FrancophonIA/ELRC3.0 huggingface dataset:
English: • a sheep and goat meat and offal withdrawal period of 14 days,
Danish: • en tilbageholdelsestid på 14 dage for kød og slagteaffald fra får og geder
English: INN
Danish: INN Styrke
English: Belgium Merial SAS 29 avenue Tony Garnier 69007 Lyon
Danish: Slovenien MERIAL SAS 29 avenue Tony Garnier 69007 Lyon
English: No residue depletion data in sheep and goat milk were provided by the applicants/marketing authorisation holders.
Danish: Ansøgerne/indehaverne af markedsføringstilladelse fremlagde ingen restkoncentrationsdata for mælk fra får og geder.
English: Route of administration
Danish: Station Works
English: No other residue depletion data in cattle milk were provided by the applicants/marketing authorisation holders.
Danish: Ansøgerne/indehaverne af markedsføringstilladelse fremlagde ingen andre restkoncentrationsdata for mælk fra kvæg.
English: Residue depletion data in goat meat and offal
Danish: Restkoncentrationsdata for kød og slagteaffald fra geder
English: No other residue depletion data in sheep meat and offal were provided by the applicants/marketing authorisation holders.
Danish: Ansøgerne/indehaverne af markedsføringstilladelse fremlagde ingen andre restkoncentrationsdata for kød og slagteaffald fra får.
English: No other residue depletion data in cattle meat and offal were provided by the applicants/marketing authorisation holders.
Danish: Ansøgerne/indehaverne af markedsføringstilladelse fremlagde ingen andre restkoncentrationsdata for kød og slagteaffald fra kvæg.
English: No residue depletion data in goat meat and offal were provided by the applicants/marketing authorisation holders.
Danish: Ansøgerne/indehaverne af markedsføringstilladelse fremlagde ingen restkoncentrationsdata for kød og slagteaffald fra geder.
English: Some cases may require longer treatment.
Danish: Nogle tilfælde kan kræve længere behandling.
English: Active substance:
Danish: Aktivt stof :
English: Do not use after the expiry date which is stated on the label after EXP.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten efter EXP.
English: Additional polar metabolites also exist.
Danish: Andre polære metabolitter eksisterer også.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Clomicalm contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver Clomicalm tablet indeholder:
English: Shelf-life of the veterinary medicinal product as packaged for sale: 4 years
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 4 år
English: MARKETING AUTHORISATION NUMBERS EU/2/98/007/001-003
Danish: EU/2/98/007/001-003
English: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs.
Danish: Anbefalinger vedrørende interaktioner mellem Clomicalm og andre lægemidler stammer fra studier med andre arter end hunde.
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)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/98/007/001 (5 mg, 30 tabletter) EU/2/98/007/002 (20 mg, 30 tabletter) EU/2/98/007/003 (80 mg, 30 tabletter)
English: SPECIAL STORAGE CONDITIONS Store in the original container.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Skal opbevares i originalemballagen.
English: Clomicalm should be used under veterinary supervision.
Danish: Clomicalm bør anvendes under tilsyn af dyrlæge.
English: Clomipramine is extensively bound to plasma proteins (>97 %) in dogs.
Danish: Clomipramin bindes i udstrakt grad til plasmaproteiner (>97 %) hos hunde.
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.
Danish: Clomipramin og dets metabolitter fordeles hurtigt i kroppen hos mus, kaniner og rotter med høje koncentrationer i organer og væv (herunder lunger, hjerte og hjerne) og med lav koncentrationer i blodet.
English: In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
Danish: I tilfælde hvor der ikke er set forbedring efter 2 måneder, bør behandlingen med Clomicalm standses.
English: Dosage per administration
Danish: Dosis per indgift
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.
Danish: Effektiviteten og sikkerheden af Clomicalm er ikke undersøgt hos hunde med en legemsvægt under på mindre end 1,25 kg eller under 6 måneders alder.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 30 tablets
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 30 tabletter
English: In dogs, the volume of distribution (VDss) is 3.8 l/kg.
Danish: Hos hunde var fordelingsvolumen 3.8 l/kg.
English: Still higher doses (725 mg/kg) produced, in addition, convulsions and death.
Danish: Endnu højere doser (725 mg/kg) forårsagede desuden kramper og død.
English: SPECIAL WARNINGS, IF NECESSARY To be used under veterinary supervision.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Bør anvendes under tilsyn af dyrlæge.
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.
Danish: Kliniske afprøvninger har vist at 2-3 måneders behandling med Clomicalm i kombination med modificerende opdragelsesteknikker er tilstrækkeligt til at kontrollere symptomerne på separationsrelaterede problemer.
English: The active components in vivo are clomipramine and its major metabolite, desmethylclomipramine.
Danish: Det aktive stof in vivo er clomipramin og dets hovedmetabolit, desmethylclomipramin.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: · BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: People with known hypersensitivity to clomipramine should administer the product with caution.
Danish: Folk med kendt overfølsomhed for clomipramin bør administrere produktet med forsigtighed.
English: EXPIRY DATE EXP {month/year}
Danish: 10. UDLØBSDATO EXP (måned/år)
English: As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Danish: Som en hjælp i behandlingen af hunde med separationsrelaterede problemer, som manifesterer sig ved destruktiv adfærd, uønsket elimination (defækation og urinering) og kun i kombination med modificerende opdragelsesteknikker.
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.
Danish: HDPE flaske med børnesikret låg og tætningsskive, indeholdende 30 tabletter og silicagel tørremiddel, pakket i æske.
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.
Danish: På grund af dets potentielle anticholinerge egenskaber skal Clomicalm også bruges med forsigtighed hos hunde med snævervinklet glaukom, nedsat gastrointestinal motilitet eller urin retention.
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.
Danish: Clomipramin absorberes godt (>80 %) fra mavetarmkanalen i hunde, når det administreres oralt, men den systemiske biotilgængelighed af clomipramin og desmethylclomipramin er 22-26% på grund af omfattende first pass metabolisme i leveren.
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.
Danish: Den principielle virkning af Clomicalm er potensering af effekten af 5-HT og noradrenalin i hjernen ved hæmning af deres neurale reuptake.
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.
Danish: Både clomipramin og desmethylclomipramin bidrager til effekten af Clomicalm: clomipramin er en potent og selektiv 5-HT reuptake-hæmmer, medens desmethylclopramin er en potent og selektiv noradrenalin reuptake-hæmmer.
English: In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Danish: Samtidig har Clomicalm en anticholinerg effekt via antagonisme over for cholinerge muskarine receptorer.
English: Clomicalm may be given with or without food.
Danish: Clomicalm kan gives med eller uden foder.
English: Clomicalm may be given orally with or without food.
Danish: Clomicalm kan gives oralt med eller uden foder.
English: The principle route of excretion in dogs is via the bile (>80%) with the remainder via the urine.
Danish: Den primære udskillelsesvej hos hunde er via galden (>80%), resten udskilles gennem nyrerne.
English: Date of last renewal: 10 April 2008
Danish: Dato for første markedsføringstilladelse: 1 april 1998 Dato for seneste fornyelse af markedsføringstilladelse: 10 april 2008
English: Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Danish: Overdosering hos mennesker medfører anticholinerge effekter, selv om CNS og det cardiovaskulære system også kan blive påvirket.
English: Vomiting may be reduced by co-administration of Clomicalm with a small quantity of food.
Danish: Opkastning kan reduceres ved administration af Clomicalm med små mængder foder.
English: Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine.
Danish: Samtidig administration af cimetidin kan føre til øget plasmakoncentration af clomipramin.
English: At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Danish: Ved steady state er ratio af plasma clomipramin: desmethylclomipramin koncentrationen ca. 3:1.
English: Manufacturer for batch release: Elanco France S.A.S.
Danish: Fremstiller ansvarlig for batchfrigivelse: Elanco France S.A.S.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 1 April 1998
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Danish: Laboratoriestudier i mus og rotter viste tegn på embryotoksisk effekt.
English: Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5HT) and noradrenaline.
Danish: Clomicalm har bredspektret virkning, idet stoffet blokerer det neurale reuptake af både serotonin (5HT) og noradrenalin.
English: The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Danish: Sikkerheden af det veterinærmedicinske produkt er ikke undersøgt i tæver under drægtighed og laktation.
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.
Danish: Gentagen administration af Clomicalm forårsager moderate stigninger i plasmakoncentrationer, akkumuleringsratio efter oral administration to gange daglig var 1.2 for clomipramin og 1.6 for desmethylclomipramin, steady state blev nået indenfor 3 dage.
English: ROUTE(S) OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til oral anvendelse.
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)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
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.
Danish: Clomicalm kan i meget sjældne tilfælde forårsage opkastning, appetitændringer, letargi eller en forhøjelse af lever enzymer, som er reversibel, når behandlingen stoppes.
English: It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Danish: Dets egenskaber svarer derfor både til en serotonin reuptake-hæmmer og et tricyklisk antidepressivum.
English: Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Danish: Bør ikke anvendes i tilfælde af erkendt overfølsomhed for clomipramin og lignende tricykliske antidepressiva.
English: Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Kunstig kødsmag Crospovidon
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.
Danish: Eliminations-t½ efter intravenøs administration af clomipraminhydroklorid hos hund var 6.4 timer for clomipramin og 3.6 timer for desmethylclomipramin.
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.
Danish: Samtidig administration af Clomicalm og foder var årsag til moderat forhøjede plasma AUC værdier for clomipramin (25%) og desmethylclomipramin (8%), sammenlignet med administration til fastende hunde.
English: The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Danish: Det anbefales at undgå administration af Clomicalm i kombination med eller indenfor 2 uger efter ophør med behandling med monoamin-oxidasehæmmere.
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.
Danish: De maksimale plasmakoncentrationer (Cmax) efter oral administration af enkelte doser af 2 mg/kg clomipraminhydrochlorid var 240 nmol/l for clomipramin og 48 nmol/l for desmethylclomipramin.
English: Do not use in male breeding dogs.
Danish: Bør ikke anvendes til avlshanner.
English: One side bears the imprint ‘CG', the other ‘D/V' and a score.
Danish: Den ene side har mærkning CG, den anden D/V og en delekærv.
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)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) -.
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
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Danish: Plasmakoncentrationen af visse anti-epileptiske lægemidler, så som phenytoin og carbamazepin, kan stige ved samtidig administration af Clomicalm.
English: Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx. 1.5-2.5 hours).
Danish: Maksimalt plasmaniveau af clomipramin og desmethylclomipramin opnås hurtigt (1½-2½ time).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Beholder
English: 6 Adverse reactions (frequency and seriousness)
Danish: 4.6 Bivirkninger (forekomst og sværhedsgrad)
English: For any information about this veterinary medicinal product, please contact the marketing authorisation holder.
Danish: For yderligere oplysninger om præparatet bedes henvendelse rettet til indehaveren af markedsføringstilladelsen.
English: Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Danish: Sygdomme i lever og galdesystem har været rapporteret, specielt ved præ-eksisterende forhold og ved samtidig administration af lægemidler, der metaboliseres via leveren.
English: Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Danish: Højere doser (500 mg/kg, d.v.s. 250 gange den anbefalede dosis) forårsagede opkastning, afføring, hængende øjne, rystelser og stille opførsel.
English: The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Danish: Biotransformationen af clomipramin sker hovedsagligt som en demethylering til desmethylclomipramin.
English: In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
Danish: Hvis produktet er indtaget oralt, søg straks læge og vis produktets etiket.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske
English: One side bears the imprint ‘C/G', the other ‘G/N' and scored on both sides.
Danish: Den ene side har mærkning C/G, den anden G/N og der er delekærv på begge sider.
English: Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Danish: Overdosering med 40 mg/kg ( 20 gange den anbefalede dosis) Clomicalm forårsagede krumrygget stilling, mindre rysteler, udspilet bug og nedsat aktivitet hos hunde.
English: Clomicalm may potentiate the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarin derivatives.
Danish: Clomicalm kan potensere effekten af det anti-arrytmiske middel quinidin, anticholinerge stoffer (f.eks. atropin), andre CNS-aktive stoffer (f.eks. barbiturater, benzodiazepiner, anæstetika, neuroleptika), sympatomimetika (f.eks. adrenalin) og coumarin derivater.
English: Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives.
Danish: Clomicalm kan forøge effekten af det anti-arrytmiske middel quinidin, anticholinerge stoffer (f.eks. atropin), andre CNS-aktive stoffer (f.eks. barbiturater, benzodiazepiner, anæstetika, neuroleptika), sympatomimetika (f.eks. adrenalin) og coumarin derivater.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2-4 mg/kg according to the following table:
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Clomicalm indgives to gange dagligt i en doser af 1 - 2 mg/kg clompramin med en total dagsdosis på 24 mg/kg i henhold til følgende tabel:
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.
Danish: Til hunde med nedsat hjertefunktion og epilepsi anbefales det at administrere Clomicalm med forsigtighed, og kun efter at have vurderet ratio af risk-benefit.
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.
Danish: Ved overdosering med 20 mg/kg Clomicalm (5 gange den maksimale terapeutiske dosis) sås bradycardi og arytmier (atrioventrikulært nodalt blok og ventrikulære eskapadeslag) ca. 12 timer efter administration.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Clomicalm 5 mg tabletter til hunde
English: Pharmacotherapeutic group: Non-selective monoamine re-uptake inhibitors, ATCvet code: QN06AA04.
Danish: Farmakoterapeutisk gruppe: Non-selektive monoamin re-uptake hæmmere.
English: WITHDRAWAL PERIOD(S) Not applicable
Danish: 10. TILBAGEHOLDELSESTID Ikke relevant
English: Clomicalm should be administered orally at a dose of 1-2 mg/kg clomipramine twice daily to give a total daily dose of 2-4 mg/kg according to the following table:
Danish: Clomicalm gives oralt i en doser på 1-2 mg/kg clomipramin to gange dagligt med en total daglig dosis på 2-4 mg/kg svarende til nedenstående tabel:
English: Clomicalm 5 mg 1.25-2.5 kg ½ tablet >2.5-5 kg
Danish: Clomicalm 5 mg 1,25 - 2,5 kg ½ tablet >2,5 - 5 kg 1 tablet
English: Clomicalm 20 mg tablets for dogs
Danish: Clomicalm 20 mg tabletter til hunde
English: Clomicalm 80 mg tablets for dogs
Danish: Clomicalm 80 mg tabletter til hunde
English: Accidental ingestion should be regarded as serious.
Danish: Utilsigtet indtagelse kan være farlig.
English: 5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride(equivalent to 71.7 mg Clomipramine)
Danish: 5 mg Clomipramin hydrochlorid (svarende til 4,5 mg clomipramin) 20 mg Clomipramin hydrochlorid (svarende til 17,9 mg clomipramin) 80 mg Clomipramin hydrochlorid (svarende 71,7 mg clomipramin)
English: Clomipramine hydrochloride
Danish: Clomipramin hydrochlorid (clomipramin.hydrochlorid.)
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.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr:
English: Keep out of sight and reach of children as accidental ingestion should be regarded as serious.
Danish: Opbevares utilgængeligt for børn, da utilsigtet indtagelse kan være farlig.
English: 5 mg tablet: Brownish-grey, oval-oblong, divisible.
Danish: 5 mg tablet: Brunlig-grå, oval-aflange, delbare.
English: Store in the original container.
Danish: Skal opbevares i orginal emballagen.
English: 80 mg (equivalent to 71.7 mg Clomipramine)
Danish: 80,00 mg (svarende til 71,7 mg clomipramin) Hjælpestof (Hjælpestoffer):