natgillin/translations-raw huggingface dataset:
It could be critisised 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.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
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 PhVWP 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 kateri koli antiepileptik mogoče povezati z nizkim tveganjem samomorilnih misli in vedenja.
Following the literature presented as well the post-marketing experience the adverse events of “nausea”, “sedation” and “extrapyrimidal disorders” are proposed to be added to the Section 4.8 “Undesirable effects” of the SPC.
Glede na predloženo literaturo in izkušnje v obdobju trženja zdravila se predlaga, da se neželeni učinki „navzeja“, „sedacija“ in „ekstrapiramidne motnje“ dodajo v poglavje 4.8 „Neželeni učinki“ povzetka glavnih značilnosti zdravila.
There is a positive benefit-risk relation with regard to the aforementioned indication.
V zvezi z navedeno indikacijo je razmerje med koristmi in tveganji pozitivno.
4.6 Pregnancy and lactation
4.6 NOSEČNOST IN DOJENJE
In case of gastrointestinal side-effects due to treatment, the prolonged-release tablets should be taken during or after a meal.
Če se zaradi zdravljenja pojavijo gastrointestinalni neželeni učinki, je treba tablete s podaljšanim sproščanjem jemati med obrokom ali po njem.
In children and adolescents:
Pri otrocih in mladostnikih:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Mania
Manija
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 ponovitve razpoloženjskih epizod z dobro zasnovanimi kliničnimi preskušanji, ki so v skladu z zahtevami „Navodila CPMP glede smernice o kliničnem raziskovanju zdravil pri zdravljenju in preprečevanju bipolarne motnje“ (CPMP/EWP/567/98), ni bila jasno dokazana.
A meta-analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Tudi metaanaliza randomiziranih, s placebom nadzorovanih preskušanj antiepileptikov je pokazala rahlo povečano tveganje samomorilnih misli in vedenja.
However, 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.
Vendar pa so lahko teoretično gledano formulacije s počasnim sproščanjem ugodnejše glede skladnosti kot tudi za preprečevanje visokih koncentracij v plazmi, ki jih utegnejo spremljati pogosti neželeni učinki.
Based on the literature references provided it can be concluded that there is evidence for the efficacy of valproate in the acute treatment of manic episode, which has been demonstrated in placebo controlled studies of three weeks.
Na podlagi razpoložljivega referenčnega gradiva je mogoče zaključiti, da obstajajo dokazi učinkovitosti valproata pri akutnem zdravljenju maničnih epizod, ki so bili potrjeni s tritedenskimi študijami, nadzorovanimi s placebom.
Generally, in the treatment of seizures no dose reduction or withdrawal of the medicine should be attempted until the patient has been free of seizures for at least two to three years.
Pri zdravljenju epileptičnih napadov navadno ni treba zmanjšati odmerka ali prekiniti jemanja zdravila, če je bolnik brez epileptičnih napadov vsaj dve ali tri leta.
If you are a woman of child-bearing age, you have to use effective contraception during treatment.
Če ste ženska v rodni dobi, morate med zdravljenjem uporabljati učinkovito kontracepcijo.
The available studies on the use of valproate to treat patients with bipolar disorder have shown that the drug was generally well tolerated and revealed no unexpected safety concern.
Razpoložljive študije o uporabi valproata pri zdravljenju bolnikov z bipolarno motnjo so pokazale, da so bolniki zdravilo v splošnem dobro prenašali in da ni bilo nepričakovanih zadržkov glede varnosti.
HOW TO TAKE {INVENTED NAME}
KAKO JEMATI ZDRAVILO {LASTNIŠKO IME}
A specialist doctor (neurologist, neuropaediatrician) should decide upon dose titration, the duration of treatment and withdrawal of Valproinsäure-ratiopharm chrono on an individual basis.
Zdravnik specialist (nevrolog, nevropediater) mora titracijo odmerka, trajanje zdravljenja in prekinitev jemanja zdravila [BLAGOVNA ZNAMKA] določiti glede na posameznika.
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 has the following proposal:
Ker v različnih državah članicah EU odobrena zdravila z valproatom vsebujejo indikacijo za zdravljenje bipolarne motnje oziroma te indikacije ne vsebujejo, je CHMP predlagal naslednje:
The mean daily dose usually ranges between 1000 and 2000 mg <valproate>.
Srednji dnevni odmerek je navadno od 1000 do 2000 mg <valproata>.
{Invented name} is used in the treatment of
Zdravilo {lastniško ime} se uporablja za zdravljenje
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 v skupini z litijem bistveno več bolnikov občutilo različne neželene učinke (tremor, poliurijo, polidipsijo) kot v skupini z valproatom.
In addition, in clinical trials a starting dose of 20 mg <valproate>/kg body weight has also shown an acceptable safety profile.
V kliničnih preskušanjih je tudi začetni odmerek 20 mg <valproata>/kg telesne mase pokazal sprejemljiv varnostni profil.
In addition the time to recurrence of manic and depression events has not shown differences.
Poleg tega se čas do ponovitve maničnih in depresivnih epizod ne razlikuje.
The need for a Risk Management Plan was discussed with the MAHs.
O potrebi po načrtu za obvladovanje tveganja so potekale razprave z imetniki dovoljenja za promet z zdravili.
In addition, in clinical trials a starting dose of 20 mg sodium valproate/kg body weight has also shown an acceptable safety profile.
V kliničnih preskušanjih je tudi začetni odmerek 20 mg natrijevega valproata/kg telesne mase pokazal sprejemljiv varnostni profil.
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.
The content, objectives and implementation of the RMP should be discussed between the relevant MAH and the NCA and it should be agreed and implemented.
O vsebini, ciljih in izvajanju načrta za obvladovanje tveganja mora zadevni imetnik dovoljenja za promet z zdravilom razpravljati s pristojnim nacionalnim organom ter z njim soglašati in ga izvajati.
Manic episodes in bipolar disorder
Manične epizode pri bipolarni motnji
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALPROATERATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA VALPROATERATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
The initial recommended daily dose is 750 mg.
Priporočeni začetni dnevni odmerek je 750 mg.
You should not take this medicine if you are pregnant or a women of child-bearing age unless explicitly advised by your doctor.
Če ste noseči ali v rodni dobi, ne smete jemati tega zdravila, razen če vam je to izrecno predpisal zdravnik.
Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterion (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.
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 because of a mood episode and due to a depressive episode, respectively, 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 oziroma 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 oziroma depresivne epizode kot bolniki, zdravljeni s placebom, pri čemer zadevna razlika ni bila statistično pomembna v primerjavi z bolniki, zdravljenimi z litijem.
- The Committee considered the referral made under article of Article 6 of Commission Regulation (EC) No 1084/2003, for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) initiated by The Netherlands.
- Odbor je proučil napotitev, ki jo je sprožila Nizozemska v skladu s členom 6 Uredbe Komisije (ES) št. 1084/2003, za zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezana imena).
To support the bipolar indication the MAHs submitted several published studies.
V podporo indikacije pri bipolarni motnji je imetnik dovoljenja za promet z zdravilom predložil več objavljenih študij.
The MAHs should update the Product Information to include the relevant sections as proposed by the CHMP regarding the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Imetniki dovoljenja za promet z zdravilom morajo informacije o zdravilu posodobiti tako, da bodo vključevale ustrezna poglavja, kot jih je predlagal CHMP v zvezi s predlagano dopolnjeno indikacijo za zdravljenje manije pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
Furthermore, according to clinical practice and the dose recommendations, the daily dose should be adapted individually to the clinical response between a specific dose range and the lowest effective dose should be used in the prevention of recurrence in bipolar disorder.
Poleg tega je treba glede na klinično prakso in priporočila glede odmerjanja dnevni odmerek prilagoditi posamično glede na klinični odziv v okviru določenega razpona odmerka, pri čemer se pri preprečevanju ponovitev bipolarne motnje uporabi najmanjši učinkoviti odmerek.
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 Leaflet 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 navodila za uporabo so navedena v Dodatku III in so v skladu s pogoji iz Dodatka IV.
CONDITIONS OF THE MARKETING AUTHORISATIONS
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Nausea, sedation, extrapyramidal disorders.
Slabost, sedacija, ekstrapiramidne motnje
Manic episodes in bipolar disorder:
Manične epizode pri bipolarni motnji:
Safety
2 Varnost
According to the CHMP recommendation for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names the indication should be adapted in the following due to the limitations and shortcomings of the data from clinical trials:
V skladu s priporočilom CHMP je treba indikacijo za zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten in z njim povezana imena zaradi omejitev in pomanjkljivosti podatkov iz kliničnih preskušanj prilagoditi na naslednji način:
Evidence of efficacy of valproate in the prevention of mood episodes is thus not completely convincing based on the performed clinical studies alone.
Dokazi učinkovitosti valproata pri preprečevanju razpoloženjskih epizod, ki izhajajo iz izvedenih kliničnih študij, zato niso najbolj prepričljivi.
4.2 Posology and method of administration
4.2 ODMERJANJE IN NAČIN UPORABE
Continuation of treatment of manic episodes in bipolar disorder should be adapted individually using the lowest effective dose.
Nadaljevanje zdravljenja maničnih epizod pri bipolarni motnji je treba prilagoditi posamezniku, tako da se uporabi najmanjši učinkoviti odmerek.
A small number of people being treated with anti-epileptics such as <active substance> have had thoughts of harming or killing themselves.
Bodite posebno pozorni pri uporabi zdravila {LASTNIŠKO IME} Majhno število ljudi, ki se zdravijo z antiepileptiki, kot je <zdravilna učinkovina>, so razmišljali o tem, da bi se poškodovali ali ubili.
Preventive treatment of mania will be adapted individually using the lowest effective dose.
Preprečevalno zdravljenje manije se prilagodi individualno na najmanjši učinkoviti odmerek.
The daily dosage should be established and controlled individually by your doctor.
Vaš dnevni odmerek mora določiti in nadzorovati zdravnik.
ANNEX III AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND THE PACKAGE LEAFLET
DODATEK III SPREMEMBE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
Concerns were raised by the Netherlands regarding the efficacious and safe use of Valproateratiopharm chrono 300/500 mg Retardtabletten (and associated names) 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 zdravila Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezanih imen), pri akutnem zdravljenju maničnih epizod in pri preprečevanju ponovitve razpoloženjskih epizod pri bolnikih z bipolarno motnjo.
Women of child-bearing potential have to use effective contraception during treatment.
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
The MAHs for valproate authorised products who apply for the new indication should contact the national competent authorities (NCAs) of the respective member states in order to submit a Risk Management Plan.
Imetniki dovoljenja za promet z odobrenimi zdravili, ki vsebujejo valproat in ki jim bo dodana nova indikacija, morajo pristojnemu nacionalnemu organu zadevne države članice predložiti načrt za obvladovanje tveganja.
<Valproinsäure-ratiopharm chrono 300 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (3 ½ and 6 ½ tablets).
<[BLAGOVNA ZNAMKA] 300 TABLETE S PODALJŠANIM SPROŠČANJEM> Razpon priporočenih dnevnih odmerkov je navadno od 1000 do 2000 mg (od 3 ½ do 6 ½ tablete).
The daily dose should be adapted to the clinical response to establish the lowest effective dose for the individual patient.
Dnevni odmerek je treba prilagoditi glede na klinični odziv, da se določi najmanjši učinkoviti odmerek za posameznega bolnika.
Furthermore, when the proposed indication is granted the MAHs should submit a Risk Management Plan to the NCAs for assessment.
Ko bo predlagana indikacija odobrena, bodo morali imetniki dovoljenja za promet z zdravilom pristojnemu organu države članice v oceno predložiti načrt za obvladovanje tveganja.
The daily dose should be adapted individually to the clinical response to establish the lowest effective dose for of the individual patient.
Dnevni odmerek je treba prilagoditi individualno glede na klinični odziv, da se določi najmanjši učinkoviti odmerek za posameznega bolnika.
Women of child-bearing potential have to use effective contraception.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko zaščito.
- The Committee considered all the available data submitted on efficacy and the safety for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names), 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 zdravila Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezanih imen) v zvezi z zdravljenjem manije pri bipolarni motnji in za preprečevanje ponovitev razpoloženjskih epizod.
Children and adolescents under 18 years of age: […] should not be used in children and adolescents under 18 years of age for the treatment of mania.
Zdravilo [...] se pri otrocih in mladostnikih, mlajših od 18 let, ne sme uporabljati za zdravljenje manije.
Ratiopharm GmbH Graf Arco Strasse 3
Združeno kraljestvo ratiopharm GmbH Graf-Arco-Strasse 3
“Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
„Zdravljenje maničnih epizod pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Zdravljenje manične epizode pri bipolarni motnji, kadar je litij kontraindiciran ali ga bolnik ne prenaša.
- The Committee concluded that the Product Information of all Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) should include information to the amended indication on the treatment of mania 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 Leaflet accordingly.
- Odbor je zaključil, da je treba v informacije o zdravilu Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezana imena) vključiti podatke o dopolnjeni indikaciji zdravljenja manije 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 concluded that Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) have a positive benefit-risk ratio in the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
- Odbor je zaključil, da ima zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten (in z njim povezana imena) pozitivno razmerje med koristmi in tveganji pri predlagani dopolnjeni indikaciji „zdravljenje maničnih epizod pri bipolarni motnji, kadar je litij kontraindiciran ali kadar ga bolnik ne prenaša.
<Valproinsäure-ratiopharm chrono 500 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (2 and 4 tablets).
<[BLAGOVNA ZNAMKA] 500 TABLETE S PODALJŠANIM SPROŠČANJEM> Razpon priporočenih dnevnih odmerkov je navadno od 1000 do 2000 mg (od 2 do 4 tablete).
The continuation of treatment after manic episode could be considered in patients who have responded to <valproate> for acute mania.
O nadaljevanju zdravljenja po manični epizodi se lahko razmisli pri bolnikih, ki so se pri akutni maniji odzvali na <valproat>.
Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Srednji dnevni odmerek Razpon priporočenih dnevnih odmerkov je navadno od 1000 do 2000 mg.
Moreover, no specific safety issues have been identified in studies in which antidepressant co-medication has been used in patients with bipolar disease.
Poleg tega iz študij, v katerih so za zdravljenje bolnikov z bipolarno motnjo uporabljali tudi antidepresive, niso razvidni posebni zadržki glede varnosti.
The daily dosage should be established and controlled individually by the treating physician.
Dnevni odmerek mora lečeči zdravnik določiti in nadzorovati glede na posameznika.
POSSIBLE SIDE EFFECTS Nausea, sedation, extrapyramidal disorders.
4.8 NEŽELENI UČINKI Navzea, sedacija, ekstrapiramidne motnje
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Pri bolnikih, ki so se zaradi več indikacij zdravili z antiepileptiki, so poročali o samomorilnih mislih in vedenju.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES
SPREMEMBE, KI JIH JE TREBA VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA BLAGOVNA ZNAMKA 300/500 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
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 smiselno pri bolnikih, ki so se odzvali na valproat pri akutni maniji.“
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF PACKAGE LEAFLET FOR VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES
SPREMEMBE, KI JIH JE TREBA VKLJUČITI V USTREZNA POGLAVJA NAVODIL ZA UPORABO ZDRAVILA BLAGOVNA ZNAMKA 300/500 MG TABLETE S PODALJŠANIM SPROŠČANJEM IN POVEZANA IMENA
As a consequence,the CHMP has recommended the granting of the variation for which the Summary of Product Characteristics and Package Leaflet is set out in Annex III for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names (see Annex I).
CHMP je posledično priporočil odobritev spremembe za zdravilo Valproate-ratiopharm chrono 300/500 mg Retardtabletten in z njim povezana imena (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila in navodilo za uporabo sta navedena v Dodatku III.
Children and adolescents under 18 years of age: {Invented name} should not be used in children and adolescents under 18 years of age for the treatment of mania.
Zdravilo {lastniško ime} se pri otrocih in mladostnikih, mlajših od 18 let, ne sme uporabljati za zdravljenje manije.
Summary of Product Characteristics and Package Leaflet.
Povzetek glavnih značilnosti zdravila in navodilo za uporabo
Product Name
Ime