natgillin/translations-raw huggingface dataset:
Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
V kratkotrajnem, s placebom nadzorovanem kliničnem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo, so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih neželenih učinkov, ki so bili pri mladostnikih, ki so prejemali aripiprazol, pogostejši kot pri odraslih, ki so prejemali aripiprazol (in pogostejši kot pri placebu): somnolenca/sedacija in ekstrapiramidne motnje so bili zelo pogosti ( ≥ 1/10), suha usta, povečan apetit in ortostatska hipotenzija pa pogosti ( ≥ 1/100, < 1/10) neželeni učinki.
Excipient with known effect 168 mg of maltose per tablet
168 mg maltoze na tableto.
Schizophrenia in adolescents aged 15 years and older: the recommended dose for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals.
Shizofrenija pri mladostnikih, starih 15 let in več: priporočeni odmerek aripiprazola je 10 mg enkrat na dan ne glede na obroke hrane.
• agitation,
• vznemirjenost,
Suicidality
Samomorilne misli
However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Priporočeni odmerek za odrasle je 15 mg enkrat na dan, toda vaš zdravnik vam lahko predpiše odmerek, ki je manjši ali večji, do največ 30 mg enkrat na dan.
Weight gain should be monitored in adolescent patients with bipolar mania.
Pri mladostnikih z bipolarno manijo je treba meriti povečanje telesne mase.
The mean weight gain over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean increase of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase (16 weeks) of the trial.
V stabilizacijski fazi (do 26. tedna) se je telesna masa bolnikov, ki so prejemali aripiprazol, v povprečju povečala za 3,2 kg, v drugi (16-tedenski) fazi preskušanja pa se je telesna masa bolnikov, ki so prejemali aripiprazol, še nadalje povečala, in sicer v povprečju za 2,2 kg, v primerjavi z 0,6 kg pri bolnikih, ki so prejemali placebo.
Overall, 1.3 % of 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 z aripiprazolom, in pri 0,6 % bolnikov, ki so dobivali placebo.
Haemodialysis
Hemodializa
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Med sočasno uporabo aripiprazola in šibkih zaviralcev CYP3A4 (npr. diltiazema) ali CYP2D6 (npr. escitaloprama) je mogoče pričakovati zmerno zvišanje koncentracije plazemskega aripiprazola.
Aripiprazole Mylan Pharma 5 mg tablets Aripiprazole Mylan Pharma 10 mg tablets Aripiprazole Mylan Pharma 15 mg tablets Aripiprazole Mylan Pharma 30 mg tablets
Aripiprazol Mylan Pharma 5 mg tablete Aripiprazol Mylan Pharma 10 mg tablete Aripiprazol Mylan Pharma 15 mg tablete Aripiprazol Mylan Pharma 30 mg tablete aripiprazol
In the pooled trials, the incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively.
Podatki združenih preskušanj kažejo, da je bila pri zdravljenju z aripiprazolom pogostnost nizkih vrednosti prolaktina v serumu pri deklicah (< 3 ng/ml) 58,7 % (27/46), pri dečkih (< 2 ng/ml) pa 86,6 % (258/298).
In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo.
Incidenca podaljšanja intervala QT je bila v kliničnih preskušanjih aripiprazola primerljiva s placebom.
LIST OF EXCIPIENTS Contains maltose.
Vsebuje maltozo.
Aripiprazole Mylan Pharma contains maltose
Zdravilo Aripiprazol Mylan Pharma vsebuje maltozo
The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
V nekaterih primerih so o njegovem pojavu poročali zgodaj po uvedbi ali zamenjavi antipsihotičnega zdravljenja, tudi pri zdravljenju z aripiprazolom (glejte poglavje 4.8).
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2 % for aripiprazole-treated patients and 15.7 % for placebo-treated patients.
V dolgotrajni 26-tedenski vzdrževalni fazi s placebo nadzorovanega preskušanja je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 18,2 %, pri bolnikih, ki so prejemali placebo pa 15,7 %.
In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
V kliničnih preskušanjih so poročali o občasnih primerih konvulzij med zdravljenjem z aripiprazolom.
Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Aripiprazol deluje antagonistično na adrenergične receptorje α1, zato lahko stopnjuje učinek nekaterih antihipertenzivnih zdravil.
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19 % for aripiprazole-treated patients and 13.1 % for placebo-treated patients.
V dolgoročnem 26-tedenskem s placebom nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19 % in pri bolnikih, ki so dobivali placebo, 13,1 %.
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Mylan Pharma, you should see your doctor.
Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Aripiprazol Mylan Pharma, obiščite zdravnika.
Aripiprazole Mylan Pharma 5 mg tablets Aripiprazole Mylan Pharma 10 mg tablets Aripiprazole Mylan Pharma 15 mg tablets Aripiprazole Mylan Pharma 30 mg tablets aripiprazole
Aripiprazol Mylan Pharma 5 mg tablete Aripiprazol Mylan Pharma 10 mg tablete Aripiprazol Mylan Pharma 15 mg tablete Aripiprazol Mylan Pharma 30 mg tablete
• The other ingredients for 10, 30 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide red (E172) and magnesium stearate.
Druge sestavine 10, 30 mg zdravila so kristalna maltoza, mikrokristalna celuloza, predgelirani škrob, premreženi natrijev karmelozat, rdeč železov oksid (E172) in magnezijev stearat.
Aripiprazole also demonstrated a comparable proportion of patients in symptomatic remission from mania as lithium or haloperidol at week 12.
V 12. tednu je bil delež bolnikov s simptomatsko remisijo manije pri uporabi aripiprazola podoben kot pri uporabi litija ali haloperidola.
• The other ingredients for 5 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, indigo carmine (E132) and magnesium stearate.
Druge sestavine 5 mg zdravila so kristalna maltoza, mikrokristalna celuloza, predgelirani škrob, premreženi natrijev karmelozat, indigotin (E132) in magnezijev stearat.
In another long-term 26-week controlled trial, the incidence of EPS was 14.8 % for aripiprazole-treated patients and 15.1 % for olanzapine-treated patients.
V drugem dolgoročnem 26tedenskem nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14,8 % in pri bolnikih, zdravljenih z olanzapinom, 15,1 %.
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
Klinična preskušanja niso pokazala, da bi aripiprazol povzročil klinično pomembno zvečanje telesne mase.
What Aripiprazole Mylan Pharma look like and contents of the pack Aripiprazole Mylan Pharma 5 mg tablets are blue, round and biconvex of 6.1 mm in diameter, engraved with ‘5' on one side.
Izgled zdravila Aripiprazol Mylan Pharma in vsebina pakiranja Tablete Aripiprazol Mylan Pharma 5 mg so modre, okrogle in bikonveksne premera 6,1 mm in z vrezano oznako '5' na eni strani.
Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Zdravilo Aripiprazol Mylan Pharma je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
Common Uncommon
Neznana pogostnost
• pain killers (such as tramadol and pethidine) used for pain relief
• zdravila proti bolečinam (kot sta tramadol in petidin) uporabljamo za ublažitev bolečine,
Smoking status
Kajenje
Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Če jemljete zdravila za uravnavanje krvnega tlaka, morate biti povsem prepričani, da ste o tem obvestili svojega zdravnika.
Weight gain has been reported post-marketing among patients prescribed aripiprazole.
V obdobju po začetku trženja aripiprazola so pri bolnikih, ki so jim ga predpisali, poročali o povečanju telesne mase.
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
V dveh 3-tedenskih s placebom nadzorovanih preskušanjih samostojnega zdravljenja s fleksibilnim odmerkom pri bolnikih z manično ali mešano epizodo bipolarne motnje I se je po 3 tednih izkazalo, da je aripiprazol pri zmanjšanju maničnih simptomov učinkovitejši od placeba.
When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased.
Pri sočasni uporabi močnih induktorjev CYP3A4 in aripiprazola je treba odmerek aripiprazola zvečati.
Tel: +31 (0)20 426 3300
Mylan BV Tel: +31 (0)20 426 3300
• The active substance is aripiprazole.
Zdravilna učinkovina je aripiprazol.
In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively.
V dveh dolgotrajnih preskušanjih z mladostniki (13 - 17 let) s shizofrenijo in bipolarno motnjo, ki so se zdravili z aripiprazolom, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 37,0 % in pri moških (< 2 ng/ml) 59,4 %.
Pink, oval and biconvex tablets of 17.1 mm in length, 8.1 mm in width, engraved with “30” on one side
Roza, ovalne in bikonveksne tablete dolžine 17,1 mm in širine 8,1, mm z vrezano oznako “30” na eni strani.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Če se pojavi togost ali neprožnost mišic z zvišano telesno temperaturo, znojenje, sprememba duševnega stanja ali zelo hiter ali nepravilen srčni utrip, o tem nemudoma obvestite svojega zdravnika.
Aripiprazole dose should be doubled when concomitant administration of aripiprazole occurs with carbamazepine.
Med sočasno uporabo aripiprazola s karbamazepinom je treba odmerek aripiprazola podvojiti.
The recommended dose for adults is 15 mg once a day.
Največji odmerek je 30 mg enkrat na dan.
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
akutno zmedenost, krče (epilepsijo), komo, kombinacijo zvišane telesne temperature, hitrega dihanja, znojenja; okorelost mišic in omotičnost ali zaspanost, upočasnjeno dihanje, dušenje, visok ali nizek krvni tlak, motnje srčnega ritma.
When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.
Prilagajanje odmerka zaradi medsebojnega delovanja Pri sočasni uporabi močnih zaviralcev CYP3A4 ali CYP2D6 in aripiprazola je treba odmerek aripiprazola zmanjšati.
Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered.
Bolniki s sočasno motnjo pomanjkanja pozornosti (ADHD - Attention deficit hyperactivity disorder) Kljub pogosti sočasni obolevnosti za bipolarno motnjo I in motnjo pomanjkanja pozornosti je na voljo zelo malo podatkov o sočasni uporabi aripiprazola in stimulansov.
Management of overdose
Ukrepanje v primeru prevelikega odmerka
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6 % and 45.0 %, respectively.
Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so bili največ 72 mesecev izpostavljeni aripiprazolu 5 do 30 mg, je bila pogostnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
Nervousness
Preobčutljivost
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Trzaji, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: N = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, izhodiščni rezultat njihovega števila trzajev po skupni oceni resnosti trzajev na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil 30.
• The other ingredients for 15 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide yellow (E172) and magnesium stearate.
Druge sestavine 15 mg zdravila so kristalna maltoza, mikrokristalna celuloza, predgelirani škrob, premreženi natrijev karmelozat, rumeni železov oksid (E172) in magnezijev stearat.
There are no differences in the pharmacokinetics of aripiprazole between healthy male and female subjects nor is there any detectable effect of gender in a population pharmacokinetic analysis in schizophrenic patients.
Prav tako med spoloma ni bilo opaznih razlik v populacijski farmakokinetični analizi shizofrenih bolnikov.
Aripiprazole Mylan Pharma 30 mg tablets
Aripiprazol Mylan Pharma 30 mg tablete
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100,
Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije (16,0 %) in utrujenosti (11,8 %), ki so bili zelo pogosti (≥ 1/10), ter bolečine v zgornjem predelu trebuha, hitrejšega srčnega utripa, povečanja telesne mase, povečanega apetita, trzanja mišic in diskinezije, ki so bili pogosti (≥ 1/100, < 1/10).
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 metabolizers.
Pri osebah, ki slabo presnavljajo s CYP2D6 lahko sočasna uporaba z močnimi zaviralci CYP3A4 povzroči večjo koncentracijo aripiprazola v plazmi kot pri osebah, ki dobro presnavljajo s CYP2D6.Pri odločanju o sočasni uporabi ketokonazola ali drugih močnih zaviralcev CYP3A4 z aripiprazolom morajo biti možne koristi za bolnika večje od možnih tveganj.
Aripiprazole Mylan Pharma 30 mg tablets are pink, oval and biconvex of 17.1mm in length, 8.1 mm in width, engraved with ‘30' on one side.
Tablete Aripiprazol Mylan Pharma 30 mg so roza, ovalne in bikonveksne dolžine 17,1 mm širine 8,1 mm ter z vrezano oznako '30' na eni strani.
Reproductive system and breast disorders
Motnje reprodukcije in dojk priapizem
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
• nenadzorovani gibi ust, jezika in udov (tardivna diskinezija),
Excipient with known effect 28 mg of maltose per tablet
28 mg maltoze na tableto.
Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Z uporabo antipsihotikov, tudi z aripiprazolom, so bile povezane motnje motilitete požiralnika in aspiracija.
Pharmathen S.A. 6, Dervenakion Pallini 15351 Attiki,
Pharmathen S.A. 6, Dervenakion
In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo.
V enem 3-tedenskem s placebom nadzorovanem preskušanju samostojnega zdravljenja s fiksnim odmerkom pri bolnikih z manično ali mešano epizodo bipolarne motnje I aripiprazol ni bil učinkovitejši od placeba.
Νο dosage adjustment is required for patients with mild to moderate hepatic impairment.
Pri bolnikih z blago do zmerno okvaro jeter odmerka ni treba prilagajati.
Excipient with known effect 56 mg of maltose per tablet
56 mg maltoze na tableto.
BGP Products Switzerland GmbH Eesti filiaal
Österreich Arcana Arzneimittel GmbH
Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Pri vrednotenju po podlestvici razdražljivosti na osnovi kontrolnega seznama odklonskega vedenja (‘Aberrant Behaviour Checklist Irritability subscale') se je izkazalo, da je aripiprazol statistično učinkovitejši od placeba, vendar pa pomen te ugotovitve za klinično uporabo ostaja neznan.
Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Bolezni jeter, žolčnika in žolčevodov odpoved jeter hepatitis zlatenica zvišana aktivnost alaninaminotransferaze (ALT) zvišana aktivnost aspartataminotransferaze (AST) zvišana aktivnost gamaglutamiltransferaze (GGT) zvišana aktivnost alkalne fosfataze
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Bolezni dihal, prsnega koša in mediastinalega kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem prostora
Microcrystalline cellulose Pregelatinised starch
Jedro tablete kristalna maltoza mikrokristalna celuloza predgelirani škrob premrežen natrijev karmelozat magnezijev stearat
In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 29.5 % and 48.3 %, respectively.
V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
Aggression
Konvulzije
Excipient with known effect 84 mg of maltose per tablet
84 mg maltoze na tableto.
• headache,
• glavobol,
Aripiprazole Mylan Pharma 30 mg tablets Each tablet contains 30 mg of aripiprazole.
Aripiprazol Mylan Pharma 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
Mylan AB
Mylan S.A.S.
• diabetes mellitus,
• sladkorna bolezen,
How to take Aripiprazole Mylan Pharma
Kako jemati zdravilo Aripiprazol Mylan Pharma
Photosensitivity reaction Alopecia
Bolezni kože in podkožja izpuščaj fotozensibilnostna reakcija alopecija hiperhidroza
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7 % weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of~80.5 kg) on aripiprazole (n = 18, or 13 % of evaluable patients), compared to olanzapine (n = 45, or 33 % of evaluable patients).
za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including aripiprazole.
V nekaterih primerih je bila zelo izrazita in povezana s ketoacidozo ali hiperosmolarno komo ali smrtjo.
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
• kombinacija zvišane telesne temperature, togosti mišic, pospešenega dihanja, znojenja,
Tardive dyskinesia Dystonia
Zapoznela diskinezija
Tablet coat
Obloga tablete
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Med zdravljenjem z aripiprazolom so poročali o mislih na samomor in samomorilnem vedenju.
Aripiprazole Mylan Pharma 15 mg tablets Each tablet contains 15 mg of aripiprazole.
Aripiprazol Mylan Pharma 15 mg tablete Ena tableta vsebuje 15 mg aripiprazola.
• stomach discomfort,
• nelagodje v trebuhu,
• tiredness,
• drgetanja,
Hepatic failure
Ledvična okvara
• trembling,
• togost,
Aripiprazole Mylan Pharma 15 mg tablets are yellow, round and biconvex of 10.1 mm in diameter, engraved with ‘15' on one side.
Tablete Aripiprazol Mylan Pharma 15 mg so rumene, okrogle in bikonveksne premera 10,1 mm in z vrezano oznako '15' na eni strani.
Aripiprazole Mylan Pharma 10 mg tablets Each tablet contains 10 mg of aripiprazole.
Aripiprazol Mylan Pharma 10 mg tablete Ena tableta vsebuje 10 mg aripiprazola.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core
6.1 Seznam pomožnih snovi
• abdominal discomfort,
• prebavne motnje,
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0 % and 53.3 %, respectively.
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Pričakovati je mogoče, da imajo drugi močni zaviralci CYP3A4, npr. itrakonazol in zaviralci proteaz HIV, podobne učinke, zato je treba odmerjanje podobno zmanjšati (glejte poglavje 4.2).Po prenehanju zdravljenja z zaviralcem CYP2D6 ali CYP3A4 je treba odmerjanje aripiprazola zvečati na raven, kakršna je bila pred uvedbo sočasne terapije.
INFORMATION IN BRAILLE Aripiprazole Mylan Pharma 30 mg
PODATKI V BRAILLOVI PISAVI Aripiprazol Mylan Pharma 30 mg
• feeling anxious,
• občutek tesnobe,
Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Splošne težave in spremembe na mestu aplikacije izčrpanost motnje termoregulacije (npr hipotermija, pireksija) bolečina v prsih periferni edemi