FrancophonIA/ELRC3.0 huggingface dataset:
English: White to off-white, oblong shaped film-coated tablets with a score-line on both sides and marked with the letters "AQ" and "S", "M" or "L" on both sides.
Estonian: Valged kuni valkjad ovaalse kujuga polümeerikattega tabletid, mille mõlemal küljel on poolitusjoon ja märge „AQ” ja „S”, „M” või „L”.
English: The dosing table below shows the number of tablets required.
Estonian: Annustamistabelis on välja toodud vajaminevate tablettide arv.
English: Please see dosing table below for the number of tablets required to achieve the recommended dose.
Estonian: Vt allpool olevat annustamistabelit, kus on välja toodud soovitatava annuse saavutamiseks vajaminevate tablettide arv.
English: Shelf life of the veterinary medicinal product as packaged for sale in blisters: 2 years.
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg (mullpakendis): 2 aastat.
English: Total body oclacitinib clearance from plasma was low - 316 ml/h/kg bodyweight (5.3 ml/min/kg bodyweight), and the apparent volume of distribution at steady-state was 942 ml/kg bodyweight.
Estonian: Oklatsitiniibi täielik plasmakliirens oli väike - 316 ml/h kehamassi kg kohta (5,3 ml/min kehamassi kg kohta) ning näiline jaotusruumala püsiseisundi korral oli 942 ml kehamassi kg kohta.
English: The requirement for longterm maintenance therapy should be based on an individual benefit-risk assessment by the responsible veterinarian.
Estonian: Pikaajalise säilitusravi vajadus peab põhinema individuaalsel kasu ja riski hinnangul.
English: The common adverse reactions seen up to day 16 of the field trials are listed in the following table: Adverse reactions observed in atopic dermatitis study up to day 16
Estonian: Sagedased kõrvaltoimed, mida täheldati väliuuringus 16. päevani, on toodud välja allolevas tabelis: 16. päevani atoopilise dermatiidi uuringus täheldatud kõrvaltoimed
English: Each film-coated tablet contains: Apoquel 3.6 mg:
Estonian: Iga õhukese polümeerikattega tablett sisaldab: Apoquel 3,6 mg:
English: The letters "S", "M" and "L" refer to the different strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg tablets, and "L" on the 16 mg tablets.
Estonian: Tähed „S”, „M” ja „L” viitavad tablettide erinevatele tugevustele: 3,6 mg tablettidel on „S”, 5,4 mg tablettidel „M” ja 16 mg tablettidel „L”.
English: The development of papillomas was noted in a number of dogs in a laboratory study.
Estonian: Laboratoorsetel uuringutel täheldati mitmetel koertel papilloomide teket.
English: Given the potential for effects on certain clinicopathological parameters (see section 4.6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
Estonian: Arvestades võimaliku mõjuga teatud kliinilis-patoloogilistele näitajatele (vt lõik 4.6), on soovitatav pikaajalisel ravil olevate koerte perioodiline jälgimine koos täieliku vereanalüüsi ja seerumi biokeemilise analüüsiga.
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Estonian: Pärast manustamist peab tablettide allaneelamise kindlustamiseks koera tähelepanelikult jälgima.
English: Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Estonian: Peale selle soovitatakse allergilise ja atoopilise dermatiidi korral teha kindlaks seisundit süvendavad tegurid, nagu bakteriaalsed, seen- või parasiitnakkused (nt kirbud ja sügelised), ja neid selle järgi ravida.
English: For maintenance therapy (after the initial 14 days of treatment), the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Estonian: Säilitusravi (pärast esialgset 14-päevast ravi) jaoks peab seejärel sama annust (0,4-0,6 mg oklatsitiniibi kehamassi kg kohta) manustama ainult üks kord päevas.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL for Bottle
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PUDELI MÄRGISTUS
English: Given the potential for effects on certain clinicopathological parameters (see section 6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
Estonian: Arvestades võimaliku mõjuga teatud kliinilis-patoloogilistele näitajatele (vt lõik 6), on soovitatav pikaajalisel ravil olevate koerte perioodiline jälgimine koos täieliku vereanalüüsi ja seerumi biokeemilise analüüsiga.
English: Oclacitinib tablets were administered to healthy, one year old Beagle dogs twice daily for 6 weeks, followed by once per day for 20 weeks, at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw for a total of 26 weeks.
Estonian: Oklatsitiniibitablette manustati tervetele 1 aasta vanustele beagle'i koertele kaks korda päevas 6 nädala jooksul, seejärel üks kord päevas 20 nädala jooksul annustes 0,6 mg kehamassi kg kohta, 1,8 mg kehamassi kg kohta ja 3,0 mg kehamassi kg kohta, kokku 26 nädala jooksul.
English: Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate).
Estonian: Iga õhukese polümeerikattega tablett sisaldab 3,6 mg, 5,4 mg või 16 mg oklatsitiniibi oklatsitiniibmaleaadina.
English: Placebo (n=147)
Estonian: Platseebo (n = 147)
English: Apoquel 16 mg tablets
Estonian: Apoquel 16 mg tabletid
English: ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
Estonian: LISA I 0BRAVIMI OMADUSTE KOKKUVÕTE
English: Clinical observations that were considered likely to be related to oclacitinib treatment included: alopecia (local), papilloma, dermatitis, erythema, abrasions and scabbing/crusts, interdigital "cysts", and oedema of the feet.
Estonian: Tõenäoliselt oklatsitiniibraviga seotud kliiniliste sümptomite hulka kuulusid alopeetsia (paikne), papilloom, dermatiit, erüteem, abrasioonid ja kärnad/koorikud, varbavahelised „tsüstid” ja jalgade turse.
English: 16 mg oclacitinib (as oclacitinib maleate) For the full list of excipients, see section 6.1.
Estonian: 16 mg oklatsitiniibi (oklatsitiniibmaleaadina) Abiainete täielik loetelu on esitatud lõigus 6.1.
English: An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.
Estonian: Vaktsineerimisel CDV ja CPV vastu saadi adekvaatne immuunvastus (seroloogia), kui kutsikatele manustati oklatsitiniibi kaks korda päevas annuses 1,8 mg kehamassi kg kohta 84 päeva jooksul.
English: Do not use in dogs with evidence of immune suppression, such as hyperadrenocorticism, or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases.
Estonian: Mitte kasutada immuunpuudulikkuse (nt hüperadrenokortitsismi) või progresseeruva pahaloomulise kasvaja kahtluse korral, sest toimeaine mõju sellistele seisunditele ei ole teada.
English: There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.
Estonian: Üleannustamise korral peab koera ravima sümptomaatiliselt.
English: EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Estonian: EU/2/13/154/001 (1 × 20 tabletti, 3,6 mg) EU/2/13/154/007 (1 × 50 tabletti, 3.6 mg) EU/2/13/154/002 (1 × 100 tabletti, 3,6 mg) EU/2/13/154/010 (20 tabletti, 3,6 mg) EU/2/13/154/011 (50 tabletti, 3,6 mg) EU/2/13/154/012 (100 tabletti, 3,6 mg) EU/2/13/154/003 (1 × 20 tabletti, 5,4 mg) EU/2/13/154/008 (1 × 50 tabletti, 5.4 mg) EU/2/13/154/004 (1 × 100 tabletti, 5,4 mg) EU/2/13/154/013 (20 tabletti, 5,4 mg) EU/2/13/154/014 (50 tabletti, 5,4 mg) EU/2/13/154/015 (100 tabletti, 5,4 mg) EU/2/13/154/005 (1 × 20 tabletti, 16 mg) EU/2/13/154/009 (1 × 50 tabletti, 16 mg) EU/2/13/154/006 (1 × 100 tabletti, 16 mg) EU/2/13/154/016 (20 tabletti, 16 mg) EU/2/13/154/017 (50 tabletti, 16 mg) EU/2/13/154/018 (100 tabletti, 16 mg)
English: Apoquel 5.4 mg tablets
Estonian: Apoquel 5,4 mg tabletid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON for Blister
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED BLISTRI PAPPKARP
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Pärast manustamist pesta käed.
English: For oclacitinib, the target cytokines are those that are proinflammatory or have a role in allergic responses/pruritis.
Estonian: Oklatsitiniib mõjutab proinflammatoorseid ja allergilistes reaktsioonides / kiheluses osalevaid tsütokiine.
English: The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Estonian: Soovitatav algannus on 0,4-0,6 mg oklatsitiniibi kehamassi kg kohta manustatuna suukaudselt kaks korda päevas kuni 14 päeva jooksul.
English: For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Estonian: Säilitusravi jaoks peaks seejärel sama annust (0,4-0,6 mg oklatsitiniibi kehamassi kg kohta) manustama ainult üks kord päevas.
English: New cutaneous or subcutaneous lumps Lethargy
Estonian: Uued nahasisesed või -alused sõlmed Letargia
English: Inhibition of canine cytochrome P450s is minimal with IC50s 50-fold greater than the observed mean Cmax (333 ng/ml or 0.997 µM) following 0.6 mg/kg bw oral administration in the target animal safety study.
Estonian: Koera tsütokroom P450 on minimaalselt pärsitud: sihtorganismi ohutusuuringus olid IC50 väärtused pärast suukaudselt manustatud ravimit annuses 0,6 mg kehamassi kg kohta 50 korda suuremad kui keskmine mõõdetud Cmax (333 ng/ml või 0,997 µM).
English: Treatment of clinical manifestations of atopic dermatitis in dogs.
Estonian: Atoopilise dermatiidi kliiniliste sümptomite ravi koertel.
English: The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear.
Estonian: Oklatsitiniibi tarvitamise ajal (soovitatava annustamisrežiimi järgi) vaktsineeritud kutsikatel täheldatud tulemuste kliiniline tähtsus ei ole teada.
English: No drug interactions were observed in field studies where oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and antiinflammatories.
Estonian: Väliuuringutel, kus oklatsitiniibi manustati samal ajal veterinaarravimitega (nt endo- ja ektoparasiitide, mikroobide ja põletikuvastaste ravimitega), ei täheldatud ravimite koostoimeid.
English: Placebo (n=220)
Estonian: Platseebo (n = 220)
English: Do not use in cases of hypersensitivity to oclacitinib or to any of the excipients.
Estonian: Mitte kasutada, kui esineb ülitundlikkust oklatsitiniibi või ravimi ükskõik milliste abiainete suhtes.
English: New cutaneous or subcutaneous lumps Weakness (Lethargy) Excessive thirst (Polydipsia)
Estonian: Kõhulahtisus Oksendamine Vähenenud söögiisu (anoreksia) Uued nahasisesed või alused sõlmed Nõrkustunne (letargia) Ülemäärane janutunne (polüdipsia)
English: EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Estonian: EU/2/13/154/010 (20 tabletti, 3,6 mg) EU/2/13/154/011 (50 tabletti, 3,6 mg) EU/2/13/154/012 (100 tabletti, 3,6 mg) EU/2/13/154/013 (20 tabletti, 5,4 mg) EU/2/13/154/014 (50 tabletti, 5,4 mg) EU/2/13/154/015 (100 tabletti, 5,4 mg) EU/2/13/154/016 (20 tabletti, 16 mg) EU/2/13/154/017 (50 tabletti, 16 mg) EU/2/13/154/018 (100 tabletti, 16 mg)
English: After day 16, the following adverse reactions have been observed: - pyoderma and non-specified dermal lumps have been observed very commonly; - otitis, vomiting, diarrhoea, histiocytoma, cystitis, yeast skin infections, pododermatitis, lipoma,
Estonian: 16 päeva möödudes täheldati järgnevaid kõrvaltoimeid: - väga sageli esines püodermat ja täpsustamata nahasõlmi - sageli esines kõrvapõletikku, oksendamist, kõhulahtisust, histiotsüstoome, põiepõletikku, naha seeninfektsioone, pododermatiiti, lipoomi, polüdipsiat, lümfadenopaatiat, iiveldust, suurenenud söögiisu ja agressiivsust.
English: Dermatitis lesions were mostly secondary to the development of interdigital furunculosis on one or more feet during the study, with the number and frequency of observations increasing with increasing dose.
Estonian: Uuringu jooksul ühel või enamal jalal esinenud dermatiidikolded tekkisid enamasti sekundaarsena varbavahelisele furunkuloosile.
English: Treatment of pruritus associated with allergic dermatitis in dogs.
Estonian: Allergilise dermatiidiga kaasneva nahasügeluse ravi koertel.
English: Lymphadenopathy of peripheral nodes was noted in all groups, increasing in frequency with increasing dose, and was frequently associated with interdigital furunculosis.
Estonian: Kõikides rühmades täheldati perifeerset lümfadenopaatiat, mille sagedus suurenes annusega.
English: EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg)
Estonian: EU/2/13/154/001 (1 × 20 tabletti, 3,6 mg) EU/2/13/154/007 (1 × 50 tabletti, 3.6 mg) EU/2/13/154/002 (1 × 100 tabletti, 3,6 mg) EU/2/13/154/003 (1 × 20 tabletti, 5,4 mg) EU/2/13/154/008 (1 × 50 tabletti, 5.4 mg) EU/2/13/154/004 (1 × 100 tabletti, 5,4 mg) EU/2/13/154/005 (1 × 20 tabletti, 16 mg) EU/2/13/154/009 (1 × 50 tabletti, 16 mg) EU/2/13/154/006 (1 × 100 tabletti, 16 mg)
English: No accumulation was observed in the blood of dogs treated for 6 months with oclacitinib.
Estonian: 6 kuud oklatsitiniibravi saanud koertel ei täheldatud ravimi kuhjumist veres.
English: Any remaining half tablet should be stored in the bottle and discarded if not used within 3 days.
Estonian: Kõik allesjäänud poolikuid tablette peab säilitama pudelis ja kasutamata jätmisel 3 päeva möödudes ära viskama.
English: Bodyweight (kg) of dog
Estonian: Koera kehakaal (kg)
English: When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g., flea allergic dermatitis, contact dermatitis, food hypersensitivity).
Estonian: Kui oklatsitiniibi kasutatakse allergilise dermatiidiga kaasneva nahasügeluse raviks, peab kindlaks tegema seisundi põhjused (nt kirbuhammustustest tingitud allergiline dermatiit, kontaktdermatiit, ülitundlikkus toidu suhtes) ja neid selle järgi ravima.
English: Apoquel 3.6 mg tablets for dogs.
Estonian: Apoquel 3,6 mg tabletid koertele.
English: Apoquel 16 mg tablets for dogs.
Estonian: Apoquel 16 mg tabletid koertele.
English: Apoquel 5.4 mg tablets for dogs.
Estonian: Apoquel 5,4 mg tabletid koertele.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding.
Estonian: Veterinaarravimi ohutus tiinuse või laktatsiooni perioodil ega isastel aretuskoertel ei ole piisavalt tõestatud.
English: 5.4 mg oclacitinib (as oclacitinib maleate)
Estonian: 5,4 mg oklatsitiniibi (oklatsitiniibmaleaadina)
English: Any remaining half tablet should be stored in the blister and discarded if not used within 3 days.
Estonian: Kõik allesjäänud poolikuid tablette peab säilitama mullpakendis ja kasutamata jätmisel 3 päeva möödudes ära viskama.
English: Strength and number of tablets to be administered: Apoquel 3.6 mg tablets
Estonian: Manustatavate tablettide tugevus ja arv Apoquel 3,6 mg tabletid
English: The tablets are breakable along the score line.
Estonian: Tablette on võimalik poolitusjoone abil osadeks jagada.
English: Cellulose, microcrystalline Lactose monohydrate Magnesium stearate Sodium starch glycolate
Estonian: Tableti sisu: mikrokristalne tselluloos, laktoosmonohüdraat, magneesiumstearaat, naatriumtärklisglükolaat.
English: Oclacitinib exhibits low protein binding with 66.3% to 69.7% bound in fortified canine plasma at nominal concentrations ranging from 10 to 1,000 ng/ml.
Estonian: Oklatsitiniib seondub valkudega vähesel määral: koera rikastatud vereplasmas oli seondumine 66,3−69,7%.
English: 16 mg oclacitinib per tablet (as oclacitinib maleate).
Estonian: 16 mg oklatsitiniibi (oklatsitiniibmaleaadina) tableti kohta.
English: Apoquel tablets are supplied in either blister packs or bottles with 20, 50 or 100 tablets per pack.
Estonian: Apoqueli tabletid on mullpakendites või pudelites.
English: The decrease in mean leukocyte count observed in oclacitinib-treated dogs was not progressive, and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts) except lymphocyte counts.
Estonian: Vähenes kõikide valgevereliblede (neutrofiilid, eosinofiilid ja monotsüüdid) arv, v.a lümfotsüütide arv.
English: Lack or loss of appetite (Anorexia)
Estonian: Kõhulahtisus Oksendamine Anoreksia
English: oclacitinib
Estonian: oklatsitiniibi
English: Adverse reactions observed in pruritus study up to day 7
Estonian: 7. päevani nahasügeluse uuringus täheldatud kõrvaltoimed
English: Following oral administration in dogs, oclacitinib maleate is rapidly and well absorbed, with a time to peak plasma concentration (tmax) of less than 1 hour.
Estonian: Pärast suukaudset manustamist koertele imendub oklatsitiniibmaleaat kiiresti ja täielikult.
English: 3.6 mg oclacitinib per tablet (as oclacitinib maleate).
Estonian: 3,6 mg oklatsitiniibi (oklatsitiniibmaleaadina) tableti kohta.
English: PACKAGE LEAFLET: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs
Estonian: PAKENDI INFOLEHT Apoquel 3,6 mg õhukese polümeerikattega tabletid koertele Apoquel 5,4 mg õhukese polümeerikattega tabletid koertele Apoquel 16 mg õhukese polümeerikattega tabletid koertele
English: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs oclacitinib
Estonian: Apoquel 3,6 mg õhukese polümeerikattega tabletid koertele Apoquel 5,4 mg õhukese polümeerikattega tabletid koertele Apoquel 16 mg õhukese polümeerikattega tabletid koertele oklatsitiniib
English: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs
Estonian: Apoquel 3,6 mg õhukese polümeerikattega tabletid koertele Apoquel 5,4 mg õhukese polümeerikattega tabletid koertele Apoquel 16 mg õhukese polümeerikattega tabletid koertele
English: 3.6 mg oclacitinib (as oclacitinib maleate)
Estonian: 3,6 mg oklatsitiniibi (oklatsitiniibmaleaadina)
English: 5.4 mg oclacitinib per tablet (as oclacitinib maleate).
Estonian: 5,4 mg oklatsitiniibi (oklatsitiniibmaleaadina) tableti kohta.
English: Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination.
Estonian: Metabolism on põhiline ravimi väljutustee.
English: - The current minimum standards for critical process parameters and limits e.g. for terminal sterilisation should be reviewed and improved, in compliance with process capabilities and best practice.
Estonian: - kriitilisi töötlemisparameetreid ja piirväärtusi, näiteks lõppastme steriliseerimise praegused miinimumnormid tuleb üle vaadata ning neid vastavalt töötlemisvõimalustele ja parimale tavale täiustada.
English: The CHMP reviewed all the data available for each of the four sites concerned.
Estonian: Inimravimite komitee vaatas läbi kõik kõnealuse nelja tootmiskoha kättesaadavad andmed.
English: Presently, the information available on the USA site is insufficient to conclude on its addition, pending the outcome of a recent inspection carried out at this site.
Estonian: USA tootmiskoha teave on selle lisamise otsustamiseks praegu ebapiisav, kuni selguvad seal hiljuti toimunud kontrolli tulemused.
English: Considering the likelihood of prolonged use of large quantities of unlicensed (imported) PD solutions on the EU market, and in order to ensure continued supply of licensed medicinal products to the EU, the necessary data packages to support the inclusion of additional manufacturing sites were expedited within the ongoing article 31 referral procedure.
Estonian: Arvestades müügiloata (imporditud) PD-lahuste pikaajalise suurtes kogustes kasutamise tõenäolisust Euroopa Liidu turul ja et tagada müügiloaga ravimite Euroopa Liitu tarnimise jätkumine, kiirendati vajalike tootmiskohtade lisamist toetavate andmete menetlemist artikli 31 kohase esildismenetluse raames.
English: Furthermore, the opinion on the Castlebar site cannot be finalised at this stage as issues remained for resolution by the marketing authorisation holder.
Estonian: Peale selle ei saa praeguses etapis esitada lõplikku arvamust Castlebari tootmiskoha kohta, sest müügilubade hoidja peab enne lahendama senised probleemid.
English: At this stage of the article 31 review procedure, sufficient data is available to recommend the variation to the marketing authorisations consisting in the inclusion of Canada, Poland and Turkey as additional manufacturing sites, as no major quality issues were identified at these sites.
Estonian: Artikli 31 kohase uurimismenetluse selles etapis on olemas piisavalt andmeid, et soovitada müügilubade muutmist Kanada, Poola ja Türgi tootmiskohtade lisamise teel, sest nendes kohtades ei avastatud olulisi kvaliteediprobleeme.
English: Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Estonian: Ilma et see piiraks artikli 31 kohast toimuvat menetlust, leiab inimravimite komitee, et on olemas piisavalt teavet käesoleva artikli 31 kohase menetluse raames esimese arvamuse esitamiseks, milles soovitatakse lisada PD-lahuste olemasolevatele müügilubadele Kanada, Poola ja Türgi tootmiskohad, võttes arvesse IV lisas sätestatud tingimusi.
English: • The CHMP considers that sufficient quality data is available to recommend the inclusion of manufacturing sites located in Canada, Poland and Turkey into the existing marketing authorisations for peritoneal dialysis solutions.
Estonian: • inimravimite komitee on seisukohal, et on olemas piisavad kvaliteetsed andmed, mille alusel soovitada Kanadas, Poolas ja Türgis paiknevate tootmiskohtade lisamist praegustele peritoneaaldialüüsi lahuste müügilubadele,
English: Overall summary of the scientific evaluation on the inclusion of additional sites into the existing licenses of dialysis solutions (Dianeal, Extraneal and Nutrineal) produced by Baxter group of companies and associated companies (see Annex I)
Estonian: Baxteri kontserni ettevõtete ja nendega seotud ettevõtete toodetavate dialüüsilahuste Dianeal, Extraneal ja Nutrineal (vt I lisa) kehtivatele müügilubadele uute tootmiskohtade lisamist käsitleva teadusliku hindamise üldkokkuvõte