FrancophonIA/ELRC3.0 huggingface dataset:
English: If 4th or subsequent doses are missed (i.e., after attainment of steady state) and time since last injection is:
Croatian: Ako se propusti 4. doza ili kasnije doze (tj., nakon što se postigne stanje dinamičke ravnoteže), a vrijeme proteklo od zadnje injekcije je:
English: These medicines may increase the risk of side effects or reduce the effect of Abilify Maintena; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.
Croatian: Ti lijekovi mogu povećati rizik od nuspojava ili smanjiti učinak lijeka Abilify Maintena; ako dobijete neki neobični simptom dok uzimate ove lijekove zajedno s lijekom Abilify Maintena, trebate posjetiti liječnika.
English: Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Croatian: Liječenje predoziranja treba biti usmjereno na potpornu terapiju, održavanje odgovarajuće prohodnosti dišnih puteva, oksigenaciju i ventilaciju te liječenje simptoma.
English: Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Croatian: Aripiprazol treba biti primjenjivan s oprezom u bolesnika s poznatom kardiovaskularnom bolešću (infarkt miokarda ili ishemijska bolest srca, zatajenje srca ili poremećaji provođenja u povijesti bolesti), cerebrovaskularnom bolešću, stanjima zbog kojih su bolesnici skloni hipotenziji (dehidracija, hipovolemija i liječenje antihipertenzivnim lijekovima) ili hipertenziji, uključujući ubrzanu ili malignu hipertenziju.
English: In the placebo group 39.6 % of the patients had progressed to impending relapse, whilst in the Abilify Maintena group impending relapse occurred in 10 % of the patients; thus patients in the placebo group had a 5.03-fold greater risk of experiencing impending relapse.
Croatian: U skupini koja je primala placebo, 39,6 % bolesnika progrediralo je do prijetećeg relapsa, dok je u skupini koja je primala Abilify Maintena relaps nastupio u 10 % bolesnika; tako su bolesnici u skupini koja je primala placebo imali 5,03 puta veći rizik od toga dožive prijeteći relaps.
English: In this PSUR, there are 15 spontaneous reports of oculogyric crisis (8 serious) in the interval and 223 cumulatively (78 serious) for the oral formulations, comparing to 5 spontaneous reports of oculogyric crisis (3 serious) in the interval and 21 cumulatively (14 serious) for the prolonged-release suspension for injection.
Croatian: spontanih prijava okulogirne krize (8 ozbiljnih) iz promatranog razdoblja i 223 kumulativno (78 ozbiljnih) za peroralne formulacije, u odnosu na 5 spontanih prijava okulogirne krize (3 ozbiljne) u promatranom razdoblju i 21 kumulativno (14 ozbiljnih) za suspenziju za injekciju s produljenim oslobađanjem.
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
Croatian: nespretnost, nemir, osjećaj opijenosti, vrućicu, znojenje ili ukočenost mišića)
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash
Croatian: • alergijska reakcija (npr. oticanje usta, jezika, lica i grla, svrbež, koprivnjača), osip
English: These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.
Croatian: Ovi lijekovi mogu povećati rizik od nuspojava; ako dobijete ikakve neobične simptome dok uzimate neki od ovih lijekova zajedno s lijekom Abilify Maintena, trebate se obratiti liječniku.
English: In case of adverse reactions despite dose adjustments of Abilify Maintena, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed.
Croatian: U slučaju nuspojava unatoč prilagodbi doze lijeka Abilify Maintena, potrebno je ponovno procjeniti potrebu istovremene primjene inhibitora CYP2D6 ili CYP3A4.
English: An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy-metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/kg/day or approximately16 to 81 times the maximum recommended human dose based on mg/m2.
Croatian: Dodatni nalaz bio je kolelitijaza kao posljedica precipitacije sulfatnih konjugata hidroksi-metabolita aripiprazola u žuči majmuna nakon ponovljenog doziranja 25 do 125 mg/kg na dan ili pri približno 16 do 81 puta većoj dozi od maksimalne preporučene doze za ljude na temelju mg/m2.
English: A simulation of dose dumping showed that the predicted median aripiprazole concentration reaches a peak of 4,500 ng/ml or approximately 9 times the upper therapeutic range.
Croatian: Simulacija naglog oslobađanja cijele doze lijeka (engl. dose dumping) pokazala je da predviđeni medijan koncentracije aripiprazola dostiže vršnu vrijednost od 4500 ng/ml ili približno 9 puta iznad gornje granice terapijskog raspona.
English: Contact your doctor or hospital immediately if you experience any of the above.
Croatian: Odmah posjetite liječnika ili otiđite u bolnicu ako osjetite bilo koji od gore opisanih simptoma.
English: Powder and solvent for prolonged-release suspension for injection Multipack: Three single packages, each containing:
Croatian: Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem Višestruko pakiranje: tri pojedinačna pakiranja, od kojih svako sadrži:
English: If you miss an injection of Abilify Maintena
Croatian: Ako propustite injekciju lijeka Abilify Maintena
English: Your doctor will decide on the dose of Abilify Maintena that is right for you.
Croatian: Liječnik će odlučiti koja je prava doza lijeka Abilify Maintena za Vas.
English: The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Croatian: Medicinski potencijalno važni znakovi i simptomi koji su bili opaženi uključivali su letargiju, povećan krvni tlak, somnolenciju, tahikardiju, mučninu, povraćanje i proljev.
English: Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in sub-therapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures approximately 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Croatian: Razvojna toksičnost, kao i zakašnjela fetalna osifikacija ovisna o dozi i mogući teratogeni učinci, bili su opaženi u štakora pri dozama koje su izazvale subterapijsku izloženost (na temelju AUC-a) te u kunića pri dozama koje su rezultirale izloženostima približno 3 i 11 puta većima od srednje vrijednosti AUC-a u stanju dinamičke ravnoteže kod maksimalne preporučene kliničke doze.
English: • jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement
Croatian: • trzajni otpor kod pasivnih kretnji kako se mišići napinju i opuštaju, nenormalno pojačan tonus mišića, spore kretnje tijela
English: For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with Abilify Maintena.
Croatian: Doziranje Bolesnici koji nikad prije nisu uzimali aripiprazol moraju razviti podnošljivost na oralni aripiprazol prije nego što se započne liječenje lijekom Abilify Maintena.
English: In these patients dosing should be managed cautiously.
Croatian: U tih je bolesnika potrebno pažljivo provesti doziranje.
English: Figure 1 Kaplan-Meier Product Limit Plot for Time to Exacerbation of Psychotic Symptoms/Impending Relapse
Croatian: Slika 1 Kaplan-Meierova krivulja granice lijeka za vrijeme do egzacerbacije psihotičkih simptoma/prijetećeg relapsa
English: Oral aripiprazole
Croatian: Oralni aripiprazol
English: • rapid heartbeat, agitation/aggressiveness, problems with speech.
Croatian: • ubrzan rad srca, uznemirenost/agresivnost, otežan govor,
English: • during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function)
Croatian: • na krvnim pretragama liječnik može pronaći da imate povišene količine kreatin fosfokinaze u krvi (enzima važnog za rad mišića)
English: Multipack Bundle pack of 3 single packs.
Croatian: Višestruko pakiranje od 3 pojedinačna pakiranja.
English: Subjects with akathisia typically received anti-cholinergic medicines as treatment, primarily benzatropine mesilate and trihexyphenidyl.
Croatian: Ispitanici s akatizijom obično su kao terapiju primali antikolinergičke lijekove, prvenstveno benzatropin mesilat i triheksifenidil.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Zabilježeni su agitacija, hipertonija, tremor, somnolencija, respiratorni distres ili poremećaj hranjenja.
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir)
Croatian: • određene lijekove za liječenje HIV-infekcije (kao što su efavirenz, nevirapin, inhibitori proteaze, npr. indinavir, ritonavir)
English: With intramuscular injection, however an inflammatory response was seen at the injection site, and consisted of granulomatous inflammation, foci (deposited drug), cellular infiltrates, oedema (swelling) and, in monkeys, fibrosis.
Croatian: Međutim, kod intramuskularne injekcije, opažen je upalni odgovor na mjestu injekcije, a sastojao se od granulomatozne upale, žarišta (istaloženi lijek), staničnih infiltrata, edema (oticanje) i, u majmuna, fibroze.
English: • heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG) QT prolongation
Croatian: • tegobe sa srcem uključujući torsades de pointes, zaustavljanje srca, nepravilnosti srčanog ritma koje mogu biti posljedica poremećenog širenja živčanih impulsa u srcu, poremećen zapis tijekom pregleda srca (EKG), produljenje QT-intervala • nesvjestica
English: Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with oral aripiprazole alone.
Croatian: Slično tome, geometrijska srednja vrijednost Cmax i AUC dehidroaripiprazola nakon istodobne primjene karbamazepina bila je 69 % odnosno 71 % niža od one nakon liječenja samo oralnim aripiprazolom.
English: f) Place and hold the vial of the reconstituted suspension on a hard surface.
Croatian: f) Postavite i držite bočicu s rekonstituiranom suspenzijom na tvrdoj podlozi.
English: Aripiprazole oral doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Croatian: Oralne doze aripiprazola u rasponu od 0,5 do 30 mg primjenjivane jedanput na dan zdravim ispitanicima tijekom 2 tjedna dovele su do smanjenog vezanja ovisnog o dozi 11C-rakloprida, liganda D2/D3 receptora, za kaudatus i putamen što se otkrilo pozitronskom emisijskom tomografijom.
English: > 4 weeks and < 5 weeks
Croatian: > 4 tjedna i < 5 tjedana
English: In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo.
Croatian: U kliničkim ispitivanjima liječenja oralnim aripiprazolom, incidencija produljenja QT intervala bila je usporediva s onom uz placebo.
English: In case of dose dumping, aripiprazole concentrations are predicted to descend rapidly to the upper limit of the therapeutic window after approximately 3 days.
Croatian: U slučaju naglog oslobađanja cijele doze lijeka, predviđa se da će se koncentracije aripiprazola brzo sniziti do gornje granice terapijskog raspona nakon približno 3 dana.
English: Single pack
Croatian: Pojedinačno pakiranje
English: After reconstitution each ml of suspension contains 200 mg aripiprazole.
Croatian: Nakon rekonstitucije, jedan ml suspenzije sadrži 200 mg aripiprazola.
English: Step 2: Reconstitution of the powder a) Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab.
Croatian: Korak 2: Rekonstitucija praška a) Uklonite poklopce s bočica s otapalom i praškom i obrišite vrh bočica sterilnom vaticom natopljenom alkoholom.
English: For all other aripiprazole products, oculogyric crisis is not listed.
Croatian: U svim drugim lijekovima koji sadrže aripiprazol okulogirna kriza nije navedena.
English: g) Visually inspect the reconstituted suspension for particulate matter and discolouration prior to administration.
Croatian: g) Prije primjene vizualno pregledajte rekonstituiranu suspenziju zbog čestica i promjene boje.
English: • during tests your doctor may find higher amounts alkaline phosphatase fluctuating results during tests to measure glucose in your blood
Croatian: • na pretragama liječnik može pronaći povišene količine alkalne fosfataze promjenjive rezultate testova kojima se mjeri glukoza u krvi
English: These included: dose-dependent adrenocortical toxicity in rats after 104 weeks of oral administration at approximately 3 to 10 times the mean steady-state AUC at the maximum recommended human dose and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at approximately 10 times the mean steady-state AUC at the maximum recommended human dose.
Croatian: Uključivali su: adrenokortikalnu toksičnost ovisnu o dozi u štakora nakon 104 tjedna oralne primjene pri približno 3 do 10 puta većoj srednjoj vrijednosti AUC-a u stanju dinamičke ravnoteže kod maksimalne preporučene doze za ljude i povećanje broja adrenokortikalnih karcinoma i kombinacije adrenokortikalnih adenoma/karcinoma u ženki štakora pri približno 10 puta većoj srednjoj vrijednosti AUC-a u stanju dinamičke ravnoteže kod maksimalne preporučene doze za ljude.
English: 87 cases had medical history of confounding risk factors such as balance disorders, loss of consciousness, syncope, somnolence, extrapyramidal disorder, femoral fracture, alcohol abuse, bundle branch block, osteoporosis, knee arthroplasty, spinal fusion surgery, road traffic accident, fall, transient ischemic attack, cerebrovascular accident, head injury and dementia with Lewy bodies and concomitant therapy with risperidone, quetiapine fumarate, clonazepam, Latuda, valium was a confounding factor in 172 cases.
Croatian: U 87 slučajeva povijest bolesti je sadržavala zbunjujuće rizične čimbenike kao što su poremećaji ravnoteže, gubitak svijesti, sinkopa, somnolencija, ekstrapiramidni poremećaj, prijelom natkoljenične kosti, zloporaba alkohola, blok grane, osteoporoza, artroplastika koljena, operacija spinalne fuzije, prometna nesreća, pad, prolazna ishemijska ataka, cerebrovaskularni incident, ozljeda glave i demencija s Lewyjevim tjelešcima, dok je istodobna terapija risperidonom,
English: Your doctor or nurse will make it into a suspension that will be given as an injection using the vial of solvent for Abilify Maintena that comes as a clear solution in a clear glass vial.
Croatian: Vaš liječnik ili medicinska sestra pripremit će od njega pomoću bočice otapala za Abilify Maintena, koje izgleda kao bistra otopina u prozirnoj staklenoj bočici, suspenziju koja će se dati kao injekcija.
English: P-values were derived from comparison for change from baseline within analysis of covariance model with treatment as term and baseline as covariate.
Croatian: P-vrijednosti bile su izvedene iz usporedbe promjene u odnosu na početnu vrijednost u modelu analize kovarijance, s liječenjem kao nezavisnom varijablom i početnom vrijednošću kao kovarijablom.
English: When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Croatian: Kad se razmatra istovremena primjena ketokonazola ili drugih jakih inhibitora CYP3A4 s aripiprazolom, moguće koristi trebaju biti veće od mogućih rizika za bolesnika.
English: Pull e) Hold syringe upright and advance plunger rod slowly to expel the air.
Croatian: Povucite e) Držite štrcaljku uspravno i polako potiskujte klip kako biste istisnuli zrak.
English: Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole.
Croatian: Abilify Maintena namijenjen je odraslim bolesnicima sa shizofrenijom koji su dovoljno stabilizirani liječenjem oralnim aripiprazolom.
English: It should only be administered by a healthcare professional.
Croatian: Lijek smije primjenjivati samo zdravstveni djelatnik.
English: Similar to the PANSS Total Score, both the PANSS positive and negative subscale scores also showed an improvement (decrease) from baseline over time.
Croatian: Slično ukupnom rezultatu na ljestvici PANSS, rezultati na podljestvicama pozitivnih i negativnih simptoma ljestvice PANSS pokazali su poboljšanje (smanjenje) tijekom vremena u odnosu na početne vrijednosti.
English: uniform milky white
Croatian: jednolično mliječno-bijela
English: • drooling, more saliva in mouth than normal
Croatian: • učestalo pražnjenje crijeva • slinjenje, veća količina sline u ustima nego obično
English: Thus, superiority of Abilify Maintena over the aripiprazole Long-Acting Injectable 50 mg/25 mg was established and the validity of the trial design was confirmed.
Croatian: Tako je bila ustanovljena superiornost lijeka Abilify Maintena nad dugodjelujućim aripiprazolom u injekcijama od 50 mg/25 mg, a valjanost ustroja ispitivanja potvrđena.
English: The reconstituted medicine is a white to off-white, fluid suspension.
Croatian: Rekonstituirani lijek bijela je do gotovo bijela tekuća suspenzija.
English: This trial consisted of a screening phase and 3 treatment phases: Conversion Phase, Oral Stabilisation Phase, and Double-blind, Active-controlled Phase.
Croatian: To se ispitivanje sastojalo od faze probira i 3 terapijske faze: faze konverzije, faze stabilizacije oralne doze i dvostruko slijepe faze kontrolirane djelatnom tvari.
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Croatian: Na temelju ispitivanja in vitro, enzimi CYP3A4 i CYP2D6 odgovorni su za dehidrogenaciju i hidroksilaciju aripiprazola, dok N-dealkilaciju katalizira enzim CYP3A4.
English: Less often substances such as propranolol and benzodiazepines (clonazepam and diazepam) were administered to control akathisia.
Croatian: Za kontrolu akatizije manje su se često primjenjivali lijekovi poput propranolola i benzodiazepina (klonazepam i diazepam).
English: 0.8 ml e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab.
Croatian: 0,8 ml e) Obrišite vršak bočice s rekonstituiranom suspenzijom sterilnom vaticom natopljenom alkoholom.
English: Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Abilify Maintena sadrži manje od 1 mmol (23 mg) natrija po dozi.
English: Add 1.9 ml solvent to reconstitute the powder.
Croatian: Dodajte 1,9 ml otapala da biste rekonstituirali prašak.
English: There was a statistically significant treatment difference in favour of Abilify Maintena 400 mg/300 mg compared to placebo at week 10 (+7.1, p < 0.0001, 95 % CI: 4.1, 10.1 using an ANCOVA model (LOCF)).
Croatian: 400 mg/300 mg u usporedbi s placebom u 10. tjednu (+7,1, p < 0,0001, 95 % CI: 4,1; 10,1 pomoću ANCOVA modela (LOCF)).
English: Ensure the needle is firmly seated on the needle protection device with a push and clockwise twist and then pull the needle cap straight away from the needle.
Croatian: Pazite da je igla čvrsto postavljena u zaštitnom nastavku za iglu tako što ćete je pritisnuti i zakrenuti u smjeru kazaljke na satu, a potom ravno s igle povucite poklopac igle.
English: The analysis included only subjects who were randomly assigned to treatment, given at least one injection, had baseline and at least one post-baseline efficacy assessment.
Croatian: U analizu su bili uključeni samo oni ispitanici koji su bili randomizirani na liječenje, dobili najmanje jednu injekciju i u kojih je djelotvornost procijenjena na početku i barem još jedanput nakon početka ispitivanja.
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain (see section 4.8).
Croatian: U kliničkim se ispitivanjima nije pokazalo da aripiprazol izaziva klinički značajno povećanje tjelesne težine (vidjeti dio 4.8).
English: However, the concentrations of the sulphate conjugates of hydroxy-aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6 % of the bile concentrations found in the monkeys in the 39-week study and are well below (6 %) their limits of in vitro solubility.
Croatian: Međutim, koncentracija sulfatnih konjugata hidroksiaripiprazola u ljudskoj žuči kod najviše predložene doze od 30 mg na dan nije bila veća od 6 % koncentracije u žuči pronađene u majmuna u
English: Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Croatian: Odmah obavijestite svog liječnika ako razmišljate o tome da si naudite.
English: If you stop receiving Abilify Maintena
Croatian: Ako prestanete primati Abilify Maintena
English: Avoid use
Croatian: Izbjegavati primjenu
English: When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 200 mg (see section 4.5).
Croatian: Kad se istovremeno primjenjuju jaki inhibitori CYP3A4, dozu treba smanjiti na 200 mg (vidjeti dio 4.5).
English: A number of symptoms of dystonia are then listed, including spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue.
Croatian: Zatim je naveden određeni broj simptoma distonije, uključujući grč vratnih mišića, koji ponekad napreduje do stezanja grla, otežanog gutanja, otežanog disanja i/ili protruzije jezika.
English: • increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol and low level of triglycerides
Croatian: • visok šećer u krvi • povišene masnoće u krvi, kao što je kolesterol, visoki trigliceridi i također niska razina kolesterola i niska razina triglicerida
English: The estimated relapse rate by end of Week 26 was 7.12 % for Abilify Maintena, and 7.76 % for oral aripiprazole tablets 10-30 mg, a difference of -0.64 %.
Croatian: Procijenjena stopa relapsa do kraja 26. tjedna iznosila je 7,12 % uz Abilify Maintena i 7,76 % uz tablete oralnog aripiprazola od 10-30 mg, što čini razliku od −0,64 %.
English: • abnormal hair loss
Croatian: • nenormalan gubitak kose
English: Overall, 1.3 % of oral aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Croatian: U tim je ispitivanjima ukupno 1,3 % bolesnika liječenih oralnim aripiprazolom prijavilo cerebrovaskularne nuspojave u usporedbi s 0,6 % bolesnika koji su primali placebo.
English: In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolisers (see section 4.2).
Croatian: U slabih CYP2D6 metabolizatora, istovremena primjena jakih inhibitora CYP3A4 može dovesti do viših koncentracija aripiprazola u plazmi u usporedbi s jakim CYP2D6 metabolizatorima (vidjeti dio 4.2).