natgillin/translations-raw huggingface dataset:
Abilify Maintena 300 mg Vial 
Abilify Maintena 300 mg viala
Overall, 1.3 % of oral aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials. 
V celoti so v teh preskušanjih cerebrovaskularne neželene učinke zabeležili pri 1,3 % bolnikov, zdravljenih s peroralnim aripiprazolom, in pri 0,6 % bolnikov, ki so dobivali placebo.
By the 7th day, the median aripiprazole concentrations further decline to concentrations following an IM depot dose with no dose dumping. 
Do 7. dne naj bi mediana koncentracij aripiprazola še naprej upadala do koncentracij po i.m.
In an open label study comparing bioavailability of Abilify Maintena administered in the deltoid or gluteal muscle, injection site related reactions were slightly more frequent in the deltoid muscle. 
V odprti študiji, ki je primerjala biorazpoložljivost zdravila Abilify Maintena, injeciranega v deltoidno oziroma glutealno mišico, je bila pojavnost reakcij na mestu aplikacije pri deltoidni mešici za spoznanje večja.
A single-dose study with oral administration of aripiprazole to subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity. 
Jetrna okvara Študija z enim samim odmerkom oralnega aripiprazola pri preiskovancih z različno stopnjo jetrne ciroze (razredi A, B in C po Child-Pughu) ni pokazala pomembnega vpliva jetrne okvare na farmakokinetiko aripiprazola in dehidroaripiprazola.
Step 2: Reconstitution of the powder a) Push plunger rod slightly to engage threads. 
Korak 2: Rekonstitucija praška a) Rahlo pritisnite na potiskalo bata, da navoji zaskočijo.
Indicator line Plunger Rod b) Vertically shake the syringe vigorously for 20 seconds until the reconstituted suspension appears uniform. 
Potiskalo bata b) Injekcijsko brizgo 20 sekund navpično močno stresajte, dokler rekonstitucijska suspenzija ni homogena.
Do not store the reconstituted suspension in the syringe. 
Rekonstituirane suspenzije ne shranjujte v injekcijski brizgi.
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir) 
• določena zdravila za zdravljenje okužbe s HIV (kot so efavirenz, nevirapin, zaviralci proteaz,
• acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening 
• akne, kožna bolezen na obrazu, za katero so značilni nenavadna pordelost nosu in lic, ekcemi,
The PSUR for the brand leader, Abilify and Abilify Maintena, gathers data from the immediate-realease formulations and the prolonged-release suspension for injection. 
Poročilo PSUR o vodilni znamki zdravil Abilify in Abilify Maintena je zbralo podatke za farmacevtske oblike suspenzij za injiciranje s takojšnim sproščanjem in s podaljšanim sproščanjem.
In the Double-blind Placebo-controlled Phase of the 52-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.38 ng/ml) compared with a mean increase in placebo (1.67 ng/ml). 
V dvojno slepi s placebom nadzorovani fazi 52-tedenskega preskušanja je bilo od izhodiščne vrednosti do zadnjega obiska srednje zmanjšanje vrednosti prolaktina v skupini, ki je prejemala zdravilo Abilify Maintena, (−0,38 ng/ml) v primerjavi s srednjim povišanjem v skupini s placebom (1,67 ng/ml).
Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria) 
anafilaktična reakcija, angioedem, vključno z oteklim jezikom, edem jezika, edem obraza, pruritus ali urtikarija)
And then, rotate plunger rod until the rod stops rotating to release diluent. 
Nato obračajte potiskalo bata, dokler se ne preneha obračati, da sprostite redčilo.
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). 
CYP2D6 lahko sočasna uporaba z močnimi zaviralci CYP3A4 povzroči večjo koncentracijo aripiprazola v plazmi kot pri osebah, ki dobro presnavljajo s CYP2D6.
Vial Type-I glass vial stoppered with a laminated rubber stopper and sealed with a flip-off aluminium cap. 
Viala iz stekla tipa I, zaprta z laminirano gumijasto zaporko in zapečatena z aluminijastim pokrovčkom s snemljivo zaporko.
Maintenance treatment of schizophrenia in adults The efficacy of Abilify Maintena in the maintenance treatment of patients with schizophrenia was established in two randomised, double-blind, long-term trials. 
Učinkovist zdravila Abilify Maintena pri vzdrževalnem zdravljenju bolnikov s shizofrenijo so ugotavljali v dveh randomiziranih dvojno slepih dolgotrajnih preskušanjih.
• distortion of the senses of taste and smell 
• popačenje čutov okusa in vonja, • fiksacija očesnih zrkel,
Acute treatment of schizophrenia in adults 
Klinična učinkovitost in varnost Vzdrževalno zdravljenje shizofrenije pri odraslih bolnikih
If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8). 
pojavijo znaki in simptomi tardivne diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja (glejte poglavje 4.8).
• during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function) 
• med krvnimi preiskavami lahko vaš zdravnik v krvi odkrije večje količine kreatin-fosfokinaze
Sodium dihydrogen phosphate monohydrate Sodium hydroxide 
Natrijev dihidrogenfosfat monohidrat Natrijev hidroksid
- higher amounts of alanine aminotransferase 
- zvišane količine jetrnih encimov, - zvišane količine alanin aminotransferaze,
Volume to Inject 
Količina za injiciranje
• a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness. 
dezorientacija, težave pri govoru, težave pri hoji, okorelost mišic ali tresenje, povišana telesna temperatura, šibkost, razdražljivost, agresija, anksioznost, povečan krvni tlak ali krči, ki lahko vodijo v nezavest;
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. 
Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Abilify Maintena, obiščite zdravnika.
Dose adjustments of Abilify Maintena in patients who are taking concomitant strong CYP2D6 inhibitors, strong CYP3A4 inhibitors, and/or CYP3A4 inducers for more than 14 days 
Prilagoditve odmerka zdravila Abilify Maintena pri bolnikih, ki več kot 14 dni sočasno jemljejo močne zaviralce CYP2D6 ali močne zaviralce CYP3A4 in/ali induktorje CYP3A4
2 ml Type-1 glass vial stoppered with a laminated rubber stopper and sealed with a flip-off aluminium cap. 
2 ml viala iz stekla tipa I, zaprta z laminirano gumijasto zaporko in zapečatena z aluminijastim pokrovčkom s snemljivo zaporko.
Twist + Pull Off b) Select one of the following hypodermic safety needles depending on the injection site and patient's weight. 
Obrnite + snemite b) Glede na mesto injiciranja in telesno maso bolnika izberite eno od spodnjih varnostnih podkožnih igel.
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole. 
V kliničnih preskušanjih, ki so trajala eno leto ali manj, so med zdravljenjem z aripiprazolom občasno poročali o diskineziji, ki se je pojavila med zdravljenjem.
The powder and solvent vials and the pre-filled syringe are for single-use only. 
Viala s praškom in viala z vehiklom ter napolnjena brizga so namenjene samo enkratni uporabi.
• ,joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited opening of mouth 
• bolečine v sklepih (artralgija), bolečine v hrbtu, zmanjšan obseg gibanja sklepov, otrdel vrat,
Oral formulation should be preferred (see section 5.2). 
Prednost mora imeti peroralna oblika zdravila (glejte poglavje 5.2).
Moreover there is also some evidence based on scientific literature that the use of antipsychotics (even second generation antipsychotics like aripiprazole) is associated with an increase in the risk of falls and fractures, especially among the older population. 
(celo druga generacija antipsihotikov, kot je aripiprazol) povezana s povečanim tveganjem za pojav padcev in zlomov, zlasti med starejšo populacijo.
Powder Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
Prašek Natrijev karmelozat, manitol, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid
The European Medicines Agency has waived the obligation to submit the results of studies with Abilify Maintena in all subsets of the paediatric population in schizophrenia (see section 4.2). 
Abilify Maintena za vse podskupine pediatrične populacije pri zdravljenju shizofrenije (glejte poglavje 4.2).
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8). 
Zaradi primarnih učinkov aripiprazola na osrednji živčni sistem je potrebna previdnost pri njegovi uporabi v kombinaciji z alkoholom ali zdravili, ki delujejo na osrednje živčevje in imajo podobne neželene učinke, npr. sedacijo (glejte poglavje 4.8).
In repeated dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable to that observed in adult animals, and there was no evidence of neurotoxicity or adverse events on development. 
Pri študijah s ponavljajočimi se odmerki pri mladih podganah in psih je bil profil toksičnosti aripiprazola primerljiv s profilom toksičnosti pri odraslih živalih.
• low sodium level in the blood 
• nizka koncentracija natrija v krvi,
Before treatment with Abilify Maintena, tell your doctor if you suffer from 
Pred začetkom zdravljenja z zdravilom Abilify Maintena morate obvestiti zdravnika, če imate:
Do not use if reconstituted suspension contains particulate matter or any discolouration. 
Če rekonstituirana suspenzija vsebuje delce ali če je razbarvana, je ne smete uporabiti.
Solvent: clear solution 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
Engage the needle safety device. 
Pritrdite varnostni pripomoček za iglo.
Similar to the PANSS Total Score, both the PANSS positive and negative subscale scores also showed an improvement (decrease) from baseline over time. 
Podobno kot pri skupni oceni PANSS je bilo izboljšanje (zmanjšanje) s časom glede na izhodišče opazno tudi v rezultatih podkategorij pozitivnih in negativnih sindromov na lestvici PANSS.
Aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8). 
Pri uporabi aripiprazola pri bolnikih s podaljšanjem intervala QT v družinski anamnezi je potrebna previdnost (glejte poglavje 4.8).
The recommended starting and maintenance dose of Abilify Maintena is 400 mg. Titration of the dose of this medicinal product is not required. 
Priporočeni začetni in vzdrževalni odmerek zdravila Abilify Maintena je 400 mg.
Engage the needle safety device by using the one-handed technique. 
Varnostni pripomoček igle namestite z eno roko.
Aripiprazole absorption into the systemic circulation is slow and prolonged following Abilify Maintena administration due to low solubility of aripiprazole particles.The average absorption half-life of Abilify Maintena is 28 days. 
Absorpcija aripiprazola v sistemski obtok je počasna in se po odmerjanju zdravila Abilify Maintena zaradi slabe topnosti delcev aripiprazola podaljša.
Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. 
Zdravilo Abilify Maintena vsebuje zdravilno učinkovino aripiprazol in spada v skupino zdravil,
Solvent Water for injections 
Vehikel Voda za injekcije
Abilify Maintena contains sodium 
Zdravilo Abilify Maintena vsebuje natrij
• injection site reactions such as redness, swelling discomfort and injection site itching 
• reakcije na mestu injiciranja, kot so pordelost, neugodje zaradi oteklin in srbečica na mestu injiciranja, • žeja,
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection EU/1/13/882/002 
Abilify Maintena 400 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem v napolnjeni injekcijski brizgi EU/1/13/882/006
The Kaplan-Meier curves of the time from randomisation to impending relapse during the 38-week, Double-blind, Active-controlled Phase for Abilify Maintena, oral aripiprazole 10-30 mg, and aripiprazole Long-Acting Injectable 50 mg/25 mg are shown in Figure 1. 
Krivulje po metodi Kaplan-Meier za čas od randomizacije do pojava znakov bližnjega relapsa bolezni v 38-tedenski dvojno slepi aktivno nadzorovani fazi pri zdravilu Abilify Maintena, pri peroralnem aripiprazolu 10-30 mg in pri dolgodelujočem parantertalnem aripiprazolu 50 mg/25 m, so prikazane na sliki 1.
Concomitant administration of Abilify Maintena and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects. 
Pri sočasni uporabi zdravila Abilify Maintena in drugih induktorjev CYP3A4 (npr. rifampicina, rifabutina, fenitoina, fenobarbitala,
For deep intramuscular gluteal or deltoid injection only. 
Samo za globoko intramuskularno injiciranje v glutealno ali deltoidno mišico.
The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle. 
Suspenzijo je treba v glutealno ali deltoidno mišico injicirati počasi z enkratno injekcijo (odmerkov ne smemo razdeliti).
Drug withdrawal syndrome neonatal (see section 4.6) 
puerperija in perinatalnem obdobju odtegnitveni sindrom pri novorojenčkih (glejte poglavje 4.6)
Six-hundred and sixty two patients eligible for the 38-week Double-blind, Active-controlled Phase were randomly assigned in a 2:2:1 ratio to double-blind treatment to one of 3 treatment groups: 1) Abilify Maintena 2) the stabilisation dose of oral aripiprazole 10-30 mg, or 3) aripiprazole LongActing Injectable 50 mg/25 mg. 
662 bolnikov, ki so bili primerni za vključitev v 38-tedensko dvojno slepo aktivno nadzorovano fazo, so bili v razmerju 2 : 2 : 1 randozimirano porazdeljeni v eno od treh spodaj navedenih preiskovanih skupin, v kateri so prejemali dvojno slepo zdravljenje: 1) zdravilo Abilify Maintena; 2) stabilizacijski odmerek peroralnega aripiprazola v 10-30 mg; ali 3) dolgodelujoči parantertalni aripiprazol 50 mg/25 mg. Odmerki dolgodelujočega parantertalnega aripiprazola 50 mg/25 mg so bili vključeni kot nizki odmerki aripiprazola, da bi preizkusili občutljivost analize pri dokazovanju neinferiornosti zdravila.
The AUC and Cmax of dehydroaripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively. 
aktivnega presnovka dehidroaripiprazola se je zmanjšala za 32 %, njegova Cmax pa za 47 %.
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8). 
Preobčutljivost Pri aripiprazolu se lahko pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4.8).
Each single pack containing one vial of powder, 2 ml vial of solvent, one 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 3 ml disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge. 
Vsako posamezno pakiranje vsebuje eno vialo s praškom, 2 ml vialo z vehiklom, eno 3 ml injekcijsko brizgo z nastavkom Luer Lock s predhodno pritrjeno 38 mm varnostno podkožno iglo velikosti 21 z varnostnim pripomočkom, eno 3 ml injekcijsko brizgo za enkratno uporabo s konico Luer Lock, enim nastavkom za vialo in tremi varnostnimi podkožnimi iglami: eno dolžine 25 mm in velikosti 23, eno dolžine 38 mm velikosti 22 in eno dolžine 51 mm velikosti 21.
The powder and solvent vials are for single-use only. 
Viala s praškom in viala z vehiklom sta namenjeni samo enkratni uporabi.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole. 
V kliničnih preskušanjih so med zdravljenjem z aripiprazolom poročali o redkih primerih MNS.
NOTE: ARIP IMD 400/300 mg = Abilify Maintena;ARIP 10-30 mg = oral aripiprazole; ARIP IMD 50/25 mg = Long-acting Injectable 
OPOMBA: ARIP IMD 400/300 mg = Abilify Maintena; ARIP 10-30 mg = peroralni aripiprazol; ARIP IMD 50/25 mg = dolgodelujoči parantertalni
In the Double-blind, Active-controlled Phase of the 38-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.33 ng/ml) compared with a mean increase in oral aripiprazole tablets 10-30 mg (0.79 ng/ml; p < 0.01). 
V dvojno slepi aktivno nadzorovani fazi 38-tedenskega preskušanja je bilo od izhodiščne vrednosti do zadnjega obiska srednje zmanjšanje vrednosti prolaktina v skupini, ki je prejemala zdravilo Abilify Maintena, (−0,33 ng/ml) v primerjavi s srednjim povišanjem v skupini, ki je prejemala aripiprazol v 10-30 mg peroralnih tabletah (0,79 ng/ml; p < 0,01).
The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively. 
dehidroaripiprazola se je zvečala za 77 %, njegova Cmax pa za 43 %.
Expel air until suspension fills needle base* 
Zrak iztiskajte, dokler suspenzija ne napolni nastavka igle*
What Abilify Maintena looks like and contents of the pack 
Izgled zdravila Abilify Maintena in vsebina pakiranja
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide Solvent 
Natrijev karmelozat, manitol, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid Vehikel
It is not possible to re-suspend after the air in the syringe is expelled. 
Po iztisu zraka iz injekcijske brizge zdravila ni mogoče ponovno suspendirati.
Abilify Maintena comes as a white to off-white powder in a clear glass vial. 
Zdravilo Abilify Maintena je na voljo kot bel do belkast prašek v viali iz prozornega stekla.
If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection. 
Če zdravila ne injicirate takoj po rekonstituciji, vialo pred injiciranjem močno stresajte vsaj 60 sekund, da ponovno suspendira.
• parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), 
• parkinsonizem - zdravstveno stanje s številnimi različnimi simptomi, ki vključujejo zmanjšane ali počasne gibe, počasnost misli, kretnje pri upogibanju udov (togost zglobov), težko premikanje, naglo korakanje, tresenje, malo ali nič obrazne mimike, mišična togost, slinjenje,
• antifungal medicines (such as ketoconazole, itraconazole) 
šentjanževka), • zdravila proti glivicam (kot sta ketokonazol, itrakonazol),
Mean baseline (SD) Mean change (SD) P-value 
Povprečna sprememba (SD) Vrednost P
Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when oral aripiprazole (30 mg) was administered alone. 
Po sočasni uporabi karbamazepina, močnega induktorja CYP3A4 in peroralnega aripiprazola pri bolnikih s shizofrenijo ali shizoafektivno motnjo sta bili geometrični sredini Cmax za 68 % in njuni
Hypertension Orthostatic hypotension Blood pressure increased 
Žilne bolezni hipertenzija ortostatska hipotenzija zvišan krvni tlak sinkopa venska trombembolija
• drooling, more saliva in mouth than normal 
• pogosti premiki v črevesju, • slinjenje, večja količina sline v ustih kot običajno,
Carmellose sodium 
Natrijev karmelozat Manitol
The most frequently observed adverse drug reactions (ADRs) reported in ≥ 5 % of patients in two double-blind, long-term trials of Abilify Maintena were weight increased (9.0 %), akathisia (7.9 %), insomnia (5.8 %), and injection site pain (5.1 %). 
Najpogostejši neželeni učinki zdravila, o katerih so poročali pri ≥ 5 % bolnikov v dvojno slepih dolgotrajnih preskušanjih zdravila Abilify Maintena, so bili povečanje telesne mase (9,0 %), akatizija
Dystonic symptoms include spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. 
Distonični simptomi vključujejo: spazem vratnih mišic, ki lahko povzroči stiskanje žrela, težave pri požiranju, težave pri dihanju in/ali protruzijo jezika.
ARIP IMD 400/300 mg vs. ARIP 10-30 mg: p value 0.9920 ARIP IMD 400/300 mg vs. ARIP IMD 50/25 mg: p value < 0.0001 
ARIP IMD 400/300 mg v primerjavi z ARIP 10-30 mg: vrednost p = 0,9920 ARIP IMD 400/300 mg v primerjavi z ARIP IMD 50/25 mg: vrednost p < 0,0001
• muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain in extremity 
• okorelost mišic, mišični krči, trzanje mišic, napetost mišic, bolečine v mišicah (mialgija),
People with this condition may also feel depressed, guilty, anxious or tense. 
Osebe s to boleznijo imajo lahko tudi občutke potrtosti,
uniform milky white 
mlečno bela
Ketoconazole and other strong CYP3A4 inhibitors 
Ketokonazol in drugi močni zaviralci CYP3A4
- One 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge hypodermic safety needle with needle protection device. 
- ena 3 ml injekcijska brizga z nastavkom Luer Lock z 38 mm predhodno pritrjeno podkožno varnostno iglo velikosti 21 z varnostnim pripomočkom,
Gently press the sheath against a flat surface until the needle is firmly engaged in the needle protection sheath. 
Tulec nežno pritisnite ob ravno podlago, dokler varnostni pripomoček za iglo povsem ne pokrije igle.
Injection site Needle size 
Mesto injiciranja Velikost igle
• altered mood 
• nihanja v razpoloženju,
Oral aripiprazole 
Peroralni aripiprazol
• unusual movements (especially of the face or tongue) and reduced level of consciousness. 
• hitro bitje srca, vznemirjenost/agresivnost, težave pri govoru; • nenavadne gibe (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
Discard f) Shake the vial vigorously for 30 seconds until the suspension appears uniform. 
Zavrzite f) Vialo močno stresajte najmanj 30 sekund, dokler suspenzija ni homogena.
Musculoskeletal stiffness 
• mišična togost,
• extreme restlesness and restless legs 
• težave z gibanjem, • skrajna nemirnost in nemirne noge,
• feeling anxious 
• občutek tesnobe,
Electrocardiogram T wave amplitude decreased Electrocardiogram abnormal Electrocardiogram T wave inversion 
Srčne bolezni ventrikularne ekstrasistole bradikardija tahikardija zmanjšanje amplitude vala t v elektrokardiogramu nenormalni elektrokardiogram inverzija vala T v elektrokardiogramu nenadna nepojasnjena smrt zastoj srca torsades de pointes ventrikularna tahikardija podaljšanje intervala QT
PANSS Total Score - Change From Baseline to Week 38-LOCF: Randomised Efficacy Samplea, b 
Skupna ocena PANSS - sprememba od izhodiščne vrednosti do 38. tedna - LOCF: randomizirani vzorec učinkovitosti a, b
Dose 
Zavrzite
Pharmacokinetics in special patient groups 
Posebne skupine bolnikov
Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain: 
generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD-obsessive compulsive disorder) in socialno fobijo, kot tudi migrene in bolečine: