natgillin/translations-raw huggingface dataset:
In the absence of product-specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP considered the available residue depletion data used for the establishment of maximum residue limits for methylprednisolone (EMEA/MRL/798/01)1.
Ker za zdravilo specifični podatki o izločanju ostankov ali druge informacije o ostankih zdravil za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat, ne obstajajo, je odbor CVMP preučil razpoložljive podatke o izločanju ostankov, ki se uporabljajo za določitev najvišjih mejnih vrednosti ostankov za metilprednizolon (EMEA/MRL/798/01)1.
Germany considered that the withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products might not be sufficient to ensure consumer safety.
Nemčija je presodila, da šestdnevna karenca za govedo (meso in organe), zdravljeno z zdravili, ki vsebujejo metilprednizolonhidrogensukcinat, morda ne zadošča za zagotavljanje varnosti potrošnikov.
On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and offal) for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Evropska agencija za zdravila (agencija) je 16. marca 2017 zaključila pregled varnosti potrošnikov glede karenc za govedo (meso in organi) za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat in so v obliki raztopine za injiciranje.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of appropriate residue depletion data, a withdrawal period for meat and offal derived from treated cattle cannot be set.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da zaradi odsotnosti ustreznih podatkov o izločanju ostankov ni mogoče določiti karence za meso in organe, pridobljene iz zdravljenega goveda.
Based on the evaluation of the currently-available data, the CVMP concluded that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal).
Na podlagi vrednotenja trenutno razpoložljivih ostankov je odbor CVMP presodil, da razmerje med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat in so v obliki raztopine za injiciranje, zaradi odsotnosti ustreznih podatkov o izločanju ostankov, ki bi utemeljili šestdnevno karenco za govedo (meso in organe), ni ugodno.
The CVMP was requested to review all available residue depletion data and to recommend withdrawal periods for meat and offal derived from treated cattle.
Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karenco za meso in organe, pridobljene iz zdravljenega goveda.
What is methylprednisolone hydrogen succinate?
Kaj je metilprednizolonhidrogensukcinat?
The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Odbor CVMP je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat.
The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Odbor CVMP je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom za ciljno vrsto govedo in spremembo obstoječih dovoljenj za promet z zdravilom, tako da se črtajo vse navedbe za ciljno vrsto govedo, za zdravila za uporabo v veterinarski medicini, ki vsebujejo metilprednizolonhidrogensukcinat in so v obliki raztopine za injiciranje.
3 Re-examination
3 Ponovna proučitev
The grounds for re-examination relate mainly to implementation issues rather than to scientific grounds.
Razlogi za ponovno presojo so povezani zlasti z izvajanjem in ne z znanstvenimi razlogi.
2 Safety
2 Varnost
The scientific conclusions of the CHMP Opinion of 17 Decemeber 2009 were revised accordingly.
Znanstveni zaključki mnenja CHMP z dne 17. decembra 2009 so bili ustrezno popravljeni.
The CHMP agreed that the recommendations are applicable to all oral use formulations.
CHMP se je strinjal, da se priporočila nanašajo na vse formulacije za oralno uporabo.
Overall Safety
Celokupna varnost
As conclusion the recurrence prevention of mania has not been demonstrated.
Če povzamemo, preprečevanje ponovitev manije ni bilo dokazano.
However, it has recently been estimated that up to 40% of the patients with bipolar disorder do not or insufficiently respond to an adequate lithium therapy.
Vendar pa nedavne ocene kažejo, da se do 40 % bolnikov z bipolarno motnjo ne odziva ali nezadostno odziva na ustrezno zdravljenje z litijem.
In addition, the time to recurrence of manic events has not shown statistically significant differences.
Poleg tega se čas do ponovitve maničnih epizod statistično bistveno ne razlikuje.
No unexpected signals have been identified from post-marketing surveillance.
Pri nadzoru zdravila v obdobju trženja ni bilo opaziti nepričakovanih signalov.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALPROIC ACID/VALPROATE CONTAINING PRODUCTS (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO VALPROJSKO KISLINO/VALPROAT (glejte Dodatek I)
Bipolar disorder is a severe mental disorder characterized by recurrent episodes of mania and depression, which as a recurrent affective illness produces significant distress and dysfunction, ranking among the top 30 causes of worldwide disability.
Bipolarna motnja je huda duševna motnja, za katero so značilne ponavljajoče se epizode manije in depresije, ki kot ponavljajoča se afektivna bolezen povzroča hudo stisko in disfunkcijo ter je med 30 najpogostejšimi vzroki nezmožnosti v svetovnem merilu.
Therefore, in pregnant women or women envisaging a pregnancy, valproate should not be used for the treatment of manic episodes, unless safer alternatives prove to be ineffective or are not tolerated.
Zato se pri nosečnicah ali ženskah, ki nameravajo zanositi, valproat ne sme uporabljati za zdravljenje maničnih epizod, razen če so varnejše alternative dokazano neučinkovite ali jih bolnica ne prenaša.
In 2008, in light of the results of the US FDA meta-analysis of clinical trial data for antiepileptics, and in light of the spontaneous and literature reports, the Pharmacovigilance Working Party concluded that any antiepileptic drug may be associated with a low risk of suicidal thoughts and behaviour.
Leta 2008 je ob upoštevanju rezultatov metaanalize podatkov kliničnega preskušanja antiepileptikov ameriškega urada FDA ter ob upoštevanju poročil na lastno pobudo in poročil iz literature delovna skupina za farmakovigilanco sklenila, da je antiepileptik mogoče povezati z nizkim tveganjem samomorilnih misli in vedenja.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Various MAHs submitted written notice to the European Medicines Agency by 27 February 2010 to request a re-examination of the Opinion.
Več imetnikov dovoljenja za promet z zdravilom je od Evropske agencije za zdravila do 27. februarja 2010 pisno zahtevalo ponovno presojo mnenja.
Based on the already well known safety profile for valproate, the MAHs are not in agreement with the submission of the Risk Management Plan.
Na podlagi že znanega varnostnega profila za valporat se imetniki dovoljenja za promet z zdravilom ne strinjajo s predlogom načrta za obvladovanje tveganja.
The treatment of bipolar disorder includes management of the current mood episode and prevention of recurrence of next mood episodes.
Zdravljenje bipolarne motnje vključuje obvladovanje trenutne razpoloženjske epizode in preprečevanje pojava naslednjih razpoloženjskih epizod.
- The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for valproic acid/valproate containing medicinal products initiated by The Netherlands.
- Odbor je obravnaval napotitev, ki jo je sprožila Nizozemska v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo valprojsko kislino/valproat.
In addition, the CHMP considered the safety profile of valproic acid/valproate in this indication and recommended some amendments to the Product Information in relation to the risk of suicidal ideation and behaviour, to the use in pregnancy and to the inclusion of nausea, sedation and extrapyramidal effects as undesirable effects.
Poleg tega je CHMP pregledal varnostni profil valprojske kisline/valproata pri tej indikaciji in priporočil nekatere spremembe informacij o zdravilu glede tveganja za pojav samomorilnega razmišljanja in vedenja, uporabe v nosečnosti ter vključitve navzeje, sedacije in ekstrapiramidnih učinkov kot neželenih učinkov.
It could be criticised that the latter study was not placebo-controlled; however the use of lithium in bipolar disorder, especially in the recurrence prevention is the established standard of care.
Kot kritiko lahko navedemo, da zadnja študija ni bila nadzorovana s placebom, vendar pa je uporaba litija pri bipolarni motnji, zlasti pri preprečevanju ponovitev, uveljavljena oblika standardnega zdravljenja.
It was highlighted that although the indication exists in many Member States, sustained efficacy both in acute mania as well as in the prevention of recurrence of mood episodes has not been clearly demonstrated in well designed clinical trials which comply with the requirements of the CPMP Note for Guidance on Clinical Investigation of Medicinal products for the Treatment and Prevention of Bipolar Disorder (CPMP/EWP/567/98).
Poudarjeno je bilo, da kljub razpoložljivosti zdravila v več državah članicah trajna učinkovitost pri akutni maniji in pri preprečevanju ponovite razpoloženjskih epizod ni bila jasno dokazana pri dobro zasnovanih kliničnih preskušanjih, ki so v skladu z zahtevami „Navodila CPMP glede smernice o kliničnem raziskovanju zdravil pri zdravljenju in preprečevanju bipolarne motnje“ (CPMP/EWP/567/98).
- The Committee considered the grounds for re-examination submitted by various MAHs for valproic acid/valproate containing medicinal products on 13 April 2010 and the discussion within the Committee;
- Odbor je proučil razloge za ponovno presojo, ki so jih dne 13. aprila 2010 predložili različni imetniki dovoljenja za promet z zdravilom za zdravila, ki vsebujejo valprojsko kislino/valproat, in razpravo znotraj odbora;
The MAHs should look into their respective safety databases and add the approapriate frequence of occurrence to the above additional adverse events.
Imetniki dovoljenja za promet z zdravilom morajo preveriti svoje baze podatkov o varnosti in vanje dodati ustrezno pogostost ponovitev zgoraj navedenih dodatnih neželenih učinkov.
Furthermore, the MAHs refer to the fact that syrups and oral solutions are also approved for bipolar disorder in some Member States.
Poleg tega se imetniki dovoljenja za promet z zdravilom sklicujejo na dejstvo, da so bili sirupi in oralne raztopine v nekaterih državah članicah odobreni tudi za bipolarno motnjo.
For theoretical reasons slow-release formulations could be advantageous for compliance reasons and also for avoiding high plasma peaks which may be accompanied by frequent adverse effects.
Teoretično gledano so lahko formulacije s počasnim sproščanjem ugodnejše glede skladnosti in tudi za preprečevanje visokih koncentracij v plazmi, ki jih utegnejo spremljati pogosti neželeni učinki.
According to the CHMP recommendation for valproate containing medicinal products the indication should be adapted as follows due to the limitations and shortcomings of the data from clinical trials as the analysis was based in relatively old clinical studies.
V skladu s priporočilom CHMP je treba za zdravila, ki vsebujejo valproat, indikacijo zaradi omejitev in pomanjkljivosti podatkov iz kliničnih preskušanj, glede na to, da je analiza temeljila na sorazmerno starih kliničnih študijah, prilagoditi na naslednji način:
Taking into account that in different EU member States the authorised valproate products may have or not the indication for the bipolar disorder the CHMP agreed with the following:
Ker v različnih državah članicah EU odobrena zdravila z valproatom vsebujejo indikacijo za zdravljenje bipolarne motnje oziroma te indikacije ne vsebujejo, se je CHMP strinjal z naslednjim:
In the two-arm study performed by Calabrese and co-workers (2005), patients in the valproate group performed better in several efficacy parameters compared to the lithium group (in a statistically nonsignificant way), however significantly more patients in the lithium group experienced various adverse effects (tremor, polyuria, polydipsia) compared to the valproate group.
V dvokraki študiji, ki so jo izvedli Calabrese in sodelavci (2005), so se bolniki v skupini z valproatom bolje izkazali pri več parametrih učinkovitosti kot skupina z litijem (na statistično nepomemben način), vendar pa je bistveno več bolnikov v skupini z litijem občutilo različne neželene učinke (tremor, poliurio, polidipsijo) kot v skupini z valproatom.
The detailed grounds for the re-examination request were submitted to the Agency by 13 April 2010.
Do 13. aprila 2010 so bili predloženi razlogi, na podlagi katerih se je zahtevala ponovna presoja.
On the basis of the evidence available to the PhVWP, it was agreed that SPCs for all antiepileptics across the European Union should be modified with regard to suicidality with the addition of a warning.
Delovna skupina za farmakovigilanco je na podlagi dokazov, ki jih je imela na voljo, zaključila, da je treba povzetke glavnih značilnosti za vse antiepileptike v Evropski uniji spremeniti ob upoštevanju samomorilnosti z dodatno navedbo opozorila.
As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out in Annex III and in accordance to the conditions set out in Annex IV.
CHMP je zato priporočil ohranitev dovoljenj za promet z zdravili iz Dodatka I, katerih dopolnila zadevnih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo so navedena v Dodatku III in so v skladu s pogoji iz Dodatka IV.
Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterium (time to recurrence of any mood episode), patients treated with valproate had better outcomes on several secondary outcome measures than those treated with lithium or placebo.
Medtem ko Bowdenova študija, ki je bila nadzorovana z litijem in placebom, ni uspela dokazati statistično pomembne razlike z vidika merila primarnega izida (čas do ponovitve katere koli razpoloženjske epizode), so bili pri bolnikih, zdravljenih z valproatom, pri več merilih sekundarnega izida opaženi boljši izidi kot pri bolnikih, zdravljenih z litijem ali placebom.
The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.”
Nadaljevanje zdravljenja po manični epizodi bi bilo morda smiselno pri bolnikih, ki so se odzvali na valproat pri akutni maniji.“
Having considered the detailed grounds for re-examination provided by the MAH in writing, the CHMP agrees that changes related to the indication in bipolar disorders are relevant to those Marketing Authorisation Holders applying to the new or amended indication, as applicable.
Odbor CHMP se je po proučitvi podrobnih razlogov za ponovno presojo, ki so jih pisno navedli imetniki dovoljenja za promet, strinjal, da so spremembe, ki se nanašajo na indikacijo bipolarne motnje, pomembne za tiste imetnike dovoljenja za promet z zdravilom, ki dajejo vlogo za novo ali spremenjeno indikacijo, kot je ustrezno.
Whereas, in the original analysis time to recurrence of any mood episode or depressive episode, respectively was not significantly different in the three treatment groups, post-hoc analyses showed that valproate treated patients dropped out significantly less frequent than placebo treated patients due to a mood episode, whereas the respective difference was not statistically significant compared to lithium treated patients.
Medtem ko se v prvotni analizi čas do ponovitve katere koli razpoloženjske oz. depresivne epizode v treh zdravljenih skupinah ni bistveno razlikoval, so naknadne analize pokazale, da so bolniki, zdravljeni z valproatom, mnogo redkeje prekinili sodelovanje zaradi razpoloženjske epizode kot bolniki, zdravljeni s placebom, pri čemer zadevna razlika ni bila statistično pomembna v primerjavi z bolniki, zdravljenimi z litijem.
The MAHs for valproic acid/valproate authorised products applying to the new indication should submit a Risk Management Plan to the the national competent authorities (NCAs) of the respective member states.
Imetniki dovoljenja za promet z odobrenimi zdravili, ki vsebujejo valprojsko kislino/valproat in ki želijo dodati novo indikacijo, morajo pristojnemu nacionalnemu organu zadevne države članice predložiti načrt za obvladovanje tveganja.
Evidence of efficacy of valproate in the prevention of mood episodes is thus not completely convincing based on the performed clinical studies.
Dokazi učinkovitosti valproata pri preprečevanju razpoloženjskih epizod, ki izhajajo iz izvedenih kliničnih študij, zato niso najbolj prepričljivi.
Concerns were raised by the Netherlands regarding the efficacious and safe use of valproic acid/valproate containing medicinal products in the acute treatment of manic episodes and the prevention of recurrence of mood episodes in patients with bipolar disorder.
Nizozemska je izrazila pomisleke glede učinkovite in varne uporabe zdravil, ki vsebujejo valprojsko kislino/valproat, pri akutnem zdravljenju maničnih epizod in pri preprečevanju ponovitve epizod razpoloženja pri bolnikih z bipolarno motnjo.
- The Committee concluded that valproic acid/valproate containing medicinal products have a positive benefit-risk ratio in the proposed amended indication “treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
- Odbor je zaključil, da imajo zdravila, ki vsebujejo valprojsko kislino/valproat, pozitivno razmerje med koristmi in tveganji pri predlagani spremenjeni indikaciji „zdravljenje maničnih epizod pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
The continuation of treatment after manic episode could be considered in patients who have responded to the medicinal product for acute mania”.
Nadaljevanje zdravljenja po manični epizodi bi bilo smiselno pri bolnikih, ki so se odzvali na zdravilo, uporabljeno pri zdravljenju akutne manije“.
Furthermore, when applying for the new indication the MAHs should submit a Risk Management Plan to the National Competent Authorities for assessment, as relevant.
Poleg tega bi morali imetniki dovoljenja za promet z zdravilom ob prijavi novih indikacij nacionalnim pristojnim organom držav člani predložiti načrt za obvladovanje tveganja, da jih slednji ocenijo, kot je ustrezno.
- The Committee concluded that the Product Information of all valproic acid/valproate containing medicinal products should be amended to include information on the treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristic and Package
- Odbor je zaključil, da je treba informacije o zdravilu za vsa zdravila, ki vsebujejo valprojsko kislino/valproat, spremeniti tako, da vključujejo podatke o zdravljenju maničnih epizod pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša, in je zato priporočil temu ustrezna dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo.
- The Committee considered all the available data submitted on efficacy and the safety for valproic acid/valproate containing products, in relation to the treatment of mania in bipolar disorder as well in the prevention of recurrence of mood episodes.
- Odbor je upošteval vse razpoložljive predložene podatke o učinkovitosti in varnosti zdravil, ki vsebujejo valprojsko kislino/valproat, v zvezi z zdravljenjem manije pri bipolarni motnji in za preprečevanje ponovitev razpoloženjskih epizod.
The content, objectives and implementation of the RMP should be discussed between the relevant MAH and the NCA.
O vsebini, ciljih in izvajanju načrta za obvladovanje tveganja se mora zadevni imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO
All MAHs expressed their agreement with the overall recommended amendments to the SPC on the understanding that changes related to the indication in bipolar disorder are relevant to those
Vsi imetniki dovoljenja za promet z zdravilom so se strinjali s splošno priporočenimi spremembami povzetka glavnih značilnosti zdravila ob upoštevanju, da so spremembe, ki se nanašajo na indikacijo bipolarne motnje, pomembne za tiste imetnike dovoljenja za promet z zdravilom, ki dajejo vlogo za novo ali spremenjeno indikacijo.
The application was submitted to France as reference Member State and to Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Predlagatelj je vlogo predložil Franciji kot referenčni državi članici ter zadevnim državam članicam Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Finski, Nemčiji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Nizozemski, Norveški, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji, Španiji in Združenemu kraljestvu.
The submitted studies are considered to be well conducted.
Predložene študije so bile ocenjene kot dobro izvedene.
However, any use of antibiotic will lead to increase of resistance and therefore, prudent use should always be recommended.
Vendar pa vsaka uporaba antibiotikov povzroči povečanje odpornosti, zato mora biti vedno priporočena preudarna uporaba.
The warnings in the product information remain appropriate.
Opozorila v informacijah o zdravilu so ustrezna.
As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 24 January 2014, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No
Ker referenčna in zadevne države članice niso mogle doseči soglasja v zvezi s spremembo, je Francija 24. januarja 2014 zadevo napotila na odbor CVMP v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
49071 Beaucouzé France
49071 Beaucouzé Francija
Walton Manor, Walton Milton Keynes MK7 7AJ United Kingdom
Walton Manor, Walton Milton Keynes MK7 7AJ Združeno kraljestvo
D-85716 Unterschleißheim Germany
D-85716 Unterschleißheim Nemčija