FrancophonIA/ELRC3.0 huggingface dataset:
English: Prophylactic use of Pedea in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased incidence of renal failure and pulmonary adverse events including hypoxia, pulmonary hypertension, pulmonary haemorrhage, as compared to curative use.
Estonian: Pedea profülaktilist kasutamist enne 28. rasedusnädalat sündinud enneaegsetel vastsündinutel 3 esimesel elupäeval (alustades 6 tunni jooksul alates sünnist) seostati neerupuudulikkuse ja pulmonaalsete kõrvaltoimete, sealhulgas hüpoksia, pulmonaalse hüpertensiooni, pulmonaalse verejooksu sageduse suurenemisega võrreldes raviotstarbelise kasutamisega.
English: Ibuprofen may increase the risk of bleeding.
Estonian: Ibuprofeen võib suurendada veritsemise riski.
English: Although a great variability is observed in the premature population, peak plasma concentrations are measured around 35-40 mg/l after the initial loading dose of 10 mg/kg as well as after the last maintenance dose, whatever gestational and postnatal age.
Estonian: Kuigi enneaegsete populatsioon on väga varieeruv, on ükskõik millisel rasedusnädalal sündinud ja ükskõik millise sünnijärgse vanusega imikute maksimaalsed plasmakontsentratsioonid pärast algset 10 mg/kg annust ja pärast viimast säilitusannust ligikaudu 35...40 mg/l.
English: After first opening of an ampoule any unused portions must be discarded.
Estonian: Pärast ampulli esmakordset avamist tuleb järelejäänud kasutamata osa kõrvaldada.
English: Solution for injection 4 x 2 ml ampoules
Estonian: Süstelahus 4 x 2 ml ampulli
English: Excipients: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, water for injections.
Estonian: Abiained: trometamool, naatriumkloriid, naatriumhüdroksiid, vesinikkloriidhape 25%, süstevesi.
English: The medical term for this condition is ‘patent ductus arteriosus', i.e. an open ductus arteriosus.
Estonian: Seda seisundit nimetatakse avatud arterioosjuhaks.
English: - Your baby may develop some bleeding from the intestines and the kidneys.
Estonian: - Imikul võib tekkida verejooks sooltest ja neerudest.
English: As ibuprofen may decrease the clearance of aminoglycosides, strict surveillance of their serum levels is recommended during co-administration with ibuprofen.
Estonian: Kuna ibuprofeen võib vähendada aminoglükosiidide kliirensit, on ravimi manustamisel koos ibuprofeeniga soovitatav rangelt jälgida nende taset seerumis.
English: Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.
Estonian: Pedea 5 mg/ml süstelahus on saadaval pappkarbis, mis sisaldab nelja 2 ml ampulli.
English: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Estonian: Hemodünaamiliselt olulise avatud arterioosjuha ravi enne 34. rasedusnädalat sündinud enneaegsetel vastsündinutel.
English: As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection.
Estonian: Ibuprofeen kui mittesteroidne põletikuvastane ravim (MSPVA) võib infektsiooni tavalisi nähte ja sümptomeid varjata.
English: Common: - Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia), - Bleeding in the lung, - Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis), - Reduced volume of urine passed, blood in the urine, fluid retention
Estonian: Sage: - koljusisene verejooks (intraventrikulaarne hemorraagia) ja ajukahjustus (periventrikulaarne leukomalaatsia) - kopsuverejooks - sooleperforatsioon ja soolekoe kahjustus (nekrotiseeriv enterokoliit) - uriinikoguse vähenemine, uriini veresisaldus, vedelikupeetus
English: GLASS AMPOULE LABEL
Estonian: KLAASAMPULLI ETIKETT
English: The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered.
Estonian: Süstitava lahuse kogumahu määramisel enneaegsetele imikutele peaks arvestama päevas kokku manustatavat vedelikukogust.
English: Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.
Estonian: Prostaglandiin on kehas looduslikult sisalduv keemiline aine, mis hoiab arterioosjuha avatuna.
English: Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care professionals.
Estonian: Pedea'd antakse teie imikule ainult spetsiaalses vastsündinute intensiivravi osakonnas, kvalifitseeritud meditsiinispetsialisti poolt.
English: Very Common: Blood creatinine increased, Blood sodium decreased
Estonian: Väga sage: vere kreatiniini sisalduse tõus, vere naatriumi sisalduse langus
English: In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within one hour of the first infusion and was reversed within 30 min after start of inhaled nitric oxide therapy.
Estonian: Nimelt esines kolmel imikul ühe tunni jooksul alates esimesest infusioonist raske hüpokseemia koos pulmonaalse hüpertensiooniga, mis taandus 30 minuti jooksul alates lämmastikoksiidi inhaleerimisega ravi alustamisest.
English: Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity.
Estonian: Ibuprofeen on mittesteroidne põletikuvastane ravim, millel on põletikuvastane, valuvaigistav ja antipüreetiline toime.
English: How to store Pedea
Estonian: Kuidas Pedea'd säilitada
English: Not known: - Perforation of the stomach
Estonian: Teadmata: - maoperforatsioon
English: This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Estonian: Seda ravimit ei tohi segada teiste ravimitega, välja arvatud naatriumkloriidi 9 mg/ml (0,9%) süstelahus või glükoosi 50 mg/ml (5%) süstelahus.
English: HOW PEDEA IS USED
Estonian: KUIDAS PEDEA'D KASUTADA
English: Very common: Bronchopulmonary dysplasia* Common: Pulmonary haemorrhage Uncommon: Hypoxemia*
Estonian: Väga sage: bronhopulmonaalne düsplaasia* Sage: kopsuverejooks
English: Each ml contains 5 mg ibuprofen Each ampoule of 2 ml contains 10 mg ibuprofen
Estonian: Üks ml sisaldab 5 mg ibuprofeeni Üks 2 ml ampull sisaldab 10 mg ibuprofeeni
English: OUTER CARTON TEXT
Estonian: TEKST VÄLISPAKENDIL
English: Common: Oliguria, Fluid retention, Haematuria Uncommon: Acute renal failure
Estonian: Sage: oliguuria, vedelikupeetus, hematuuria Aeg-ajalt: äge neerupuudulikkus.
English: - corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding.
Estonian: - kortikosteroidid: ibuprofeen võib suurendada mao-sooletrakti verejooksude riski.
English: Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%), solution for injection.
Estonian: Enne ja pärast Pedea manustamist tuleb vältida kokkupuudet happeliste lahustega ja loputada infusioonisüsteemi 15 minuti jooksul 1,5 kuni 2 ml naatriumkloriidi 9 mg/ml (0,9%) või glükoosi 50 mg/ml (5%) süstelahusega.
English: Uncommon: - Acute failure of the kidney's functions - Bleeding in the intestine - Below normal oxygen content in the arterial blood (hypoxemia)
Estonian: Aeg-ajalt: - äge neerufunktsiooni puudulikkus - sooleverejooks - arteriaalse vere normaalsest madalam hapnikusisaldus (hüpokseemia)
English: BEFORE PEDEA IS ADMINISTERED TO YOUR BABY
Estonian: MIDA ON VAJA TEADA ENNE PEDEA MANUSTAMIST TEIE IMIKULE
English: In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Estonian: Vältimaks pH taseme olulist varieerumist infusioonisüsteemi jäänud happeliste ravimite jääkide toimel, tuleb viimast enne ja pärast iga toote manustamist loputada 1,5 kuni 2 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahusega või glükoosi 50 mg/ml (5%) süstelahusega.
English: If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.
Estonian: Kui arterioosjuha ei sulgu ka pärast teist ravikuuri, võib pakkuda operatsiooni võimalust.
English: Pedea 5 mg/ml solution for injection
Estonian: Pedea 5 mg/ml süstelahus
English: In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha. Low levels were sustained up to 72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were observed at 72 hours after only 1 dose of ibuprofen.
Estonian: Enneaegsetel vastsündinutel vähendas ibuprofeen oluliselt prostaglandiinide ja nende metaboliitide, eriti PGE2 ja 6-keto-PGF-1-alfa kontsentratsioone plasmas.
English: Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Estonian: Seevastu seostati Pedea profülaktilise kasutamisega vastsündinute III-IV astme intraventrikulaarse verejooksu ja kirurgilise ligeerimise sageduse vähenemist.
English: Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Estonian: Trometamool, naatriumkloriid, naatriumhüdroksiid (pH taseme reguleerimiseks), vesinikkloriidhape 25% (pH taseme reguleerimiseks), süstevesi.
English: - The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.
Estonian: - Abiained on trometamool, naatriumkloriid, naatriumhüdroksiid (pH taseme reguleerimiseks), vesinikkloriidhape 25% (pH taseme reguleerimiseks) ja süstevesi.
English: If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.
Estonian: Kui seisund ei muutu ka pärast teist ravikuuri, võib osutuda vajalikuks avatud arterioosjuha opereerida.
English: Each ml contains 5 mg ibuprofen.
Estonian: Iga ml sisaldab 5 mg ibuprofeeni.
English: Careful monitoring of both renal and gastrointestinal function is recommended.
Estonian: Nagu muudegi mittesteroidsete põletikuvastaste ravimite puhul, on soovitatav hoolikalt jälgida nii neerude kui ka mao-sooletrakti funktsiooni.
English: If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Estonian: Vajaduse korral võib süstitava vedeliku mahtu suurendada naatriumkloriidi 9 mg/ml (0,9%) süstelahusega või glükoosi 50 mg/ml (5%) süstelahusega.
English: Each ampoule of 2 ml contains 10 mg ibuprofen.
Estonian: Iga 2 ml ampull sisaldab 10 mg ibuprofeeni.
English: Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Estonian: Ravi Pedea'ga peaks toimuma ainult vastsündinute intensiivravi osakonnas kogenud neonatoloogi järelevalve all.
English: Pedea 5 mg/ml solution for injection Ibuprofen
Estonian: Pedea 5 mg/ml süstelahus Ibuprofeen
English: Ibuprofen may increase the anti-clotting effect of this product.
Estonian: Ibuprofeen võib ravimi hüübimisvastast toimet võimendada.
English: A course of therapy is defined as three intravenous injections of Pedea given at 24-hour intervals.
Estonian: Ravikuur koosneb Pedea kolmest intravenoossest annusest, mida manustatakse 24-tunniste intervallidega.
English: Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Estonian: Ravi Pedea'ga peab toimuma ainult vastsündinute intensiivravi osakonnas kogenud neonatoloogi järelevalve all.
English: Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
Estonian: Süstitava vedeliku koguse reguleerimiseks kasutage ainult naatriumkloriidi 9 mg/ml (0,9%) süstelahust või glükoosi 50 mg/ml (5%) lahust.
English: See leaflet
Estonian: II LISA
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux France
Estonian: Müügiloa hoidja Recordati Rare Diseases Immeuble „Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Prantsusmaa
English: Each ml of the solution contains 5 mg ibuprofen.
Estonian: Iga ml lahust sisaldab 5 mg ibuprofeeni.
English: rd injections: 5 mg/kg.
Estonian: Ibuprofeeni annust korrigeeritakse kehakaalu suhtes järgmiselt: - I süst: 10 mg/kg, - II ja III süst: 5 mg/kg.
English: While a baby is inside its mother's womb it does not need to use its lungs.
Estonian: Emaüsas ei pea loode oma kopse kasutama.
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France
Estonian: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Prantsusmaa
English: Recordati Rare Diseases Tel: +33 1 47 73 64 58 Franza
Estonian: Recordati Rare Diseases Tel: +33 1 47 73 64 58
English: Posology
Estonian: Lisainfo
English: Uncommon: Gastrointestinal haemorrhage Unknown: Gastric perforation
Estonian: Sage: nekrotiseeriv enterokoliit, sooleperforatsioon Aeg-ajalt: mao-sooletrakti verejooks Teadmata: maoperforatsioon
English: Renal and urinary disorders
Estonian: Neerude ja kuseteede häired
English: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux France
Estonian: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F-92800 Puteaux - Prantsusmaa
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France or
Estonian: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F-92800 Puteaux Prantsusmaa või
English: Ref. EMEA/307582/2009 EMEA/H/C/895
Estonian: London, 29. mai 2009 Viide: EMEA/307582/2009 EMEA/H/C/895
English: What is Lunivia?
Estonian: Mis on Lunivia?
English: The company presented the results of eight main studies involving over 4,000 adults to support its application.
Estonian: Taotluse toetuseks esitas ettevõte kaheksa põhiuuringu (üle 4000 täiskasvanud patsienti) tulemused.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete ravimi kliinilises uuringus ja vajate oma ravi kohta lisateavet, pöörduge palun teile ravimi määranud arsti poole.
English: The company withdrew before the European Commission had issued a decision on this opinion.
Estonian: Ettevõte võttis taotluse tagasi enne Euroopa Komisjoniotsust käesoleva arvamuse kohta.
English: The CHMP had no major concerns and the application could have been approved.
Estonian: Inimravimite komitee ei näinud olulisi põhjuseid ettevaatlikkuseks ja taotluse oleks võinud heaks kiita.
English: Zopiclone has been available in the European Union (EU) as a treatment for insomnia since the mid-1980s.
Estonian: Sopiklooni on Euroopa Liidus kasutatud unetuse raviks alates 1980. aastate keskelt.
English: As a consequence, Lunivia would not have been able to benefit from 10 years of ‘market exclusivity'.
Estonian: Selle tulemusena ei saa Lunivia 10-aastast ainuõigust turul.
English: The evaluation had finished and the CHMP had given a positive opinion.
Estonian: Hindamine oli lõppenud ja inimravimite komitee oli andnud positiivse arvamuse.
English: However, the Committee had also concluded that eszopiclone could not be considered to be a new active substance.
Estonian: Lisaks otsustas komitee, et essopiklooni ei saa pidada uuenduslikuks toimeaineks.
English: The letter from the company notifying the Agency of the withdrawal of the application is available here.
Estonian: Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud siin.
English: The studies looked at ‘transient' insomnia (in this case, insomnia caused by spending a night in an unfamiliar setting), at primary insomnia (insomnia with no other cause) and at insomnia caused by other conditions (major depression, generalised anxiety disorder, the menopause and rheumatoid arthritis).
Estonian: Uuringutes vaadeldi ajutist unetust (unetuse põhjustas magamine võõras ümbruses), primaarset unetust (unetusel puudus muu põhjus) ning muudest haigustest põhjustatud unetust (raske depressioon, generaliseerunud ärevushäire, menopaus ja reumatoidartriit).
English: Although it is chemically different from the benzodiazepines, eszopiclone acts on the same receptors in the brain.
Estonian: Essopikloon erineb keemiliselt bensodiasepiinidest, kuid avaldab ajus toimet samadele retseptoritele.
English: The main measures of effectiveness were how long it took for the patients to fall asleep or how long the patients were awake during the night after first falling asleep.
Estonian: Efektiivsuse põhinäitajaks oli patsientidel uinumiseks kulunud aeg või pärast uinumist öise ärkveloleku aeg.
English: On 13 May 2009, Sepracor Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lunivia, for the treatment of insomnia.
Estonian: 13. mail 2009 teatas ettevõte Sepracor Ltd. ametlikult inimravimite komiteele, et soovib tagasi võtta unetuse raviks ette nähtud ravimi Lunivia müügiloa taotluse.
English: This is the period during which other companies would have been prevented from marketing ‘generic medicines' of Lunivia (medicines that contain the same active substance at the same dose as Lunivia and that are used for the same conditions).
Estonian: See on ajavahemik, mille jooksul teistel ettevõtetel ei oleks olnud võimalik turustada Lunivia geneerilisi ravimeid (samas annuses sama toimeainet sisaldavaid ravimeid, mida kasutatakse samade haiguste raviks).
English: How does Lunivia work?
Estonian: Kuidas Lunivia toimib?
English: All of the studies compared Lunivia with placebo (a dummy treatment).
Estonian: Kõikides uuringutes võrreldi Luniviat platseeboga (näiv ravim).
English: It activates receptors in the brain called gamma-aminobutyric acid A (GABA-A) receptors, which are involved in bringing about sleep.
Estonian: See aktiveerib organismis gamma-aminovõihappe A-retseptorid (GABA-A), mis aitavad kaasa uinumisele.
English: Based on the review of the data and the company's response to the CHMP's lists of questions, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Lunivia for the treatment of insomnia.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, oli komitee andnud taotluse tagasivõtmise ajal positiivse arvamuse ning soovitas anda Luniviale unetusravis kasutamiseks müügiloa.
English: It is a purified form of one of the two ‘enantiomers' (mirror-image forms) of the substance zopiclone.
Estonian: See on puhastatud sopiklooni üks kahest enantiomeerist (molekulistruktuur, mis on teise peegelpilt).
English: Lunivia was expected to be used to treat adults with insomnia, including difficulty falling asleep, waking up during the night and waking up early, usually for short periods.
Estonian: Luniviat kavatseti kasutada täiskasvanute unetuse, sealhulgas uinumisraskuste, öiste ärkamiste ja varase ärkamise lühiajaliseks raviks.
English: Lunivia is a medicine that contains the active substance eszopiclone.
Estonian: Lunivia on ravim, mis sisaldab toimeainena essopiklooni.
English: By activating these receptors, eszopiclone can help patients with insomnia to sleep.
Estonian: Nende retseptorite aktiveerimine essopiklooni toimel aitab patsientidel uinuda.
English: Questions and answers on the withdrawal of the marketing authorisation application for Lunivia eszopiclone
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Lunivia essopikloon
English: What are the consequences of the withdrawal for patients in clinical trials using Lunivia?
Estonian: Kuidas mõjutab tagasivõtmine praegu Luniviaga kliinilistes uuringutes osalevaid patsiente?
English: The active substance in Lunivia, eszopiclone, belongs to a group of medicines that are related to the benzodiazepines.
Estonian: Lunivias toimeainena sisalduv essopikloon kuulub bensodiasepiinidega seotud ravimite rühma.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Lunivia.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Lunivia kliinilistes uuringutes osalevaid patsiente tagasivõtmine ei mõjuta.
English: The effects of Lunivia were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Lunivia toimet muude katsetega.
English: What was Lunivia expected to be used for?
Estonian: Milleks kavatseti Luniviat kasutada?
English: The company had requested a re-examination of the CHMP's opinion, but after re-examining the opinion, the Committee had confirmed its earlier opinion.
Estonian: Komitee vaatas arvamuse uuesti läbi ning kinnitas oma varasemat arvamust.
English: Whereas:
Estonian: Võttes arvesse, et:
English: B-2321 Hoogstraten Belgium
Estonian: B-2321 Hoogstraten Belgia
English: Indirect or additional benefits
Estonian: Kaudne või täiendav kasulikkus
English: The warnings in the product literature remain appropriate.
Estonian: Ravimiteabes toodud hoiatused on asjakohased.
English: Marketing authorisation granted
Estonian: Müügiluba antud
English: Florgane 300 mg/ml suspension for injection has been authorised for use in cattle as a hybrid of Nuflor 300 mg/ml solution for injection using the decentralised procedure with Germany as a reference Member State and Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain and the United Kingdom as concerned Member States.
Estonian: Florgane 300 mg/ml süstesuspensioon kiideti veistel kasutamiseks heaks Nuflor 300 mg/ml süstelahuse hübriidtaotlusena detsentraliseeritud menetluse kaudu, kus viiteliikmesriik oli Saksamaa ning asjaomased liikmesriigid Austria, Belgia, Bulgaaria, Tšehhi Vabariik, Taani, Prantsusmaa, Kreeka, Ungari, Iirimaa, Itaalia, Leedu, Luksemburg, Madalmaad, Poola, Portugali, Rumeenia, Slovakkia, Hispaania ja Ühendkuningriik.
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Estonian: Täiendavaid riskijuhtimis- või vähendamismeetmeid ei ole selle esildismenetluse järgi vaja võtta.
English: Risk management or mitigation measures
Estonian: Riskijuhtimis- või vähendamismeetmed
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Estonian: Veterinaarravimi nimetuste, ravimvormide, tugevuste, loomaliikide, manustamisteede ja müügiloa taotlejate loetelu liikmesriikides
English: • the data package submitted by the applicant is considered sufficient taking into account the nature of this application for an extension of the marketing authorisation (hybrid application);
Estonian: • müügiloa taotleja esitatud andmete pakett on piisav, võttes arvesse, et see on olemasoleva müügiloa laiendamise taotlus (hübriidtaotlus);
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Estonian: Esitatud andmete alusel tegi veterinaarravimite komitee Saksamaa tõstatud küsimuste kohta alltoodud järeldused.
English: The product is presented in four multidose vial sizes of 50 ml, 100 ml, 250 ml and 500ml.
Estonian: Veterinaarravim on mitmeannuselistes viaalides neljas suuruses: 50 ml, 100 ml, 250 ml ja 500 ml.