FrancophonIA/ELRC3.0 huggingface dataset:
English: After topical administration at a single site at the base of the skull, both metaflumizone and amitraz were rapidly distributed throughout the surface of the skin.
Estonian: Pärast lokaalset manustamist ühele kohale koljubaasi juures, jaotusid nii metaflumisoon kui amitraas kiiresti üle kogu nahapinna..
English: It is important to apply the dose to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Estonian: Oluline on manustada doos nahale piirkonnas, kus loom ei saa seda ise ära lakkuda.
English: The use of protective gloves while handling the product is recommended.
Estonian: Soovitav on preparaadiga töötamisel kasutada kaitsekindaid.
English: In case of accidental spillage onto skin, wash off immediately with soap and water.
Estonian: Ravimi juhuslikul sattumisel nahale pesta koheselt vee ja seebiga.
English: Dogs over 8 weeks of age
Estonian: Üle 8 nädala vanused koerad.
English: Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Estonian: Üks ml sisaldab 150 mg metaflumisooni ja 150 mg amitraasi.
English: Known side-effects of amitraz and metabolites are sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing.
Estonian: Amitraasi teadaolevateks kõrvaltoimeteks on sedatsioon, letargia, KNS depressioon, hüperglükeemia, bradükardia ja aeglane, pinnapealne hingamine.
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 putukate halvatuse ja surma.
English: For a full list of excipients, see section 6.1.
Estonian: Abiaine(d): Abiainete terviklik loetelu on esitatud punktis 6.1.
English: Dogs should be prevented from accessing streams and rivers for the 24-hour period following treatment.
Estonian: Koerte pääsu veekogude juurde tuleks takistada 24 h jooksul pärast ravimi manustamist.
English: If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.
Estonian: Kõrvaltoimete ilmnemisel pärast preparaadiga kokku puutumist pöörduda viivitamatult arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: Weight Range of Dog (kg)
Estonian: Koera kehamassi vahemik (kg)
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site.
Estonian: Veterinaarpreparaadi manustamine võib põhjustada karvastiku lokaalset, ajutist kokkukleepumist ja õlist väljanägemist manustamiskohal.
English: Metaflumizone and amitraz are combined in the final formulation to provide a broad spectrum of activity against both fleas and ticks, respectively, due to non-systemic exposure of the parasites on the skin and hair.
Estonian: Metaflumisoon ja amitraas on lõppproduktis kombineeritud, et tagada laia toimespektrit nii kirpude kui ka puukide vastu, toimides neisse mittesüsteemse kokkupuute kaudu parasiitidega nahal ja karvadel.
English: Do not administer to puppies under 8 weeks of age.
Estonian: Mitte manustada all 8 nädala vanustele kutsikatele.
English: and lice (Trichodectes canis) in dogs.
Estonian: ning täide (Trichodectes canis) tõrjeks koertel.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Estonian: Kasutamata veterinaarravimid või nende jäätmed tuleb hävitada vastavalt kohalikule seadusandlusele
English: Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
Estonian: Teiste amitraasi sisaldavate preparaatide kasutamine samaaegselt ProMeris Duo täpilahusega koertele pole soovitav.
English: Part the hair and apply the contents of the pipette to a single spot on the skin of the dog at the base of the skull.
Estonian: Lükata karv laiali ja manustada pipeti sisu naha peale ühele kohale koera kuklal koljubaasi juures.
English: In very rare cases, pemphigus foliaceous-like cutaneous signs have been reported.
Estonian: Väga harva on teatatud lehtja vill-lööbe sarnastest nahanähtudest.
English: Do not apply the veterinary medicinal product to the surface of the dog's hair coat.
Estonian: Mitte manustada veterinaarpreparaati koera karvastiku pinnale.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Estonian: TOOTJAPOOLNE PARTII NUMBER Partii{number}
English: ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
Estonian: ProMeris Duo 100,5 mg + 100,5 mg täpilahus väikestele koertele ProMeris Duo 199,5 mg + 199,5 mg täpilahus keskmisekasvulistele koertele ProMeris Duo 499,5 mg + 499,5 mg täpilahus keskmisekasvulistele/suurtele koertele ProMeris Duo 799,5 mg + 799,5 mg täpilahus suurtele koertele ProMeris Duo 999 mg + 999 mg täpilahus ülisuurtele koertele
English: The veterinary medicinal product remains effective if the animal becomes wet.
Estonian: Veterinaarpreparaat säilitab oma toime ka looma märjakssaamise korral.
English: For further information see package leaflet.
Estonian: Täpsemat informatsiooni lugeda pakendi infolehelt.
English: for Small Dogs (≤ 5 kg) for Medium Sized Dogs - (5.1 - 10.0 kg) for Medium/Large Sized Dogs (10.1 - 25.0 kg) for Large Dogs (25.1 - 40.0 kg) for Extra Large Dogs (40.1 - 50.0 kg)
Estonian: väikestele koertele (≤ 5 kg) keskmisekasvulistele koertele - (5,1-10,0 kg) keskmisekasvulistele/suurtele koertele (10,1-25,0 kg) suurtele koertele (25,1- 0,0 kg) ülisuurtele koertele (40,1- 0,0 kg)
English: BATCH NUMBER LOT {number}
Estonian: PARTII NUMBER LOT {number}
English: TARGET SPECIES For dogs over 8 weeks of age.
Estonian: LOOMALIIGID Üle 8 nädala vanused koerad.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001-010
Estonian: EU/2/06/065/001-010
English: Each unit dose (pipette) of ProMeris Duo delivers: ProMeris Duo Spot-on for Dogs
Estonian: Iga ProMeris Duo üksikdoos (pipett) sisaldab: ProMeris Duo täpilahus
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substances
Estonian: TOIMEAINE(D) JA MUUD ABIAINE(D) Toimeained:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription 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: PHARMACEUTICAL PARTICULARS 6.1 List of excipients N, N-Diethyl-m-toluamide 1-Methoxy-2-propyl-acetate Dimethyl sulfoxide
Estonian: Abiainete loetelu N, N-dietüül-m-toluamiid 1-metoksü-2-propüül-atsetaat
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Estonian: MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS” Ainult veterinaarseks kasutamiseks
English: Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.
Estonian: Hoiduda ravimi sattumisest koera silma ja suu kaudu looma organismi.
English: For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and lice.
Estonian: NÄIDUSTUS(ED) Kirbu- ja puugiinvasiooni raviks ja tõrjeks ja demodikoosi raviks ning täide tõrjeks.
English: Dermal exposure to the product should therefore be avoided.
Estonian: Seetõttu tuleks hoiduda naha kokkupuutest veterinaarpreparaadiga.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 6.66 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 6,66 ml pipett sisaldab:
English: 5.3 Environmental properties
Estonian: Keskkonnaomadused
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium/large sized dogs
Estonian: Keskmisekasvulistele/suurtele koertele
English: Active substance: 100.5 mg metaflumizone and 100.5 mg amitraz
Estonian: Toimeaine: 100,5 mg metaflumisooni ja 100,5 mg amitraasi.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.67 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 0,67 ml pipett sisaldab:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo 100,5 mg + 100,5 mg täpilahus väikestele koertele {≤ 5 kg}
English: ProMeris Duo for Small Dogs 5.1 - 10.0 ProMeris Duo Medium Sized Dogs 10.1 - 25.0 ProMeris Duo Spot-on for Medium/Large Sized Dogs 25.1 - 40.0 ProMeris Duo Spot-on for Large Dogs 40.1 - 50.0 ProMeris Duo Spot-on for Extra Large Dogs
Estonian: ProMeris Duo väikestele koertele ProMeris Duo keskmisekasvulistele koertele 10,1 - 25,0 ProMeris Duo keskmisekasvulistele/suurtele koertele ProMeris Duo suurtele koertele ProMeris Duo ülisuurtele koertele
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 999 mg + 999 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 999 mg + 999 mg
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 100.5 mg + 100.5 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 100,5 mg + 100,5 mg
English: Active substance: 999 mg metaflumizone and 999 mg amitraz
Estonian: Toimeaine: 999 mg metaflumisooni ja 999 mg amitrazi.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 799.5 mg + 799.5 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 799,5 mg + 799,5 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 0.67ml
Estonian: Fooliumpakend 0,67 ml
English: 1, 8-Cineole
Estonian: Dimetüülsulfoksiid 1, 8-tsineool Gamma-heksalaktoon
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 499.5 mg + 499.5 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 499,5 mg + 499,5 mg
English: Active substance: 799.5 mg metaflumizone and 799.5 mg amitraz
Estonian: Toimeaine: 799,5 mg metaflumisooni ja 799,5 mg amitraasi.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 199.5 mg + 199.5 mg
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 199,5 mg + 199,5 mg
English: This is normal and will generally resolve within a few days after administration, though may persist longer on rare occasions.
Estonian: See on normaalne ja kaob tavaliselt 1-4 päeva jooksul pärast manustamist.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M/L
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo M/L Täpilahus
English: Active substance: 499.5 mg metaflumizone and 499.5 mg amitraz
Estonian: Toimeaine: 499,5 mg metaflumisooni ja 499,5 mg amitraasi.
English: Box of 1 blister card of 3 x 6.66 ml pipettes Box of 2 blister cards of 3 x 6.66 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaart 3 x 6,66 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 6,66 ml pipetiga
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs {10.1 - 25.0 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo 499,5 mg + 499,5 mg täpilahus keskmisekasvulistele/suurtele koertele {10,1 - 25,0 kg}
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 6.66ml
Estonian: Fooliumpakend 6.66 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 - 40.0 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo 799,5 mg + 799,5 mg täpilahus suurtele koertele {25,1 - 40,0 kg}
English: Active substance: 199.5 mg metaflumizone and 199.5 mg amitraz
Estonian: Toimeaine: 199,5 mg metaflumisooni ja 199,5 mg amitrazi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card - Carton box for 2 blister cards
Estonian: Pappkarp 1 blisterkaardiga -Pappkarp 2 blisterkaardiga
English: Do not allow puppies to lick the application site of their mothers when it is still wet.
Estonian: Kuni emasloomadel on manustamiskoht märg, mitte lasta kutsikatel seda lakkuda.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 3.33 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 3,33 ml pipett sisaldab:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.33 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 1,33 ml pipett sisaldab:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 - 10.0 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo 199,5 mg + 199,5 mg täpilahus keskmisekasvulistele koertele {5,1 - 10,0 kg}
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 5.33 ml pipette delivers:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Iga 5,33 ml pipett sisaldab:
English: Box of 1 blister card of 3 x 0.67 ml pipettes Box of 2 blister cards of 3 x 0.67 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaart 3 x 0,67 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 0,67 ml pipetiga
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 - 50.0 kg}
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo 999 mg + 999 mg täpilahus ülisuurtele koertele {40,1 - 50,0 kg}
English: Do not use after the expiry date stated on the carton after “EXP”.
Estonian: Pärast pakendil märgitud kõlblikkusaja lõppu mitte kasutada.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/009 - 1 blister card of 3 pipettes of 6.66 ml EU/2/06/065/010 - 2 blister cards of 3 pipettes of 6.66 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/065/009 - 1 blisterkaart 3 x 6,66 ml pipetiga EU/2/06/065/010 - 2 blisterkaarti 3 x 6,66 ml pipetiga
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo XL
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo XL
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo M
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo M
English: Box of 1 blister card of 3 x 5.33 ml pipettes Box of 2 blister cards of 3 x 5.33 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaart 3 x 5,33 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 5,33 ml pipetiga
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 1.33ml
Estonian: Fooliumpakend 1.33 ml
English: Excipients
Estonian: Täpilahus
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 5.33ml
Estonian: Fooliumpakend 5.33 ml
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for medium sized dogs
Estonian: Keskmisekasvulistele koertele
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/007 - 1 blister card of 3 pipettes of 5.33 ml EU/2/06/065/008 - 2 blister cards of 3 pipettes of 5.33 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/065/007 - 1 blisterkaart 3 x 5,33 ml pipetiga EU/2/06/065/008 - 2 blisterkaarti 3 x 5,33 ml pipetiga
English: Box of 1 blister card of 3 x 1.33 ml pipettes Box of 2 blister cards of 3 x 1.33 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaart 3 x 1,33 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 1,33 ml pipetiga
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 3.33ml
Estonian: Fooliumpakend 3.33 ml
English: Box of 1 blister card of 3 x 3.33 ml pipettes Box of 2 blister cards of 3 x 3.33 ml pipettes
Estonian: Pappkarp, milles on 1 blisterkaart 3 x 3,33 ml pipetiga Pappkarp, milles on 2 blisterkaarti 3 x 3,33 ml pipetiga
English: Treatment schedule:
Estonian: Keeluaeg
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/001 - 1 blister card of 3 pipettes of 0.67ml EU/2/06/065/002 - 2 blister cards of 3 pipettes of 0.67ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/065/001 - 1 blisterkaart 3 x 0,67 ml pipetiga EU/2/06/065/002 - 2 blisterkaarti 3 x 0,67 ml pipetiga
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/003 - 1 blister card of 3 pipettes of 1.33ml EU/2/06/065/004 - 2 blister cards of 3 pipettes of 1.33ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/065/003 - 1 blisterkaart 3 x 1,33 ml pipetiga EU/2/06/065/004 - 2 blisterkaarti 3 x 1,33 ml pipetiga
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo L
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo L
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/065/005 - 1 blister card of 3 pipettes of 3.33 ml EU/2/06/065/006 - 2 blister cards of 3 pipettes of 3.33 ml
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/06/065/005 - 1 blisterkaart 3 x 3,33 ml pipetiga EU/2/06/065/006 - 2 blisterkaarti 3 x 3,33 ml pipetiga
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo S
Estonian: VETERINAARRAVIMI NIMETUS ProMeris Duo S
English: Kent CT13 9NJ
Estonian: Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for small dogs
Estonian: MIINIMUMNÕUDED ANDMETE OSAS, MIS PEAVAD OLEMA ÄRA MÄRGITUD VÄIKESEL VAHETUL SISEPAKENDIL
English: Patients were followed up for 3 years and could be given repeat treatment if appropriate.
Estonian: Patsiente jälgiti 3 aasta vältel ja nad võisid saada kordusravi, kui asjakohane.
English: Ozurdex received a marketing authorisation valid throughout the European Union on 27 July 2010.
Estonian: Ozurdex on saanud müügiloa, mis kehtib kogu ELis, 27. juulil 2010.
English: Further information on Ozurdex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ozurdex.
Estonian: Lisateave Ozurdexi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/ozurdex.
English: In addition, injections do not need to be given frequently because the implant stays in the eye for several months.
Estonian: Lisaks ei pea süste tegema sageli, sest implantaat on silmas mitu kuud.
English: Further treatments can be given if the patient's condition improves but then gets worse and if the doctor believes that the patient will benefit from further treatment.
Estonian: Patsiendile võib teha ka lisaravi, kui tema seisund alguses paraneb, kuid seejärel halveneb, ning kui arst arvab, et lisaravi on patsiendile kasulik.
English: What measures are being taken to ensure the safe and effective use of Ozurdex?
Estonian: Mis meetmed võetakse, et tagada Ozurdexi ohutu ja efektiivne kasutamine?
English: The implant is made of a material that dissolves over several months while gradually releasing the dexamethasone.
Estonian: Implantaat koosneb materjalist, mis lahustub mitme kuu jooksul, vabastades järk-järgult deksametasooni.
English: Ozurdex (dexamethasone)
Estonian: Ozurdex (deksametasoon)
English: As for all medicines, data on the use of Ozurdex are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Ozurdexi kasutamise kohta pidevat järelevalvet.
English: Side effects reported with Ozurdex are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ozurdexi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Other information about Ozurdex
Estonian: Muu teave Ozurdexi kohta
English: Eyesight was measured using the ‘best corrected visual acuity' (BCVA) indicating how well a person can see (after they have been given corrective lenses).
Estonian: Nägemist mõõdeti parima korrigeeritud nägemisteravusega (BCVA), mis näitab, kui hästi inimene näeb (pärast korrigeerivate läätsede saamist).
English: What is Ozurdex and what is it used for?
Estonian: Mis on Ozurdex ja milleks seda kasutatakse?
English: Each implant is in an applicator and contains 700 micrograms of the active substance, dexamethasone.
Estonian: Iga implantaat on aplikaatoris ning sisaldab 700 µg toimeainet deksametasooni.
English: Therefore the use of Ozurdex in patients with macular oedema related to diabetes was restricted to these two groups.
Estonian: Seetõttu piirati Ozurdexi kasutamine diabeediga seotud makulaarse ödeemiga patsientidel nende kahe rühmaga.
English: In addition, the company that makes Ozurdex will ensure that patients are provided an information pack, including a booklet and an audio CD.
Estonian: Lisaks tagab Ozurdexi tootjaettevõte, et patsiendid saavad teabepakme, mis sisaldab brošüüri ja audio-CDd.
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation.
Estonian: See toimib rakkudesse sisenedes ja blokeerides vaskulaarse endoteeli kasvufaktori (VEGF) ning prostaglandiinide (põletikus osalevad ained) tekke.
English: • damage to blood vessels caused by diabetes in patients who have an artificial lens in their eye or in whom other treatment did not work or was unsuitable.
Estonian: • diabeedist tingitud veresoonte kahjustumine patsientidel, kellel on silmas tehislääts või kellel muu ravi ei toiminud või kellele see ei sobi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ozurdex have been included in the summary of product characteristics and the package leaflet.
Estonian: Ozurdexi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: For more information about using Ozurdex, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Ozurdexi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: The bleeding is thought to be caused by the injection procedure and not by the medicine itself.
Estonian: Arvatakse, et verejooksu ei põhjusta ravim, vaid süstimine.
English: Why is Ozurdex authorised in the EU?
Estonian: Miks Ozurdex ELis heaks kiideti?
English: Patients whose vision gets better and stays better should not receive any more implants.
Estonian: Patsientidele, kellel nägemine paraneb ja jääb sellisena püsima, ei tohi lisaimplantaate süstida.
English: • blockage of the veins carrying blood from the back of the eye;
Estonian: • silma tagaosa veenide ummistumine;
English: In two main studies involving a total of 1,267 adults Ozurdex was more effective than the sham treatment at improving patients' eyesight.
Estonian: Kahes põhiuuringus, milles osales kokku 1267 täiskasvanut, oli Ozurdex patsientide nägemise parandamisel platseeboravist efektiivsem.
English: Patients whose vision is getting worse and is not improved by Ozurdex should also not receive any more implants.
Estonian: Patsientidele, kellel Ozurdex halvenevat nägemist ei paranda, ei tohi samuti lisaimplantaate süstida.
English: This ensures that adequate amounts of dexamethasone reach the area inside the eye where the inflammation in macular oedema and uveitis occurs.
Estonian: See tagab piisava koguse deksametasooni jõudmise silmasisesesse põletikupiirkonda, kus esineb makulaarne ödeem ja uveiit.
English: Macular oedema related to diabetes
Estonian: Diabeediga seotud makulaarne ödeem
English: The most common side effects with Ozurdex (which may affect more than 1 in 10 people) are increased intraocular pressure (the pressure inside the eye), conjunctival haemorrhage (bleeding from the membrane over the white of the eye) and cataract (clouding of the lens - in patients with uveitis and with diabetes).
Estonian: Ozurdexi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on suurenenud intraokulaarne rõhk (silma siserõhk), konjunktivaalne verejooks (silma kõvakesta katva membraani verejooks) ja kae (läätse hägunemine; uveiidiga ja diabeediga patsientidel).
English: Ozurdex must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes) and in patients with advanced glaucoma (damage to the nerve of the eye usually caused by high pressure inside the eye) that is not adequately controlled with medicines alone.
Estonian: Ozurdexi ei tohi kasutada patsiendid, kellel on silma- või silmaümbruse infektsioonid või kellel neid kahtlustatakse, samuti patsiendid, kellel on kaugelearenenud glaukoom (silmanärvi kahjustus, mis on enamasti tingitud silma kõrgest siserõhust) ja mis ei ole piisavalt hallatav üksnes ravimitega.