FrancophonIA/ELRC3.0 huggingface dataset:
English: In very rare cases temporary local hair loss may occur.
Estonian: Väga harvadel juhtudel võib esineda ajutist lokaalset karva kadu.
English: This is not a sign of intoxication and disappears within minutes without treatment.
Estonian: See ei ole mürgistusnäht ja kaob mõne minuti jooksul täiendava ravita.
English: This is normal and will generally resolve within 1 - 4 days after administration.
Estonian: See on normaalne ja kaob tavaliselt 1-4 päeva jooksul pärast manustamist.
English: It is therefore recommended to treat the animals during the evening.
Estonian: Seetõttu soovitatakse manustada ravimit loomadele õhtul.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Estonian: MÜÜGI, TARNIMISE JA/VÕI KASUTAMISE KEELD Ei kohaldata
English: Avoid direct contact with skin, eyes or mouth.
Estonian: Hoiduda otsekontaktist naha, silmade ja suuga.
English: Pharmacotherapeutic group: ATC Vet Code QP 53AX25
Estonian: Farmakoterapeutiline rühm: ATCvet kood QP 53AX25
English: Allow the application site to dry before permitting contact with such materials.
Estonian: Laske manustamiskohal kuivada, enne kui võimaldate kokkupuudet selliste materjalidega.
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: Selle müügiloa hoidja on kohustatud Euroopa Nõukogu teavitama antud otsusega heaks kiidetud ravimi turustamisplaanidest.
English: A dry residue may also be observed.
Estonian: Samuti võib täheldada kuiva ravimjäägi esinemist.
English: Recently treated animals are not allowed to sleep with owners, especially children.
Estonian: Hiljuti ravitud loomadel ei tohiks lubada magada koos omanikega, eriti lastega.
English: EXPIRY DATE EXP {month/year}
Estonian: KÕLBLIKKUSAEG EXP {month/year}
English: The MAH must ensure that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Estonian: Müügiloa hoidja peab tagama, et müügiloa taotluse I osas kirjeldatud ravimiohutuse järelevalve süsteem on olemas ja toimib enne veterinaarravimi turule toomist ja turustamise ajal.
English: Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days posttreatment.
Estonian: Maksimaalsed kontsentratsioonid karvastikus saavutati tavaliselt 1 kuni 2 päeva jooksul pärast manustamist ja need langesid järk-järgult 56 manustamisjärgse päeva vältel.
English: In addition, it is recommended to treat the environment with a suitable insecticide.
Estonian: Lisaks on soovitav töödelda keskkonda sobiva insektitsiidiga.
English: These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.
Estonian: Need tulemused on kooskõlas laboratoorsete toimeuuringutega, mis näitasid toimet kuni 56 päeva vältel pärast manustamist.
English: Children should not be allowed to play with treated animals until the application site is dry.
Estonian: Lastel ei tohi lubada mängida ravitud loomadega kuni manustamiskoht on kuivanud.
English: The solvent in ProMeris may stain certain materials including leather, fabrics, plastics and finished surfaces.
Estonian: ProMerise lahusti võib jätta plekke teatud materjalidele, kaasaarvatud nahale, riidele, plastikule ja lõppviimistletud pindadele.
English: Metaflumizone (mg)
Estonian: Metaflumisoon (mg)
English: Avoid direct contact with treated animals until the application site is dry.
Estonian: Hoiduda otsekontaktist ravitud loomadega, kuni manustamiskoht on kuiv.
English: After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Estonian: Pärast lokaalset manustamist ühele kohale kassi kuklal koljubaasi juures olid metaflumisooni plasmakontsentratsioonid liiga madalad, et võimaldada standardsete farmakokineetiliste parameetrite arvutamist.
English: It is therefore recommended to treat the animals during the evening and that recently treated animals are not allowed to sleep with owners, especially children.
Estonian: Seetõttu soovitatakse manustada ravimit loomadele õhtul, samuti mitte lubada hiljuti ravitud loomadel magada koos omanikega, eriti lastega.
English: Correct application will minimise licking of the application site.
Estonian: Õige manustamismetoodika minimeerib manustamiskoha lakkumist.
English: Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects.
Estonian: Metaflumisoon on naatriumikanalite antagonist ja pärsib närvifunktsioone, kutsudes selle tulemusena esile parasiidi halvatuse ja surma.
English: Do not administer orally or via any other route.
Estonian: Mitte manustada suukaudselt või mingil muul viisil.
English: Wash hands thoroughly after use.
Estonian: Pärast kasutamist pesta käed.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C
Estonian: SÄILITAMISE ERITINGIMUSED Mitte hoida temperatuuril üle 25°C
English: Carefully dispose of used pipettes immediately after use.
Estonian: Kasutatud pipetid kohe pärast kasutamist hoolikalt ära visata.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris L
Estonian: VETERINAARRAVIMI NIMETUS ProMeris L
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Estonian: TEKSTI ÜLEVAATAMISE KUUPÄEV Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt aadressil http://www.ema.europa.eu
English: The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package.
Estonian: Veterinaarpreparaat on pakendatud üksikdoosi sisaldavatesse läbipaistvatesse plastikpipettidesse, mis on omakorda pakendatud alumiiniumfooliumisse.
English: Metaflumizone was still measurable in the hair 56 days following treatment.
Estonian: Metaflumisooni oli karvades võimalik määrata 56 päeva pärast manustamist.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Estonian: 4.10 Üleannustamine (sümptomid, esmaabi, antidoodid), vajadusel 8 nädala vanustel ja vanematel kassidel, kellele manustati 3- kuni 5-kordne soovituslik doos 7 korda kahenädalaste intervallidega, ei täheldatud mingeid kõrvaltoimeid.
English: If the veterinary medicinal product accidentally gets into eyes, flush the eyes thoroughly with water.
Estonian: Juhuslikul ravimi sattumisel silma loputada silma põhjalikult veega.
English: The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight.
Estonian: Minimaalne soovituslik doos on 40 mg metaflumisooni/kg kehamassi kohta, mis võrdub 0,20ml/kg kehamassi kohta.
English: In rare cases, transient irritation may occur at the site of the product application.
Estonian: Harvadel juhtudel võib esineda preparaadi manustamise kohal mööduvat ärritust.
English: For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Estonian: Kirbuinvasiooni optimaalseks kontrolliks tuleks veterinaarpreparaati manustada 4 kuni 6 nädalaste intervallidega kogu kirbuhooaja vältel või tugineda raviskeemi koostamisel kohalikule epidemioloogilisele olukorrale.
English: DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Estonian: PAKENDI INFOLEHE VIIMASE KOOSKÕLASTAMISE KUUPÄEV Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt aadressil http://www.ema.europa.eu
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001-004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/064/001-004
English: The top of the tip will fold back against the pipette.
Estonian: Pipetiotsa tipp paindub tagasi vastu pipetti.
English: The veterinary medicinal product will prevent flea infestation for up to 6 weeks following a single administration depending on the level of environmental rechallenge.
Estonian: Veterinaarpreparaat hoiab kirbuinvasiooni ära kuni 6 nädala vältel pärast ühekordset manustamist, sõltuvalt keskkonna kirbuinvasiooni intensiivsusest.
English: For cutaneous use only.
Estonian: Ainult kutaanseks kasutamiseks.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Estonian: B. HANKE- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD Veterinaarne retseptiravim.
English: Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents.
Estonian: Asetada pipeti ots vastu nahka ja tühjendada vajutades kogu pipeti sisu nahale.
English: Gamma-hexalactone
Estonian: Gamma-heksalaktoon
English: The following table defines the size of pipette to be used according to the weight of the cat.
Estonian: Järgnev tabel toob ära kasutatava pipeti suuruse vastavalt kassi kehamassile.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years 6.4.
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 3 aastat.
English: 4.2 Indications for use, specifying the target species Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Estonian: 4.2 Näidustused, määrates kindlaks vastavad loomaliigid Kirbuinvasiooni (Ctenocephalides canis ja C. felis) raviks ja tõrjeks kassidel.
English: In case of accidental spillage onto skin, wash off immediately with soap and water.
Estonian: Ravimi sattumisel nahale pesta koheselt vee ja seebiga.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For cutaneous use only.
Estonian: MANUSTAMISVIIS JA -TEE(D) Ainult kutaanseks manustamiseks.
English: In sick or debilitated animals, use only according to the benefit/risk assessment by the responsible veterinarian.
Estonian: Haigetel või nõrkadel loomadel kasutada ainult vastavalt loomaarsti tehtud kasu-riski suhte hinnangule.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 320 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 320 mg
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site.
Estonian: Veterinaarpreparaadi manustamine võib põhjustada karvastiku lokaalset, ajutist kokkukleepumist ja õlist väljanägemist manustamiskohal.
English: Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania Italy
Estonian: 18, Via Franco Gorgone 95121 Catania Itaalia
English: Metaflumizone is an ectoparasiticide belonging to the semicarbazone group of compounds.
Estonian: Metaflumisoon on semikarbasoonide hulka kuuluv ektoparasititsiid.
English: Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line.
Estonian: Hoides pipetti püstiasendis, painutada pipeti otsa, et murda ots mööda märgistatud joont.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 160 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 160 mg
English: For use only under the supervision of a veterinary surgeon.
Estonian: Kasutamiseks ainult veterinaarse järelevalve all.
English: Excipients For a full list of excipients, see section 6.1.
Estonian: Abiaine(d): Abiainete terviklik loetelu on esitatud punktis 6.1.
English: Consult your veterinarian before using the veterinary medicinal product on sick or debilitated cats.
Estonian: Enne veterinaarpreparaadi manustamist haigetele ja nõrkadele kassidele pidada nõu loomaarstiga.
English: ProMeris for Large Cats (> 4 kg)* *Due to limited space on the packaging, the abbreviations "S" and "L", which represent "small" and "large", respectively, are used on the blister foil and applicator pipettes.
Estonian: Seoses piiratud ruumiga pakendil kasutatakse blisteritel ja aplikaatorpipettidel lühendeid „S“, ja „L“, mis tähendavad vastavalt „väikestele“ ja „suurtele“.
English: Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.
Estonian: Iga veterinaarpreparaadi tugevus on saadaval ühte ja kahte 3 pipetiga blisterkaarti sisaldavas pappkarbis.
English: No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Estonian: 8 nädala vanustel ja vanematel kassidel, kellele manustati 3- kuni 5-kordne soovituslik doos 7 korda kahenädalaste intervallidega, ei täheldatud mingeid kõrvaltoimeid.
English: After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone is rapidly distributed throughout the surface of the skin.
Estonian: Pärast lokaalset manustamist ühele kohale kassi kuklal koljubaasi juures jaotub metaflumisoon kiiresti üle kogu nahapinna.
English: Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.
Estonian: Tuleb jälgida, et pipeti sisu ega manustatav doos ei satuks ravitava looma ja/või teiste loomade silmae või suhu.
English: Do not smoke, drink or eat while handling the veterinary medicinal product.
Estonian: Veterinaarpreparaadiga töötamise ajal on keelatud suitsetada, süüa või juua.
English: Active substance: 160 mg metaflumizone
Estonian: Toimeaine: 160 mg metaflumisooni
English: Active substance: 320 mg metaflumizone
Estonian: Toimeaine: 320 mg metaflumisooni
English: Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Estonian: Kirbuinvasiooni (Ctenocephalides canis ja C. felis) raviks ja tõrjeks kassidel.
English: Do not apply the veterinary medicinal product to the surface of the cat's hair coat.
Estonian: Mitte manustada veterinaarpreparaati kassi karvastiku pinnale.
English: The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Estonian: Ravimit võib kasutada komponendina kirbuallergiast põhjustatud dermatiidi ravis.
English: Cats over 8 weeks of age.
Estonian: Üle 8 nädala vanused kassid
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris S
Estonian: VETERINAARRAVIMI NIMETUS ProMeris S
English: Part the fur on the cat's neck at the base of the skull until the skin is visible.
Estonian: Lükata karv koljubaasi juures laiali, kuni nahk on nähtav.
English: Remove the pipette from the package.
Estonian: Eemaldada pipett pakendist.
English: For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Estonian: Mitme lemmikloomaga majapidamistes tuleks kirbuprobleemi optimaalseks kontrolli alla saamiseks ravida insektitsiididega kõiki loomi.
English: This veterinary medicinal product is for spot-on application only.
Estonian: See veterinaarravim on ainult välispidiseks manustamiseks täpilahusena.
English: For animal treatment only - to be supplied only on veterinary prescription.
Estonian: Ainult veterinaarseks kasutamiseks ─ tarnida üksnes veterinaararsti retsepti olemasolul.
English: Apply the content of the pipette to a single spot on the skin of the cat's neck at the base of the skull.
Estonian: Manustada pipeti sisu ühele kohale kassi kuklal koljubaasi juures.
English: C. STATEMENT OF THE MRLs Not applicable
Estonian: C. RAVIMJÄÄKIDE PIIRNORMID Ei kohaldata.
English: It is important to apply the dose to an area where the animal cannot lick it off. Do not allow animals to groom each other following treatment.
Estonian: Oluline on manustada doos nahale piirkonnas, kus looma ei saa seda ise ära lakkuda.
English: Metaflumizone is active against fleas due to non-systemic exposure of the parasites on the skin and hair.
Estonian: Metaflumisoon toimib kirpudesse mittesüsteemse kokkupuute kaudu parasiitidega nahal ja karvadel.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.60 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 1,60 ml pipett sisaldab:
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS , IF ANY
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD PREPARAADI VÕI NENDE JÄÄTMETE, KUI NEID TEKIB, HÄVITAMISEL
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001 - 1 blister card of 3 pipettes of 0.80 ml EU/2/06/064/002 - 2 blister cards of 3 pipettes of 0.80 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/064/001 - 1 blisterkaart 3 x 0,80 ml pipetiga EU/2/06/064/002 - 2 blisterkaarti 3 x 0,80 ml pipetiga
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Estonian: D. MUUD TINGIMUSED JA NÕUDED MÜÜGILOALE Ravimiohutuse järelevalve süsteem
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/003 - 1 blister card of 3 pipettes of 1.60 ml EU/2/06/064/004 - 2 blister cards of 3 pipettes of 1.60 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/064/003 - 1 blisterkaart 3 x 1,60 ml pipetiga EU/2/06/064/004 - 2 blisterkaarti 3 x 1,60 ml pipetiga
English: INDICATION(S) For the treatment and prevention of infestations by fleas.
Estonian: NÄIDUSTUS(ED) Kirbuinvasiooni raviks ja tõrjeks.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.80 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 0,80 ml pipett sisaldab:
English: ProMeris for Large Cats (> 4 kg)
Estonian: ProMeris suurtele kassidele (> 4 kg)
English: It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box.
Estonian: Ühel pappkaardil asetseb kolm pipetti, pappkarbis sisaldub üks või kaks kolmepipetilist pappkaarti.
English: Hypersalivation may occur if the animal licks the application site immediately after treatment.
Estonian: Kui loom lakub manustamiskohta kohe pärast ravimi manustamist, võib esineda hüpersalivatsiooni.
English: Manufacturer for the batch release Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania
Estonian: 18, Via Franco Gorgone 95121 Catania
English: CONTRAINDICATIONS
Estonian: ERIHOIATUSED
English: NAME OF THE MARKETING AUTHORISATION HOLDER PFIZER
Estonian: MÜÜGILOAHOIDJA PFIZER
English: ProMeris for Small Cats (≤ 4 kg)*
Estonian: ProMeris väikestele kassidele (≤ 4 kg)*
English: ProMeris for Small Cats (≤ 4 kg)
Estonian: ProMeris väikestele kassidele (≤ 4 kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats {< 4 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris 160 mg Spot-on Täpilahus väikestele kassidele {≤ 4 kg}
English: PACKAGE LEAFLET ProMeris Spot-on for cats
Estonian: PAKENDI INFOLEHT ProMeris täpilahus kassidele
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 320 mg Spot-on for large cats {> 4 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris 320 mg Spot-on Täpilahus suurtele kassidele {> 4 kg}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats ProMeris 320 mg Spot-on for large cats
Estonian: VETERINAARRAVIMI NIMETUS ProMeris 160 mg täpilahus väikestele kassidele ProMeris 320 mg täpilahus suurtele kassidele
English: TARGET SPECIES For cats over 8 weeks of age.
Estonian: LOOMALIIGID Üle 8 nädala vanused kassid.
English: Carton box for 2 blister cards
Estonian: Pappkarp 1 blisterkaardiga -Pappkarp 2 blisterkaardiga
English: Do not use in kittens under 8 weeks of age.
Estonian: VASTUNÄIDUSTUSED Mitte manustada all 8 nädala vanustele kassipoegadele.
English: Box of 1 blister card of 3 x 1.60 ml pipettes Box of 2 blister cards of 3 x 1.60 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaartl 3 x 1,60 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 1,60 ml pipetiga
English: WITHDRAWAL PERIOD Not applicable
Estonian: KEELUAJAD Ei rakendata.
English: Box of 1 blister card of 3 x 0.80 ml pipettes Box of 2 blister cards of 3 x 0.80 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaart 3 x 0,80 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 0,80 ml pipetiga
English: Do not administer to kittens under 8 weeks of age.
Estonian: Mitte manustada alla 8 nädala vanustele kassipoegadele.
English: Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.
Estonian: Hoiduda ravimi kokkupuutest kassi silmadega ja ravimi suukaudsest sattumisest looma organismi.
English: PHARMACEUTICAL FORM Spot-on solution
Estonian: RAVIMVORM Täpilahus
English: Box of 1 or 2 blister card of 3 x 0.80 ml pipettes Box of 1 or 2 blister card of 3 x 1.60 ml pipettes
Estonian: Pappkarp 1 või 2 blisterkaardiga, millel on 3 x 1,60 ml pipetti.
English: Weight Of Cat (kg)
Estonian: Kassi kehamass (kg)
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage:
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISTEE(D) JA -MEETOD
English: 4.5 Special precautions for use
Estonian: 6.4 Säilitamise eritingimused
English: Ibuprofen
Estonian: Ibuprofeen
English: In view of the elements described above, BfArM considered that there was a need to take action at EU level.
Estonian: Arvestades ülalkirjeldatud osasid, leidis BfArm, et tuleb tegutseda ELi tasemel.
English: Conclusions
Estonian: Järeldused
English: Riluzole
Estonian: Rilusool
English: It has been highlighted that all the CAPAs agreed after the BfArM/IGZ inspection have been either implemented (for critical observations) or committed to (for other observations).
Estonian: Toodi välja, et kõiki BfArm/IGZ kontrolli järel välja toodud parandus- ja ennetusmeetmeid kas rakendatakse (kriitiliste tähelepanekute kohta) või võetakse kasutusele (teiste tähelepanekute kohta).
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories;
Estonian: • komitee vaatas läbi kõik olemasolevad andmed ja müügiloa hoidjate/taotleja esitatud teabe, samuti Alkem Laboratoriesi antud teabe;
English: However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal.
Estonian: Inimravimite komitee on siiski seisukohal, et ravimiohutuse järelevalve signaalide tuvastamata jätmine ei anna piisavat kindlustunnet, sest ei ole kindlaks tehtud, et ravimiohutuse järelevalvega seotud tegevus võib olla kavandatud selliste signaalide tuvastamiseks.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that:
Estonian: Sel põhjusel otsustab inimravimite komitee direktiivi 2001/83/EÜ artiklite 31 ja 32 kohaselt järgmist.
English: Three bioequivalence trials, two performed in 2013 and one performed in 2014, were inspected.
Estonian: Kontrolliti kolme bioekvivalentsuse uuringut, millest kaks viidi läbi 2013. aastal ja üks 2014. aastal.
English: A later MHRA inspection (March 2016) has also resulted in one critical and 2 major observations, for which CAPAs have already been agreed with the inspectors.
Estonian: Hilisemal MHRA (Ühendkuningriigi järelevalveasutuste inspektorid) kontrollil (märtsis 2016) tuvastati samuti üks kriitiline ja kaks olulist tähelepanekut, mille kohta on parandus- ja ennetusmeetmed juba kokku lepitud.
English: The Federal Institute of Drugs and Medical Devices (BfArM), Germany, and the Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands performed a joint GCP inspection from 9 - 12 March 2015 at Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, India (Inspection references: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).
Estonian: Saksamaa ravimite ja meditsiinseadmete föderaalne instituut (BfArM) ja Madalmaade tervishoiuministeeriumi tervishoiu inspektsioon (IGZ) viisid läbi ühise heade kliiniliste tavade ülevaatuse 9.-12. märtsil 2015 asutuses Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, India (Ülevaatuse esildised: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).