FrancophonIA/ELRC3.0 huggingface dataset:
English: <Parabens> <Paroxetine oral suspension contains methyl and propyl hydroxybenzoate (parabens), which are known to cause urticaria; generally delayed type reactions, such as contact dermatitis, but rarely immediate reaction with bronchospasm.> [To be completed nationally].
Slovenian: <Parabeni> <Peroralna suspenzija paroksetina vsebuje metil- in propilhidroksibenzoat (parabena), ki sta znana povzročitelja urtikarije; običajno odložen tip reakcij, kot na primer kontaktni dermatitis, redko pa takojšnja reakcija z bronhospazmom.> [potrebno dopolniti lokalno]
English: The use of paroxetine has not been studied in children less than 7 years.
Slovenian: Uporaba paroksetina pri otrocih mlajših od 7 let ni bila raziskana.
English: As with other psychotropic drugs patients should be advised to avoid alcohol use while taking paroxetine.
Slovenian: Tako kot pri drugih psihotropnih zdravilih je potrebno bolnikom svetovati, da se naj med jemanjem paroksetina izogibajo pitju alkohola.
English: Studies indicate that, in contrast to antidepressants which inhibit the uptake of noradrenaline, paroxetine has a much reduced propensity to inhibit the antihypertensive effects of guanethidine.
Slovenian: Študije kažejo, da je, v nasprotju z antidepresivi, ki zavirajo prevzem noradrenalina, nagnjenost paroksetina k zaviranju antihipertenzivnih učinkov gvanetidina veliko manjša.
English: The CHMP also considered the available data supporting the recommended posology for each of the above indications.
Slovenian: V CHMP so upoštevali tudi razpoložljive podatke, potrjujoče priporočeno odmerjanje za vsako od zgornjih indikacij.
English: The principal metabolites of paroxetine are polar and conjugated products of oxidation and methylation which are readily cleared.
Slovenian: Glavni presnovki paroksetina so polarni in konjugirani produkti oksidacije in metiliranja, ki se z lahkoto očistijo.
English: Review of the wording with regards to the possibility of increasing the recommended dose if after some weeks of treatment on the recommended dose insufficient response is seen.
Slovenian: Pregled besedila glede možnosti povečanja priporočenega odmerka po nekaj tednih zdravljenja, v kolikor ni opaziti zadostnega odziva na priporočeni odmerek.
English: NAME OF MEDICINAL PRODUCT {INVENTED NAME} {Strength} {Pharmaceutical form} [To be completed nationally]
Slovenian: IME ZDRAVILA {LASTNIŠKO IME ZDRAVILA} {jakost} {farmacevtska oblika} [potrebno dopolniti lokalno]
English: Efficacy in children
Slovenian: Učinkovitost pri otrocih
English: Anticonvulsants: carbamazepine, phenytoin, sodium valproate.
Slovenian: Antiepileptiki: karbamazepin, fenitoin, natrijev valproat.
English: As expected with lipophilic amines, including tricyclic antidepressants, phospholipidosis was detected in rats.
Slovenian: Kot je pričakovati pri lipofilnih aminih, vključno s tricikličnimi antidepresivi, je pri podganah prišlo do fosfolipidoze.
English: On 13 June 2003, UK triggered a referral to the EMEA under Article 31 of Directive 2001/83/EC, as amended, to medicinal products containing paroxetine.
Slovenian: 13. junija 2003 je Velika Britanija sprožila napotilo EMEA po 31. členu Direktive 2001/83/ES, kot je bila dopolnjena, za zdravila, vsebujoča paroksetin.
English: The incidence of possible suicide-related events and selfharm in the paroxetine group were 2-3 times that seen in the placebo group, while hostility events in the paroxetine occurred with a frequency 6 times that seen in the placebo group.
Slovenian: Pojavnost možnih s samomorom povezanih dogodkov in samopoškodovanja v skupini paroksetina je bila 2-3-kratnik videne v skupini placeba, sovražni dogodki pa so se v skupini s paroksetinom pojavljali s 6-kratnikom pogostnosti, sicer videne v skupini placeba.
English: This period may be several months or even longer (see section 5.1 Pharmacodynamic Properties)
Slovenian: Zdravljenje lahko traja nekaj mesecev ali celo več (glejte poglavje 5.1 Farmakodinamične lastnosti).
English: Animal studies showed reproductive toxicity, but did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Section 5.3 Preclinical Safety Data).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, ne kažejo pa na neposreden škodljiv vpliv na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3 Predklinični podatki o varnosti).
English: In view of their relative lack of pharmacological activity, it is most unlikely that they contribute to paroxetine's therapeutic effects.
Slovenian: Glede na to, da so relativno farmakološko neaktivni je malo verjetno, da bi prispevali k terapevtskemu učinku paroksetina.
English: Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.
Slovenian: Dajanje tioridazina samega lahko povzroči podaljšanje intervala QTc s pridruženo resno ventrikularno aritmijo, kot je torsades de pointes, in nenadno smrt.
English: The CHMP reviewed available data from published literature and spontaneous reports in relation to withdrawal reactions in neonates whose mothers used paroxetine during pregnancy.
Slovenian: V CHMP so pregledali razpoložljive podatke iz objavljene literature in spontanih poročil v zvezi z odtegnitvenimi reakcijami pri novorojenčkih, katerih matere so v nosečnosti uporabljale paroksetin.
English: Data on a limited number of exposed pregnancies provide no indication of an increased risk of congenital malformations in the newborn.
Slovenian: Podatki zbrani pri majhnem številu nosečnic, ki so bile izpostavljene zdravilu ne kažejo na povečano tveganje za pojav kongenitalnih malformacij pri novorojencu.
English: Denmark DuraScan Medical Products A/S Svendborgvej 243
Slovenian: DuraScan Medical Products A/S Svendborgvej 243
English: However, as with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.
Slovenian: Vendar pa je treba bolnike opozoriti, da naj bodo, tako kot pri vseh psihoaktivnih zdravilih, pozorni na svojo sposobnost vožnje in upravljanja strojev.
English: Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily.
Slovenian: Nekaterim bolnikom lahko koristi povečevanje odmerka, vendar pa največji odmerek ne sme preseči 40 mg dnevno.
English: If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Slovenian: Če se po znižanju odmerka ali po prekinitvi zdravljenja pojavijo neznosni simptomi, se lahko razmisli o ponovnem zdravljenju s prej predpisanim odmerkom.
English: In response to these data UK contraindicated the use of paroxetine in children aged 18 years or less with major depressive disorders.
Slovenian: Kot odziv na te podatke so v Veliki Britaniji kontraindicirali uporabo paroksetina pri otrocih z veliko depresivno motnjo, starih 18 let ali manj.
English: Paroxetine has low affinity for muscarinic cholinergic receptors and animal studies have indicated only weak anticholinergic properties.
Slovenian: Paroksetin ima nizko afiniteto za muskarinske holinergične receptorje in raziskave na živalih so pokazale le šibke antiholinergične lastnosti.
English: Therefore, this SPC may not necessarily represent the current text.
Slovenian: Zaradi tega je možno, da ta Povzetek glavnih značilnosti zdravila ne predstavlja trenutno veljavnega besedila.
English: Genthon BV Box 7071
Slovenian: Nizozemska Genthon BV Box 7071
English: Any subsequent dosage adjustment should be guided by clinical effect (tolerability and efficacy).
Slovenian: Pri vseh nadaljnjih prilagajanjih odmerkov je potrebno upoštevati klinično učinkovitost (prenosljivost in učinkovitost).
English: Steady state systemic levels are attained by 7 to 14 days after starting treatment with immediate or controlled release formulations and pharmacokinetics do not appear to change during long-term therapy.
Slovenian: Ravnotežno stanje sistemskih vrednosti je doseženo 7 do 14 dni po začetku zdravljenja z oblikami s takojšnim ali prirejenim sproščanjem; pri dolgotrajnem zdravljenju ni opaziti spremenjenih farmakokinetičnih lastnosti.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for paroxetine containing medicinal products referred in Annex I as amended in accordance with the SPC set out in Annex III and under the conditions set out in Annex IV.
Slovenian: Zato je CHMP priporočil vzdrževanje Dovoljenj za promet za zdravila, vsebujoča paroksetin, navedena v Dodatku I, dopolnjena v skladu z SPC v Dodatku III, ter pod pogoji, navedenimi v Dodatku IV.
English: Significant and relevant results were obtained in the short-term studies but not in the long-term studies and therefore the CHMP concluded that the long-term efficacy has not been sufficiently demonstrated.
Slovenian: V kratkotrajnih študijah so dobili značilne in pomembne rezultate, ne pa tudi v dolgotrajnih študijah, zato so v CHMP zaključili, da dolgoročna učinkovitost ni bila zadostno dokazana.
English: Belgium Bexal Av J. Bordet 168, 1140 Brussels, Belgium
Slovenian: Av J. Bordet 168, 1140 Brussels, Belgium
English: In addition, these conditions may be co-morbid with major depressive disorder.
Slovenian: Razen tega pa se ta stanja lahko pojavljajo sočasno s hudo depresivno motnjo.
English: Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Slovenian: O hiponatriemiji so poročali predvsem pri starejših bolnikih in je včasih povezana s sindromom neustreznega izločanja antidiuretičnega hormona (SIADH).
English: Therefore the CHMP considered that the benefit/risk balance of paroxetine containing medicinal products in the agreed indications is favourable and the Marketing Authorisations should be maintained in accordance with the:
Slovenian: Zato so v CHMP sklenili, da je razmerje koristi/tveganja zdravil, vsebujočih paroksetin, za dogovorjene indikacije ugodno ter da naj se Dovoljenja za promet z zdravilom ohranijo v skladu s:
English: Suicidal related behaviours associated with paroxetine in the clinical trials were more clearly seen in the depression studies than in studies of OCD or SAD.
Slovenian: Samomorilna povezana vedenja, povezana s paroksetinom, v kliničnih preskušanjih, so bolj očitno opažali v študijah depresije kot v študijah OCD ali SAD.
English: The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Slovenian: Tveganje za pojav odtegnitvenih simptomov je lahko odvisno od različnih dejavnikov vključno s trajanjem zdravljenja, odmerkom in obsegom zmanjševanja odmerka.
English: Suicidal behaviour, self-harm and hostility
Slovenian: Samomorilno vedenje, samopoškodovanje in sovražno razpoloženje Odrasli
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for paroxetine containing medicinal products.
Slovenian: - je Odbor upošteval napotilo pod 31. členom Direktive 2001/83/EC, kot je bilo dopolnjeno, za zdravila, vsebujoča paroksetin.
English: Withdrawal reactions
Slovenian: Odtegnitvene reakcije
English: Inhibition of CYP2D6 may lead to increased plasma concentrations of coadministered drugs metabolised by this enzyme.
Slovenian: Zaviranje CYP2D6 lahko privede do povečanih plazemskih koncentracij sočasno uporabljenih zdravil, ki jih presnavlja ta encim.
English: Denmark United Nordic Pharma A/S Hammervej 7
Slovenian: United Nordic Pharma A/S Hammervej 7
English: On the basis of the new assessed data the CHMP concluded the following: - The new evidence from the GPRD studies is more vulnerable to various biases, e.g. confounding by indication, compared to evidence coming from clinical trials.
Slovenian: Na podlagi na novo obravnavanih podatkov je CHMP sklenil naslednje: - Novi dokazi na podlagi GPRD-raziskav so v primerjavi z dokazi iz kliničnih raziskav bolj občutljivi za različne odklone, kot je npr. zamenjana indikacija.
English: In May 2003 UK reviewed data from clinical trials with paroxetine in the treatment of paediatric OCD, SAD and MDD and concluded that these data provided evidence of an association between the use of paroxetine and an increased risk of emotional lability including self-harm, hostility and suicidal behaviour in children and adolescents.
Slovenian: Maja 2003 so v Veliki Britaniji pregledali podatke iz kliničnih preskušanj paroksetina pri zdravljenju pediatričnih OCD, SAD in MDD ter zaključili, da ti podatki kažejo na povezavo med uporabo paroksetina in povečanim tveganjem za čustveno labilnost, vključujoč samopoškodovanje, sovražno in samomorilno vedenje pri otrocih in mladostnikih.
English: Therefore, dosage should be restricted to the lower end of the dosage range.
Slovenian: Pri odmerjanju se je torej potrebno omejiti na spodnjo mejo odmernega intervala.
English: • Pregnancy and Lactation
Slovenian: • Nosečnost in dojenje
English: PHARMACEUTICAL FORM <Tablet> <Coated tablet> <Film-coated tablet> <Oral solution> <Oral suspension>
Slovenian: FARMACEVTSKA OBLIKA <Tableta> <Obložena tableta> <Filmsko obložena tableta> <Peroralna raztopina> <Peroralna suspenzija>
English: Denmark Copyfarm A/S Energivej 15
Slovenian: Copyfarm A/S Energivej 15
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [potrebno dopolniti lokalno]
English: Belgium Ratiopharm Belgium s.a./n.v.
Slovenian: Ratiopharm Belgium s.a./n.v.
English: Paroxetine is a phenylpiperidine derivative and is a potent and selective inhibitor of the presynaptic 5hydroxytryptamine (5-HT) reuptake.
Slovenian: Paroksetin je fenilpiperidinski derivat ter močan in selektivni zaviralec presinaptičnega ponovnega privzema 5-hidroksitriptamina (5-HT).
English: Bexal Produtos Farmacêuticos S.A. Rua Prof. Ricardo Jorge, 5 AMiraflores
Slovenian: Portugalska Bexal Produtos Farmacêuticos S.A. Rua Prof. Ricardo Jorge, 5 AMiraflores
English: Musculoskeletal disorders Rare: arthralgia, myalgia
Slovenian: Bolezni mišično-skeletnega sistema Redki: artralgija, mialgija
English: Urinary excretion of unchanged paroxetine is generally less than 2% of dose whilst that of metabolites is about 64% of dose.
Slovenian: Na splošno se z urinom v nespremenjeni obliki izloči manj kot 2 % odmerka paroksetina, v obliki metabolitov pa se izloči približno 64 % odmerka.
English: Patients with a history of suicidal behaviour or thoughts, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Slovenian: Pri bolnikih s samomorilnim vedenjem ali mislimi v anamnezi ali bolnikih, ki kažejo znatno stopnjo samomorilne miselnosti pred pričetkom zdravljenja obstaja večje tveganje za samomorilne misli ali samomorilne poskuse in jih je potrebno med zdravljenjem skrbno nadzorovati.
English: In rats, increased pup mortality and delayed ossification were observed.
Slovenian: Pri podganah so opazili večjo smrtnost med mladiči in zakasnelo osifikacijo.
English: Pharmacotherapeutic group: Antidepressants - selective serotonin reuptake inhibitors, ATC code: N06A B05
Slovenian: Farmakoterapevtska skupina: Antidepresivi - selektivni zaviralci prevzema serotonina, Oznaka ATC: N06A B05.
English: Rua Ramalho Ortigão, 45-A, 1070-228 Lisboa Portugal
Slovenian: Rua Ramalho Ortigão, 45-A, 1070-228 Lisboa
English: Adverse drug reactions are listed below by system organ class and frequency.
Slovenian: Spodaj navedeni neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
English: Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Slovenian: Na splošno ti simptomi minejo sami po sebi v 2 tednih, pri posameznikih pa lahko trajajo dlje časa (2-3 mesece ali več).
English: Metabolite excretion is biphasic, being initially a result of first-pass metabolism and subsequently controlled by systemic elimination of paroxetine.
Slovenian: Izločanje presnovkov je dvofazno, na začetku kot posledica metabolizma prvega prehoda, nato pa pod nadzorom sistemskega izločanja paroksetina.
English: Therefore, patients treated with higher doses, those treated for a longer duration and patients whose treatment is abruptly stopped may be at an increased risk of withdrawal symptoms upon stopping treatment with paroxetine.
Slovenian: Zato je lahko pri bolnikih, zdravljenih z višjimi odmerki, zdravljenih dalj časa, ter pri bolnikih, kjer zdravljenje nenadoma prekinemo, tveganje za pojav odtegnitvenih simptomov ob ukinitvi zdravljenja s paroksetinom povečano.
English: On the basis of the available data the CHMP considered that the above information on the symptoms which can occur in the neonate after maternal paroxetine use in later stages of pregnancy, should be included in section 4.6 (Pregnancy and Lactation) of the SPC.
Slovenian: Na podlagi razpoložljivih podatkov so v CHMP sklenili, da je treba zgoraj navedene podatke o simptomih, ki se lahko pojavijo pri novorojenčku po materini uporabi paroksetina v zadnjih mesecih nosečnosti, vključiti v poglavje 4.6 (Nosečnost in dojenje) SPC-ja.
English: Common: dizziness, tremor
Slovenian: Pogosti: omotica, tremor
English: There has been a concern about withdrawal reactions associated with paroxetine since its licensing.
Slovenian: V zvezi z odtegnitvenimi reakcijami, povezanimi s paroksetinom, so se od pridobitve dovoljenja pojavile zaskrbljenosti.
English: This results in disproportionate increases in plasma concentrations of paroxetine and hence pharmacokinetic parameters are not constant, resulting in non-linear kinetics.
Slovenian: To povzroči nesorazmerno povečanje koncentracij paroksetina v plazmi, zaradi česar so farmakokinetični parametri nestalni, kar se kaže v nelinearni farmakokinetiki.
English: Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects).
Slovenian: Odtegnitveni simptomi po prekinitvi zdravljenja so pogosti, še posebej, če se zdravljenje prekine nenadno (glejte poglavje 4.8 Neželeni učinki).
English: Paroxetine use has been associated with the development of akathisia.
Slovenian: Uporabo paroksetina povezujejo z razvojem akatizije.
English: However, the non-linearity is generally small and is confined to those subjects who achieve low plasma levels at low doses.
Slovenian: Nelinearnost pa je na splošno majhna in je omejena le na tiste osebe, pri katerih se z majhnimi odmerki dosežejo majhne koncentracije v plazmi.
English: Based on the above data concerning withdrawal reactions and suicidal behaviour, UK considered that there was Community interest to reassess the balance of risks and benefits of paroxetine and requested the CHMP to give an opinion on whether the marketing authorisations for paroxetine containing medicinal products should be maintained, varied or withdrawn.
Slovenian: Na podlagi zgoraj navedenih podatkov o odtegnitvenih reakcijah in samomorilnem vedenju, so v Veliki Britaniji ocenili, da naj se v Skupnosti ponovno oceni razmerje tveganj in koristi paroksetina in zaprosili Odbor za lastniška zdravila (CHMP - Committee for Proprietary Medicinal Products) za mnenje o ohranitvi, spremembah ali preklicu dovoljenj za promet z zdravili, vsebujočimi paroksetin.
English: Following evacuation, 20 to 30 g of activated charcoal may be administered every 4 to 6 h during the first 24 h after ingestion.
Slovenian: Po izpraznitvi se lahko med prvimi 24 urami po zaužitju zdravila vsake 4 do 6 ur daje 20 do 30 g aktivnega oglja.
English: There are insufficient data concerning the risk of suicide related behaviour in treatment naïve patients, but careful monitoring might be warranted.
Slovenian: Pri zdravljenju predhodno nezdravljenih bolnikov je premalo podatkov o tveganju za samomorilno vedenje, vendar pa je skrben nadzor lahko utemeljen.
English: Alpharma ApS Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Slovenian: Portugalska Alpharma ApS Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
English: Multipharma BV, Gemeenschapspolderweg 28 P.O.Box 216
Slovenian: Nizozemska Multipharma BV, Gemeenschapspolderweg 28 P.O.Box 216
English: Clinical experience has shown that therapy with paroxetine is not associated with impairment of cognitive or psychomotor function.
Slovenian: Klinične izkušnje so pokazale, da zdravljenje s paroksetinom ni povezano z okvaro kognitivnega in psihomotoričnega delovanja.
English: Instituto Luso-Fármaco, Lda.
Slovenian: Portugalska Instituto Luso-Fármaco, Lda.
English: Generics UK Ltd. Potters Bar
Slovenian: Madžarska Generics UK Ltd. Potters Bar
English: Phospholipidosis was not observed in primate studies of up to one-year duration at doses that were 6 times higher than the recommended range of clinical doses.
Slovenian: V študijah na primatih, ki so trajale do enega leta, pa pri odmerkih, ki so bili šestkrat večji od priporočenih kliničnih odmerkov, fosfolipidoze niso opazili.
English: Overall the incidence of seizures is less than 0.1% in patients treated with paroxetine.
Slovenian: Celotna pojavnost epileptičnih napadov je pri s paroksetinom zdravljenih bolnikih manjša od 0,1 %.
English: As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate.
Slovenian: V 3 do 4 tednih po začetku zdravljenja je, tako kot pri vseh antidepresivih, odmerjanje potrebno oceniti in ga po potrebi prilagoditi, kasneje pa mora biti odmerjanje v skladu s presojo kliničnega stanja.
English: In addition, the CHMP agreed that information with regards to the dose response studies should be included in section 5.1 (Pharmacodynamic Properties) of the SPC.
Slovenian: Poleg tega so v CHMP soglašali, da je treba podatke o študijah odziva na odmerek vključiti v poglavje 5.1 (Farmakodinamične lastnosti) SPC-ja.
English: Known hypersensitivity to paroxetine or any of the excipients.
Slovenian: Znana preobčutljivost za paroksetin ali katero koli pomožno snov.
English: Hyponatraemia has been reported rarely, predominantly in the elderly.
Slovenian: O hiponatriemiji so poročali redko in predvsem pri starostnikih.
English: 4.4 Special Warnings and Special Precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: Analysis of the available data from clinical trials and spontaneous reporting data indicate that the risk of withdrawal reactions is dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Slovenian: Analiza razpoložljivih podatkov iz kliničnih preskušanj in podatkov iz spontanih poročil kažejo, da je tveganje za odtegnitvene reakcije odvisno od več dejavnikov, vključno s trajanjem in odmerkom zdravljenja ter hitrostjo nižanja odmerka.
English: Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Slovenian: Prekinitev zdravljenja s paroksetinom (še posebej nenadna) pogosto vodi do odtegnitvenih simptomov.
English: Behavioural and EEG studies indicate that paroxetine is weakly activating at doses generally above those required to inhibit 5-HT uptake.
Slovenian: Vedenjske in elektroencefalogramske (EEG) študije kažejo, da je paroksetin v odmerkih, ki so na splošno večji od tistih, ki so potrebni za zaviranje prevzema 5-HT, slabo aktivirajoč.
English: The CHMP also agreed that the above-mentioned information with regards to longterm efficacy should be included in section 5.1 (Pharmacodynamic Properties) of the Summary of Product Characteristics (SPC).
Slovenian: V CHMP so tudi soglašali, da je treba zgoraj navedene podatke glede dolgoročne učinkovitosti vključiti v poglavje 5.1 (Farmakodinamične lastnosti) v Povzetku glavnih značilnosti zdravila (Summary of Product Characteristics, SPC).