natgillin/translations-raw huggingface dataset:
In volunteers with severe renal impairment (creatinine clearance <30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100 % and 88 % respectively compared to age-matched volunteers with no renal impairment. 
Pri prostovoljcih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) se je očistek sildenafila zmanjšal, to pa je povzročilo povprečno zvečanje AUC za 100 %
Visual colour distortions**, Visual disturbance, Vision blurred 
Očesne bolezni motnje zaznavanja barv**, motnje vida, zamegljen vid motnje solzenja***,
Each tablet contains 25 mg of sildenafil (as the citrate salt). 
Ena tableta vsebuje 25 mg sildenafila (v obliki soli sildenafilijevega citrata).
Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil. 
Sildenafil Teva 25 mg filmsko obložene tablete Ena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
Chest pain, Fatigue, Feeling hot 
bruhanje, bolečine v zgornjem delu trebuha, suha usta hipestezija ust
Uncommon (≥ 1/1,000 and 
(≥ 1/1.000 in
Hepatic impairment 
občutek vročine razdražljivost
Each tablet contains 50 mg of sildenafil (as the citrate salt). 
Ena tableta vsebuje 50 mg sildenafila (v obliki soli sildenafilijevega citrata).
Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil 
Ena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
Eye disorders 
draženje oči,
Sildenafil Teva 100 mg are white, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side. 
Sildenafil Teva 100 mg filmsko obložene tablete so bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 100' na eni strani in brez oznak na drugi strani.
Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. 
Sildenafil Teva 50 mg filmsko obložene tablete Ena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil 
Ena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper, 
Bolezni prebavil navzea, dispepsija gastroezofagealna refluksna bolezen,
Sildenafil Teva 50 mg are white, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side. 
Sildenafil Teva 50 mg filmsko obložene tablete so bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 50' na eni strani in brez oznak na drugi strani.
Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil 
Ena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose. 
Pri prostovoljcih z blago do zmerno okvaro ledvic (očistek kreatinina = 30 do 80 ml/min)
White, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side. 
Bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 25' na eni strani in brez oznak na drugi strani.
Film-coat 
- Filmska obloga:
When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC). 
je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182 %zvečanja sistemske izpostavljenosti (AUC) sildenafilu.
Sildenafil Teva 25 mg film-coated tablets sildenafil 
Sildenafil Teva 25 mg filmsko obložene tablete sildenafil
Sildenafil Teva 25 mg film-coated tablets 
Sildenafil Teva 25 mg filmsko obložene tablete
White, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side. 
Bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 100' na eni strani in brez oznak na drugi strani.
White, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side. 
Bele, filmsko obložene tablete ovalne oblike, z vtisnjeno oznako ‘S 50' na eni strani in brez oznak na drugi strani.
Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral discoloration 
arteriosklerotična retinopatija, motnj e mrežnice, glavkom, izpad vidnega polja, diplopija, zmanjšanje ostrine vida, miopija, astenopija, motnjave v steklovini,
Sildenafil Teva 100 mg film-coated tablets sildenafil 
Sildenafil Teva 100 mg filmsko obložene tablete sildenafil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 25 mg Film-coated tablets 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Sildenafil Teva 25 mg filmsko obložene tablete
Penile haemorrhage, Priapism,* Haematospermia , Erection increased 
Motnje reprodukcije in dojk krvavitev iz penisa, priapizem,* hematospermija, dolgotrajna erekcija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 100 mg Film-coated tablets 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Sildenafil Teva 100 mg filmsko obložene tablete
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered. 
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina <30 ml/min) je očistek sildenafila zmanjšan, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
Sildenafil Teva 50 mg film-coated tablets sildenafil 
Sildenafil Teva 50 mg filmsko obložene tablete sildenafil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 50 mg Film-coated tablets 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - Sildenafil Teva 50 mg filmsko obložene tablete
Sildenafil Teva 100 mg film-coated tablets 
Sildenafil Teva 100 mg filmsko obložene tablete
Sildenafil Teva 50 mg film-coated tablets 
Sildenafil Teva 50 mg filmsko obložene tablete
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness. 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): slabost s siljenjem na bruhanje, zardevanje obraza, vročinski oblivi (simptomi vključujejo nenaden občutek vročine v zgornjem delu telesa),
The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80 % of administered oral dose) and to a lesser extent in the urine (approximately 13 % of administered oral dose). 
Sildenafil se po peroralni in intravenski uporabi izloča v obliki presnovkov, pretežno z blatom (približno 80 %
You should not take Sildenafil Teva if you are a woman. 
Če ste ženska, zdravila Sildenafil Teva ne smete jemati.
Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary. 
Pri bolnikih z okvaro jeter (npr. ciroza) je očistek sildenafila zmanjšan, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je potrebno.
Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8). 
V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano in med opazovalno študijo poročali o primerih nearteritične anteriorne ishemične optične nevropatije,
Plasma concentrations of this metabolite are approximately 40 % of those seen for sildenafil. 
Koncentracija tega presnovka v plazmi je približno
What Sildenafil Teva is and what it is used for What you need to know before you take Sildenafil Teva How to take Sildenafil Teva Possible side effects 
Zdravilo Sildenafil Teva lahko povzroči omotico in lahko neugodno vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na zdravilo Sildenafil Teva.
The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. 
PDE6, ki sodeluje pri fototransdukcijski kaskadi v mrežnici.
vision blurred. 
obarvanje beločnice
• Chest pains - this occurs uncommonly If this occurs during or after intercourse 
• Bolečine v prsnem košu - to se zgodi občasno
Dizziness 
Občasni
Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3). 
Zato je njegova hkratna uporaba z donorji dušikovega oksida ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje 4.3).
Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, 
motnje šarenice, midriaza, videnje svetlobnih krogov, očesni edem,
Talk to your doctor, pharmacist or nurse before taking Sildenafil Teva 
V primeru zdravstvene obravnave morate povedati zdravniku, farmacevtu ali medicinki sestri, da ste vzeli zdravilo Sildenafil Teva in kdaj ste ga vzeli.
Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion,* Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, 
občutek svetlosti pri gledanju, konjunktivitis nearteritična anteriorna ishemična optična nevropatija (NAION), *
The Member States shall ensure that the Marketing Authorisation Holder provides all physicians who are expected to prescribe YERVOY with the following: 
Države članice morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom vsem zdravnikom, ki bodo predpisovali zdravilo YERVOY, priskrbi:
The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse. 
Kartica bolnike opozarja na ključne simptome, o katerih morajo nemudoma obvestiti zdravnika/medicinsko sestro.
Key elements for the Patient Information Brochure and Alert Card: 
Ključni elementi brošure z informacijami za bolnike in opozorilne kartice:
• Patient Information Brochures including Alert Cards 
• brošure z informacijami za bolnike, vključno z opozorilnimi karticami.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da se izvajajo vsi v nadaljevanju navedeni pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila:
• Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen. 
• Opis glavnih simptomov imunsko pogojenih neželenih učinkov in pomembnost, da bolnik o njih nemudoma obvesti svojega zdravnika, če se simptomi pojavijo, vztrajajo ali poslabšajo.
• Follow-up of patients due to late onset (months after treatment) of irARs 
• Spremljanje bolnikov zaradi možnosti zakasnelega pojava imunsko pogojenih neželenih učinkov (več mesecev po zdravljenju).
The National Competent Authority shall agree the format and content of the above material with the Marketing Authorisation Holder prior to launch of the product in its territory. 
Pred začetkom trženja zdravila mora pristojni nacionalni organ potrditi obliko in vsebino zgoraj navedenega materiala, ki ga pripravi imetnik dovoljenja za promet z zdravilom.
o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain, o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful 
o prebavila: driska, krvavo blato, bolečine v trebuhu, slabost ali bruhanje; o jetra: rumeno obarvanje kože ali očesnih beločnic; o koža: izpuščaj, mehurji in/ali luščenje, vnetje ustne sluznice; o oči: zamegljen vid, spremembe vida, bolečine v očesu;
• The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals). 
• Pomembnost, da imajo bolniki ves čas pri sebi opozorilno kartico, ki jo morajo pokazati pri vsakem obisku zdravnika (npr. nujna zdravniška pomoč), razen ob obisku zdravnika, ki je zdravilo predpisal.
It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab. 
Kartica drugim zdravnikom služi kot opozorilo, da se bolnik zdravi z ipilimumabom.
• Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician. 
• Opomnik, da je treba bolnikom posredovati brošuro z informacijami za bolnike, ter da je bolnike in/ali njihove skrbnike, treba seznaniti s simptomi imunsko pogojenih neželenih učinkov in jim pojasniti pomembnost tega, da o njihovem pojavu nemudoma obvestijo zdravnika.
• Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment. 
• Pomen vrednotenja testov delovanja jeter, ščitnice in znakov/simptomov imunsko pogojenih neželenih učinkov pred aplikacijo vsakega posameznega odmerka.
• The importance of not attempting to self-treat any symptoms without consulting their Healthcare professional first. 
• Pomembnost, da bolnik ne začne zdraviti simptomov brez predhodnega posveta z zdravnikom.
• Request to inform the physician of all medical conditions before treatment. 
• Zahteva, da mora bolnik pred začetkom zdravljenja zdravnika natančno obvestiti o svojem zdravstvenem stanju.
• Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immunerelated adverse reactions in section 4.4 of the SmPC. 
povzročijo smrt in zahtevajo hitro ukrepanje, kot je opisano v smernicah za ukrepanje v primeru imunsko pogojenih neželenih učinkov v poglavju 4.4 Povzetka glavnih značilnosti zdravila.
• List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system. 
o vnetje jeter, kot je hepatitis, ki lahko povzroči odpoved jeter, o vnetje kože, ki lahko povzroči hudo kožno reakcijo (toksična epidermalna nekroliza), o vnetje živcev, ki lahko povzroči nevropatijo, o vnetje endokrinega sistema, vključno z nadledvično žlezo, hipofizo ali ščitnico, o vnetje oči, o drugi imunsko pogojeni neželeni učinki (npr. pljučnica, glomerulonefritis, odpoved več organov...), o huda infuzijska reakcija.
• Placeholder including the weblink of the Package Leaflet on the EMA website 
• Spletno povezavo do navodila za uporabo na spletni strani Evropske agencije za zdravila.
Key elements of the Healthcare Professional FAQ Brochure (Q&A format): 
Ključni elementi brošure s pogostimi vprašanji za zdravstvene delavce (v obliki vprašanj in odgovorov):
• Healthcare Professional FAQ Brochure 
• brošuro s pogostimi vprašanji za zdravstvene delavce,
(See sections 4.2 and 5.2). 
(Glejte poglavji 4.2 in 5.2.)
Date of first authorisation: 05 December 2014 Date of latest renewal: 
Datum prve odobritve: 05. december 2014 Datum zadnjega podaljšanja:
Consequently, newborns should be monitored carefully. 
Posledično je treba novorojenčke skrbno spremljati.
The difference is not likely to be of clinical relevance. 
Razlika verjetno ni klinično pomembna.
Place on a clean surface. 
Odložite na čisto površino.
Time(days) since Randomization 
Čas (dnevi) od randomizacije
This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines. 
To je treba upoštevati v primerih, v katerih je potrebna popolna budnost in pozornost, npr. med vožnjo avtomobila ali pri upravljanju strojev.
1 month after day 8 
1 mesec po 8. dnevu
The primary efficacy variable was time to first relapse. 
Primarna spremenljivka za oceno učinkovitosti je bil čas do prvega relapsa.
Check suspension 
Preverite izgled suspenzije
Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive at the time of your next scheduled injection. 
Glede na vaše simptome lahko zdravnik poveča ali zmanjša količino zdravila, ki jo boste prejeli ob naslednjem načrtovanem injiciranju.
The data presented in this paragraph are based on a population pharmacokinetic analysis. 
Podatki, navedeni v tem odstavku, izhajajo iz populacijske farmakokinetične analize.
Use the recommended re-initiation regimen shown in the table below. 
Odmerjajte po priporočeni shemi ponovne uvedbe, ki je prikazana v preglednici spodaj.
> 3½ months up to 4 months 
> 3 mesece in pol do 4 mesece
The following terms and frequencies are applied: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). 
Pri navajanju pogostnosti so uporabljeni naslednji izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Immediate medical treatment may be needed. 
Morda bo potrebna takojšnja zdravniška pomoč.
Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to TREVICTA is known. 
Zato je treba bolnikom svetovati, naj ne vozijo ali upravljajo s stroji, dokler ne bodo poznali svoje individualne občutljivosti za zdravilo TREVICTA.
4 months to 9 months 
4 mesece do 9 mesecev
Elderly Efficacy and safety in elderly > 65 years have not been established. 
Starejši Učinkovitosti in varnosti pri bolnikih, starejših od 65 let, niso dokazali.
The safety and efficacy of TREVICTA in children and adolescents < 18 years of age have not been established. 
Varnost in učinkovitost zdravila TREVICTA pri otrocih in mladostnikih, starih < 18 let, nista bili dokazani.
The release of the active substance starts as early as day 1 and lasts for as long as 18 months. 
Sproščanje zdravilne učinkovine se začne že 1. dan in traja tudi do 18 mesecev.
None of these events were serious or led to discontinuation. 
Nobeden od teh dogodkov ni bil resen in zaradi nobenega ni bilo treba prekiniti zdravljenja.
The median time to relapse in either group could not be estimated due to low percentage of subjects with relapse. 
Mediane časa do relapsa ni bilo mogoče oceniti v nobeni od skupin zaradi nizkega odstotka preiskovancev z relapsom.
The efficacy results were consistent across population subgroups (gender, age, and race) in both studies. 
Rezultati glede učinkovitosti so bili v vseh podskupinah študijske populacije (po spolu, starosti in rasni pripadnosti) približno enaki v obeh študijah.
TREVICTA with alcohol Alcohol should be avoided. 
Zdravilo TREVICTA skupaj z alkoholom Uživanju alkohola se je treba izogibati.
Week 19 to Week 24, inclusive 
teden 12 do vključno teden 19 do vključno od tedna 25 naprej
Last TREVICTA dose (Week 0) 
Zadnji odmerek zdravila TREVICTA (teden 0)
Do not use TREVICTA - if you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila TREVICTA - če ste alergični na paliperidon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If the patient remains symptomatic, they should be managed according to clinical practice. 
Če simptomi pri bolniku vztrajajo, jih je treba obvladovati v skladu s klinično prakso.
Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 4 hours. 
Bolnike je treba poučiti, da poiščejo nujno zdravniško pomoč, če priapizem ne izzveni v 4 urah.
Read complete instructions prior to use. 
Pred uporabo preberite navodila v celoti.
The study was terminated on the basis of a pre-planned interim analysis conducted when 283 subjects had been randomised and 42 relapse events had been observed. 
Študija je bila prekinjena na osnovi vnaprej načrtovane vmesne analize, po randomizaciji 283 preiskovancev in po 42 relapsih.
If patient weighs: Less than 90 kg pink hub 
Če je bolnikova telesna masa: manj kot 90 kg rožnati nastavek
The suspension should appear uniform and milky white in colour. 
Suspenzija mora biti enotna in mlečno bele barve.
> 9 months 
> 9 mesecev
Four metabolic pathways have been identified in vivo, none of which accounted for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission. 
In vivo so odkrili štiri presnovne poti, od katerih nobena ni predstavljala več kot 10% odmerka: dealkilacija, hidroksilacija, dehidrogenacija in cepitev benzizoksazola.
DO NOT divide dose into multiple injections. 
Odmerka NE SMETE razdeliti na več injekcij.
Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. 
Takoj je treba začeti s spremljanjem srca in ožilja, ki mora vključevati neprekinjeno elektrokardiografsko spremljanje zaradi morebitnih aritmij.
There was a significant difference (p < 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA. 
Med skupinama je bila tudi pomembna razlika (p < 0,0001) v času do relapsa in sicer v prid zdravilu TREVICTA.
Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo. 
Pri tistih, ki so jih zdravili z risperidonom, je bila smrtnost 4% v primerjavi s 3,1% pri placebu.
No in vivo data are available and the clinical relevance is unknown. 
Podatki raziskav in vivo niso na voljo in klinični pomen teh ugotovitev ni znan.
The European Medicines Agency has waived the obligation to submit the results of studies with TREVICTA in all subsets of the paediatric population in schizophrenia. 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom TREVICTA za vse podskupine pediatrične populacije s shizofrenijo.
Proceed to the next step immediately after shaking. 
Takoj po stresanju nadaljujte z naslednjim korakom.
No interaction study between TREVICTA and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur. 
Študij medsebojnega delovanja zdravila TREVICTA in litija niso izvedli, vendar ni verjetno, da bo prišlo do farmakokinetične interakcije.
TREVICTA should not be used during pregnancy unless clearly necessary. 
Zdravilo TREVICTA se med nosečnostjo ne sme uporabljati, razen če je to nujno potrebno.
What you need to know before you use TREVICTA 
Kaj morate vedeti, preden boste uporabili zdravilo TREVICTA
What TREVICTA is and what it is used for 
Kaj je zdravilo TREVICTA in za kaj ga uporabljamo
For both studies, the primary outcome was based on relapse. 
V obeh študijah je bil primarni cilj opazovanja relaps.
Figure 1: Kaplan-Meier plot of time to relapse - Final analysis 
Slika 1: Kaplan-Meierjeva krivulja časa do relapsa - končna analiza
Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep. 
Zelo pogosti neželeni učinki: pojavijo se lahko pri več kot 1 od 10 bolnikov • težave z uspavanjem ali vzdrževanjem spanca.