natgillin/translations-raw huggingface dataset:
Съдържа активната субстанция лотиланер (lotilaner).
It contains the active substance lotilaner.
Активната субстанция в Credelio, лотиланер, действа като „ектопаразитицид“.
The active substance in Credelio, lotilaner, acts as an ‘ectoparasiticide'.
Какви ползи от Credelio са установени в проучванията?
What benefits of Credelio have been shown in studies?
Лотиланер убива паразитите, погълнали кръвта на животното, като действа върху нервната им система.
Lotilaner kills these parasites that have ingested the blood by acting on their nervous system.
Какви са рисковете, свързани с Credelio?
What are the risks associated with Credelio?
Какво представлява Credelio и за какво се използва?
What is Credelio and what is it used for?
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.
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.
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.
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.
Credelio може да се използва като част от лечението на алергичен дерматит, предизвикан от бълхи (алергична реакция към ухапване от бълхи).
Credelio can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Credelio е ветеринарномедицински продукт, който се използва за третиране на опаразитяване с бълхи и кърлежи при кучета и котки.
Credelio is a veterinary medicine used to treat flea and tick infestations in dogs and cats.
Преглед на Credelio и причини за лицензирането му ЕС
An overview of Credelio and why it is authorised in the EU
Credelio намалява броя на бълхите с 97 % в продължение на един месец и е също толкова ефективен, колкото другото лекарство.
Credelio reduced flea counts by 97% over one month and was as effective as the other medicine.
След прилагане при кучета Credelio убива бълхите до 4 часа, а кърлежите до 48 часа след прикрепването им.
After being given to dogs, Credelio kills fleas within 4 hours and ticks within 48 hours of attachment.
Как действа Credelio?
How does Credelio work?
Как се използва Credelio?
How is Credelio used?
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.
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.
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.
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.
Credelio е също толкова ефективен, колкото другото лекарство за намаляване на броя на кърлежите, като намалява кърлежите с 99 % по време на проучването.
Credelio was as effective as the other medicine in reducing tick counts and reduced ticks by 99% during the study.
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.
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.
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.
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.
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.
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.
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 %.
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%.
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.
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.
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.
After being given to cats, Credelio kills fleas within 12 hours and ticks within 24 hours of attachment.
90 (3 x 30) таблетки (групова опаковка)
Pack size blister (alu/alu) 30 tablets blister (alu/alu) 90 (3 x 30) tablets (multipack)
РУ (ЕС) номер (Свободно избрано) име
MA (EU) Numbers
Taki ukrepi pomagajo varovati okolje.
These measures will help to protect the environment.
Zelo redki, neznani*
Very rare, not known*
24 mesecev
24 months
Zdravilo jemljite redno, vsak dan ob istem času.
You should take your medicine regularly at the same time each day.
Optimalno trajanje zdravljenja še ni bilo formalno potrjeno.
The optimal duration of treatment has not been formally established.
Klinična učinkovitost in varnost
Clinical efficacy and safety
Za dodatne informacije glejte poglavje 5.1.
For further information please refer to section 5.1.
Cmax je dosežena približno 30 do 60 minut po uporabi zdravila.
Cmax occurs approximately 30 to 60 minutes after dosing.
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.
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.
Nekateri neželeni učinki so lahko resni.
Some of the side effects may be serious.
tega zdravila otrokom ali mladostnikom, ker ne deluje.
Children and adolescents Do not give this medicine to children because it does not work.
s hrano ali brez nje.
You can take it with or without food.
Dodatno je bilo klinično prenašanje dobro pri vseh bolnikih.
In addition, clinical tolerance was good in all patients.
• morate zdravniku povedati, če načrtujete operativni poseg (vključno z zobozdravstvenim
• You should tell your doctor if surgery (including dental) is planned
TTP je potencialno usodno stanje, ki zahteva takojšnje zdravljenje vključno s plazmaferezo.
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Bolnike so zdravili do 5 let.
Patients were treated for up to 5 years.
teh analiz ni imela zadostne velikosti za odkritje razlik v izidu pri slabih metabolizatorjih.
None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The expiry date refers to the last day of that month.
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).
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).
Bolniki so bili zdravljeni do enega leta.
Patients were treated for up to one year.
bo vaš zdravnik morda naročil preiskave krvi.
• Your doctor may order blood tests
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.
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.
Klinični pomen te interakcije ni znan.
The clinical relevance of this interaction is uncertain.
2031 GA Haarlem Nizozemska
2031 GA Haarlem The Netherlands
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.
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.
Mehanizem delovanja
Mechanism of action
Zaradi pomanjkanja podatkov, klopidogrela ne moremo priporočati v prvih 7 dneh po akutni ishemični kapi.
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
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).
Pomožne snovi z znanim učinkom:
Excipients with known effect:
V populaciji bolnikov je bilo 41,8 % žensk.
The patient population included 41.8 % women.
To je povezano z načinom delovanja vašega zdravila, saj le-to preprečuje strjevanje krvi.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
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.
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.
Študija ACTIVE-A pa je vključila bolnike, ki niso mogli prejemati zdravljenja z VKA, ker zanj niso bili primerni ali ga niso želeli.
The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Izdelovalci:
Manufacturer:
V literaturi je za azijske populacije na voljo malo podatkov za oceno kliničnih posledic genotipizacije tega CYP na dogodke kliničnega izida.
From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events.
To so lahko znaki zmanjšanja števila nekaterih krvnih celic.
These may be due to a decrease of some blood cells
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.
The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel is bleeding.
Distribucija
Distribution
Neposrednega (blaga toksičnost) ali posrednega (neprijeten okus) učinka zato ni mogoče izključiti.
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Bolniki morajo zdravnike in zobozdravnike obvestiti, da jemljejo klopidogrel, preden določijo termin za kakršenkoli kirurški poseg in preden začnejo jemati katerokoli novo zdravilo.
Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Absorpcija je najmanj 50 %, na podlagi metabolitov klopidrogela, izločenih z urinom.
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Podatki iz kliničnih preskušanj podpirajo uporabo do 12 mesecev, največjo korist pa so opazili po 3 mesecih (glejte poglavje 5.1).
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (seesection 5.1).
so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
svojega zdravnika, če jemljete ali ste pred kratkim jemali katero od naslednjih zdravil:
Talk to your doctor if you are using or have recently used any of the following medicines:
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.
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.
Če se pri vas pojavi kateri od sledečih simptomov, se nemudoma posvetujte z zdravnikom:
If you suffer from any of the following symptoms you should contact your doctor immediately:
Poleg tega varnostne značilnosti klopidogrela v tej podskupini bolnikov niso bile
Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Ena tableta vsebuje 62,16 mg laktoze monohidrata in 10 mg hidrogeniranega ricinusovega olja.
Each tablet contains 62.16 mg lactose monohydrate and 10 mg hydrogenated castor oil.
Kemična in fizikalna stabilnost zdravila v HDPE steklenički je bila dokazana za naslednje obdobje:
For the HDPE bottle presentation chemical and physical in-use stability have been demonstrated for:
Pred uporabo preberite priloženo navodilo.
Read the package leaflet before use.
C. DRUGI POGOJI ALI ZAHTEVE DOVOLJENJA
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Atrijska fibrilacija
Atrial fibrillation
TEVA Santé SA Rue Bellocier 89107 Sens Francija
TEVA Santé SA Rue Bellocier 89107 Sens France
Tableto položitev v usta in jo pogoltnite skupaj z vodo ali drugo tekočino.
Put the tablet in your mouth and swallow with water or another liquid.
Vendar pa je zaradi pomanjkanja študij o interakcijah z drugimi nesteroidnimi protivnetnimi zdravili trenutno nejasno, ali povečano tveganje za pojav gastrointestinalne krvavitve obstaja pri vseh nesteroidnih protivnetnih zdravilih.
However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Preiskave
Investigations
Poleg neželenih učinkov v kliničnih študijah so bile neželene reakcije prijavljene tudi spontano.
In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Populacijo bolnikov je sestavljalo 19,7 % žensk in 29,2 % bolnikov v starosti ≥ 65 let.
The patient population included 19.7% women and 29.2% patients ≥65 years.
Ustrezna odmerna shema za to populacijo bolnikov v kliničnih preskušanjih ni bila ugotovljena.
An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJ
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Velika Britanija
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Store in the original package to protect from light.
Med jemanjem tega zdravila ne smete dojiti.
You should not breastfeed while taking this medicine.
Med tem dolgoročnim spremljanjem niso ugotovili novih
No new safety concerns were noted during this long-term follow-up.
Analiza skupne umrljivosti kot sekundarnega opazovanega dogodka ni pokazala značilne razlike med klopidogrelom (5,8 %) in acetilsalicilno kislino (6,0 %).
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
in glavni krožeči (neaktivni) metabolit se in vitro reverzibilno vežeta na humane plazemske proteine (98 % oziroma 94 %).
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Nosečnost in dojenje Priporočljivo je, da tega zdravila v nosečnosti ne uporabljate.
Pregnancy and breast-feeding It is preferable not to use this medicine during pregnancy.
Na primer ibuprofen, diklofenak in meloksikam.
E.g. ibuprofen, diclofenac and meloxicam.
driska,
It may harm them,
Manj izrazita zmanjšana izpostavljenost presnovkov je bila opažena pri pantoprazolu ali lansoprazolu.
Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
TEVA Santé SA, Rue Bellocier, 89107 Sens, Francija
TEVA Santé SA, Rue Bellocier, 89107 Sens, France
Ko so klopidogrel dajali podganam v obdobju laktacije, je povzročil rahlo upočasnitev razvoja mladičev.
When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Pri vezavi in vitro ni nasičenja v širokem koncentracijskem razponu.
The binding is non-saturable in vitro over a wide concentration range.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, steklenički in pretisnem omotu.
Do not use this medicine after the expiry date which is stated on the outer carton, bottle or blister after EXP.
Študiji ACTIVE-W in ACTIVE-A, ločeni preskušanji v programu ACTIVE, sta vključili bolnike z atrijsko fibrilacijo (AF), ki so imeli vsaj en dejavnik tveganja za žilne dogodke.
The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Klopidogrel podaljša čas krvavitve in ga je potrebno uporabljati previdno pri bolnikih z lezijami, ki so nagnjene h krvavitvi (zlasti gastrointestinalne in intraokularne).
Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
zmedenost in halucinacije,
Confusion or hallucinations
Citokrom P450 2C19 (CYP2C19)
Cytochrome P450 2C19 (CYP2C19)
Učinka na delež ponovnih hospitalizacij zaradi nestabilne angine niso opazili.
There was no observed effect on the rate of rehospitalisation for unstable angina.
Vseeno sočasna uporaba 500 mg acetilsalicilne kisline dvakrat na dan en dan ni pomembno povečala podaljšanja časa krvavitve, sprožene z jemanjem klopidogrela.
However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by clopidogrel intake.
Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, Nizozemska
Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands
Ko so slabi metabolizatorji prejemali shemo 600 mg/150 mg, je bila izpostavljenost aktivnemu presnovku večja kot s shemo 300 mg/75 mg.
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Če ste imeli alergijo ali alergijsko reakcijo na katero koli zdravilo, ki ste ga jemali.
• You have had an allergy or reaction to any medicine used to treat your disease.
Ker kliničnih podatkov o izpostavljenosti klopidogrelu med nosečnostjo ni, je kot previdnostni ukrep zaželeno, da se klopidogrela v nosečnosti ne uporablja.
As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
V študiji relativne biološke uporabnosti pri odraslih je imela pripravljena raztopina klopidogrela podoben obseg in rahlo večjo hitrost absorpcije glavnega krožečega (neaktivnega) presnovka kakor odobrena tableta.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet
- Stekleničke vsebujejo 30 ali 100 filmsko obloženih tablet.
- Bottles contain 30 or 100 film-coated tablets.
Agregacija trombocitov in čas krvavitve sta se postopoma vrnila na izhodiščno vrednost, na splošno v 5 dneh po ukinitvi zdravljenja.
Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.
ZA SPROŠČANJE SERIJ B. POGOJI ALI ZAHTEVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Ni znano ali se klopidogrel pri človeku izloča v materino mleko.
It is unknown whether clopidogrel is excreted in human breast milk.
svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Če ste noseči ali sumite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete zdravilo Klopidogrel Teva Pharma B.V..
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Pharma B.V.
Približno 88 % bolnikov je sočasno prejemalo acetilsalicilno kislino (v razponu od 1 do 23 mg/kg/dan).
Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
In vitro poteka ta presnovna pot s CYP3A4, CYP2C19, CYP1A2 in CYP2B6.
In vitro, this metabolic pathway is mediated by CYP3A4, CYP2C19, CYP1A2 and CYP2B6.
• heparin (zdravilo, ki se uporablja za preprečevanje strjevanja krvi).
• Heparin (medicine used to prevent blood clotting).
V podskupini z miokardnim infarktom je večina bolnikov prejemala acetilsalicilno kislino prvih nekaj dni po akutnem miokardnem infarktu.
In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
Antacidi niso spremenili obsega absorpcije klopidogrela.
Antacids did not modify the extent of clopidogrel absorption.
Nedavni miokardni infarkt (MI), nedavna kap ali ugotovljena periferna arterijska bolezen
Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Za vse morebitne informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: