FrancophonIA/ELRC3.0 huggingface dataset:
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.
Bulgarian: В контекста на това преразглеждане се взема предвид ограничената информация за профила на стомашно-чревна токсичност, в сравнение с други
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.
Bulgarian: Че дозата на кофеина изразена като кофеин база е половината от дозата на кофеина изразен като кофеин цитрат (20 mg кофеин цитрат са еквивалентни на 10 mg кофеин база) и че рецептите трябва ясно да посочват, че ще се приема кофеин цитрат.
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.
Bulgarian: Държавите членки трябва да съгласуват с Притежателя на разрешението за употреба окончателния текст за карта, подходяща за показване в отделения за интензивни неонатални грижи.
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.
Bulgarian: В частност ако се заподозрат конвулсии, припадъци, некротизиращ ентероколит, симптоми и признаци на отнемане на кофеин, медицински нетипично намаление на натрупването на тегло на новороденото или взаимодействия с други лекарства, свързани с употребата на кофеин цитрат, те трябва да се докладват до <впишете местното наименование и адрес на Chiesi Farmaceutici S.p.A.>
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Bulgarian: И ЕФЕКТИВНА УПОТРЕБА НА ЛЕКАРСТВЕНИЯ ПРОДУКТ, КОИТО ЩЕ БЪДАТ НАЛОЖЕНИ
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.
Bulgarian: Че лечение с Peyona трябва да се осигури в едно интензивно отделение за неонатални грижи и започнато и следено от лекар, който има опит при интензивни неонатални грижи.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Bulgarian: Валиднaта кратка характеристика на продукта, опаковката и листовката за пациента, са окончателните текстове, постигнати по време на процедурата в Координационната група.
English: Annex III Summary of product characteristics, labelling and package leaflet
Bulgarian: ПРИЛОЖЕНИЕ III КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА, ОЗНАЧЕНИЯ ВЪРХУ ОПАКОВКАТА
English: Further information on Credelio can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Bulgarian: Допълнителна информация за Credelio може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The dose depends on the animal's weight.
Bulgarian: Дозата зависи от телесното тегло на животното.
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.
Bulgarian: Европейската агенция по лекарствата реши, че ползите от Credelio са по-големи от рисковете и този продукт може да бъде лицензиран за употреба в ЕС.
English: This overview was last updated in April 2018.
Bulgarian: Дата на последно актуализиране на настоящия преглед 04-2018.
English: In all studies below animals had natural infestations.
Bulgarian: Във всички проучвания, описани по-долу, животните са били естествено опаразитени.
English: Why is Credelio authorised in the EU?
Bulgarian: Защо Credelio е лицензиран в ЕС?
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).
Bulgarian: Той блокира нормалното движение на заредените частици в нервните клетки и извън тях, особено на свързаните с гама-аминомаслена киселина (GABA) и глутамат - две субстанции, които предават съобщения между нервните клетки (невротрансмитери).
English: Credelio received a marketing authorisation valid throughout the EU on 25 April 2017.
Bulgarian: На 25 април 2017 г. Credelio получава лиценз за употреба, валиден в Европейския съюз.
English: This means that it kills parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Bulgarian: Това означава, че убива паразитите, които живеят по кожата или в козината на животните, например бълхи и кърлежи.
English: Lotilaner kills fleas before they can lay eggs and so helps to reduce contamination of the animal's environment.
Bulgarian: Лотиланер убива бълхите, преди да могат да снесат яйца, и по този начин помага да се намали замърсяването на средата на животното.
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.
Bulgarian: За да бъдат изложени на действието на активната субстанция, бълхите и кърлежите трябва да се прикрепят към кожата и да започнат да се хранят с кръвта на животното.
English: Other information about Credelio
Bulgarian: Допълнителна информация за Credelio:
English: For more information about using Credelio, see the package leaflet or contact your veterinarian or pharmacist.
Bulgarian: За повече информация относно употребата на Credelio прочетете листовката или се свържете със своя ветеринарен лекар или фармацевт.
English: It contains the active substance lotilaner.
Bulgarian: Съдържа активната субстанция лотиланер (lotilaner).
English: The active substance in Credelio, lotilaner, acts as an ‘ectoparasiticide'.
Bulgarian: Активната субстанция в Credelio, лотиланер, действа като „ектопаразитицид“.
English: What benefits of Credelio have been shown in studies?
Bulgarian: Какви ползи от Credelio са установени в проучванията?
English: Lotilaner kills these parasites that have ingested the blood by acting on their nervous system.
Bulgarian: Лотиланер убива паразитите, погълнали кръвта на животното, като действа върху нервната им система.
English: What are the risks associated with Credelio?
Bulgarian: Какви са рисковете, свързани с Credelio?
English: What is Credelio and what is it used for?
Bulgarian: Какво представлява Credelio и за какво се използва?
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.
Bulgarian: За да бъдат убити от лекарството, кърлежите трябва да започнат да се хранят от животното и не е изключен риск от предаване на болести, с които може да са заразени.
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.
Bulgarian: Credelio се предлага под формата на таблетки за дъвчене в седем различни концентрации (двете по-ниски концентрации са за котки, останалите - за кучета), които се дават на животните с храна или в рамките на 30 минути след хранене.
English: Credelio can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Bulgarian: Credelio може да се използва като част от лечението на алергичен дерматит, предизвикан от бълхи (алергична реакция към ухапване от бълхи).
English: Credelio is a veterinary medicine used to treat flea and tick infestations in dogs and cats.
Bulgarian: Credelio е ветеринарномедицински продукт, който се използва за третиране на опаразитяване с бълхи и кърлежи при кучета и котки.
English: An overview of Credelio and why it is authorised in the EU
Bulgarian: Преглед на Credelio и причини за лицензирането му ЕС
English: Credelio reduced flea counts by 97% over one month and was as effective as the other medicine.
Bulgarian: Credelio намалява броя на бълхите с 97 % в продължение на един месец и е също толкова ефективен, колкото другото лекарство.
English: After being given to dogs, Credelio kills fleas within 4 hours and ticks within 48 hours of attachment.
Bulgarian: След прилагане при кучета Credelio убива бълхите до 4 часа, а кърлежите до 48 часа след прикрепването им.
English: How does Credelio work?
Bulgarian: Как действа Credelio?
English: How is Credelio used?
Bulgarian: Как се използва Credelio?
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.
Bulgarian: В малко практическо проучване при кучета, опаразитени с кърлежи, 47 кучета са третирани веднъж с Credelio, а 35 кучета - с лекарство за накапване, съдържащо фипронил и друга активна субстанция, (s)-метопрен.
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.
Bulgarian: В проучването е установено, че Credelio е също толкова ефективен, колкото другото лекарство за намаляване на броя на кърлежите за период от четири седмици, като броят на кърлежите намалява със 100 % при третираните с Credelio кучета.
English: Credelio was as effective as the other medicine in reducing tick counts and reduced ticks by 99% during the study.
Bulgarian: Credelio е също толкова ефективен, колкото другото лекарство за намаляване на броя на кърлежите, като намалява кърлежите с 99 % по време на проучването.
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.
Bulgarian: В допълнително тримесечно проучване при котки, опаразитени с кърлежи, 112 котки са третирани с Credelio всеки месец, а 57 котки - с лекарство за накапване, съдържащо фипронил.
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.
Bulgarian: В едномесечно практическо проучване при котки, опаразитени с бълхи, 121 котки са третирани с Credelio, а 61 котки - с лекарство за накапване, съдържащо фипронил и (s)-метопрен.
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.
Bulgarian: В 12-седмично практическо проучване при кучета, опаразитени с бълхи, 128 кучета са третирани с Credelio на всеки четири седмици, а 64 кучета - с лекарство за накапване, съдържащо фипронил, друго лекарство за третиране на опаразитяване с бълхи.
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%.
Bulgarian: В проучването е установено, че Credelio е също толкова ефективен, колкото другото лекарство за намаляване на броя на бълхите за период от 12 седмици, като при кучетата, третирани с Credelio, броят на бълхите намалява с 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.
Bulgarian: Във второ, по-голямо практическо проучване на кучета, опаразитени с кърлежи, са обхванати 127 кучета, третирани ежемесечно с Credelio за 3 месеца, като същевременно 68 кучета са третирани с лекарство за накапване, съдържащо фипронил и (s)-метопрен.
English: After being given to cats, Credelio kills fleas within 12 hours and ticks within 24 hours of attachment.
Bulgarian: След прилагане при котки Credelio убива бълхите до 12 часа, а кърлежите до 24 часа след прикрепването им. Credelio е ефективен в продължение на един месец, а лечението може да се повтаря всеки месец.
English: Pack size blister (alu/alu) 30 tablets blister (alu/alu) 90 (3 x 30) tablets (multipack)
Bulgarian: 90 (3 x 30) таблетки (групова опаковка)
English: MA (EU) Numbers
Bulgarian: РУ (ЕС) номер (Свободно избрано) име
English: These measures will help to protect the environment.
Bulgarian: Taki ukrepi pomagajo varovati okolje.
English: Very rare, not known*
Bulgarian: Zelo redki, neznani*
English: 24 months
Bulgarian: 24 mesecev
English: You should take your medicine regularly at the same time each day.
Bulgarian: Zdravilo jemljite redno, vsak dan ob istem času.
English: The optimal duration of treatment has not been formally established.
Bulgarian: Optimalno trajanje zdravljenja še ni bilo formalno potrjeno.
English: Clinical efficacy and safety
Bulgarian: Klinična učinkovitost in varnost
English: For further information please refer to section 5.1.
Bulgarian: Za dodatne informacije glejte poglavje 5.1.
English: Cmax occurs approximately 30 to 60 minutes after dosing.
Bulgarian: Cmax je dosežena približno 30 do 60 minut po uporabi zdravila.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Bulgarian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Some of the side effects may be serious.
Bulgarian: Nekateri neželeni učinki so lahko resni.
English: Children and adolescents Do not give this medicine to children because it does not work.
Bulgarian: tega zdravila otrokom ali mladostnikom, ker ne deluje.
English: You can take it with or without food.
Bulgarian: s hrano ali brez nje.
English: In addition, clinical tolerance was good in all patients.
Bulgarian: Dodatno je bilo klinično prenašanje dobro pri vseh bolnikih.
English: • You should tell your doctor if surgery (including dental) is planned
Bulgarian: • morate zdravniku povedati, če načrtujete operativni poseg (vključno z zobozdravstvenim
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Bulgarian: TTP je potencialno usodno stanje, ki zahteva takojšnje zdravljenje vključno s plazmaferezo.
English: Patients were treated for up to 5 years.
Bulgarian: Bolnike so zdravili do 5 let.
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Bulgarian: teh analiz ni imela zadostne velikosti za odkritje razlik v izidu pri slabih metabolizatorjih.
English: The expiry date refers to the last day of that month.
Bulgarian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) , not known (cannot be estimated from the available data).
Bulgarian: Njihova pogostnost je navedena z upoštevanjem naslednjega dogovora: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patients were treated for up to one year.
Bulgarian: Bolniki so bili zdravljeni do enega leta.
English: • Your doctor may order blood tests
Bulgarian: bo vaš zdravnik morda naročil preiskave krvi.
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Bulgarian: Ker študija CAPRIE ni bila načrtovana za oceno učinkovitosti v posameznih podskupinah, ni jasno, ali so razlike pri zmanjšanju relativnega tveganja glede na vključitvene pogoje resnične ali slučajne.
English: The clinical relevance of this interaction is uncertain.
Bulgarian: Klinični pomen te interakcije ni znan.
English: 2031 GA Haarlem The Netherlands
Bulgarian: 2031 GA Haarlem Nizozemska
English: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Bulgarian: Varnost klopidogrela so vrednotili pri več kot 44.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 12.000 bolniki, ki so se zdravili 1 leto ali več.
English: Mechanism of action
Bulgarian: Mehanizem delovanja
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Bulgarian: Zaradi pomanjkanja podatkov, klopidogrela ne moremo priporočati v prvih 7 dneh po akutni ishemični kapi.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Bulgarian: Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Excipients with known effect:
Bulgarian: Pomožne snovi z znanim učinkom:
English: The patient population included 41.8 % women.
Bulgarian: V populaciji bolnikov je bilo 41,8 % žensk.
English: This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Bulgarian: To je povezano z načinom delovanja vašega zdravila, saj le-to preprečuje strjevanje krvi.
English: In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Bulgarian: Med dolgoročnim varnostnim spremljanjem te študije je 26 bolnikov, ki so pri enem letu starosti še vedno imeli spoj, prejemalo klopidogrel do 18. meseca starosti.
English: The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Bulgarian: Študija ACTIVE-A pa je vključila bolnike, ki niso mogli prejemati zdravljenja z VKA, ker zanj niso bili primerni ali ga niso želeli.
English: Manufacturer:
Bulgarian: Izdelovalci:
English: From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events.
Bulgarian: V literaturi je za azijske populacije na voljo malo podatkov za oceno kliničnih posledic genotipizacije tega CYP na dogodke kliničnega izida.
English: These may be due to a decrease of some blood cells
Bulgarian: To so lahko znaki zmanjšanja števila nekaterih krvnih celic.
English: The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel is bleeding.
Bulgarian: Najpogostejši neželeni učinek (pojavi se pri 1 do 10 bolnikih na 100 bolnikov), o katerem so poročali ob jemanju zdravil, ki vsebujejo klopidogrel, je krvavitev.
English: Distribution
Bulgarian: Distribucija
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Bulgarian: Neposrednega (blaga toksičnost) ali posrednega (neprijeten okus) učinka zato ni mogoče izključiti.
English: Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Bulgarian: Bolniki morajo zdravnike in zobozdravnike obvestiti, da jemljejo klopidogrel, preden določijo termin za kakršenkoli kirurški poseg in preden začnejo jemati katerokoli novo zdravilo.
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Bulgarian: Absorpcija je najmanj 50 %, na podlagi metabolitov klopidrogela, izločenih z urinom.
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (seesection 5.1).
Bulgarian: Podatki iz kliničnih preskušanj podpirajo uporabo do 12 mesecev, največjo korist pa so opazili po 3 mesecih (glejte poglavje 5.1).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Bulgarian: so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
English: Talk to your doctor if you are using or have recently used any of the following medicines:
Bulgarian: svojega zdravnika, če jemljete ali ste pred kratkim jemali katero od naslednjih zdravil:
English: In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Bulgarian: Poleg tega analiza podskupin glede na starost nakazuje, da so koristi klopidogrela pri bolnikih, starejših od 75 let, manjše od tistih, ki so jih opazili pri bolnikih ≤ 75 let.
English: If you suffer from any of the following symptoms you should contact your doctor immediately:
Bulgarian: Če se pri vas pojavi kateri od sledečih simptomov, se nemudoma posvetujte z zdravnikom:
English: Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Bulgarian: Poleg tega varnostne značilnosti klopidogrela v tej podskupini bolnikov niso bile
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Bulgarian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Each tablet contains 62.16 mg lactose monohydrate and 10 mg hydrogenated castor oil.
Bulgarian: Ena tableta vsebuje 62,16 mg laktoze monohidrata in 10 mg hidrogeniranega ricinusovega olja.
English: For the HDPE bottle presentation chemical and physical in-use stability have been demonstrated for:
Bulgarian: Kemična in fizikalna stabilnost zdravila v HDPE steklenički je bila dokazana za naslednje obdobje:
English: Read the package leaflet before use.
Bulgarian: Pred uporabo preberite priloženo navodilo.