It contains two active substances, imidacloprid and moxidectin.
Slovenian: Vsebuje dve učinkovini, imidakloprid in moksidektin.
English: Skin contact with the pipette contents should be avoided and animals should not be stroked or groomed until the application site is dry.
Slovenian: Preprečiti je treba stik kože z vsebino merilne kapalke, živali pa se ne sme božati ali negovati, dokler se mesto nanosa ne posuši.
English: The effectiveness of Advocate against the specified parasites was investigated in laboratory studies in cats, ferrets and dogs.
Slovenian: Učinkovitost zdravila Advocate proti navedenim zajedavcem je bila proučena z laboratorijskimi študijami pri mačkah, belih dihurjih in psih.
English: The results of the laboratory and field trials in cats, ferrets and dogs showed that Advocate is effective, when used as detailed in the package leaflet (see “What is Advocate and what is it used for?” above, or for more details see the package leaflet).
Slovenian: Rezultati laboratorijskih in terenskih preskušanj na mačkah, belih dihurjih in psih so pokazali, da je zdravilo Advocate učinkovito, če se uporablja v skladu z navodilom za uporabo (glej razdelek „Kaj je zdravilo Advocate in za kaj se uporablja?“ zgoraj, za več podrobnosti pa navodilo za uporabo).
English: Moxidectin causes paralysis and death of parasites by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.
Slovenian: Moksidektin povzroči ohromitev in pogin zajedavcev tako, da ovira prenos signalov med živčnimi celicami (živčni prenos) v njihovem živčevju.
English: Imidacloprid interferes with certain specific receptors (nicotinergic acetylcholine receptors) in the nervous systems of lice and fleas, which results in their subsequent paralysis and death.
Slovenian: Imidakloprid ovira nekatere posebne receptorje (nikotinske acetilholinske receptorje) v živčnem sistemu uši in bolh, kar povzroči njihovo ohromitev in pogin.
English: The content of a full pipette is applied onto the animal's skin, after parting the fur.
Slovenian: Vsebina celotne merilne kapalke se nanese na kožo živali po razmiku dlake.
English: The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Slovenian: Vehikel v zdravilu Advocate lahko pusti madeže na nekaterih materialih, kot so usnje, tkanine, plastika in lakirane površine, oziroma jih poškoduje, zato je treba preprečiti stik zdravila s tovrstnimi površinami.
English: In both cats and dogs, the most common side effects are local reactions at the site of application, such as temporary itchiness, and on rare occasions, greasy fur and redness of the skin.
Slovenian: Pri mačkah in psih so najpogostejši neželeni učinki lokalne reakcije na mestu nanosa zdravila, kot so začasno srbenje ter v redkih primerih mastna dlaka in pordelost kože.
English: Advocate is a medicine used on cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections (caused by several different types of parasites):
Slovenian: Zdravilo Advocate se uporablja pri mačkah, belih dihurjih in psih, ki imajo mešane parazitske okužbe (ki jih povzročajo različne vrste zajedavcev) ali pri katerih obstaja tveganje zanje:
English: Advocate should not be used in dogs classified as Class 4 for heartworm disease.
Slovenian: Uporabljati se ne sme niti pri psih, ki so razvrščeni v razred 4 obolenja, ki ga povzroča srčna glista.
English: How is Advocate used?
Slovenian: Kako se zdravilo Advocate uporablja?
English: Advocate is available as a spot-on solution in pre-filled pipettes (small plastic droppers), and comes in different strengths and pack sizes, depending on whether it is for use on cats, ferrets, or dogs, and on the size of the animal being treated.
Slovenian: Zdravilo Advocate je na voljo kot raztopina za kožni nanos v napolnjeni merilni kapalki (majhni plastični kapalki), in sicer v različnih jakostih in pakiranjih glede na to, ali je namenjeno za uporabo pri mačkah, belih dihurjih ali psih, ter glede na velikost zdravljene živali.
English: • as part of treatment strategies for flea allergy dermatitis (an allergic reaction to flea bites) in cats and dogs;
Slovenian: • kot del strategije zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh) pri mačkah in psih;
English: Cats, ferrets and dogs from various breeds, age groups and weights were treated.
Slovenian: Zdravljeni so bili psi, beli dihurji in mačke različnih pasem, starosti in telesnih mas.
English: • for the treatment of skin diseases in dogs caused by parasitic mites (sarcoptic mange and demodicosis);
Slovenian: • za zdravljenje kožnih bolezni, ki jih povzročajo parazitske pršice (garje vrste Sarcoptes in demodikoze) pri psih;
English: Only the product called “Advocate spot-on solution for small cats and ferrets” should be used for ferrets.
Slovenian: imenovano Advocate raztopina za kožni nanos za majhne mačke in bele dihurje (Advocate Spot-on solution for Small Cats and Ferrets).
English: • for the treatment of infections with certain gastrointestinal roundworms, hookworms and whipworms in cats and dogs.
Slovenian: • za zdravljenje okužb z nekaterimi želodčno-črevesnimi glistami, trakuljami in bičeglavci pri mačkah in psih.
English: Advocate comes in different strengths and different pipette sizes depending on whether it is for use on cats, ferrets or dogs.
Slovenian: Zdravilo je na voljo v različnih jakostih in v merilnih kapalkah različnih velikosti glede na to, ali se uporablja za zdravljenje mačk, belih dihurjev ali psov.
English: • for the prevention and treatment of skin worm (infection with Dirofilaria repens) in dogs;
Slovenian: • za preprečevanje in zdravljenje kožnih glist (okužba z glistami Dirofilaria repens) pri psih;
English: • for the prevention of spirocercosis (a worm infection affecting the gullet) in dogs;
Slovenian: • za preprečevanje spirocerkoze (okužbe z zajedavci, ki prizadene požiralnik) pri psih;
English: • for the prevention of heartworm disease (infection with Dirofilaria immitis) in cats, ferrets and dogs;
Slovenian: • za preprečevanje obolenj, ki jih povzročajo srčne gliste (okužba z glistami Dirofilaria immitis) pri mačkah, belih dihurjih in psih;
English: • for the prevention and treatment of lungworm in cats and dogs;
Slovenian: • za preprečevanje in zdravljenje okužb s pljučnimi glistami pri mačkah in psih;
English: • for the treatment and prevention of flea infestations in cats, ferrets and dogs;
Slovenian: • za zdravljenje in preprečevanje infestacij z bolhami pri mačkah, belih dihurjih in psih;
English: How does Advocate work?
Slovenian: Kako zdravilo Advocate deluje?
English: The dose and frequency of application depend on why Advocate is being used and whether it is used in cats, ferrets or dogs; the package leaflet includes detailed information on dosage and duration of treatment.
Slovenian: Odmerek in pogostost nanosa sta odvisna od razloga za uporabo zdravila Advocate in od tega, ali se uporablja pri mačkah, belih dihurjih ali psih.
English: • for the treatment of ear mite infestations in cats and dogs;
Slovenian: • za zdravljenje ušesnih garij pri mačkah in psih;
English: • for the treatment of eye worm in cats and dogs;
Slovenian: • za zdravljenje očesnih zajedavcev pri mačkah in psih;
English: • for the treatment of nasal worm in dogs;
Slovenian: • za zdravljenje nosnih zajedavcev pri psih;
English: • for the treatment of notoedric mange in cats;
Slovenian: • za zdravljenje garjavosti, ki jo povzročajo pršice vrste Notoedres, pri mačkah;
English: • for the treatment of biting lice infestations in dogs;
Slovenian: • za zdravljenje ušivosti pri psih;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. december 1998 Datum zadnjega podaljšanja: 16. december 2008
English: It is important that you take Kinzalmono every day until your doctor tells you otherwise.
Slovenian: Pomembno je, da jemljete zdravilo Kinzalmono vsak dan, dokler vam zdravnik ne naroči drugače.
English: See also information under the heading “Do not take Kinzalmono”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Kinzalmono”.
English: Aluminium/aluminium blisters (PA/PA/Al/PVC/Al).
Slovenian: Pretisni omoti iz aluminija/aluminija (PA/Al/PVC/Al ali PA/PA/Al/PVC/Al).
English: Some side effects can be serious and need immediate medical attention You should see your doctor immediately if you experience any of the following symptoms:
Slovenian: Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravstveno oskrbo Nemudoma morate obiskati zdravnika, če se pojavi kateri od naslednjih simptomov:
English: One blister contains 7 tablets.
Slovenian: En pretisni omot vsebuje 7 tablet.
English: What Kinzalmono is and what it is used for
Slovenian: Kaj je zdravilo Kinzalmono in za kaj ga uporabljamo
English: This applies especially to the medicines listed below taken at the same time with Kinzalmono:
Slovenian: To velja zlasti za spodaj našteta zdravila, kadar jih jemljete hkrati z zdravilom Kinzalmono:
English: Your doctor will normally advise you to stop taking Kinzalmono before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinzalmono.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravilo Kinzalmono prenehate jemati, preden boste zanosili ali takoj ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Kinzalmono jemljete drugo zdravilo.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Digoksin