FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the risk of chronic use in the treatment of osteoarthritis and aiming further minimisation of the risks associated with nimesulide, the CHMP concluded that nimesulide has no longer a positive risk- benefit in this indication.
Slovenian: Ob upoštevanju tveganja pri kronični uporabi za zdravljenje osteoartritisa in z namenom nadaljnjega zmanjševanja tveganj, povezanih z nimesulidom, je CHMP sklenil, da nimesulid nima več pozitivnega razmerja med koristmi in tveganjem za to indikacijo.
English: It seems that the risk profile of nimesulide is not better than for other NSAIDs with regards to cardiovascular disorders.
Slovenian: Kaže, da profil tveganja nimesulida v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili pri srčno-žilnih obolenjih ni boljši.
English: Based on available data, it is concluded that the proven efficacy of nimesulide in short-term clinical studies is consistent with the indication for short-term use only (i.e. maximum 15 days of treatment) as previously restricted to minimise the risks for hepatoxicity.
Slovenian: Na podlagi razpoložljivih podatkov je ugotovljeno, da je dokazana učinkovitost nimesulida pri kratkotrajnih kliničnih študijah v skladu z indikacijo samo za kratkotrajno uporabo (to je največ 15 dni zdravljenja), kot je bilo predhodno omejeno, za zmanjševanje tveganja toksičnosti za jetra.
English: • The Committee considered that nimesulide overall gastrointestinal toxicity is comparable to other NSAIDs but that nimesulide is associated with an increased risk for hepatotoxicity.
Slovenian: • Odbor je menil, da je splošna toksičnost nimesulida za prebavila primerljiva z drugimi nesteroidnimi protivnetnimi zdravili, nimesulid pa je povezan s povečanim tveganjem toksičnosti za jetra.
English: In view of the uncertainties regarding the magnitude and the determinants of possible nimesulide-induced harm, the riskbenefit balance was considered positive subject to amendments to the product information and conditions to the Marketing Authorisations for all products containing nimesulide for systemic use.
Slovenian: Ob upoštevanju negotovosti glede obsega in dejavnikov možne škode zaradi nimesulida se je upoštevalo, da je razmerje med koristmi in tveganjem pozitivno pod pogojem, da se v informacije o zdravilu vključijo določena dopolnila in pogoji za dovoljenje za promet za vsa zdravila, ki vsebujejo nimesulid za sistemsko rabo.
English: Nimesulide was subject of an Article 31 referral to the CHMP in 2002, following national suspension of the Marketing Authorisations for nimesulide-containing medicinal products in Finland, and subsequently in Spain due to concerns regarding hepatotoxicity.
Slovenian: Za nimesulid je bil leta 2002 po nacionalnem umiku dovoljenja za promet z zdravili, ki vsebujejo nimesulid, na Finskem sprožen napotitveni postopek na CHMP v skladu s členom 31 ter posledično tudi v Španiji zaradi zadržkov glede toksičnosti za jetra.
English: Overall and further to consideration of the data submitted, it was concluded that a small increase in the absolute risk for hepatotoxic reactions, including severe hepatic reactions, associated with nimesulide could not be excluded.
Slovenian: Na splošno in po nadaljnjem preučevanju predloženih podatkov je bilo ugotovljeno, da ni mogoče izključiti majhnega povečanja absolutnega tveganja, povezanega z uporabo nimesulida, za toksične reakcije na jetrih, vključno s hudimi jetrnimi reakcijami.
English: Nimesulide efficacy is proven in short-term clinical studies which is consistent with the indication for short-term use (i.e. maximum 15 days of treatment) previously introduced to minimise the risks for hepatoxicity.
Slovenian: Učinkovitost nimesulida je dokazana pri kratkotrajnih kliničnih študijah, kar je v skladu z indikacijo za kratkotrajno uporabo (to je največ 15 dni zdravljenja), kar je bilo že prej dodano k zmanjšanju tveganja toksičnosti za jetra.
English: In the context of this review, limited information on the gastrointestinal toxicity profile of nimesulide in comparison to other NSAIDs, and the possible consequences of switching to other NSAIDs with a higher gastrointestinal toxicity risk was considered.
Slovenian: V okviru tega pregleda so obravnavali omejene informacije o toksičnem profilu nimesulida za prebavila v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili ter možnih posledicah zamenjave z drugimi nesteroidnimi protivnetnimi zdravili z večjim tveganjem za toksičnost za prebavila.
English: No new safety issue with respect to cardiovascular disorders, renal safety, skin, immunological and nervous system safety has arisen from the data submitted during this review.
Slovenian: Iz podatkov, ki so bili predloženi med tem pregledom, ne izhajajo nobeni novi zadržki v zvezi s srčno-žilnimi obolenji, varnostjo za ledvica, kožo ter imunskim in živčnim sistemom.
English: Overall, gastrointestinal toxicity of nimesulide is regarded to be comparable to other available NSAIDs.
Slovenian: Na splošno se upošteva, da je toksičnost nimesulida za prebavila primerljiva z drugimi razpoložljivimi nesteroidnimi protivnetnimi zdravili.
English: Further to the review of all available data, it is overall concluded that nimesulide seems to have a worst safety profile for hepatotoxicity compared to diclofenac and naproxen, both for severe liver injury requiring transplant and for hospitalisation for liver injury.
Slovenian: Po pregledu razpoložljivih podatkov je bilo ugotovljeno, naj bi imel nimesulid slabši varnostni profil toksičnosti za jetra v primerjavi z diklofenakom in naproksenom tako za hude poškodbe jeter, ki zahtevajo presaditev, kot za hospitalizacijo pri poškodbi jeter.
English: The additional measures would contribute to minimising the risks associated with the use of nimesulide whilst awaiting the full risk-benefit assessment of the Article 31 referral.
Slovenian: Dodatni ukrepi bi med čakanjem na celotno oceno razmerja med koristmi in tveganji po napotitvi v skladu s členom 31 vplivali na zmanjšanje tveganj, povezanih z uporabo nimesulida,.
English: The reported cases showed an association with non-A non-B non-paracetamol-related fulminant hepatic failure requiring liver transplantation in Ireland higher with nimesulide than with any other medicinal product.
Slovenian: V primerih, o katerih so poročali na Irskem, se je pokazalo, da je povezava med fulminantno odpovedjo jeter, ki ni bila povezana s hepatitisom A, hepatitisom B ali paracetomolom, ko je bila potrebna presaditev jeter, in med nimesulidom močnejša kot pri kateremkoli drugem zdravilu.
English: Some of these cases were considered to be confounded by concomitant disease/hepatotoxic medication and a clear causal relationship with nimesulide could not be concluded.
Slovenian: Vendar naj bi se v nekaterih primerih kazali tudi učinki sočasnega zdravljenja z drugimi zdravili, ki so toksična za jetra, in jasne vzročne povezave z nimesulidom ni bilo mogoče dokazati.
English: When combining both liver injury and GI toxicity nimesulide falls in the mid range of the other NSAIDs.
Slovenian: Če upoštevamo tako poškodbe jeter kot toksičnost za prebavila, je nimesulid v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili v srednjem segmentu.
English: At that time the magnitude of the increased risk of severe hepatic adverse reactions with nimesulide compared to other NSAIDs seen in spontaneous reporting, clinical and epidemiological studies seemed slight, with the exception of the signal raised by Ireland.
Slovenian: Takrat so rezultati spontanih poročil, kliničnih in epidemioloških študij pokazali, da je obseg povečanega tveganja za hude jetrne neželene reakcije pri uporabi nimesulida, v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili, relativno majhen z izjemo opozorilnega znaka, ki so ga opazili na Irskem.
English: The combined safety profile in terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse than some other alternative NSAIDs such as diclofenac and naproxen.
Slovenian: Skupni varnostni profil nimesulida v smislu toksičnosti za jetra in toksičnosti za prebavila je v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili, kot sta diklofenak in naproksen, dokazano slabši.
English: The safety profile in terms of hepatotoxicity and gastro intestinal toxicity for nimesulide is shown as worse than alternative NSAIDs such as diclofenac and naproxen.
Slovenian: Varnostni profil nimesulida je v smislu toksičnosti za jetra in toksičnosti za prebavila v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili, kot sta diklofenak in naproksen, dokazano slabši.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: PRILOGA POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI JIH MORAJO UVELJAVITI DRŽAVE ČLANICE
English: - That the dose of caffeine expressed as caffeine base is one half the dose of caffeine expressed as caffeine citrate (20mg caffeine citrate is equivalent to 10mg caffeine base) and that prescriptions should clearly indicate that caffeine citrate is to be administered.
Slovenian: - Podatek, da je odmerek kofeina, izražen kot kofeinska baza, ena polovica odmerka kofeina, izraženega kot kofein citrat (20 mg kofein citrata je enakovredno 10 mg kofeinske baze) in da morajo recepti jasno navajati, da je treba uporabiti kofein citrat.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES The Member States shall agree with the Marketing Authorisation Holder the final text of a card suitable for display in neonatal intensive care units.
Slovenian: POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA, KI JIH MORAJO UVELJAVITI DRŽAVE ČLANICE Imetniki dovoljenja za promet z zdravilom bodo z državami članicami sklenili dogovor glede končnega besedila kartice, primernega za prikazovanje v enotah za intenzivno nego novorojenčkov.
English: - That the product should be used immediately after opening the ampoule and unused portions left in the ampoule should be discarded - That baseline plasma levels may need measuring because of an increased risk of toxicity if o The neonate has been previously treated with theophylline o The mother has been consuming large amounts of caffeine prior to delivery or breast feeding - That caffeine and theophylline should not be used concurrently - That if caffeine and doxapram are used concurrently, the patient should be closely monitored - That additional plasma caffeine monitoring and dosage adjustment may be necessary in at risk situations such as preterm infants: o With cholestatic hepatitis o With significant renal impairment o With seizure disorders o With cardiac disease o less than 28 weeks gestational age and/or body weight <1000g particularly when receiving parenteral nutrition o with co-administration of medicinal products known to interfere with caffeine metabolism - That cardiac disorders (including arrhythmias) may arise in neonates with pre-existing cardiac disease - That all suspected adverse reactions should be reported in accordance with national reporting requirements - In particular, if convulsions, seizures, necrotising enterocolitis, symptoms and signs of caffeine withdrawal, medically abnormal decrease in infant weight gain or interactions with other medicines are suspected as being associated with the use of caffeine citrate, these should be reported to <insert local name and address of Chiesi Farmaceutici S.p.A.
Slovenian: - Podatek, da bo morda potrebno dodatno spremljanje kofeina v plazmi in prilagajanje odmerka v tveganih situacijah, kot pri prezgodaj rojenih dojenčkih: o s holestatičnim hepatitisom, o z znatnim poslabšanjem delovanja ledvic, o z motnjami napadov, o z boleznimi srca, o z manj kot 28 tedni gestacijske starosti in/ali telesno maso < 1000 g, še posebej pri prejemanju parenteralne prehrane, o s sočasnim dajanjem zdravil, ki motijo metabolizem kofeina.
English: The Member States shall ensure that the card contains the following key elements and is provided by the Marketing Authorisation Holder to all neonatal intensive care units where the product is likely to be used at launch of the product: - That Peyona is for the treatment of primary apnoea - That treatment with Peyona must be provided in a neonatal intensive care unit and initiated and supervised by a physician experienced in neonatal intensive care - Details of the loading and maintenance dosages and that caffeine may accumulate in premature neonates because of its long half-life.
Slovenian: Države članice morajo zagotoviti, da kartica vsebuje naslednje ključne elemente in jo imetnik dovoljenja za promet z zdravilom priskrbi vsem enotam za intenzivno nego novorojenčkom, kjer se bo zdravilo po vsej verjetnosti uporabljalo ob izdaji zdravila na trg: - Zdravilo Peyona je namenjeno zdravljenju primarne apneje.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanja in navodila za uporabo, so zadnje verzije pridobljene v postopku koordinacijske skupine
English: Annex III Summary of product characteristics, labelling and package leaflet
Slovenian: PRILOGA III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILO ZA UPORABO
English: This overview was last updated in April 2018.
Slovenian: Pregled je bil nazadnje posodobljen aprila 2018.
English: Further information on Credelio can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Credelio so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In all studies below animals had natural infestations.
Slovenian: V vseh študijah, navedenih v nadaljevanju, so živali imele naravne infestacije.
English: Credelio received a marketing authorisation valid throughout the EU on 25 April 2017.
Slovenian: Zdravilo Credelio je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 25. aprila 2017.
English: The European Medicines Agency decided that Credelio'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 Credelio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Credelio
Slovenian: Druge informacije o zdravilu Credelio
English: Lotilaner kills fleas before they can lay eggs and so helps to reduce contamination of the animal's environment.
Slovenian: Lotilaner ubije bolhe, preden te lahko izležejo jajčeca, in tako pomaga zmanjšati kontaminacijo okolja živali.
English: Credelio is effective for one month and treatment can be repeated every month.
Slovenian: Zdravilo Credelio učinkuje en mesec, zdravljenje pa se lahko ponovi vsak mesec.
English: Because ticks must start feeding on the animal 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 živali, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so morda okuženi.
English: Why is Credelio authorised in the EU?
Slovenian: Zakaj je zdravilo Credelio odobreno v EU?
English: This means that it kills parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Slovenian: To pomeni, da ubije zajedavce, ki živijo na koži ali v dlaki živali, kot so na primer bolhe in klopi.
English: It contains the active substance lotilaner.
Slovenian: Vsebuje učinkovino lotilaner.
English: It blocks the normal movement of charged 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 delcev v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gamaaminomasleno kislino (GABA) in glutamatom, tj. snovema, ki prenašata sporočila med živci (živčna prenašalca).
English: Lotilaner kills these parasites that have ingested the blood by acting on their nervous system.
Slovenian: Lotilaner ubije zajedavce, ki so zaužili kri živali, tako da deluje na njihov živčni sistem.
English: An overview of Credelio and why it is authorised in the EU
Slovenian: Pregled zdravila Credelio in zakaj je odobreno v EU
English: The dose depends on the animal's weight.
Slovenian: Odmerek je odvisen od telesne mase živali.
English: What are the risks associated with Credelio?
Slovenian: Kakšna tveganja so povezana z zdravilom Credelio?
English: In order to be exposed to the active substance, fleas and ticks must have attached to the skin and commenced feeding on the animal's blood.
Slovenian: Da bi bili bolhe in klopi izpostavljeni učinkovini, se morajo pritrditi na kožo in se začeti hraniti s krvjo živali.
English: What benefits of Credelio have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Credelio izkazalo v študijah?
English: The active substance in Credelio, lotilaner, acts as an ‘ectoparasiticide'.
Slovenian: Učinkovina v zdravilu Credelio, lotilaner, deluje kot ektoparaziticid.
English: What is Credelio and what is it used for?
Slovenian: Kaj je zdravilo Credelio in za kaj se uporablja?
English: Credelio is available as chewable tablets in seven different strengths (the lowest two strengths for cats, the rest for dogs) which are given to the animals with food or within 30 minutes after feeding.
Slovenian: Zdravilo Credelio je na voljo v obliki žvečljivih tablet s sedmimi jakostmi (najnižji dve jakosti za mačke, preostale pa za pse), ki se živalim dajejo skupaj s hrano ali v 30 minutah po njej.
English: For more information about using Credelio, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Credelio glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: Credelio can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Slovenian: Uporablja se lahko kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh).
English: Credelio is a veterinary medicine used to treat flea and tick infestations in dogs and cats.
Slovenian: Zdravilo Credelio je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje infestacij z bolhami in klopi pri psih in mačkah.
English: Credelio reduced flea counts by 97% over one month and was as effective as the other medicine.
Slovenian: Zdravilo Credelio je v enem mesecu število bolh zmanjšalo za 97 % in je bilo enako učinkovito kot drugo zdravilo.
English: How does Credelio work?
Slovenian: Kako zdravilo Credelio deluje?
English: After being given to dogs, Credelio kills fleas within 4 hours and ticks within 48 hours of attachment.
Slovenian: Pri dajanju zdravila Credelio psom to bolhe ubije v štirih urah, klope pa v 48 urah po prisesanju.
English: After being given to cats, Credelio kills fleas within 12 hours and ticks within 24 hours of attachment.
Slovenian: Pri dajanju zdravila mačkam to bolhe ubije v 12 urah, klope pa v 24 urah po prisesanju.
English: How is Credelio used?
Slovenian: Kako se zdravilo Credelio uporablja?
English: In a small field study involving dogs with ticks, 47 dogs were treated once with Credelio and 35 dogs were treated with a spot-on medicine containing fipronil and another active substance, (s)-methoprene.
Slovenian: V manjši terenski študiji, ki je vključevala pse s klopi, so 47 psov enkrat zdravili z zdravilom Credelio, 35 psov pa z zdravilom za kožni nanos, ki vsebuje fipronil in drugo učinkovino, (s)-metopren.
English: The study showed Credelio to be as effective as the other medicine in reducing tick counts over four weeks and tick counts were reduced by 100% for Credelio treated dogs.
Slovenian: Študija je pokazala, da je zdravilo Credelio pri zmanjševanju števila klopov v štiritedenskem obdobju enako učinkovito kot drugo zdravilo, in sicer se je število klopov pri psih, zdravljenih z zdravilom Credelio, zmanjšalo za 100 %.
English: In a one month study involving cats with fleas, 121 cats were treated with Credelio and 61 cats with a spot-on medicine containing fipronil and (s)-methoprene.
Slovenian: V enomesečni študiji, ki je vključevala mačke z bolhami, je bilo 121 mačk zdravljenih z zdravilom Credelio, 61 mačk pa z zdravilom za kožni nanos, ki vsebuje fipronil in (s)-metopren.
English: In a 12-week field study involving dogs with fleas, 128 dogs were treated with Credelio every four weeks and 64 dogs with a spot-on medicine containing fipronil, another medicine to treat flea infestation.
Slovenian: V 12-tedenski terenski študiji, ki je vključevala pse z bolhami, so 128 psov zdravili z zdravilom Credelio vsake štiri tedne, 64 psov pa z zdravilom za kožni nanos, ki vsebuje fipronil, tj. drugim zdravilom za zdravljenje infestacij z bolhami.
English: Credelio was as effective as the other medicine in reducing tick counts and reduced tick counts by 99% during the study.
Slovenian: Zdravilo Credelio je bilo pri zmanjševanju števila klopov enako učinkovito kot drugo zdravilo, in sicer se je število klopov med študijo zmanjšalo za 99 %.
English: A second larger field study of dogs with ticks involved 127 dogs treated with Credelio monthly for 3 months whilst 68 dogs were treated with a spot-on medicine containing fipronil and (s)-methoprene.
Slovenian: Druga, večja terenska študija pri psih s klopi je vključevala 127 psov, ki so bili v obdobju treh mesecev enkrat mesečno zdravljeni z zdravilom Credelio, in 68 psov, zdravljenih z zdravilom za kožni nanos, ki vsebuje fipronil in (s)-metopren.
English: In a further three month study involving cats with ticks, 112 cats were treated with Credelio every month and 57 cats with a spot-on medicine containing fipronil.
Slovenian: V drugi, trimesečni študiji z mačkami s klopi je bilo 112 mačk enkrat mesečno zdravljenih z zdravilom Credelio, 57 mačk pa z zdravilom za kožni nanos, ki vsebuje fipronil.
English: The study showed Credelio to be as effective as the other medicine in reducing the flea counts over the 12 weeks and dogs treated with Credelio had flea counts reduced by 99%.
Slovenian: Študija je pokazala, da je zdravilo Credelio pri zmanjševanju števila bolh v 12-tedenskem obdobju enako učinkovito kot drugo zdravilo, in sicer se je število bolh pri psih, zdravljenih z zdravilom Credelio, zmanjšalo za 99 %.
English: MA (EU) Numbers
Slovenian: Številka MA (EU)
English: Pack size blister (alu/alu) 30 tablets blister (alu/alu) 90 (3 x 30) tablets (multipack)
Slovenian: 90 (3 x 30) tablet (večje pakiranje)
English: You should take your medicine regularly at the same time each day.
Slovenian: Zdravilo jemljite redno, vsak dan ob istem času.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/649/001-016
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/649/001-016
English: • Your doctor may order blood tests
Slovenian: • bo vaš zdravnik morda naročil preiskave krvi.
English: This may be detectable via blood or urine tests.
Slovenian: To je mogoče ugotoviti s preiskavami krvi ali urina.
English: Changes in levels of certain substances in your blood or urine.
Slovenian: • spremembe ravni določenih snovi v krvi ali urinu.
English: Some of the side effects may be serious.
Slovenian: Nekateri neželeni učinki so lahko resni.
English: Not applicable.
Slovenian: ni priporočena.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Slovenian: TTP je potencialno usodno stanje, ki zahteva takojšnje zdravljenje vključno s plazmaferezo.
English: Magyarország Teva Gyógyszergyár Zrt.
Slovenian: Teva Gyógyszergyár Zrt