FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness was determined based on both examinations by a veterinarian and assessments by the animal's owner of some signs of osteoarthritis (such as lameness, pain or difficulty moving).
Estonian: Ravimite efektiivsust hinnati nii veterinaarse läbivaatuse kui ka selle järgi, kuidas hindas osteoartroosi mõningaid nähte (näiteks lonkamine, valu või liikumisraskus) looma omanik.
English: A second study involved dogs (various ages from four months upwards) undergoing either orthopaedic or soft tissue surgery.
Estonian: Teises uuringus osalesid koerad (eri vanuses alates 4 kuust), kellele tehti ortopeediline või pehmekudede operatsioon.
English: These field studies involved dogs of different age groups, genders and breeds.
Estonian: Uuringutes osalesid eri vanuses, soost ja tõust koerad.
English: Cimalgex is a veterinary medicine that contains cimicoxib.
Estonian: Cimalgex on veterinaarravim, mis sisaldab toimeainena tsimikoksiibi.
English: The dogs received either Cimalgex or a comparator product (carprofen).
Estonian: Koerad said Cimalgexi või võrdlusravimit (karprofeen).
English: The benefit-risk balance may be found in the Scientific Discussion part of this EPAR.
Estonian: Ravimi kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu kokkuvõttes.
English: Cimalgex has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“field studies”) in which Cimalgex was compared with other licensed veterinary NSAID medicines.
Estonian: Cimalgexi uuriti laboriloomadel ja mitmetes Euroopa veterinaariakliinikutes ja -eravastuvõttudes ravitud koertel (väliuuringud), milles seda võrreldi teiste veterinaarsete NSAID-ravimitega, millel on müügiluba.
English: The most common side effects with Cimalgex are mild and transient vomiting or diarrhoea.
Estonian: Cimalgexi kõige sagedamad kõrvalnähud on kerge ja mööduv oksendamine ja kõhulahtisus.
English: The CVMP decided that the benefits of Cimalgex are greater than its risks for the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-operative pain due to orthopaedic or soft tissue surgery, and recommended that Cimalgex be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et Cimalgexi kasulikkus osteoartroosiga seotud valu ja põletiku ning ortopeediliste ja pehmekudede operatsioonijärgse valu ravis on suurem kui kaasnevad riskid, ja soovitas anda Cimalgexi müügiloa.
English: Cimalgex must also not be used in dogs that are hypersensitive (allergic) to cimicoxib or any of the other ingredients in the tablets.
Estonian: Samuti ei tohi Cimalgexi kasutada koertel, kes on tsimikoksiibi või Cimalgexi tablettide mis tahes koostisaine suhtes ülitundlikud (allergilised).
English: People with a known hypersensitivity (allergy) to cimicoxib should avoid contact with Cimalgex tablets.
Estonian: Inimesed, kes teavad, et on tsimikoksiibi suhtes ülitundlikud (allergilised), peavad vältima kokkupuudet Cimalgexi tablettidega.
English: By blocking the production of prostaglandins, cimicoxib reduces the pain and inflammation caused by osteoarthritis or surgery on the bones or soft tissues.
Estonian: Prostaglandiinide teket blokeerides vähendab tsimikoksiib osteoartroosist või luude ja pehmekudede operatsioonist tingitud valu ja põletikku.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Estonian: See ensüüm osaleb valu- ja põletikuprotsessides osalevate ainete prostaglandiinide tekkes.
English: What is Cimalgex?
Estonian: Mis on Cimalgex?
English: For a full list of all side-effects reported with Cimalgex, see the Package Leaflet.
Estonian: Cimalgexi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Given daily, Cimalgex reduced pain and inflammation (and the signs of these, such as lameness) in dogs with chronic osteoarthritis, and was as effective as the comparator NSAID, firocoxib.
Estonian: Üks kord ööpäevas manustatuna vähendas Cimalgex kroonilise osteoartroosiga koertel valu ja põletikku (samuti nende sümptomeid, näiteks lonkamist) ning oli sama efektiivne kui võrdlusravimina kasutatud NSAID-ravim firokoksiib.
English: Cimalgex should not be used in dogs that are pregnant, breeding or lactating, or in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems.
Estonian: Cimalgexi ei tohi kasutada tiinetel, poegivatel või imetavatel koertel, mao- või sooleprobleemidega (näiteks haavandid või verejooks) koertel ega verejooksuprobleemidega koertel.
English: The active substance in Cimalgex, cimicoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Estonian: Cimalgexi toimeaine tsimikoksiib kuulub mittesteroidsete põletikuvastaste ravimite (NSAID) klassi.
English: When used for osteoarthritis, the tablets are given to the dog once a day, with or without food, at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight.
Estonian: Osteoartroosi raviks manustatakse Cimalgexi tablette üks kord ööpäevas, koos toiduga või ilma, annuses 2 mg kehakaalu kg kohta, kasutades koera kehakaalule vastavat üht või mitut tabletti.
English: Why has Cimalgex been approved?
Estonian: Miks Cimalgex heaks kiideti?
English: It is also used for the management of pain and inflammation associated with surgery to the bones or soft tissues (such as muscles).
Estonian: Samuti kasutatakse seda luude ja pehmekudede (nt lihaste) operatsiooniga seotud valu ja põletiku raviks.
English: Cimicoxib may cause skin sensitisation and people should wash their hands after handling the tablets.
Estonian: Tsimikoksiib võib põhjustada naha ülitundlikkust, mille tõttu peavad ravimit manustavad inimesed pärast Cimalgexiga kokkupuudet pesema käsi.
English: Cimalgex was also shown to be as effective as the comparator NSAID, carprofen, in the management of peri-operative pain due to orthopaedic or soft tissue surgery during the first 24 hours after surgery.
Estonian: Samuti oli Cimalgex ortopeediliste või pehmekudede operatsioonide järgse valu ravis esimese 24 tunni vältel pärast operatsiooni sama efektiivne kui NSAID-võrdlusravim karprofeen.
English: What is the risk associated with Cimalgex?
Estonian: Mis riskid Cimalgexiga kaasnevad?
English: Cimalgex is used in dogs to treat the pain and inflammation associated with osteoarthritis (a long term disease causing damage and pain in the joints).
Estonian: Cimalgexi kasutatakse osteoartroosist (pikaajaline haigus, mis põhjustab liigesekahjustusi ja -valu) tingitud valu ja põletiku raviks koertel.
English: Cimalgex cimicoxib
Estonian: Cimalgex tsimikoksiib
English: Other information about Cimalgex:
Estonian: Muu teave Cimalgexi kohta
English: Once a day the dogs were given either Cimalgex or firocoxib, a medicine authorised for use for this condition.
Estonian: Koertele anti üks kord ööpäevas kas Cimalgexi või firokoksiibi (samuti ravim, millel on kõnealuse haiguse raviks müügiluba).
English: What is Cimalgex used for?
Estonian: Milleks Cimalgexi kasutatakse?
English: How does Cimalgex work?
Estonian: Kuidas Cimalgex toimib?
English: When used with surgery, the tablets are given to the dog around two hours before the start of the operation at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight, and then once a day for the following three to seven days, based on the judgment of the veterinary surgeon.
Estonian: Operatsioonist tingitud valu ja põletiku raviks antakse Cimalgexi tabletid koerale ligikaudu 2 tundi enne operatsiooni algust annuses 2 mg kehakaalu kg kohta, kasutades koera kehakaalule vastavat üht või mitut tabletti.
English: What benefit has Cimalgex shown during the studies?
Estonian: Milles seisneb uuringute põhjal Cimalgexi kasulikkus?
English: How has Cimalgex been studied?
Estonian: Kuidas Cimalgexi uuriti?
English: According to Article 62(1) of Regulation (EC) 726/2004, such new data cannot be considered in the context of the re-examination.
Estonian: Vastavalt määruse (EÜ) 726/2004 artikli 62 lõikele 1 ei saa selliseid uusi andmeid taasläbivaatamise kontekstis kaaluda.
English: In the European Union, it was considered that this could potentially impact the marketing authorisations of a number of medicinal products.
Estonian: Euroopa Liidus võib see potentsiaalselt mõjutada mitme ravimi müügiluba.
English: Overall conclusion and benefit-risk balance
Estonian: Üldine järeldus ning kasulikkuse ja riski suhe
English: It is used to reduce cholesterol levels in patients at risk of cardiovascular disease.
Estonian: Seda kasutatakse kolesteroolisisalduse vähendamiseks kardiovaskulaarse haiguse riskiga patsientidel.
English: The inspection identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.
Estonian: Kontrollimisel tuvastati olulisi üleastumisi ja föderaalseaduste rikkumisi, sh dokumentide võltsimist ja proovidega manipuleerimist.
English: In light thereof, the CHMP therefore confirmed its previous conclusions.
Estonian: Seetõttu kinnitas inimravimite komitee oma varasemaid järeldusi.
English: The MAHs therefore stated their intention to repeat the study, with a study report expected to be available by 15th November 2012.
Estonian: Seetõttu teatasid müügiloa hoidjad oma kavatsusest uuringut korrata - uuringu aruanne valmib eelduste kohaselt 15. novembriks 2012.
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Estonian: II lisa Teaduslikud järeldused ja müügilubade peatamise alused
English: It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia.
Estonian: Seda kasutatakse üksi või koos statiinidega hüperkolesteroleemia ja hüpertriglütserideemia raviks.
English: The single pivotal bioequivalence study 10540314 using the 160 mg tablets was conducted by the Cetero Research facilities in Houston in 2005.
Estonian: Ainus oluline bioekvivalentsuse uuring 10540314, milles kasutati 160 mg tablette, viidi 2005. aastal läbi ettevõtte Cetero Research keskuses Houstonis.
English: On 01 August 2012, the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC for the identified nationally authorised products.
Estonian: 1. augustil 2012 algatas Ühendkuningriik direktiivi 2001/83/EÜ artikli 31 kohase esildise riikliku müügiloa saanud ravimite kohta.
English: Grounds for suspension of the marketing authorisations
Estonian: Müügilubade peatamise alused
English: The conditions for the lifting of the suspension of the Marketing Authorisations are set out in Annex III of the CHMP opinion.
Estonian: Müügilubade peatamise lõpetamise tingimused on inimravimite komitee arvamuse III lisas.
English: Other Cetero Research sites were not affected.
Estonian: Teisi Cetero Researchi keskusi see ei puudutanud.
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Fenofibrato Pensa and Fenofibrato Ranbaxy, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Estonian: Selle tulemusena soovitas inimravimite komitee Fenofibrato Pensa ja Fenofibrato Ranbaxy müügiload direktiivi 2001/83/EÜ artikli 116 alusel peatada, sest a. riski ja kasulikkuse suhet ei saa pidada soodsaks, b. andmeid, mis toetavad direktiivi 2001/83/EÜ artikli 10 kohast taotlust, ei saa pidada korrektseks.
English: The CHMP therefore recommended the suspension of the marketing authorisations until adequate bioequivalence data is made available.
Estonian: Seetõttu soovitas inimravimite komitee müügiload peatada, kuni on kättesaadavad piisavad bioekvivalentsuse andmed.
English: Following the adoption of the CHMP opinion during the September 2012 CHMP meeting, a request for re-examination was received from the MAH.
Estonian: Pärast arvamuse vastuvõtmist inimravimite komitee septembris 2012 peetud koosolekul saadi müügiloa hoidjalt taasläbivaatamise taotlus.
English: The CHMP was of the opinion that the previous conclusions regarding bioequivalence will need to be confirmed by repeating the bioequivalence study.
Estonian: Inimravimite komitee oli arvamusel, et varasemaid bioekvivalentsuse järeldusi on vaja kinnitada bioekvivalentsuse uuringu kordamise teel.
English: Following the assessment of the grounds for the re-examination, the CHMP noted that the results from the new bioequivalence study became available after the CHMP adopted its opinion and were therefore not available to the CHMP during its initial assessment.
Estonian: Hinnates taasläbivaatamise taotluse alust, märkis inimravimite komitee, et bioekvivalentsuse uue uuringu tulemused saadi pärast seda, kui inimravimite komitee oli vastu võtnud arvamuse, ning seega ei olnud uuring inimravimite komitee algse hinnangu andmise ajal kättesaadav.
English: The MAH submitted grounds for the re-examination, which consisted of a new bioequivalence study (study 2016_FENOF_11), carried out to replace the pivotal bioequivalence study (study 10540314), for which serious doubts were raised regarding the reliability and the correctness of the data.
Estonian: Müügiloa hoidja esitas taasläbivaatamise alusena uue bioekvivalentsuse uuringu (uuring 2016_FENOF_11), mis tehti, et asendada keskne bioekvivalentsuse uuring (uuring 10540314), mille andmete usaldusväärsus ja õigsus oli tekitanud tõsiseid kahtlusi.
English: The US Food and Drug Administration informed the European Medicines Agency that following an inspection, concerns have been raised about the conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) during the period from April 2005 to June 2010.
Estonian: USA toidu- ja ravimiamet teatas Euroopa Ravimiametile, et kontrollimisel avastati ettevõtte Cetero Research Houstoni keskuses (Texase osariik, USA) aprillist 2005 kuni juunini 2010 korraldatud bioanalüütilistes uuringutes puudusi.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy contain fenofibrate, a drug of the fibrate class.
Estonian: Fenofibrato Pensa ja Fenofibrato Ranbaxy sisaldavad fenofibraati, mis on fibraatide klassi kuuluv ravim.
English: The CHMP noted the absence of samples from the critical pivotal bioequivalence study 10540314 and that there is therefore no possibility to reanalyse the data.
Estonian: Inimravimite komitee märkis kriitilise tähtsusega bioekvivalentsuse uuringu 10540314 proovide puudumist ja et sellepärast ei ole võimalik andmeid uuesti analüüsida.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy are both available as 160mg tablets.
Estonian: Fenofibrato Pensa ja Fenofibrato Ranbaxy on mõlemad müügil 160 mg tablettidena.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Fenofibrato Pensa and Fenofibrato Ranbaxy.
Estonian: • inimravimite komitee kaalus Fenofibrato Pensa ja Fenofibrato Ranbaxy kohta direktiivi 2001/83/EÜ artikli 31 alusel algatatud menetlust;
English: The EMA, CMD(h) and CHMP initiated a process to identify and assess all medicinal product dossiers that include studies conducted at the above mentioned facility during the identified time period.
Estonian: Euroopa Ravimiamet, vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm ning inimravimite komitee algatasid menetluse, et tuvastada ja hinnata kõigi selliste ravimite toimikuid, mis sisaldavad eelnimetatud ettevõtte poolt kõnealusel ajavahemikul korraldatud uuringuid.
English: In response to the CHMP list of questions, the MAHs stated that no samples were available to carry out a re-analysis.
Estonian: Vastuseks inimravimite komitee küsimustele väitsid müügiloa hoidjad, et uue analüüsi tegemiseks ei ole proove.
English: Overall summary of the scientific evaluation of Fenofibrato Pensa and Fenofibrato Ranbaxy (see Annex I)
Estonian: Fenofibrato Pensa ja Fenofibrato Ranbaxy (vt I lisa) teadusliku hindamise üldkokkuvõte
English: In conclusion, the CHMP considered that the potential deficiencies in the conduct of bio-analytical studies by the Cetero Research facilities invalidate the pivotal bioequivalence study.
Estonian: Kokkuvõttes leidis inimravimite komitee, et bioanalüütiliste uuringute läbiviimisel Cetero Researchi keskuses ilmnenud võimalikud puudujäägid muudavad olulise bioekvivalentsuse uuringu kehtetuks.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 10540314, submitted in support of the marketing authorisations, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to their reference product, the CHMP was unable to conclude on the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy.
Estonian: Arvestades tõsiseid kahtlusi müügiloa toetuseks esitatud kriitilise tähtsusega bioekvivalentsuse uuringu 10540314 andmete usaldusväärsuses ja õigsuses ning usaldusväärse bioekvivalentsuse uuringu puudumist, mis oleks spetsiaalselt ette nähtud Fenofibrato Pensa ja Fenofibrato Ranbaxy ning võrdlusravimi bioekvivalentsuse kindlakstegemiseks, ei saanud inimravimite komitee järeldada Fenofibrato Pensa ja Fenofibrato Ranbaxy bioekvivalentsust.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to its EU reference product, the benefit-risk balance of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be considered to be favourable.
Estonian: Sel põhjusel ja et puudub usaldusväärne bioekvivalentsuse uuring, mis näitaks spetsiifiliselt Fenofibrato Pensa ja Fenofibrato Ranbaxy bioekvivalentsust ELi võrdlusravimiga, ei saa Fenofibrato Pensa ja Fenofibrato Ranbaxy kasulikkuse ja riski suhet soodsaks pidada.
English: Having assessed the available data, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisations.
Estonian: Olles hinnanud kättesaadavaid andmeid, on inimravimite komiteel pärast ettevõtte Cetero Research Houstoni keskuses (Texase osariik, USA) tehtud kontrolli tõsised kahtlused müügiloa toetuseks esitatud kriitilise tähtsusega bioekvivalentsuse uuringu tulemuste usaldusväärsuses ja õigsuses.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Estonian: • inimravimite komitee leidis, et olemasolevad andmed tekitavad tõsiseid kahtlusi Fenofibrato Pensa ja Fenofibrato Ranbaxy ning ELi võrdlusravimi bioekvivalentsuse andmete usaldusväärsuses, arvestades Cetero Researchi keskuses tehtud kontrolli tulemusi;
English: • The Committee is of the opinion that considering the serious doubts in respect of the evidence of bioequivalence, the benefit-risk of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be confirmed.
Estonian: • inimravimite komitee on arvamusel, et arvestades bioekvivalentsuse tõenditega seotud tõsiseid kahtlusi, ei saa kinnitada Fenofibrato Pensa ning Fenofibrato Ranbaxy kasulikkuse ja riski suhet.
English: • The Committee considered that the responses of the MAH are not adequate to refute the serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product.
Estonian: • inimravimite komitee leidis, et müügiloa hoidja vastused ei ole piisavad, et lükata ümber tõsised kahtlused seoses Fenofibrato Pensa ja Fenofibrato Ranbaxy ning ELi võrdlusravimi bioekvivalentsusega;
English: The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Estonian: Samuti paluti avaldada arvamust, kas nende ravimite müügiload, mille uuringud ja proovide analüüsid korraldas kõnealusel ajaperioodil Cetero Research, tuleks alles jätta, muuta, peatada või tühistada.
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants in the Member States
Estonian: Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, taotlejate loetelu liikmesriikides
English: Yvidually 0,02 mg/3 mg apvalkotās tabletes
Estonian: Delivrie 0,02 mg/3 mg Filmtabletten
English: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011
Estonian: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011 EU/2/10/119/012
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/119/001-012
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/10/119/001-012
English: The elimination half-life (t1/2) is 1.38 (± 0.24) hours.
Estonian: Eliminatsiooni poolväärtusaeg (t1/2) on 1,38 (±0,24) tundi.
English: Refer also to section 4.8
Estonian: Vt lõik 4.8.
English: Furthermore, in very rare cases, renal failure has been reported.
Estonian: Peale selle on väga harvadel juhtudel teatatud neerupuudulikkusest.
English: If such use cannot be avoided, these animals require careful veterinary monitoring.
Estonian: Kui sellist kasutamist ei ole võimalik vältida, on vaja neid loomi hoolikalt veterinaarselt jälgida.
English: The choice of the most suitable tablet type or tablet parts is left to the discretion of the veterinarian based on the circumstances in each case, without leading to important over- or underdosing.
Estonian: Kõige sobivama tabletitüübi või tabletiosa valiku teeb loomaarst sõltuvalt iga juhtumi asjaoludest, põhjustamata olulist üle- või alaannustamist.
English: Vétoquinol SA Magny-Vernois 70200 Lure France
Estonian: Vétoquinol SA Magny-Vernois 70200 Lure Prantsusmaa
English: Do not use in breeding, pregnant or lactating animals (see Section 12 “Special precautions for dogs”).
Estonian: Mitte kasutada paarituvatel, tiinetel või imetavatel loomadel (vt lõik 12 „Erihoiatused koertele”).
English: The tablets are flavoured and studies (in healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.
Estonian: Tabletid on maitsestatud ja uuringud (tervetel jahikoertel) on näidanud, et enamik koeri võtab neid suure tõenäosusega vabatahtlikult.
English: Do no use in dogs less than 10 weeks of age.
Estonian: Mitte kasutada alla 10 nädala vanustel koertel.
English: Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, ATCvet code: QM01AH93
Estonian: Farmakoterapeutiline rühm: mittesteroidsed põletiku- ja reumavastased ained, ATCvet kood: QM01AH93
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Estonian: Müügiloa hoidja peab informeerima Euroopa Komisjoni antud otsusega heakskiidetud ravimi turundusplaanidest.
English: The peak concentration (Cmax) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735) µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.
Estonian: Maksimaalne plasmakontsentratsioon (Cmax) on 0,3918 (±0,09021) µg/ml, kontsentratsioonikõvera alune pindala (AUC) on 1,676 (±0,4735) µg.hr/ml ja biosaadavus suukaudsel manustamisel 44,53 (±10,26) protsenti.