natgillin/translations-raw huggingface dataset:
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 728042 Madrid, Spain
JANSSEN CILAG, SA Paseo de las 12 estrellas, 5- 7 Madrid, Španija
Janssen Cilag, SA Paseo de las Doce Estrellas 5-7 28042 Madrid Spain
JANSSEN CILAG, SA Paseo de las 12 estrellas, 5- 7 Madrid, Španija
Janssen-Cilag AB Box 7073 192 07 Sollentuna
Janssen- Cilag AB Box 7073 192 07 Sollentuna Švedska
Marketing Authorisation Holder
Janssen- Cilag AB Box 7073 192 07 Sollentuna Švedska
Strength
Belivon
Sverige
2 mg
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen- Cilag AB Box 7073 192 07 Sollentuna Švedska
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen- Cilag AB Risperidone Box 7073 192 07 Sollentuna Švedska
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Risperidone Saunderton High- Wycombe Buckinghamshire HP 14 4HJ Zdruzeno kraljestvo
Coated Tablet
Obložene tablete
United Kingdom
Zdruzeno kraljestvo
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Risperidone Saunderton
United Kingdom
vsebina (koncentracij a)
Janssen-Cilag Ltd.
(Velika Britanija)
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
High- Wycombe Buckinghamshire HP 14 4HJ Zdruzeno kraljestvo
Risperidone
Janssen- Cilag Ltd.
Saunderton High Wycombe Buckinghamshire HP14 4HJ
Risperidone Saunderton High- Wycombe Buckinghamshire HP 14 4HJ Zdruzeno kraljestvo
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Risperidone Saunderton High- Wycombe Buckinghamshire HP 14 4HJ
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Saunderton High- Wycombe Buckinghamshire HP 14 4HJ Zdruzeno kraljestvo
United
Zdruzeno kraljestvo (Velika Britanija)
Orodispersible
Orodisperzibilne tablete
46 ANNEX II
46 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
47 SCIENTIFIC CONCLUSIONS
47 ZNANSTVENI ZAKLJUČKI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA RISPERDAL IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Risperdal (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Zdravilo Risperdal (risperidon) je derivat benzisoksazola z močnimi združenimi zaviralnimi lastnostmi serotonina 5HT2A in dopamina D2.
Adrenergic α 1 and, to a lesser extent, histamine H1 and adrenergic α 2 receptors are also antagonised by risperidone.
Risperidon se veže tudi na α1 adrenergične receptorje in v manjšem obsegu na histaminske H1 in α2 adrenergične receptorje.
Authorised formulations of oral risperidone include oral film-coated tablets, orodispersible tablets and an oral solution.
Odobreni peroralni pripravki risperidona vključujejo filmsko obložene tablete, orodisperzibilne tablete in peroralno raztopino.
The Referral procedure under Article 30 of Directive 2001/ 83/ EC, as amended for Risperdal was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to the sections on indication, posology and method of administration, contraindications, special warnings and precautions for use and interactions with other medicinal products or other forms of interactions.
Napotitveni postopek skladu s členom 30 Direktive 2001/ 83/ ES, kakor je bila spremenjena, za zdravilo Risperdal je bil v sprožen za razrešitev neskladij med nacionalno odobrenimi besedili navodila za uporabo v posameznih državah članicah v EU in EGS, zlasti v zvezi s poglavji o indikacijah, odmerjanju in načinu uporabe, kontraindikacijah, posebnih opozorilih in previdnostnih ukrepih ter interakcijah z drugimi zdravili in drugimi oblikami interakcij.
The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues:
Odbor za zdravila za uporabo v humani medicini (CHMP) je preučil predlagano besedilo imetnika dovoljenja za promet z zdravilom in posebno pozornost posvetil naslednjim vprašanjem:
For the indication in Schizophrenia, the CHMP assessed the proposed dosing, and was of the opinion that although the 8 mg dose could be considered as a treatment option for particular patients with schizophrenia, treating physicians should individualise treatment and use the lowest efficacious dose for each patient with a target dose of 4 to 6 mg/ day.
Pri indikaciji shizofrenije je CHMP ocenil predlagano odmerjanje in menil, da morajo lečeči zdravniki, čeprav odmerek 8 mg lahko pomeni ustrezen odmerek pri zdravljenju določenih bolnikov s shizofrenijo, zdravljenje prilagoditi posameznemu bolniku in uporabiti najnižji še učinkoviti odmerek, s ciljnim odmerkom od 4 do 6 mg/ dan.
Regarding the posology in elderly with schizophrenia, the CHMP considered that the data in elderly patients is limited but suggests that a lower starting dose with a more conservative dose titration than in younger adults is recommended and adopted the following wording:
V zvezi z odmerjanjem zdravila pri starejših bolnikih s shizofrenijo je CHMP menil, da so sicer podatki pri zdravljenju starejših bolnikov omejeni, a kažejo, da je priporočljivo začeti zdravljenje z manjšim odmerkom z bolj konzervativno titracijo kot pri mlajših bolnikih, ter sprejel naslednjo besedilo:
“ A starting dose of 0.5 mg twice daily is recommended.
„ Začetni priporočeni odmerek je 0, 5 mg dvakrat na dan.
This dosage can be individually adjusted with 0.5 mg twice-daily increments to 1 to 2 mg twice daily .”
Odmerek se lahko po potrebi prilagodi posameznemu bolniku in se z odmerka 0, 5 mg dvakrat na dan poveča na 1 do 2 mg dvakrat na dan. “
For the indication in Manic episodes associated with Bipolar Disorders, the CHMP assessed the safety and efficacy of the proposed 2 mg and 3 mg starting doses and noted that no comparisons on the change in efficacy measurements in the first days of treatment were made.
Pri indikaciji manične epizode, povezane z bipolarno motnjo, je CHMP preučil varnost in učinkovitost predlaganega začetnega odmerka 2 mg in 3 mg ter ugotovil, da v prvih dneh zdravljenja ni bilo nobenih primerjav o spremembah v učinkovitosti.
Therefore the CHMP was of the opinion that starting doses should be restricted to 2 mg for the first day in bipolar mania.
Tako je CHMP menil, da naj bo začetni odmerek za prvi dan bipolarne manije omejen na 2 mg.
The CHMP also assessed the optimal, recommended dose range for bipolar mania and considered, based on the submitted efficacy analysis of risperidone patients, grouped according to their mode daily dose during the study, that efficacy was demonstrated over the recommended dose range 1 to 6 mg/ day, and that some patients can effectively be treated at doses in the lower end of this dose range.
CHMP je prav tako preučil optimalni, priporočeni interval odmerkov za bipolarno manijo in na podlagi predložene analize učinkovitosti pri bolnikih, zdravljenih z risperidonom in razvrščenih glede na način prejemanja dnevnega odmerka med študijo, menil, da je bila učinkovitost ustrezno potrjena za priporočene intervale odmerkov od 1 do 6 mg/ dan ter da so nekateri bolniki lahko učinkovito zdravljeni tudi z nižjimi odmerki znotraj tega intervala.
The CHMP also assessed the efficacy data for bipolar mania in elderly patients.
CHMP je preučil tudi podatke o učinkovitosti za bipolarno manijo pri starejših bolnikih.
Due to the low number of patients and based on the limited data available, the CHMP did not consider it justified to treat elderly with bipolar mania with the posology recommended in adults.
Zaradi majhnega števila sodelujočih bolnikov in na podlagi omejenih razpoložljivih podatkov je CHMP menil, da ni upravičeno zdraviti starejše bolnike z bipolarno manijo z odmerki, priporočenimi za zdravljenje odraslih.
The CHMP concluded that the upper limit of dosage should be restricted and adopted the following dosage recommendations:
CHMP je sklenil, da je treba najvišji možni odmerek omejiti, ter sprejel naslednjo priporočilo o odmerjanju:
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Odmerek se lahko po potrebi prilagodi posameznemu bolniku in se z odmerka 0, 5 mg dvakrat na dan poveča na 1 do 2 mg dvakrat na dan.
Since clinical experience in elderly is limited, caution should be exercised .”
Zaradi omejenosti kliničnih izkušenj pri starejših je pri zdravljenju potrebna posebna previdnost. “
Finally, the CHMP assessed the data submitted on the use of risperidone in the treatment of mild forms of mania.
Nazadnje je CHMP preučil tudi predložene podatke o uporabi risperidona pri zdravljenju blagih oblik manije.
Given the small number of patients with mild mania in clinical trials and the limited data available, the CHMP could not guarantee that the balance between efficacy and safety in patients with mild mania is the same as in patients with moderate to severe mania.
Glede na majhno število bolnikov z blagimi oblikami manije v kliničnih preskusih in omejene razpoložljive podatke CHMP ni mogel z gotovostjo ugotoviti, da je razmerje med učinkovitostjo in varnostjo pri bolnikih z blago obliko manije enako kot pri bolnikih z zmerno ali hudo obliko manije.
The CHMP therefore adopted the following wording in line with the indication for other approved antipsychotics:
Zato je sprejel naslednje besedilo v skladu z indikacijo za druge odobrene antipsihotike:
“ Risperdal is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders .”
48 „ Risperdal je indiciran za zdravljenje zmernih do hudih maničnih epizod, povezanih z bipolarnimi motnjami. “
48 the optimum treatment duration, in light of the need to balance the significant safety issues against the severity of symptoms in the targeted population (severe aggression).
Pri indikaciji hude agresije pri Alzheimerjevi demenci je CHMP preučil predložene podatke o optimalnem trajanju zdravljenja, ob upoštevanju potrebe po uravnoteženosti med varnostnimi vprašanji in resnostjo simptomov pri ciljni populaciji (huda agresija).
The CHMP decided to restrict the duration of the short-term therapy to 6 weeks, due to safety considerations.
CHMP se je zaradi varnostnih zadržkov odločil trajanje kratkotrajne terapije omejiti na 6 tednov.
Regarding the qualification of “ severe aggression”, the CHMP considered that rating scales were not practical in clinical settings and that the most important clinical criteria to be met before treatment is initiated is that the aggression places the person or carer at risk of harm and that the behaviour is persistent.
Glede opredelitve „ hude agresivnosti “ je CHMP menil, da ocenjevalne lestvice v kliničnem okolju niso praktične ter da je najpomembnejše klinično merilo, ki mora biti izpolnjeno pred pričetkom zdravljenja, izraz agresivnosti, ki ogroža posameznika ali skrbnika, ter da je takšno vedenje trajno.
Accordingly, the following wording was adopted:
V skladu s tem je bilo sprejeto naslednje besedilo:
“ Risperdal is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’ s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others .”
„ Risperdal je indiciran za kratkotrajno zdravljenje (do 6 tednov) trajne agresivnosti pri bolnikih z zmerno do hudo Alzheimerjevo demenco, ki se ne odziva na nefarmakološke pristope in kadar obstaja ogroženost samega sebe ali drugih. “
The CHMP was of the opinion that the efficacy in Alzheimer’ s dementia was similar compared to efficacy in vascular/ mixed dementias and that patients with severe aggression in vascular/ mixed dementias should be excluded from treatment with risperidone because of safety concerns.
CHMP je menil, da je učinkovitost pri Alzheimerjevi demenci podobna učinkovitosti pri vaskularnih/ mešanih demencah ter da se naj bolniki s hudo agresivnostjo pri vaskularnih/ mešanih demencah zaradi varnostnih zadržkov izključijo iz zdravljenja z risperidonom.
Restriction of the indication to patients with Alzheimer’ s dementia is also correct in view of efficacy.
Omejitev indikacije za bolnike z Alzheimerjevo demenco je primerna tudi z vidika učinkovitosti.
The CHMP decided to limit the indication to AD, however the CHMP amended the warning in the SPC, regarding the magnitude of the risk for CVAEs in patients with MD/ VD to the following wording:
CHMP je sklenil omejiti indikacijo na Alzheimerjevo demenco, opozorilo v povzetku glavnih značilnosti zdravila glede obsežnosti tveganja za cerebrovaskularne neželene učinke pri bolnikih z mešano/ vaskularno demenco pa je dopolnil z naslednjim besedilom:
“ The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer dementia.
„ Tveganje za cerebrovaskularne neželene učinke je bistveno večje pri bolnikih z mešano ali vaskularno obliko demence v primerjavi z Alzheimerjevo demenco.
Therefore, patients with other types of dementias than Alzheimer’ s should not be treated with risperidone .”
Zato naj se bolniki z drugimi vrstami demence, razen z Alzheimerjevo, ne zdravijo z risperidonom. “
In addition, the CHMP assessed the safety and efficacy of risperidone and implemented warning and precaution texts in section 4.4 of the SPC, to address the increased risk for CVAE and the increased mortality with atypical antipsychotics in patients with dementia.
Poleg tega je CHMP preučil varnost in učinkovitost risperidona ter uvedel opozorilo in posebne varnostne ukrepe v poglavju 4. 4 povzetka glavnih značilnosti zdravila za vključitev povečanega tveganja za cerebrovaskularne neželene učinke ter povečano smrtnost z netipičnimi antipsihotiki pri bolnikih z demenco.
Further warnings were implemented with regards to patients with mixed or vascular type of dementia and to the need for close monitoring of patients with Alzheimer’ s dementia.
Uvedena so bila tudi dodatna opozorila v zvezi z bolniki z mešano in vaskularno obliko demence in potrebo po pozornem nadzorovanju bolnikov z Alzheimerjevo demenco.
The CHMP also adopted wordings further restricting the target population and the treatment duration.
CHMP je sprejel tudi besedila, ki dodatno omejujejo ciljno populacijo in trajanje zdravljenja.
In conclusion, the CHMP was of the opinion that the current weight of evidence is that the benefit-risk assessment remains favourable in this restricted target population indication of persistent aggression in Alzheimer’ s dementia for short-term treatment only (6 weeks) and with all restrictions and conditions indicated in the SPC.
Na koncu je CHMP menil, da trenutni dokazi kažejo, da razmerje med koristmi in tveganji ostaja pozitivno pri tej omejeni ciljni populaciji za indikacijo trajne agresivnosti pri Alzheimerjevi demenci, vendar le pri kratkotrajnem zdravljenju (6 tednov) in z vsemi omejitvami in pogoji, navedenimi v povzetku glavnih značilnosti zdravila.
Finally, the CHMP noted the data and the responses submitted by the MAH with regards to safety signals, both in normal and elderly patients and agreed with the revised and corrected tables on CVAEs and ADRs.
Ne nazadnje je CHMP upošteval podatke in odgovore, ki jih je predložil imetnik dovoljenja za promet z zdravilom glede varnostnih znakov pri normalnih kot starejših bolnikih, ter soglašal s pregledanimi in popravljenimi preglednicami o cerebrovaskularnih neželenih učinkih in poročilih o neželenih učinkih.
For the indication in Severe Aggression in Children/ Adolescents with Conduct Disorder, the CHMP assessed the safety profile in children/ adolescents, requesting further clarifications, especially with regards to the Contradictions and discrepancies between the actual Safety Overview (April 2008) and the previous Safety Overview (January 2008) in children/ adolescents with Disruptive Behaviour Disorder (DBD).
Pri indikaciji hude agresivnosti pri otrocih/ mladostnikih z vedenjskimi motnjami je CHMP ovrednotil varnostni profil pri otrocih/ mladostnikih ter zahteval dodatna pojasnila, zlasti glede kontraindikacij in neskladij med zadnjim varnostnim pregledom (april 2008) in predhodnim varnostnim pregledom (januar 2008) pri otrocih/ mladostnikih z vedenjskimi motnjami (DBD).
The CHMP also assessed the consistency of the Extrapyramidal Symptoms and the evidence suggesting regression in sexual maturation.
CHMP je preučil tudi doslednost ekstrapiramidnih simptomov in dokazov, ki kažejo na regresijo pri spolnem dozorevanju.
The CHMP considered that while regression of sexual maturation was not supported, the SPC states that ” the effects of long-term treatment on sexual maturation and height have not been adequately studied” and as a consequence, the sentence “ Treatment with risperidone for up to 1 year showed no adverse effects on sexual maturation” in section 4.4 should be deleted.
CHMP je menil, da sicer regresija v spolnem dozorevanju ni bila potrjena, a je v povzetku glavnih značilnosti zdravila navedeno „ vplivi dolgotrajnega zdravljenja na spolno dozorevanje in višino niso bili ustrezno preučeni “, zato bi bilo posledično treba stavek v poglavju 4. 4 „ Zdravljenje z risperidonom v trajanju do 1 leta ni pokazalo nobenih neželenih učinkov na spolno dozorevanje “ izbrisati.
The CHMP assessed the “ Relapse Prevention Study” (12 weeks of open-label and single-blind risperidone treatment followed by a 6-month double-blind) and was of the opinion that it may only be considered as supportive, due to the fact that only responders entered the double-blind phase.
49 CHMP je ocenil „ Študijo preprečevanja ponovnega pojavljanja “ (12- tedensko zdravljenje v okviru oprte (open label) in enojno slepe (single- blind) študije z risperidonom, čemur je sledilo 6- mesečno obdobje dvojno slepe študije (double- blind)) ter menil, da je lahko podporna v toliko, da so v dvojno slepi fazi sodelovali le tisti bolniki, ki so se odzvali na zdravljenje.
The two 6 week- short term studies are considered as the main efficacy studies and the treatment should be restricted to short-term treatment (6 weeks) as the safety profile in children/ adolescents appears worse than in adults.
Obe šesttedenski kratkotrajni študiji štejeta kot glavni študiji učinkovitosti, zdravljenje pa je treba omejiti na kratkotrajno zdravljenje (6 tednov), saj se zdi, da je varnostni profil pri otrocih/ mladostnikih slabši kot pri odraslih.
The CHMP also discussed the use of risperidone in children with normal intellectual functioning, noting that the controlled trials are predominantly conducted in children with borderline IQ or mental retardation.
CHMP je razpravljal tudi o uporabi risperidona pri otrocih z normalnim intelektualnim delovanjem ter ugotovil, da se kontrolni preskusi predvsem izvajajo z otroci z mejnim inteligenčnim kvocientom ali duševno zaostalimi.
According to the safety profile of risperidone in children, the population of use should not be expanded to children and adolescents with a normal IQ, since due to the structural differences between the brains of
V skladu z varnostnim profilom risperidona pri otrocih se v populacijo, kateri je namenjena uporaba zdravila, ne smejo vključiti otroci in mladostniki z normalnim inteligenčnim kvocientom, saj zaradi strukturnih razlik med možgani otrok in mladostnikov z normalnim inteligenčnim kvocientom in tistimi, pri katerih se pojavlja duševna zaostalost, ni mogoče sklepati, da bi se obe populaciji na antipsihotično zdravilo odzvali na enak način.
However, the CHMP decided to adopt an indication without restriction to specific IQ.
Kljub temu pa se je CHMP odločil in sprejel indikacijo brez omejitev glede na določen inteligenčni kvocient.
The CHMP further discussed efficacy in Children and Adolescents with Autistic Disorder, a Pervasive Developmental Disorder that is different from Conduct Disorder which is a Disruptive Behaviour Disorder.
CHMP je razpravljal o učinkovitosti pri otrocih in mladostnikih z avtističnimi motnjami, pervazivno razvojno motnjo, ki se razlikuje od motnje obnašanja, ki je disruptivna vedenjska motnja (DBD).
As a consequence, children with autistic disorders are not included in the proposed indication.
Posledično otroci z avtističnimi motnjami niso vključeni v predlagano indikacijo.
This exclusion is supported by the fact that the primary symptoms of the autism disorder cannot successfully be treated with Risperdal because the target symptoms in autism for which Risperdal has demonstrated its most robust efficacy are associated symptoms rather than a broad spectrum of symptoms of the disease.
Njihovo izključitev podpira dejstvo, da primarnih simptomov avtističnih motenj ni mogoče uspešno zdraviti z zdravilom Risperdal, saj so ciljni simptomi avtizma, za katere se je zdravilo Risperdal izkazalo kot najučinkovitejše, le povezani simptomi in ne širok spekter simptomov te bolezni.
Because of the lack of specificity and the availability of other treatment options, the CHMP did not considered the indication in Autistic Disorder as supported.
Zaradi pomanjkanja specifičnosti in razpoložljivosti drugih možnosti zdravljenja CHMP ni preučil indikacije za avtistične motnje.
In conclusion, the CHMP adopted the following indication:
Na koncu je sprejel naslednjo indikacijo:
“ Risperdal is indicated for the short-term symptomatic treatment (up to 6 weeks) of severe persistent aggression in conduct or other disruptive behaviour disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment.
„ Risperdal je indiciran za kratkotrajno simptomatsko zdravljenje (do 6 tednov) hude trajne agresivnosti pri vedenjskih ali drugih disruptivnih motnjah pri otrocih od petega leta starosti in mladostnikih s podpovprečnim inteligenčnim delovanjem ali duševno zaostalostjo, diagnosticirano v skladu z merili DSM- IV, pri katerih resnost agresivnosti ali drugih disruptivnih vedenjskih motenj zahteva farmakološko zdravljenje.
Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention.
Farmakološko zdravljenje mora biti sestavni del celostnejšega programa zdravljenja, vključno s psihosocialnim in izobraževalnim posredovanjem.
It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct Disruptive Behaviour disorder of children and adolescents .”
Priporočeno je, da risperidon predpisuje le specialist otroške nevrologije ter psihiatrije za otroke in mladostnike ali zdravniki, ki so dobro seznanjeni z zdravljenjem disruptivnih vedenjskih motenj obnašanja pri otrocih in mladostnikih. “
For section 4.2, the CHMP revised the wording stating that risperidone should not be recommended for use in children/ adolescents under 18 years of age with schizophrenia or with bipolar mania, due to a lack of systematic efficacy/ safety and clinical data for this age group.
V poglavju 4. 2 je CHMP preučil besedilo, ki pravi, da se risperidon ne priporoča za uporabo pri otrocih/ mladostnikih, mlajših od 18 let, s shizofrenijo ali bipolarno manijo zaradi pomanjkanja sistemskih in kliničnih podatkov o učinkovitosti/ varnosti pri tej starostni skupini.
For section 4.4, the CHMP implemented a revised wording for the hyperprolactinaemia section, excluding specific mention of prolactinoma and breast cancer, as although data supporting a possible relationship between hyperprolactinaemia and risk of some prolactin-dependent tumours exists, the data is still largely inconclusive from a clinical perspective.
V poglavju 4. 4 je CHMP vključil pregledano besedilo za del o hiperprolaktinemiji, pri čemer je izključil posebno omembo prolaktinoma in raka dojk, ker, čeprav obstajajo podatki, ki podpirajo možno povezavo med hiperprolaktinemijo in tveganjem za nekatere tumorje, odvisne od prolaktina, so podatki s kliničnega stališča še vedno v veliki meri nedokončni.