FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) - link sample presented a level of 10.09 µg/kg, close to the MRL (of 10 µg/kg) at the 8th milking after administration.
Maltese: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) - link kbira ta' ħalib.
English: The first study was conducted in 2000 with the veterinary medicinal product ‘Zanil Fluke Drench' at the single maximum recommended dose volume of 105 ml of product per animal and in accordance with the VICH Guideline 482.
Maltese: L-ewwel studju sar fl-2000 bil-prodott mediċinali veterinarju “Zanil Fluke Drench” bil-volum ta' doża rakkomandat massimu wieħed ta' 105 ml ta' prodott għal kull annimal u skont il-Linja gwida ta' VICH 482.
English: 4.11 Withdrawal period(s) Cattle:
Maltese: 4.11 Perjod(i) tal-irtirar Frat:
English: The recommended doses are 10 mg oxyclozanide per kg bw for cattle and 15 mg oxyclozanide per kg bw for sheep and goats.
Maltese: Id-dożi rakkomandati huma ta' 10 mg oxyclozanide għal kull kg bw għall-frat u 15 mg oxyclozanide għal kull kg bw għan-nagħaġ u għall-mogħoż.
English: According to the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL) the pharmacokinetics and residue depletion data are not significantly different between cattle, sheep and goats.
Maltese: Skont l-EPMAR tas-CVMP għal oxyclozanide (EMEA/MRL/889/03-FINAL), il-farmakokinetiċi u d-data dwar it-tnaqqis tar-residwi mhumiex differenti b'mod sinifikanti bejn il-frat, in-nagħaġ u l-mogħoż.
English: In the absence of species specific data, the CVMP agreed to recommend application of the meat and offal withdrawal period proposed for sheep in goats because the dose regimen (15 mg oxyclozanide per kg body weight) is the same in both species and, as reported in paragraph 29 of the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL) the pharmacokinetics of oxyclozanide is considered to be similar in sheep and goats.
Maltese: Fin-nuqqas ta' data speċifika għall-speċi, is-CVMP qabel li jirrakkomanda applikazzjoni tal-perjodu talirtirar tal-laħam u l-ġewwieni propost għan-nagħaġ fil-mogħoż minħabba li r-reġimen tad-dożaġġ (15 mg oxyclozanide għal kull kg tal-piż tal-ġisem) huwa l-istess fiż-żewġ speċijiet u, kif irrappurtat filparagrafu 29 tal-EPMAR tas-CVMP għal oxyclozanide (EMEA/MRL/889/03-FINAL) il-farmakokinetiċi ta' oxyclozanide jitqiesu li huma simili fin-nagħaġ u fil-mogħoż.
English: WITHDRAWAL PERIOD
Maltese: PERJODU TAL-IRTIRAR
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.
Maltese: Il-kwalità, is-sigurtà tal-annimal fil-mira, is-sigurtà tal-utent, ir-riskju ambjentali u r-reżistenza għallparassiti għal Zanil u ismijiet assoċjati, u għall-prodotti ġeneriċi tiegħu ma ġewx ivvalutati f'din ilproċedura ta' referenza.
English: A GLP-compliant residue depletion study in cattle was submitted, conducted with the veterinary medicinal product ‘Zanil Fluke Drench' at the recommended dose (10 mg oxyclozanide per kg body weight).
Maltese: Tnaqqis tar-residwi fil-laħam u fil-ġewwieni tal-frat Ġie ppreżentat studju dwar it-tnaqqis tar-residwi konformi mal-GLP fil-frat, li sar bil-prodott mediċinali veterinarju “Zanil Fluke Drench” bid-doża rakkomandata (10 mg oxyclozanide għal kull kg tal-piż tal ġisem).
English: The European reference product is Zanil which has been authorised for decades in several Member States of the European Union.
Maltese: Il-prodott ta' referenza Ewropea huwa Zanil li ilu awtorizzat għal deċennji f'diversi Stati Membri talUnjoni Ewropea.
English: Belgium Merial SAS 29 avenue Tony Garnier 69007 Lyon
Maltese: In-Netherlands Merial SAS 29 avenue Tony Garnier 69007 Lyon
English: For example for cattle meat and offal the approved withdrawal periods ranged from 10 days to 28 days; for cattle milk from zero hours to 108 hours; for sheep meat and offal from 14 days to 28 days; for sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days.
Maltese: Pereżmpju għal-laħam u l-ġewwieni tal-frat, il-perjodi talirtirar approvati varjaw minn 10 ijiem għal 28 jum; għall-ħalib tal-frat minn żero sigħat għal 108 sigħat; għal-laħam u l-ġewwieni tan-nagħaġ minn 14-il jum sa 28 jum; għall-ħalib tan-nagħaġ minn “tużahx f'ħalib prodott min-nagħaġ għall-użu mill-bniedem” għal 7 ijiem.
English: It was noted that a 14C-oxyclozanide radiolabelled study reported in paragraph 25 of the CVMP European Public MRL Assessment Report (EPMAR) for oxyclozanide (EMEA/MRL/889/03-FINAL)1 indicates that all total 14C-oxyclozanide residues were below the MRL at fourteen days and that they did not increase thereafter.
Maltese: Ġie nnutat li studju radjotikkettat dwar 14C-oxyclozanide rrappurtat f'paragrafu 25 tar-Rapport Pubbliku Ewropew ta' Valutazzjoni tal-MRL (EPMAR, European Public MRL Assessment Report) tas-CVMP għal oxyclozanide (EMEA/MRL/889/03-FINAL)1 jindika li r-residwi kollha totali ta' 14C-oxyclozanide kienu taħt sew l-MRL wara erbatax-il jum u li ma żdidux wara dan.
English: The concentration of oxyclozanide residues in liver, kidney, muscle and fat were below the respective MRLs and lower limit of quantification at 10 and 15 days after administration.
Maltese: Il-konċentrazzjoni tarresidwi ta' oxyclozanide fil-fwied, fil-kliewi, fil-muskolu u fix-xaħam kienu taħt l-MRLs rispettivi u kien hemm limitu ta' kwantifikazzjoni aktar baxx fil-jiem 10 u 15 wara l-għoti.
English: Meat and offal: 13 days.
Maltese: Laħam u ġewwieni tal-annimal: 13-il jum.
English: Whilst these veterinary medicinal products (the reference product Zanil and its generics Chanil/Rumenil) are oral suspensions, bioequivalent and should have similar withdrawal periods the two residue depletion studies led to substantially different withdrawal periods.
Maltese: Filwaqt li dawn il-prodotti mediċinali veterinarji (il-prodott t' referenza Zanil u l-ġeneriċi tiegħu Chanil/Rumenil) huma sospensjonijiet orali, bijoekwivalenti u għandu jkollhom perjodi tal-irtirar simili, iż-żewġ studji dwar it-tnaqqis tar-residwi wasslu għal perjodi tal-irtirar differenti sostanzjalment.
English: The concentration of oxyclozanide residues in liver, kidney and muscle were below the respective maximum residue limits (MRLs) at 7 days after administration, whilst residues in fat were well below the MRL at 10 days after administration.
Maltese: Il-konċentrazzjoni tarresidwi ta' oxyclozanide fil-fwied, fil-kliewi u fil-muskoli kienu taħt il-limiti massimi ta' residwi (MRLs) rispettivi fil-jum 7 wara l-għoti, waqt li r-residwi fix-xaħam kienu taħt sew l-MRL fil-jum 10 wara lgħoti.
English: In the low milk yield group, 3 of 9 cows had residue levels above the MRL.
Maltese: Fil-grupp ta' produzzjoni żgħira ta' ħalib, 3 minn 9 baqar kellhom livelli tar-residwi ‘l fuq mill-MRL.
English: Residues levels were also below the MRLs (and limit of quantification) in liver, kidney and muscle on day 21.
Maltese: Il-livelli tar-residwi wkoll kienu taħt l-MRLs (u l-limitu ta' kwantifikazzjoni) fil-fwied, il-kliewi u lmuskolu fil-jum 21.
English: In summary, based on the residue depletion study performed with the ‘Nilzan Drench Plus' combination product, considering the residue depletion results presented in the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL), and taking account of the withdrawal period recommended in cattle and the estimated half-life in fat a withdrawal period of 14 days for sheep meat and offal is recommended.
Maltese: Fid-dawl tan-nuqqasijiet innutati fl-istudju b'“Nilzan Drench Plus”, prinċipalment il-fatt li l-prodott li ntuża kien prodott ikkombinat (oxyclozanide u levamisole) minflok il-monoprodott Zanil (oxyclozanide) u r-riżultati anormali nkisbu fil-jum 21, l-użu ta' fattur ta' sigurtà suffiċjenti ta' tal-inqas 30 % ġie kkunsidrat bħala wieħed xieraq fid-derivazzjoni tal-perjodu tal-irtirar.
English: Meat and offal: 14 days.
Maltese: Laħam u ġewwieni tal-annimal: 14-il jum.
English: While the efficacy of the products in cattle, sheep and goats has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and control of fasciolosis caused by adult flukes (Fasciola spp.).
Maltese: Waqt li l-effikaċja tal-prodotti fil-frat, fin-nagħaġ u fil-mogħoż ma ġietx ivvalutata speċifikament bħala parti minn din ir-referenza, il-prodotti li qed jiġu vvalutati huma kkunsidrati li huma effettivi fil-kura u fil-kontroll tal-fasciolosis ikkawżata minn parassiti adulti (Fasciola spp.).
English: Chanelle Pharmaceuticals Manufacturing Ltd Loughrea
Maltese: Ir-Renju Unit Chanelle Pharmaceuticals Manufacturing Ltd
English: 26 Rue de la Chapelle 68330 Huningue France
Maltese: 26 Rue de la Chapelle 68330 Huningue
English: Date of last renewal: 10 April 2008
Maltese: Data tal-aħħar tiġdid: 10 ta' April 2008
English: MARKETING AUTHORISATION NUMBERS EU/2/98/007/001-003
Maltese: EU/2/98/007/001-003
English: Manufacturer for batch release: Elanco France S.A.S.
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Elanco France S.A.S.
English: 6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 1 April 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 1 ta' April 1998
English: 4.3 Contraindications
Maltese: 4.3 Kontraindikazjonijiet
English: Clomicalm 5 mg 1.25-2.5 kg ½ tablet >2.5-5 kg
Maltese: Clomicalm 5 mg 1.25-2.5 kg ½ pillola >2.5-5 kg
English: In dogs, the volume of distribution (VDss) is 3.8 l/kg.
Maltese: (VDss) hu ta' 3.8 l/kg.
English: 5 mg (equivalent to 4.5 mg Clomipramine)
Maltese: 5 mg (ekwivalenti għal 4.5 mg Clomipramine)
English: Pack size: 30 tablets
Maltese: Daqs tal-pakkett: 30 pillola.
English: 80 mg (equivalent to 71.7 mg Clomipramine)
Maltese: 80 mg (ekwivalenti għal 71.7 mg Clomipramine)
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)
Maltese: EU/2/98/007/002 (20 mg, 30 pillola)
English: BATCH NUMBER Lot {number} EXPIRY DATE EXP {month/year}
Maltese: DATA TA' SKADENZA EXP {xahar/sena}
English: 20 mg (equivalent to 17.9 mg Clomipramine)
Maltese: 20 mg (ekwivalenti għal 17.9 mg Clomipramine)
English: The active components in vivo are clomipramine and its major metabolite, desmethylclomipramine.
Maltese: Il-komponenti attivi in vivo huma clomipramine u l-metabolit ewlieni tiegħu desmethylclomipramine.
English: 1-2 mg clomipramine/kg bw twice daily.
Maltese: 1-2 mg/kg clomipramine darbtejn kuljum.
English: Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5HT) and noradrenaline.
Maltese: Clomipramine għandu azzjoni estensiva fl-impediment tal-irkupru newronali ta' serotonin (5-HT) u noradrenalina.
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.
Maltese: It-t1/2 tal-eliminazjoni wara l-għoti ġewwa l-vina ta' clomipramine hydrochloride kienet ta' 6.4 sigħat għal clomipramine u 3.6 sigħat għal desmethylclomipramine.
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.
Maltese: clomipramine hu impeditur potenti u selettiv li jirkupra 5-HT waqt li desmethylclomipramine hu impeditur potenti u selettiv li jirkupra n-noradrenalina.
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.
Maltese: Wara doża eċċessiva ta' 20mg/kg Clomicalm (daqs 5 darbiet id-doża massima terapewtika), ġew osservati bradikardja u arritmji (blokk tan-nod atrioventrikulari u ventricular escape beats) bejn wieħed u ieħor 12-il siegħa wara li ngħatat id-doża.
English: Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1.25 - 2.5 kg ½ tablet >2.5 - 5 kg 1 tablet
Maltese: Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1.25-2.5 kg ½ pillola >2.5-5 kg
English: ROUTE(S) OF ADMINISTRATION For oral use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
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)
Maltese: 5 mg Clomipramine hydrochloride (ekwivalenti għal 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (ekwivalenti għal 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride (ekwivalenti għal 71.7 mg Clomipramine)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs
Maltese: VETERINARJU Clomicalm 5 mg pilloli għall-klieb
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.
Maltese: Clomicalm jista' jżid l-effett tal-mediċina anti-arritmika quinidine, aġenti anti-kolinerġiċi (pereżempju atropina), mediċini oħrajn li jaħdmu fuq is-sistema nervuża ċentrali (pereżempju barbiturate, benzodiazepines, anestetiċi ġenerali, newrolettiċi), aġenti simpatomimetiċi (pereżempju adrenalina) u derivattivi ta' coumarin.
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.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma (Cmax) wara l-għoti orali ta' dożi waħdanin ta' 2 mg/kg clomipramine hydrochloride kienu: 240 nmol/l għal clomipramine u 48 nmol/l għal desmethylclomipramine.
English: ½ tablet
Maltese: ½ pillola
English: STATEMENT OF ACTIVE SUBSTANCES 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)
Maltese: ATTIVA(I) 5 mg Clomipramine hydrochloride (ekwivalenti għal 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (ekwivalenti għal 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride (ekwivalenti għal 71.7 mg Clomipramine)
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.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Wara doża eċċessiva ta' 20mg/kg Clomicalm (daqs 5 darbiet id-doża massima terapewtika), ġew osservati bradikardja u arritmji (blokk tan-nod atrioventrikulari u ventricular escape beats) bejn wieħed u ieħor 12-il siegħa wara li ngħatat id-doża.
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.
Maltese: L-għoti ta' Clomicalm mal-ikel jirriżulta f'valuri moderatament ogħla ta' AUC għal clomipramine (25%) u desmethylclomipramine (8%) fil-plażma meta mqabblin ma' klieb sajmin.
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.
Maltese: Clomipramine jiġi assorbit tajjeb (>80%) mill-apparat gastrointestinali tal-klieb meta jiġi mogħti mill-ħalq imma l-bijodisponibilità għal clomipramine u desmethylclomipramine hi 22-26% minħabba metaboliżmu estensiv first pass mill-fwied.
English: Additional polar metabolites also exist.
Maltese: Metaboliti polari oħrajn jeżistu wkoll.
English: Dosage per administration
Maltese: Doża kull amministrazzjoni
English: One side bears the imprint ‘CG', the other ‘D/V' and a score.
Maltese: Naħa minnhom fiha l-kliem stampat ‘CG', in-naħa l-oħra ‘D/V' u ferq.
English: Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Maltese: Studji tal-laboratorju fuq ġrieden u firien urew evidenza ta' effetti ta' ħsara lill embrijoni.
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)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn annimal 1 minn kull 10 ittrattati juri reazzjoni(jiet) avversa(i)) - komuni (aktar minn annimal 1 iżda inqas minn 10 annimali minn kull 100 ittrattat) - mhux komuni (aktar minn annimal 1 iżda inqas minn 10 annimali minn kull 1,000 ittrattat) - rari (aktar minn annimal 1 iżda inqas minn 10 annimali minn kull 10,000 ittrattat)
English: Clomicalm should be used under veterinary supervision.
Maltese: Clonicalm għandu jintuża taħt is-superviżjoni ta' veterinarju.
English: Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Maltese: Tużax f'każijiet ta' sensittività eċċessiva għal clomipramine u antidepressanti triċikliki relatati magħrufin.
English: The principle route of excretion in dogs is via the bile (>80%) with the remainder via the urine.
Maltese: Fil-klieb ir-rotta prinċipali ta' eliminazjoni hi mal-bila (>80%) u li fadal jiġi eliminat mal-awrina.
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.
Maltese: L-għoti ripetut ta' clomipramine jista' jwassal għal żidiet moderati filkonċentrazzjonijiet fil-plażma, proporzjonijiet ta' akkumulazzjoni wara l-għoti mill-ħalq darbtejn kuljum kienu 1.2 għal clomipramine u 1.6 għal desmethylclomipramine bi stat stabbli jintlaħaq fi żmien 3 ijiem.
English: 5 mg tablet: Brownish-grey, oval-oblong, divisible.
Maltese: Pillola 5 mg: Lewn minn kannella sa griża, ovali-oblonga, tista' tinqasam.
English: Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Maltese: Livelli filplażma ta' ċerti mediċini anti-epilessiċi, bħal pereżempju phenytoin u carbamazepine jistgħu jiżdiedu jekk jingħataw flimkien ma' Clomicalm.
English: In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Maltese: Barraminhekk, clomipramine għandu wkoll effetti anti-kolinerġiċi minħabba antagoniżmu lejn riċettaturi kolinerġiċi muskariniċi.
English: METHOD AND ROUTE OF ADMINISTRATION For oral use.
Maltese: U METODU TA' AMMINISTRAZZJONI
English: 20 mg tablet: Brownish-grey, oval-oblong, divisible.
Maltese: Pillola 20 mg: Lewn minn kannella sa griża, ovali-oblonga, tista' tinqasam.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs Clomipramine hydrochloride
Maltese: VETERINARJU Clomicalm 5 mg pilloli għall-klieb Clomicalm 20 mg pilloli għall-klieb Clomicalm 80 mg pilloli għall-klieb
English: 80 mg tablet: Brownish-grey, oval-oblong, divisible.
Maltese: Pillola ta' 80 mg: Lewn minn kannella- sa griża, ovali-oblonga, tista' tinqasam.
English: Clomicalm 80 mg
Maltese: Piż tal-ġisem Clomicalm 80 mg >20-40 kg
English: Store in the original container.
Maltese: 11. PREKAWZJONIJIET SPEĊJALI GĦALL-ĦAŻNA Aħżen fil-kontenitur oriġinali.
English: 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:
Maltese: Clomicalm huwa amministrat darbtejn kuljum b'doża ta' 1-2mg/kg clomipramine biex bħala total tingħata doża ta' 2-4mg/kg kuljum skont it-tabella li hawn taħt:
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.
Maltese: Bħala għajnuna fil-kura ta' disturbi relatati ma' separazzjoni murija b'distruzzjoni u b'eliminazzjoni mhux kif suppost (ippurgar u għemil tal-awrina) u biss f'kombinazzjoni ma' tekniki maħsubin biex jimodifikaw l-imġiba.
English: Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx. 1.5-2.5 hours).
Maltese: L-ogħla livelli fil-plażma malajr jintlaħqu (bejn wieħed u ieħor wara 1.5-2.5 sigħat).
English: Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
Maltese: Clomicalm 5 mg pilloli għall-klieb Clomicalm 20 mg pilloli għall-klieb Clomicalm 80 mg pilloli għall-klieb
English: Do not use after the expiry date which is stated on the label after EXP.
Maltese: Tużax wara d-data ta' skadenza li tidher fuq it-tabella wara EXP.
English: Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Maltese: Doża eċċessiva ta' 40mg/kg (daqs 20 darba d-doża rakkomandata) ta' Clomicalm irriżultat f'qagħda mħattba, rogħda, ħmura fiż-żaqq u nuqqas fl-attività fil-klieb.
English: Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Maltese: Dożi ikbar (500mg/kg, daqs 250 darba d-doża rakkomandata) irriżultaw f'emeżi (rimettar), ippurgar, għajnejn baxxi, rogħda u aspett kwiet.
English: The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Maltese: Impedituri mhux selettivi ta' assorbiment mill-ġdid ta' monoamine.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Clomicalm contains:
Maltese: Kull pillola ta' Clomicalm fiha:
English: Disposal: read package leaflet
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Pharmacotherapeutic group: Non-selective monoamine re-uptake inhibitors, ATCvet code: QN06AA04.
Maltese: Żmien kemm idum tajjeb il-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ: 4 snin.
English: 1 tablet Read the package leaflet before use.
Maltese: 4.11 Perjodu ta' tiżmim Mhux applikabbli.
English: Body weight
Maltese: Piż korporali
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva
English: Date of first authorisation: 11/12/2009 Date of first renewal: 11/07/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 11/12/2009 Data tal-ewwel tiġdid: 11/07/2014
English: H-1114 Budapest Tel.: + 36 1 430 2890
Maltese: Budapest Tel.: + 36 1 430 2890
English: Domaniewska 50 C PL-02-672 Warszawa Tel: + 48 22 549 15 00
Maltese: PL-02-672 Warszawa Tel: + 48 22 549 15 00
English: - The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide , red iron oxide , titanium dioxide , and shellac.
Maltese: - Is-sustanzi l-oħra huma hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide, red iron oxide, titanium dioxide,u shellac.