FrancophonIA/ELRC3.0 huggingface dataset:
English: - dementia (loss of memory and other mental abilities) especially if you are elderly - Parkinson's disease - if you have diabetes or risk factors for diabetes (e.g. obesity, or someone else in your family has diabetes).
Croatian: - ako patite od demencije (gubitka pamćenja i drugih mentalnih sposobnosti), osobito ako ste stariji - ako imate Parkinsonovu bolest - ako imate šećernu bolest ili čimbenike rizika za šećernu bolest (npr. pretilost ili ako netko drugi u Vašoj obitelji ima šećernu bolest).
English: Seizures and convulsions
Croatian: Napadaji i konvulzije
English: What Reagila is and what it is used for What you need to know before you take Reagila How to take Reagila
Croatian: Što je Reagila i za što se koristi Što morate znati prije nego počnete uzimati lijek Reagila Kako uzimati lijek Reagila
English: Elimination of cariprazine and its major active metabolites is mainly through hepatic metabolism.
Croatian: Eliminacija kariprazina i njegovih glavnih aktivnih metabolita uglavnom se odvija jetrenim metabolizmom.
English: Breast-feeding should be discontinued during treatment with cariprazine.
Croatian: Dojenje treba prekinuti tijekom liječenja kariprazinom.
English: PANSS total (MMRM) RGH-MD-16 (n=711)
Croatian: RGH-MD-16 (n = 711)
English: Cariprazine has no appreciable affinity for cholinergic muscarinic receptors (IC50 > 1000 nM).
Croatian: Kariprazin ima zanemariv afinitet za kolinergičke muskarinske receptore (IC50 > 1000 nM).
English: Women of childbearing potential must be advised to avoid pregnancy while on Reagila.
Croatian: Žene u reproduktivnoj dobi se mora savjetovati da izbjegavaju trudnoću dok uzimaju Reagilu.
English: Schizophrenia is a disease characterised by symptoms such as hearing, seeing or sensing things which are not there (hallucination), suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Croatian: Shizofrenija je bolest koju karakteriziraju simptomi kao što su da bolesnik čuje, vidi ili osjeća stvari kojih nema (halucinacija), sumnjičavost, pogrešno vjerovanje, nepovezan govor i ponašanje te emocionalna tupost.
English: The rate of discontinuation due to EPS related ADRs was low.
Croatian: Stopa prekida liječenja zbog nuspojava povezanih s EPS-om bila je niska.
English: Persistent predominant negative symptoms were defined as symptoms lasting for a period of at least 6 months with high level of negative symptoms and low level of positive symptoms [(PANSS factor score for negative symptoms ≥ 24, a score of ≥ 4 on a minimum 2 of the 3 PANSS items (N1: flat affect, N4: avolition, and N6: poverty of speech) and PANSS factor score for positive symptoms ≤ 19].
Croatian: Ustrajni predominantno negativni simptomi bili su definirani kao simptomi koji traju tijekom najmanje 6 mjeseci s visokim stupnjem negativnih simptoma i niskim stupnjem pozitivnih simptoma [(PANSS rezultat za negativne simptome (engl. factor score for negative symptoms, FSNS) ≥ 24, rezultat ≥ 4 za minimalno 2 od 3 PANSS stavke (N1: osjećajna zaravnjenost, N4: avolicija i N6: osiromašenje govora) i PANSS rezultat za pozitivne simptome ≤ 19].
English: There are no or limited amount of data from the use of cariprazine in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni kariprazina u trudnica ograničeni.
English: Therefore CYP2D6 inhibitors are unlikely to have a clinically relevant effect on cariprazine metabolism.
Croatian: Stoga nije vjerojatno da bi inhibitori CYP2D6 mogli klinički značajno utjecati na metabolizam kariprazina.
English: The efficacy of cariprazine for the treatment of acute schizophrenia was studied in three multi-center, multinational, randomized, double-blind, placebo-controlled 6-week trials including 1,754 patients with the age of 18 to 60 years.
Croatian: Djelotvornost kariprazina u liječenju akutne shizofrenije ispitivala se u tri multicentrična, multinacionalna, randomizirana, dvostruko slijepa, placebom kontrolirana, 6-tjedna ispitivanja koja su uključivala 1754 bolesnika u dobi od 18 do 60 godina.
English: The metabolites of HCAR, HDCAR, and HDDCAR are subsequently biotransformed to their corresponding sulfate and glucuronide conjugates.
Croatian: Metaboliti HCAR, HDCAR i HDDCAR zatim se biotransformiraju u odgovarajuće sulfatne i glukuronidne konjugate.
English: Time to relapse (92 vs. 326 days-based on the 25th percentile) was therefore significantly longer in the cariprazine group than in the placebo group (p=0.009).
Croatian: Stoga je vrijeme do relapsa (92 naspram 326 dana, prema 25. percentilu) bilo značajno dulje u skupini liječenoj kariprazinom nego u skupini koja je primala placebo (p = 0,009).
English: Reagila is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Croatian: Primjena lijeka Reagila ne preporučuje se u trudnica i žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
English: Potential for other medicinal products to affect cariprazine
Croatian: Potencijal drugih lijekova da utječu na kariprazin
English: Patients should have their weight monitored regularly (see section 4.8).
Croatian: Potrebno je redovno pratiti tjelesnu težinu bolesnika (vidjeti dio 4.8).
English: During the schizophrenia clinical development program of cariprazine, few cataract cases were reported, characterized with minor lens opacities with no visual impairment (13/3192; 0.4%).
Croatian: Tijekom programa kliničkog razvoja kariprazina za liječenje shizofrenije, zabilježeno je nekoliko slučajeva katarakte koji su karakterizirani manjom neprozirnosti leće bez poremećaja vida (13/3192; 0,4%).
English: Given the primary central nervous system effects of cariprazine, Reagila should be used with caution in combination with other centrally acting medicinal products and alcohol.
Croatian: Budući da kariprazin prvenstveno djeluje na središnji živčani sustav, potreban je oprez kad se Reagila primjenjuje u kombinaciji s drugim lijekovima koji djeluju na središnjih živčani sustav i alkoholom.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with cariprazine and preventive measures undertaken.
Croatian: Budući da bolesnici liječeni antipsihoticima često imaju stečene čimbenike rizika za VTE, potrebno je utvrditi sve moguće čimbenike rizika za VTE prije i tijekom liječenja kariprazinom te poduzeti preventivne mjere.
English: Due to the long half-life of the active moieties of cariprazine a further increase in plasma exposure of total cariprazine can be expected during longer co-administration.
Croatian: Zbog dugog poluvijeka aktivnih spojeva kariprazina, može se očekivati daljnji porast plazmatske izloženosti ukupnom kariprazinu tijekom dugotrajnije istodobne primjene.
English: - irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring), and tell your doctor if you are taking other medicines, because they might cause or worsen this ECG change.
Croatian: - ako imate nepravilne srčane otkucaje ili je netko drugi u Vašoj obitelji imao nepravilne srčane otkucaje (uključujući takozvano produljenje QT intervala uočeno na EKG-u) i recite svom lječniku ako uzimate druge lijekove budući da oni mogu uzrokovati ili pogoršati ove promjene na EKG-u.
English: The recommended starting dose is 1.5 mg once a day by mouth.
Croatian: Preporučena početna doza je 1,5 mg kroz usta jedanput na dan.
English: Patients with secondary negative symptoms, such as moderate to severe depressive symptoms and clinically relevant parkinsonism (EPS) were excluded.
Croatian: U ispitivanje nisu bili uključeni bolesnici sa sekundarnim negativnim simptomima, kao što su umjereni do teški depresivni simptomi i klinički relevantni parkinsonizam (EPS).
English: The same information is also available on the following URL: www.reagila.com
Croatian: Iste su informacije dostupne i na sljedećoj internetskoj adresi: www.reagila.com
English: Efficacy with short-term use
Croatian: Djelotvornost pri kratkotrajnoj primjeni
English: These are medicines used to treat heart diseases containing digoxin, blood thinners containing dabigatran, or medicines affecting your mental functions.
Croatian: Radi se o lijekovima koji se primjenjuju za liječenje bolesti srca, a sadrže digoksin, lijekovima koji razrjeđuju krv, a sadrže dabigatran ili lijekovima koji utječu na vaše mentalne funkcije.
English: Most EPS cases were mild to moderate in intensity and could be handled with common anti-EPS medicinal products.
Croatian: Većina slučajeva EPS-a bila je blage do umjerene težine te ih je bilo moguće zbrinuti uobičajenim lijekovima za EPS.
English: The recommended starting dose of cariprazine is 1.5 mg once daily.
Croatian: Preporučena početna doza kariprazina je 1,5 mg jedanput na dan.
English: No significant relationship was found between cariprazine plasma clearance and creatinine clearance.
Croatian: Nije utvrđena značajna povezanost između plazmatskog klirensa kariprazina i klirensa kreatinina.
English: In the population PK analysis there were no clinically relevant differences in the PK parameters (AUC and Cmax of the sum of cariprazine and its major active metabolites) based on age, gender and race.
Croatian: U populacijskoj farmakokinetičkoj analizi nije bilo klinički značajnih razlika u farmakokinetičkim parametrima (AUC i Cmax za zbroj kariprazina i njegovih glavnih aktivnih metabolita) na temelju dobi, spola i rase.
English: If you were taking another medicine to treat schizophrenia before starting Reagila, your doctor will decide whether to stop the other medicine gradually or immediately and how to adjust the dose of Reagila.
Croatian: Ako ste prije početka liječenja lijekom Reagila uzimali neki drugi lijek za liječenje shizofrenije, Vaš liječnik će odlučiti hoće li se njegova primjena prekinuti postupno ili trenutačno te utvrditi kako prilagoditi dozu lijeka Reagila.
English: Tell your doctor immediately: - if you are having any thoughts or feelings about hurting yourself or to commit suicide.
Croatian: Odmah obavijestite svog liječnika: - ako razmišljate o samoozljeđivanju ili osjećate da biste si mogli nauditi ili počiniti samoubojstvo.
English: Based on a population pharmacokinetic analysis, the apparent volume of distribution (V/F) was 916 L for cariprazine, 475 L for DCAR and 1,568 L for DDCAR, indicating extensive distribution of cariprazine and its major active metabolites.
Croatian: Na temelju populacijske farmakokinetičke analize, prividan volumen raspodjele (V/F) iznosio je 916 l za kariprazin, 475 l za DCAR i 1568 l za DDCAR, što ukazuje na opsežnu distribuciju kariprazina i njegovih glavnih aktivnih metabolita.
English: In elderly patients above 65 years of age data are limited.
Croatian: Ograničeni podaci prikupljeni su za bolesnike starije od 65 godina.
English: Richter Gedeon Nyrt.
Croatian: Magyarország Richter Gedeon Nyrt.
English: Cariprazine and its metabolites were excreted in milk of rats during lactation.
Croatian: Kariprazin i njegovi metaboliti izlučivali su se u mlijeko ženki štakora tijekom laktacije.
English: Studies in animals have shown reproductive toxicity including developmental malformations in rats (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost uključujući i razvoj malformacija u ženki štakora (vidjeti dio 5.3).
English: 1103 Budapest, Hungary
Croatian: 1103 Budimpešta, Mađarska
English: Cariprazine can cause orthostatic hypotension as well as hypertension (see section 4.8).
Croatian: Kariprazin može uzrokovati i ortostatsku hipotenziju i hipertenziju (vidjeti dio 4.8).
English: Taking Reagila together with some medicines may require a dose adjustment of Reagila or the other medicine.
Croatian: Ako uzimate lijek Reagila zajedno s nekim drugim lijekovima, možda će biti potrebna prilagodba doze lijeka Reagila ili tih drugih lijekova.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING folded carton
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU kartonska kutija
English: Cariprazine should be used with caution in patients with known cardiovascular disease predisposing to blood pressure changes.
Croatian: Kariprazin treba primjenjivati uz oprez u bolesnika za koje se zna da imaju kardiovaskularnu bolest koja može stvoriti predispoziciju za promjene krvnog tlaka.
English: The effects of cariprazine on the QT interval were evaluated in patients with schizophrenia or schizoaffective disorder.
Croatian: Učinci kariprazina na QT interval ocjenjivali su se u bolesnika sa shizofrenijom ili shizoafektivnim poremećajem.
English: Women of childbearing potential/contraception
Croatian: Žene u reproduktivnoj dobi / kontracepcija
English: Akathisia is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting.
Croatian: Akatizija je poremećaj pokreta koji karakterizira osjećaj unutarnjeg nemira i neodgodiva potreba za stalnim kretanjem, kao i radnjama kao što su ljuljanje tijekom stajanja ili sjedenja, podizanje stopala poput marširanja u mjestu i prekriživanje i razdvajanje nogu tijekom sjedenja.
English: The mean terminal half-life (1 to 3 days for cariprazine and DCAR and 13 to 19 days for DDCAR) is not predictive of time to reach steady state or plasma concentration decline after treatment discontinuation.
Croatian: Srednja vrijednost terminalnog poluvijeka (1 - 3 dana za kariprazin i DCAR te 13 - 19 dana za DDCAR) nije pretkazatelj vremena do postizanja stanja dinamičke ravnoteže ni pada plazmatske koncentracije nakon prekida liječenja.
English: Thereafter the dose can be increased slowly in 1.5 mg increments to a maximum dose of 6 mg/day, if needed.
Croatian: Ako je potrebno, doza se nakon toga može polagano povećavati u koracima od 1,5 mg do maksimalne doze od 6 mg/dan.
English: Elevated liver transaminases
Croatian: Povišene vrijednosti jetrenih transaminaza
English: p-value
Croatian: P-vrijednost
English: The capsules are packed in transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing.
Croatian: Kapsule su pakirane u prozirni tvrdi PVC/PE/PVDC blister toplinski zavaren za podlogu od tvrde aluminijske folije.
English: At steady state, exposure to DDCAR is approximately two to three-fold higher than to cariprazine, and exposure to DCAR is approximately 30% of cariprazine exposure.
Croatian: Izloženost DDCAR-u u stanju dinamičke ravnoteže približno je dva do tri puta veća nego izloženost kariprazinu, dok izloženost DCAR-u iznosi približno 30% izloženosti kariprazinu.
English: ECG changes
Croatian: Promjene na EKG-u
English: Women of childbearing potential must use highly effective contraception while taking cariprazine and at least for 10 weeks after stopping treatment (see sections 4.5 and 4.6).
Croatian: Žene u reproduktivnoj dobi moraju koristiti visoko učinkovitu kontracepciju tijekom uzimanja kariprazina te najmanje još 10 tjedana nakon prekida liječenja (vidjeti dio 4.5 i 4.6).
English: If your baby develops any of these symptoms you should contact your doctor.
Croatian: Ako se kod Vašeg djeteta razvije bilo koji od tih simptoma, obratite se svom liječniku.
English: DCAR and DDCAR were not inhibitors of transporter P-gp although cariprazine was a P-gp inhibitor in the intestine (see section 4.5).
Croatian: DCAR i DDCAR također nisu inhibirali P-gp, dok je kariprazin inhibirao P-gp u crijevima (vidjeti dio 4.5).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS blisterfoil
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP folija blistera
English: The plasma concentration of total cariprazine decreases by 50% in ~1 week and greater than 90% decline in total cariprazine concentration occurs in ~3 weeks.
Croatian: Plazmatska koncentracija ukupnog kariprazina smanjuje se za 50% nakon ~ 1 tjedna, dok se smanjenje koncentracije ukupnog kariprazina za više od 90% bilježi nakon ~ 3 tjedna.
English: No QT interval prolongation was detected following supratherapeutic doses (9 mg/day or 18 mg/day).
Croatian: Nije utvrđeno produljenje QT intervala nakon primjene doza iznad terapijskog raspona (9 mg/dan ili 18 mg/dan).
English: Management of overdose should concentrate on supportive therapy including maintenance of an adequate airway, oxygenation and ventilation and management of symptoms.
Croatian: Liječenje predoziranja treba biti usmjereno na potpornu terapiju, uključujući održavanje prohodnosti dišnih puteva, oksigenaciju i ventilaciju te zbrinjavanje simptoma.
English: The most frequently reported ADRs with cariprazine in the dose range (1.5-6 mg) were akathisia (19%) and parkinsonism (17.5%).
Croatian: Najčešće prijavljene nuspojave kod primjene kariprazina u navedenom rasponu doza (1,5 - 6 mg) bile su akatizija (19%) i parkinsonizam (17,5%).
English: Transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing packed in folded carton box.
Croatian: Proziran, tvrd PVC/PE/PVDC blister toplinski zavaren za podlogu od tvrde aluminijske folije, zapakiran u kartonsku kutiju.
English: Totally, 751 patients with acute symptoms of schizophrenia received cariprazine 3-9 mg/day for 20 weeks, of whom 337 received cariprazine in the dose-range of 3 or 6 mg/day.
Croatian: U ispitivanju je ukupno 751 bolesnik s akutnim simptomima shizofrenije tijekom 20 tjedana primao kariprazin od 3 do 9 mg/dan, od čega je 337 bolesnika primalo kariprazin s rasponom doze od 3 ili 6 mg/dan.
English: ° increased blood glucose (blood sugar), increased bile pigment (bilirubin) in the blood
Croatian: ° povišena razina glukoze u krvi (šećera u krvi), povišena razina žučnog pigmenta (bilirubina)
English: A 2-part study (a single dose of 1 mg cariprazine [Part A] and a daily dose of 0.5 mg cariprazine for 14 days [Part B] was conducted in patients with varying degrees of impaired hepatic function (ChildPugh Classes A and B).
Croatian: Provedeno je dvodijelno ispitivanje (jedna doza kariprazina od 1 mg [dio A] i dnevna doza kariprazina od 0,5 mg tijekom 14 dana [dio B] u bolesnika s različitim stupnjevima oštećenja funkcije jetre (ChildPugh stadij A i B).
English: Cariprazine has minor or moderate influence on the ability to drive and use machines.
Croatian: Kariprazin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder.
Croatian: Prijavljeni su agitacija, hipertonija, hipotonija, tremor, somnolencija, respiratorni distres ili poremećaj hranjenja.
English: As cariprazine causes akathisia and restlessness, it should be used cautiously in patients who are prone to or already exhibit symptoms of akathisia.
Croatian: Budući da kariprazin uzrokuje akatiziju i nemir, treba ga primjenjivati uz oprez u bolesnika sklonim aktaziji ili koji već pokazuju simptome akatizije.
English: It is unknown whether cariprazine or its major active metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se kariprazin ili njegovi glavni aktivni metaboliti u majčino mlijeko.
English: - if you experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome).
Croatian: - ako ste iskusili vrućicu u kombinaciji sa znojenjem, ubrzanim disanjem, ukočenošću mišića i omamljenošću ili pospanošću (mogu biti znakovi neuroleptičkog malignog sindroma).
English: Cariprazine and its metabolites are excreted in milk of rats during lactation (see section 5.3).
Croatian: Kariprazin i njegovi metaboliti izlučuju se u mlijeko ženki štakora tijekom laktacije (vidjeti dio 5.3).
English: Administration of a single dose of 1.5 mg cariprazine with a high-fat meal (900 to 1,000 calories) did not significantly affect the Cmax or AUC of cariprazine (AUC0-∞ increased by 12%, Cmax decreased by < 5% under fed condition versus fasting).
Croatian: Primjena jednokratne doze kariprazina od 1,5 mg uz obrok s visokim udjelom masti (900 - 1000 kalorija) nije značajno utjecala na Cmax ni AUC kariprazina (AUC0-∞ se povećao za 12%, dok se Cmax smanjio za < 5% kod primjene s hranom u odnosu na primjenu natašte).
English: In vivo non-clinical studies demonstrated that cariprazine occupies D3 receptors to a similar extent as D2 receptors at pharmacologically effective doses.
Croatian: Neklinička ispitivanja in vivo pokazala su da kariprazin u farmakološki učinkovitim dozama zauzima D3 receptore u sličnoj mjeri kao i D2 receptore.
English: Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Croatian: Dodatni znakovi mogu uključivati mioglobinuriju (rabdomiolizu) i akutno zatajenje bubrega.
English: Therefore, cariprazine should be used cautiously in patients with known cardiovascular disease or in patients with a family history of QT prolongation and in patients treated with medicinal products that might cause QT prolongation (see section 5.1).
Croatian: Stoga, kariprazin treba primjenjivati uz oprez u bolesnika s poznatom kardiovaskularnom bolešću ili onih koji u obiteljskoj anamnezi imaju produljenje QT intervala te u bolesnika liječenih lijekovima koji mogu uzrokovati produljenje QT intervala (vidjeti dio 5.1).
English: Keep the blister in the outer carton in order to protect from light.
Croatian: Blister čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: - depression - sudden and severe confusion - spinning sensation - unpleasant, abnormal sense of touch - drowsiness, lack of energy or a lack of interest in doing things - involuntary movements, most commonly of the tongue or face.
Croatian: - depresija - iznenadna i teška smetenost - osjećaj vrtnje - neugodan, neuobičajen osjet dodira - omamljenost, nedostatak energije ili nedostatak interesa za aktivnosti - nevoljni pokreti najčešće jezika ili lica.
English: - dizziness on standing up due to a drop in your blood pressure, which may cause fainting - a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots - a history of stroke, especially if you are elderly or know that you have other risk factors for stroke.
Croatian: - ako imate omaglicu pri ustajanju uslijed pada krvnog tlaka, što može izazvati nesvjesticu - ako ste imali krvne ugruške ili ako ih je imao netko drugi u Vašoj obitelji, jer se lijekovi za shizofreniju povezuju s nastankom krvnih ugrušaka - ako ste pretrpjeli moždani udar, osobito ako ste starija osoba ili znate da imate druge čimbenike rizika za nastanak moždanog udara.
English: ‘QR code to be included' + www.reagila.com
Croatian: „Umetnuti QR kod“ + www.reagila.com
English: Ketoconazole, a strong CYP3A4 inhibitor, caused two fold increase in plasma exposure for total cariprazine (sum of cariprazine and its active metabolites) during short-term (4 days) co-administration, either if unbound or unbound+bound moieties considered.
Croatian: Ketokonazol, snažan inhibitor CYP3A4, uzrokovao je udvostručenje plazmatske izloženosti ukupnom kariprazinu (zbroj kariprazina i njegovih aktivnih metabolita) tijekom kratkotrajne (4-dnevne) istodobne primjene, bilo da su razmatrani samo nevezani ili nevezani i vezani spojevi.
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Croatian: U slučaju teških ekstrapiramidnih simptoma treba primijeniti antikolinergike.
English: Neonates exposed to antipsychotics (including cariprazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: U novorođenčadi izložene antipsihoticima (uključujući kariprazin) tijekom trećeg tromjesečja trudnoće postoji rizik da se nakon poroda razviju nuspojave, uključujući ekstrapiramidne simptome i/ili simptome ustezanja od lijeka, koje mogu varirati prema težini i trajanju.