FrancophonIA/ELRC3.0 huggingface dataset:
English: Evaluation and conclusions on the benefit-risk balance Having considered the grounds for referral and the available data, the CVMP concluded that the withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats should be amended as recommended to provide assurance for consumer safety.
Estonian: Võttes arvesse esildise aluseid ja olemasolevaid andmeid, järeldas veterinaarravimite komitee, et ravitud veistelt, lammastelt ja kitsedelt saadud piima, liha ja söödavate kudede keeluaegasid tuleb soovitatud viisil muuta, et tagada tarbijaohutus.
English: Quality, target animal safety, user safety, environmental risk and parasitic resistance for Zanil and associated names, and generic products thereof have not been assessed in this referral procedure.
Estonian: Selles esildismenetluses ei hinnatud Zanili ja sarnaste nimetuste ning nende geneeriliste ravimite kvaliteeti, ohutust sihtloomadele, kasutajaohutust, keskkonnariski ega parasiitide resistentsust.
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Estonian: International B.V.
English: Package leaflet:
Estonian: Arvestades, et:
English: Chanelle Pharmaceuticals Manufacturing Ltd Loughrea
Estonian: Ühendkuningriik Chanelle Pharmaceuticals Manufacturing Ltd Loughrea
English: Residue depletion in sheep meat and offal
Estonian: Ravimijääkide kadumine lammaste lihast ja söödavatest kudedest
English: Four treated animals (two of each sex) were slaughtered at 5, 10 15 and 21 days after administration.
Estonian: 5., 10., 15. ja 21. päeval pärast ravimi manustamist tapeti neli ravitud looma (mõlemast soost kaks).
English: Annex I
Estonian: 7AJ
English: Residue depletion data in sheep and goat milk
Estonian: Andmed ravimijääkide kadumise kohta lamba- ja kitsepiimast
English: A risk of residue levels exceeding the MRLs after some of the approved withdrawal periods was identified based on the milk, meat and offal residue depletion data provided.
Estonian: Võttes arvesse ravimijääkide piimast, lihast ja söödavatest kudedest kadumise kohta esitatud andmeid, tehti kindlaks risk, et ravimijääkide sisalduse väärtused võivad pärast teatavate heakskiidetud keeluaegade möödumist ületada jääkide piirnorme.
English: No residue depletion data in sheep and goat milk were provided by the applicants/marketing authorisation holders.
Estonian: Müügiloa taotlejad/hoidjad ei esitanud andmeid ravimijääkide kadumise kohta lamba- ja kitsepiimast.
English: MERIAL SAS 29 avenue Tony Garnier 69007 Lyon
Estonian: MERIAL SAS 29 avenue Tony Garnier
English: In view of deficiencies noted in the ‘Nilzan Drench Plus' study, namely the fact that the product used was a combination product (oxyclozanide and levamisole) instead of the mono-product Zanil
Estonian: Pidades silmas ravimiga Nilzan Drench Plus tehtud uuringus täheldatud puudusi - st seda, et ainsa ravimi Zanil (oksüklosaniid) asemel kasutati kombinatsioonravimit (oksüklosaniid ja levamisool), ning normist kõrvalekalduvaid tulemusi 21. päeval - peeti asjakohaseks rakendada keeluaja arvutamisel vähemalt 30%-list mõõtemääramatuse tegurit.
English: Belgium Merial SAS 29 avenue Tony Garnier 69007 Lyon
Estonian: Merial SAS 29 avenue Tony Garnier
English: Residue depletion data in goat meat and offal
Estonian: Andmed ravimijääkide kadumise kohta kitsede lihast ja söödavatest kudedest
English: No other residue depletion data in sheep meat and offal were provided by the applicants/marketing authorisation holders.
Estonian: Müügiloa taotlejad/hoidjad ei esitanud muid andmeid ravimijääkide kadumise kohta lammaste lihast ja söödavatest kudedest.
English: 29 avenue Tony Garnier 69007 Lyon
Estonian: 69007 Lyon
English: No other residue depletion data in cattle meat and offal were provided by the applicants/marketing authorisation holders.
Estonian: Müügiloa taotlejad/hoidjad ei esitanud muid andmeid ravimijääkide kadumise kohta veiste lihast ja söödavatest kudedest.
English: No other residue depletion data in cattle milk were provided by the applicants/marketing authorisation holders.
Estonian: Müügiloa taotlejad/hoidjad ei esitanud muid andmeid ravimijääkide kadumise kohta lehmapiimast.
English: 29 Avenue Tony Garnier 69007 Lyon
Estonian: Post box 7123 29 Avenue Tony Garnier
English: Merial SAS
Estonian: II lisa
English: No residue depletion data in goat meat and offal were provided by the applicants/marketing authorisation holders.
Estonian: Müügiloa taotlejad/hoidjad ei esitanud andmeid ravimijääkide kadumise kohta kitsede lihast ja söödavatest kudedest.
English: Some cases may require longer treatment.
Estonian: Mõnedel juhtudel võib vaja minna pikemat ravi.
English: 6 Adverse reactions (frequency and seriousness)
Estonian: Kõrvaltoimed (sagedus ja tõsidus)
English: Additional polar metabolites also exist.
Estonian: Samuti eksisteerivad liskas polaarsed metaboliidid.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Estonian: Kui täheldate ükskõik milliseid kõrvaltoimeid, isegi neid, mida pole käesolevas pakendi infolehes mainitud, või arvate, et veterinaarravim ei toimi, teavitage palun sellest oma veterinaararsti
English: Date of last renewal: 10 April 2008
Estonian: Müügiloa viimase uuendamise kuupäev: 10 aprill 2008
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 1 April 1998
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev:1. aprill 1998
English: The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Estonian: Clomicalmi efektiivsust ja ohutust ei ole uuritud koertel, kes kaaluvad vähem kui 1,25 kg või on nooremad kui kuus kuud.
English: In dogs, the volume of distribution (VDss) is 3.8 l/kg.
Estonian: Koertel on jaotumise maht (VDss) 3,8 l/kg.
English: None known.
Estonian: Ei ole teada
English: MARKETING AUTHORISATION NUMBERS EU/2/98/007/001-003
Estonian: EU/2/98/007/001-003
English: Shelf-life of the veterinary medicinal product as packaged for sale: 4 years
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 4 aastat
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: MARKETING AUTHORISATION NUMBER EU/2/98/007/001 (5 mg, 30 tablets) EU/2/98/007/002 (20 mg, 30 tablets) EU/2/98/007/003 (80 mg, 30 tablets)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/98/007/001(5 mg, 30 tabletti) EU/2/98/007/002 (20 mg, 30 tabletti) EU/2/98/007/003 (80 mg, 30 tabletti)
English: SPECIAL STORAGE CONDITIONS Store in the original container.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida originaalpakendis.
English: In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
Estonian: Juhusliku allaneelamise korral pöörduda koheselt arsti poole ja näidata arstile ravimi etiketti.
English: SPECIAL WARNINGS, IF NECESSARY To be used under veterinary supervision.
Estonian: ERIHOIATUS(ED), KUI VAJALIK Manustamiseks loomaarsti järelevalve all.
English: Clomicalm should be used under veterinary supervision.
Estonian: Clomicalmi manustada vaid loomaarsti järelevalve all.
English: Clomipramine and its metabolites are rapidly distributed in the body in mice, rabbits, and rats with high concentrations being achieved in organs and tissues (including the lungs, heart and brain) and low concentrations remaining in the blood.
Estonian: Klomipramiin ja tema metaboliidid jaotuvad kiiresti hiirte, jäneste ja rottide organismis ning sellega kaasnevad kõrged kontsentratsioonid organites ja kudedes (k.a kopsud, süda ja aju) ning madalad kontsentratsionid veres.
English: Clomipramine is extensively bound to plasma proteins (>97 %) in dogs.
Estonian: Klomipramiin seondub suurel määral plasma proteiinidega (>97 %) koertel.
English: The principle route of excretion in dogs is via the bile (>80%) with the remainder via the urine.
Estonian: Peamine väljutamine koertel toimub sapi kaudu (>80%), ülejäänud osa väljutatakse uriiniga.
English: One HDPE bottle with child resistant closure and sealing disk, containing 30 tablets and one silica gel desiccant sachet, packed within a cardboard box.
Estonian: Üks HDPE pudel, millel on lapsekindel sulgur ja katteplaat, sisaldab 30 tabletti ja ühte ränidioksiidgeelist kuivatuskotti, pakituna pappkarpi.
English: Still higher doses (725 mg/kg) produced, in addition, convulsions and death.
Estonian: Veel suuremad doosid (725 mg/kg) põhjustasid lisaks ka krampe ja surma.
English: Do not use after the expiry date which is stated on the label after EXP.
Estonian: Pärast pakendil märgitud kõlblikkusaja lõppu pärast EXP mitte kasutada.
English: Manufacturer for batch release: Elanco France S.A.S.
Estonian: Partii vabastamise eest vastutav tootja: Elanco France S.A.S.
English: The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Estonian: Clomicalmi ei soovitata manustada koos või 2 nädalat enne ja pärast ravi monoamiini oksüdaasi inhibiitoritega.
English: Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine.
Estonian: Samaaegne tsimetidiini manustamine võib viia klomipramiini plasmataseme tõusuni.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt http://www.ema.europa.eu
English: Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx. 1.5-2.5 hours).
Estonian: Nii klomipramiini kui desmetüülklomipramiini kõrge plasmasisaldus saavutatakse kiiresti (umbes 1,5-2,5 tunniga).
English: One side bears the imprint ‘CG', the other ‘D/V' and a score.
Estonian: Ühele küljele on sisse pressitud ‘CG', teisele ‘D/V' ja poolitusjoon.
English: Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Estonian: Clomicalm võib väga harva põhjustada sporaadilist oksendamist, isu muutumist, letargiat või maksaensüümide taseme tõusu, mis on ravimi ärajätmisel pöörduv.
English: Both clomipramine and desmethylclomipramine contribute to the effects of Clomicalm: clomipramine is a potent and selective 5-HT reuptake inhibitor while desmethylclomipramine is a potent and selective noradrenaline reuptake inhibitor.
Estonian: Nii klomipramiin kui desmetüülklomipramiin osalevad Clomicalmi toimes: klomipramiin on tugev selektiivne 5-HT tagasihaarde inhibiitor, samal ajal kui desmetüülklomipramiin on tugev selektiivne noradrenaliini tagasihaarde inhibiitor.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Clomicalm contains:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS 1 tablett sisaldab:
English: One side bears the imprint ‘C/G', the other ‘G/N' and scored on both sides.
Estonian: Ühele küljele on sisse pressitud ‘C/G', teisele ‘G/N' ja poolitusjooned on mõlemal küljel.
English: PACKAGE SIZE 30 tablets
Estonian: Pakendi suurus: 30 tabletti
English: Clomipramine is well absorbed (>80%) from the gastrointestinal tract in dogs when administered orally but the systemic bioavailability for clomipramine and desmethylclomipramine is 22-26% due to extensive first pass metabolism by the liver.
Estonian: Suukaudse manustamise järgselt imendub klomipramiin hästi (>80%) koerte seedetraktist, kuid klomipramiini ja desmetüülklomipramiini süsteemne biosaadavus on 22-26% ekstensiivse esmase metabolismi tõttu maksas.
English: Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone
Estonian: Laktoosmonohüdraat Mikrokristalne tselluloos Kunstlik liha maitselisand Krospovidoon
English: In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
Estonian: Kui ravi ei anna 2 kuu jooksul tulemusi, tuleb ravi Clomicalmiga katkestada.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Estonian: · VETERINAARRAVIMI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED JA PIIRANGUD
English: Vomiting may be reduced by co-administration of Clomicalm with a small quantity of food.
Estonian: Oksendamist võib vähendada, kui manustada Clomicalmi vähese toiduga.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In children, accidental ingestion should be regarded as serious.
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Lastel tuleb juhuslikku allaneelamist käsitleda tõsise juhtumina.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10,000-st ravitud loomast) - väga harv (vähem kui 1-l loomal 10,000-st ravitud loomast, kaasaarvatud üksikjuhud).
English: The active components in vivo are clomipramine and its major metabolite, desmethylclomipramine.
Estonian: In vivo on toimeaineteks klomipramiin ja selle peamine metaboliit desmetüülklomipramiin.
English: ½ tablet
Estonian: ½ tabletti
English: It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Estonian: Seetõttu toimib ta serotoniini tagasihaarde inhibiitorina ja sarnaselt tritsüklilise antidepressandiga.
English: Administration of Clomicalm with food causes moderately higher plasma AUC values for clomipramine (25%) and desmethylclomipramine (8%) as compared with administration to fasted dogs.
Estonian: Clomicalmi manustamine söödaga põhjustab mõõdukalt kõrgemaid plasma AUC väärtusi - klomipramiinil 25% ja desmetüülklomipramiinil 8%, võrreldes manustamisega dieedil olnud koertele.
English: Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Estonian: Mitte kasutada, kui esineb ülitundlikkust klomipramiini ja tritsükliliste antidepressantide suhtes.
English: Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention.
Estonian: Clomicalmi antikoliinergiliste omaduste tõttu tuleb kasutada seda ka ettevaatusega koertel, kellel on kitsanurgaline glaukoom, vähene seedekulgla aktiivsus või uriinipeetus.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 30 tablets
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 30 tabletti.
English: The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Estonian: Veterinaarravimi ohutust ei ole uuritud emastel koertel tiinuse ja laktatsiooni ajal.
English: The principle mechanism of action of clomipramine is potentiation of the effects of 5-HT and noradrenaline in the brain by inhibiting their neuronal reuptake.
Estonian: Peamine klomipramiini toimemehhanism on 5-HT ja noradrenaliini toime potenseerimine ajus nende tagasihaarde inhibeerimise kaudu.
English: The maximal plasma concentrations (Cmax) after oral administration of single doses of 2 mg/kg clomipramine hydrochloride were: 240 nmol/l for clomipramine and 48 nmol/l for desmethylclomipramine.
Estonian: Maksimaalsed plasmakontsentratsioonid (Cmax) suukaudse manustamise järgselt ühekordse doosina 2 mg/kg klomipramiinvesinikkloriidi olid 240 nmol/l klomipramiinil ja 48 nmol/l desmetüülklomipramiinil.
English: People with known hypersensitivity to clomipramine should administer the product with caution.
Estonian: Klopramiinile teadaoleva ülitundlikkusega inimesed peaksid manustama seda preparaati ettevaatusega.
English: In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders.
Estonian: Kliinilistes katsetes, kus ravi kestis 2-3 kuud (Clomicalm koos käitumishäirete raviga) oli piisav, et haigustunnused kaoks.
English: The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Estonian: Klomipramiini peamine bitransformatsiooni tee on demetüleerumine desmetüülklomipramiiniks.
English: Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Estonian: Laboriuuringutes hiirte ja rottidega on täheldatud embrüotoksilist efekti.
English: Repeated administration of Clomicalm causes moderate increases in plasma concentrations, accumulation ratios after oral administration twice daily were 1.2 for clomipramine and 1.6 for desmethylclomipramine, with steady state being reached within 3 days.
Estonian: Korduv Clomicalmi manustamine põhjustab mõõdukat plasmakontsentratsiooni tõusu, akumuleerumine suukaudse manustamise järgselt (kaks korda päevas) oli 1,2 klomipramiinil ja 1,6 desmetüülklomipramiinil, mis püsis kolm päeva.
English: One side bears the imprint ‘I/I', the other no imprint and scored on both sides.
Estonian: Ühele küljele on sisse pressitud ‘I/I', teisel küljel märgistus puudub ja poolitusjooned on mõlemal küljel.
English: Interaction with other medicinal products and other forms of interaction: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs.
Estonian: Koostoimed teiste ravimitega ja muud koostoimed Koostoimete uuringud pärinevad teistelt loomaliikidelt, mitte koertelt.
English: Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Estonian: Üledoos põhjustab inimestel antikoliinergilist toimet ning mõjutab ka KNS ja südame-veresoonkonda.
English: 1-2 mg clomipramine/kg bw twice daily.
Estonian: 1-2 mg klomipramiini /kg kaks korda päevas
English: 5 mg (equivalent to 4.5 mg Clomipramine)
Estonian: 5 mg (ekvivalentne 4,5 mg klomipramiinile)
English: 1 tablet Read the package leaflet before use.
Estonian: 1 tablett Enne ravimi kasutamist lugege pakendi infolehte KEELUAEG
English: Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Estonian: Mõnede epilepsiavastaste ravimite, näiteks fenütoiini ja karbamasepiini tase plasmas võib tõusta Clomicalmi samaaegsel manustamisel.
English: In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Estonian: Lisaks on klomipramiinil antikoliinergiline toime koliinergiliste muskariiniretseptoritele antagoniseerimise kaudu.
English: 80 mg (equivalent to 71.7 mg Clomipramine)
Estonian: 80 mg (ekvivalentne 71,7 mg klomipramiinile)
English: The elimination t1/2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Estonian: Poolestusaeg klomipramiinvesinikkloriidi veenisisese manustamise järgselt koertel on 6,4 tundi klomipramiinil ja 3,6 tundi desmetüülklomipramiinil.
English: Clomicalm 5 mg 1.25-2.5 kg ½ tablet >2.5-5 kg
Estonian: Clomicalm 5 mg 1.25-2.5 kg ½ tabletti >2.5-5 kg
English: Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Estonian: Suuremad doosid (500 mg/kg e. 250-kordne doos) põhjustasid oksendamist, roojamist, silmalaugude allavajumist, krampe ja loidust.
English: Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Estonian: Kahekümnekordses üledoosis (40 mg/kg) manustamine põhjustas küürutõmbumist, värinaid, kõhupuhitust ja vähenenud aktiivsust koertel.
English: At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Estonian: Püsivalt on klomipramiini ja desmetüülklomipramiini plasma sisaldus umbes 3:1.
English: Clomicalm may be given with or without food.
Estonian: Preparaati võib manustada kas toiduga või ilma.
English: 20 mg (equivalent to 17.9 mg Clomipramine)
Estonian: 20 mg (ekvivalentne 17,9 mg klomipramiinile)
English: Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5HT) and noradrenaline.
Estonian: Klomipramiin on laia toimega, takistades nii serotoniini (5-HT) kui noradrenaliini tagasihaaret neuronites.
English: Pregnancy: Laboratory studies in mice and rats have shown evidence of embryotoxic effects.
Estonian: Tiinus Uuringutes rottide ja hiirtega on täheldatud embrüotoksilist toimet.
English: Clomicalm may be given orally with or without food.
Estonian: Manustada võib suukaudselt kas söödaga või ilma.
English: Overdose (symptoms, emergency procedures, antidotes):At overdose with 20 mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
Estonian: Üleannustamine (sümptomid, esmaabi, antidoodid) Viiekordses üledoosis (20 mg/kg Clomicalmi) manustatuna täheldati 12 tunni pärast bradükardiat ja arütmiat (atrioventrikulaarne blokaad ja ventrikulaarsed ekstrasüstolid).
English: Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Estonian: Teatatud on hepatobiliaarsest haigusest, eriti eelsoodumuse korral ning maksa läbivate ravimite samaaegsel manustamisel.
English: Special precautions for use in animals It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio.
Estonian: Kardiovaskulaarsüsteemi häiretega või epilepsiaga koertele on soovitav kasutada ettevaatusega ning ainult pärast riski ja kasulikkuse kaalumist.
English: Vomiting may be reduced by co-administration with a small quantity of food.
Estonian: Oksendamist saab vähendada vähese söömisega ravimi manustamise ajal.
English: Keep out of sight and reach of children as accidental ingestion should be regarded as serious.
Estonian: Hoida laste eest varjatud ja kättesaamatus kohas, kuna juhuslik manustamine on ohtlik.
English: Clomipramine hydrochloride
Estonian: Klomipramiinvesinikkloriid
English: As an aid in the treatment of separation related disorders manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Estonian: Kasutamiseks lahusolekuga seotud häirete korral, millega kaasnevad tahtmatu roojamine ja urineerimine ning ainult koos käitumishäirete raviga.
English: Accidental ingestion should be regarded as serious.
Estonian: Juhuslik manustamine on ohtlik.
English: At overdose with 20 mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
Estonian: Viiekordses üledoosis (20 mg/kg Clomicalmi) manustatuna täheldati 12 tunni pärast bradükardiat ja arütmiat (atrioventrikulaarne blokaad ja ventrikulaarsed ekstrasüstolid).