FrancophonIA/ELRC3.0 huggingface dataset:
English: Infection (G3/4: 3.6%)
Estonian: aste: 4,6%)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Estonian: ÄRGE KASUTAGE koos selle ravimiga (DOCETAXEL KABI 80 mg/4 ml infusioonilahuse kontsentraat, mille pakend sisaldab ainult 1 viaali) teisi dotsetakseeli sisaldavaid ravimeid, mille pakendis on 2 viaali (kontsentraat ja lahusti).
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Estonian: Dotsetakseeliga ravitud patsientidel on teatatud tsüstilisest maakula ödeemist.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/770/003
English: Nausea (G3/4: 3.3%);
Estonian: aste: 3,3%);
English: DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
Estonian: DOCETAXEL KABI 80 mg/4 ml INFUSIOONILAHUSE KONTSENTRAADI KASUTUSJUHIS
English: This regimen is administered every 3 weeks for 4 cycles.
Estonian: Seda raviskeemi korratakse 3-nädalaste vahedega 3 tsüklit.
English: Pharyngolaryngeal pain (G3/4: 2%)
Estonian: Ninaverejooks (3./4.
English: DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
Estonian: RAVIMPREPARAADI NIMETUS DOCETAXEL KABI 180 mg/9 ml infusioonilahuse kontsentraat docetaxelum
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Estonian: Pakendi infoleht: teave kasutajale DOCETAXEL KABI 80 mg/4 ml infusioonilahuse kontsentraat Docetaxelum
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Estonian: aste: 3,6%); Vedelikupeetus (3./4.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/770/002
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).
Estonian: - pneumoonia (kopsupõletik) - kopsufibroos (kopsukoe armistumine ja tihkestumine koos õhupuudusega), - hägune nägemine, mis on tingitud reetina tursest silmas (tsüstiline maakula ödeem), - naatriumi, kaaliumi, magneesiumi ja/või kaltsiumi sisalduse vähenemine teie veres
English: What you need to know before you use DOCETAXEL KABI 3.
Estonian: 1. Mis ravim on DOCETAXEL KABI ja milleks seda kasutatakse 2. Mida on vaja teada enne DOCETAXEL KABI kasutamist 3.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 120 mg/6 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Estonian: Pakendi infoleht: teave kasutajale DOCETAXEL KABI 120 mg/6 ml infusioonilahuse kontsentraat Docetaxelum
English: (95% CI) ***p-value
Estonian: (95% CI) *p-väärtus Keskmine PFS (kuud) (95% CI)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/770/001
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Estonian: Pakendi infoleht: teave kasutajale DOCETAXEL KABI 160 mg/8 ml infusioonilahuse kontsentraat Docetaxelum
English: Hearing impaired (G3/4: 0%)
Estonian: Nahakahjustus (3./4.
English: Skin and subcutaneous Alopecia (G3/4:4.0%)
Estonian: Alopeetsia; Nahareaktsioon (3./4.
English: DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Estonian: DOCETAXEL KABI 20 mg/1 ml INFUSIOONILAHUSE KONTSENTRAADI KASUTUSJUHIS
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4: 20.7%); Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4: 12.0%);
Estonian: Selles uuringus esines AT harus võrreldes AC omaga enam rasket neutropeeniat (90% vs 68,6%), febriilset neutropeeniat (33,3% vs 10%), infektsioone (8% vs 2,4%), diarröad (7,5% vs 1,4%), asteeniat (8,5% vs 2,4%) ja valu (2,8% vs 0%).
English: Median overall survival (months) (95% CI)
Estonian: Elulemuse mediaan kuudes (95% CI)
English: DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Estonian: DOCETAXEL KABI kombinatsioonis tsisplatiini ja 5-fluorouratsiiliga on näidustatud mao metastaatilise adenokartsinoomi, k.a.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 180 mg/9 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Estonian: Pakendi infoleht: teave kasutajale DOCETAXEL KABI 180 mg/9 ml infusioonilahuse kontsentraat Docetaxelum
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with capecitabine
Estonian: Kõrvaltoimete tabel rinnanäärmevähi kombinatsioonravi korral DOCETAXEL KABI-ga annuses 75 mg/m2 ja kapetsitabiiniga
English: Weight increased (G3/4: 0%);
Estonian: Suurenenud pisaraeritus (3./4.
English: Infection (G3/4: 3.3%)
Estonian: Infektsioon (3./4.
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Estonian: aste: 0,8%); Diarröa (3./4.
English: Nausea (G3/4: 9.6%);
Estonian: aste: 3,9%);
English: Alopecia (G3/4: 4.0%); Rash pruritic
Estonian: aste: 1%); Isutus
English: Anaemia (G3/4: 3%); Neutropenia (G3/4: 59.2%);
Estonian: aste: 20,9%); Neutropeenia (3./4.
English: Thrombocytopenia (G3/4: 3%)
Estonian: Trombotsütopeenia (3./4.
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Estonian: Rinnanäärmevähi kõrvaltoimete valikuline kirjeldus DOCETAXEL KABI 100 mg/m² monoteraapia korral
English: The severity of adverse events of DOCETAXEL KABI may be increased when DOCETAXEL KABI is given in combination with other chemotherapeutic agents.
Estonian: DOCETAXEL KABI manustamisel kombinatsioonis teiste kemoterapeutiliste ravimitega võivad kõrvaltoimed olla tõsisemad.
English: Constipation (G3/4: 1.0%);
Estonian: aste: 1,0%);
English: Cough (G3/4: 0%)
Estonian: Ödeem (3./4.
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Estonian: 10 aasta üldine elulemus TAC ravihaaras oli oluliselt tõusnud, võrreldes FAC ravihaaraga (vastavalt 76% vs 69%), st surmariski absoluutne vähenemine 7% võrra (p = 0,002).Lümfisõlmede haaratuse astme 4+ korral ei olnud haigusevaba elulemuse (DFS) ja üldise elulemuse (OS) puhul täheldatud kasu statistiliselt oluline, mistõttu jäi TAC kasu/riski positiivne suhe lümfisõlmede haaratuse astme 4+ korral lõppanalüüsis täielikult tõestamata.
English: Nausea (G3/4: 6%);
Estonian: aste: 6%);
English: Vomiting (G3/4: 4%); Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Estonian: aste (G3/4), 4. raskusaste = 4. aste (G4)) COSTART ja MedDRA termineid.
English: Arrhythmia (G3/4: 1.0%)
Estonian: Artralgia (3./4.
English: Abdominal pain
Estonian: Avamata viaal
English: The amended information to doctors and patients is available here.
Estonian: Parandatud teave arstidele ja patsientidele on siin
English: What is Meronem?
Estonian: Mis on Meronem?
English: Also, not all Member States had authorised the medicine for use in children.
Estonian: Samuti ei ole kõik liikmesriigid kiitnud heaks ravimi kasutamist lastel.
English: Ref. EMEA/CHMP/466849/2009 EMEA/H/A-30/1003
Estonian: London, 19.oktoober 2009 Viide: EMEA/714039/2009 EMEA/H/A-30/1003
English: Why was Meronem reviewed?
Estonian: Miks Meronemi taotlus uuesti üle vaadati?
English: 23 July 2009
Estonian: 23.juuli 2009
English: Meronem and associated names are authorised in the EU via national procedures.
Estonian: Meronem ja sarnased ninmetused on Euroopa Liidus heaks kiidetud riiklike menetluste kaudu.
English: The review was carried out under an ‘Article 30' referral1.
Estonian: Taotlus vaadati läbi artikli 301 kohase esildismenetluse korras.
English: The European Medicines Agency has completed a review of Meronem and associated names.
Estonian: Euroopa Ravimiamet on lõpetanud Meronemi ja sarnaste nimetuste kohta tehtud taotluse läbivaatamise.
English: Company responses provided on: 26 January 2009 Opinion date:
Estonian: Ettevõtte vastuste laekumise kuupäe 26. jaanuar 2009, 25. mai 2009, 3. juuli 2009 Arvamuse esitamise kuupäev:
English: The active substance in Meronem, meropenem, is an antibiotic that belongs to the group ‘carbapenems'.
Estonian: Meronemi toimeaine meropeneem on karbapeneemide rühma kuuluv antibiootikum.
English: It is also available in the EU under the trade names Optinem and Merrem.
Estonian: Seda turustatakse Euroopa Liidus ka nimetuste all Optinem ja Merrem.
English: The new wording mentions that medicines containing valproic acid should be avoided when taking Meronem.
Estonian: Uus sõnastus hoiatab, et valproehappe kasutamist tuleb Meronemiga ravi ajal vältida.
English: On 1 October 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Meronem and associated names in the EU.
Estonian: 1. oktoobril 2008 tegi Euroopa Komisjon inimravimite komiteele esildise Meronemi ja sarnaste nimetuste müügilubade ühtlustamiseks Euroopa Liidus.
English: Because the recommended dose for both adults and children differed among Member States, the CHMP recommended harmonised dosage schedules:
Estonian: Et täiskasvanute ja laste soovituslik annus on liikmesriikides erinev soovitas inimravimite komitee ühtlustada annustamise järgmiselt:
English: The CHMP agreed on the following diseases for which the medicine may be used:
Estonian: Inimravimite komitee otsustas, et ravimit kasutatakse järgmiste haiguste korral:
English: Meronem may also be used in patients with neutropenic fever (fever associated with low levels of neutrophils, a type of white blood cell) that is suspected to be caused by bacterial infection.
Estonian: Meronemi võib samuti kasutada patsientidel, kellel on neutropeeniline palavik (valgeliblede vähesusega kaasnev palavik), mille on oletatavasti tekitanud bakteriaalne infektsioon.
English: At the start of the referral, some of the indications such as skin and skin tissue infections and urinary tract infections or infections of the female reproductive system were not approved in all Member States.
Estonian: Esildise alguses olevad näidustused, nagu naha- ja nahakoe infektsioonid, kuseteede infektsioonid või naiste reproduktiivsüsteemi infektsioonid ei ole heaks kiidetud kõikides liikmesriikides.
English: • broncho-pulmonary infections in patients with cystic fibrosis;
Estonian: • bronhopulmonaalsed infektsioonid tsüstilise fibroosi korral;
English: The Committee also harmonised the SPC section on interactions with other medicines.
Estonian: Komitee ühtlustas samuti ravimi omaduste kokkuvõtte jaotise “Koostoimed teiste ravimitega”.
English: The CHMP harmonised the SPC section on special warnings and retained warnings about convulsions and hepatic reactions.
Estonian: Inimravimite komitee ühtlustas ravimi omaduste kokkuvõtte erihoiatuste lõigu ning jättis samaks hoiatused krampide ja maksareaktsioonide esinemise kohta.
English: The company that markets Meronem is AstraZeneca.
Estonian: Ravimit turustab ettevõte AstraZeneca.
English: • for broncho-pulmonary infections in cystic fibrosis and acute bacterial meningitis, the CHMP recommended a dose of 2 g every eight hours in adults and children weighing over 50 kg, and 40 mg/kg every eight hours in children aged from three months to 11 years and those weighing less than 50 kg.
Estonian: • tsüstilise fibroosi korral esinevate bronhopulmonaalsete infektsioonide ja ägeda bakteriaalse meningiidi ravis soovitas inimravimite komitee kasutada täiskasvanutel ja üle 50 kg kaaluvatel lastel 2 g iga kaheksa tunni järel ning vähemalt 3-kuulistel kuni 11-aastastel ja alla 50 kg kaaluvatel lastel 40 mg/kg iga kaheksa tunni järel.
English: It contains the active substance meropenem.
Estonian: Ravim sisaldab toimeainena meropeneemi.
English: Meronem is a powder that is made up into a solution for injection or infusion.
Estonian: Meronem on pulber, millest valmistatakse süste- või infusioonilahus.
English: Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g
Estonian: Teave järgmise ravimi esildise kohta: Meronem ja sarnased nimetused meropeneem, pulber süste- või infusioonilahuse valmistamiseks 500 mg ja 1 g
English: • for pneumonia, complicated urinary tract infections, complicated intra-abdominal infections, intraand post-partum infections and complicated skin and soft tissue infections, the recommended dose in adults and children weighing more than 50 kg should 500 mg or 1 g every eight hours, while children aged from three months to 11 years and those weighing less than 50 kg should be given 10 or 20 mg/kg every eight hours.
Estonian: • Kopsupõletiku, tüsistunud kuseteede infektsioonide, tüsistunud intraabdominaalsete infektsioonide, sünnitusaegsete ja -järgsete infektsioonide ning tüsistunud naha- ja pehmekoe infektsioonide ravis on soovitatav annus täiskasvanutel ja üle 50 kg kaaluvatel lastel 500 mg või 1 g iga kaheksa tunni järel.
English: At the start of the referral, some Member States did not include hypersensitivity (allergy) to carbapenems, penicillins or other beta-lactam antibiotics as contra-indications (situations where the medicine must not be used) and some Member States included hypersensitivity to excipients (other ingredients in the medicine).
Estonian: Esildismenetluse alguses ei lisanud osad liikmesriigid vastunäidustustesse ülitundlikkust (allergilisust) karbapeneemide, pentsilliinide või muude beetalaktaam-antibiootikumide suhtes ning mõned liikmesriigid lisasid ülitundlikkuse abiainete suhtes.
English: This has led to divergences across member states in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Estonian: Sel põhjusel ravimi kasutamisviisid eri liikmesriikides ei ühti: riikides, kus ravim on müügil, on ravimi omaduste kokkuvõte, pakendimärgistus ja pakendi infoleht erinev.
English: • complicated skin and soft tissue infections;
Estonian: • naha ja pehmekoe tüsistunud infektsioonid
English: The Committee noted that for most indications Meronem should be used for children above three months of age, but that doctors should retain the option of treating younger children.
Estonian: • äge bakteriaalne meningiit (pea- ja seljaaju kelmete põletik) Komitee märkis, et Meronemi võib kasutada ka vähemalt 3-kuulistel lastel enamiku näidustuste korral, kuid arstid ei tohiks noorematele lastele seda ravimit määrata.
English: Co-rapporteur(s):
Estonian: Kaasettekandja:
English: Meronem is used to treat various bacterial infections including infections of the lungs, urinary tract (structures that carry urine), the abdomen, skin, the female reproductive system and brain.
Estonian: Meronemi kasutatakse sealhulgas kopsude, kuseteede, kõhuõõne, naha-, naiste reproduktiivsüsteemi ja aju bakteriaalsete infektsioonide raviks.
English: The Committee recommended that Meronem should not be used in patients who are hypersensitive to any carbapenem medicine or in patients who have severe hypersensitivity to any type of beta-lactam anti-bacterial medicines such as penicillins or cephalosporins.
Estonian: Inimravimite komitee kiitis heaks vastunäidustuste ühtlustatud nimekirja: Inimravimite komitee leidis, et Meronemi ei tohi kasutada patsientidel, kes on mis tahes karbapeneemi ravimite suhte ülitundlikud ega patsientidel, kellel on raske ülitundlikkus mis tahes beetalaktaamravimite (nt penitsilliinid või tsefalosporiinid) suhtes.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Meronem and associated names in the European Union (EU).
Estonian: Inimravimite komitee otsustas, et Euroopa Liidus on vaja ühtlustada Meronemi määramisega seotud teave.
English: • intra- and post-partum infections (infections during and after childbirth);
Estonian: • sünnitusaegsed ja -järgsed infektsioonid;
English: • complicated urinary tract infections;
Estonian: • kõhuõõne tüsistunud infektsioonid;
English: Meronem has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordinatsioonirühm nimetas Meronemi ühtlustamist vajavaks ravimiks.
English: • complicated infections in the abdomen;
Estonian: • kuseteede tüsistunud infektsioonid;
English: This summary was last updated in 07-2009.
Estonian: Kokkuvõtte viimane uuendus: 07-2009.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries); The medicine can only be obtained with a prescription.
Estonian: • perifeersete arterite haigusega (arteriverevoolu probleemiga) patsiendid; Seda ravimit saab üksnes retsepti alusel.
English: clopidogrel EPAR summary for the public
Estonian: klopidogreel Kokkuvõte üldsusele
English: The standard dose of Clopidogrel Acino Pharma GmbH is one 75 mg tablet once a day, taken with or without food.
Estonian: Clopidogrel Acino Pharma GmbH tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
English: This means that Clopidogrel Acino Pharma GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel Acino Pharma GmbH on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino Pharma GmbH to Acino Pharma GmbH on 21 September 2009.
Estonian: Muu teave Clopidogrel Acino Pharma GmbH kohta Euroopa Komisjon andis Clopidogrel Acino Pharma GmbH müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Acino Pharma GmbH 21. septembril 2009.
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Clopidogrel Acino Pharma GmbH on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma GmbH has been shown to have comparable quality and to be bioequivalent to Plavix.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel Acino Pharma GmbH võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
English: Clopidogrel Acino Pharma GmbH can be given to the following groups of patients:
Estonian: Clopidogrel Acino Pharma GmbH-d võib kasutada järgmiste patsiendirühmade korral:
English: Clopidogrel Acino Pharma GmbH can be started between seven days and six
Estonian: Clopidogrel Acino Pharma GmbH manustamist võib alustada seitsme päeva kuni kuue kuu jooksul pärast insulti;
English: Clopidogrel Acino Pharma GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Clopidogrel Acino Pharma GmbH-d kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: The Committee recommended that Clopidogrel Acino Pharma GmbH be given marketing authorisation.
Estonian: Komitee soovitas anda Clopidogrel Acino Pharma GmbH-le müügiloa.
English: Clopidogrel Acino Pharma GmbH is a medicine that contains the active substance clopidogrel.
Estonian: Clopidogrel Acino Pharma GmbH on ravim, mis sisaldab toimeainena klopidogreeli.
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Estonian: Et Clopidogrel Acino Pharma GmbH on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Clopidogrel Acino Pharma GmbH bioekvivalentsust võrdlusravimiga Plavix.
English: The full EPAR for Clopidogrel Acino Pharma GmbH can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Clopidogrel Acino Pharma GmbH kohta leiate siit.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Plavixi korral, ületab Clopidogrel Acino Pharma GmbH kasulikkus sellega kaasnevad riskid.
English: Clopidogrel Acino Pharma GmbH is a ‘generic medicine'.
Estonian: Clopidogrel Acino Pharma GmbH on geneeriline ravim.
English: GmbH can be started between a few days and 35 days after the attack;
Estonian: Clopidogrel Acino Pharma GmbH manustamist võib alustada mõne kuni 35 päeva jooksul pärast infarkti;
English: What is Clopidogrel Acino Pharma GmbH?
Estonian: Mis on Clopidogrel Acino Pharma GmbH?
English: Why has Clopidogrel Acino Pharma GmbH been approved?
Estonian: Miks Clopidogrel Acino Pharma GmbH heaks kiideti?
English: How has Clopidogrel Acino Pharma GmbH been studied?
Estonian: Kuidas Clopidogrel Acino Pharma GmbH-d uuriti?
English: How does Clopidogrel Acino Pharma GmbH work?
Estonian: Kuidas Clopidogrel Acino Pharma GmbH toimib?
English: What is Clopidogrel Acino Pharma GmbH used for?
Estonian: Milleks Clopidogrel Acino Pharma GmbH-d kasutatakse?
English: How is Clopidogrel Acino Pharma GmbH used?
Estonian: Kuidas Clopidogrel Acino Pharma GmbH-d kasutatakse?
English: The active substance in Clopidogrel Acino Pharma GmbH, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Clopidogrel Acino Pharma GmbH toimeaine klopidogreel on trombotsüütide agregatsiooni (vereliistakute kokkukleepumise) inhibiitor, mis aitab ennetada organismis trombide tekkimist.
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Estonian: • inimravimite komitee arutas määruse (EÜ) nr 1234/2008 artikli 13 lõike 2 kohast esildist;
English: On the basis of the questions raised by the Netherlands the points to be considered by the CHMP were:
Estonian: Madalmaade tõstatatud küsimuste alusel vaatles inimravimite komitee järgmisi küsimusi.
English: The MU Opiate Receptor Knock-out Mouse Shows Increased Sensitivity to Pain, Increased Motor Activity During the Sleep Period and Decreased Serum Iron Parallel to Human Restless Legs Syndrome.
Estonian: 2 Walters AS et al. The MU Opiate Receptor Knock-out Mouse Shows Increased Sensitivity to Pain, Increased Motor Activity During the Sleep Period and Decreased Serum Iron Parallel to Human Restless Legs Syndrome.
English: As the reference and concerned member states were not able to reach an agreement in respect of the variation, on 2 May 2014, Germany triggered a referral under Article 13(2) of Regulation EC No
Estonian: Et viiteliikmesriik ja asjaomased liikmesriigid ei jõudnud muudatuse osas kokkuleppele, algatas Saksamaa 2. mail 2014 määruse (EÜ) nr 1234/2008 artikli 13 lõike 2 kohase esildise.
English: Overall summary of the scientific evaluation of Oxynal and Targin and associated names (see Annex I)
Estonian: Oxynali ja Targini ja sarnaste nimetuste (vt I lisa) teadusliku hindamise üldkokkuvõte Taustteave
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Estonian: II lisa Teaduslikud järeldused ja müügiloa tingimuste muutmise alused
English: Therefore, further justification that the different criteria for approval on the basis of one pivotal trial should be provided by the applicant.
Estonian: Seepärast peab taotleja esitama lisatõendeid selle kohta, et ühe keskse katse põhjal on heakskiitmise eri kriteeriumid täidetud.
English: There is a lack of confirmatory evidence regarding the maintenance of efficacy and the long-term safety, which has not been provided by the open-label extension study phase, due to its methodological limitations.
Estonian: Puuduvad efektiivsuse säilimist ja pikaajalist ohutust kinnitavad tõendid, mida ei leitud uuringu avatud jätkufaasis selle metodoloogiliste piirangute tõttu.