FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose: the initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10kg, you should take 1g per day, or 5 tablets), For patients suffering from N-acetylglutamate synthase deficiency, in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Estonian: Tavaannus: - alguses on päevane annus tavaliselt 100 mg iga kehakaalu kilogrammi kohta kuni maksimaalse 250 mg kehakaalu kilogrammi kohta (näiteks kui kaalute 10 kg, peate võtma 1 g ehk 5 tabletti päevas), - N-atsetüülglutamaadi sünteesi defitsiidiga patsientide puhul jääb pikaajalises perspektiivis päevane annus 10 kuni 100 mg vahele kehakaalu kilogrammi kohta.
English: Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Estonian: Carbaglu'd ei tohi võtta patsiendid, kes on ülitundlikud (allergilised) kargluumhappe või mõne teise Carbaglu koostisosa suhtes.
English: • Common: increased sweating
Estonian: • Sage: suurenenud higistamine
English: Carglumic acid was shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content of carbamoyl phosphate synthetase activators was significantly increased.
Estonian: Kargluumhape vähendas ammoniaagi taset ja tõstis uurea taset veres ning uriinis, kusjuures maksa karbamüülfosfaatsüntetaasi aktivaatorite sisaldus oli märkimisväärselt tõusnud.
English: A proportion of carglumic acid is metabolised.
Estonian: Osa kargluumhappest metaboliseeritakse.
English: Single doses of carglumic acid up to 2800 mg/kg orally and 239 mg/kg intravenously did not induce any mortality or abnormal clinical signs in adult rats.
Estonian: Kargluumhape-kuni 2800 mg/kg mahuga suu kaudu manustatavad ja 239 mg/kg intravenoosselt manustatavad üksikannused ei põhjustanud täiskasvanud rottide suremust ega ebanormaalseid kliinilisi nähte.
English: If you forget to take Carbaglu Do not take a double dose to make up for forgotten individual doses.
Estonian: Kui te unustate Carbaglu'd võtta Kahekordset annust ei tohi korraga võtta, kui ravim jäi eelmisel korral võtmata.
English: In patients with organic acidaemia (neonates and non-neonates), the treatment with carglumic acid induced a quick decrease of ammonia plasma levels, reducing the risk of neurological complications.
Estonian: Orgaanilise atsideemiaga patsientidel (vastsündinud ja muud) tekitas ravi kargluumhappega kiire lämmastiku plasmataseme languse, vähendades neuroloogiliste tüsistuste ohtu.
English: In rats and rabbits no evidence has been seen of embryotoxicity, foetotoxicity or teratogenicity up to maternotoxic doses leading to fifty times exposure as compared to humans in rats and seven times in rabbits.
Estonian: Rottidel ja küülikutel tehtud uuringutes pole saadud viiteid kahjulike toimete kohta embrüole, lootele ega väärarengute teket, kui kasutati emasloomale toksilisi annuseid, mis olid rottide puhul viiskümmend korda ja küülikute puhul seitse korda suuremad kui inimesele mõeldud vastavad annused.
English: You may need to read it again.
Estonian: - Hoidke see infoleht alles, et seda vajadusel uuesti lugeda.
English: Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Estonian: Carbaglu ravikuuri tuleb alustada metaboolsete häirete ravi puhul kogenud arsti järelevalve all.
English: Always take Carbaglu exactly as your doctor has instructed you.
Estonian: Kasutage Carbaglu'd alati vastavalt arsti juhistele.
English: The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half life up to 28 hours).
Estonian: Kargluumhappe plasmast eliminatsiooni kõver on kahefaasiline, esimesele kiirele faasile (12 tundi pärast manustamist) järgneb aeglane faas (terminaalne poolväärtusaeg 28 tundi).
English: Metabolites are detectable in plasma with a peak at 36-48 hours and a very slow decline (half-life around 100 hours).
Estonian: Metaboliitide plasmasisaldus on suurim 36-48 tunni möödudes ja see näitaja langeb väga aeglaselt (poolväärtusajaga ligikaudu 100 tundi).
English: After a single oral dose of 100 mg/kg body weight, 9% of the dose is excreted unchanged in the urine and up to 60% in the faeces.
Estonian: Pärast 100 mg/kg kargluumhappe ühekordset suu kaudu võtmist eritub 9% muutumatul kujul toimeainet uriiniga ja 60% väljaheitega.
English: In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
Estonian: N-atsetüülglutamaadi sünteesi defitsiidiga patsientide puhul tekitas kargluumhape kiire lämmastikutaseme normaliseerumise tavaliselt 24 tunni jooksul.
English: Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Estonian: Kargluumhape on N-atsetüülglutamaadi struktuuriline analoog, mis esineb karbamüülfosfaadi süntetaasi aktivaatorina, uurea tsükli esimese ensüümina.
English: It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4).
Estonian: Seejärel tuleb annust individuaalselt reguleerida, et säilitada plasma normaalne ammoniaagi tase (vt jaotis 4.4).
English: The excretion of carglumic acid into breast milk has not been studied in women.
Estonian: Kargluumhappe eritumist rinnapiima ei ole naistel uuritud.
English: One metabolite that has been identified in the faeces is glutamic acid.
Estonian: Üks väljaheites kindlaks tehtud metaboliit on glutamaat.
English: Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants to adolescents, treated with various daily doses (7 - 122 mg/kg/day).
Estonian: Kargluumhappe taset plasmas mõõdeti kõikide vanusekategooriate puhul alates vastsündinutest kuni täisealisteni, kellele manustati igapäevaseid annuseid (7...122 mg/kg/päevas).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Estonian: ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS (VAJADUSEL), VASTAVALT RAVIMPREPARAADILE ESITATUD NÕUETELE.
English: No adverse effects have been observed on male or female fertility.
Estonian: Kahjulikku toimet emas- ja isasloomade viljakusele ei ole täheldatud.
English: After first opening of the tablet container: do not refrigerate, do not store above 30C.
Estonian: Pärast tabletipakendi esmast avamist ei tohi hoida külmkapis, ei tohi hoida temperatuuril üle 30 C.
English: No carcinogenicity study has been conducted with carglumic acid.
Estonian: Kargluumhappega-ei ole kartsinogeensusuuringuid läbi viidud.
English: Uncommon: diarrhoea, vomiting
Estonian: Aeg-ajalt: kõhulahtisus, oksendamine
English: This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for Nacetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
Estonian: Seda võib seletada järgmistelt: i) Mitokondri membraan on kargluumhappe jaoks kergemini läbitav kui N-atsetüülglutamaadi jaoks.
English: Carglumic acid has been shown in vitro to activate liver carbamoyl phosphate synthetase.
Estonian: Kargluumhape on in vitro näidanud maksa karbamüülfosfaatsüntetaasi aktiveerimist.
English: This medicine is for oral use ONLY (ingestion or via a nasogastric tube using a syringe, if necessary).
Estonian: See ravim on AINULT suukaudseks kasutamiseks (allaneelamine või vajadusel manustamine läbi nina-mao sondi ja süstla).
English: 2.2 Qualitative and quantitative composition For a full list of excipients, see section 6.1
Estonian: Abiainete täielik loetelu vt lõik 6.1
English: Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/kg/day and a higher mortality of pups from dams treated with 2000 mg/kg/day, a dose that caused maternotoxicity.
Estonian: Kargluumhape eritub lakteerivate rottide rinnapiima ja kuigi arengunäitajaid ei mõjutatud, täheldati mõningaid toimeid kehakaalu/kehakaalu iibesse nendel rotipoegadel, kelle emad said kargluumhapet annuses 500 mg/kg päevas ja suremus oli kõrgem nende rotipoegade seas, kelle emad said kargluumhapet annuses 2000 mg/kg päevas (emale toksiline annus).
English: Each tablet contains 200 mg of carglumic acid.
Estonian: Iga tablett sisaldab 200 mg kargluumhapet.
English: In newborn rats receiving daily carglumic acid by oral gavage for 18 days as well as in young rats receiving daily carglumic acid for 26 weeks, the No Observed Effect Level (NOEL) was established at 500 mg/kg/day and the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg/day.
Estonian: Vastsündinud rottide puhul, kes said igapäevaselt suu kaudu kargluumhapet 18 päeva jooksul, ega noorte rottide puhul, kes said igapäevaselt kargluumhapet 26 nädala jooksul, määrati mittemärgatavaks mõju tasemeks kogus 500 mg/kg/päevas ja mittemärgatava ebasoodsa mõju tasemeks 1000 mg/kg/päevas.
English: For carglumic acid no clinical data on exposed pregnancies are available.
Estonian: Kargluumhappe kasutamise kohta raseduse ajal ei ole kliinilisi andmeid.
English: 5-, 15- or 60- high density polyethylene tablet containers closed by a child resistant polypropylene cap with a desiccant unit.
Estonian: 5, 15 või 60 tabletti sisaldav suure tihedusega polüetüleenist purk, mis on suletud lapsekindla polüpropüleenist korgiga, mis sisaldab kuivusainet.
English: What Carbaglu looks like and contents of the pack Carbaglu 200mg tablet is a bar-shaped tablet, with 4 punches on one side with 3 break-mark sides.
Estonian: Carbaglu 200 mg tablett on pikliku kujuga, selle ühele küljele on sisse pressitud neli auku ja sellel on kolm murdejoont.
English: • Not known: rash
Estonian: • Teadmata: lööve
English: Therefore, breast-feeding during the use of carglumic acid is contraindicated (see section 4.3).
Estonian: Seetõttu on kargluumhappe võtmise ajal rinnaga toitmine vastunäidustatud (vt lõik 4.3).
English: Occasionally, the use of quarter tablets may also be useful to adjust the posology prescribed by the physician.
Estonian: Mõnikord on arstil otstarbekohane annustamise paremaks reguleerimiseks välja kirjutada ka veerandtablette.
English: Protein binding has not been determined.
Estonian: Valkudele seondumist pole kinnitatud.
English: Pregnancy and Breast-feeding
Estonian: Rasedus ja imetamine
English: Microcrystalline cellulose sodium laurilsulfate hypromellose croscarmellose sodium silica colloidal anhydrous sodium stearyl fumarate
Estonian: Mikrokristalne tselluloos naatriumlaurilsulfaat hüpromelloos kroskarmelloosnaatrium kolloidaalne anhüdreeritud ränidioksiid naatriumstearüülfumaraat
English: - In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels.
Estonian: - Mõõdukate hüperammoneemiate puhul kasutage testdoosi 100...200 mg/kg/päevas kolme päeva jooksul pideva valgu manustamise ja lämmastikutaseme kontrolliga (enne sööki ja üks tund peale sööki), et selgitada välja annus, mis tagab normaalse lämmastikutaseme.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Estonian: MÜÜGILOAHOIDJA NIMI JA AADRESS
English: Carbaglu is indicated in treatment of
Estonian: Carbaglu on näidustatud järgmistel juhtudel:
English: General disorders and Administration site conditions
Estonian: Üldised häired ja manustamiskoha reaktsioonid
English: Carbaglu 200 mg dispersible tablets
Estonian: Carbaglu 200 mg dispergeeritavad tabletid
English: 60 dispersible tablets
Estonian: 60 dispergeeritavat tabletti
English: Your doctor may prescribe supplemental arginine or restrict your protein intake.
Estonian: Arst võib määrata lisaks arginiini või piirata valku sisaldavate ainete söömist.
English: Keep the container tightly closed in order to protect from moisture.
Estonian: Niiskuskaitseks tuleb pakendit hoida tihedalt suletuna.
English: Batch {number}
Estonian: Partii nr:{number}
English: HOW TO TAKE CARBAGLU
Estonian: KUIDAS CARBAGLU'D KASUTADA
English: Not known: rash
Estonian: Teadmata: lööve
English: HOW TO STORE CARBAGLU
Estonian: KUIDAS CARBAGLU'D SÄILITADA
English: After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Estonian: Ühekordselt suu kaudu võetud 100 mg/kg kargluumhappe annusest imendub ligikaudu 30%.
English: Do not take Carbaglu during breast-feeding
Estonian: Ärge kasutage Carbaglu'd imetamise ajal.
English: Common: increased sweating Not known: rash
Estonian: Naha ja nahaaluskoe kahjustused Sage: suurenenud higistamine Teadmata: lööve
English: It should then be individually adjusted in order to maintain normal ammonia plasma levels (see section 4.4).
Estonian: Seejärel tuleb annustamist reguleerida individuaalselt vastavalt normaalsele lämmastikutasemele plasmas (vt lõiku 4.4).
English: Diffusion into erythrocytes is non existent.
Estonian: Erütrotsüütidesse toimeaine ei difundeeru.
English: The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients) and not known (frequency cannot be estimated from the available data).
Estonian: Järgmistest kõrvaltoimetest teatati järgmiste sagedustega: väga sage (esineb vähemalt ühel patsiendil 10-st), sage (esineb vähemalt ühel patsiendil 100-st), aeg-ajalt (esineb vähemalt ühel patsiendil
English: 6.6 Special precautions for disposal
Estonian: 6.6 Erihoiatused hävitamiseks
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 60 TABLETS
Estonian: VÄLISPAKENDI KARTONGIST KARBI JA TABLETIPURGI ETIKETT X 60 TABLETTI
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 5 TABLETS
Estonian: VÄLISPAKENDI KARTONGIST KARBI JA TABLETIPURGI ETIKETT X 5 TABLETTI
English: 5 dispersible tablets
Estonian: 5 dispergeeritavat tabletti
English: Carbaglu 200 mg dispersible tablets Carglumic acid
Estonian: Carbaglu 200 mg dispergeeritavad tabletid Kargluumhape
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 15 TABLETS
Estonian: VÄLISPAKENDI KARTONGIST KARBI JA TABLETIPURGI ETIKETT X 15 TABLETTI
English: • For N-acetylglutamate synthase deficiency:
Estonian: • N-atsetüülglutamaadi sünteesi defitsiidi puhul:
English: 15 dispersible tablets
Estonian: 15 dispergeeritavat tabletti
English: Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-acetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats.
Estonian: on kargluumhape näidanud in vivo karbamüülfosfaatsüntetaasi stimuleerimist ja suuremat efektiivsust rottidel lämmastikumürgistuse ärahoidmisel kui N-atsetüülglutamaat.
English: - If you have further questions, please ask your doctor or your pharmacist.
Estonian: - Kui teil on lisaküsimusi, palume pidada nõu arsti või apteekriga.
English: Dispersible tablet
Estonian: Dispergeeritav tablett
English: - The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose,
Estonian: - Abiained on mikrokristalne tselluloos, naatriumlaurilsulfaat, hüpromelloos, kroskarmelloosnaatrium, kolloidaalne anhüdreeritud ränidioksiid, naatriumstearüülfumaraat.
English: • hyperammonaemia due to propionic acidaemia.
Estonian: • propioonhape-atsideemiast tingitud hüperammoneemia ravi.
English: Do not use after the expiry date stated on the tablet container.
Estonian: Ärge kasutage Carbaglu'd pärast kõlblikkusaega, mis on märgitud tablettide karbil.
English: The breaking of the tablets in halves allows most of the required posology adjustments.
Estonian: Tablettide poolitamise abil saab annustamist reguleerida.
English: The dose should be individually adjusted in order to maintain normal ammonia plasma levels.
Estonian: Annustamist tuleb reguleerida individuaalselt normaalse lämmastikutaseme järgi plasmas.
English: Carglumic acid responsiveness test It is recommended to test individual responsiveness to carglumic acid before initiating any long term treatment.
Estonian: Enne pikaajalise ravikuuri alustamist on soovitav läbi viia individuaalne kargluumhappe tundlikkuse test.
English: Gastrointestinal disorders
Estonian: Kargluumhappe tundlikkuse test
English: Carbaglu 200 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) Carbaglu 200 mg
English: Cardiac disorders
Estonian: - Orgaanilise atsideemia kõrvaltoimed Südame häired
English: • isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia.
Estonian: • Isopalderjanhape-atsideemia, metüülhape-atsideemia ja propioonhape-atsideemia puhul:
English: Your doctor will evaluate your individual responsiveness to carglumic acid before initiating any long term treatment.
Estonian: Enne pikaajalise ravikuuri alustamist hindab arst teie individuaalset kargluumhappe tundlikkust.
English: Oral use ONLY Read the package leaflet before use
Estonian: Enne ravimi kasutamist lugege pakendi infolehte
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED:
English: Uncommon: bradycardia
Estonian: Aeg-ajalt: bradükardia
English: Do not take Carbaglu:
Estonian: Carbaglu'd ei tohi tarvitada
English: - Undesirable effects in N-acetylglutamate synthase deficiency
Estonian: - N-atsetüülglutamaadi sünteesi defitsiidi kõrvaltoimed
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
Estonian: Müügiloa hoidja Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux Prantsusmaa
English: LIST OF EXCIPIENTS
Estonian: ABIAINETE LOEND
English: • hyperammonaemia due to isovaleric acidaemia.
Estonian: • isopalderjanhape-atsideemiast tingitud hüperammoneemia ravi
English: • hyperammonaemia due to N-acetylglutamate synthase primary deficiency.
Estonian: • spetsiifilise maksaensüümi N-atsetüülglutamaadi sünteesi defitsiidist.
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: 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: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)
English: Do not refrigerate.
Estonian: Pärast tabletipakendi esmast avamist Mitte hoida külmkapis.
English: Oral use ONLY Read the package leaflet before use.
Estonian: Enne ravimi kasutamist lugege pakendi infolehte.
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: BEFORE YOU TAKE CARBAGLU
Estonian: MIDA ON VAJA TEADA ENNE CARBAGLU TARVITAMIST
English: Breast-feeding
Estonian: Raviseire
English: • hyperammonaemia due to methymalonic acidaemia.
Estonian: • metüülmaloonhape-atsideemiast tingitud hüperammoneemia ravi
English: ANNEX I
Estonian: 1 LISA
English: Package size
Estonian: Pakendi iseloomustus
English: The European Commission issued a decision on 6 August 2009.
Estonian: Euroopa Komisjon tegi otsuse 6. augustil 2009.
English: Dr Pieter Neels (Belgium)
Estonian: Dr Pieter Neels (Belgia)
English: The Committee noted that this product was previously authorised in a number of other Member States on the basis of the same data.
Estonian: Komitee märkis, et kõnealune ravim oli varem heaks kiidetud paljudes teistes liikmesriikides samade andmete alusel.
English: These countries are Austria, Denmark, Finland, Germany, Greece, Norway, Portugal, Spain, Sweden and the United Kingdom.
Estonian: Need riigid on Austria, Hispaania, Kreeka, Norra, Portugal, Rootsi, Saksamaa, Soome, Taani ja Ühendkuningriik.
English: Prof. Michal Pirożynski (Poland)
Estonian: Prof Michal Pirożynski (Poola)
English: ‘Idiopathic' means that the cause of the urticaria is not known.
Estonian: „Idiopaatiline” tähendab, et urtikaaria põhjus ei ole teada.
English: 29 May 2009
Estonian: 29. mai 2009
English: The company wanted the authorisation to be recognised in Bulgaria, the Czech Republic, Estonia, France, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovenia and Slovakia (the ‘concerned Member States').
Estonian: Ettevõte soovis müügiloa tunnustamist Bulgaarias, Eestis, Itaalias, Leedus, Lätis, Poolas, Prantsusmaal, Rumeenias, Slovakkias, Sloveenias, Tšehhi Vabariigis ja Ungaris (asjaomased liikmesriigid).
English: Loratadine is an antihistamine.
Estonian: Loratadiin on antihistamiin.
English: Ref. EMEA/CHMP/563259/2009 EMEA/H/A-29/1060
Estonian: London, 17. august 2009 Viide: EMEA/CHMP/559824/2009 EMEA/H/A-29/1060
English: Company responses provided on: 23 March 2009 Opinion date:
Estonian: Ettevõtte vastuste laekumise kuupäe 23. märts 2009 Arvamuse esitamise kuupäev:
English: The marketing authorisation in the Netherlands should also be suspended.
Estonian: Ka Madalmaades antud müügiluba tuleb peatada.
English: However, these Member States were not able to reach an agreement and the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008.
Estonian: Nimetatud liikmesriigid ei jõudnud selles küsimuses kokkuleppele ja Madalmaade ravimiamet tegi 31. juulil 2008 inimravimite komiteele esildise vahekohtumenetluse alustamiseks.
English: This means that it is similar to a ‘reference medicine' already authorised in the EU called Clarityne.
Estonian: See tähendab, et see sarnaneb võrdlusravimiga Clarityne, millel juba on Euroopa Liidus müügiluba.
English: When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Estonian: Kui retseptorid on blokeeritud, ei saa histamiin toimet avaldada ning sellest tulenevalt allergiasümptomid vähenevad.
English: Loratadine Sandoz 10 is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itching and patches on the skin).
Estonian: Ravimit Loratadine Sandoz 10 kasutatakse allergilise riniidi (allergiast, näiteks heinapalavikust või tolmulestaallergiast põhjustatud ninaõõnepõletik) ja pikaajalise idiopaatilise urtikaaria (sügelus ja laigud nahal) sümptomite leevendamiseks.
English: It works by blocking the receptors that histamine, a substance in the body that causes allergic symptoms, normally attaches to.
Estonian: See blokeerib retseptorid, mille külge histamiin - allergilisi sümptomeid põhjustav aine organismis - tavaliselt kinnitub.
English: Until the results of these studies are assessed, the marketing authorisation for Loratadine Sandoz 10 in the Netherlands should be suspended.
Estonian: Nende uuringute tulemuste hindamise lõpetamiseni tuleb Loratadine Sandoz 10 müügiluba Madalmaades peatada.
English: The Czech Republic and Poland argued that the original study presented by the company was not in line with current guidance, and did not show bioequivalence of Loratadine Sandoz 10 and Clarityne.
Estonian: Tšehhi Vabariik ja Poola väitsid, et ettevõtte esitatud algne uuring ei olnud kooskõlas kehtivate suunistega ega näidanud Loratadine Sandoz 10 ja Clarityne'i bioekvivalentsust.