natgillin/translations-raw huggingface dataset:
Palonosetron Hospira is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). 
Zdravilo Palonosetron Hospira se uporablja za preprečevanje navzeje (slabosti) in bruhanja, ki ju povzroča kemoterapija (zdravila za zdravljenje raka).
What is Palonosetron Hospira and what is it used for? 
Kaj je zdravilo Palonosetron Hospira in za kaj se uporablja?
Therefore, the CHMP's view was that, as for Aloxi, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Aloxi odtehtajo znana tveganja.
The active substance in Palonosetron Hospira, palonosetron, is a ‘5HT3 antagonist'. 
Zdravilna učinkovina zdravila Palonosetron Hospira, palonosetron, je „antagonist 5HT3“.
Palonosetron Hospira is a ‘generic medicine'. 
Zdravilo Palonosetron Hospira je „generično zdravilo“.
Palonosetron Hospira should only be given before chemotherapy and can only be obtained with a prescription. 
Zdravilo Palonosetron Hospira se daje samo pred kemoterapijo, izdaja pa je le na recept.
It is not intended to provide practical advice on how to use Palonosetron Hospira. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Palonosetron Hospira approved? 
Zakaj je bilo zdravilo Palonosetron Hospira odobreno?
the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight. 
Pri otrocih se raztopina v odmerku 20 mikrogramov na kilogram telesne mase 15 minut daje z infundiranjem (kapalno infuzijo) v veno.
No additional studies were needed as Palonosetron Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi. 
Ker je zdravilo Palonosetron Hospira generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Aloxi, niso bile potrebne nobene dodatne študije.
How is Palonosetron Hospira used? 
Kako se zdravilo Palonosetron Hospira uporablja?
Palonosetron Hospira contains the active substance palonosetron. 
Zdravilo Palonosetron Hospira vsebuje zdravilno učinkovino palonosetron.
How has Palonosetron Hospira been studied? 
Kako je bilo zdravilo Palonosetron Hospira raziskano?
Date of first authorisation: 10 January 2008 Date of latest renewal: 20 September 2012 
Datum prve odobritve: 10. januar 2008 Datum zadnjega podaljšanja: 20. september 2012
STOP taking TESAVEL and contact a doctor immediately if you notice any of the following serious side effects: 
Zdravilo TESAVEL takoj PRENEHAJTE jemati in se posvetujte z zdravnikom, če opazite katerega koli od naslednjih resnih neželenih učinkov:
TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 
Zdravila TESAVEL se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
What TESAVEL is and what it is used for 
Kaj je zdravilo TESAVEL in za kaj ga uporabljamo
If you take more TESAVEL than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately. 
Če ste vzeli večji odmerek zdravila TESAVEL, kot bi smeli Če ste vzeli večji odmerek tega zdravila od predpisanega, se takoj posvetujte z zdravnikom.
Other medicines and TESAVEL 
Druga zdravila in zdravilo TESAVEL
Your doctor may ask you to stop TESAVEL. 
Zdravnik vam bo morda naročil, da prenehate z jemanjem zdravila TESAVEL.
Do not take TESAVEL - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila TESAVEL - če ste alergični na sitagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What you need to know before you take TESAVEL 
Kaj morate vedeti, preden boste vzeli zdravilo TESAVEL
Due to lack of human data, TESAVEL should not be used during pregnancy. 
Zaradi pomanjkanja podatkov pri ljudeh se zdravila TESAVEL med nosečnostjo ne sme jemati.
For adult patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control: 
Pri odraslih bolnikih s sladkorno boleznijo tipa 2 je zdravilo TESAVEL indicirano za izboljšanje urejenosti glikemije:
What TESAVEL is and what it is used for What you need to know before you take TESAVEL How to take TESAVEL 
Kaj je zdravilo TESAVEL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo TESAVEL Kako jemati zdravilo TESAVEL Možni neželeni učinki
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of TESAVEL and periodically thereafter. 
Ker prilagoditev odmerka temelji na ledvični funkciji, pred začetkom zdravljenja z zdravilom TESAVEL in periodično tekom zdravljenja priporočamo oceno ledvične funkcije.
The European Medicines Agency has deferred the obligation to submit the results of studies with TESAVEL in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom TESAVEL za vse skupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and TESAVEL administered concomitantly. 
Pri uporabi v kombinaciji z metforminom in/ali agonistom PPAR je treba odmerek metformina in/ali agonista PPAR ohraniti in zdravilo TESAVEL uporabljati sočasno.
Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation 
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 ljudi): nizek krvni sladkor Pogosti: zaprtje
If you forget to take TESAVEL 
Če ste pozabili vzeti zdravilo TESAVEL
If you stop taking TESAVEL 
Če ste prenehali jemati zdravilo TESAVEL
5 How to store TESAVEL Contents of the pack and other information 
Shranjevanje zdravila TESAVEL Vsebina pakiranja in dodatne informacije
The usual recommended dose is: one 100mg film-coated tablet once a day by mouth 
Običajni priporočeni odmerek je: - ena 100 mg filmsko obložena tableta, - enkrat na dan,
Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, TESAVEL may be administered with or without food. 
Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo TESAVEL lahko jemlje s hrano ali brez nje.
TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control. 
Zdravilo TESAVEL je indicirano tudi kot dodatno zdravljenje k insulinu (z metforminom ali brez), če z dieto in s telesno aktivnostjo ter stabilnim odmerkom insulina urejenost glikemije ni zadostna.
TESAVEL has no or negligible influence on the ability to drive and use machines. 
Zdravilo TESAVEL nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
It is important to stay on the diet and exercise recommended by your doctor while taking TESAVEL. 
Med jemanjem zdravila TESAVEL je pomembno, da se držite diete in telesne aktivnosti, ki vam ju je priporočil zdravnik.
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo. 
Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V kliničnih preskušanjih zdravila TESAVEL kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (tj. metforminom in/ali agonistom PPAR), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers. 
Če bolnik izpusti odmerek zdravila TESAVEL, ga mora vzeti takoj, ko se spomni.
For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily. 
Pri bolnikih s hudo ledvično okvaro (GFR ≥ 15 do < 30 ml/min) ali bolnikih s končno ledvično odpovedjo (ESRD - end-stage renal disease) (GFR < 15 ml/min), vključno s tistimi, ki potrebujejo hemodializo ali peritonealno dializo, je odmerek zdravila TESAVEL 25 mg enkrat na dan.
What TESAVEL looks like and contents of the pack 
Izgled zdravila TESAVEL in vsebina pakiranja
When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4). 
Pri uporabi zdravila TESAVEL v kombinaciji s sulfonilsečnino ali z insulinom lahko po potrebi zmanjšate odmerek sulfonilsečnine ali insulina, da se tako zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.4).
How to take TESAVEL 
Kako jemati zdravilo TESAVEL
TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2). 
Pri bolnikih s hudo jetrno okvaro uporaba zdravila TESAVEL ni raziskana, zato je potrebna previdnost (glejte poglavje 5.2).
For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily. 
Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je odmerek zdravila TESAVEL 50 mg enkrat na dan.
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL (see section 4). 
Pri bolnikih, ki so prejemali zdravilo TESAVEL, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
Method of administration TESAVEL can be taken with or without food. 
Način uporabe Zdravilo TESAVEL lahko bolnik jemlje skupaj s hrano ali brez nje.
What TESAVEL contains 
Kaj vsebuje zdravilo TESAVEL
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors. 
Zdravilo TESAVEL spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP-4).
If a hypersensitivity reaction is suspected, TESAVEL should be discontinued. 
Če obstaja sum na preobčutljivostno reakcijo, morate prenehati zdravljenje z zdravilom TESAVEL.
The level of digoxin in your blood may need to be checked if taking with TESAVEL. 
Med sočasnim jemanjem z zdravilom TESAVEL vam bodo morda morali preveriti vrednosti digoksina v krvi.
Paediatric No studies with TESAVEL have been performed in paediatric patients. 
Otroci Pri otrocih študij z zdravilom TESAVEL niso izvedli.
TESAVEL should not be used during breast-feeding. 
Med dojenjem se zdravila TESAVEL ne sme jemati.
If pancreatitis is suspected, TESAVEL and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, TESAVEL should not be restarted. 
Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila TESAVEL in drugih zdravil, ki bi lahko povzročila pankreatitis.
TESAVEL contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. 
Zdravilo TESAVEL vsebuje učinkovino sitagliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil peptidaze 4).
Placebo-corrected mean change in HbA1c (%) (95 % CI) 
S placebom korigirana srednja sprememba vrednosti HbA1c
No dose adjustment for TESAVEL is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9). 
Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
- type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, 
- sladkorno bolezen tipa 1 - diabetično ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem) - kakršne koli težave z ledvicami v sedanjosti ali v preteklosti - alergijsko reakcijo na zdravilo TESAVEL (glejte poglavje 4)
In addition, patients should be alerted to the risk of hypoglycaemia when TESAVEL is used in combination with a sulphonylurea or with insulin. 
Poleg tega je treba bolnike, ki jemljejo zdravilo TESAVEL skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
If bullous pemphigoid is suspected, TESAVEL should be discontinued. 
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom TESAVEL prekiniti.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis. 
Za doseg podobnih plazemskih koncentracij sitagliptina, kot so pri bolnikih z normalno ledvično funkcijo, se pri bolnikih z GFR < 45 ml/min ter bolnikih s končno ledvično odpovedjo, ki potrebujejo hemodializo ali peritonealno dializo, priporočajo manjši odmerki zdravila (glejte poglavji 4.2 in 5.2).
EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets 
EU/1/07/435/013 14 filmsko obloženih tablet EU/1/07/435/014 28 filmsko obloženih tablet EU/1/07/435/023 30 filmsko obloženih tablet EU/1/07/435/015 56 filmsko obloženih tablet EU/1/07/435/016 84 filmsko obloženih tablet EU/1/07/435/024 90 filmsko obloženih tablet EU/1/07/435/017 98 filmsko obloženih tablet EU/1/07/435/018 50 x 1 filmsko obložena tableta
EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets 
EU/1/07/435/007 14 filmsko obloženih tablet EU/1/07/435/008 28 filmsko obloženih tablet EU/1/07/435/021 30 filmsko obloženih tablet EU/1/07/435/009 56 filmsko obloženih tablet EU/1/07/435/010 84 filmsko obloženih tablet EU/1/07/435/022 90 filmsko obloženih tablet EU/1/07/435/011 98 filmsko obloženih tablet EU/1/07/435/012 50 x 1 filmsko obložena tableta
EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets 
EU/1/07/435/001 14 filmsko obloženih tablet EU/1/07/435/002 28 filmsko obloženih tablet EU/1/07/435/019 30 filmsko obloženih tablet EU/1/07/435/003 56 filmsko obloženih tablet EU/1/07/435/004 84 filmsko obloženih tablet EU/1/07/435/020 90 filmsko obloženih tablet EU/1/07/435/005 98 filmsko obloženih tablet EU/1/07/435/006 50 x 1 filmsko obložena tableta
How to store TESAVEL 
Shranjevanje zdravila TESAVEL
- If you get any side effects gets talk to your doctor, pharmacist, or nurse. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
TESAVEL 25 mg film-coated tablets 
TESAVEL 25 mg filmsko obložene tablete
TESAVEL 100 mg film-coated tablets 
TESAVEL 100 mg filmsko obložene tablete
TESAVEL 25 mg film-coated tablets Sitagliptin 
TESAVEL 25 mg filmsko obložene tablete sitagliptin
TESAVEL 50 mg film-coated tablets 
TESAVEL 50 mg filmsko obložene tablete
TESAVEL 100 mg film-coated tablets Sitagliptin 
TESAVEL 100 mg filmsko obložene tablete sitagliptin
TESAVEL 50 mg film-coated tablets Sitagliptin 
TESAVEL 50 mg filmsko obložene tablete sitagliptin
12 vials + 72 injection syringes with attached needle + 144 cleansing swabs 
12 vial + 72 injekcijskih brizg s pritrjeno iglo + 144 čistilnih tamponov
2 vials + 12 injection syringes with attached needle + 24 cleansing swabs 
2 viali + 12 injekcijskih brizg s pritrjeno iglo + 24 čistilnih tamponov
1 vial + 6 injection syringes with attached needle + 12 cleansing swabs 
1 viala + 6 injekcijskih brizg s pritrjeno iglo + 12 čistilnih tamponov
2 vials 
Stična ovojnina
1 150 mg indoxacarb + 480 mg permethrin/ml 
1 150 mg indoksakarba + 480 mg permetrina/ml
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA** 
A/Brisbane/02/2018 (H1N1)pdm09 podoben sev (A/Idaho/07/2018) 15 mikrogramov HA** A/Kansas/14/2017 (H3N2) podoben sev (A/Indiana/08/2018) 15 mikrogramov HA** B/Colorado/06/2017 podoben sev (B/Iowa/06/2017) 15 mikrogramov HA** B/Phuket/3073/2013 podoben sev (B/Singapore/INFTT-16-0610/2016) 15 mikrogramov HA** na 0,5 mililitrski odmerek
--¹ 1 Each 0.5 ml dose contains: 
--¹ En 0,5 ml odmerek vsebuje:
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin 
* razmnoženi v celicah pasjih ledvic Madin Darby Canine Kidney (MDCK) ** hemaglutinina
Intramuscular use Pre-filled syringe (glass) without needle 
Sevi* virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza), inaktivirani:
They may also have episodes of depression. 
Imajo pa lahko tudi epizode depresije.
The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Aripiprazol Zentiva, veljavno po vsej Evropski uniji, izdala dne 25. junija 2015.
The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Aripiprazol Zentiva sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
To prevent manic episodes in adults, the same dose should be continued. 
Za preprečevanje maničnih epizod pri odraslih je treba nadaljevati z jemanjem enakega odmerka.
Aripiprazole Zentiva aripiprazole 
Aripiprazol Zentiva aripiprazol
Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg). 
Zdravilo Aripiprazol Zentiva je na voljo v obliki tablet (5, 10, 15 in 30 mg) in orodisperzibilnih tablet (tablete, ki se raztopijo v ustih; 10, 15 in 30 mg).
• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). 
• shizofrenijo, tj. duševno boleznijo s številnimi simptomi, ki vključujejo neorganizirano mišljenje in govor, halucinacije (bolnik vidi in sliši stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
The Committee recommended that Aripiprazole Zentiva be approved for use in the EU. 
Priporočil je, da se zdravilo Aripiprazol Zentiva odobri za uporabo v EU.
A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Aripiprazol Zentiva je bil pripravljen načrt obvladovanja tveganj.
In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years. 
Poleg tega bo družba, ki trži zdravilo Aripiprazol Zentiva, priskrbela izobraževalno gradivo, ki ga bodo prejeli bolniki ali njihovi negovalci ter zdravniki, v katerem bo pojasnjena varna uporaba zdravila pri bolnikih, starih od 13 do 17 let.
This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Abilify.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Aripiprazol Zentiva primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body. 
Odmerek je treba prilagoditi pri bolnikih, ki jemljejo druga zdravila, ki vplivajo na presnovo zdravila Aripiprazol Zentiva v telesu.
Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past. 
Zdravilo Aripiprazol Zentiva se uporablja pri odraslih za zdravljenje zmernih in hudih maničnih epizod ter za preprečevanje pojava novih maničnih epizod pri odraslih, ki so se v preteklosti že odzvali na zdravilo.
Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Aripiprazol Zentiva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Aripiprazole Zentiva is used in patients with the following mental illnesses: 
Zdravilo Aripiprazol Zentiva se uporablja pri bolnikih z naslednjimi duševnimi boleznimi:
The orodispersible tablets can be used in patients who have difficulty swallowing tablets. 
Pri bolnikih, ki težko pogoltnejo tableto, se lahko uporabljajo orodisperzibilne tablete.
Aripiprazole Zentiva is used in patients aged 15 years or over; 
Zdravilo Aripiprazol Zentiva se uporablja pri bolnikih, starih 15 let ali več;
For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Aripiprazol Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Aripiprazole Zentiva 
Druge informacije o zdravilu Aripiprazol Zentiva
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Aripiprazol Zentiva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify. 
Ker je zdravilo Aripiprazol Zentiva generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Abilify.
For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines. 
Za zdravljenje maničnih epizod pri bipolarni motnji pri odraslih je priporočeni začetni odmerek 15 mg peroralno enkrat na dan, samostojno ali v kombinaciji z drugimi zdravili.