natgillin/translations-raw huggingface dataset:
• The PRAC considered, based on the assessment of the impact of risk minimisation measures already implemented (reduction of the dose and implementation of a sequential treatment scheme) and on the published literature, that the additional risk minimisation measures proposed by the Marketing Authorisation Holder and discussed during the assessment would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level.
• PRAC je uzeo u obzir, na temelju ocjene učinka mjera smanjenja rizika koje se već provode (smanjenje doze i provedba sheme sekvencijalnog liječenja) i objavljene literature, da dodatne mjere smanjenja rizika koje predlaže nositelj odobrenja za stavljanje lijeka u promet (MAH) i o kojima je raspravljano tijekom postupka ocjene neće biti u mogućnosti primjereno smanjiti rizike od ozbiljnih nuspojava na klinički prihvatljivoj razini.
Further risk minimisation measures such as additional amendments to the product information (restriction of the indication and contra-indications), communication material (dear Health Care Professional Communication) and restricted prescription were also considered during the discussions.
Daljnje mjere smanjenja rizika poput dodatnih izmjena podataka o proizvodu (ograničenje indikacija i kontraindikacija), komunikacijskog materijala (komunikacija sa zdravstvenim radnikom) i ograničenih recepata također su razmotrene tijekom rasprava.
During the assessment, the MAH confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical benefit of oral almitrine in in the management of chronic hypoxemia in COPD.
Tijekom ocjene, MAH je potvrdio da su izneseni svi dostupni podaci i da neće biti u mogućnosti osigurati dodatne podatke koji bi pokazali kliničku korist oralne primjene almitrina u upravljanju kroničnom hipoksemijom kod KOBP-a.
No published data focusing on the proper mechanism of almitrine in the occurrence of those adverse events was provided by the MAH.
MAH nije dostavio ikakve objavljene podatke vezane za ispravan mehanizam almitrina kod pojavljivanja navedenih štetnih događaja.
• The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of almitrine in its approved indications.
• PRAC je uzeo u obzir da su dostupni podaci o učinkovitosti, uključujući podatke koji su postali dostupni nakon prvotnog odobrenja za stavljanje gotovog lijeka u promet, pokazali samo izuzetno ograničenu kliničku učinkovitost almitrina u njegovim odobrenim indikacijama.
With regards to peripheral neuropathy, a total of 2304 cases of peripheral neuropathy have been spontaneously reported in patients exposed to almitrine since the launch of the product (from 1983 to December 2012).
Što se tiče periferne neuropatije, u ispitanika izloženih almitrinu od stavljanja proizvoda u promet (od 1983. do prosinca 2012.) spontano je prijavljeno ukupno 2304 slučaja periferne neuropatije.
Further risk minimisation measures, as proposed by the MAH, such as additional amendments to the product information (restriction of the indication and contra-indications), communication material (dear Health Care Professional Communication) and restricted prescription (restriction to one month for pneumologists and hospital's use) were also considered during the discussions.
Daljnje mjere smanjenja rizika, prema prijedlogu MAH-a, poput dodatnih izmjena podataka o proizvodu (restrikcija indikacija i kontraindikacija), komunikacijskog materijala (komunikacija sa zdravstvenim radnikom) i restriktivnih recepata (restrikcija na jedan mjesec za pulmologe i bolničku primjenu) također su razmotrene tijekom rasprava.
In addition to publications of clinical studies, the PRAC reviewed post marketing data provided by the MAH.
Osim publikacija kliničkih ispitivanja, PRAC je revidirao podatke MAH-a zabilježene nakon stavljanja gotovog lijeka u promet.
Among the clinical studies in Chronic Obstructive Pulmonary Disease (COPD) patients, only those with more than 30 patients treated with therapeutic doses of almitrine for at least 3-month were selected for an efficacy and safety overview.
U slučaju kliničkih ispitivanja ispitanika s kroničnom opstruktivnom plućnom bolesti (KOBP), za reviziju učinkovitosti i neškodljivosti odabrana su samo ona s više od 30 ispitanika liječenih terapijskim dozama almitrina kroz najmanje tri mjeseca.
• The PRAC took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of oral almitrine in chronic obstructive pulmonary disease (COPD).
• PRAC je uzeo u obzir stav MAH-a da su svi dostupni podaci izneseni i da ne postoji mogućnost pružanja dodatnih podataka radi pokazivanja kliničke koristi oralne primjene almitrina kod kronične opstruktivne bolesti pluća (KOBP).
Long-term use of almitrine bismesylate is currently recommended at a dose level of 50 to 100 mg per day with limitation of the dose at 50 mg per day in patients with body weight less than 50 kg. After 3-month treatment, maintenance therapy of the sequential type is recommended: a 1-month interval for every 2 months treatment.
Dugoročna primjena almitrin bismesilata trenutačno je preporučena u dozi od 50 do 100 mg na dan s ograničenjem doze od 50 mg na dan u pacijenata tjelesne težine manje od 50 kg.
Important weight losses and peripheral neuropathies which can potentially not recover or lead to sequelae, are still reported with almitrine despite risk minimisation measures in place for several years.
neuropatije, kod kojih postoji mogućnost neoporavka ili posljedica, i dalje se prijavljuju vezano za almitrin usprkos mjerama smanjenja rizika koje su na snazi nekoliko godina.
Despite sequential doses regimen and amendments in the SmPC, the PRAC noted serious cases of neuropathy and weight loss continued to be reported, including some cases with positive rechallenge, and leading sometimes to sequelae.
Usprkos propisanim sekvencijalnim dozama i izmjenama SmPC-a, PRAC je zapazio ozbiljne slučajeve neuropatije i gubitka težine koji se i dalje prijavljuju, ponekad s pozitivnom ponovnom primjenom, ponekad s posljedicama.
Overall, based on the available published data and data from spontaneous reports, the PRAC considers that almitrine use is associated with serious cases of peripheral neuropathy, some with positive rechallenge, and weight loss.
Sveukupno, na temelju dostupnih objavljenih podataka i podataka spontanih prijava, PRAC smatra da je primjena almitrina povezana s ozbiljnim slučajevima periferne neuropatije, uz pozitivnu ponovnu primjenu u pojedinim slučajevima, i gubitkom težine.
The PRAC therefore concluded that the benefit-risk balance of almitrine containing medicinal products for oral administration is not favourable.
PRAC je stoga zaključio da uravnoteženost koristi i rizika medicinskih proizvoda za oralnu primjenu koji sadrže almitrin nije povoljna.
• The PRAC considered the totality of the data available for almitrine containing products for oral administration in relation to the risk of peripheral neuropathy and weight loss.
• PRAC je razmotrio ukupne dostupne podatke vezane za proizvode za oralnu primjenu koji sadrže almitrin u vezi s rizikom od periferne neuropatije i gubitka težine.
Based on the published literature and post marketing data, the PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
Na temelju objavljene literature i podataka dobivenih nakon stavljanja gotovog lijeka u promet, PRAC smatra da mjere smanjenja rizika koje je predložio MAH ne bi mogle primjereno smanjiti rizike od ozbiljnih nuspojava na klinički prihvatljivu razinu: bilo kakva dodatna komunikacija o rizicima vezanima za neuropatije i gubitak težine, s kojima su liječnici koji propisuju lijekove već upoznati, ne bi doprinijela sigurnoj primjeni proizvoda.
The PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
PRAC smatra da mjere smanjenja rizika koje je predložio MAH ne bi mogle primjereno smanjiti rizike od ozbiljnih nuspojava na klinički prihvatljivu razinu: bilo kakva dodatna komunikacija o rizicima vezanim za neuropatije i gubitak težine, s kojima su liječnici koji propisuju lijekove već upoznati, ne bi doprinijela sigurnijoj primjeni proizvoda.
Further to the review of the available efficacy data, including data which became available since the initial marketing authorisation, the PRAC concluded that the available data only showed very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Nastavno na reviziju dostupnih podataka o učinkovitosti, uključujući podatke koji su postali dostupni nakon prvotnog odobrenja za stavljanje gotovog lijeka u promet, PRAC je zaključio da su dostupni podaci pokazali samo izuzetno ograničenu učinkovitost oralne primjene almitrina u njegovim odobrenim indikacijama što se ne smatra dokazom koristi za pacijente u trenutačnom kontekstu terapijske strategije i znanja stečenog vezano za respiratorne bolesti.
Based on the above, the PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Na temelju prethodno navedenog, PRAC je smatrao da su dostupni podaci o učinkovitosti, uključujući podatke koji su postali dostupni nakon prvotnog odobrenja za stavljanje lijeka u promet, pokazali samo izuzetno ograničenu učinkovitost oralne primjene almitrina u njegovim odobrenim indikacijama što se ne smatra dokazom koristi za pacijente u trenutačnom kontekstu terapijske strategije i znanja stečenog vezano za respiratorne bolesti.
Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp.
Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp. 2003 ; 70 : 275-283 (PE32001)
Overall summary of the scientific evaluation of Almitrine containing medicinal products for oral use by PRAC
Cjelokupni sažetak PRAC-ove znanstvene ocjene medicinskih proizvoda za oralnu primjenu koji sadrže almitrin
Almitrine bismesylate is indicated in patients with respiratory failure with hypoxemia related to obstructive bronchitis.
Almitrin bismesilat (almitrine bismesylate) izdaje se pacijentima s respiratornim problemima i hipoksemijom povezanom s opstruktivnim bronhitisom.
Sequential treatment with low dose Almitrine bismesylate in hypoxaemic chronic obstructive airways disease.
Two years treatment with Almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
Pneumology 1998 Mar;52(3):121-7 (PE24412) Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of Almitrine in patients with chronic obstrutive lung disease.
Pneumology 1998 Mar;52(3):121-7 (PE24412) 11 Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour
Based on the data from clinical studies and post-marketing experience, the two main safety concerns with almitrine are peripheral neuropathy and weight loss.
Podaci kliničkih ispitivanja i iskustva nakon stavljanja lijeka u promet pokazali su da su periferna neuropatija i gubitak težine dva glavna pitanja neškodljivosti vezana za almitrin.
The PRAC, as a consequence, concluded that pursuant to Article 116 of Directive 2001/83/EC the risk-benefit balance for almitrine containing products for oral administration is not favourable.
Direktive 2001/83/EZ uravnoteženost koristi i rizika za proizvode za oralnu primjenu koji sadrže almitrin nije povoljna.
Ansquer J.C., Bertrand A., Blaive B., Charpin J., Chretien J., Decroix G., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Sadoul P., Voisin C. The therapeutic value and acceptability of Vectarion 50 mg coated tablets (Almitrine bismesylate) at the dose of 100 mg per day.
Ansquer J.C., Bertrand A., Blaive B., Charpin J., Chretien J., Decroix G., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Sadoul P., Voisin C.
The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the Almitrine containing medicinal products for oral use, agrees with the recommendation therein as stated below:
Nakon razmatranja preporuke Povjerenstva za ocjenu rizika na području farmakovigilancije (PRAC, Pharmacovigilance Risk Assessment Committee) od 16. svibnja 2013. vezane za medicinske proizvode za oralnu primjenu koji sadrže almitrin, Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh, Mutual Recognition & Decentralised Procedures - Human) slaže se s preporukom kako je navedeno u nastavku:
• The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
• PRAC je uzeo u obzir da je oralna primjena almitrina povezana s ozbiljnim nuspojavama periferne neuropatije i gubitka težine, ponekad s posljedicama.
Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt J.A.
Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt J.A. Sequential treatment with low dose Almitrine bismesylate in hypoxaemic chronic obstructive airways disease.
• Central nervous events (sleep disorders such as insomnia, drowsiness, agitation, anxiety, palpitations, dizziness) Based on the available publications of clinical studies with sequential treatment scheme891011 (i.e. two months of treatment followed by one month treatment interruption), the rate of withdrawal remained predominant in the almitrine groups as compared to placebo groups in the majority of the publications.
Na temelju dostupnih publikacija kliničkih ispitivanja sa sekvencijalnom shemom liječenja891011 (odnosno dvomjesečnim liječenjem praćenim jednomjesečnim prekidom liječenja), stopa ustezanja
Based on the above the PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Na temelju gore navedenog PRAC je zaključio da je oralna primjena almitrina povezana s ozbiljnim nuspojavama periferne neuropatije i gubitka težine, ponekad s posljedicama.
The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Opći zaključak PRAC je uzeo u obzir da je oralna primjena almitrina povezana s ozbiljnim nuspojavama periferne neuropatije i gubitka težine, ponekad s posljedicama.
Bardsley P.A., Howard P., De-Backer W., Vermeire P., Mairesse M., Ledent C., Radermecker M., Bury T., Ansquer J.. Two years treatment with Almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
4 Bardsley P.A., Howard P., De-Backer W., Vermeire P., Mairesse M., Ledent C., Radermecker M., Bury T., Ansquer J..
This summary was last updated in 06-2016.
Sažetak je posljednji put ažuriran 06.2016.
The medicine can only be obtained with a prescription.
Lijek se može nabaviti samo uz recept.
For patients weighing less than 50 kg, the dose depends on body weight.
Za bolesnike koji imaju manje od 50 kg, doza ovisi o tjelesnoj težini.
It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Dostupan je u obliku tableta (250 mg, 500 mg, 750 mg i 1000 mg).
This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
To je vrsta epilepsije kod koje pretjerana električna aktivnost u jednom dijelu mozga uzrokuje simptome kao što su iznenadni trzaji jednog dijela tijela, oštećenje sluha, njuha ili vida, otupljenost ili iznenadni osjećaj straha.
Lower doses are used in patients who have problems with their kidneys (such as older patients).
Manje doze koriste se u bolesnika koji imaju probleme s bubrezima (na primjer stariji bolesnici).
The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Točno djelovanje levetiracetama nije jasno, ali povezuje se s proteinom pod nazivom sinaptički vezikularni protein 2A koji sudjeluje u otpuštanju kemijskih glasnika iz živčanih stanica.
The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Levetiracetam Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Patients who cannot take tablets should be given a solution containing levetiracetam.
Bolesnicima koji ne mogu uzimati tablete potrebno je dati otopinu koja sadržava levetiracetam.
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).
• primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u bolesnika starijih od 12. godine života s idiopatskom generaliziranom epilepsijom (vrsta epilepsije za koju se vjeruje da je nasljedna).
This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.
To lijeku Levetiracetam Accord pomaže da stabilizira električnu aktivnost u mozgu i spriječi napadaje.
What measures are being taken to ensure the safe and effective use of Levetiracetam Accord?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Levetiracetam Accord?
For more information about treatment with Levetiracetam Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Levetiracetam Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
• miokloničkih napadaja (kratki, snažni trzaji mišića ili skupine mišića) u bolesnika starijih od 12. godine života s juvenilnom miokloničkom epilepsijom;
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.
Europska komisija izdala je odobrenje za stavljanje lijeka Levetiracetam Accord u promet koje vrijedi na prostoru Europske unije od 3. listopada 2011.
This means that Levetiracetam Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
To znači da je Levetiracetam Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Keppra.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Accord have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Levetiracetam Accord nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
Levetiracetam Accord can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Levetiracetam Accord može se primjenjivati samostalno u bolesnika od 16. godine života s novodijagnosticiranom epilepsijom, u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje.
Because Levetiracetam Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Levetiracetam Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
• partial-onset seizures with or without generalisation in patients from 1 month of age;
• parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u dojenčadi od prvog mjeseca života;
When Levetiracetam Accord is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Kada se Levetiracetam Accord dodaje drugom antiepileptičkom liječenju, početna doza u bolesnika od 12. godine života koji imaju više od 50 kg iznosi 500 mg dvaput dnevno.
What are the benefits and risks of Levetiracetam Accord?
Koje su koristi i rizici lijeka Levetiracetam Accord?
The daily dose can be increased up to 1,500 mg twice a day.
Dnevna doza može se povećati do 1500 mg dvaput dnevno.
Other information about Levetiracetam Accord
Ostale informacije o lijeku Levetiracetam Accord
This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Levetiracetam Accord.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Accord.
Objašnjava kako je Odbor za za humanu uporabu (CHMP) ocijenio lijek kako bi preporučio njegovo odobrenje u EU-u te uvjete za primjenu lijeka Levetiracetam Accord.
Because Levetiracetam Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Budući da je Levetiracetam Accord generički lijek, ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Keppra.
Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Stoga je stav CHMP-a da korist nadmašuje identificiran rizik, kao i za Keppru.
The Committee recommended that Levetiracetam Accord be given marketing authorisation.
Odbor je preporučio davanje odobrenja za stavljanje lijeka Levetiracetam Accord u promet.
When Levetiracetam Accord is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kad se Levetiracetam Accord samostalno uzima, početna doza je 250 mg dvaput dnevno, a nakon dva tjedna povećava se na 500 mg dvaput dnevno.
Levetiracetam Accord is a medicine that contains the active substance levetiracetam.
Levetiracetam Accord je lijek koji sadržava djelatnu tvar levetiracetam.
What is Levetiracetam Accord?
Što je Levetiracetam Accord?