natgillin/translations-raw huggingface dataset:
How is Avandia used? 
Kuidas Avandiat kasutatakse?
Avandia can also be used with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy'). 
Avandiat võib kasutada koos metformiini ja sulfonüüluureaga patsientidel, kelle haigus ei allu piisavalt suukaudsele ravile kahe preparaadiga (ravi kolme preparaadiga).
How has Avandia been studied? 
Kuidas Avandiat uuriti?
Avandia is used in adults who have type 2 diabetes, particularly those wh addition to diet and exercise. 
Avandiat kasutatakse eelkõige ülekaaluliste täiskasvanud patsientide II tüüpi diabeedi (suhkurtõve) raviks.
Avandia, rosiglitazone, makes cells and this helps to control type 2 diabetes. 
Selle tulemusel väheneb vere glõkoosisisaldus, aidates sel viisil reguleerida II tüüpi suhkurtõbe.
It has also been studied in metformin, a sulphonylurea, or both metformin and a sulphonylurea. 
Avandiat uuriti patsientidel, kes juba kasutasid metformiini, teatud sulfonüüluurearavimit või mõlemaid koos.
Avandia, used on its own, has been compared with placebo (a dummy treatment), metformin and patients who were already using es measured the level of an indication of how ontrolled. 
Avandiat ainsa ravimina võrreldi platseeboga (näiv ravim), metformiini ja glibenklamiidiga (teatud sulfonüüluurearavim).
The full EPAR for Avandia can be found here 
Euroopa avaliku hindamisaruande täistekst Avandia kohta on siin.
If Avandia is used in combination with other antidiabetes medicines, other this can lead to heart und the body). 
Avandia kasutamisel teiste diabeediravimitega võivad esineda ka teised kõrvalnähud.
glibenclamide (a sulphonylurea). 
Avandia rosiglitasoon
Ref.: EMEA/717671/2009 EMEA/H/C/1093 
Viide: EMEA/711407/2009 EMEA/H/C/1093
Irbesartan Teva irbesartan 
Irbesartan Teva irbesartaan
It is available as white tablets (75, 150 and 300 mg). 
Seda turustatakse valgete tablettidena (75, 150 või 300 mg).
Irbesartan Teva is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group. 
Irbesartan Tevat ei soovitata kasutada alla 18 aasta vanustel patsientidel, sest ohutuse ja efektiivsuse andmed selle vanuserühma kohta puuduvad.
Irbesartan Teva is taken by mouth, with or without food. 
Irbesartan Tevat manustatakse suu kaudu, koos toiduga või ilma.
The usual recommended dose is 150 mg once a day. 
Tavaline soovituslik annus on 150 mg üks kord ööpäevas.
A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age. 
Algannust 75 mg võib kasutada hemodialüüsi (teatud verepuhastustehnika) saavatel patsientidel või üle 75-aastastel patsientidel.
If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. 
Kui see ei anna vererõhu alandamisel piisavat tulemust, võib annust suurendada kuni 300 mg-ni ööpäevas või kasutada lisaks muid kõrgvererõhuravimeid, nt hüdroklorotiasiidi.
The Committee recommended that Irbesartan Teva be given marketing authorisation. 
Komitee soovitas anda Irbesartan Tevale müügiloa.
What is Irbesartan Teva? 
Mis on Irbesartan Teva?
Irbesartan Teva is a ‘generic medicine'. 
Irbesartan Teva on geneeriline ravim.
This means that Irbesartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel. 
See tähendab, et Irbesartan Teva on sarnane võrdlusravimiga Aprovel, millel juba on Euroopa Liidus müügiluba.
Irbesartan Teva is a medicine that contains the active substance irbesartan. 
Irbesartan Teva on ravim, mis sisaldab toimeainena irbesartaani.
The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Teva to Teva Pharma B.V. on 30 October 2009. 
Euroopa Komisjon andis Irbesartan Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Teva Pharma B.V.
Irbesartan Teva is used in patients who have essential hypertension (high blood pressure). 
Irbesartan Tevat kasutatakse patsientidel, kellel on essentsiaalne hüpertensioon (kõrgvererõhutõbi).
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan Teva has been shown to have comparable quality and to be bioequivalent to Aprovel. 
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Irbesartan Teva võrdväärne kvaliteet ja bioekvivalentsus ravimiga Aprovel.
The active substance in Irbesartan Teva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Irbesartan Teva toimeaine irbesartaan on angiotensiin II retseptori antagonist, mis blokeerib organismi hormooni angiotensiin II toime.
Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). 
Irbesartan Tevat kasutatakse ka neeruhaiguste raviks hüpertensiooniga ja II tüüpi diabeediga (insuliinisõltumatu suhkurtõvega) patsientidel.
Because Irbesartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine. 
Et Irbesartan Teva on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
The full EPAR for Irbesartan Teva can be found here. 
Euroopa avaliku hindamisaruande täisteksti Irbesartan Teva kohta leiate siit.
Why has Irbesartan Teva been approved? 
Miks Irbesartan Teva heaks kiideti?
In patients with hypertension and type 2 diabetes, Irbesartan Teva is added to other treatments for hypertension. 
Kõrgvererõhuga ja II tüüpi diabeediga patsientidel kasutatakse Irbesartan Tevat lisaks teistele kõrgvererõhu ravimitele.
Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk. 
Seetõttu arvas inimravimite komitee, et nagu ka Aproveli korral, ületab Irbesartan Teva kasulikkus sellega kaasnevad riskid.
Other information about Irbesartan Teva: 
Muu teave Irbesartan Teva kohta
Because Irbesartan Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel. 
Et Irbesartan Teva on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Irbesartan Teva bioekvivalentsust võrdlusravimiga Aprovel.
What are the benefit and risk of Irbesartan Teva? 
Milles seisneb Irbesartan Teva kasulikkus ja mis riskid ravimiga kaasnevad?
How has Irbesartan Teva been studied? 
Kuidas Irbesartan Tevat uuriti?
How does Irbesartan Teva work? 
Kuidas Irbesartan Teva toimib?
How is Irbesartan Teva used? 
Kuidas Irbesartan Tevat kasutatakse?
What is Irbesartan Teva used for? 
Milleks Irbesartan Tevat kasutatakse?
This summary was last updated in 06-2012. 
Kokkuvõtte viimane uuendus: 06-2012.
It can be taken at any time of day. 
Ravimit tohib võtta mis tahes kellaajal.
Fablyn lasofoxifene 
Fablyn lasofoksifeen
The full EPAR for Fablyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Euroopa avaliku hindamisaruande täistekst Fablyni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Fablyn on 24 February 2009. 
Euroopa Komisjon andis Fablyni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 24. veebruaril
Also, results with the 250-microgram dose were pointing to 500 micrograms being more effective. 
Samuti näitas 250 µg annuse kasutamine, et 500 µg annus on efektiivsem.
The recommended dose of Fablyn is one tablet once a day. 
Fablyni soovitatav annus on üks tablett üks kord ööpäevas.
What measures are being taken to ensure the safe use of Fablyn? 
Mis meetmeid võetakse, et tagada Fablyni kasutamise ohutus?
The main measure of effectiveness was the number of women who had a new fracture in the spine as seen on X-rays. 
Efektiivsuse põhinäitaja oli nende naiste arv, kellel tekkis uus röntgenipildil nähtav lülisambamurd.
The CHMP decided that Fablyn's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Inimravimite komitee otsustas, et Fablyni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
This is a summary of the European public assessment report (EPAR) for Fablyn. 
See on ravimi Fablyn Euroopa avaliku hindamisaruande kokkuvõte.
Other information about Fablyn 
Muu teave Fablyni kohta
The study also looked at existing spine fractures that got worse, new fractures in other parts of the body and the density of bones throughout the body. 
Uuringus vaadeldi ka juba olemasolevaid ja süvenevaid lülisambamurde, muid uusi luumurde ja luude tihedust kogu organismis.
It must not be used in women with unexplained bleeding from the womb. 
Ravimit ei tohi kasutada emaka seletamatu veritsuse korral.
Fablyn is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant, or women who are pregnant or breastfeeding. 
Fablyni tohib kasutada ainult menopausijärgses eas naistel ning seda ei tohi kasutada rasestuda võivatel naistel, rasedatel ega imetavatel naistel.
The programme will include information about the risk of venous thromboembolism, changes in the womb that may occur when taking the medicine, and the need to investigate unexplained bleeding from the womb. 
Programm sisaldab teavet veenide trombemboolia riski ja ravimi kasutamisel emakas toimuvate muutuste kohta ning teavitab vajadusest uurida emaka seletamatut verejooksu.
The company that makes Fablyn will make sure that an educational programme is available in all Member States for all healthcare workers who will prescribe Fablyn or order pelvic ultrasound scans for women taking the medicine. 
Fablyni tootja tagab koolitusprogrammi liikmesriikide tervishoiutöötajatele, kes kirjutavad välja Fablyni või määravad seda ravimit võtvatele naistele ultraheliuuringuid.
For more information about treatment with Fablyn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate Fablyniga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
Fablyn is a medicine that contains the active substance lasofoxifene. 
Fablyn on ravim, mis sisaldab toimeainena lasofoksifeeni.
Fablyn was more effective than placebo at reducing the number of new fractures. 
Fablyn oli uute luumurdude arvu vähendamisel efektiivsem kui platseebo.
The most common side effect with Fablyn (seen in more than 1 patient in 10) is muscle cramps. 
Fablyni kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on lihaskrambid.
When deciding whether to prescribe Fablyn or other treatments, doctors should consider whether the patient has any symptoms of the menopause, and the possible effects of treatment on the womb, the breast, and the heart and blood vessels. 
Fablyni ravi eelistamisel muule ravile peab arst hindama menopausi sümptomite olemasolu ning ravi võimalikku mõju emakale, rindadele, südamele ja veresoontele.
It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye). 
Seda ei tohi kasutada patsiendid, kellel on veenide trombemboolia, sealhulgas süvaveenitromboos, kopsuemboolia (trombid kopsudes) või silma võrkkesta tromboos.
Fablyn must not be used in people who are hypersensitive (allergic) to lasofoxifene or any of the other ingredients. 
Fablyni ei tohi kasutada patsiendid, kes on lasofoksifeeni või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
Fablyn has been shown to reduce fractures in the spine and elsewhere in the body, but not in the hip. 
On tõestatud, et Fablyn vähendab lülisambamurde ja muid luumurde, kuid mitte puusamurde.
Fablyn did not reduce the number of hip fractures to a level that would be relevant for patients. 
Fablyn ei vähendanud puusamurdude arvu patsientide jaoks olulisel määral.
Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744). 
Viie aasta jooksul tekkis uus lülisambamurd 6%-l naistest (155 naist 2748-st), kes said 500 µg Fablyni.
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 Fablyn. 
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
What is Fablyn? 
Mis on Fablyn?
For the full list of all side effects reported with Fablyn, see the package leaflet. 
Fablyni kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
The active substance in Fablyn, lasofoxifene, is a selective oestrogen receptor modulator (SERM). 
Fablyni toimeaine lasofoksifeen on selektiivne östrogeeni retseptori modulaator (SERM).
What is the risk associated with Fablyn? 
Mis riskid Fablyniga kaasnevad?
Fablyn should be used with caution in women with severe liver or kidney problems. 
Fablyni kasutamisel raskete maksa- või neeruprobleemidega naistel peab olema ettevaatlik.
Why has Fablyn been approved? 
Miks Fablyn heaks kiideti?
Fewer women taking the higher dose had a fracture outside the spine and there were greater increases in bone density. 
Suurema annuse manustanud naistel oli vähem lülisambaväliseid luumurde ja nende luutihedus suurenes rohkem.
Lasofoxifene has the same effect as oestrogen in the bone. 
Lasofoksifeen toimib luudele samamoodi kui östrogeen.
Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Fablyn is intended for long-term use. 
Kui patsient ei saa toidust piisavalt kaltsiumi ja D-vitamiini, tuleb võtta täiendavalt neid sisaldavaid valmistisi.
The effects of Fablyn were first tested in experimental models before being studied in humans. 
Enne inimuuringuid kontrolliti Fablyni toimet muude katsetega.
Two doses of Fablyn (250 and 500 micrograms once a day) have been compared with placebo (a dummy treatment) in one main study involving almost 9,000 postmenopausal women with osteoporosis aged 60 to 80 years. 
Ühes uuringus, milles osales ligikaudu 9000 osteoporoosiga menupausijärgses eas naist vanuses 6080, võrreldi Fablyni kaht annust (250 ja 500 µg) platseeboga (näiva ravimiga).
Lasofoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. 
Lasofoksifeen toimib teatud organismi kudedes östrogeeniretseptori agonistina (stimuleerib seda retseptorit).
Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who have been through the menopause). 
Fablyni kasutatakse menopausijärgses eas naistel osteoporoosi (luu-urbnemuse) raviks.
How does Fablyn work? 
Kuidas Fablyn toimib?
How is Fablyn used? 
Kuidas Fablyni kasutatakse?
What is Fablyn used for? 
Milleks Fablyni kasutatakse?
How has Fablyn been studied? 
Kuidas Fablyni uuriti?
What benefit has Fablyn shown during the studies? 
Milles seisneb uuringute põhjal Fablyni kasulikkus?
SI-1000 Ljubljana SLOVENIA 
SI-1000 Ljubljana SLOVEENIA
A-1140 Wien AUSTRIA 
A-1140 Wien
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States 
I lisa Ravimi nimetuste, ravimvormide, tugevuste, manustamisviiside ja müügiloa hoidjate loetelu liikmesriikides
A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA 
A. Goštauto g. 40A, LT-01112 Vilnius, LEEDU
GlaxoSmithKline Oy P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND 
GlaxoSmithKline Oy P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, SOOME
Middlesex UB6 0NN UNITED KINGDOM 
Middlesex UB6 0NN ÜHENDKUNINGRIIK
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic 
GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava
GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA 
GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408
GlaxoSmithKline Latvia SIA,Bruņinieku 5, Rīga, LV-1001 
GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 LÄTI
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND 
GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IIRIMAA
Granules for Suspension 
Suspensiooni graanulid
GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13 1332 Genval BELGIUM 
Rue du Tilleul 13 1332 Genval BELGIA
GlaxoSmithKline S.p.A.Via A. Fleming, 237135 Verona ITALY 
- Via A. Fleming, 237135 Verona
Sweden 
ROOTSI
Malesci Istituto Farmacobiologico S.p.A Via Lungo l'Ema 7, 50012 Bagno A Ripoli Firenze 
Via Lungo l´Erna 7, 50012 Bagno A Ripoli Firenze
980 Great West Road Brentford, Middlesex, TW8 9GS 
Brentford, Middlesex, TW8 9GS
C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN 
C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) HISPAANIA
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN 
Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) HISPAANIA
Zinnat 250 mg apvalkotās tabletes 250mg Film-coated Tablets 
Zinnat 250 mg apvalkotās tabletes 250mg
Zinnat 500 mg apvalkotās tabletes 500mg Film-coated Tablets 
Zinnat 500 mg apvalkotās tabletes 500mg
Wellcome Farmacéutica, S.A. .- Parque Tecnológico de MadridC/Severo Ochoa, 2 28760 Tres Cantos (Madrid) 
Wellcome Farmacéutica, S.A. .- Parque Tecnológico de MadridC/Severo Ochoa, 2 28760 Tres Cantos (Madrid) HISPAANIA
GlaxoSmithKline Export Ltd 
GlaxoSmithKline Export Ltd 980 Great West Road
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN 
Glaxo Group Ltd., Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN ÜHENDKUNINGRIIK
Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM 
Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, ÜHENDKUNINGRIIK
Granules 
graanulid
Wellcome Farmacéutica, S.A. 
Malesci Instituto Farmacobiologico S.p.A.
Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, 
Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, ÜHENDKUNINGRIIK
Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN 
Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN ÜHENDKUNINGRIIK
250mg 
Oraxim 250mg
Laboratoire 
Õhukese
Glaxo Wellcome House Berkeley avenue Greenford, Middlesex United Kingdom UB6 0NN 
Glaxo Wellcome UK Limited Glaxo Wellcome House Berkeley avenue Greenford, Middlesex ÜHENDKUNINGRIIK UB6 0NN
GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) 
Wellcome Farmacéutica, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) HISPAANIA
Ref. EMA/562492/2010 Rev. EMEA/H/A-31/968 
London, 14. juuni 2010 Viide: EMA/562492/2010 Rev. EMEA/H/A-31/968
What are the recommendations for patients? 
Millised on soovitused patsientidele?
1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest. 
1 Muudetud direktiivi 2001/83/EÜ artikkel 31 - esildis ühenduse huvidest lähtuvalt.
However, there were insufficient data on their effectiveness. 
Sellegipoolest ei olnud andmed nende ravimite efektiivsuse kohta piisavad.
Because of this, a number of Member States have carried out safety reviews of this combination, but these have led to different conclusions. 
Sel põhjusel on mitu liikmesriiki hinnanud kõnealuse kombinatsiooni ohutust ent nende hindamiste tulemused on erinevad.
In the United Kingdom and Sweden, the marketing authorisations for these medicines were withdrawn from 2005. 
Ühendkuningriigis ja Rootsis võeti nende ravimite müügiload tagasi 2005. aastal.
Quite often, the patients had taken medicines prescribed for someone else. 
Väga sageli olid patsiendid võtnud kellelegi teisele välja kirjutatud ravimeid.
Medicines containing dextropropoxyphene on its own are authorised in 10 Member States (Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden) and medicines containing dextropropoxyphene combined with paracetamol (sometimes with caffeine) are authorised in six Member States (Belgium, Cyprus, France, Luxembourg, Malta and Portugal) as well as Norway. 
Toimeainena ainult dekstropropoksüfeeni sisaldavatel ravimitel on praegu müügiluba kümnes Euroopa Liidu liikmesriigis (Belgia, Hispaania, Itaalia, Kreeka, Luksemburg, Madalmaad, Prantsusmaa, Rootsi, Soome ja Taani) ning dekstropropoksüfeeni ja paratsetamooli (vahel ka koos kofeiiniga) kombinatsioonravimil on müügiluba kuues liikmesriigis (Belgia, Küpros, Luksemburg, Malta, Portugal ja Prantsusmaa), samuti Norras.
The CHMP also considered the views received from patient organisations. 
Samuti võttis inimravimite komitee arvesse patsiendiorganisatsioonide seisukohti.
Proposed activities to reduce this risk, such as including further warnings or restrictions, or limiting the size of packs, were not considered to be adequate to protect public health. 
Riski vähendamiseks kavandatavaid meetmeid, nagu uued hoiatused või ravimi kasutamise piirangud või väiksemates pakendites turustamine, ei peetud rahvatervise kaitsmiseks piisavaiks.
The review was carried out under an ‘Article 31' referral1. 
Hindamine toimus artikli 31 kohase esildismenetluse korras1.
On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines. 
25. juunil 2009 lõpetas Euroopa Ravimiamet dekstropropoksüfeeni sisaldavate ravimite ohutuse ja efektiivsuse hindamise.
At the request of the marketing authorisation holders, the CHMP re-examined its opinion. 
Müügiloa hoidjate taotlusel vaatas inimravimite komitee oma arvamuse taas läbi.
What happened during the re-examination? 
Mis toimus arvamuse taasläbivaatamisel?
Dextropropoxyphene is a painkiller that is used to treat short- and long-term (chronic) pain. 
Dekstropropoksüfeen on valuvaigisti, mida kasutatakse lühi- ja pikaajalise (kroonilise) valu raviks.
It will be the responsibility of each Member State to set the timeframe for this withdrawal and assess the need for other activities such as recommendations for prescribers and patients on safe and effective pain relief. 
Iga liikmesriik otsustab ise, millal müügiload lõplikult tagasi võetakse, ning hindab muude meetmete otstarbekust, näiteks ravimeid välja kirjutavatele meditsiinitöötajatele ja patsientidele ette nähtud soovitused ohutu ja efektiivse valuravi kohta.
What were the conclusions of CHMP after the initial review? 
Mis olid inimravimite komitee järeldused pärast esialgset läbivaatamist?
Therefore, the Committee recommended that the marketing authorisations for these medicines be withdrawn across the EU. 
Seetõttu soovitas inimravimite komitee nende ravimite müügiload kogu ELis tagasi võtta.
This means that the difference between the dose needed to treat the patient and the dose that could harm the patient is small. 
See tähendab, et patsiendi raviks vajaliku annuse ja võimaliku kahjuliku toimega annuse erinevus on väike.
The CHMP noted that safety was less of a concern for the parenteral form, because these medicines are only given in a hospital setting where there is a lower risk of overdose. 
Inimravimite komitee märkis, et ohutusprobleem oli parenteraalse ravimvormi puhul väiksem, kuna neid ravimeid manustatakse ainult haiglatingimustes, mille puhul on üleannustamisrisk väiksem.