natgillin/translations-raw huggingface dataset:
[the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
[spodaj navedene trenutno odobrene indikacije je treba izbrisati (natančna navedba indikacije se lahko od zdravila do zdravila razlikuje)]
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
• Simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)
• Prophylaxis of migraine headache All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
• Preprečevanje migrenskega glavobola Vse sklice na zgoraj navedene indikacije je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
A. Summary of Product Characteristics
A. Povzetek glavnih značilnosti zdravila
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Vse sklice na zgoraj navedene indikacije je treba izbrisati iz ustreznih poglavij navodil za uporabo.
• Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)
• Pomožno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II)
• Acute retinopathies of vascular origin
• Akutne retinopatije žilnega izvora
• Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
• Pomožno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Popravki ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
• Ancillary treatment of Raynaud's syndrome
• Pomožno zdravljenje Raynaudovega sindroma
B. Package Leaflet
Priloga III
The PRAC therefore revised the indication accordingly.
PRAC je v skladu s to ugotovitvijo ustrezno spremenil indikacijo.
This was reflected in the product information in order to adequately inform healthcare providers and patients.
Ta sprememba je bila vključena v informacije o zdravilu, da bodo zdravstveni delavci in bolniki z njo ustrezno seznanjeni.
PRAC recommendation
Priporočilo odbora PRAC
The PRAC considered that the clinical development data on acipimox was very limited and noted that no clinical outcome studies were conducted.
PRAC je menil, da so podatki o acipimoksu iz kliničnega razvoja zelo omejeni, in ugotovil, da niso bile opravljene nobene študije o kliničnem izidu.
Nevertheless, the PRAC considered that the efficacy of acipimox in lowering blood lipids in patients with some forms of hyperlipoproteinaemia is demonstrated.
Kljub temu pa je menil, da je bila učinkovitost acipimoksa pri zniževanju ravni lipidov v krvi pri bolnikih z določenimi oblikami hiperlipoproteinemije dokazana.
As a result of the review, the PRAC recommended the suspension of the marketing authorisations of these products.
Na podlagi pregleda je PRAC priporočil začasni umik dovoljenj za promet s temi zdravili.
The PRAC also noted that according to the experts, the current data available did not have any major impact on the safety profile of acipimox.
Prav tako je PRAC upošteval, da po mnenju izvedencev trenutno razpoložljivi podatki ne vplivajo bistveno na varnostni profil acipimoksa.
The safety data available for acipimox, including data on nicotinic acid obtained from HPS2-THRIVE, showed that the safety profile of acipimox is well characterised.
Podatki o varnosti, ki so na voljo za acipimoks, vključno s podatki o nikotinski kislini, pridobljenimi v študiji HPS2-THRIVE, kažejo, da je varnostni profil acipimoksa dobro opredeljen.
Following the conclusion of these procedures, the PRAC was of the view that the concerns regarding the combination products may also be of relevance for the mono-component products and the Danish Health and Medicines Authority therefore initiated a review under Article 31 of Directive 2001/83/EC to assess the impact of the HPS2-THRIVE data on the benefitrisk balance of these products and to give its recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked and if the supply of the medicinal product should be prohibited.
Po zaključku teh postopkov je PRAC menil, da bi lahko varnostni pomisleki v zvezi s kombiniranimi zdravili veljali tudi za enokomponentna zdravila, zaradi česar je danski organ, pristojen za zdravstvo in zdravila, sprožil pregled v skladu s členom 31 Direktive 2001/83/ES, da bi ocenili, kako podatki iz študije HPS2-THRIVE vplivajo na razmerje med tveganji in koristmi teh zdravil, in da bi podali priporočilo o tem, ali naj se njihova dovoljenja za promet ohranijo, spremenijo, začasno umaknejo ali prekličejo in ali naj se prepove oskrba s temi zdravili.
Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for acipimox-containing medicinal products.
Potem ko je PRAC preučil zadevo, je priporočil spremembo dovoljenj za promet z zdravili, ki vsebujejo acipimoks.
On 19 December 2012, the European Medicines Agency was made aware of preliminary results from a large randomised clinical study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) designed to assess the incremental benefit of extended release nicotinic acid (ERN)/laropiprant (LRPT) versus placebo in over 25,673 high-risk patients.
Evropska agencija za zdravila je bila dne 19. decembra 2012 seznanjena s predhodnimi rezultati obsežne randomizirane klinične študije (Študija zaščite srca 2 - zdravljenje HDL za zmanjšanje pojavnosti vaskularnih dogodkov - HPS2-THRIVE), ki je bila zasnovana za oceno dodatnih koristi nikotinske kisline s podaljšanim sproščanjem (ERN)/laropipranta (LRPT) v primerjavi s placebom pri več kot 25 673 bolnikih z visokim tveganjem.
• The PRAC considered that the available safety data identified a potential risk of muscle toxicity, for which a warning was added to the product information.
• PRAC je menil, da so razpoložljivi podatki o varnosti razkrili možno tveganje za toksične učinke na mišice, zaradi česar so v informacije o zdravilu dodali opozorilo.
Most identified adverse events are already reflected in the acipimox product information and the PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity, which was addressed by adding a warning to the product information.
Večina znanih neželenih dogodkov je že obravnavana v informacijah o zdravilu za acipimoks, poleg tega pa je PRAC menil, da razpoložljivi podatki niso razkrili nobenih novih varnostnih informacij, ki bi vplivale na razmerje med tveganji in koristmi acipimoksa, z izjemo možnega tveganja za toksične učinke na mišice, v zvezi s katerim so v informacije o zdravilu vključili opozorilo.
A review of all available data was undertaken by the Pharmacovigilance Risk Assessment Committee (PRAC) to assess the above safety concerns and their impact on the benefit-risk balance of the centrally authorised combination products Tredaptive, Trevaclyn and Pelzont.
Odbor za oceno tveganja na področju farmakovigilance (PRAC) je pregledal vse razpoložljive podatke, da bi ocenil zgoraj omenjene pomisleke glede varnosti in njihov vpliv na razmerje med tveganji in koristmi kombiniranih zdravil Tredaptive, Trevaclyn in Pelzont, ki so bila odobrena po centraliziranem postopku.
The PRAC also agreed that acipimox should not be indicated for increasing HDL-C or for cardiovascular prevention in line with the recent data casting doubts on the association between elevating HDL-C levels and reducing the risk of cardiovascular disease.
PRAC se je tudi strinjal, da acipimoks ne sme biti indiciran za zviševanje ravni holesterola HDL ali za preprečevanje srčnožilnih bolezni, saj najnovejši podatki vzbujajo dvome o povezavi med višjimi ravnmi holesterola HDL in manjšim tveganjem za srčno-žilne bolezni.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for nicotinic-acid and related substances initiated by Denmark and decided to restrict the scope of the procedure to products containing acipimox, the only high-dose nicotinic acid-related substance indicated in lipid disorders authorised in the EU;
• PRAC je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES, ki ga je Danska sprožila na podlagi farmakovigilančnih podatkov za nikotinsko kislino in sorodne učinkovine, ter se odločil, da bo v sklopu postopka obravnaval samo zdravila, ki vsebujejo acipimoks, saj je to edina v EU odobrena visokoodmerna učinkovina, sorodna nikotinski kislini, ki je indicirana za lipidne motnje;
The PRAC also took into account the views of the European experts consulted in an Ad-Hoc expert meeting, according to which acipimox has a role as lipid-lowering therapy in well-defined settings and indications, such as the treatment of severe hypertriglyceridaemia but only as a second or third line agent.
PRAC je upošteval tudi poglede evropskih izvedencev, s katerimi se je posvetoval na strokovnem sestanku ad hoc in ki so menili, da ima acipimoks vlogo zdravila za zniževanje ravni lipidov pri natančno določenih stanjih in indikacijah, kot je zdravljenje hude hipertrigliceridemije, vendar le kot zdravilo druge ali tretje izbire.
Having reviewed the list of EU products containing nicotinic acid or related substances, the PRAC noted that acipimox is the only high-dose substance indicated in lipid disorders still authorised in the EU and the scope of the procedure was therefore restricted to acipimox-containing products.
Potem ko je pregledal seznam zdravil v EU, ki vsebujejo nikotinsko kislino ali sorodne učinkovine, je PRAC ugotovil, da je acipimoks edina visokoodmerna učinkovina, indicirana za lipidne motnje, ki je še vedno odobrena v EU, zato so v sklopu postopka obravnavali samo zdravila, ki vsebujejo acipimoks.
The CMDh, having considered the PRAC recommendation pursuant to article 107k of Directive 2001/83/EC dated 7 November 2013, reached a position on the variation to the terms of the marketing authorisations of acipimox for which the relevant sections of the summary of product characteristics and package leaflets are set out in Annex III.
Skupina CMDh je na podlagi preučitve priporočila, ki ga je dne 7. novembra 2013 v skladu s členom 107k Direktive 2001/83/ES podal PRAC, sprejela stališče o spremembi pogojev dovoljenj za promet z zdravili, ki vsebujejo acipimoks, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodili za uporabo, opredeljenimi v Prilogi III.
• The PRAC reviewed the totality of the available data, including studies and publications on acipimox, the MAH responses as well as relevant data on nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies;
• PRAC je pregledal vse razpoložljive podatke, vključno s podatki o acipimoksu iz študij in publikacij, odgovori imetnika dovoljenja za promet in ustreznimi podatki o nikotinski kislini, med katerimi so bili tudi tisti iz študij AIM-HIGH in HPS2-THRIVE;
The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo acipimoks, v običajnih pogojih uporabe še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
Having reviewed all the available data, including studies and publications on acipimox as well as data on the related substance nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies, the PRAC considered the efficacy of acipimox in the treatment of certain well-defined lipid disorders to be demonstrated and that acipimox therefore remains a treatment alternative in the management of lipid disorders characterised by elevated plasma levels of triglycerides (Fredrickson type IV hyperlipoproteinaemia), or both triglycerides and cholesterol
Potem ko je pregledal vse razpoložljive podatke, vključno s podatki o acipimoksu iz študij in publikacij ter podatki o sorodni učinkovini nikotinski kislini, med katerimi so bili tudi tisti iz študij AIM-HIGH in HPS2-THRIVE, je PRAC menil, da je učinkovitost acipimoksa pri zdravljenju nekaterih natančno določenih lipidnih motenj dokazana, zaradi česar acipimoks ostaja alternativno zdravilo za zdravljenje lipidnih motenj, za katere so značilne zvišane plazemske koncentracije trigliceridov (hiperlipoproteinemija tipa IV po Fredricksonu) ali trigliceridov in holesterola (hiperlipoproteinemija tipa IIb po Fredricksonu).
The preliminary results of the HPS2-THRIVE study showed that the study did not meet its primary endpoint (reduction of the risk of major vascular events such as heart attack and stroke) as well as a statistically significant increase in the incidence of non-fatal but serious adverse events in the nicotinic acid/laropiprant group compared to the placebo group.
Predhodni rezultati študije HPS2-THRIVE so pokazali, da ni bil dosežen primarni cilj študije (zmanjšanje tveganja za večje vaskularne dogodke, kot sta srčna ter možganska kap) in da se je v skupini z nikotinsko kislino/laropiprantom v primerjavi s skupino s placebom statistično značilno povečala incidenca neželenih učinkov, ki so se sicer končali brez smrtnega izida, vendar so bili resni.
• The PRAC considered that acipimox is efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia) but only, on the basis of available evidence including current medical knowledge on the use of acipimox, as a second or third line agent in patients who have not responded adequately to other treatments such as statin or fibrate treatment;
• PRAC je menil, da je acipimoks učinkovit pri zniževanju ravni trigliceridov pri bolnikih s hipertrigliceridemijo (hiperlipoproteinemijo tipa IV po Fredricksonu) ter bolnikih s hiperholesterolemijo in hipertrigliceridemijo (hiperlipoproteinemijo tipa IIb po Fredricksonu), vendar, kot kažejo razpoložljivi dokazi, vključno s trenutnim medicinskim znanjem o uporabi acipimoksa, samo kot zdravilo druge ali tretje izbire pri bolnikih, ki se niso ustrezno odzvali na zdravljenje z drugimi zdravili, kot so statini ali fibrati;
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing acipimox identified in Annex I remains favourable, subject to the agreed changes to the product information.
Posledično je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo acipimoks in so navedena v Prilogi I, še naprej ugodno pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
The CMDh considered the below PRAC recommendation dated 7 November 2013 with regard to substances related to nicotinic acid (acipimox) indicated for the treatment of lipid disorders.
Skupina CMDh je preučila spodnje priporočilo odbora PRAC z dne 7. novembra 2013 glede učinkovin, sorodnih nikotinski kislini (acipimoks), ki so indicirane za zdravljenje lipidnih motenj.
Based on the available data, acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Na podlagi razpoložljivih podatkov je zaključil, da je acipimoks učinkovit pri zniževanju ravni trigliceridov pri bolnikih s hipertrigliceridemijo (hiperlipoproteinemijo tipa IV po Fredricksonu) in veliko učinkovitejši od placeba pri bolnikih s hiperholesterolemijo in hipertrigliceridemijo (hiperlipoproteinemijo tipa IIb po Fredricksonu).
However, taking into account the available data as well as the current use of the product and on the basis of expert advice, the PRAC was of the opinion that acipimox should only be used to reduce triglyceride levels in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate therapy alone and should therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Vendar pa je ob upoštevanju razpoložljivih podatkov, trenutne uporabe zdravila in izvedenskega svetovanja menil, da se lahko acipimoks uporablja samo za zniževanje ravni trigliceridov pri bolnikih, ki ne prenašajo statinov ali fibratov, in bolnikih, pri katerih samo s statini ali fibrati ni mogoče doseči želenih ravni trigliceridov, kar pomeni, da se lahko uporablja kot alternativno ali dodatno zdravilo za zniževanje ravni trigliceridov pri teh bolnikih.
It was noted that acipimox was of particular use in patients who either do not tolerate a statin or do not achieve triglyceride goals with statin therapy alone and could therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Upošteval je, da se acipimoks uporablja predvsem pri bolnikih, ki ne prenašajo statinov, in bolnikih, pri katerih samo s statini ni mogoče doseči želenih ravni trigliceridov, kar pomeni, da se lahko uporablja kot alternativno ali dodatno zdravilo za zniževanje ravni trigliceridov pri teh bolnikih.
No new significant information was identified regarding this risk.
V zvezi s tem tveganjem niso bile odkrite nobene pomembne nove informacije.
The medicinal products will continue to be listed in the additional monitoring list.
Zdravila bodo še naprej na seznamu za dodatno spremljanje.
Although several limitations exist, the study suggests that there was some transgenerational effect.
Čeprav obstaja več omejitev, študija kaže, da je prisoten določen transgeneracijski učinek.
In the previous European review (2014)3, several educational measures for patients and healthcare professionals (HCPs) were recommended.
V prejšnjem evropskem pregledu (2014)3 je bilo priporočenih več izobraževalnih ukrepov za bolnike in zdravstvene delavce.
The PRAC adopted a recommendation on 08 February 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 8. februarja 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products containing substances related to valproate.
• Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo valproatu sorodne snovi.
In addition all products should have in place a risk management plan.
Poleg tega mora biti pri vseh zdravilih vzpostavljen načrt za obvladovanje tveganja.
From these consultations it was evident that the specialists are aware of the risks discussed, but the information is not adequately reaching the patients timely and effectively.
Iz teh posvetovanj je bilo jasno, da se specialisti zavedajo omenjenih tveganj, vendar informacije do bolnikov ne pridejo pravočasno in učinkovito.
In addition to the boxed text this may include a symbol/pictogram, with the details to be adapted at national level.
Poleg besedila v okvirčku lahko to vključuje simbol/piktogram s podrobnostmi, ki jih je treba prilagoditi na nacionalni ravni.
For the following risk minimisation measures, the CMDh clarified that:
Pri ukrepih za zmanjševanje tveganj, navedenih v nadaljevanju, je skupina CMDh pojasnila naslednje:
This resulted in a value which was more than 25,000 times lower than the AUC in a woman treated orally with an equal dose (single oral dose 500 mg).
Rezultat je bila vrednost, ki je bila 25 000-krat nižja od AUC pri ženski, peroralno zdravljeni z enakim odmerkom (enkratnim peroralnim odmerkom 500 mg).
The PRAC requested the conduct of a retrospective observational study to further characterise this theoretical risk.
Odbor PRAC je zahteval izvedbo retrospektivne opazovalne študije za nadaljnje določanje tega teoretičnega tveganja.
They also provided experience from clinical practice on the management of women who wish to become pregnant or are pregnant.
Podane so bile tudi izkušnje iz klinične prakse obravnavanja žensk, ki si želijo zanositi ali so noseče.
This included the responses submitted by the marketing authorisation holders in writing as well as the outcomes of the scientific advisory groups in neurology and psychiatry.
To je vključevalo tudi odzive, ki so jih pisno predložili imetniki dovoljenja za promet z zdravilom ter zaključke znanstvenih svetovalnih skupin s področja nevrologije in psihiatrije.
Several tests for chromosome damage were positive.
Več preskušanj okvar kromosomov je bilo pozitivnih.
Further investigation is recommended by PRAC.
Odbor PRAC priporoča nadaljnje preiskave.
An early communication of complete information about the risks of valproate is considered essential.
Velja, da je bistveno zgodnje sporočanje popolnih informacij o tveganjih valproata.
However, tests for gene mutations were negative.
Vendar so bili preskusi mutacij genov negativni.
This was not shown for teratogenic effects as malformations in the first generation offspring was not observed in the second and third generation offspring (Choi et al, 2016)2.
Za teratogene učinke to ni bilo dokazano, saj okvar iz prve generacije potomcev v drugi in tretji generaciji niso opazili (Choi et al., 2016)2.
The use of effective contraception without interruption during the all course of treatment should be included as well as a reminder for annual re-assessment.
Vključiti je treba uporabo učinkovite kontracepcije brez prekinitve med celotnim potekom zdravljenja ter opomnik o letnem ponovnem ocenjevanju.
Having reviewed the PRAC recommendation, the CMDh agrees with the PRAC overall conclusions and grounds for recommendation.
Po pregledu priporočila odbora PRAC se je skupina CMDh strinjala s končnimi zaključki odbora PRAC in s podlago za priporočilo.
There is no clear evidence that mitochondrial dysfunction caused by valproate is associated with the development of autism.
Ni jasnega dokaza o tem, da je mitohondrijska disfunkcija, ki jo povzroča valproat, povezana z razvojem avtizma.
Nevertheless, as shown in the data reviewed in this procedure educational measures did not reach the targeted audience in a satisfactory rate in order to have any significant impact on prescriptions.
Kot dokazujejo podatki, pregledani pri tem postopku, izobraževalni ukrepi kljub temu niso dosegli predvidene publike v zadostni meri, da bi kakor koli pomembno vplivali na predpisovanje.
Severe chromosome damage is expected to lead to death of sperm cells / reduced fertility and not to transmission of mutations to the offspring.
Pričakovano je, da hude okvare kromosomov vodijo k odmrtju celic spermijev/zmanjšani plodnosti in ne k prenosu mutacij na potomce.
With regards to the patient card, the CMDh clarifies that the information is intended to act as a reminder for long-term use of valproate.
V zvezi s kartico za bolnika skupina CMDh pojasnjuje, da so informacije predvidene kot opomnik za dolgotrajno uporabo valproata.
In addition, the PRAC considered the views of patient organisations, patients, families and carers, and the views of healthcare professionals in a public hearing and dedicated meeting.
Poleg tega je odbor PRAC upošteval tudi stališča organizacij bolnikov, družin in skrbnikov ter stališča zdravstvenih delavcev, izražena v javni obravnavi in na temu namenjenem sestanku.
The PRAC re-iterate that a single version of educational materials is disseminated in each member state, where appropriate.
PRAC znova izjavlja, da je treba v vseh državah članicah, v katerih je to smiselno, razdeljevati enotno različico izobraževalnega gradiva.