natgillin/translations-raw huggingface dataset:
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. 
Noorukite (13...17 aastat) skisofreenia populatsioonil ekspositsiooniga kuni 2 aastat koondandmetes oli madal prolaktiini tase naissoo (< 3 ng/ml) ja meessoo (< 2 ng/ml) korral vastavalt 29,5 % ja
Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side. 
Aripiprazole Sandoz 5 mg tabletid on sinised kirjud ümarad, ligikaudu 6,0 mm läbimõõduga tabletid, mille ühel küljel on graveering "SZ" ja teisel "444".
Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg aripiprazole. 
Aripiprazole Sandoz 10 mg tabletid Iga tablett sisaldab 10 mg aripiprasooli.
Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Yellow iron oxide (E172) 
Mikrokristalliline tselluloos Hüdroksüpropüültselluloos Magneesiumstearaat Indigokarmiin (E132) alumiiniumlakk
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 
Aripiprasooli kasutamisel võib esineda ülitundlikkusreaktsioone, mida iseloomustavad eeskätt allergilised sümptomid (vt lõik 4.8).
Aripiprazole Sandoz 20 mg tablets 
Aripiprazole Sandoz 20 mg tabletid
Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet. 
Teadaolevat toimet omav(ad) abiaine(d): 71 mg laktoosmonohüdraati tableti kohta.
Aripiprazole Sandoz 30 mg tablets 
Aripiprazole Sandoz 30 mg tabletid
Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0mm, debossed with “SZ” on one side and “446” on the other side. 
Aripiprazole Sandoz 10 mg tabletid on roosad kirjud ümarad, ligikaudu 6,0 mm läbimõõduga tabletid, mille ühel küljel on graveering "SZ" ja teisel "446".
Hepatitis 
Pankreatiit
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole 
TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 15 mg aripiprasooli
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): 
Skisofreenia noorukitel vanuses 15 aastat ja vanemad Lühiaegses platseebokontrolliga kliinilises uuringus 302 skisofreeniaga noorukil (vanuses 13...17 aastat) oli kõrvaltoimete sagedus ja tüüp sarnane täiskasvanutel täheldatuga, välja arvatud järgnevalt loetletud kõrvaltoimed, mida esines aripiprasooli saanud noorukitel sagedamini kui aripiprasooli saanud täiskasvanutel (ning mis esinesid suurema sagedusega kui platseebo kasutamisel): unisus/sedatsioon ja ekstrapüramidaalhäired esinesid väga sageli (≥ 1/10), suu kuivus, isu suurenemine ja ortostaatiline hüpotensioon esinesid sageli (≥ 1/100, < 1/10).
To allow the start of the treatment at a low dose you can use an alternative formulation (oral solution - liquid) more suitable than Aripiprazole Sandoz tablets. 
Aripiprasooli kasutamist võib alustada väiksema annusega, kasutades suukaudse lahuse (vedelik) ravimvormi.
Aripiprazole Sandoz 10 mg tablets 
Aripiprazole Sandoz 10 mg tabletid
Aripiprazole Sandoz 5 mg tablets 
Aripiprazole Sandoz 5 mg tabletid
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061 
MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1029/061
Aripiprazole Sandoz15mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0mm, debossed with “SZ” on one side and “447” on the other side. 
Aripiprazole Sandoz 15 mg tabletid on kollased kirjud ümarad, ligikaudu 6,0 mm läbimõõduga tabletid, mille ühel küljel on graveering "SZ" ja teisel "447".
INFORMATION IN BRAILLE Aripiprazole Sandoz 20 mg 
TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Aripiprazole Sandoz 20 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg 
Aripiprazole Sandoz 15 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042 
MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1029/042
INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg 
Aripiprazole Sandoz 10 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg 
Aripiprazole Sandoz 5 mg
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole 
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 30 mg tabletid aripiprasool
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued. 
Kõikide psühhoosivastaste ravimite, sealhulgas aripiprasooli manustamine tuleb lõpetada, kui patsiendil ilmnevad võimalikud MNS tunnused või sümptomid või täiendavate MNS kliiniliste tunnusteta ebaselge etioloogiaga kõrge palavik.
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 30 mg 
TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Väliskarp: Aripiprazole Sandoz 30 mg
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole 
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 20 mg tabletid aripiprasool
Aripiprazole Sandoz 15 mg tablets 
Aripiprazole Sandoz 15 mg tabletid
Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets) 
MÜÜGILOA NUMBER (NUMBRID) Aripiprazole Sandoz 5 mg tabletid EU/1/15/1029/001 (10 tabletti) EU/1/15/1029/002 (14 tabletti) EU/1/15/1029/003 (16 tabletti) EU/1/15/1029/004 (28 tabletti) EU/1/15/1029/005 (30 tabletti) EU/1/15/1029/006 (35 tabletti) EU/1/15/1029/007 (56 tabletti) EU/1/15/1029/008 (70 tabletti) EU/1/15/1029/009 (14 x 1 tabletti) EU/1/15/1029/010 (28 x 1 tabletti) EU/1/15/1029/011 (49 x 1 tabletti) EU/1/15/1029/012 (56 x 1 tabletti) EU/1/15/1029/013 (98 x 1 tabletti) EU/1/15/1029/014 (100 tabletti)
INFORMATION IN BRAILLE Outer carton:Aripiprazole Sandoz 5 mg 
TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Väliskarp: Aripiprazole Sandoz 5 mg
Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch 
Aripiprazole Sandoz 20 mg tabletid Laktoosmonohüdraat Maisitärklis
In addition, cases of stroke or "mini" stroke have been reported. 
Lisaks on teatatud ajurabandust või aju mikrorabandust.
INFORMATION IN BRAILLE Aripiprazole Sandoz 30 mg 
TEAVE BRAILLE' KIRJAS (PUNKTIKIRJAS) Aripiprazole Sandoz 30 mg
Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets) 
Aripiprazole Sandoz 10 mg tabletid EU/1/15/1029/015 (10 tabletti) EU/1/15/1029/016 (14 tabletti) EU/1/15/1029/017 (16 tabletti) EU/1/15/1029/018 (28 tabletti) EU/1/15/1029/019 (30 tabletti) EU/1/15/1029/020 (35 tabletti) EU/1/15/1029/021 (56 tabletti) EU/1/15/1029/022 (70 tabletti) EU/1/15/1029/023 (14 x 1 tabletti) EU/1/15/1029/024 (28 x 1 tabletti) EU/1/15/1029/025 (49 x 1 tabletti) EU/1/15/1029/026 (56 x 1 tabletti) EU/1/15/1029/027 (98 x 1 tabletti) EU/1/15/1029/028 (100 tabletti)
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg 
TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Väliskarp: Aripiprazole Sandoz 10 mg
Suicide attempt, suicidal ideation and completed suicide (see section 4.4) 
Suitsiidikatse, suitsidaalsed mõtted, täideviidud suitsiid (vt lõik 4.4) Patoloogiline mängurlus Impulsi kontrolli häired Liigsöömine
EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets 
EU/1/15/1029/015 10 tabletti EU/1/15/1029/016 14 tabletti EU/1/15/1029/017 16 tabletti EU/1/15/1029/018 28 tabletti EU/1/15/1029/019 30 tabletti EU/1/15/1029/020 35 tabletti EU/1/15/1029/021 56 tabletti EU/1/15/1029/022 70 tabletti EU/1/15/1029/023 14 x 1 tabletti EU/1/15/1029/024 28 x 1 tabletti EU/1/15/1029/025 49 x 1 tabletti EU/1/15/1029/026 56 x 1 tabletti EU/1/15/1029/027 98 x 1 tabletti
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole 
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 5 mg tabletid aripiprasool
Aripiprazole Sandoz 30 mg tablets Lactose monohydrate Maize starch 
Aripiprazole Sandoz 30 mg tabletid Laktoosmonohüdraat Maisitärklis
Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets) 
Aripiprazole Sandoz 30 mg tabletid EU/1/15/1029/048 (10 tabletti) EU/1/15/1029/049 (14 tabletti) EU/1/15/1029/050 (16 tabletti) EU/1/15/1029/051 (28 tabletti) EU/1/15/1029/052 (30 tabletti) EU/1/15/1029/053 (35 tabletti) EU/1/15/1029/054 (56 tabletti) EU/1/15/1029/055 (70 tabletti) EU/1/15/1029/056 (14 x 1 tabletti) EU/1/15/1029/057 (28 x 1 tabletti) EU/1/15/1029/058 (49 x 1 tabletti) EU/1/15/1029/059 (56 x 1 tabletti) EU/1/15/1029/060 (98 x 1 tabletti) EU/1/15/1029/061 (100 tabletti)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014 
MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1029/014
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole 
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 15 mg tabletid aripiprasool
Aripiprazole Sandoz 10 mg tablets Lactose monohydrate Maize starch 
Aripiprazole Sandoz 10 mg tabletid Laktoosmonohüdraat Maisitärklis
Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets) 
Aripiprazole Sandoz 15 mg tabletid EU/1/15/1029/029 (10 tabletti) EU/1/15/1029/030 (14 tabletti) EU/1/15/1029/031 (16 tabletti) EU/1/15/1029/032 (28 tabletti) EU/1/15/1029/033 (30 tabletti) EU/1/15/1029/034 (35 tabletti) EU/1/15/1029/035 (56 tabletti) EU/1/15/1029/036 (70 tabletti) EU/1/15/1029/037 (14 x 1 tabletti) EU/1/15/1029/038 (28 x 1 tabletti) EU/1/15/1029/039 (49 x 1 tabletti) EU/1/15/1029/040 (56 x 1 tabletti) EU/1/15/1029/041 (98 x 1 tabletti) EU/1/15/1029/042 (100 tabletti)
EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets 
EU/1/15/1029/00110 tabletti EU/1/15/1029/002 14 tabletti EU/1/15/1029/003 16 tabletti EU/1/15/1029/004 28 tabletti EU/1/15/1029/005 30 tabletti EU/1/15/1029/006 35 tabletti EU/1/15/1029/007 56 tabletti EU/1/15/1029/008 70 tabletti EU/1/15/1029/009 14 x 1 tabletti EU/1/15/1029/010 28 x 1 tabletti EU/1/15/1029/011 49 x 1 tabletti EU/1/15/1029/012 56 x 1 tabletti EU/1/15/1029/013 98 x 1 tabletti
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg 
TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Väliskarp: Aripiprazole Sandoz 15 mg
How to store Aripiprazole Sandoz tablets 
Kuidas Aripiprazole Sandozt säilitada
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole 
RAVIMPREPARAADI NIMETUS Aripiprazole Sandoz 10 mg tabletid aripiprasool
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide. 
hüdroksüpropüültselluloos, magneesiumstearaat, kollane raudoksiid.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, 
• kardiovaskulaarsed haigused (südame ja veresoonkonna haigused), kardiovaskulaarhaigus lähisugulastel, insult või „mikroinsult”, liiga kõrge või madal vererõhk;
EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets 
EU/1/15/1029/029 10 tabletti EU/1/15/1029/030 14 tabletti EU/1/15/1029/031 16 tabletti EU/1/15/1029/032 28 tabletti EU/1/15/1029/033 30 tabletti EU/1/15/1029/034 35 tabletti EU/1/15/1029/035 56 tabletti EU/1/15/1029/036 70 tabletti EU/1/15/1029/037 14 x 1 tabletti EU/1/15/1029/038 28 x 1 tabletti EU/1/15/1029/039 49 x 1 tabletti EU/1/15/1029/040 56 x 1 tabletti EU/1/15/1029/041 98 x 1 tabletti
Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch 
Aripiprazole Sandoz 5 mg tabletid Laktoosmonohüdraat Maisitärklis
Aripiprazole Sandoz 15 mg tablets Lactose monohydrate Maize starch 
Aripiprazole Sandoz 15 mg tabletid Laktoosmonohüdraat Maisitärklis
EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets 
EU/1/15/1029/048 10 tabletti EU/1/15/1029/049 14 tabletti EU/1/15/1029/050 16 tabletti EU/1/15/1029/051 28 tabletti EU/1/15/1029/052 30 tabletti EU/1/15/1029/053 35 tabletti EU/1/15/1029/054 56 tabletti EU/1/15/1029/055 70 tabletti EU/1/15/1029/056 14 x 1 tabletti EU/1/15/1029/057 28 x 1 tabletti EU/1/15/1029/058 49 x 1 tabletti EU/1/15/1029/059 56 x 1 tabletti EU/1/15/1029/060 98 x 1 tabletti
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172). 
hüdroksüpropüültselluloos, magneesiumstearaat, punane raudoksiid (E172).
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. 
72 kuud oli madala prolaktiini taseme esinemissagedus naistel (< 3 ng/ml) ja meestel (<2 ng/ml) vastavalt 25,6 % ja 45,0 %.
Magnesium stearate 
Liigne süljeeritus
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028 
MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1029/015-027
Pancreatitis Dysphagia Diarrhoea 
Diabeetiline ketoatsidoos
The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Euroopa avaliku hindamisaruande täistekst PegIntroni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss. 
Täiskasvanuil on PegIntroni kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) viirusnakkused, farüngiit (neelupõletik), aneemia (vere punaliblede vähesus), neutropeenia (neutrofiilide ehk vere teatud valgeliblede vähesus), isutus, depressioon (masendus), ärevus, emotsionaalne labiilsus (meeleolu kõikuvus), keskendumisraskused, unetus, peavalu, peapööritus, düspnoe (hingamisraskused), köha, oksendamine, iiveldus, kõhuvalu, kõhulahtisus, suukuivus, alopeetsia (juuste väljalangemine), pruritus (kihelus), nahakuivus, nahalööve, müalgia (lihasevalu), artralgia (liigesevalu), luu-lihaskonna valu, süstekoha reaktsioonid, süstekoha põletik, väsimus, asteenia (nõrkus), ärrituvus, külmavärinad, palavik, gripilaadsed sümptomid ja kehakaalu kaotus.
The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000. 
Euroopa Komisjon andis PegIntroni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. mail
Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment. 
Et PegIntroniga seonduvad sellised kõrvalnähud nagu depressioon, peab patsiente ravi ajal tähelepanelikult jälgima.
The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Inimravimite komitee otsustas, et PegIntroni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
This document is a summary of the European Public Assessment Report (EPAR) for PegIntron. 
See on ravimi PegIntron Euroopa avaliku hindamisaruande kokkuvõte.
Other information about PegIntron: 
Muu teave PegIntroni kohta
For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate PegIntroniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10. 
Lastel ja noorukitel, kes said PegIntroni koos ribaviriiniga, olid kõrvalnähud samasugused kui täiskasvanutel, kuigi ka kasvupeetust esines enam kui 1 patsiendil 10st.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PegIntron. 
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed. 
PegIntroni tohib kasutada täiskasvanud (vähemalt 18-aastastel) patsientidel, keda varem ei ole ravitud või kelle varasem ravi on ebaõnnestunud.
The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before. 
PegIntroni ja ribaviriini kombinatsiooni uuriti ka uuringus, kus osales 1354 täiskasvanut, kelle varasem ravi oli ebaõnnestunud, ja uuringus, kus osales 107 varem ravimata 3-17-aastast last ja noorukit.
PegIntron is also linked to weight loss and reduced growth in children and adolescents. 
PegIntroni seostatakse lastel ja noorukitel ka kehakaalu kaotuse ja kasvupeetusega.
PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems. 
PegIntroni ei tohi kasutada patsiendid, kellel on raske terviseseisund, rasked maksaprobleemid, ravile allumatu kilpnäärmehaigus või epilepsia või muud kesknärvisüsteemi häired.
PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients. 
PegIntroni ei tohi kasutada patsiendid, kes on mis tahes interferooni või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
What is PegIntron? 
Mis on PegIntron?
For the full list of all side effects reported with PegIntron, see the package leaflet. 
PegIntroni kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Why has PegIntron been approved? 
Miks PegIntron heaks kiideti?
The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV. 
PegIntroni ja ribaviriini kombinatsioon oli efektiivne tsirroosiga ja HIVnakkusega patsientidel.
PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV. 
PegIntroni kasutamist koos ribaviriiniga või ilma võrreldi alfa-2b-interferooniga viies põhiuuringus, milles osales kokku üle 6000 täiskasvanud patsiendi, kellel oli C-hepatiit ja keda varem ei olnud ravitud, sh 328 tsirroosiga patsienti ja 507 patsienti, kellel oli ka HIV-nakkus.
The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b. 
PegIntronis sisalduvat alfa2b-interferooni valmistatakse rekombinant-DNA-tehnika abil: seda toodab bakter, millele on lisatud alfa-2b-interferooni teket võimaldav geen (DNA).
PegIntron peginterferon alfa-2b 
PegIntron alfa-2b-peginterferoon
In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin. 
Teistele täiskasvanud patsientidele, kelle veres on C-hepatiidi viirus, sh neile, kes on nakatunud ka inimese immuunpuudulikkuse viirusega (HIV), manustatakse PegIntroni koos ribaviriiniga (ravi kahe preparaadiga) või ainsa ravimina, kui patsient ribaviriini ei talu.
What is the risk associated with PegIntron? 
Mis riskid PegIntroniga kaasnevad?
PegIntron is a medicine that contains the active substance peginterferon alfa-2b. 
PegIntron on ravim, mis sisaldab toimeainena alfa-2b-peginterferooni.
Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately. 
Sõltuvalt kõrvalnähtude raskusest võib olla vaja ravi (sh ka botsepreviiri manustamine) täielikult lõpetada.
PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease). 
PegIntroni tohib anda koos ribaviriini ja botsepreviiriga (ravi kolme preparaadiga) täiskasvanud patsientidele 1. tüüpi C-hepatiidi korral, kui patsiendi maks on kahjustatud, ent võimeline normaalselt talitlema (kompenseeritud maksahaigus).