natgillin/translations-raw huggingface dataset:
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Krka d.d.
Iz varnostnih razlogov naj matere, ki se zdravijo z zdravilom Clopidogrel Krka d.d., ne dojijo.
• Severe hepatic impairment.
- Huda jetrna okvara.
The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
ST-spojnice (nestabilna angina ali MI brez Q-zobca) do 24 ur po zadnji epizodi bolečine v prsih ali simptomih, značilnih za ishemijo.
In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group .The incidence of major bleeding was similar between groups .
V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA.
Name and address of the manufacturer responsible for batch release
PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Acquired haemophilia
Pridobljena hemofilija
Acquired haemophilia has been reported following use of clopidogrel.
Po uporabi klopidogrela je bila opisana pridobljena hemofilija.
A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition has been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
Pri bolnikih, okuženih z virusom HIV, ki se zdravijo s protiretrovirusnim zdravljenjem, okrepljenim z ritonavirjem ali kobicistatom, so dokazali pomembno zmanjšano izpostavljenost aktivnemu presnovku klopidogrela in zmanjšano zaviranje trombocitov.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Klopidogrel previdno dajemo bolnikom, ki prejemajo sočasno zaviralce glikoproteina IIb/IIIa (glejte poglavje 4.4).
(4 tablets of 75 mg) once at the start of treatment.
(štiri 75-mg tablete).
The recommended dose for ASA was 75 to 100 mg/day.
Priporočeni odmerek ASA je bil od 75 do 100 mg na dan. Bolnike so zdravili do 5 let.
STATEMENT OF ACTIVE SUBSTANCE(S)
Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin)
If you forget to take a dose of Clopidogrel Krka d.d., but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Pri manjših urezninah ali poškodbah, npr. pri britju, navadno ni razloga za skrb, če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4 "Možni neželeni učinki").
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR =
Pri bolnikih, ki so bili v preizkušanje vključeni samo na podlagi nedavnega MI, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT: -4 %; IZ: -22,5 do 11,7 /p = 0,639/).
While you are taking Clopidogrel Krka d.d.
Ko jemljete zdravilo Clopidogrel Krka d.d.
contains - The active substance is clopidogrel.
- Učinkovina je klopidogrel.
SSRIs: since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Selektivni zaviralci privzema serotonina (SSRI; Selective serotonin re-uptake inhibitors): Selektivni zaviralci privzema serotonina vplivajo na aktivacijo trombocitov in povečajo nevarnost krvavitve, zato je ob sočasnem jemanju selektivnih zaviralcev privzema serotonina in klopidogrela potrebna previdnost.
ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
V skupini s klopidogrelom + ASA je bilo več intrakranialnih krvavitev (1,4 %) kot v skupini s placebom + ASA (0,8 %).
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions'').
Pri manjših vrezninah ali poškodbah, npr. če se urežete ali brijete, navadno ni razloga za skrb, če pa ste glede krvavitve v kakršnihkoli dvomih, se morate takoj posvetovati s svojim zdravnikom, (glejte poglavje 2 "Opozorila in previdnostni ukrepi").
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: - zvišana telesna temperatura, znaki okužbe ali huda utrujenost, kar so znaki redkega zmanjšanja števila določenih krvnih celic; - znaki jetrnih težav, npr. porumenelost kože in/ali oči (zlatenica), ki so lahko povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2 "Opozorila in previdnostni ukrepi"); - otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži kar so lahko znaki alergijske reakcije.
Haematoma
Encimi
Pharmaceutical Form
Farmacvtska oblika
EMA Number
Številka EU
29 May 2013 EMA/313994/2013
29. maj 2013 EMA/313994/2013
The Agency's recommendations are based on an EU-wide safety review.
Priporočila agencije temeljijo na varnostnem pregledu na celotnem območju EU.
The review of oral almitrine-containing medicines was initiated in December 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Pregled peroralnih zdravil, ki vsebujejo almitrin, je bil sprožen decembra 2012 na zahtevo Francije v skladu s členom 31 Direktive 2001/83/ES.
A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Pregled teh podatkov je najprej izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
Patients who have any questions should speak to their doctor or pharmacist.
Bolniki, ki imajo kakršna koli vprašanja, naj se pogovorijo z zdravnikom ali farmacevtom.
Additional results from clinical studies suggested that neuropathy was most common after three months or more of treatment.
Dodatni rezultati kliničnih študij so pokazali, da je bila nevropatija najpogostejša po zdravljenju, ki je trajalo 3 mesece ali dlje.
PRAC recommendation will be directly implemented following CMDh consensus
Priporočilo odbora PRAC se bo izvajalo neposredno po sprejetju soglasja v skupini CMDh
The PRAC noted that cases continue to be reported even after additional precautions on the use of the medicines were put in place.
Odbor PRAC je opazil, da še vedno poročajo o primerih, čeprav so uvedli dodatne previdnostne ukrepe za uporabo teh zdravil.
• Because almitrine has been shown to carry a risk of damage to the nerves in the hands and feet as well as weight loss, and because a number of alternative treatments are now available, it will be withdrawn across the EU.
• Ker so pokazali, da je pri almitrinu prisotno tveganje za poškodbo živcev v dlaneh in stopalih ter izguba telesne mase, in ker so zdaj na voljo številne druge oblike zdravljenja, bo zdravilo umaknjeno na celotnem območju EU.
• The understanding of COPD and the therapeutic options for its management have changed considerably since the original authorisation of oral almitrine.
• Razumevanje KOPB in terapevtske možnosti za obravnavo te bolezni so se od prvotne odobritve peroralnega almitrina zelo spremenili.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the EU Member States, has endorsed the recommendation by the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the European Union (EU).
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), tj. regulativni organ za zdravila, ki predstavlja države članice EU, je potrdila priporočilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, da je treba dovoljenje za promet s peroralnimi zdravili, ki vsebujejo almitrin, umakniti po celotni Evropski uniji (EU).
The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be withdrawn throughout the EU.
Skupina CMDh se je strinjala s sklepom odbora PRAC, da koristi teh zdravil ne odtehtajo z njimi povezanih tveganj, ter sprejela dokončno stališče, da je treba dovoljenja za promet z zdravili po vsej Evropi umakniti.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Skupina CMDh je organ, ki zastopa države članice EU, in je odgovorna za zagotovitev enotnih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
• Almitrine, a medicine that was authorised several years ago to be taken by mouth to help breathing, is not one of the currently recommended treatments for lung diseases.
• Almitrin, zdravilo, odobreno pred več leti za pomoč pri dihanju, ki se zaužije skozi usta (peroralno), ni ena od trenutno priporočenih oblik zdravljenja pljučnih bolezni.
These conditions pose a particular problem in patients with lung conditions known as chronic obstructive pulmonary disease (COPD), where the airways and air sacs inside the lungs become damaged or blocked.
Ti pogoji še zlasti predstavljajo težavo pri bolnikih s pljučno boleznijo, imenovano kronična obstruktivna pljučna bolezen (KOPB), pri kateri postanejo dihalne poti in zračni mešički v pljučih poškodovani ali zaprti.
As almitrine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Ker so vsa zdravila, ki vsebujejo almitrin, odobrena na nacionalni ravni, so bila priporočila odbora PRAC poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
• Oral almitrine-containing products should no longer be prescribed or dispensed to patients.
• Peroralnih zdravil, ki vsebujejo almitrin, bolnikom ni več dovoljeno predpisovati ali dajati.
Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD.
Poleg tega peroralni almitrin ni več vključen kot priporočeno zdravljenje v mednarodne smernice za obravnavo KOPB.
• The PRAC noted that cases of weight loss and peripheral neuropathy have continued to be reported, despite the introduction of a number of risk minimisation measures, including sequential administration (two months treatment followed by a one-month break), dose reduction and appropriate warnings in the product information.
• Odbor PRAC je ugotovil, da še vedno poročajo o primerih izgube telesne mase in periferne nevropatije, čeprav so uvedli številne ukrepe za zmanjševanje tveganja, vključno s ciklično uporabo (dva meseca zdravljenja, ki mu sledi enomesečni presledek), zmanjšanjem odmerka in ustreznimi opozorili v informacijah o zdravilu.
Almitrine is a stimulant of the part of the brain responsible for the breathing reflex.
Almitrin spodbuja del možganov, odgovoren za dihalni refleks.
In three of the latter cases, patients were rechallenged with almitrine and this led to a recurrence of neuropathic symptoms, including sequelae in two.
Pri treh primerih so pri bolnikih ponovno uporabili almitrin, kar je povzročilo ponoven pojav nevropatskih simptomov, vključno s posledicami pri dveh primerih.
In 489 cases, neuropathy was indicated to have been irreversible, or to have led to sequelae.
Pri 489 primerih je bila nevropatija označena kot ireverzibilna ali s posledicami.
• Prescribers and pharmacists will be sent a letter giving them further information on the withdrawal of oral almitrine.
• Zdravniki, ki predpisujejo zdravilo, in farmacevti bodo prejeli pismo z dodatnimi informacijami o umiku peroralnega almitrina.
In view of the potentially serious adverse effects and the lack of an established role in the current management of hypoxaemic pulmonary disease, the benefit-risk of oral almitrine is no longer considered favourable.
Zaradi morebitnih resnih neželenih učinkov in odsotnosti uveljavljene vloge pri trenutni obravnavi pljučne bolezni s hipoksemijo razmerje med tveganji in koristmi peroralnega almitrina ni več ugodno.
Almitrine is a respiratory stimulant, a medicine that stimulates the part of the brain responsible for the breathing reflex.
Almitrin je respiratorni stimulans, ki spodbuja del možganov, odgovoren za dihalni refleks.
Almitrine is not one of the treatments currently recommended in international guidelines for COPD management (GOLD), and the available evidence does not support a clinical benefit for long-term oral treatment with the medicine.
Almitrin ni ena od oblik zdravljenja, ki se trenutno priporočajo v mednarodnih smernicah za obravnavo KOPB (GOLD), razpoložljivi dokazi pa ne podpirajo klinične koristi dolgotrajnega peroralnega zdravljenja s tem zdravilom.
• If you are taking an almitrine-containing medicine, you should make a non-urgent appointment with your doctor to review your treatment.
• Če jemljete zdravila, ki vsebujejo almitrin, se dogovorite za neurgenten obisk pri svojem zdravniku, ki bo pregledal vaše zdravljenje.
The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients.
Odbor PRAC je sklenil, da obstaja jasna povezava med zdravljenjem s peroralnim almitrinom in morebitno resno ter dolgotrajno periferno nevropatijo (poškodbo živcev v dlaneh in stopalih) in veliko izgubo telesne mase, ki dodatno ošibi bolnike.
As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the Member States where oral almitrine is authorised, according to an agreed timetable which should be completed by 25 July 2013.
Ker je skupina CMDh soglasno podprla priporočilo odbora PRAC, ga bodo odslej neposredno izvajale vse države članice, v katerih je odobren peroralni almitrin, v skladu z dogovorjenim časovnim razporedom, ki bo pripravljen do 25. julija 2013.
The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD.
Francoska agencija za zdravila, Nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM), je zaprosila za varnostni pregled peroralnega almitrina zaradi pomislekov glede neželenih učinkov in stališča, da razpoložljivi dokazi niso podprli uporabe tega zdravila za trenutno obravnavo KOPB.
In line with the PRAC recommendation, the marketing authorisations for oral almitrine-containing medicines will be revoked in the affected Member States, which means that permission for the medicines to be marketed has been withdrawn.
Skladno s priporočilom odbora PRAC se bodo dovoljenja za promet s peroralnimi zdravili, ki vsebujejo almitrin, odvzela v zadevnih državah članicah, kar pomeni, da se je dovoljenje za promet s temi zdravili umaknilo.
Of the spontaneous reports, 7 cases of weight loss and 20 of peripheral neuropathy had been reported since September 2003 when all these measures were in operation.
Od septembra 2003, ko so uvedli vse te ukrepe, so spontano poročali o 7 primerih izgube telesne mase in 20 primerih periferne nevropatije.
• The safety review confirmed a clear association of oral almitrine therapy with significant weight loss and peripheral neuropathy (which can be long-lasting and possibly irreversible).
• Varnostni pregled je potrdil jasno povezavo med zdravljenjem s peroralnim almitrinom in veliko izgubo telesne mase ter periferno nevropatijo (ki je lahko dolgotrajna in morebitno ireverzibilna).
• Pharmacists should refer patients presenting a new or repeat prescription to their treating physician.
• Farmacevti morajo bolnike, ki imajo nov ali obnovljiv recept, napotiti k njihovim lečečim zdravnikom.
• Patients being treated with oral almitrine should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered.
• Zdravljenje bolnikov, ki jemljejo peroralni almitrin, je treba pregledati ob naslednjem načrtovanem obisku in razmisliti o uporabi drugih ustreznih oblik zdravljenja.
In the EU, it is authorised in France, Poland and Portugal as 50-mg tablets (Vectarion, Armanor) for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).
V EU je v obliki 50-miligramskih tablet (Vectarion, Armanor) odobren v Franciji, na Poljskem in Portugalskem, kjer se uporablja za zdravljenje kronične dihalne odpovedi (nezmožnosti pljuč za pravilen vnos kisika in izdihovanje ogljikovega dioksida), povezane s hipoksemijo (nižje ravni kisika v krvi od normalnih).
In the EU, it is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).
V EU je odobren v Franciji, na Poljskem in Portugalskem, kjer se uporablja peroralno za zdravljenje kronične dihalne odpovedi (nezmožnosti pljuč za pravilen vnos kisika in izdihovanje ogljikovega dioksida), povezane s hipoksemijo (nižje ravni kisika v krvi od normalnih).
As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where oral almitrine-containing medicines are authorised.
Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice, v katerih so peroralna zdravila, ki vsebujejo almitrin, odobrena.
The company marketing almitrine identified 795 spontaneously reported cases of weight loss and 2,304 cases of peripheral neuropathy over the 30-year period that the medicine has been marketed (representing several million patient months of treatment).
Imetnik dovoljenja za promet z almitrinom je v 30-letnem obdobju trženja zdravila (kar predstavlja več milijonov bolnikovih mesecev zdravljenja) odkril 795 spontano poročanih primerov izgube telesne mase in 2304 primerov periferne nevropatije.
This will depend on your individual situation.
Ta bo odvisna od vaše individualne situacije.
However, a risk cannot be completely excluded.
Vendar tveganja ni mogoče popolnoma izključiti.
Read the information carefully and follow the instructions.
Informacije si pozorno preberite in sledite navodilom.
The usual doses are shown below.
Običajni odmerki so prikazani spodaj.
Children aged 2 to 18 years
Otroci (stari od 2 do 18 let)
Your doctor will have to advise you on what vaccines you can have.
Vaš zdravnik vam bo svetoval, katera cepiva lahko prejmete.
The effect of sunlight
Učinek sončne svetlobe
Take the medicine pack with you.
S seboj vzemite škatlo zdravila.
• wearing protective clothing which also covers your head, neck, arms and legs
• uporabljate zaščitna oblačila, ki pokrijejo tudi vašo glavo, vrat, roke in noge,
Your doctor will do regular blood tests to check for any changes in
Vaš zdravnik bo izvajal redne preiskave krvi, da bo preverjal spremembe v:
• You have sex without using an effective method of contraception.
• imate spolne odnose brez uporabe učinkovite metode kontracepcije.
Influenza vaccination may be of value.
Cepljenje proti gripi je lahko koristno.
This means you may catch more infections than usual.
To pomeni, da se lahko okužite pogosteje kot ponavadi.
Do this by:
To storite tako, da:
These patients should also be carefully observed.
Te bolnike moramo še posebej skrbno nadzorovati.
Usual problems
Običajne težave
Do not take this medicine if any of the above applies to you.
Ne jemljite tega zdravila, če karkoli izmed naštetega velja za vas.
Other unwanted effects may include:
Drugi neželeni učinki lahko vključujejo:
In many of these cases, no adverse events were reported.
Pri veliko teh primerov o neželenih dogodkih niso poročali.
Prescribers should refer to national guidelines for influenza vaccination.
Predpisovalci se morajo ravnati po nacionalnih navodilih za cepljenje proti gripi.
• using a sunscreen with a high protection factor.
• uporabljate sončne kreme z visokim zaščitnim faktorjem.
The amount you take depends on the type of transplant you have had.
Količina ki jo vzamete, je odvisna od tipa presadka, ki ga imate.
If you are planning to have a child, talk to your doctor about the potential risks.
Če nameravate imeti otroka, se pogovorite z zdravnikom o možnih tveganjih.
Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
Čim prej se posvetujte z zdravnikom, če menite, da vaša kontracepcija morda ni bila učinkovita oziroma če ste pozabili vzeti kontracepcijsko tableto.
• the number of your blood cells
• številu krvnih celic,
Hepatic transplant patients were followed for at least 1 year, but less than 3 years.
Bolnikom z jetrnim presadkom so sledili vsaj 1 leto, vendar pa manj kot 3 leta.
As a result, there is an increased risk of skin cancer.
Posledično obstaja zvečana možnost nastanka kožnega raka.
Date of latest renewal: 27 May 2015
Datum zadnje revizije besedila: 27. maj 2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 7. oktober 2010
Guides should also mention that patients should not to give this drug to any other person.
V vodnikih mora biti prav tako omenjeno, da bolniki ne smejo dati tega zdravila drugim osebam.
Effects of hepatic disease on this process probably depend on the particular disease.
Učinki jetrne bolezni na ta proces so verjetno odvisni od vrste bolezni.
This is because small amounts of the medicine can pass into the mother's milk.
Manjše količine zdravila namreč lahko prehajajo v materino mleko.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Zdi se, da je tveganje bolj odvisno od intenzivnosti in trajanja imunosupresije kot od uporabe določene učinkovine.
See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Glejte tudi dodatne informacije v tem poglavju pod "Opozorila in previdnostni ukrepi" in "Nosečnost in dojenje".
Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Zdravnik lahko zahteva več kot en test, da se pred začetkom zdravljenja zagotovi, da niste noseči.
Results of all pregnancy tests should be discussed with the patient.
O rezultatih vseh testov nosečnosti se je treba pogovoriti z bolnico.
Contraception (see section 4.6)
Kontracepcija (glejte poglavje 4.6)
These changes are not associated with impaired neutrophil function.
Te spremembe niso povezane s slabšo funkcijo nevtrofilcev.
Talk to your doctor about the most suitable contraception for you.
S svojim zdravnikom se pogovorite o izbiri kontracepcije, ki je za vas najbolj primerna.
There are limited safety and efficacy data in children below the age of 2 years.
O varnosti in učinkovitosti pri otrocih, mlajših od dveh let je na voljo premalo podatkov.