FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be permanently discontinued in case of renal toxicity, immune-mediated haemolytic anaemia (IMHA) and/or anaemia due to lack of regeneration, and if severe neutropenia, and/or severe diarrhoea and/or severe vomiting persist after dose reduction.
Estonian: Ravi tuleb lõplikult katkestada neerutoksilisuse korral, kui tekib immunoloogiliselt vahendatud hemolüütiline aneemia (IMHA) ja/või aneemia regeneratsiooni vähesuse tõttu ning kui raske neutropeenia ja/või raske kõhulahtisus ja/või raske oksendamine püsivad pärast annuse vähendamist.
English: If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
Estonian: Kui tablett regurgiteeritakse või oksendatakse välja rohkem kui 10 minuti jooksul pärast manustamist, ei tohi ravi korrata.
English: Overdose:
Estonian: Üleannustamine:
English: Children should not have close contact to treated dogs, treated dog faeces or vomit.
Estonian: Lapsed ei tohi kokku puutuda ravitavate koerte, nende väljaheidete ega oksega.
English: Medicines should not be disposed of via wastewater or household waste.
Estonian: Kasutamata jäänud ravimeid ega jäätmematerjali ei tohi ära visata kanalisatsiooni kaudu ega koos olmejäätmetega.
English: • is pregnant or nursing puppies,
Estonian: • ta on tiine või imetab kutsikaid,
English: • Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Estonian: • Aminotransferaaside (ALT või AST) tõus keskmise kestusega ligikaudu 29 päeva.
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD) that was derived from repeat dose toxicity studies in healthy Beagle dogs.
Estonian: Soovitatav ööpäevane annus 12,5 mg kehamassi kg kohta vastab maksimaalsele talutavale annusele (MTD), mis saadi korduvate annuste toksilisuse uuringutel tervetel Beagle'i koertel.
English: For oral use.
Estonian: Suukaudne manustamine.
English: In case of positive semiquantitative dipstick results (protein > 30 mg/dl), urinalysis should be performed to determine urinary protein creatinine (UPC) ratio, and a blood sample to measure creatinine, albumin and BUN.
Estonian: Positiivse semikvantitatiivse ribatesti tulemuse korral (valk ≥ 30 mg/dl) tuleb teha uriini analüüs, et määrata uriini valgu-kreatiniini (UPC) suhe, ja võtta vereproov, et määrata kreatiniin, albumiin ja vere uurea lämmastik (BUN).
English: 9 mg per kg bodyweight once daily as presented in the table below.
Estonian: 9 mg kehamassi kg kohta üks kord päevas alltoodud tabeli järgi.
English: • Mild or moderate neutropenia with a mean duration of approximately 24 days.
Estonian: • Kerge või mõõdukas neutropeenia keskmise kestusega ligikaudu 24 päeva.
English: ADVERSE REACTIONS Should I expect side effects for my dog during Masivet therapy?
Estonian: KÕRVALTOIMED Kas ma pean ootama, et mu koeral tekivad Masivetiga ravi ajal kõrvalnähud?
English: Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg) Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
Estonian: 150 mg masitiniibi (vastab 178.9 mg masitiniibmesülaadile).
English: Anaemia due to lack of regeneration, i.e. haemoglobin< 10 g/dl and reticulocytes < 80,000/mm
Estonian: Aneemia regeneratsiooni vähesuse tõttu, st hemoglobiin < 10 g/dl ja retikulotsüüte < 80 000/mm
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD).
Estonian: Soovitatav ööpäevane annus 12,5 mg kehamassi kg kohta vastab suurimale talutavale annusele (MTD).
English: Repeated dermal contact with masitinib may impair female fertility and foetal development.
Estonian: Korduv nahakontakt masitiniibiga võib mõjutada naiste fertiilsust ja põhjustada loote arengu häireid.
English: For any mast cell tumor treatable by syrgery, surgery should be the first choice of treatment.
Estonian: Iga kirurgiliselt ravitava nuumrakulise kasvaja puhul on esimeseks ravivalikuks lõikus.
English: Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Estonian: Aminotransferaaside (ALT või AST) tõus keskmise kestusega ligikaudu 29 päeva.
English: 6 mg per kg bodyweight once daily as presented in the table below.
Estonian: 6 mg kehamassi kg kohta üks kord päevas alltoodud tabeli järgi.
English: • Lipoma (mean duration 53 days).
Estonian: • Lipoom (keskmine kestus 53 päeva).
English: • Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively.
Estonian: • Letargia ja asteenia keskmise kestusega vastavalt ligikaudu 8 ja 40 päeva.
English: Each tablet contains either 50 mg or 150 mg of masitinib, which is the active substance.
Estonian: Üks tablett sisaldab kas 50 mg või 150 mg toimeainet masitiniibi.
English: In the case of adverse reactions, doses might be reduced to once daily doses of 9 mg/kg bodyweight (range 7.5-10.5 mg/kg) or 6 mg/kg bw (range 4.5-7.5 mg/kg) according to the tables below.
Estonian: Kõrvaltoimete korral saab annuseid vähendada 9 mg/kg-ni (ulatus 7,5-10,5 mg/kg) või 6 mg/kg-ni (ulatus 4,57,5 mg/kg) alltoodud tabelite järgi.
English: Do not use after the expiry date which is stated on the label after “EXP”.
Estonian: Pärast etiketil märgitud kõlblikkusaja lõppu mitte kasutada.
English: Haemoglobin < 10 g/dl and either free bilirubin > 1.5 ULN and haptoglobin < 0.1 g/dl or reticulocytes < 80,000/mm
Estonian: Hemoglobiin < 10 g/dl ja kas vaba bilirubiin > 1,5 ULN ja haptoglobiin < 0,1 g/dl või retikulotsüüdid < 80 000/mm
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILISTE TOIMEAINETE TOOTJA, KES VASTUTAB RAVIMIPARTII VÄLJASTAMISE EEST
English: If UPC ratio > 2, or creatinine > 1.5 upper limit of normal (ULN), or albumin < 0.75 lower limit of normal (LLN) or blood urea nitrogen (BUN) > 1.5 ULN, discontinue treatment.
Estonian: Kui UPC suhe on > 2 või kreatiniin on > 1,5 ×x normi ülemine piir (ULN) või albumiin on < 0,75 × normi alumine piir (LLN) või vere uurea lämmastik (BUN) on > 1,5 × ULN, katkestage ravi.
English: Do not use in pregnant or lactating bitches.
Estonian: Mitte kasutada tiinetel või lakteerivatel koertel.
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor.
Estonian: Farmakoterapeutiline rühm: proteiin-türosiinkinaasi inhibiitor, ATCvet kood: QL01XE90.
English: Lipoma (mean duration 53 days).
Estonian: Lipoom (keskmine kestus 53 päeva).
English: In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/dl), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
Estonian: Positiivse semikvantitatiivse ribatesti korral (valk ≥ 30 mg/dl) tehke uriini analüüs, et määrata uriini valgu-kreatiniini (UPC) suhe.
English: 12.1 Special precautions for use: Special warnings:
Estonian: Erihoiatused Erihoiatused:
English: Mild or moderate neutropenia with a mean duration of approximately 24 days.
Estonian: Kerge või mõõdukas neutropeenia keskmise kestusega ligikaudu 24 päeva.
English: Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7 days.
Estonian: Mõõdukas kuni raske aneemia (aplastiline/hemolüütiline) keskmise kestusega ligikaudu 7 päeva.
English: Albumin < 0.75 LLN or UPC >2
Estonian: Albumiin < 0,75 LLN või UPC > 2 (2. kord)
English: • is suffering from inadequate liver or renal function,
Estonian: • tal on maksa- või neerupuudulikkus,
English: Very common effects:
Estonian: Väga sagedased kõrvaltoimed
English: Name and address of the manufacturer responsible for batch release
Estonian: Ravimipartii väljastamise eest vastutavate tootja nimi ja aadress
English: • Cough (mean duration 23 days).
Estonian: • Köha (keskmine kestus 23 päeva).
English: 60 ml bottle containing 30 Masivet 150 mg film-coated tablets.
Estonian: 60 ml pudel sisaldab 30 Masivet 150 mg õhukese polümeerikattega tabletti.
English: days.
Estonian: 18 päeva.
English: Hepatic toxicity (ALT or AST elevation), neutropenia In case of an increase of ALT or AST > 3 ULN, decrease of neutrophil count < 2,000/mm or any other severe adverse events, treatment should be modified as follows: At the first occurrence, treatment should be interrupted until resolution, and then resumed at the same dose level;
Estonian: Maksatoksilisus (ALT või AST tõus), neutropeenia Kui ALT või AST tõusevad > 3 × ULN, neutrofiilide arv väheneb < 2000/mm või esinevad muud rasked kõrvaltoimed, tuleb ravi muuta järgmiselt.
English: Albumin < 0.75 LLN or UPC > 2
Estonian: Albumiin < 0,75 LLN või UPC > 2 (1. kord)
English: • Wear protective gloves while disposing of vomit, urine or faeces of treated dogs.
Estonian: • Kandke ravitavate koerte okset, uriini või väljaheiteid koristades kaitsekindaid.
English: Masitinib treatment should only be used in dogs with non-resectable mast cell tumours, which express the mutated c-kit tyrosine kinase receptor.
Estonian: Masitiniibravi tuleb kasutada ainult mitteresetseeritavate nuumrakuliste kasvajate korral, millel esineb muteerunud c-KIT türosiinkinaasi retseptori ekspressioon.
English: • Avoid skin contact with faeces, urine, and vomit of treated dogs.
Estonian: • Vältige nahakontakti ravitavate koerte väljaheite, uriini ja oksega.
English: 40 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Estonian: 40 ml pudel sisaldab 30 Masivet 50 mg õhukese polümeerikattega tabletti.
English: Lymphadenopathy (mean duration 47 days).
Estonian: Lümfadenopaatia (keskmine kestus 47 päeva).
English: • Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Estonian: • Söögiisu vähenemine või anoreksia keskmise kestusega vastavalt ligikaudu 45 päeva ja
English: Cough (mean duration 23 days).
Estonian: Köha (keskmine kestus 23 päeva).
English: • Oedema (mean duration of oedema was 7 days).
Estonian: • Tursed (keskmine tursete kestus oli 7 päeva).
English: Management of Hepatic Toxicity (ALT or AST)
Estonian: Maksatoksilisus (ALT või AST)
English: Manufacturer for batch release:
Estonian: Partii väljastamise eest vastutav tootja:
English: Cellulose, microcrystalline Povidone K30
Estonian: Mikrokristalne tselluloos, povidoon K30, seamaksapulber, krospovidoon, magneesiumstearaat.
English: • Lymphadenopathy (mean duration 47 days).
Estonian: • Lümfadenopaatia (keskmine kestus 47 päeva).
English: Titanium dioxide (E171) Sunset yellow (E110) aluminium lake.
Estonian: Tableti kate: makrogool 3350, polüvinüülalkohol, talk, titaandioksiid (E171), päikeseloojangukollane (E110) alumiiniumlakk.
English: • Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7
Estonian: • Mõõdukas kuni raske aneemia (aplastiline/hemolüütiline) keskmise kestusega ligikaudu 7 päeva.
English: Pig liver powder Crospovidone Magnesium stearate
Estonian: Koera kehamass kg mg mg väikse m mass suurem mass
English: MASIVET 50 mg film-coated tablets for dogs MASIVET 150 mg film-coated tablets for dogs
Estonian: MASIVET 50 mg, õhukese polümeerkattega tabletid koertele MASIVET 150 mg, õhukese polümeerkattega tabletid koertele
English: 3 avenue George V 75008 Paris
Estonian: 3 avenue George V FR-75008 Pariis Prantsusmaa
English: Oedema (mean duration of oedema was 7 days).
Estonian: Tursed (keskmine tursete kestus oli 7 päeva).
English: AB Science S.A. 3 avenue George V FR-75008 Paris France
Estonian: AB Science S.A. 3 avenue George V 75008 Pariis Prantsusmaa
English: CONTENTS
Estonian: Kõlblikkusaeg
English: 12.5 mg/kg bw Number of tablets per day
Estonian: 12,5 mg kehamassi kg kohta
English: White HDPE bottle closed with a thermosealable film and covered by a child-resistant closure cap. 30 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Estonian: Valge HDPE-pudel, mis on suletud termosulguva kilega ja kaetud lapsekindla korgiga.
English: 150 mg lower weight upper weight
Estonian: Koera kehakaal kg 50 mg 150 mg väiksem kaal suurem kaal
English: Masivet is for the treatment of dogs with non-resectable mast cell tumours (Grade 2 or 3) with a confirmed mutated c-kit tyrosine kinase receptor.
Estonian: Masivet on ette nähtud kindlaks tehtud muteerunud c-KIT türosiinkinaasi retseptoriga mitteresetseeritavate nuumrakuliste kasvajate (2 või 3 staadium) raviks koertel.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Estonian: TOIMEAINE(D) JA MUUD ABIAINED
English: Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor.
Estonian: Kindlaks tehtud muteerunud c-KIT türosiinkinaasi retseptoriga mitteresetseeritavate nuumrakuliste kasvajate (2. või 3. staadium) ravi koertel.
English: MASIVET is a light-orange, round, film-coated tablet.
Estonian: MASIVET on heleoranž ümmargune õhukese polümeerkattega tablett.
English: Discontinuation
Estonian: Keeluajad
English: Film-coated tablet
Estonian: Õhukese polümeerkattega tablett.
English: Dog body-weight in kg 50 mg
Estonian: Koera kehakaal kg 50 mg 150 mg väikse m kaal suure m kaal
English: Talc
Estonian: Masitiniib
English: 5.2 Pharmacokinetic particulars
Estonian: Farmakokineetilised omadused
English: WITHDRAWAL PERIOD
Estonian: Sagedased kõrvaltoimed
English: Mild to moderate alopecia with a mean duration of approximately 26 days.
Estonian: Kerge või mõõdukas alopeetsia keskmise kestusega ligikaudu 26 päeva.
English: < 2,000/mm st time)
Estonian: < 2000/mm (4. kord)
English: Interruption
Estonian: Vastunäidustus
English: MASIVET 150 mg film-coated tablets for dogs Masitinib
Estonian: MASIVET 150 mg õhukese polümeerkattega tabletid koertele.
English: MASIVET 50 mg film-coated tablets for dogs Masitinib
Estonian: MASIVET 50 mg õhukese polümeerkattega tabletid koertele.
English: Haemolytic anaemia, i.e. haemoglobin < 10 g/dl and haemolysis,
Estonian: Hemolüütiline aneemia, st hemoglobiin < 10 g/dl, hemolüüs, st vaba bilirubiin > 1,5 × ULN.
English: • Severe renal toxicity may occur in dogs suffering from renal disorders at the start of treatment
Estonian: • Raske neerutoksilisus võib esineda koertel, kellel on ravi algul neeruhäired (sealhulgas vere suur kreatiniinisisaldus või proteinuuria).
English: Mild to moderate hair loss with a mean duration of approximately 26 days.
Estonian: Kerge või mõõdukas karvakaotus keskmise kestusega ligikaudu 26 päeva.
English: Dog body-weight in kg
Estonian: Koera kehakaal kg mg mg väikse m kaal suurem kaal
English: Pregabalin Accord is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Estonian: Pregabalin Accordi turustatakse kapslitena (25, 50, 75, 100, 150, 200, 225 ja 300 mg) ja see on retseptiravim.
English: To stop treatment with Pregabalin Accord, the dose should be reduced gradually, over at least a week.
Estonian: Pregabalin Accordiga ravi katkestades tuleb annust järk-järgult vähendada vähemalt ühe nädala jooksul.
English: The full EPAR for Pregabalin Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Pregabalin Accordi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The exact way in which pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Estonian: Pregabaliini täpne toimemehhanism ei ole veel täielikult teada, kuid arvatakse, et see mõjutab viisi, kuidas kaltsium siseneb närvirakkudesse.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Accord?
Estonian: Mis meetmed võetakse, et tagada Pregabalin Accordi ohutu ja efektiivne kasutamine?
English: As for every medicine, the company provided studies on the quality of Pregabalin Accord.
Estonian: Nagu iga ravimi korral, esitas ettevõte uuringud ravimi Pregabalin Accord kvaliteedi kohta.
English: Pregabalin Accord pregabalin
Estonian: Pregabalin Accord pregabaliin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Accord on 28 August 2015.
Estonian: Euroopa Komisjon andis Pregabalin Accordi müügiloa, mis kehtib kogu Euroopa Liidus, 28. augustil
English: The Committee recommended that Pregabalin Accord be approved for use in the EU.
Estonian: Komitee soovitas Pregabalin Accordi kasutamise Euroopa Liidus heaks kiita.
English: Pregabalin Accord is a medicine used to treat adults with the following conditions:
Estonian: Pregabalin Accord on ravim, mida kasutatakse järgmiste haigusseisundite raviks täiskasvanutel:
English: The active substance in Pregabalin Accord, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Estonian: Pregabalin Accordi toimeaine pregabaliin sarnaneb struktuurilt organismi loodusliku neurotransmitteri gamma-aminobutüürhappega (GABA), kuid on teistsuguse bioloogilise toimega.
English: What is Pregabalin Accord and what is it used for?
Estonian: Mis on Pregabalin Accord ja milleks seda kasutatakse?
English: This means that Pregabalin Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Estonian: See tähendab, et Pregabalin Accord sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Lyrica, millel juba on Euroopa Liidus müügiluba.
English: Because Pregabalin Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Pregabalin Accord on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Accord has been shown to have comparable quality and to be bioequivalent to Lyrica.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pregabalin Accord võrreldav kvaliteet ja bioekvivalentsus ravimiga Lyrica.
English: Other information about Pregabalin Accord
Estonian: Muu teave Pregabalin Accordi kohta
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Accord have been included in the summary of product characteristics and the package leaflet.
Estonian: Pregabalin Accordi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Accord.
Estonian: Võrdlusravimiga Lyrica on juba tehtud toimeaine heakskiidetud kasutusviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Pregabalin Accord korrata.
English: Pregabalin Accord is a ‘generic medicine'.
Estonian: Pregabalin Accord on geneeriline ravim.
English: For practical information about using Pregabalin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Pregabalin Accordi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: It is not intended to provide practical advice on how to use Pregabalin Accord.
Estonian: Hindamisaruandes ei anta Pregabalin Accordi kasutamise praktilisi nõuandeid.
English: Why is Pregabalin Accord approved?
Estonian: Miks Pregabalin Accord heaks kiideti?
English: For more information about treatment with Pregabalin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Pregabalin Accordiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Accord.
Estonian: See on ravimi Pregabalin Accord Euroopa avaliku hindamisaruande kokkuvõte.
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Lyrica korral, ületab ravimi Pregabalin Accordi kasulikkus sellega kaasnevad riskid.
English: After one week, the dose can be increased to 300 mg per day.
Estonian: Ühe nädala möödudes võib ööpäevast annust suurendada 300 mg-ni. Annust tohib veelgi suurendada, kuni on saavutatud efektiivseim annus.
English: Pregabalin Accord contains the active substance pregabalin.
Estonian: Pregabalin Accord sisaldab toimeainena pregabaliini.
English: How is Pregabalin Accord used?
Estonian: Kuidas Pregabalin Accordi kasutatakse?
English: How has Pregabalin Accord been studied?
Estonian: Kuidas Pregabalin Accordi uuriti?
English: What are the benefits and risks of Pregabalin Accord?
Estonian: Milles seisneb Pregabalin Accordi kasulikkus ja mis riskid ravimiga kaasnevad?
English: How does Pregabalin Accord work?
Estonian: Kuidas Pregabalin Accord toimib?
English: 56 capsules + 1 inhaler
Estonian: 56 kapslit + 1 inhalaator
English: 448 (8x 56) capsules +10 inhalers (2 x monthly multipack)
Estonian: 448 (8x 56) kapslit + 10 inhalaatorit (2 x kuuajaline multipakend)
English: 224 (4x 56) capsules + 5 inhalers (monthly multipack)
Estonian: 224 (4x 56) kapslit + 5 inhalaatorit (kuuajaline multipakend)
English: Do not smoke, eat or drink while handling the product.
Estonian: Ärge suitsetage, sööge ega jooge ravimi käsitsemise ajal.
English: ATC vet code: QP54AA05.
Estonian: ATCvet kood: QP54AA05.
English: The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances.
Estonian: Alopeetsia ja ärritus mööduvad tavaliselt iseenesest, kuid mõningatel juhtudel võib vaja olla sümptomaatilist ravi.
English: Date of first authorisation: 19 July 2019
Estonian: Esmase müügiloa väljastamise kuupäev: 19/07/2019
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt (http://www.ema.europa.eu).
English: 06517 Carros France service-conso@virbac.fr
Estonian: 06517 Carros Prantsusmaa service-conso@virbac.fr
English: Animals older than six weeks of age:
Estonian: Üle 6 nädala vanused loomad
English: The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Estonian: Ravimit ei tohi sattuda veekogudesse, sest on ohtlik kaladele ja teistele veeorganismidele.
English: Squeeze the pipette firmly to empty the contents in one spot.
Estonian: Pigistage pipetti tugevasti, tühjendades selle sisu ühte punkti.
English: Each single-dose (pipette) delivers:
Estonian: Iga üksikannus (pipett) sisaldab:
English: SPECIAL WARNING(S), IF NECESSARY
Estonian: KEELUAEG ERIHOIATUS(ED), KUI VAJALIK
English: This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
Estonian: See on normaalne ja kaob tavaliselt 24 tunni jooksul ega mõjuta veterinaarravimi ohutust ja toimet.
English: Potency (mg/ml)
Estonian: Tugevus (mg/ml)
English: On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children.
Estonian: Ravimise päeval ei tohi lapsed ravitud loomi katsuda ning loomadel ei tohi lubada magada omanikega, eriti koos lastega.
English: VIRBAC LTD Suffolk, IP30 9UP U.K.
Estonian: VIRBAC LTD Suffolk, IP30 9UP
English: Colourless to yellow solution.
Estonian: Värvitu kuni kollane lahus.
English: Interaction with other medicinal products and other forms of interaction: None known.
Estonian: Koostoimed teiste ravimitega ja muud koostoimed Ei ole teada.
English: This product is a skin and eye irritant.
Estonian: Ravim võib põhjustada naha ja silmade ärritust.
English: Cats and/or dogs.
Estonian: Kass ja/või koer.