FrancophonIA/ELRC3.0 huggingface dataset:
English: What Olazax is and what it is used for What you need to know before you take Olazax How to take Olazax
Estonian: Mis ravim on Olazax ja milleks seda kasutatakse Mida on vaja teada enne Olazax'i võtmist Kuidas Olazax'i võtta
English: - If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Estonian: • Kui teil on diagnoositud probleeme silmadega, nagu nt kindlad glaukoomi vormid (suurenenud surve silmas).
English: What Olazax looks like and contents of the pack
Estonian: Kuidas Olazax välja näeb ja pakendi sisu
English: Date of renewal: 22.08.2014
Estonian: 11. detsember 2009 22. august 2014
English: If you are pregnant or think you might be pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Estonian: Kui te olete rase, imetate või arvate end olevat rase või kavatsete rasestuda, pidage enne selle ravimi kasutamist nõu oma arsti või apteekriga.
English: What you need to know before you take Olazax
Estonian: Mida on vaja teada enne Olazax võtmist
English: Aspartame E 951
Estonian: Aspartaam E951
English: Children and adolescents Olazax is not for patients who are under 18 years
Estonian: Lapsed ja noorukid OLAZAX ei ole mõeldud alla 18-aastastele patsientidele.
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril kuni 30C
English: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with longterm exposure (at least 24 weeks) than with short-term exposure.
Estonian: Kaalutõusu ulatus ning kliiniliselt olulise kaalutõusuga noorukieas patsientide suhe oli suurem pikaajalise avaldumise puhul (vähemalt 24 nädalat) kui lühiajalise avaldumise puhul.
English: Patients who have taken more Olazax than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Estonian: Patsientidel, kes on võtnud Olazax't rohkem kui ette nähtud, on esinenud järgmisi sümptomeid: kiired südamelöögid, ärevus/agressiivsus, kõnehäired, ebaharilikud liigutused (eriti näo või keele) ja vähenenud teadlikkuse tase.
English: You should not be given this medicine when breast-feeding, as small amounts of Olazax can pass into breast milk.
Estonian: Rinnaga toitmise perioodil ei tohi seda ravimit kasutada, kuna Olazax väikesed kogused võivad erituda rinnapiima.
English: • The use of OLAZAX in elderly patients with dementia is not recommended as it may have serious side effects.
Estonian: • Olazax't ei soovitata anda dementsetele eakatele patsientidele, sest neil võivad tekkida tõsised kõrvaltoimed.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.emea.europa.eu
Estonian: Täpne informatsioon selle ravimpreparaadi kohta on Euroopa Ravimiameti (EMA) kodulehel http://www.ema.europa.eu/
English: If you take more Olazax than you should
Estonian: Kui Te võtate Olazax't rohkem kui ette nähtud
English: If you stop taking Olazax
Estonian: Kui Te lõpetate Olazax võtmise
English: In patients with Parkinson's disease Olazax may worsen the symptoms
Estonian: Parkinsoni tõbe põdevatel haigetel võib Olazax sümptomeid halvendada.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olazax dose
Estonian: • Karbamasepiini (epilepsiavastane ja meeleolu stabiliseeriv ravim), fluvoksamiini (antidepressant) või tsiprofloksatsiini (antibiootikum) - võib olla on vaja teie Olazax annust korrigeerida.
English: What OLAZAX is and what it is used for
Estonian: Mis ravim on Olazax ja milleks seda kasutatakse
English: Olazax tablets are for oral use.
Estonian: Olazax kaetud tabletid on suukaudseks kasutamiseks.
English: You should take your Olazax tablets once a day following the advice of your doctor.
Estonian: Te peate Olazax tablette võtma üks kord ööpäevas, vastavalt raviarsti õpetusele.
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Estonian: 16 Prolaktiini sisalduse suurenemist plasmas registreeriti 47,4 %-l noorukieas patsientidel.
English: 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Estonian: 1 Kliiniliselt olulist kehakaalu tõusu täheldati kõigis esialgse kehamassi indeksi (KMI) kategooriates.
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during shortterm clinical trials in adolescent patients.
Estonian: Järgnev tabel loetleb kõrvaltoimed, mida on noorte patsientide (vanuses13-17 aastat) seas täheldatud suurema sagedusega kui täiskasvanute seas või kõrvaltoimed, mis on registreeritud ainult noorukitega läbiviidud lühiajalistest uuringutest.
English: It is important that you carry on taking Olazax for as long as your doctor tells you.
Estonian: Tähtis on, et jätkaksite tablettide võtmist niikaua, kui arst seda nõuab.
English: How to take Olazax
Estonian: Kuidas võtta Olazax`t
English: Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Estonian: Skisofreenia: Olansapiini soovituslik algannus on 10 mg/ööpäevas.
English: Do not take Olazax - If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Estonian: • Kui olete olansapiini või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: Olazax, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28 or 56 tablets
Estonian: Olazax 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg on saadaval alumiiniumfooliumist blistrites, milles on 28 & 56 tabletti
English: PHARMACEUTICAL FORM AND CONTENTS Tablet
Estonian: RAVIMVORM JA PAKENDI SUURUS Tablett
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Estonian: Ärge kasutage seda ravimit Olazax'i pärast kõlblikkusaega, mis on märgitud karbil ja blistril.
English: Do not drink any alcohol if you have been given Olazax as together with alcohol it may make you feel drowsy.
Estonian: Kui olete manustanud Olazax't, siis ärge jooge mingeid alkohoolseid jooke, kuna Olazax ja alkohol koos võivad tekitada unisust.
English: The following symptoms may occur in newborn babies, of mothers that have used OLAZAX in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Estonian: Vastsündinutel, kelle emad on raseduse viimasel trimestril (raseduse kolme viimase kuu jooksul) kasutanud Olazax't, võib esineda järgmisi sümptomeid: värisemine, lihasjäikus ja/või nõrkus, unisus, rahutus, hingamisraskus ja raskused toitmisel.
English: Olazax has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Estonian: On teada, et Olazax hoiab ära nende sümptomite taastekke bipolaarse meeleoluhäirega patsientidel, kellel maania episoodid on allunud olansapiin-ravile.
English: If you suddenly stop taking Olazax, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Estonian: Kui Te lõpetate Olazax võtmise järsku, võivad ilmneda sellised sümptomid nagu higistamine, võimatus magada, värinad, ärevus või iiveldus ja oksendamine.
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 01/10,000), not known (cannot be estimated from the data available).
Estonian: Esinemissagedused on loetletud järgmiselt: Väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10000 kuni < 1/1000), väga harv (< 1/10000) ja pole teada (ei ole võimalik hinnata olemasolevate andmete põhjal).
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α 1 adrenergic; and histamine H1 receptors.
Estonian: Prekliinilistes uuringutes on olansapiinil ilmnenud hulk afiinsusi (Ki; < 100 nM) - serotoniini 5 HT2A/2C-, 5 HT3-, 5 HT6-, dopamiini D1-, D2-, D3-, D4-, D5-, koliinergiliste muskariini M1-M5, 1adrenergiliste ja histamiini H1-retseptorite suhtes.
English: Olazax 5 mg tablets Olazax 7.5 mg tablets Olazax 10 mg tablets Olazax 15 mg tablets Olazax 20 mg tablets Olanzapine
Estonian: Olazax 5 mg tabletid Olazax 7,5 mg tabletid Olazax 10 mg tabletid Olazax 15 mg tabletid Olazax 20 mg tabletid
English: Neuroleptic malignant syndrome (see section 4.4)12
Estonian: Maliigne neuroleptikumisünd -room (vt lõik 4.4)12
English: Olazax contains the active substance olanzapine.
Estonian: Olazax sisaldab toimeainet olansapiini.
English: There is a risk of feeling drowsy when you are given Olazax.
Estonian: Olazax kasutamise ajal võite end uimasena tunda.
English: (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l
Estonian: (≥ 1,467 mmol/l) ja esialgse piiripealse tühja kõhu triglütseriidide taseme (≥ 1,016 mmol/l< 1,467 mmol/l) muutumist kõrgeks (≥ 1,467 mmol/l).
English: In the offspring of rats given olanzapine, delays in foetall development and transient decreases in offspring activity levels were seen.
Estonian: Olansapiini saanud rottide järglaskonnas on täheldatud loote arengu peetust ning järglaste aktiivsusetaseme ajutist langust.
English: How to store Olazax
Estonian: KUIDAS OLAZAX'I SÄILITADA
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax.
Estonian: • Olazax't kasutavatel patsientidel on täheldatud kõrge veresuhkru ja kõrge rasva tasemeid (triglütseriidid ja kolesterool).
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olazax and regularly during treatment.
Estonian: Regulaarselt ravi ajal ning enne Olazax võtmise alustamist peaks arst peaks teie veresuhkru ja teatud rasvade tasemeid vereanalüüside teel kontrollima.
English: QTc prolongation (see section
Estonian: Bradükardia QTc intervalli pikenemine (vt lõik
English: If this happens after you have been given Olazax, tell your doctor.
Estonian: Kui teil seesugused nähud pärast Olazax manustamist esinevad, rääkige sellest raviarstile.
English: Olazax tablet contains aspartame, which is a source of phenylalanine.
Estonian: Olazax sisaldab Aspartaam Olazax sisaldab fenüülalaniini allikat.
English: What Olazax contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Estonian: Üks tablett sisaldab 5 mg, 7,5 mg, 10 mg, 15 mg või 20 mg olansapiini - Abiained on mannitool (E421), mikrokristalne tselluloos, aspartaam (E951), krospovidoon,
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton.
Estonian: Alumiinium/alumiinium blistrid karpides, mis sisaldavad 28 & 56 tabletti.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Estonian: Olansapiini korral esines suurem in vitro afiinsus serotoniini 5HT2 kui dopamiini D2-retseptorite suhtes ja suurem 5HT2- kui D2-aktiivsus in vivo.
English: • Weight gain has been seen in patients taking Olazax.
Estonian: • Olazax't kasutavatel patsientidel on täheldatud kaalutõusu.
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to
Estonian: Esinemissagedused on loetletud järgmiselt: Väga sage (1/10), sage ( 1/100 kuni< 1/10).
English: Store below 30°C
Estonian: Hoida temperatuuril kuni 30C
English: Thromboembo lism (including pulmonary embolism and deep vein thrombosis) (see section
Estonian: Trombemboolia (sh kopsuarteri emboolia ja süvaveenide tromboos) (vt lõik
English: This leaflet was last revised in {month/YYYY}.
Estonian: Infoleht on viimati uuendatud
English: Elevated triglyceride levels2,5
Estonian: Triglütseriidide sisalduse tõus2,5 Glükosuuria Söögiisu suurenemine
English: Olazax 7.5 mg tablets
Estonian: Olazax 7,5 mg tabletid
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use.
Estonian: MANUSTAMISVIIS JA -TEE Enne ravimi kasutamist lugege pakendi infolehte Suukaudne.
English: dyskinesia11
Estonian: Ülitundlikkus11
English: Talk to your doctor or pharmacist before you take OLAZAX.
Estonian: Enne Olazax võtmist pidage nõu oma arsti või apteekriga.
English: Only take other medicines while you are on Olazax if your doctor tells you that you can. You might feel drowsy if Olazax is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Estonian: Kui olete manustanud Olazax't koos antidepressantidega või ärevust vähendavate ja und soodustavate ravimitega (trankvillisaatoritega), võite ennast unisena tunda.
English: Olazax 7.5 mg: yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Estonian: Olazax 7,5 mg: kollast värvi ringikujulised lamedad kaldservaga tabletid, mille ühele küljele on pressitud „C”.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor sideeffects.
Estonian: Psühhoosivastast aktiivsust näitavas testis vähendas olansapiin tingitud vältimisreaktsiooni katalepsiat tekitavatest annustest väiksemates annustes, mis osutab motoorsetele kõrvaltoimetele.
English: Reversible neutropenia, thrombocytopenia, or anaemiaa developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Estonian: Vähestel koertel, keda raviti annustega 8 või 10 mg/kehakaalu kg/ööpäevas (tsirkuleeriva olansapiini koguhulk [AUC] on 12 kuni 15 korda suurem kui inimesel, kes on saanud 12 mg annuse), arenesid neutropeenia, trombotsütopeenia või aneemia, mis olid mööduvad.
English: Consult your doctor if your symptoms return but do not stop taking Olazax unless your doctor tells you to.
Estonian: Olazax ööpäevane annus on 5 mg ja 20 mg. Sümptomite taastumisel konsulteerige arstiga, kuid ärge katkestage Olazax kasutamist ilma arsti korralduseta.
English: Olazax 20 mg tablets
Estonian: Olazax 20 mg tabletid
English: High Gamma Glutamyltransferase10
Estonian: Kreatiinfosfokinaasi aktiivsuse tõus11 Suurenenud gamma glutamüültransferaas i hulk10
English: Discontinuation of treatment
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: Olazax 5mg is supplied as a yellow coloured circular flat beveled edge tablet with ‘B' debossed on one side.
Estonian: Olazax 5 mg on saadaval kollast värvi ringikujuliste lamedate kaldservaga tablettidena, mille ühele küljele on pressitud „B”.
English: High creatine phosphokinase11
Estonian: Kõhuseina pingsus9 Pankreatiit11
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAVAD TOOTJAD
English: NAME OF THE MEDICINAL PRODUCT Olazax 7.5 mg tablets
Estonian: RAVIMPREPARAADI NIMETUS Olazax 7,5 mg tabletid
English: ss legs syndrome
Estonian: Rahutute jalgade sündroom
English: Postural hypotension
Estonian: Ortostaatiline hüpotensioon1
English: You should swallow the Olazax X tablets whole, with water.
Estonian: Olazax tablett tuleb tervelt alla neelata ning juua peale vett.
English: Olazax 20 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
Estonian: Olazax 20 mg: kollast värvi ringikujulised lamedad kaldservaga tabletid, mille ühele küljele on pressitud „OL” ja teisele küljele on pressitud „F”.
English: Neuroleptic Malignant Syndrome (NMS)
Estonian: Teadmata nismi haaravate sümptomitega (DRESSsündroom)
English: Olazax 15 mg tablets
Estonian: Olazax 15 mg tabletid
English: Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Estonian: Kollast värvi ringikujulised lamedad kaldservaga tabletid, mille ühele küljele on pressitud „C”.
English: Olazax 5 mg tablets
Estonian: Olazax 5 mg tabletid
English: Olazax 10 mg tablets
Estonian: Olazax 10 mg tabletid
English: MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
Estonian: MÜÜGILOA HOIDJA Glenmark Pharmaceuticals s.r.o.
English: Olazax 15 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Estonian: Olazax 15 mg: kollast värvi ringikujulised lamedad kaldservaga tabletid, mille ühele küljele on pressitud „OL” ja teisele küljele on pressitud „E”.
English: Keep this medicine out of sight and reach of children.
Estonian: Hoidke sedamravimit laste eest varjatud ja kättesaamatus kohas.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/004
Estonian: MÜÜGILOA NUMBER EU/1/09/597/004
English: Each tablet contains 7.5 mg olanzapine.
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 7,5 mg olansapiini.
English: crospovidone, magnesium stearate
Estonian: Kusepidamatus, kusepeetus
English: NAME OF THE MEDICINAL PRODUCT Olazax 20 mg tablets
Estonian: RAVIMPREPARAADI NIMETUS Olazax 20 mg tabletid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/005
Estonian: MÜÜGILOA NUMBER EU/1/09/597/005
English: Excipient with known effect: Each tablet contains 0.23 mg aspartame For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 0,23 mg aspartaami Abiainete täielik loetelu vt lõik 6.1.
English: Olazax 10 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Estonian: Olazax 10 mg: kollast värvi ringikujulised lamedad kaldservaga tabletid, mille ühele küljele on pressitud „OL” ja teisele küljele on pressitud „D”.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
Estonian: MÜÜGILOA HOIDJA NIMI Glenmark Pharmaceuticals s.r.o.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga tablett sisaldab 5 mg olansapiini.
English: Excipient with known effect: Each tablet contains 0.46 mg aspartame For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 0,46 mg aspartaami Abiainete täielik loetelu vt lõik 6.1.
English: NAME OF THE MEDICINAL PRODUCT Olazax 5 mg tablets
Estonian: RAVIMPREPARAADI NIMETUS Olazax 5 mg tabletid
English: Excipient with known effect: Each tablet contains 0.35 mg aspartame For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 0,35 mg aspartaami Abiainete täielik loetelu vt lõik 6.1.
English: NAME OF THE MEDICINAL PRODUCT Olazax 10 mg tablets
Estonian: RAVIMPREPARAADI NIMETUS Olazax 10 mg tabletid
English: NAME OF THE MEDICINAL PRODUCT Olazax 15 mg tablets
Estonian: RAVIMPREPARAADI NIMETUS Olazax 15 mg tabletid
English: Excipient with known effect: Each tablet contains 0.69 mg aspartame For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 0,69 mg aspartaami Abiainete täielik loetelu vt lõik 6.1.
English: Dysarthria Stuttering11Restle
Estonian: Tardiivdüskineesia1
English: Tardive Dyskinesia
Estonian: Seedetrakti häired
English: 13Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Estonian: (kg) väga sage (40,6 %), ≥ 15 % esialgsest kehakaalust oli sage (7,1 %) ja ≥ 25 % oli aeg-ajalt (2,5 %).
English: categories.
Estonian: D.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Estonian: Ravimilööve koos eosinofiilia ja kogu orga
English: Name and address of the manufacturer responsible for batch release
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg olanzapine Excipient with known effect: Each tablet contains 0.92 mg aspartame For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 0,92 mg aspartaami Abiainete täielik loetelu vt lõik 6.1.
English: EU/1/09/597/008
Estonian: EU/1/09/597/003 EU/1/09/597/008
English: These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Estonian: Ravim võib olla neile kahjulik, isegi kui haigusnähud on sarnased.
English: (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Estonian: Esialgse piiripealse tühja kõhu üldkolesterooli taseme (≥ 5,17...< 6,2 mmol/l) muutumine kõrgeks (≥ 6,2 mmol/l) oli väga sage.
English: EU/1/09/597/006
Estonian: EU/1/09/597/001 EU/1/09/597/006
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Estonian: 6.6 Erihoiatused ravimi hävitamiseks
English: Your doctor will urgently review your treatment.
Estonian: Teie arst vaatab teie ravi viivitamatult üle.
English: • For migraine prevention (in countries where this use is authorised)
Estonian: • migreeni ennetamine (riikides, kus see kasutus on heaks kiidetud):
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Estonian: Valproaati sisaldavad ravimid on riiklike menetluste kaudu heaks kiidetud kõigis Euroopa Liidu liikmesriikides ning Norras ja Islandil.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel.
Estonian: Neid turustatakse mitme kaubamärgi all, sh: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil ja Valhel.
English: * The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Estonian: * Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm
English: The warnings aim to ensure that patients are aware of the risks and that they take valproate only when clearly necessary.
Estonian: Hoiatuste eesmärk on tagada, et patsiendid tunneksid riske ja manustaksid valproaati ainult ilmse vajaduse korral.
English: The review of valproate medicines started in October 2013 at the request of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Article 31 of Directive 2001/83/EC, following the publication of new data on the risks of malformations and developmental problems in babies exposed to valproate in the womb.
Estonian: Valproaati sisaldavate ravimite läbivaatamine algas 2013. aasta oktoobris Ühendkuningriigi ravimiameti taotlusel direktiivi 2001/83/EÜ artikli 31 alusel pärast uute andmete avaldamist väärarengute ja arenguprobleemide riskide kohta üsasiseselt valproaadiga kokkupuutunud imikutel.
English: • If you can become pregnant, you should use an effective method of contraception.
Estonian: • Kui olete fertiilses eas, peaksite kasutama efektiivset rasestumisvastast meetodit.