FrancophonIA/ELRC3.0 huggingface dataset:
English: Preparation of intravenous infusions and stability: add without delay the reconstituted solution of 1 g (as prepared above - these are minimum volumes) to 100 ml infusion fluid (e.g. using a mini bag or in-line burette).
Slovenian: Priprava intravenske infuzije in stabilnost: 1 g rekonstituirane raztopine (kot je pripravljena zgoraj - to so minimalni volumni) je treba brez odlašanja dodati v 100 ml tekočine za infundiranje (npr. z uporabo mini vrečke ali birete v liniji).
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 1 g dispersible tablets [See Annex I - To be completed nationally]
Slovenian: Amoxil in povezana imena (glejte Prilogo I) 1 g disperzibilne tablete [glejte Prilogo I - izpolni država članica] amoksicilin
English: 500 mg Powder for Oral Suspension sachets Belgium - Clamoxyl
Slovenian: 500 mg prašek za peroralno suspenzijo (vrečice) Belgija - Clamoxyl
English: These primary packs are placed in a carton with a syringe.
Slovenian: Primarne ovojnine so v škatli s priloženo odmerno žličko.
English: • Lyme disease
Slovenian: Bolezni sečil
English: 250 mg/5 ml powder for oral suspension (bottles) Powder for oral suspension White powder with yellowish grains.
Slovenian: 250 mg/5 ml prašek za peroralno suspenzijo (steklenice) Prašek za peroralno suspenzijo Bel prašek z rumenkastimi zrni.
English: • Acute exacerbations of chronic bronchitis
Slovenian: • akutno poslabšanje kroničnega bronhitisa • pljučnica, dobljena v domačem okolju
English: 500 mg powder for oral suspension (sachets) Powder for oral suspension White powder with yellowish grains.
Slovenian: 500 mg prašek za peroralno suspenzijo (vrečice) Prašek za peroralno suspenzijo Bel prašek z rumenkastimi zrni.
English: Each sachet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin.
Slovenian: Ena viala vsebuje 250 mg amoksicilina v obliki amoksicilin trihidrata.
English: being sick (vomiting).
Slovenian: • siljenje na bruhanje (navzea), • driska.
English: Acute streptococcal tonsillitis and pharyngitis Acute exacerbations of chronic bronchitis
Slovenian: Akutni streptokokni tonzilitis in faringitis
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 500 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Amoxil in povezana imena (glejte Prilogo I) 500 mg/5 ml prašek za peroralno suspenzijo
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 250 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Amoxil in povezana imena (glejte Prilogo I) 250 mg/5 ml prašek za peroralno suspenzijo
English: 125 mg/5 ml powder for oral suspension (bottles) Powder for oral suspension White powder with yellowish grains.
Slovenian: 125 mg/5 ml prašek za peroralno suspenzijo (steklenice) Prašek za peroralno suspenzijo Bel prašek z rumenkastimi zrni.
English: Amoxil 250 mg/5 ml powder for oral suspension contains aspartame, maltodextrin and sodium benzoate
Slovenian: Zdravilo Amoxil 250 mg/5 ml prašek za peroralno suspenzijo vsebuje aspartam, maltodekstrin in natrijev benzoat.
English: Amoxicillin
Slovenian: amoksicilin
English: 200 mg/kg/day in 3 to 4 equally divided does of up to 25 mg/kg or infusions of up to 50 mg/kg
Slovenian: 200 mg/kg/dan v 3 do 4 enako razdeljenih odmerkih do 25 mg/kg ali infuzijah do 50 mg/kg
English: 1 g powder for solution for injection or infusion Powder for solution for injection or infusion Vials containing a white to off-white sterile powder.
Slovenian: 1 g prašek za raztopino za injiciranje ali infundiranje Prašek za raztopino za injiciranje ali infundiranje Viale vsebujejo bel do skoraj bel sterilen prašek.
English: IM
Slovenian: Opomba2
English: Amoxil 500 mg powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Slovenian: Zdravilo Amoxil 500 mg prašek za raztopino za injiciranje ali infundiranje je bel do skoraj bel sterilen prašek polnjen v 25 ml viale iz prozornega stekla s klorobutilnim gumijastim zamaškom in zaščitnim tesnilnim obročkom.
English: 6 g/day in divided doses for 10 to 30 days *Consideration should be given to the official treatment guidelines for each indication
Slovenian: (od 10 do 21 dni) Pozni stadij (sistemska prizadetost): 500 mg do 2 g vsakih 8 ur do največ 6 g/dan v deljenih odmerkih, od 10 do 30 dni *Upoštevati je treba uradne smernice zdravljenja za vsako indikacijo.
English: 2 g powder for solution for injection or infusion Powder for solution for injection or infusion Vials containing a white to off-white sterile powder.
Slovenian: 2 g prašek za raztopino za injiciranje ali infundiranje Prašek za raztopino za injiciranje ali infundiranje Viale vsebujejo bel do skoraj bel sterilen prašek.
English: Gelatin
Slovenian: Tetraciklini
English: Amoxil 125 mg/5 ml powder for oral suspension contains aspartame, maltodextrin and sodium benzoate
Slovenian: Zdravilo Amoxil 125 mg/5 ml prašek za peroralno suspenzijo vsebuje aspartam, maltodekstrin in natrijev benzoat.
English: Common (may affect up to 1 in 10 people) skin rash feeling sick (nausea) diarrhoea.
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • “gobice” (glivična okužba nožnice, ust ali kožnih gub); zdravilo za gobice vam lahko da zdravnik,
English: Packs of 10 vials
Slovenian: NALEPKA NA VIALI
English: 125 mg/1.25 ml, 125 mg/5 ml, 250 mg/5 ml and 500 mg/5 ml powder for oral suspension (bottles) Carboxymethylcellulose Sodium 12
Slovenian: 125 mg/1.25 ml, 125 mg/5 ml, 250 mg/5 ml in 500 mg/5 ml prašek za peroralno suspenzijo (steklenice) natrijeva karboksimetil celuloza 12 aroma limone-breskve-jagode krospovidon aspartam (E951) natrijev benzoat (E211) ksantanski gumi (E415) silicijev dioksid, hidrofobni, koloidni magnezijev stearat
English: 750 mg and 1 g dispersible tablets Crospovidone
Slovenian: 750 mg in 1 g disperzibilne tablete krospovidon aspartam (E951) aroma poprove mete magnezijev stearat
English: Amoxil 250 mg powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Slovenian: Zdravilo Amoxil 250 mg prašek za raztopino za injiciranje ali infundiranje je bel do skoraj bel sterilen prašek polnjen v 25 ml viale iz prozornega stekla s klorobutilnim gumijastim zamaškom in zaščitnim tesnilnim obročkom.
English: Keep this leaflet.
Slovenian: Izpuščaj na koži
English: The other ingredients are: Crospovidone, Peach-Lemon-Strawberry dry flavour, Magnesium Stearate, Aspartame (E951), Lactose Monohydrate 1 g sachets
Slovenian: 250 mg in 500 mg prašek za peroralno suspenzijo (vrečice) krospovidon aroma breskve-limone-jagode magnezijev stearat aspartam (E951) laktoza monohidrat
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 250 mg capsules, hard [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Amoxil in povezana imena (glejte Prilogo I) 250 mg kapsule, trde
English: Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Amoxil is used for a long time.
Slovenian: Med dolgotrajno uporabo zdravila Amoxil se lahko pojavijo »gobice« (glivična okužba vlažnih predelov telesa, ki lahko povzroči bolečnost, srbenje in bel izcedek).
English: 500 mg/5 ml powder for oral suspension (bottles) Powder for oral suspension White powder with yellowish grains.
Slovenian: 500 mg/5 ml prašek za peroralno suspenzijo (vrečice) Prašek za peroralno suspenzijo Bel prašek z rumenkastimi zrni.
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 250 mg powder for oral suspension [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Amoxil in povezana imena (glejte Prilogo I) 250 mg prašek za peroralno suspenzijo
English: Amoxil 125 mg/5 ml Powder for Oral Suspension is a white powder with yellowish grains filled into clear glass bottles with a nominal volume of 107 ml (for 40 ml or 60 ml presentations) or 147 ml (for 80 ml, 100 ml or 120 ml presentations).
Slovenian: Zdravilo Amoxil 125 mg/5 ml prašek za peroralno suspenzijo je bel prašek z rumenkastimi zrni, polnjen v steklenicah iz prozornega stekla z nominalnim volumnom 107 ml (za 40 ml ali 60 ml obliko) ali 147 ml (za
English: Amoxil 1 g powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Slovenian: Zdravilo Amoxil 1 g prašek za raztopino za injiciranje ali infundiranje je bel do skoraj bel sterilen prašek polnjen v 25 ml viale iz prozornega stekla s klorobutilnim gumijastim zamaškom in zaščitnim tesnilnim obročkom.
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 500 mg capsules, hard [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Amoxil in povezana imena (glejte Prilogo I) 500 mg kapsule, trde
English: Signs include: tiredness,
Slovenian: Znaki vključujejo:
English: Thrush (a yeast infection of moist areas of the body which causes soreness, itching and white discharge) may develop if Amoxil is used for a long time.
Slovenian: Med dolgotrajno uporabo zdravila Amoxil se lahko pojavijo »gobice« (glivična okužba vlažnih predelov telesa, ki povzroči bolečnost, srbenje in bel izcedek).
English: Warnings and Precautions Talk to your doctor, pharmacist or nurse before taking Amoxil if you:
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, da jemljete zdravilo Amoxil.
English: Amoxil 2 g powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Slovenian: Zdravilo Amoxil 2 g prašek za raztopino za injiciranje ali infundiranje je bel do skoraj bel sterilen prašek polnjen v 25 ml viale iz prozornega stekla s klorobutilnim gumijastim zamaškom in zaščitnim tesnilnim obročkom.
English: • Acute pyelonephritis
Slovenian: • lymska borelioza
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 500 mg powder for oral suspension [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA Amoxil in povezana imena (glejte Prilogo I) 500 mg prašek za peroralno suspenzijo
English: Neisseria meningitidis
Slovenian: Listeria monocytogenes
English: Silica Hydrophobic Colloidal
Slovenian: Borrelia burgdorferi
English: The active substance in each vial is 250 mg, 500 mg, 1 g or 2 g amoxicillin.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Amoxil - Zdravilna učinkovina v viali je 250 mg, 500 mg, 1 g ali 2 g amoksicilina.
English: This medicinal product contains sorbitol (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
English: Gram-positive anaerobes:
Slovenian: Skupina Streptococcus viridans Grampozitivni anaerobi:
English: Prosthetic joint infections
Slovenian: Za zdravljenje infekcij
English: Packs of 1 or 10 vials
Slovenian: Pakiranje po 1 ali 10 vial.
English: • thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) • “gobice” (glivična okužba nožnice, ust ali kožnih gub); zdravilo za gobice vam lahko da zdravnik ali farmacevt,
English: This is uncommon (may affect up to 1 in 100 people).
Slovenian: Pojavljajo se občasno (pojavijo se lahko pri največ 1 od 100
English: Preparation of intravenous infusions and stability: add without delay the reconstituted solution of 2 g (as prepared above - these are minimum volumes) to 100 ml infusion fluid (e.g. using a mini bag or in-line burette).
Slovenian: 2 g prašek za raztopino za injiciranje ali infundiranje Priprava intravenske infuzije in stabilnost: 2 g rekonstituirane raztopine (kot je pripravljena zgoraj - to so minimalni volumni) je treba brez odlašanja dodati v 100 ml tekočine za infundiranje (npr. z uporabo mini vrečke ali birete v liniji).
English: Available in packs of 3, 6, 12, 20, 24, 30 and 500 sachets.
Slovenian: Škatla vsebuje 3, 6, 12, 20, 24, 30 in
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains amoxicillin sodium equivalent to 2 g amoxicillin.
Slovenian: Ena viala vsebuje 2 g amoksicilina v obliki amoksicilin trihidrata.
English: • the Jarisch-Herxheimer reaction which occurs during treatment with Amoxil for Lyme disease and causes fever, chills, headache, muscle pain and skin rash
Slovenian: • Jarisch-Herxheimerjeva reakcija, ki se pojavi med zdravljenjem lymske borelioze z zdravilom Amoxil,
English: 1 g powder for solution for injection or infusion Each vial contains amoxicillin sodium equivalent to 1 g amoxicillin Excipient with known effect
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1. 1 g prašek za raztopino za injiciranje ali infundiranje Ena viala vsebuje 1 g amoksicilina v obliki amoksicilin trihidrata.
English: Premature Neonates < 4kg Indication*
Slovenian: Nedonošenčki < 4kg
English: Usual daily dose of 20 to 150 mg/kg/day given in 3 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg
Slovenian: Od 50 do 150 mg/kg/dan v 3 enako razdeljenih odmerkih do 25 mg/kg ali infuzijah do 50 mg/kg
English: 500 mg powder for oral suspension (sachets) Each sachet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.
Slovenian: 250 mg prašek za peroralno suspenzijo (vrečice) Ena vrečica vsebuje 250 mg amoksicilina v obliki amoksicilin trihidrata.
English: Adults and children ≥ 40
Slovenian: Odrasli in otroci ≥
English: The patient fully recovered the same day.
Slovenian: Bolnik je še istega dne povsem okreval.
English: This can appear after short or long term use.
Slovenian: To se lahko pojavi po kratkotrajni ali dolgotrajni uporabi.
English: 86% of patients were less than 55 years old, 54% of them were male.
Slovenian: 86 % bolnikov je bilo mlajših od 55 let, 54 % jih je bilo moških.
English: Your doctor will carefully select the appropriate dose for your needs.
Slovenian: Zdravnik bo skrbno izbral ustrezni odmerek za vaše potrebe.
English: Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Slovenian: Samomorilne misli in vedenje so bolj verjetni ob začetku zdravljenja.
English: *compared to placebo
Slovenian: *v primerjavi s placebom
English: The mechanism for this increased risk is not known.
Slovenian: Mehanizem tega povečanja ni znan.
English: Of the 2,844 patients 933 were female (see section 4.2).
Slovenian: Med 2.844 bolniki je bilo 933 žensk (glejte poglavje 4.2).
English: Estimated Treatment Difference
Slovenian: Ocenjena razlika zdravljenja
English: Some of these patients had confounding factors.
Slovenian: Nekateri od teh bolnikov so imeli sočasne dejavnike.
English: The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost kariprazina pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: The primary outcome of the study was time to relapse.
Slovenian: Primarni opazovani dogodek študije je bil čas do ponovitve.
English: Consequently, newborns should be monitored carefully.
Slovenian: Novorojence je zato treba pozorno spremljati.
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Slovenian: Ne vozite in ne upravljajte orodij ali strojev, dokler niste prepričani, da to zdravilo na vas ne vpliva negativno.
English: Your doctor will advise you to visit an ophthalmologist.
Slovenian: Zdravnik vam bo svetoval, da obiščete oftalmologa.
English: This analysis included 2,844 patients of different races, involving 536 patients between the ages of 50 and 65.
Slovenian: V to analizo je bilo vključenih 2.844 bolnikov različnih etničnih pripadnosti, vključno s 536 bolniki, starimi od 50 do 65 let.
English: Cariprazine can be administered with or without food.
Slovenian: Kariprazin se lahko daje s hrano ali brez nje.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Slovenian: Povečanja tveganja za ostale antipsihotike ali druge populacije bolnikov ni mogoče izključiti.
English: The maximum dose should not exceed 6 mg once a day.
Slovenian: Največji odmerek ne sme preseči 6 mg enkrat na dan.
English: If your doctor decides that you should take this medicine during pregnancy, your doctor will monitor your baby closely after birth.
Slovenian: Če se zdravnik odloči, da naj to zdravilo jemljete med nosečnostjo, bo zdravnik vašega otroka po rojstvu skrbno spremljal.
English: (See section “Pregnancy and breastfeeding”).
Slovenian: (Glejte poglavje „Nosečnost in dojenje“).
English: Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Slovenian: Takoj je treba uvesti kardiovaskularno spremljanje, vključno s stalnim elektrokardiografskim spremljanjem možnih aritmij.
English: In elderly patients above 65 years of age data are limited.
Slovenian: Podatki pri starejših bolnikih, starih več kot 65 let, so omejeni.
English: The effect of food on the exposure of the metabolites DCAR and DDCAR was also minimal.
Slovenian: Tudi učinek hrane na izpostavljenost presnovkom DCAR in DDCAR je bil minimalen.
English: Tell your doctor immediately if you notice any signs of a stroke.
Slovenian: Zdravniku takoj povejte, če opazite kakršne koli znake možganske kapi.
English: These may be signs of muscle damage which can cause very serious kidney problems.
Slovenian: To so lahko znaki poškodbe mišic, ki lahko povzroči zelo resne težave z ledvicami.
English: Smoking status
Slovenian: Status kajenja
English: Consumption of grapefruit juice should be avoided.
Slovenian: Izogibati se je treba uživanju soka grenivke.
English: This is because the medicine will stay in your body for some time after the last dose was taken.
Slovenian: Vzrok je v tem, ker zdravilo v telesu ostane še nekaj časa po zadnjem odmerku.
English: The lowest effective dose should be maintained according to the clinical judgement of the treating physician.
Slovenian: Treba je vzdrževati najmanjši učinkovit odmerek v skladu s klinično presojo lečečega zdravnika.
English: Do not take this medicine during pregnancy unless your doctor has told you to do so.
Slovenian: Tega zdravila ne jemljite med nosečnostjo, razen če vam je tako naročil zdravnik.
English: Do not take Reagila: - if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Reagila: - če ste alergični na kariprazin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Even if you feel better, do not alter or stop your daily dose of Reagila unless told to do so by your doctor as your symptoms may return.
Slovenian: Tudi če se počutite bolje, ne spreminjajte dnevnega odmerka zdravila Reagila in ga ne prenehajte jemati, če vam tega ni naročil zdravnik, saj se lahko vaši simptomi vrnejo.
English: For the management of patients treated with cariprazine, the effective half-life is more relevant than the terminal half-life.
Slovenian: Za obravnavo bolnikov, zdravljenih s kariprazinom, je učinkovita razpolovna doba bolj pomembna kot končna razpolovna doba.
English: These symptoms may occur early during treatment with Reagila.
Slovenian: Ti simptomi se lahko pojavijo zgodaj med zdravljenjem z zdravilom Reagila.
English: Most events were mild to moderate in severity.
Slovenian: Večina dogodkov je bila blagih do zmernih.
English: Results for the primary outcome parameter are summarized in Table 1 below.
Slovenian: Rezultati parametrov primarnega opazovanega dogodka so povzeti spodaj v preglednici 1.
English: Thereafter, the dose may be slowly adjusted by your doctor, in steps of 1.5 mg, depending on how the treatment works for you.
Slovenian: Nato lahko zdravnik počasi odmerek prilagodi v korakih po 1,5 mg, kar je odvisno od tega, kako zdravljenje deluje pri vas.
English: Reagila should not be used by elderly patients with dementia (loss of memory).
Slovenian: Zdravilo Reagila se ne sme uporabljati pri starejših bolnikih z demenco (izgubljanjem spomina).
English: Tell your doctor immediately: - if you are having any thoughts or feelings about hurting yourself or to commit suicide.
Slovenian: Zdravniku takoj povejte: - če imate kakršne koli misli ali občutke o samopoškodovanju ali o tem, da bi storili samomor.
English: - high or low blood pressure, cardiovascular disease.
Slovenian: - imate visok ali nizek krvni tlak, srčno-žilno bolezen.
English: Because cariprazine is not a substrate for CYP1A2, smoking is not expected to have an effect on the pharmacokinetics of cariprazine.
Slovenian: Ker kariprazin ni substrat za CYP1A2, ni pričakovati, da bi kajenje vplivalo na farmakokinetiko kariprazina.
English: This patient experienced orthostasis and sedation.
Slovenian: Ta bolnik je bil ortostatičen in sediran.
English: Cariprazine and its major active metabolites are highly bound (96 to 97% for CAR, 94% to 97% for DCAR and 92% to 97% for DDCAR) to plasma proteins.
Slovenian: Kariprazin in njegova glavna aktivna presnovka se obsežno vežejo (96 do 97 % za CAR, 94 % do 97 % za DCAR in 92 % do 97 % za DDCAR) na beljakovine v plazmi.
English: None of the cariprazine treated patients had any liver damage.
Slovenian: Noben od bolnikov, zdravljenih s kariprazinom, ni imel poškodb na jetrih.
English: Blood pressure changes
Slovenian: Spremembe krvnega tlaka
English: Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone.
Slovenian: Podrobne in posodobljene informacije o zdravilu so na voljo s skeniranjem kode QR spodaj in na škatli s pametnim telefonom.
English: What Reagila is and what it is used for
Slovenian: Kaj je zdravilo Reagila in za kaj ga uporabljamo
English: Results for the secondary outcome parameter (CGI) and additional endpoints were supportive of the primary endpoint.
Slovenian: Rezultati parametrov sekundarnega opazovanega dogodka (CGI) in dodatnih opazovanih dogodkov podpirajo primarni opazovani dogodek.
English: Patients with secondary negative symptoms, such as moderate to severe depressive symptoms and clinically relevant parkinsonism (EPS) were excluded.
Slovenian: Bolniki s sekundarnimi negativnimi simptomi, kot so zmerni do hudi simptomi depresije, in klinično pomembnim parkinsonizmom (EPS) so bili izključeni.
English: The effective (functional) half-life is ~ 2 days for cariprazine and DCAR, 8 days for DDCAR and is ~1 week for total cariprazine.
Slovenian: Učinkovita (funkcionalna) razpolovna doba je ~ 2 dni za kariprazin ter DCAR, 8 dni za DDCAR in ~ 1 teden za skupni kariprazin.
English: Given the primary central nervous system effects of cariprazine, Reagila should be used with caution in combination with other centrally acting medicinal products and alcohol.
Slovenian: Glede na primarne učinke kariprazina na osrednji živčni sistem je potrebna previdnost pri uporabi zdravila Reagila v kombinaciji z drugimi zdravili s centralnim delovanjem in alkoholom.
English: Most EPS cases were mild to moderate in intensity and could be handled with common anti-EPS medicinal products.
Slovenian: Večina primerov EPS je bila blagih do zmernih po intenzivnosti in obvladljivih z običajnimi zdravili proti EPS.
English: Allura red AC is a coloring agent, which may cause allergic reactions.
Slovenian: Alurno rdeče AC je barvilo, ki lahko povzroči alergijske reakcije.
English: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with Reagila does not affect them adversely.
Slovenian: Bolnike je treba opozoriti, da nevarnih strojev, vključno z motornimi vozili, ne upravljajo, dokler se ne prepričajo, da zdravilo Reagila nanje nima neželenih vplivov.