qanastek/EMEA-V3 huggingface dataset:
Comments Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Idrokarboni minerali, b’ viskożità baxxa jew għolja li jinkludu xemgħat mikrokristallini, bejn wieħed u ieħor C10- C60; komposti alifatiċi, alifatiċi mferrgħin u aliċikliċi.
CR No 2804/ 95
Nru. taċ - Ċertifikat 2804/ 95
Included in Annex II for all food producing species
Inkluż f’ Anness II għall - ispeċi kollha li jipproduċu l- ikel
For use only as preservatives in multidose vaccines at a concentration not exceeding 0.02%.
Għandu jintuża biss bħala preservattiv f’ tilqim b’ ħafna dożi f’ konċentrat ta '0. 02%.
Cr No 749/ 97
Nru. taċ- Ċertifikat 749/ 97
Sorbitan oleate (sorbitan monoleate) Polysorbate 85 (Polyoxyethylene sorbitan trioleate)
Polysorbate 85 (Polyoxyethylene sorbitan trioleate)
Included in Annex II for all food producing species Included in Annex II for all food producing species
Inkluż f’ Anness II għall - ispeċi kollha li jipproduċu l- ikel
Approved food additive (E 494) CR No 2034 CR No 1231/ 06
Nru. taċ- Ċertifikat 1231/ 06
LABELLING AND PACKAGE LEAFLET
TIKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
1 vial of suspension (5 dose size) + 1 vial of emulsion (5 dose size) 10 x 5 doses:
5 dożi: kunjett wieħed bis- suspensjoni (daqs 5 dożi) + kunjett wieħed bl- emulsjoni (daqs 5 dożi) 10 x 5 dożi:
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size) 10 x 25 doses:
10 kunjetti bis- suspensjoni (daqs 5 dożi) + 10 kunjetti bl- emulsjoni (daqs 5 dożi) 25 doża: kunjett wieħed bis- suspensjoni (daqs 25 doża) + kunjett wieħed bl- emulsjoni (daqs 25 doża) 10 x 25 doża:
10 vials of suspension (25 dose size) + 10 vials of emulsion (25 dose size)
10 kunjetti bis- suspensjoni (daqs 25 doża) + 10 kunjetti bl- emulsjoni (daqs 25 doża)
One reconstituted 2 ml dose contains:
Doża waħda ta ’ 2 ml rrikonstitwiti fiha:
Inactivated porcine circovirus type 2 (PCV2)................................................ ≥ 2.1 log10 ELISA. Units Excipient:
Ċirkovirus tal- ħnieżer tat- tip 2 inattivat (PCV2)............................................ ≥ 2. 1 log10 Unitajiet ELISA.
494 to 501 mg
Żejt tal- Paraffin Ħafif..................................................................................................... 494 għal 501 mg
5 doses:
5.
10 vials of suspension (25 dose size) + 10 vials of emulsion (25 dose size)
SPEĊI GĦAL XIEX HUWA INDIKAT IL- PRODOTT
Pigs (gilts and sows).
Ħnieżer (ħnieżer nisa żgħar u majjaliet)
Passive immunisation of piglets to reduce lesions in lymphoid tissues and as an aid to reduce PCV2- linked mortality.
Tilqim passiv tal- qżieqeż biex jonqsu l- feriti fit- tessuti tal- limf u bħala għajnuna biex jonqsu l- imwiet relatati mal- PCV2.
12 8.
12 Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
Withdrawal period: zero days.
Żmien ta 'Tiżmim: xejn.
Accidental injection is dangerous – read the package leaflet before use.
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
EXP {month/ year} Use within 3 hours after mixing.
Jiskadi {xahar / sena} La darba jinfetaħ uża fi żmien 3 sigħat.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
For animal treatment only – to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni veterinarja.
EU/ 2/ 07/ 075/ 001 5 doses:
EU/ 2/ 07/ 075/ 001 5 dożi: kunjett wieħed bis- suspensjoni (daqs 5 dożi) + kunjett wieħed bl- emulsjoni (daqs 5 dożi)
1 vial of suspension (5 dose size) + 1 vial of emulsion (5 dose size) EU/ 2/ 07/ 075/ 002 10 x 5 doses:
13 EU/ 2/ 07/ 075/ 002 10 x 5 dożi:
1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size)
10 kunjetti bis- suspensjoni (daqs 5 dożi) + 10 kunjetti bl- emulsjoni (daqs 5 dożi) EU/ 2/ 07/ 075/ 003 25 doża: kunjett wieħed bis- suspensjoni (daqs 25 doża) + kunjett wieħed bl - emulsjoni (daqs 25 doża) EU/ 2/ 07/ 075/ 004 10 x 25 doża:
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Vial of 5 doses of suspension Vial of 25 doses of suspension
Kunjett ta ’ 5 dożi ta ’ suspensjoni Kunjett ta ’ 25 doża ta ’ suspensjoni
Circovac Suspension
Circovac
Porcine circovirus 2
Ċirkovirus 2 tal- Ħnieżer
5 doses 25 doses
5 dożi 25 doża
EXP {month/ year}
Jis{ xahar/ sena}
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Vial of 5 doses of emulsion Vial of 25 doses of emulsion
Kunjett ta ’ 5 dożi ta ’ suspensjoni Kunjett ta ’ 25 doża ta ’ suspensjoni
Circovac Emulsion
Circovac
Light paraffin oil and Thiomersal After reconstitution contains PCV2.
Żejt tal- paraffin ħafif u Thiomersal Wara r- rikostituzzjoni jinkludi PCV2.
ROUTE(S) OF ADMINISTRATION
MOD TA ’ AMMINISTRAZZJONI
Zero days.
Żmien ta ’ tiżmim: xejn.
EXP {month/ year}
Jis {xahar/ sena}
MERIAL, 29 Avenue Tony Garnier, F-69007 Lyon, France
MERIAL, 29 Avenue Tony Garnier, F- 69007 Lyon, Franza
Manufacturer for batch release:
Manifattur li jħalli l- konsenja tmur fis- suq:
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France
MERIAL, Laboratoire Porte des Alpes, Rue de l' Aviation, F- 69800 Saint Priest, Franza
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
3 DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
Inactivated porcine circovirus type 2 (PCV2)................................................ ≥ 2.1 log10 ELISA. Units Excipient:
Ċirkovirus tal- ħnieżer tat- tip 2 inattivata (PCV2)............................................ ≥ 2. 1 log10 Unitajiet ELISA.
INDICATION(S)
4 INDIKAZZJONI( JIET)
Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2- linked mortality.
Tilqim passiv tal- qżieqeż permezz tal- kolostrum, wara t- tilqim attiv tal- ħnieżer nisa żgħar u tal - majjaliet, biex jonqsu l- feriti fit- tessuti tal- limf assoċjati ma ’ l- infezzjoni b’ PCV2 u bħala għajnuna biex jonqsu l- imwiet relatati mal- PCV2.
Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake.
5 KONTRA- INDIKAZZJONIJIET
These reactions resolve spontaneously, in a maximum of 4 days on average, without any consequence on the health and the zootechnical performance of the sow or gilt.
Dawn ir- reazzjonijiet jgħaddu waħedhom bejn wieħed u ieħor fi żmien erbat ’ ijiem mingħajr konsegwenzi fuq is- saħħa u l- imġieba żooteknika tal- ħnieżer nisa żgħar u tal- majjaliet.
18 In clinical studies, post-mortem examination of the injection sites performed at most 50 days after the vaccination revealed limited lesions such as a discoloration and a granuloma in the majority of animals as well as necrosis or fibrosis (in approximately half of the animals).
18 Fi studji kliniċi, l- investigazzjoni li saret fuq il- postijiet fejn ingħatat l- inezzjoni sa mhux aktar 50 ġurnata wara li ngħatat it- tilqima, urew feriti limitati fosthom telf fil- kulur u granuloma fil- biċċa l - kbira ta ’ l- annimali, kif ukoll nekrożi jew fibrożi (f’ madwar nofs l- annimali).
Within the 2 days following the injection, an average increase in rectal temperature up to 1.4°C can occur.
Sa jumejn wara l- injezzjoni, jista ’ jkun hemm żjieda medja fit- temperatura tal- warrani ta ’ mhux aktar minn 1. 4°C.
Vaccination may exceptionally cause hypersensitivity reactions.
F’ każijiet eċċezzjonali, it- tilqim jista ’ jikkawża reazzjonijiet ta ’ sensittitvità eċċessiva.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
8 DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
Reconstitute immediately after removal from the refrigerator (or other cold storage).
Irrikostitwixxi minnufih wara li tneħħi mill- friġġ (jew minn post ieħor li jkessaħ).
To use the vaccine, shake vigorously the vial of suspension and inject its content into the vial of emulsion.
Biex tuża t- tilqima, ħawwad sew il- flixkun bis- suspensjoni u injetta l- kontenut tiegħu fil- flixkun bl - emulsjoni.
Administer one 2 ml dose by deep intramuscular injection in accordance with the following vaccination scheme:
Agħti doża waħda ta ’ 2 ml permezz ta ’ injezzjoni fil- fond ġol- muskolu skond l- iskema li ġejja għat - tilqima:
One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before mating.
Injezzjoni waħda, bit- tieni injezzjoni bejn 3 u 4 ġimgħat wara, u mill- inqas ġimagħtejn qabel it- tgħammir.
One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before farrowing.
Injezzjoni waħda, bit- tieni injezzjoni bejn 3 u 4 ġimgħat wara, u sa mill- inqas ġimagħtejn qabel ma l- ħanżira tferragħ.
Revaccination: • One injection at each gestation, at least 2 to 4 weeks before farrowing.
Tilqim mill- ġdid: • Injezzjoni waħda f’ kull tqala, bejn ġimagħtejn u 4 ġimgħat qabel ma l- ħanżira tferragħ.
To use the vaccine, shake vigorously the vial of antigen suspension and inject its content into the vial of emulsion containing adjuvant.
Biex tuża t- tilqima, ħawwad sew il- flixkun bis- suspensjoni ta ’ l- antiġen u injetta l- kontenut tiegħu fil - flixkun ta ’ l- emulsjoni li fih l- adjuvant.
Gently mix before use.
Ħawwad bil- mod qabel ma tużah.
The reconstituted vaccine is a homogeneous white emulsion.
It- tilqima rikonstitwita hi emulsjoni bajda omoġenja.
SPECIAL STORAGE PRECAUTIONS 19 Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Store and transport refrigerated (2 C – 8 C).
Aħżen u ttrasporta fil- friġġ (2°C – 8°C).
Use within 3 hours after mixing.
La darba jinfetaħ uża fi żmien 3 sigħat.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ l- iskadenza fuq it- tikketta.
Can be used during pregnancy.
Jista ’ jintuża waqt it- tqala.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
M’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma ’ xi prodott ieħor.
It is therefore recommended that no other vaccines should be administered concurrently within 14 days before or after vaccination with the product.
Għaldaqstant huwa rrakkomandat li ma tintuża l- ebda tilqima oħra fi żmien 14- il jum qabel jew wara li tlaqqam b’ dan il- prodott.
No adverse reactions, except those mentioned in the section “ Adverse Reactions” were observed after the administration of a double dose of vaccine.
L- ebda reazzjoni avversa, ħlief dawk imsemmija fis- sezzjoni “ Effetti mhux mixtieqa ” ma ntweriet wara li ngħatat doża doppja tat- tilqima.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek jista 'jirriżulta f' uġigħ kbir u nefħa specjalment jekk tinjetta f' ġog jew saba ’ u f' kazijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mal- ewwel.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tiġi njettat bi żball b' dan il- prodott, fittex għajnuna medika, anke jekk ammont żgħir ħafna ġie injettat u ħu il- fuljetta ta 'informazzjoni li tinsab fil- pakkett miegħek.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta ’ dan il - prodott tista 'tikkawza nefħa intensa, li tista' per eżempju tikkawża nekrożi iskimika u anke l- bżonn li jinqata 'xi saba ’.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata mal- ewwel u jista ’ jkun hemm bżonn li jinfetaħ is- saba ’ u tiġi rrigata l- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il- laħam tas- saba ’ u t- tendin tal- muskolu.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
The reconstituted vaccine contains an inactivated porcine circovirus type 2 (PCV2) in an oily adjuvant (o/ w).
20 It- tilqima rrikonstitwita fiha Ċirkovirus tal- ħnieżer tat- tip 2 inattivat (PCV2) f’ adjuvant żejtni (o/ w).
It is intended to stimulate active immunity in gilts and sows to provide passive immunity in piglets, through colostrum intake.
Għandu l- għan li jqanqal immunità attiva fil- ħnieżer nisa żgħar u fil- majjaliet, sabiex jipprovdi immunità passiva fil- qżieqeż, permezz tat- teħid tal- kolostrum.
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju li jingħata bi preskrizzjoni veterinarja.
Invented name
Isem kummerċjali
Pharmaceutical Target Species form
Għamla Farmaċewtika
Route of administration
Speċi li fuqhom Mod ta ’ għandu jintuża l - Amministrazzjoni prodott
HDPE bottle with child resistant closure
Flixkun ta ’ l -
30 tablets and a 1 bottle in a desiccant sachet cardboard box
30 pillola u 1 flixkun Mhux
N/ A
kartun
HDPE bottle with child resistant closure
HDPE b’ għeluq pakkett tad - f’ kaxxa tal - applikabbli
30 tablets and a 1 bottle in a desiccant sachet cardboard box
reżistenti għat - tfal
EMEA/ CVMP/ 064/ 97
30 pillola u
1/ 1
1 flixkun Mhux
©EMEA 2006
kartun
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta 'Valutazzjoni Pubblika Ewropew.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet dwar il- kundizzjonijiet ta ’ l- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jissostitwixxi diskussjoni wiċċ imb' wiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament ta 'l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq iktar informazzjoni relatata mar - rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Clomicalm?
X' inhu Clomicalm?
Clomicalm is a veterinary medicine containing the active substance clomipramine.
Clomicalm hija mediċina veterinarja li fiha s- sustanza attiva klomipramina (clomipramine).
It is available as tablets containing 5 mg, 20 mg or 80 mg clomipramine.
Hija disponibbli bħala pilloli li fihom 5 mg, 20 mg jew 80 mg klomipramina.
What is Clomicalm used for?
Għal xiex jintuża Clomicalm?
Clomicalm is used as an aid in the treatment of dogs that have behavioural problems when separated from their owners, their normal home, or other dogs.
Clomicalm jintuża bħala għajnuna fit- trattament ta 'klieb bi problemi fl- imġiba (komportamentali) meta jiġu sseparati minn sidhom, id- dar fejn jgħixu jew minn klieb oħra.
These behavioural problems might be expressed for example by destructive behaviour or inappropriate defecation or urination in the house.
Dawn il- problemi fl- imġiba aktarx li huma espressi bħala mġiba distruttiva jew li l- annimal iħammeġ fid- dar b' mod inapproprjat.
Clomicalm should not be used on its own but only in dogs that are also undergoing behavioural therapy.
Clomicalm ma għandux jintuża waħdu iżda esklussivament fi klieb li huma sottoposti għal terapija komportamentali wkoll.
Clomicalm tablets are given twice a day.
Il- pilloli ta 'Clomicalm jingħataw darbtejn kuljum.
The strength and number of tablet(s) to use is adjusted according to the dog’ s weight, so that the dog is given between 2 mg and 4 mg clomipramine per kg of the dog’ s bodyweight per day.
Il- qawwa u l- għadd ta 'pillola/ i li għandhom jintużaw huwa/ hija aġġustat( a) skond kemm jiżen il- kelb, sabiex lill- kelb tingħatalu bejn 2 mg u 4 mg klomipramina għal kull kilo tal- piż tal- ġisem tal- kelb għal kull ġurnata.
How does Clomicalm work?
Kif jaħdem Clomicalm?
The active substance in Clomicalm, clomipramine, belongs to the group of the tricyclic antidepressants.
Is- sustanza attiva fi Clomicalm, il- klomipramina, hija parti mill- grupp ta 'l- antidepressivi triċikliċi.
In the body, clomipramine and its major metabolite, desmethylclomipramine prevent some neurotransmitters from being taken back up into nerve cells in the brain and spinal cord.
Fil- ġisem, il- klomipramina u l- metabolita prinċipali tagħha, desmetilklomipramina (desmethylclomipramine) jimpedixxu lil xi newrotrasmettituri milli jerġgħu jittellgħu fiċ - ċelluli tan- nervituri fil- moħħ u fis- sinsla tad- dahar.
Neurotransmitters are substances that transfer chemical signals from one nerve cell to another one.
In- newrotrasmettituri huma sustanzi li jittasferixxu sinjali kimiċi minn ċellula tan- nervituri għall- oħra.
Clomipramine prevents the re-uptake of serotonin (5-hydroxytryptamine) and desmethylclomipramine prevents the re-uptake of noradrenalin.
Il- klomipramina timpedixxi li s- serotonina (5- hydroxytryptamine) terġa 'tiġi assorbita u d- desmetilklomipramina tagħmel l - istess bin- noradrenalina.
Low levels of neurotransmitters in the central nervous system may be associated with depression, anxiety or aggression.
Livelli baxxi ta 'newrotrasmettituri fis- sistema nervuża ċentrali jistgħu jkunu assoċjati ma' depressjoni, ansjetà jew aggressjoni.
By blocking the re-uptake of serotonin and noradrenalin into nerve cells, clomipramine and its metabolite allow the levels to remain higher.
Il- klomipramina u l - metabolita tagħha, billi jimblokkaw l- assorbiment mill- ġdid tas- serotonina u tan- noradrenalina fiċ- ċelloli tan- nervituri, jippermettu li l- livelli jibqgħu ogħla.
This can improve the clinical signs (behavioural problems) in dogs with separation-related disorders.
Dan jista 'jtejjeb is- sintomi kliniċi (problemi fl- imġiba) fil- klieb b' disturbi minħabba separazzjoni.
In order to treat a dog with anxiety, the animal should not only receive medicines but also behavioural therapy.
Bil- għan li jiġi ttrattat kelb li għandu ansjetà, mhux biss għandu l- annimal jirċievi mediċini iżda wkoll ikun sottopost għal terapija komportamentali.
Behavioural modification therapy is the most important part of therapy; however, the use of the medicine allows for a more speedy recovery of the animal patient.
It- terapija tal- modifikazzjoni komportamentali tirrappreżenta l - aktar parti importanti tat- terapija; madankollu, l- użu tal- mediċina tippermetti li l- pazjent annimal jirkupra aktar malajr.
How has Clomicalm been studied?
Kif ġie studjat Clomicalm?
The effective dose of Clomicalm has been established in clinical studies in dogs.
Id- doża effikaċi ta 'Clomicalm ġiet stabbilita fi studji kliniċi fil- klieb.
The efficacy and tolerance of the medicine in animal patients was confirmed in clinical studies in various veterinary practices or clinics in the USA, and in a number of countries in Europe (“ field studies”).
L- effikaċja u t - tolleranza tal- mediċina f' pazjenti annimali ġiet ikkonfermata fi studji kliniċi f' varji studji u kliniċi veterinarji fl- Istati Uniti, u f' għadd ta 'pajjiżi fl- Ewropa ("studji fuq il- post").
In each study, treatment with clomipramine was combined with behaviour modification techniques.
F' kull studju, it- trattament bil- klomipramina ġie kkombinat ma 'tekniki ta' modifikazzjoni komportamentali.
The treatment results in these dogs were compared to treatment results in dogs receiving behavioural therapy alone (no medication).
Ir- riżultati tat- trattament f' dawn il- klieb tqabblu mar- riżultati tat- trattament fi klieb li jirċievu terapija komportamentali waħedha (bl- ebda medikazzjoni).
What benefit has Clomicalm shown during the studies?
Liema benefiċċji wera Clomicalm f' dawn l- istudji?
Results of the field studies indicated that the administration of clomipramine in combination with behaviour modification techniques was effective in the relief of clinical signs of separation anxiety.
Ir- riżultati mill- istudji fuq il- post indikaw li meta l- klomipramina tingħata flimkien ma 'tekniki ta' modifikazzjoni komportamentali, dan kien effikaċi għas- serħan mis- sintomi kliniċi ta 'l - ansjetà minħabba separazzjoni.
Treatment with clomipramine at twice daily doses of 1 - 2 mg/ kg bodyweight was effective, when compared to lower doses or to treatment with behavioural therapy alone (placebo).
It- trattament bil- klomipramina f' dożi ta '1- 2 mg/ kg tal- piż tal - ġisem darbtejn kuljum kien effikaċi meta mqabbel ma' dożi anqas qawwijin jew ma 'trattament bit- terapija komportamentali waħedha (plaċebo).
What is the risk associated with Clomicalm?
X' inhu r- riskju assoċjat ma 'Clomicalm?
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (sleepiness) or an elevation in liver enzymes, which are reversible when the product is discontinued.
Clomicalm jista 'rarament jikkawża remettar, tibdil fl- aptit, letarġija (ħedla tan- ngħas) jew kwalunkwe żieda fl- enzimi epatiċi (tal- fwied), li huma reversibbli ladarba l- prodott ma jibqax jingħata.
Effects on the liver have been reported, especially in dogs with existing liver problems.
Ġew irrapportati effetti fuq il- fwied, speċjalment fi klieb li diġà jbatu minn problemi bil- fwied.
Vomiting may be reduced by giving the tablets with a small quantity of food.
Ir- remettar jista 'jitnaqqas billi l- pilloli jingħataw bi kwantità żgħira ta' ikel.
At overdose with 20 mg/ kg Clomicalm (5 times the maximum therapeutic dose), a reduction in heart rate were observed approximately 12 hours after dosing.
B' doża eċċessiva bi Clomicalm ta '20 mg/ kg (id- doża terapewtika massima għal 5 darbiet), ġie osservat tnaqqis fir- rata kardijaka madwar 12- il siegħa wara d- dożaġġ.
Since Clomicalm has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation.
Billi Clomicalm ma ġiex ittestjat fuq klieb ħobla jew li jreddgħu, l- użu tiegħu mhuwiex rakkomandat matul il - ħbulija jew it- treddigħ.
Due to potential interactions, the administration of Clomicalm is not recommended in combination with a number of other medicines listed in the package leaflet.
Minħabba interazzjonijiet potenzjali, l- użu ta 'Clomicalm mhuwiex rakkomandat f' kombinazzjoni ma' għadd ta 'mediċini oħra elenkati fil- fuljett ta' tagħrif.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
X' inhuma l- prekawzjonijiet li għandha tieħu persuna li tagħti l- mediċina jew li tiġi f' kuntatt ma 'l- annimal?
Since accidental ingestion might cause serious reactions in children, the tablets are supplied in a bottle fitted with a child resistant closure.
Billi l- inġestjoni aċċidentali tista 'tikkawża reazzjonijiet gravi fit- tfal, il- pilloli huma preżentati fi flixkun b' għatu ta' sigurtà għat- tfal.
This veterinary medicine has been developed especially for dogs and is not for use in humans.
Din il- mediċina veterinarja ġiet żviluppata apposta għall- klieb u ma għandhiex tintuża fuq il - bnedmin.
If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Jekk persuna aċċidentalment tieħu l- mediċina, fittex immedjatament għajnuna medika u uri lit- tabib il- fuljett tat- tagħrif jew it- tikketta.
Why has Clomicalm been approved?
Għaliex ġie approvat Clomicalm?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Clomicalm exceed the risks when used in combination with behavioural modification techniques as an aid in the treatment of dogs with separation-related disorders, and recommended that Clomicalm be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta 'Clomicalm huma akbar mir- riskji meta jintuża f' kombinazzjoni ma' tekniki ta 'modifikazzjoni komportamentali bħala għajnuna fit- trattament ta' klieb b' disturbi minħabba separazzjoni, u rrakkomanda li Clomicalm jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il - bilanċ bejn il- benefiċċji u r- riskji jista 'jiġi kkonsultat fil- modulu 6 ta' dan l- EPAR.
Other information about Clomicalm:
Tagħrif ieħor dwar Clomicalm:
The European Commission granted a marketing authorisation valid throughout the European Union, for Clomicalm to Novartis Tiergesundheit GmbH, Germany on 1 April 1998, which was renewed in 2003 and 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Clomicalm lil Novartis Tiergesundheit GmbH, il- Ġermanja fl- 1 ta 'April 1998 u din ġiet imġedda fl- 2003 u fl- 2008.
Information on the prescription status of this product may be found on the label/ outer package.
It- tagħrif dwar l- istatus tal- preskrizzjoni ta 'dan il- prodott jista' jiġi kkonsultat mit- tikketta/ mill- pakkett ta 'barra.
This summary was last updated in May 2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Page 2/ 2
© EMEA 2008 Paġna 2/ 2
Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
Clomicalm 5 mg pilloli għall- klieb Clomicalm 20 mg pilloli għall- klieb Clomicalm 80 mg pilloli għall- klieb
Each tablet of Clomicalm contains:
Kull pillola ta ’ Clomicalm fiha:
5 mg (equivalent to 4.5 mg Clomipramine)
5 mg (ekwivalenti għal 4. 5 mg Clomipramine)
20 mg (equivalent to 17.9 mg Clomipramine) 80 mg (equivalent to 71.7 mg Clomipramine)
20 mg (ekwivalenti għal 17. 9 mg Clomipramine) 80 mg (ekwivalenti għal 71. 7 mg Clomipramine)
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara
4.1 Target species
4. 1 Speċi li fuqhom ser jintuża il- prodott
Dog
Klieb
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża il- prodott
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.
Bħala għajnuna fil- kura ta ’ disturbi relatati ma ’ separazzjoni murija b’ distruzzjoni u b’ eliminazzjoni mhux kif suppost (ippurgar u għemil ta ’ l- awrina) u biss f’ kombinazzjoni ma ’ tekniki maħsubin biex jimodifikaw l- imġiba.
4.3 Contraindications
4. 3 Kontra indikazjonijiet
Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Tużax f’ każijiet ta ’ sensittività eċċessiva għal clomipramine u antidepressanti triċikliki relatati magħrufin.
Do not use in male breeding dogs.
Tużax fi klieb ta ’ sess maskili li jkunu qed jintużaw għat- tnissil.
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
L- effikaċja u s- sigurtà ta ’ Clomicalm fil- klieb li jiżnu inqas minn 1. 25 kg jew li għandhom inqas minn sitt xhur għadhom mhux stabbiliti.
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.
Prekawzjonijiet speċjali għall- użu fl- annimali Huwa rakkomandat li Clomicalm jingħata b’ kawtela lil klieb li għandhom disturbi kardjovaskulari jew epilessija, u dejjem wara valutazzjoni li tixtarr is- siwi kontra r- riskji.
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.
Minħabba l- karatteristiċi anti- kolinerġici potenzjali tiegħu, Clomicalm għandu jintuża b’ kawtela fi klieb bi glawkoma ta ’ angolu dejjaq, b’ nuqqas fil- motilità gastrointestinali jew ritenzjoni ta ’ l- awrina.
Clomicalm should be used under veterinary supervision.
Clonicalm għandu jintuża taħt is- superviżjoni ta ’ veterinarju.
2 Special precautions to be taken by the person administering the veterinary medicinal product to animals In children, accidental ingestion should be regarded as serious.
2 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Jekk dan il- prodott mediċinali jinbela ’ bi żball mit- tfal, dan għandu jitqies bħala każ serju.
There is no specific antidote.
M’ hemm l - ebda antidot speċifiku.
In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
F’ każ li tibla ’ dan il- prodott mediċinali bi żball, fittex parir mediku minnufih u uri t- tikketta tal- prodott lit- tabib.
Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Doża eċċessiva fil- bnedmin tista ’ twassal għal effetti anti- kolinerġiċi, imma jista ’ jkun hemm effett fuq is- sistema nervuża ċentrali u s- sistema kardjovaskulari wkoll.
People with known hypersensitivity to clomipramine should administer the product with caution.
Nies li huma magħrufin li għandhom sensittività eċċessiva għal clomipramine għandhom jamministraw dan il- prodott b’ kawtela.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Clomicalm jista ’ rarament jikkawża rimettar sporadiku, tibdil fl- aptit, jew letarġija jew żieda fl- enzimi tal- fwied, li jistgħu jiġu rimedjati jekk il- kura bil- prodott titwaqqaf.
Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Ġiet irrapportata marda ħepato - biljari, b’ mod speċjali flimkien ma ’ kundizzjonijiet pre- eżistenti, u amministrazzjonijiet fl- istess ħin ta ’ mediċini metabolizzati permezz tas- sistema ħepatika.
Vomiting may be reduced by co-administration of Clomicalm with a small quantity of food.
Ir- rimettar jista ’ jitnaqqas billi jingħata wkoll Clomicalm ma ’ ammont żgħir ta ’ ikel.
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi klieb tas- sess femminili waqt it- tqala u waqt it- treddigħ.
Laboratory studies in mice and rats have shown evidence of embryotoxic effects.
Studji tal- laboratorju fuq ġrieden u firien urew evidenza ta ’ effetti embrijotossiċi.
Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs.
Ir- rakkomandazzjonijiet fuq l- interazzjoni bejn Clomicalm u mediċini oħrajn huma miksubin wara studji fuq speċji li mhumiex klieb.
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.
Clomicalm jista ’ jsaħħaħ l- effett tal- mediċina anti- arritmika quinidine, aġenti anti- kolinerġiċi (per eżempju atropina), mediċini oħrajn li jaħdmu fuq is- sistema nervuża ċentrali (per eżempju barbiturate, benzodiazepines, anestetiċi ġenerali, newrolettiċi), aġenti simpatomimetiċi (per eżempju adrenalina) u derivattivi ta ’ coumarin.
The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
L- għoti ta ’ Clomicalm flimkien ma ’, jew sa ġimagħtejn wara, kura b’ inibituri ta ’ monoamine oxidase, mhuwiex rakkomandat.
Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine.
L- għoti fl- istess ħin ma ’ cimetidine jista ’ tirriżulta f’ livelli għoljin ta ’ clomipramine fil- plażma.
Plasma levels of certain anti- epileptic drugs, such as phenytoin and carbamazepine, may be increased by co-administration with Clomicalm.
Livelli fil - plażma ta ’ ċerti mediċini anti- epilessiċi, bħal per eżempju phenytoin u carbamazepine jistgħu jiżdiedu jekk jingħataw flimkien ma ’ Clomicalm.
4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu tal- amministrazzjoni
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:
Clomicalm għandu jingħata mill- ħalq u d- doża għandha tkun ta ’ 1 – 2 mg/ kg clomipramine darbtejn kuljum għal doża totali ta ’ 2- 4 mg/ kg kuljum skond it- tabella ta ’ hawn taħt:
Dosage per administration Body weight 1.25 - 2.5 kg > 2.5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Doża kull amministrazzjoni Piż korporali 1. 25 - 2. 5 kg > 2. 5 - 5 kg > 5 - 10 kg > 10 - 20 kg > 20 - 40 kg > 40 - 80 kg
Clomicalm 5 mg ½ tablet 1 tablet
Clomicalm 5 mg ½ pillola 1 pillola
Clomicalm 20 mg ½ tablet 1 tablet
Clomicalm 20 mg ½ pillola 1 pillola
Clomicalm 80 mg ½ tablet 1 tablet
Clomicalm 80 mg ½ pillola 1 pillola
Clomicalm may be given with or without food.
Clomicalm jista ’ jittieħed ma ’ l- ikel jew mingħajru.
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.
Fi provi kliniċi, kura bil- Clomicalm għal 2- 3 xhur kombinata ma ’ tekniċi maħsubin biex jimmodifikaw l- imġieba kienet biżżejjed biex ikunu kontrollati s- sintomi ta ’ disturbi relatati ma ’ separazjoni.
Some cases may require longer treatment.
Xi każijiet jistgħu jkollhom bżonn żmien itwal ta ’ kura.
In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
F’ każijiet fejn m’ hemm l- ebda titjib fil- kundizzjoni wara xahrejn, il- kura b’ Clomicalm għandha titwaqqaf.
3 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenża, antidoti) jekk ikun hemm bżonn
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.
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.
Overdose with 40 mg/ kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
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.
250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Dożi ikbar (500mg/ kg, daqs 250 darba d- doża rakkomandata) irriżultaw f’ emeżi (rimettar), ippurgar, għajnejn baxxi, rogħda u aspett kwiet.
Still higher doses (725 mg/ kg) produced, in addition, convulsions and death.
Dożi ikbar (725mg/ kg) irriżultaw ukoll f’ aċċessjonijiet u mewt.
4.11 Withdrawal period
4. 11 Perjodu ta ’ tiżmin
QN06AA04.
Impedituri mhux selettivi ta ’ assorbiment mill- ġdid ta ’ monoamine, Kodiċi ATĊ veterinarja QN06AA04.
Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5- HT) and noradrenaline.
Clomipramine għandu azzjoni estensiva fl- impediment ta ’ l- irkupru newronali ta ’ serotonin (5- HT) u noradrenalina.
It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Għaldaqstant għandu l- karatteristiċi ta ’ impeditur ta ’ l- irkupru ta ’ serotonin u ta ’ antidipressant triċikliku.
The active components in vivo are clomipramine and its major metabolite, desmethylclomipramine.
Il- komponenti attivi in vivo huma clomipramine u l- metabolit ewlieni tiegħu desmethylclomipramine.
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.
Kemm clomipramine u desmethylclomipramine jikkontribwixxu għall- effetti ta ’ Clomicalm: clomipramine hu impeditur potenti u selettiv li jirkupra 5- HT waqt li desmethylclomipramine hu impeditur potenti u selettiv li jirkupra n- noradrenalina.
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.
Il- mekkaniżmu ewlieni ta ’ azzjoni ta ’ clomipramine hu li jsaħħaħ l- effetti ta ’ 5- HT u noradrenalina fil- moħħ billi jimpedixxi l- assorbiment newronali tagħhom.
In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Barraminhekk, clomipramine għandu wkoll effetti anti- kolinerġiċi minħabba antagoniżmu lejn riċettaturi kolinerġiċi muskariniċi.
5.2 Pharmacokinetic particulars
5. 2 Tagħrif farmakokinetiċi
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.
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.
Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx.
L- ogħla livelli fil- plażma malajr jintlaħqu (bejn wieħed u ieħor wara 1. 5- 2. 5 sigħat).
The maximal plasma concentrations (Cmax) after oral administration of single doses of 2 mg/ kg clomipramine hydrochloride were:
L- ogħla konċentrazzjonijiet fil- plażma (Cmax) wara l- għoti orali ta ’ dożi waħdanin ta ’ 2 mg/ kg clomipramine hydrochloride kienu:
240 nmol/ l for clomipramine and 48 nmol/ l for desmethylclomipramine.
240 nmol/ l għal clomipramine u 48 nmol/ l għal desmethylclomipramine.
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.
L- għoti ripetut ta ’ clomipramine jista ’ jwassal għal żidiet moderati fil- konċentrazzjonijiet 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.
At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Fi stat stabbli l- proporzjoni ta ’ clomipramine fil- plażma meta mqabbel ma ’ konċentrazzjonijiet ta ’ desmethylclomipramine hu ta ’ madwar 3. 1.
Administration of Clomicalm with food causes moderately higher plasma AUC values for clomipramine (25%) and desmethylclomipramine (8%) as compared with administration to fasted dogs.
L- għoti ta ’ Clomicalm ma ’ l- ikel jirriżulta f’ valuri moderatament ogħla ta ’ AUC għal clomipramine (25%) u desmethylclomipramine (8%) fil- plażma meta mqabblin ma ’ klieb sajmin.
Clomipramine is extensively bound to plasma proteins (> 97%) in dogs.
Clomipramine huwa estensivament marbut mal - proteini tal- plażma fil- klieb (> 97%).
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.
Clomipramine u l- metaboliti tiegħu jiġu distribwiti malajr fil- ġisem fil- każ ta ’ ġrieden, fniek u firien u b’ konċentrazzjonijiet għoljin f’ organi u tessuti (inkluż il- pulmuni, qalb u moħħ) u konċentrazzjonijiet baxxi fid- demm.
In dogs, the volume of distribution (VDss) is 3.8 l/ kg.
Fil- klieb, il- volum ta ’ distribuzzjoni (VDss) hu ta ’ 3. 8 l/ kg.
The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Ir- rotta ewlenija ta ’ bijotrasformazzjoni ta ’ clomipramine hi dimetilazzjoni biex jifforma desmethylclomipramine.
Additional polar metabolites also exist.
Metaboliti polari oħrajn jeżistu wkoll.
The elimination t1/ 2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
It- t1/ 2 ta ’ l- eliminazjoni wara l- għoti ġewwa l- vina ta ’ clomipramine hydrochloride kienet ta ’ 6. 4 sigħat għal clomipramine u 3. 6 sigħat għal desmethylclomipramine.
The principle route of excretion in dogs is via the bile (> 80%) with the remainder via the urine.
Fil- klieb ir- rotta prinċipali ta ’ eliminazjoni hi mal- bila (> 80%) u li fadal jiġi eliminat ma ’ l- awrina.
6.1 List of excipients
4 6. 1 Lista ta ’ ingredjenti
None known.
M’ hemm xejn magħruf
One HDPE bottle with child resistant closure and sealing disk, containing 30 tablets and one silica gel desiccant sachet, packed within a cardbox.
Flixkun wieħed ta ’ l- HDPE b’ għeluq reżistenti għat- tfal u ssiġillat b’ disk, li fih 30 pillola u qartas wieħed b’ dessikant tas- silica gel, ippakkjat ġo kaxxa tal- kartunċin.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodott mediċinali veterinarju mhux użat jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Novartis Tiergesundheit GmbH Zielstattstrasse 40 D-81379 Munich Germany
Novartis Tiergesundheit GmbH Zielstattstrasse 40 D- 81379 Munich Il- Ġermanja
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
1 April 1998 / 19 May 2003
1 ta ’ April 1998 / 19 ta ’ Mejju 2003
5 10 DATE OF REVISION OF THE TEXT
5 10 DATA TA ’ META ĠIET RIVEDUTA DIN IL- KITBA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea tal- Mediċini (EMEA) http: // www. emea. europa. eu.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (BIOLOĠIĊI) ATTIVA( I) U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
STATEMENT OF THE MRLs
DIKJARAZZJONI TA ’ L - MRLs
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (BIOLOĠIĊI) ATTIVA( I) U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
Usine de Huningue 26, rue de la Chapelle F-68332 Huningue Cedex France
Usine de Huningue 26, rue de la Chapelle F- 68332 Huningue Cedex Franza
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL - KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
To be supplied only on veterinary prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARDBOX
KAXXA
Clomicalm 5 mg tablets for dogs
Clomicalm 5 mg pilloli għall- klieb
Tablets.
Pilloli
INDICATION
INDIKAZZJONI
As an aid in the treatment of separation-related disorders in combination with behavioural modification techniques.
Bħala għajnuna fil- kura ta ’ disturbi relatati ma ’ separazzjoni f’ kombinazzjoni ma ’ tekniki maħsubin bil- għan li jimmodifikaw l- imġiba.
METHOD AND ROUTE OF ADMINISTRATION
METODU U MOD TA ’ AMMINISTRAZZJONI
For oral use.
Għal użu orali
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:
Clomicalm huwa amministrat darbtejn kuljum b’ doża ta ’ 1- 2mg/ kg clomipramine biex bħala total tingħata doża ta ’ 2- 4mg/ kg kuljum skond it- tabella li hawn taħt:
Clomicalm 5 mg
Piż Clomicalm 5 mg
1.25-2.5 kg > 2.5-5 kg
1. 25 - 2. 5 kg > 2. 5 - 5 kg
½ tablet 1 tablet
½ pillola Pillola waħda
Read the package leaflet before use.
Aqra l- fuljett tat- tagħrif fil- pakkett qabel l- użu.
WITHDRAWAL PERIOD
ŻMIEN TA ’ TIŻMIN
SPECIAL WARNINGS, IF NECESSARY
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
To be used under veterinary supervision.
Għandu jintuża taħt superviżjoni veterinarja.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif fil- pakkett qabel tuża ’.
EXP {month/ year}
JISKADI {xahar/ sena}
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TAL- PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal dan il- prodott mediċinali għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM “ GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA JEW L- UŻU jekk applikabbli
For animal treatment only – to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss – Għandu jingħata biss bi preskrizzjoni medika.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
Accidental ingestion should be regarded as serious.
Jekk jinbela ’ bi żball dan għandu jitqies bħala każ serju.
MARKETING AUTHORISATION NUMBER
NUMRI TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
12 Numru tal- lott:
Clomicalm 20 mg tablets for dogs
Clomicalm 20 mg pilloli għall- klieb
20 mg (equivalent to 17.9 mg Clomipramine)
20 mg (ekwivalenti għal 17. 9 mg Clomipramine)
Clomicalm 20 mg
Piż Clomicalm 5 mg
> 5-10 kg > 10-20 kg
1. 25 - 2. 5 kg > 2. 5 - 5 kg
Lot {number}
15 Numru tal- lott:
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Clomicalm 80 mg tablets for dogs
Clomicalm 80 mg pilloli għall- klieb
80 mg (equivalent to 71.7 mg Clomipramine)
80 mg (ekwivalenti għal 71. 7 mg Clomipramine)
METHOD AND ROUTES OF ADMINISTRATION
METODU U MOD TA ’ AMMINISTRAZZJONI
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:
Clomicalm huwa amministrat darbtejn kuljum b’ doża ta ’ 1- 2mg/ kg clomipramine biex bħala total tingħata doża ta ’ 2- 4mg/ kg kuljum skond it- tabella li hawn taħt:
Clomicalm 80 mg
Piż Clomicalm 5 mg
> 20-40 kg > 40-80 kg
1. 25 - 2. 5 kg > 2. 5 - 5 kg
½ 5 tablet 1 tablet
½ pillola Pillola waħda
MARKETING AUTHORISATION NUMBER(S)
NUMRI TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
Lot {number}
18 Numru tal- lott: